| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2829567 | 12 | M | WA | 03/04/2025 |
IPV |
SANOFI PASTEUR |
W1c741M |
Circumstance or information capable of leading to medication error, No adverse e...
Circumstance or information capable of leading to medication error, No adverse event
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No adverse reaction in patient. This was a vaccine error or suspected error. The IPOL is a 10 dose...
No adverse reaction in patient. This was a vaccine error or suspected error. The IPOL is a 10 dose vial and 11 doses were pulled from vial. According to system, the 11th dose is invalid. We had siblings vaccinated together and we are unsure of who actually received the 11th dose, so was told we needed to delete both, notify the parents and recommend re vaccination, in addition to creating this VAERS report. Parents were notified.
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| 2829568 | 47 | F | CT | 03/04/2025 |
COVID19 |
PFIZER\BIONTECH |
ER8732 |
Dizziness, Hypotension, Pruritus
Dizziness, Hypotension, Pruritus
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Itching all over that started within 1 hour of vaccination. Then for that day and the next I had ve...
Itching all over that started within 1 hour of vaccination. Then for that day and the next I had very low blood pressure and a feeling like I was going to pass out. The same thing happened with my Pfizer booster one month later. The itching and low blood pressure lasted almost 48 hours
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| 2829569 | PA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004085 |
Product storage error
Product storage error
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Four patients took two doses of not refrigerated Vivotif, reaching 70 degrees Fahrenheit for ten day...
Four patients took two doses of not refrigerated Vivotif, reaching 70 degrees Fahrenheit for ten days; Four patients took two doses of not refrigerated Vivotif, reaching 70 degrees Fahrenheit for ten days; Case reference number US-BN-2024-002913 is a spontaneous case initially received from pharmacist via Med Communications (reference number: USBAV24-3353) on 19-Dec-2024 and concerns a seven-year-old female patient, 10-year-old male patient, 11-year-old female patient and 14-year-old male patient. The patients medical history and concomitant medication details were not provided. On 16-Dec-2024, the patients took the first dose of Vivotif (batch number: 3004085) orally, at unknown dose, for typhoid immunisation. On 18-Dec-2024, two days after the first dose, the patients took the second dose of Vivotif (batch number: 3004085) orally, at unknown dose. Each patient took both doses while not refrigerated, maximum temperature was 70 Fahrenheits for ten days (explicitly coded as 'Product storage error' and 'Product administration error'). At the time of the initial report, it was unknown if the patients experienced any adverse events due to Vivotif. Additional information received from Med Communications on 19-Dec-2024 included additional reference numbers (USBAV24-3356, USBAV24-3357 and USBAV24-3359).; Reporter's Comments: This case report concerns a seven-year-old female patient, 10-year-old male patient, 11-year-old female patient and 14-year-old male patient. The patients took the first dose of Vivotif orally, at unknown dose, for typhoid immunisation and two days after the first dose, the patients took the second dose of Vivotif orally, at unknown dose. Each patient took both doses while not refrigerated, maximum temperature was 70 Fahrenheits for ten days which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Vivotif. The patients medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case report concerns a seven-year-old female patient, 10-year-old male patient, 11-year-old female patient and 14-year-old male patient. The patients took the first dose of Vivotif orally, at unknown dose, for typhoid immunisation and two days after the first dose, the patients took the second dose of Vivotif orally, at unknown dose. Each patient took both doses while not refrigerated, maximum temperature was 70 Fahrenheits for ten days which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Vivotif. The patients medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829570 | 51 | F | CA | 03/04/2025 |
FLU3 FLU3 HEP HEP IPV IPV MMR MMR PNC20 PNC20 TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5RE93 5RE93 945655 945655 X1C89IM X1C89IM Y003499 Y003499 LC5483 LC5483 CX4HL CX4HL |
Computerised tomogram head, Dysarthria, Dysphagia, Electrocardiogram, Facial par...
Computerised tomogram head, Dysarthria, Dysphagia, Electrocardiogram, Facial paralysis; Hypoaesthesia, Hypoaesthesia oral, Laboratory test, Lumbar puncture, Paraesthesia; Computerised tomogram head, Dysarthria, Dysphagia, Electrocardiogram, Facial paralysis; Hypoaesthesia, Hypoaesthesia oral, Laboratory test, Lumbar puncture, Paraesthesia; Computerised tomogram head, Dysarthria, Dysphagia, Electrocardiogram, Facial paralysis; Hypoaesthesia, Hypoaesthesia oral, Laboratory test, Lumbar puncture, Paraesthesia; Computerised tomogram head, Dysarthria, Dysphagia, Electrocardiogram, Facial paralysis; Hypoaesthesia, Hypoaesthesia oral, Laboratory test, Lumbar puncture, Paraesthesia; Computerised tomogram head, Dysarthria, Dysphagia, Electrocardiogram, Facial paralysis; Hypoaesthesia, Hypoaesthesia oral, Laboratory test, Lumbar puncture, Paraesthesia; Computerised tomogram head, Dysarthria, Dysphagia, Electrocardiogram, Facial paralysis; Hypoaesthesia, Hypoaesthesia oral, Laboratory test, Lumbar puncture, Paraesthesia
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Two weeks after vaccinations client developed tingling and numbness to the lower and upper extremiti...
Two weeks after vaccinations client developed tingling and numbness to the lower and upper extremities, numbness of tongue and right face paralysis, slurred speech and unable to swallow.
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| 2829571 | F | CA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Product administration error
Product administration error
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The patient ate after first and second dose of Vivotif, and did not wait an hour; Case reference num...
The patient ate after first and second dose of Vivotif, and did not wait an hour; Case reference number US-BN-2024-002918 is a spontaneous case initially received from physician via Med Communications (reference number: USBAV24-3321) on 17-Dec-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took the first dose on Vivotif (batch number: unknown), at a dose of one capsule, orally, for unknown indication. On unspecified date, unknown amount of time after the first dose, the patient took the second dose on Vivotif (batch number: unknown), at a dose of one capsule, orally. As reported, the patient ate after the first and second dose of Vivotif and did not wait an hour (explicitly coded as 'Product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unspecified age ate after the first and second dose of Vivotif and did not wait an hour, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error is considered as unlisted per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age ate after the first and second dose of Vivotif and did not wait an hour, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error is considered as unlisted per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2829572 | F | IA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient took second dose of Vivotif vaccine on day two instead on day three; Case reference numb...
The patient took second dose of Vivotif vaccine on day two instead on day three; Case reference number US-BN-2024-002925 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV24-3373) on 23-Dec-2024 and concerns a adult female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 21-Dec-2024, the patient received first dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route or site of administration for unknown indication. On 22-Dec-2024, one day after the first dose, the patient received second dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route or site of administration. (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: An adult female patient of unspecified age received second dose of Vivotif vaccine one day after the first dose, at an unknown dose, route or site of administration which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult female patient of unspecified age received second dose of Vivotif vaccine one day after the first dose, at an unknown dose, route or site of administration which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829573 | F | CA | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Incomplete course of vaccination
Incomplete course of vaccination
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The patient forgot to take the fourth dose of Vivotif and left town, the patient was due last dose a...
The patient forgot to take the fourth dose of Vivotif and left town, the patient was due last dose at the time of the report; Case reference number US-BN-2024-002930 is a spontaneous case initially received from nurse via Med Communication (reference number: USBAV24-3392) on 26-Dec-2024 and concerns adult female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 20-Dec-2024, the patient received first dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route or site of administration for unknown indication. On 22-Dec-2024, two days after the first dose, the patient received second dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route or site of administration. On 24-Dec-2024, four days after the first dose, the patient received third dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route or site of administration. The patient forgot to take the fourth dose of Vivotif and left town (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: An adult female patient of unspecified age forgot to take the fourth dose of Vivotif which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult female patient of unspecified age forgot to take the fourth dose of Vivotif which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829574 | M | CO | 03/04/2025 |
TYP |
BERNA BIOTECH, LTD. |
Unknown |
Inappropriate schedule of product administration, Product dose omission issue
Inappropriate schedule of product administration, Product dose omission issue
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The patient took the third dose of the Vivotif vaccine six days after the first dose, and the fourth...
The patient took the third dose of the Vivotif vaccine six days after the first dose, and the fourth dose eight days after the first dose.; Case reference number US-BN-2025-000001 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-3417) on 31-Dec-2024 and concerns a 74-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 21-Dec-2024, the patient took first dose of Vivotif (batch number: unknown), at unknown dose, orally for Typhoid immunization. On 23-Dec-2024, two days after first dose of Viviotif, the patient took second dose of Vivotif (batch number: unknown), at unknown dose, orally. On 27-Dec-2024, six days after first dose of Viviotif, the patient took third dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On 29-Dec-2024, eight days after first dose of Viviotif, the patient took fourth dose of Vivotif (batch number: unknown), at unknown dose, orally. As reported, the patient missed the middle dose and extended the last dose by another day (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from health care professional via Med Communications (reference number: USBAV24-3419) on 31-Dec-2024: Information included reference number, additional reporter and confirmation that the patient took Vivotif incorrectly.; Reporter's Comments: A 74-years-old male patient missed the middle dose and extended the last dose by another day which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 74-years-old male patient missed the middle dose and extended the last dose by another day which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829575 | M | MN | 03/04/2025 |
SMALLMNK |
BAVARIAN NORDIC |
Unknown |
Incorrect route of product administration
Incorrect route of product administration
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The patient received Jynneos in the muscle instead of under the skin; Case reference number US-BN-20...
The patient received Jynneos in the muscle instead of under the skin; Case reference number US-BN-2025-000157 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV25-0180) on 23-Jan-2025 and concerns a 57-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with a dose of Jynneos (batch number: unknown), at an unknown dose or site of administration in the muscle instead of under the skin for an unknown indication (explicitly coded as 'inappropriate route of vaccination'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination. No further information was provided.; Reporter's Comments: A 57-year-old male patient was vaccinated with a dose of Jynneos, at an unknown dose or site of administration in the muscle instead of under the skin for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 57-year-old male patient was vaccinated with a dose of Jynneos, at an unknown dose or site of administration in the muscle instead of under the skin for an unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829576 | 03/04/2025 |
SMALLMNK |
BAVARIAN NORDIC |
Unknown |
Product storage error
Product storage error
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The Jynneos vaccine was improperly stored in the refrigerator upon arrival; The patients were accide...
The Jynneos vaccine was improperly stored in the refrigerator upon arrival; The patients were accidentally received a dose of Jynneos vaccine after 4 week period which was improperly stored in the refrigerator; The patients were accidentally received a dose of Jynneos vaccine after 4 week period which was improperly stored in the refrigerator; Case reference number US-BN-2025-000169 is a spontaneous case report initially received from pharmacist via Med Communications (reference number: USBAV25-0207) on 28-Jan-2025 and concerns five patients of unspecified age and gender (Multi 5). The patient's medical history and concomitant medication details were not provided. On unspecified date in Sep-2024, the pharmacy received a shipment of Jynneos (NDC: 50632-0001-03). On an unknown date, upon arrival, the vaccine was improperly stored in the refrigerator (explicitly coded as 'product storage error'). On an unspecified date, the five patients accidentally received improperly stored Jynneos vaccines after 4 week period (batch number: unknown) at unknown dose, route or site administration for unknown indication (explicitly coded as 'product administration error' and 'expired vaccine used'). At the time of the initial report, it was unknown if the patients experienced any adverse event due to Jynneos vaccine. Additional information received from pharmacist on 29-Jan-2025 included: confirmed that five patients received improperly stored Jynneos vaccine.; Reporter's Comments: This case concerns five patients of unspecified age and gender who accidentally received improperly stored Jynneos vaccines after 4 week period at unknown dose, route or site administration for unknown indication which is considered as product administration error and expired vaccine used. Reportedly, the vaccine was improperly stored in the refrigerator which is considered as product storage error. Product storage error, product administration error and expired product administered are all considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and expired product administered are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case concerns five patients of unspecified age and gender who accidentally received improperly stored Jynneos vaccines after 4 week period at unknown dose, route or site administration for unknown indication which is considered as product administration error and expired vaccine used. Reportedly, the vaccine was improperly stored in the refrigerator which is considered as product storage error. Product storage error, product administration error and expired product administered are all considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse event due to Jynneos vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and expired product administered are all assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2829577 | 03/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise, Pneumonia
Malaise, Pneumonia
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Pneumonia/ sick; This serious case was reported by a consumer via interactive digital media and desc...
Pneumonia/ sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pneumonia (Verbatim: Pneumonia/ sick) (serious criteria GSK medically significant). The outcome of the pneumonia was not resolved. It was unknown if the reporter considered the pneumonia to be related to Shingles vaccine. The company considered the pneumonia to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 25-FEB-2025 This case was reported by a patient via interactive digital media. Patient took the vaccine for shingles. Patient was not sure if he/she should have had the vaccine. Patient said he/she had no clue what they had put in the body. Patient was currently sick for the 2nd time in two months. Patient had pneumonia right now for almost 3 weeks. The follow-up could not be possible as no contact details were available.; Sender's Comments: Pneumonia is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
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| 2829578 | 03/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pain, Swelling
Pain, Swelling
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Pain; swelling; This non-serious case was reported by a consumer via call center representative and ...
Pain; swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included mucinous breast carcinoma. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: Pain) and swelling (Verbatim: swelling). The outcome of the pain and swelling were not reported. It was unknown if the reporter considered the pain and swelling to be related to Shingrix. It was unknown if the company considered the pain and swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 21-FEB-2025 The reporter reported a chatbot conversation in which the patient reported that he/she was currently being treated for mucinous carcinoma of the breast. Patient had his first Shingrix shot the day before his/her biopsy. Patient asked that could he/she take Shingrix while being treated for mucinous carcinoma. Also, had the first shot and experienced pain, swelling.
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| 2829579 | 03/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Arthralgia, Feeling abnormal, Feeling cold, Pain
Arthralgia, Feeling abnormal, Feeling cold, Pain
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very painful/body painful; all the join hurt; chilly; feeling very very bad; This non-serious case w...
very painful/body painful; all the join hurt; chilly; feeling very very bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: very painful/body painful), joint pain (Verbatim: all the join hurt), chilliness (Verbatim: chilly) and feeling bad (Verbatim: feeling very very bad). The outcome of the general body pain, joint pain, chilliness and feeling bad were not reported. It was unknown if the reporter considered the general body pain, joint pain, chilliness and feeling bad to be related to Shingles vaccine. It was unknown if the company considered the general body pain, joint pain, chilliness and feeling bad to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that the vaccine was very very painful. Patient had 2nd dose It notch patient down. The night got vaccine all his/her body painful, all the join hurt, chilly. Patient was feeling very very bad. He/she just over 50 athletic healthy and active.
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| 2829580 | 03/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Headache, Pain
Headache, Pain
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headache; body aches; This non-serious case was reported by a consumer via interactive digital media...
headache; body aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (patient got shingles during covid). Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose on unknown date, no reaction to first shot). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: headache) and general body pain (Verbatim: body aches). The outcome of the headache and general body pain were not reported. It was unknown if the reporter considered the headache and general body pain to be related to Shingles vaccine. It was unknown if the company considered the headache and general body pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 24-FEB-2025 This case was reported by a patient via interactive digital media. Patient got the vaccine, no reaction to first shot, second one he/she had minor headache and body aches. Patient got shingles during covid, he/she got the vaccine two years later, insurance did not cover until he/she turned 60. Patient indicated to get the shot shingles because it was awful. The follow-up could not be possible as no contact details were available.
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| 2829581 | F | 03/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactiv...
Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-FEB-2025 This case was reported by patient's husband via interactive digital media.. The patient had the Shingles shot and still got them. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2829582 | 03/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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shingles very badly even after receiving the vaccine/ suspected vaccination failure; shingles very b...
shingles very badly even after receiving the vaccine/ suspected vaccination failure; shingles very badly; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shingles very badly even after receiving the vaccine/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles very badly). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 25-FEB-2025 This case was reported by a patient via interactive digital media. The reporter's friend had the shingles very badly even after receiving the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2829583 | 03/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 20-FEB-2025 This case was reported by a patient via interactive digital media. Patient had the Shingles vaccine, but he/she had shingles bad twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2829584 | 03/04/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Cough, Malaise, Nasopharyngitis
Cough, Malaise, Nasopharyngitis
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Cough; cold symptoms; This non-serious case was reported by a consumer via interactive digital media...
Cough; cold symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In DEC-2024, the patient received RSV vaccine. On 27-JAN-2025, between 1 and 2 months after receiving RSV vaccine, the patient experienced cough (Verbatim: Cough) and cold symptoms (Verbatim: cold symptoms). The patient was treated with prednisone. The outcome of the cough and cold symptoms were resolving. It was unknown if the reporter considered the cough and cold symptoms to be related to RSV vaccine. It was unknown if the company considered the cough and cold symptoms to be related to RSV vaccine. Additional Information: GSK Receipt Date: 24-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the RSV shot in December. On January 27th, he/she had a terrible cough and cold symptoms. The patient had scheduled appointment with his/her physician on that day. The physician prescribed antibiotics and something for the cough. One week in and patient was still sick, so the physician sent him/her a prednisone pack. Three weeks later the patient was just getting better. The patient was thanking his/her physician. The patient further stated, he/she could not remember when he/she was that sick.
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| 2829585 | VA | 03/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Fatigue, Myalgia, Pyrexia
Fatigue, Myalgia, Pyrexia
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Fever; Tiredness; Muscle pain; This non-serious case was reported by a nurse via call center represe...
Fever; Tiredness; Muscle pain; This non-serious case was reported by a nurse via call center representative and described the occurrence of fever in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Fever), tiredness (Verbatim: Tiredness) and muscle pain (Verbatim: Muscle pain). The outcome of the fever, tiredness and muscle pain were unknown. It was unknown if the reporter considered the fever, tiredness and muscle pain to be related to Shingrix. It was unknown if the company considered the fever, tiredness and muscle pain to be related to Shingrix. Additional Information: GSK Receipt Date: 12-FEB-2025 The registered nurse mentioned during the call as an example that his mother felt muscle pain, tiredness and fever after receiving Shingrix, and that 95% of their patients are usually feeling similar symptoms after a Shingrix dose. The reporter did not have lot number for the vaccine and refused to provide any additional details about this case.; Sender's Comments: US-GSK-US2025018347:same reporter
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| 2829586 | F | TN | 03/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Rash, Vaccination failure
Herpes zoster, Rash, Vaccination failure
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Suspeceted vaccination failure; Shingles; This serious case was reported by a physician via sales re...
Suspeceted vaccination failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 25-FEB-2025 and 28-FEB-2025 The patient had been vaccinated with Shingrix and still developed a mild case of shingles with a small area of rash. The physician felt as if the Shingrix had prevented the patient case of shingles from being more severe. The reported felt that the patient's case of shingles would have been much worse if the patient had not previously been vaccinated with Shingrix. This case was considered as suspected vaccination failure as completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
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| 2829587 | 03/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Blister, Herpes zoster, Pain, Scar, Vaccination failure
Blister, Herpes zoster, Pain, Scar, Vaccination failure
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Suspected vaccination failure; Shingles; Scars; This serious case was reported by a consumer via int...
Suspected vaccination failure; Shingles; Scars; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and scar (Verbatim: Scars). The outcome of the vaccination failure and shingles were not reported and the outcome of the scar was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and scar to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and scar to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-FEB-2025 This case was reported by a patient via interactive digital media. The patient had been vaccinated three years before he/she got shingles, was not diagnosed by medical people for five days because it could not be shingles. The patient had excruciating pain, the blisters was awful. The patient still had the scars. When the patient asked if he/she should get vaccinated again they said no, only once was necessary and further he/she stated you were susceptible to getting shingles again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2829588 | 03/04/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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suspected vaccination failuer; shingles; This serious case was reported by a consumer via interactiv...
suspected vaccination failuer; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failuer) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 25-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the two shingles vaccines and had shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine dose 1 and Shingles vaccine dose 2.
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| 2829589 | F | CA | 03/04/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
4LM54 |
Extra dose administered
Extra dose administered
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received a 2nd Flulaval during the same flu season; This non-serious case was reported by a nurse vi...
received a 2nd Flulaval during the same flu season; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 4LM54, expiry date 30-JUN-2025) for prophylaxis. Previously administered products included Flulaval (received 1st dose on an unknown date). On 07-FEB-2025, the patient received the 2nd dose of FluLaval 2024-2025 season. On 07-FEB-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: received a 2nd Flulaval during the same flu season). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-FEB-2025 The register nurse called and reported that so they had one of our adult patients, received a 2nd Flulaval during the same flu season, so they were wondering what were the typical adverse reactions that could occurred just they could notify the patient which led to extra dose administered. The vaccine administration facility was the same as primary reporter.
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| 2829590 | 74 | F | CA | 03/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7349L |
Product storage error
Product storage error
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placed in the refrigerator on Friday at 3pm then administere to pateint today at 10am.; This non-ser...
placed in the refrigerator on Friday at 3pm then administere to pateint today at 10am.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 7349L, expiry date 25-MAR-2027) for prophylaxis. On 24-FEB-2025 10:00, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: placed in the refrigerator on Friday at 3pm then administere to pateint today at 10am.). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 24-FEB-2025 The reporter reported that patient received shingrix which was prepared, reconstituted and withdrawn into syringe which was placed in the refrigerator on Friday at 3 pm then administered to patient on the day of reporting at 10 am, which led to incorrect storage of drug.
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| 2829591 | 19 | F | NY | 03/04/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS PFIZER\WYETH |
5YP3L |
Interchange of vaccine products; Interchange of vaccine products
Interchange of vaccine products; Interchange of vaccine products
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Interchangeability; This non-serious case was reported by a nurse via call center representative and...
Interchangeability; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number 5YP3L, expiry date 31-JAN-2026) for prophylaxis. Co-suspect products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba) for prophylaxis. Previously administered products included Menactra (received 1st dose on 03-AUG-2016) and Menactra (received 2nd dose on 16-NOV-2021). On 12-FEB-2025, the patient received Bexsero. On 23-AUG-2022, the patient received Trumenba. On 12-FEB-2025, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: Interchangeability). The outcome of the interchange of vaccine products was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-FEB-2025 The nurse reported that a patient received in the past 2 Menactra doses on August 3rd 2016 and November 16th 2021, and 1 dose of Trumenba on August 23rd 2022, and on February 12th 2025 they received a Bexsero vaccine, which led to interchange of vaccine products. Only Bexsero was given at their facility.
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| 2829592 | GA | 03/04/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Incorrect route of product administration
Incorrect route of product administration
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in the muscle in the upper arm instead of the subcutaneous area; This non-serious case was reported ...
in the muscle in the upper arm instead of the subcutaneous area; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: in the muscle in the upper arm instead of the subcutaneous area). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-FEB-2025 The pharmacist reported that a patient mentioned they got the new Measles, Mumps, and Rubella Vaccine in the muscle in the upper arm instead of the subcutaneous area which led to subcutaneous injection formulation administered by other route. The patient mentioned that vaccine comes in a vial with a syringe, but they were not sure of the brand name and did not provide a lot number. The pharmacist enquired if it was Priorix, the patient said that probably that was the one they got.
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| 2829593 | 56 | M | 03/04/2025 |
CHIK |
VALNEVA USA, INC. |
24B011 |
Headache, Injection site pain, Malaise, Musculoskeletal pain
Headache, Injection site pain, Malaise, Musculoskeletal pain
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Severe musculoskeletal pain; Mild headache; Mild malaise; Injection site tenderness both application...
Severe musculoskeletal pain; Mild headache; Mild malaise; Injection site tenderness both application sites; The following information was received from a physician on 02 Dec 2024. A 56-year-old male received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number 24B011) i.m. on 25 Nov 2025 into the right deltoid muscle. Co-suspect vaccinations included COMIRNATY (COVID-19 vaccine) and FLUCELVAX TRIVAL (Influenza vaccine) on the same day, both into the left deltoid muscle. Ten days before he received one dose of Typhim Vi (Typhoid vaccine) and Adacel (Tetanus, Diphtheria and Pertussis vacccine) with mild to moderate injection site pain. Three weeks before administration of IXCHIQ he had a mild cold. Past drug history included seven vaccinations against COVID, annually vaccination against Influenza (for the last 10 years), vaccination against MMR, TDPA, Hepatitis A and B. Adverse reactions were limited to injection site pain and one or two occasions of flu-like symptoms. On 25-Nov-2024 he developed injection site tenderness at both injection sites. On 28 Nov 2025 he experienced moderate musculoskeletal pain of an overall dull but somewhat burning character. At the same time, there he noted an increase in injection site pain for IXCHIQ. It was most pronounced between shoulder blades and on the proximal limbs (here most noticeable on the upper back of the thighs when sitting), but also on the distal upper limbs. There was no arthralgia. The pain persisted at rest but allowed to sleep before it escalated to severe during the day, preventing daily activties. Additional symptoms included mild malaise and mild headache; the latter was worsened by shaking the head. There was no fever or other systemic symptom. The adverse reactions were left untreated, decreased to moderate during 29 Nov 2024 and resolved on 30 Nov 2024.; Reporter's Comments: This spontaneous case was reported by a consumer / pharmacovigilance expert and describes the occurrence of severe musculoskeletal pain as well as mild headache, fatigue and injection site tenderness in a 56 year-old male who was vaccinated with IXCHIQ (Lot no., 24B011) against Chikungunya virus infection. Co-suspect products included COMIRNATY 0.5mL (2024-2025 formula, LOT no. LN0588) for Covid 19 vaccination and FLUCELVAX TRIVAL 2024-2025 (LOT no. 391416) for Influenza vaccination. The consumer had no relevant medical history, a mild cold had resolved three weeks before IXCHIQ application, and there were no concurrent conditions or concomitant drugs. Previously used drugs included numerous vaccintions against COVID (x7), Influenza (annually for last 10 years), MMR, TDAP, Hepatitis A and B. In the vast majority of these vaccine applications, adverse reactions were limited to injection site pain with only one or two occasions of flu-like symptoms. Ten days prior to IXCHIQ vaccination the patient had addtionally received vaccines against Typhoid (Typhim Vi, Lot no. unknown), as well as against Tetanus, Diphtheria and Pertussis (Adacel, Lot X2A421M) with mild to moderate injection on site pain as the only adverse drug reactions. On 25-NOV-2024 at 8:10am, the consumer was injected with IXCHIQ 0.5 mL, into the right deltoid muscle. Within 30 minutes COMIRNATY and FLUCELVAX were injected, both into the left deltoid muscle. Injection site tenderness was very mild at the IXCHIQ application site for the next 2 days. The tenderness, was moderate at the other vaccine injection sites on 26-NOV-2024 but had almost resolved at the time of below events. Between midnight and 3am on 28-NOV-2024, after a day and evening of desk work and while sitting at the desk, the consumer developed moderate musculoskeletal pain of an overall dull but somewhat burning character. At the same time, there he noted an increase in injection site pain for IXCHIQ. It was most pronounced between shoulder blades and on the proximal limbs (here most noticeable on the upper back of the thighs when sitting), but also on the distal upper limbs. There was no arthralgia. The pain persisted at rest but allowed to sleep before it escalated to severe during the day, preventing daily activties. Additional symptoms included mild malaise and mild headache; the latter was worsened by shaking the head. There was no fever or other systemic symptom. The adverse reactions were left untreated, decreased to moderate during 29-NOV-2024 and resolved on 30-NOV-2024. The reporter commented: Due to the identical temporal relationship and risk profile, all three vaccines are potentially to blame, however severe myalgia has been identified particularly as a common adverse reactition to IXCHIQ vaccine. Given my usually mild reactions to past vaccinations for influenza and COVID, which tended to occur within 24h of injection, as well as the impression of a delayed increase of injection site pain at the IXCHIQ injection site, I would assess IXCHIQ to be probably related, with COMIRNATY and FLUCELVAX as less likely alternative explanations. Outcome: Recovered; Sender's Comments: Causality assessed as possibly related for all reported events, as time to onset is plausible (within 3 days past vaccination) and as they are all well known for IXCHIQ directly or by medical concept, indicative of a local vaccination site reaction for the injection site tenderness and Injection site pain and indicative of a systemic vaccination reaction for Musculoskeletal pain, Malaise and Headache However, co-suspect vaccinations with Comirnaty and Flucelvax Trival on the same day should be taken into consideration, too.
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| 2829594 | F | MI | 03/04/2025 |
COVID19 |
MODERNA |
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Immunisation reaction, Post-acute COVID-19 syndrome, Weight decreased, Weight in...
Immunisation reaction, Post-acute COVID-19 syndrome, Weight decreased, Weight increased
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she had "26 side effects"; Patient had the "long covid" and continued to get cov...
she had "26 side effects"; Patient had the "long covid" and continued to get covid and said that has been going on 5 years/had COVID multiple times; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (Patient had the "long covid" and continued to get covid and said that has been going on 5 years/had COVID multiple times) and IMMUNISATION REACTION (she had "26 side effects") in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. In 2020, the patient experienced POST-ACUTE COVID-19 SYNDROME (Patient had the "long covid" and continued to get covid and said that has been going on 5 years/had COVID multiple times). On an unknown date, the patient experienced IMMUNISATION REACTION (she had "26 side effects"). At the time of the report, POST-ACUTE COVID-19 SYNDROME (Patient had the "long covid" and continued to get covid and said that has been going on 5 years/had COVID multiple times) and IMMUNISATION REACTION (she had "26 side effects") had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: went down to 100 lbs. On an unknown date, Weight increased: gained 5 lbs in 5 years. No concomitant medication was reported. Caller stated she had 5 shots. She said she got COVID back in 2020 when COVID hit, she got it really bad and it continued and continued. Then she had the long covid and she continued to get covid and said that had been going on 5 years. She verified she had had 5 COVID vaccines but had COVID multiple times. She had seen her doctor, but he had not helped according to her. She reiterated that she has been really sick, in the bed and she has missed her birthday New Year's Eve. No treatment information was reported.
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| 2829595 | F | 03/04/2025 |
PNC13 |
PFIZER\WYETH |
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Drug ineffective, Pneumonia
Drug ineffective, Pneumonia
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Has pneumonia; Has pneumonia; This is a spontaneous report received from a Pharmacist from medical i...
Has pneumonia; Has pneumonia; This is a spontaneous report received from a Pharmacist from medical information team. An 88-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2015 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX), in 2016 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "Has pneumonia". The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of efficacy (Pneumonia) with PREVNAR 13 can not be fully excluded.
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| 2829596 | F | 03/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cerebrovascular accident, Thrombosis
Cerebrovascular accident, Thrombosis
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stroke; Clot; This is a spontaneous report received from a Consumer or other non HCP from a sales re...
stroke; Clot; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An elderly female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), 10 days after the suspect product(s) administration, outcome "unknown", described as "stroke"; THROMBOSIS (medically significant), 10 days after the suspect product(s) administration, outcome "unknown", described as "Clot". It was unknown if therapeutic measures were taken as a result of cerebrovascular accident, thrombosis. Clinical course: an infection preventionist in a nursing home said that one her residents received Comminarty and 10 days later she had a clot and a stroke. The events were reported as non-serious. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2829597 | F | AR | 03/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Reaction to excipient
Reaction to excipient
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reaction to the vaccine/was likely due to the polyethylene glycol; This is a spontaneous report rece...
reaction to the vaccine/was likely due to the polyethylene glycol; This is a spontaneous report received from a Physician. A female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "reaction to the vaccine/was likely due to the polyethylene glycol". It was unknown if therapeutic measures were taken as a result of reaction to excipient. Additional information: The patient was described as having a reaction to the vaccine, however, the reaction and its severity were not described. The physician believed reaction was likely due to the polyethylene glycol. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2829598 | 73 | M | VT | 03/04/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1780 |
Parosmia
Parosmia
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Olfactory issue. Breathing in odor/having a smelling issue. When patient breathe in with nose, patie...
Olfactory issue. Breathing in odor/having a smelling issue. When patient breathe in with nose, patient smell something different and there is no outside influences. Right it is olfactory issues; This is a spontaneous report and received from Consumer or other non HCPs. A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Feb2025 at 15:00 as dose 1, single (Lot number: LP1780) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypersensitivity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAROSMIA (non-serious) with onset 28Feb2025 at 16:00, outcome "not recovered", described as "Olfactory issue. Breathing in odor/having a smelling issue. When patient breathe in with nose, patient smell something different and there is no outside influences. Right it is olfactory issues". Therapeutic measures were not taken as a result of parosmia. Additional information: Facility vaccine was administered from pharmacy or drug store. Patient was not receive any other vaccines within 4 weeks PRIOR to the vaccine. Patient was not taking any other medications within 2 weeks of the event starting. Reported Event Olfactory issue. Breathing in I notice an odor. Patient stated, having a smelling issue. When patient breathe in with nose, patient smell something different and there is no outside influences. Right, it is olfactory issues, smelling.
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| 2829599 | 38 | M | IL | 03/04/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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COVID-19, Drug ineffective; Cardiac disorder, Confusional state, Headache, Illne...
COVID-19, Drug ineffective; Cardiac disorder, Confusional state, Headache, Illness, Memory impairment; COVID-19, Drug ineffective; Cardiac disorder, Confusional state, Headache, Illness, Memory impairment
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had COVID; had COVID; This is a spontaneous report received from a Consumer or other non HCP. A 41-...
had COVID; had COVID; This is a spontaneous report received from a Consumer or other non HCP. A 41-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunization. The anatomical location of the vaccine was reported as "left". patient's relevant medical history included: "Covid" (unspecified if ongoing); "flu" (unspecified if ongoing). The patient reported that he was very healthy actually, very healthy. There were no concomitant medications. The patient was not taking any medications. The patient did not receive any other vaccines on the same date as BNT162B2 as he did not take flu vaccines, because he did not get the flu, that is just what he was, very healthy like that. If he did get the flu, it did not bother his immune system, it did not "touch" the patient. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had COVID". The event "had covid" required physician office visit and emergency room visit. The patient received the vaccine to protect him and save the world, he will not be putting other people at risk and he was doing a real good thing. The patient stated, "I do not know, they gave me one dose and then they said you gotta take two shots. We cannot do it in one. So that second shot made me definitely ill. They made me extremely. I had to go to the emergency room. I though I broke my back. I was vomiting everywhere. I had a fever, headache and very, very serious situation and that was from your 2nd shot. They said I had COVID. I already had COVID and that was not like any different COVID and if I already had COVID, it did not bother me. The first time I had it, did not need the vaccine. The vaccine did this, it was the vaccine's interaction with the COVID. I really do not know and I really do not care because I got a vaccine so I would not get covered in the first place. So I do not know how I got the vaccine and then 2 weeks later I had COVID and I am in the emergency room for it. That just does not make any sense. I think it was a centered around the vaccine itself." The patient did not underwent any investigations. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500047620 same patient/vaccine, different dose /event;
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| 2829600 | F | IN | 03/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Breast inflammation
Breast inflammation
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almost lose my breast due to inflammation; This is a spontaneous report received from a Consumer or ...
almost lose my breast due to inflammation; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST INFLAMMATION (medically significant), outcome "unknown", described as "almost lose my breast due to inflammation". The patient stated that the vaccination caused her to almost lose breast due to inflammation. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2829625 | 6 | F | ID | 03/04/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
34MF9 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received Kinrix 1-28-25 (Dtap dose #5, IPV dose #4) as due. Returned for another vaccine 2-1...
Patient received Kinrix 1-28-25 (Dtap dose #5, IPV dose #4) as due. Returned for another vaccine 2-19-2025 and received MMR and another dose of KINRIX . No signs or symptoms- NO issues. Vaccine error where 6 year old got an extra dose of Dtap and IPV. It does not effect the schedule and child is up to date on vaccines.
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| 2829626 | 52 | F | NJ | 03/04/2025 |
FLU3 |
SANOFI PASTEUR |
UT8459MA |
Hypoaesthesia, Injection site pain, Mobility decreased
Hypoaesthesia, Injection site pain, Mobility decreased
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Patient states she has problems with Shoulder rotation. Soreness around injection site. Numbness on...
Patient states she has problems with Shoulder rotation. Soreness around injection site. Numbness on left thigh . When hands are in water or wet the is numbness of fingertips .
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| 2829627 | 64 | F | CA | 03/04/2025 |
PNC21 |
MERCK & CO. INC. |
Y011819 |
Arthralgia, Injection site erythema, Injection site pain, Neck pain, Pain
Arthralgia, Injection site erythema, Injection site pain, Neck pain, Pain
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REDNESS TO INJECTION AREA WITH PAIN RADIATING TO SHOULDER AND NECK, THAT BEEN ON GOING SINCE INJECTI...
REDNESS TO INJECTION AREA WITH PAIN RADIATING TO SHOULDER AND NECK, THAT BEEN ON GOING SINCE INJECTION DATE. AND ITS BEEN 5 DAYS.
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| 2829628 | 63 | M | NY | 03/04/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
4ds4n |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient has completed Heplisav B series of 2 in 2023, however, RPH didn't notice and has given...
Patient has completed Heplisav B series of 2 in 2023, however, RPH didn't notice and has given #1 Twinrix. This was discovered when pt came back for #2 dose. No issue occurred.
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| 2829629 | 66 | F | TX | 03/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7GH33 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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pt received a 3rd dose of shingrix when only 2 needed - no adverse effects reported by pt
pt received a 3rd dose of shingrix when only 2 needed - no adverse effects reported by pt
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| 2829630 | 82 | M | FL | 03/04/2025 |
PNC20 TDAP |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Patient received dose of Prevnar 20 on 04/29/2024 and also on 02/27/2025
Patient received dose of Prevnar 20 on 04/29/2024 and also on 02/27/2025
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| 2829631 | 63 | F | AL | 03/04/2025 |
PNC20 |
PFIZER\WYETH |
LJ5284 |
Erythema, Extra dose administered, Pain in extremity
Erythema, Extra dose administered, Pain in extremity
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PCV20 was given twice to patient. Once on 2/11/24 and again on 2/28/25. Patient experience no abnorm...
PCV20 was given twice to patient. Once on 2/11/24 and again on 2/28/25. Patient experience no abnormal adverse reaction, besides a sore arm and some redness. Patient did also receive a COVID booster in the same arm at the same time.
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| 2829632 | 50 | M | AZ | 03/04/2025 |
HEPAB MMR |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
324BY Y004117 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Patient came in to pharmacy and showed a couple of immunization forms that patient told our technici...
Patient came in to pharmacy and showed a couple of immunization forms that patient told our technicians, that the Health Clinic did not have the HepA/B vaccine and told to come to our pharmacy. After the patient received his immunization he pulled out a yellow immunization record card stating he just received the Twinrix. The pharmacy then contacted the health clinic and there was miscommunication between them and the patient and did not receive the MMR. So the patient received 2 doses of Twinrix the same day.
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| 2829633 | 45 | M | WA | 03/04/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2412 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No adverse events. but patient got the first flu shot in august last year. he is not supposed to rec...
No adverse events. but patient got the first flu shot in august last year. he is not supposed to receive the second dose.
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| 2828977 | 61 | F | 03/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Arthralgia, Injection site pain, Pain, Product administered at inappropriate sit...
Arthralgia, Injection site pain, Pain, Product administered at inappropriate site, Wrong technique in product usage process
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even hurts where the injection was made.; Pain and soreness in my shoulder; but also double injected...
even hurts where the injection was made.; Pain and soreness in my shoulder; but also double injected my arm/ did not administered the vaccine properly; did not administered the vaccine properly/ worng spot; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 27-MAR-2024, the patient received the 1st dose of Shingles vaccine. On 27-MAR-2024, less than a day after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: even hurts where the injection was made.), shoulder pain (Verbatim: Pain and soreness in my shoulder), wrong technique in product usage process (Verbatim: but also double injected my arm/ did not administered the vaccine properly) and vaccine administered at inappropriate site (Verbatim: did not administered the vaccine properly/ worng spot). Shingles vaccine was discontinued. The outcome of the injection site pain and shoulder pain were not resolved and the outcome of the wrong technique in product usage process and vaccine administered at inappropriate site were not applicable. It was unknown if the reporter considered the injection site pain and shoulder pain to be related to Shingles vaccine. It was unknown if the company considered the injection site pain and shoulder pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-FEB-2025 The patient 's shoulder constantly ached and was sometimes very sore or even hurts where the injection was made. It sometimes radiated into joint. The patient didn't have this type of ongoing ache, pain and soreness in my shoulder in that exact spot before the vaccination. The nurse practitioner did not administered the vaccine properly and not only in the worng spot but also double injected her arm, which led to wrong technique in product usage process and vaccine administered at inappropriate site. The patient did not go back to get the second dose. The patient didn't need additional injury for a second dose of vaccine. The patient could not get in touch to report this medical event or get in touch with the actual location to report to them. This needs to be corrected. There would be no more vaccines for the patient.
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| 2828978 | 66 | M | FL | 03/03/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Product use in unapproved indication, Vaccination failure; Herpes...
Herpes zoster, Product use in unapproved indication, Vaccination failure; Herpes zoster, Product use in unapproved indication, Vaccination failure
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Shingles; Shingles; Suspected vaccination failure; Shingles; had active shingles at the time of the ...
Shingles; Shingles; Suspected vaccination failure; Shingles; had active shingles at the time of the vaccination; This serious case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypercholesterolemia, sinusitis, hypertension and shingles (had active shingles at the time of the 1st vaccination). Concomitant products included atorvastatin calcium (Lipitor), montelukast sodium (Singulair) and lisinopril. In JUL-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, the patient received Shingrix (intramuscular). In MAR-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: had active shingles at the time of the vaccination). In MAR-2024, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). In SEP-2024, the patient experienced shingles (Verbatim: Shingles). In DEC-2024, the patient experienced shingles (Verbatim: Shingles). The outcome of the vaccination failure was not resolved and the outcome of the shingles, shingles and shingles were resolved and the outcome of the drug use for unapproved indication was not applicable. It was unknown if the reporter considered the vaccination failure, shingles, shingles and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure, shingles, shingles and shingles to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 19-FEB-2025 The patient self-reported this case for himself. The patient stated that he received the two doses of Shingrix vaccine. The patient stated that he received his first Shingrix dose and had active shingles at the time of the vaccination which led to drug use in unapproved indication. The patient had experienced 4 shingles outbreaks. In March 2024, between 8 and 9 months after 2nd dose and between 1 and 2 years after 1st dose, the patient had shingles. In September 2024 and December 2024, between 1 and 2 years after 1st and 2nd dose, the patient had two more shingles. This case was considered as suspected vaccination failure laboratory confirmation regarding shingles was unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2828979 | 11 | M | FL | 03/03/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVB056A |
Product preparation issue
Product preparation issue
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Inappropriate reconstitution technique; received only the liquid conjugate; This non-serious case wa...
Inappropriate reconstitution technique; received only the liquid conjugate; This non-serious case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB056A, expiry date 31-AUG-2025) for prophylaxis. On 20-FEB-2025, the patient received Menveo (intramuscular) .5 ml. On 20-FEB-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate reconstitution technique) and inappropriate dose of vaccine administered (Verbatim: received only the liquid conjugate). On 20-FEB-2025, the outcome of the inappropriate preparation of medication was not applicable. The outcome of the inappropriate dose of vaccine administered was not applicable. Additional Information: GSK Receipt Date: 20-FEB-2025 The patient received only the liquid conjugate component of Menveo, and the liquid conjugate vial was not combined with the lyophilized conjugate component of Menveo, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The location of administration of the vaccine was unknown.
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| 2828980 | 03/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Chills, Erythema, Limb mass, Pain in extremity
Chills, Erythema, Limb mass, Pain in extremity
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red painful lump on their arm; red painful lump; painful lump; chilled; couldn't function for t...
red painful lump on their arm; red painful lump; painful lump; chilled; couldn't function for the rest of the day; This non-serious case was reported by a consumer and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 05-FEB-2025, the patient received Shingrix. On 05-FEB-2025, 4 hrs after receiving Shingrix, the patient experienced activities of daily living impaired (Verbatim: couldn't function for the rest of the day). On 06-FEB-2025, the patient experienced erythema (Verbatim: red painful lump on their arm), local swelling (Verbatim: red painful lump), pain (Verbatim: painful lump) and chills (Verbatim: chilled). The outcome of the erythema, local swelling, pain and activities of daily living impaired were not resolved and the outcome of the chills was not reported. It was unknown if the reporter considered the erythema, local swelling, pain, chills and activities of daily living impaired to be related to Shingrix. It was unknown if the company considered the erythema, local swelling, pain, chills and activities of daily living impaired to be related to Shingrix. Additional Information: GSK Receipt Date: 07-FEB-2025 The patient received the Shingrix vaccine and after 4 hours, could not function for the rest of the day. The patient had a chilled, red painful lump on their arm.
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| 2828981 | 03/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Diarrhoea
Diarrhoea
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took arexvy and it gave Diarrhea; This non-serious case was reported by a consumer via interactive d...
took arexvy and it gave Diarrhea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of diarrhea in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced diarrhea (Verbatim: took arexvy and it gave Diarrhea). The outcome of the diarrhea was not reported. It was unknown if the reporter considered the diarrhea to be related to Arexvy. It was unknown if the company considered the diarrhea to be related to Arexvy. Additional Information: GSK Receipt Date: 19-FEB-2025 The patient received Arexvy and had diarrhea.
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| 2828982 | KY | 03/03/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Choking, Cyanosis
Choking, Cyanosis
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Baby chocked; Turned blue; This serious case was reported by a nurse via sales rep and described the...
Baby chocked; Turned blue; This serious case was reported by a nurse via sales rep and described the occurrence of choking in a patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced choking (Verbatim: Baby chocked) (serious criteria GSK medically significant) and cyanosis (Verbatim: Turned blue). The outcome of the choking and cyanosis were not reported. It was unknown if the reporter considered the choking and cyanosis to be related to Rotavirus vaccine and Rotarix Unspecified Oral Administation Device. The company considered the choking and cyanosis to be unrelated to Rotavirus vaccine and Rotarix Unspecified Oral Administation Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-FEB-2025 The nurse gave Rotatix to the patient The patient chocked and turned blue.; Sender's Comments: Choking and Cyanosis are unlisted events which are considered unrelated to GSK vaccine Rotavirus vaccine and Rotarix UNSPECIFIED ORAL ADMINISTATION DEVICE.
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| 2828983 | 03/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Influenza like illness
Influenza like illness
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I felt like I had the flu for 4 days after my 1st shingles vaccine; This non-serious case was report...
I felt like I had the flu for 4 days after my 1st shingles vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza (Verbatim: I felt like I had the flu for 4 days after my 1st shingles vaccine). The outcome of the influenza was resolved (duration 4 days). It was unknown if the reporter considered the influenza to be related to Shingles vaccine. It was unknown if the company considered the influenza to be related to Shingles vaccine. Additional Information: GSK Receipt date: 24-FEB-2025 This case was reported by a patient via (shingrix GSK chatbot) interactive digital media. The patient felt like had the flu for 4 days after 1st shingles vaccine. The reporter ask should expect the same reaction from the 2nd shot.
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