| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2862028 | M | MA | 09/29/2025 |
SMALLMNK |
BAVARIAN NORDIC |
Unknown |
Incorrect route of product administration, Injection site induration
Incorrect route of product administration, Injection site induration
|
The patient developed induration at the injection site pretty big and 3-4 cm; The patient received J...
The patient developed induration at the injection site pretty big and 3-4 cm; The patient received Jynneos intramuscularly; Case reference number US-BN-2025-001182 is a spontaneous case report initially received from a physician via Communication (reference number: USBAV25-1684) on 10-Jul-2025 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not reported. On an unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at an unknown dose intramuscularly at unknow site of administration for unknown indication (explicitly coded as 'inappropriate route of vaccination') On an unspecified date, unknown amount of time after vaccination, the patient developed an induration at the injection site that was pretty big three to four centimeter. At the time of initial report, the patient was not recovered from the event of 'injection site induration'. The reporter assessed the event of 'injection site induration' as non-serious, and causality as possibly related to Jynneos. No further information provided.; Reporter's Comments: This case concerns a male patient of unknown age, who had received the first dose of Jynneos vaccine, intramuscularly for an unknown indication, which is considered as 'inappropriate route of vaccination. Patient has experienced a non-serious event of injection site induration on unspecified date, after the dose of Jynneos vaccine for unknown indication. Injection site induration is listed and expected per CCDS v7 and USPI. Inappropriate route of vaccination is considered as listed as per company convention. The patient's past medical history and concomitant medication details were not provided. Outcome is not recovered. However, considering plausible temporal relationship and plausible biological mechanism the contributory role of the suspect vaccine cannot be excluded, and the reported event have been considered as related to Jynneos. Inappropriate route of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a male patient of unknown age, who had received the first dose of Jynneos vaccine, intramuscularly for an unknown indication, which is considered as 'inappropriate route of vaccination. Patient has experienced a non-serious event of injection site induration on unspecified date, after the dose of Jynneos vaccine for unknown indication. Injection site induration is listed and expected per CCDS v7 and USPI. Inappropriate route of vaccination is considered as listed as per company convention. The patient's past medical history and concomitant medication details were not provided. Outcome is not recovered. However, considering plausible temporal relationship and plausible biological mechanism the contributory role of the suspect vaccine cannot be excluded, and the reported event have been considered as related to Jynneos. Inappropriate route of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2862029 | M | MD | 09/29/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
|
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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Had First Dose 22-Feb-2025, Second Dose Received 11-Sep-2025; Initial report received on 11-Sep-2025...
Had First Dose 22-Feb-2025, Second Dose Received 11-Sep-2025; Initial report received on 11-Sep-2025. A consumer reported that he, a 28-year-old male, received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization about six months after the first dose. No medical history or concomitant medications were reported. On 22-Feb-2025 the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC # not reported)] intramuscularly in the left upper arm. On 11-Sep-2025, approximately 6 months after having been vaccinated with dose 1 of HEPLISAV-B, the patient reported that they received dose 2 of HEPLISAV-B (lot # 945664, expiration date, NDC # 43528-0003-05) intramuscularly in the left upper arm. No side effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2862030 | M | VA | 09/29/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946064 |
Hypotension, No adverse event, Product storage error
Hypotension, No adverse event, Product storage error
|
HEPLISAV-B Exposed to a Temperature 32.8 C and Out of Range For 93 Hours, And It Was Administered to...
HEPLISAV-B Exposed to a Temperature 32.8 C and Out of Range For 93 Hours, And It Was Administered to a Patient; Initial report received on 11-Sep-2025. A pharmacist reported that a 57-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had been exposed to a temperature above 27๏ฟฝC. No medical history or concomitant medications were reported. On 10-Sep-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 946064; expiration date 31-Aug-2027, and NDC # not reported)] administered intramuscularly in the left deltoid. The HEPLISAV-B had been exposed to a temperature above 27๏ฟฝC. The product was exposed to a temperature of 32.8๏ฟฝC and was out of range for 93 hours. The patient did not experience any adverse events after receiving HEPLISAV-B. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2862031 | M | 09/29/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
|
Chills
Chills
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Chills 24 Hours a Day; Initial report received on 12-Sep-2025. A consumer reported that a male pa...
Chills 24 Hours a Day; Initial report received on 12-Sep-2025. A consumer reported that a male patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced chills 24 hours a day. No medical history or concomitant medications were reported. On 08-Sep-2025, the patient received dose 1 of hepatitis B vaccine [HEPLISAV-B (lot, expiration date, NDC, site and route not reported)]. On 08-Sep-2025, after having been vaccinated with HEPLISAV-B, the patient has had chills 24 hours a day. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2862032 | 54 | F | 09/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Injection site erythema, Injection site pain, Injection site swelling, Myalgia
|
Pain, swelling, redness at site; Pain, swelling, redness at site; Pain, swelling, redness at site; M...
Pain, swelling, redness at site; Pain, swelling, redness at site; Pain, swelling, redness at site; Muscle ache; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included multiple sclerosis. Concomitant products included ofatumumab (Kesimpta). On 27-AUG-2025, the patient received Shingles vaccine. On 27-AUG-2025, less than a day after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Pain, swelling, redness at site), injection site swelling (Verbatim: Pain, swelling, redness at site), injection site erythema (Verbatim: Pain, swelling, redness at site) and muscle pain (Verbatim: Muscle ache). The outcome of the injection site pain, injection site swelling, injection site erythema and muscle pain were not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and muscle pain to be related to Shingles vaccine. It was unknown if the company considered the injection site pain, injection site swelling, injection site erythema and muscle pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-AUG-2025 The patient self-reported this case for herself. The patient stated that she had multiple sclerosis (MS), and her neurologist had recommended administration of the shingles vaccine. Following vaccination, the patient experienced pain, swelling, and redness at the injection site, as well as muscle aches. No treatment was administered for these symptoms.
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| 2862033 | F | FL | 09/29/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Headache, Mobility decreased, Pain, Peripheral swelling, Pyrexia
Headache, Mobility decreased, Pain, Peripheral swelling, Pyrexia
|
Large arm swelling; 101 fever; headache; extreme body aches; she cannot move her arm; This non-serio...
Large arm swelling; 101 fever; headache; extreme body aches; she cannot move her arm; This non-serious case was reported by a physician via sales rep and described the occurrence of large arm swelling in a female patient who received Men B NVS (Bexsero) for prophylaxis. In AUG-2025, the patient received Bexsero (left deltoid). On an unknown date, an unknown time after receiving Bexsero, the patient experienced large arm swelling (Verbatim: Large arm swelling), fever (Verbatim: 101 fever), headache (Verbatim: headache), general body pain (Verbatim: extreme body aches) and mobility decreased (Verbatim: she cannot move her arm). The outcome of the large arm swelling was resolving and the outcome of the fever, headache, general body pain and mobility decreased were not reported. The reporter considered the large arm swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the reporter considered the fever, headache, general body pain and mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the large arm swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the fever, headache, general body pain and mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe 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: 10-SEP-2025 The reporter reported that the patient received Bexsero vaccine and had 101-degree Celsius fever, neck, headache extreme body aches and she cannot move her arm without extreme pain
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| 2862034 | F | AR | 09/29/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
UNK UNK UNK UNK UNK UNK |
Fatigue, Feeling abnormal, Headache, Herpes zoster, Rash; Rash vesicular, Scab, ...
Fatigue, Feeling abnormal, Headache, Herpes zoster, Rash; Rash vesicular, Scab, Vaccination failure; Fatigue, Feeling abnormal, Headache, Herpes zoster, Rash; Rash vesicular, Scab, Vaccination failure; Fatigue, Feeling abnormal, Headache, Herpes zoster, Rash; Rash vesicular, Scab, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call cente...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Varicella zoster vaccine live (Oka/Merck) (Zostavax) for prophylaxis. Concurrent medical conditions included hyperlipidemia. Concomitant products included evolocumab (Repatha). On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Zostavax. On 11-SEP-2025, more than 2 years after receiving Shingrix and Shingrix and an unknown time after receiving Zostavax, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Zostavax. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix, Shingrix and Zostavax. It was unknown if the company considered the vaccination failure to be related to Zostavax. Additional Information: GSK Receipt Date: 15-SEP-2025 The patient reported that she received both Shingrix vaccine doses 3 or 4 years ago. She also received Zostavax vaccine a few years prior to the Shingrix vaccine. On 11-SEP-2025 she broke out with shingles. She states that it started with a headache, fatigue, and generally feeling bad. Then a small rash consisting of 10 to 15 very small lesions appeared on her right ribcage area. They were blistered but now are scabbed over. The patient was on antihypertensive drug. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, more than 2 years after receiving Shingrix(1st and 2nd), in a 67-year-old female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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| 2862035 | F | MD | 09/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
suspected vaccination failure; Shingles; This serious case was reported by a consumer via call cente...
suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 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: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were unknown. 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: 22-SEP-2025 The reporter stated that the patient received the Shingrix vaccine and experienced another case of shingles. 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: A case of Vaccination failure, unknown time after receiving Shingrix, in a female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2862037 | 09/29/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Haematochezia
Haematochezia
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Specks of blood in stool 5 days after vaccination; This serious case was reported by a physician via...
Specks of blood in stool 5 days after vaccination; This serious case was reported by a physician via sales rep and described the occurrence of blood in stool in a patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of Rotavirus vaccine. On an unknown date, 5 days after receiving Rotavirus vaccine, the patient experienced blood in stool (Verbatim: Specks of blood in stool 5 days after vaccination) (serious criteria GSK medically significant). The outcome of the blood in stool was resolved. The reporter considered the blood in stool to be related to Rotavirus vaccine. It was unknown if the reporter considered the blood in stool to be related to Rotarix Unspecified Oral Administration Device. The company considered the blood in stool to be unrelated to Rotavirus vaccine and Rotarix Unspecified Oral Administration 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: 27-SEP-2025 Physician reported that patient experienced specks of blood in stool 5 days after vaccination.; Sender's Comments: A case of Haematochezia, 5 days after receiving Rotavirus vaccine and Rotarix UNSPECIFIED ORAL ADMINISTATION DEVICE in a patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2862038 | F | 09/29/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Allergy to vaccine, Peripheral swelling, Skin fissures, Skin lesion
Allergy to vaccine, Peripheral swelling, Skin fissures, Skin lesion
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the skin between her fingers burst and had lesions; the skin between her fingers burst and had lesio...
the skin between her fingers burst and had lesions; the skin between her fingers burst and had lesions; allergy to the Tdap Boostrex was diagnosed 4-5 years ago; swelling of her hands; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of skin lesion in a adult female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. The patient's past medical history included necrotizing fasciitis and multiple sclerosis. Previously administered products included Zofran with an associated reaction of pruritus (The IV Zofran caused itching, hives and weeping on her arms). Concurrent medical conditions included esophageal acid reflux, asthma, nausea, neuropathy, bipolar disorder, blood pressure high, anxiety, spasms, bladder disorder (Bladder control), fatigue, urinary tract infection, inflammation localized, back pain, diabetes (diet controlled diabetic), anaphylactic shock (which was treated with IV Benadryl the oral Benadryl), shortness of breath, hives (She was treated with Benadryl), facial swelling (Treatment was an Epi Pen), throat swelling (Treatment was an Epi Pen), wheezing (which was treated with a breathing treatment and a weeksworth of steroids), skin blotches, pruritus, vomiting (He was treated with promethazine), hallucination, penicillin allergy (started when she was a little girl), allergy to antibiotic, drug allergy (was diagnosed in her younger days and she experienced shortness of breath, hives, swelling of the face and throat.), sulfonamide allergy (was diagnosed when she was a little girl She experienced hives and was given liquid Benadryl.), drug allergy (allergy to Lyrica was diagnosed in 2019), allergic reaction to analgesics, allergy to antibiotic (was diagnosed in 2015), allergic reaction to analgesics (allergy to Tramadol was diagnosed in 2010), allergy to antibiotic (was diagnosed in 2015), shellfish allergy and fruit allergy (allergy to pineapple was diagnosed in 2020). Concomitant products included salbutamol (Albuterol Hfa), promethazine teoclate (Promethazine), bupropion, alprazolam (Xanax) and gabapentin (Neurontin). On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced skin lesion (Verbatim: the skin between her fingers burst and had lesions), skin cracked (Verbatim: the skin between her fingers burst and had lesions), allergy to vaccine (Verbatim: allergy to the Tdap Boostrex was diagnosed 4-5 years ago) and hand swelling (Verbatim: swelling of her hands). The outcome of the skin lesion, skin cracked, allergy to vaccine and hand swelling were not resolved. It was unknown if the reporter considered the skin lesion, skin cracked, allergy to vaccine and hand swelling to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the skin lesion, skin cracked, allergy to vaccine and hand swelling to be related to Boostrix and Boostrix Pre-Filled Syringe 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: 04-SEP-2025 Patient's concurrent condition included flares, acid reflux, asthma, nausea, neuropathy, bipolar disorder, high blood pressure, anxiety, spasms, bladder control, fatigue, urinary tract infection, inflammation in back, back pain, diet-controlled diabetic, anaphylactic shock. Her allergy to penicillin started when she was a little girl, and she experienced anaphylactic shock which was treated with iv Benadryl the oral Benadryl. She was diagnosed with a shellfish allergy after eating shrimp in 2003 or 2004. She has a severe anaphylactic reaction what caused her face, tongue and throat to swell up. She was treated in the er with a Benadryl drip and steroids. She was ordered an epi pen as needed for future allergy symptoms. She was diagnosed with an allergy to fentanyl patches in 2010 and experiences redness around the edge of the patch and hives. As treatment the patch was removed, and she used antibiotic cream on her arms for the hives. Her allergy to cipro started in 2015 and she experienced shortness of breath and hives. She was treated with Benadryl. Her allergy to aspirin was diagnosed in her younger days and she experienced shortness of breath, hives, swelling of the face and throat. Treatment was an epi pen. Her allergy to sulfa was diagnosed when she was a little girl. She experienced hives and was given liquid Benadryl. Her allergy to clindamycin was diagnosed in 2015 and she experienced vomiting. He was treated with promethazine. Her allergy to tramadol was diagnosed in 2010 and she experienced hallucinations. The tramadol was discontinued as treatment. Her allergy to doxycycline was diagnosed in 2015 and she experienced nausea and vomiting. She was treated with iv Zofran - which she then was diagnosed as having an allergy to. The iv Zofran caused itching, hives and weeping on her arms. As treatment, the iv was stopped and she was given oral Benadryl. Her allergy to pineapple was diagnosed in 2020 and she experienced tongue itching and swelling. She was treated with Benadryl. Her allergy to Lyrica was diagnosed in 2019. She experienced wheezing which was treated with a breathing treatment and a weeks worth of steroids. Her allergy to Demerol was diagnosed in 2023 and she experienced purple splotches on her skin, itching and nausea. She treated with iv Benadryl in the hospital. On unknown date, patient started therapy with Boostrix for unknown indication, it was reported that patient experienced her allergy to the Tdap Boostrix was diagnosed 4-5 years ago and she experienced swelling of her hands and the skin between her fingers burst and had lesions. She was treated with steroids and oral antibiotics and antibiotic cream for the lesions.
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| 2862039 | F | 09/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Malaise
Malaise
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Deathly ill; This serious case was reported by a consumer via interactive digital media and describe...
Deathly ill; This serious case was reported by a consumer via interactive digital media and described the occurrence of unwell in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unwell (Verbatim: Deathly ill) (serious criteria other: Serious as per reporter). The outcome of the unwell was resolved (duration 3 weeks). The reporter considered the unwell to be related to Shingrix. The company considered the unwell to be unrelated to Shingrix. Additional Information: GSK Receipt Date:07-SEP-2025 This case was reported by a patient via interactive digital media. The patient took the two Shingrix shots and after the 2nd shot she was deathly ill for 3 weeks. It was horrible experience.; Sender's Comments: A case of Malaise, unknown time after receiving Shingrix in a adult female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2862040 | 39 | F | NC | 09/29/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
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Arthritis, Asthenia, Injection site pain, Muscle rigidity, Musculoskeletal stiff...
Arthritis, Asthenia, Injection site pain, Muscle rigidity, Musculoskeletal stiffness; Nerve conduction studies, Tremor
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Chronic pain deterioration in right arm injection site, severe arm, rigidity, chronic stiffness, wea...
Chronic pain deterioration in right arm injection site, severe arm, rigidity, chronic stiffness, weakness arthritis in ability to relax, arm, trembling
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| 2862041 | 77 | F | MA | 09/29/2025 |
RSV |
PFIZER\WYETH |
LN5464 |
Extra dose administered
Extra dose administered
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None, Vaccine given in January. So she wasn't due for a second dose
None, Vaccine given in January. So she wasn't due for a second dose
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| 2862042 | 24 | F | TN | 09/29/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
4d255 |
Injection site pain, Pain
Injection site pain, Pain
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Immediate pain with injection causing continued soreness aching and limited ROM due to pain. Treated...
Immediate pain with injection causing continued soreness aching and limited ROM due to pain. Treated with rest, ice, heat, ibuprofen x 12 days. Referred to Ortho walk-in clinic 9/29/25 for further evaluation and treatment.
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| 2862043 | 70 | F | FL | 09/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7523j |
Back pain, Chills, Pyrexia, Tremor
Back pain, Chills, Pyrexia, Tremor
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Chills and shakes; fever 100.3 , lower back p ain
Chills and shakes; fever 100.3 , lower back p ain
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| 2862044 | 64 | F | PA | 09/29/2025 |
PNC20 |
PFIZER\WYETH |
ln4931 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received a second dose of the Prevnar 20 vaccine. During the clinic patient stated no histor...
Patient received a second dose of the Prevnar 20 vaccine. During the clinic patient stated no history of a PNU vaccine. After the clinic during billing, it was found that the patient received a Prevnar 20 vaccine last year (2024). Patient states no side effects from vaccine or concerns when spoken with on the phone 9/29/25 at 9:05am.
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| 2862045 | 09/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Neuralgia, Vaccination failure
Herpes zoster, Neuralgia, Vaccination failure
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Suspected vaccination failure; I had shingles two years ago; nerve pain; This serious case was repo...
Suspected vaccination failure; I had shingles two years ago; nerve pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 74-year-old patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had shingles two years ago) and post herpetic neuralgia (Verbatim: nerve pain). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 09-SEP-2025 This case was reported by a patient via interactive digital media. The patient had shingles two years ago and still had severe pain. No doctor would help the patient. The patient had nerve pain and nothing they could did. It was pathetic that no doctor could help. 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: A case of Vaccination failure, an unknown time after receiving Herpes Zoster vaccine, in a 74-year-old patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2862046 | 54 | F | MN | 09/29/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
U8823CA LX2498 |
Myalgia, Rash, Skin warm; Myalgia, Rash, Skin warm
Myalgia, Rash, Skin warm; Myalgia, Rash, Skin warm
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Red rash going down arm, muscle pain, warm to the touch
Red rash going down arm, muscle pain, warm to the touch
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| 2862047 | 37 | F | TX | 09/29/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
73BN2 |
Urticaria
Urticaria
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approximately 4-5 hours after the vaccine, developed hives on left shoulder which spread across to r...
approximately 4-5 hours after the vaccine, developed hives on left shoulder which spread across to right shoulder, splotchy on the neck and across the top of the back above the shoulder blades. It also spread down the torso to the belly button area. Taking zyrtec in the morning and 50mg benadryl at night since day the hives started (9/25/25). Still have hives as of today (same areas listed above) 9/29/25.
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| 2862048 | 6 | F | NC | 09/29/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
KM25M5 |
Syncope
Syncope
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Patient experienced syncope after vaccine administration. Patient was positioned lying down with leg...
Patient experienced syncope after vaccine administration. Patient was positioned lying down with legs elevated. Vital signs were taken: BP: 107/70, pulse: 106. Patient experienced jerky muscle movements for a few seconds, skin became clammy and cold, face was pale. Patient did not lose sphincter control, did not suffer any fall, or injuries, and was responding coherently to questions after a few seconds of episode. Comfort measures provided (reassurance, cold compress). Patient was observed during 30 minutes after episode and left the clinic without any complications. Education was provided to the parents regarding the episode and how to proceed at home if any reaction was observed.
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| 2862049 | 11 | M | NY | 09/29/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
PX3P7 |
Lip swelling, Sensory disturbance, Swelling face
Lip swelling, Sensory disturbance, Swelling face
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mother states he woke up on Monday and his lips are swollen. Under his right eye and right side of h...
mother states he woke up on Monday and his lips are swollen. Under his right eye and right side of his nose are swollen and his face feels tight. No fever at this time. She gave him ibuprofen and he has an appt with his doctor appt today.
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| 2862050 | 1.25 | M | MA | 09/29/2025 |
DTAPIPVHIB DTAPIPVHIB |
SANOFI PASTEUR SANOFI PASTEUR |
|
Aphasia, Autism spectrum disorder, Eating disorder, Hyperacusis, Lethargy; Stari...
Aphasia, Autism spectrum disorder, Eating disorder, Hyperacusis, Lethargy; Staring, Stereotypy
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Within 20 mins, lost all milestones. No longer had words, no longer babbled, stopped eating solid fo...
Within 20 mins, lost all milestones. No longer had words, no longer babbled, stopped eating solid food, very lethargic and vacant looking. No longer smiled or laughed. Over the next two days, started covering ears and verbally swimming, began arm flapping
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โ | |||||
| 2862051 | 27 | F | NC | 09/29/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Delivery, Exposure during pregnancy, Product use issue
Delivery, Exposure during pregnancy, Product use issue
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Patient was G1P0 at 36w4d, Arexvy vaccine was given that is contraindicated in pregnancy. Patient w...
Patient was G1P0 at 36w4d, Arexvy vaccine was given that is contraindicated in pregnancy. Patient was given close MFM follow up. Patient delivered at 38w3d on 9/16.
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| 2862052 | 7 | F | NJ | 09/29/2025 |
DTAP HEP IPV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
47Y5M 47Y5M Y1A201M |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
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Dose of Polio was given in error. Patient already had 4 doses with one of the doses being given on ...
Dose of Polio was given in error. Patient already had 4 doses with one of the doses being given on or after the 4th birthday.
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| 2862053 | 87 | M | WI | 09/29/2025 |
FLU3 |
SEQIRUS, INC. |
407246 |
Mobility decreased
Mobility decreased
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patient who received his flu shot on Friday 9/26 call the afternoon on 09/28/2025 and spoke with the...
patient who received his flu shot on Friday 9/26 call the afternoon on 09/28/2025 and spoke with the pharmacist on duty stating that he was experiencing "paralysis", saying he was unable to move his legs and had very little movement in his arms. He said it began Saturday morning and that he has been unable to get out of bed and that it has been getting worse since. I clarified with him that he wasn't just feeling extremely tired/unwell after the vaccine, but he insisted he could not move his legs at all. (withheld name) RPh on duty advised the patient it could be from the vaccine although rare but regardless to seek medical treatment and be evaluated. Note was left on profile and sent to pharmacy manager (myself) for follow up.
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| 2862054 | 77 | F | MI | 09/29/2025 |
COVID19 TDAP |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
00069-2528-10 58160-0842-52 |
Dizziness; Dizziness
Dizziness; Dizziness
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Sudden severe dizziness unrelated to position or blood pressure 6 days (to the hour) post vaccine. N...
Sudden severe dizziness unrelated to position or blood pressure 6 days (to the hour) post vaccine. No change in bp. Dizziness unrelated to position - can occur when supine. Now (day ten) becoming intermittent.
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| 2862055 | 7 | M | AR | 09/29/2025 |
HEP IPV TDAP |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR |
GC3N4 X1C891M 3CA30C1 |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration
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During a record audit done by (withheld name), it was noted that Tdap and Polio were given on 3/5/25...
During a record audit done by (withheld name), it was noted that Tdap and Polio were given on 3/5/25 before the recommended date. Last doses were given on 10/3/24 which made the interval too short and the doses were invalid. Catch-up schedule states there must be 6 months between doses.
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| 2862056 | 73 | M | NC | 09/29/2025 |
COVID19 |
MODERNA |
8146670 |
Chest discomfort, Pain, Pain in extremity, Sleep disorder
Chest discomfort, Pain, Pain in extremity, Sleep disorder
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Patient started experiencing bad arm pain with any type of movement on the evening of the vaccinatio...
Patient started experiencing bad arm pain with any type of movement on the evening of the vaccination, 9/26. Arm soreness caused disruption in sleep, and some chest tightness for 15 minutes on 9/27. He has been using tylenol with little relief.
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| 2862057 | 49 | F | WI | 09/29/2025 |
UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
F4A7R F4A7R F4A7R |
Dizziness, Ear discomfort, Ear pain, Headache, Hypoacusis; Injection site pain, ...
Dizziness, Ear discomfort, Ear pain, Headache, Hypoacusis; Injection site pain, Injection site swelling, Swelling, Swelling face, Tenderness; Tinnitus
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I was administered the influenza vaccine in my left upper arm from a clinic Wednesday 9/24/25 at 93...
I was administered the influenza vaccine in my left upper arm from a clinic Wednesday 9/24/25 at 935 am in my office Upon administration of vaccine, I developed severe burning sensation at site. I then had swelling and tenderness at immunization site (left upper arm). Approximately 6 hours after receiving the immunization I developed swelling in the left side of my neck, jaw, and face. No erythema or warmth. No fever. It was associated with pain in my left TMJ and left ear. The pain became severe in my left ear about 8 hours after the immunization (8/10 sharp stabbing pain). My hearing in left ear was diminished at this time. I utilized tylenol, aleve, sudafed, and benadyrl with little benefit. I went to bed with severe pain in my ear and head. The next morning my left ear pain had diminished but I lost most hearing in the left ear and had a sensation of fullness in the left ear. I developed mild tinnitus and some dizziness with quick movements (like leaning forward and getting up too fast). The swelling in my left neck and face slowly resolved and was gone by Thursday 9/25/25 afternoon. I still had tenderness behind my left ear and over my left TMJ. Thursday afternoon I had another physician (friend) look at my ear to confirm a ruptured TM. Today, I continue to have left ear fullness and Description of Incident Body Part Body Part Position diminished to no hearing on left side. I have occasional tinnitus in left ear. The immunization site, left upper arm, continues to be sore. Ear - Left (Incl. hearing, eardrum) Left
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| 2862058 | 72 | M | ME | 09/29/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0846 |
No adverse event, Underdose
No adverse event, Underdose
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Patient was administered the pediatric covid vaccine 10mcg/0.3ml for 5 year old to 11 year old patie...
Patient was administered the pediatric covid vaccine 10mcg/0.3ml for 5 year old to 11 year old patients instead of the adult vaccine. The error was discovered the next day. Per guidance from the CDC, the patient was administered a regular adult dose the next day. The patient did not report any adverse events following either vaccine
More
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| 2862059 | 5 | F | IN | 09/29/2025 |
COVID19 |
MODERNA |
3052579 |
Circumstance or information capable of leading to medication error, No adverse e...
Circumstance or information capable of leading to medication error, No adverse event, Underdose
More
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Patient did not experience an adverse event. This is a reporting of an administration error. During ...
Patient did not experience an adverse event. This is a reporting of an administration error. During administration of the pediatric Spikevax COVID-19 vaccine, patient jumped and pulled away. This resulted in the needle coming out of the muscle and failure in delivery of the entire dose of vaccine. According to the CDC Interim Clinical Considerations for COVID-19 Vaccination, Appendix: Vaccine Administration Errors and Deviations, recommendation is to repeat dose immediately (no minimum interval). Did discuss with parent who stated that they were in agreement as they were unsure where they would receive a re-administered dose in the future. Patient was administered an entire dose of pediatric Spikevax COVID-19 vaccine without issue.
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| 2862060 | 5 | M | TN | 09/29/2025 |
FLU3 |
SEQIRUS, INC. |
406995 |
Injection site erythema, Injection site pain
Injection site erythema, Injection site pain
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evening of receiving flu vaccine, pt developed redness and pain at the injection site. He was seen i...
evening of receiving flu vaccine, pt developed redness and pain at the injection site. He was seen in (withheld name) After Hours and instructed to use warm compresses per father of pt. Pt presented to (withheld name) Clinic on 09/28/25 due to increase in area of redness. He was dx with cellulitis and started on cephalexin for 5 days.
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| 2862061 | 18 | M | NH | 09/29/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
Not provided by |
Arthralgia, Arthritis reactive, Condition aggravated, Loss of personal independe...
Arthralgia, Arthritis reactive, Condition aggravated, Loss of personal independence in daily activities
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Flare of up of arthritis with severe joint pain causing patient to no be able to perform daily activ...
Flare of up of arthritis with severe joint pain causing patient to no be able to perform daily activities
More
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โ | |||||
| 2862062 | 09/29/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
COVID-19, Malaise
COVID-19, Malaise
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Took the shot it made me sicker than I've in my life just begging to feel like myself and got c...
Took the shot it made me sicker than I've in my life just begging to feel like myself and got covid.; got covid; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included sickness (patient was sicker than they had in life). On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Took the shot it made me sicker than I've in my life just begging to feel like myself and got covid.) and covid-19 (Verbatim: got covid). The outcome of the sickness and covid-19 were not reported. It was unknown if the reporter considered the sickness and covid-19 to be related to RSV vaccine. It was unknown if the company considered the sickness and covid-19 to be related to RSV vaccine.
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| 2862063 | 61 | F | AL | 09/29/2025 |
COVID19 FLU3 HEP PNC21 |
MODERNA SANOFI PASTEUR DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. |
3052087 TFAA2503 946064 Z006076 |
Injection site erythema, Injection site swelling, Injection site warmth; Injecti...
Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth
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Patient reported swelling, redness, and heat from shoulder to elbow of left arm beginning on Sunday ...
Patient reported swelling, redness, and heat from shoulder to elbow of left arm beginning on Sunday (9/28/25) evening. She treated with tylenol and ice. Advised to continue those therapies and to add benadryl and to call her primary physician is symptoms progress.
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| 2862064 | 66 | F | TN | 09/29/2025 |
COVID19 COVID19 COVID19 UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Asthenia, Balance disorder, Chills, Crying, Dizziness; Dyspnoea exertional, Dyss...
Asthenia, Balance disorder, Chills, Crying, Dizziness; Dyspnoea exertional, Dysstasia, Fall, Feeling hot, Headache; Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain, Pyrexia; Asthenia, Balance disorder, Chills, Crying, Dizziness; Dyspnoea exertional, Dysstasia, Fall, Feeling hot, Headache; Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain, Pyrexia
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pt became dizzy and hot. She couldn't stand more than 5 minutes at a time. She would became hot...
pt became dizzy and hot. She couldn't stand more than 5 minutes at a time. She would became hot and short of breath when walking. She was not able to take care of her brother because she was too weak. She had chills, body aches, headache, stiff neck and fever. She would cry every time she laid down. She would lose balance and fall. She took a Tylenol that made her feel worse. She then took ibuprofen and started to feel better. Her head still doesn't feel right as it still hurting and she is still weak. She feels some better today.
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| 2862065 | 57 | F | TX | 09/29/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
unknown unknown |
Diarrhoea, Fatigue, Headache, Nausea, Rash; Viral rash
Diarrhoea, Fatigue, Headache, Nausea, Rash; Viral rash
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Severe fatigue for the first two days following the vaccination. Piercing headache on 2nd day. Inter...
Severe fatigue for the first two days following the vaccination. Piercing headache on 2nd day. Intermittent nausea and diarrhea 2nd and 3rd day and a viral rash which is common for me when I have a virus. All over my abdomen and chest. Still present on the third day but feeling overall better.
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| 2862066 | 81 | M | MN | 09/29/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER |
EN6202 ER8727 FF2587 FK9894 GH9697 HF9298 unknown |
Asthenia, Viral test; Asthenia, Viral test; Asthenia, Viral test; Asthenia, Vira...
Asthenia, Viral test; Asthenia, Viral test; Asthenia, Viral test; Asthenia, Viral test; Asthenia, Viral test; Asthenia, Viral test; Asthenia, Viral test
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Weakness
Weakness
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โ | |||||
| 2862067 | 65 | F | KS | 09/29/2025 |
FLU3 |
SANOFI PASTEUR |
|
Diarrhoea, Nausea, Oropharyngeal pain, Pain, Pyrexia
Diarrhoea, Nausea, Oropharyngeal pain, Pain, Pyrexia
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fever, sore throat, body aches, diarrhea, nausea
fever, sore throat, body aches, diarrhea, nausea
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| 2862068 | 11 | M | SC | 09/29/2025 |
HPV9 TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y013818 Y3Z9P |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
More
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Boostrix was given when patient received a dose on 3-14-2025(Too soon)
Boostrix was given when patient received a dose on 3-14-2025(Too soon)
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| 2862069 | 55 | F | VA | 09/29/2025 |
FLU3 |
SANOFI PASTEUR |
|
Immediate post-injection reaction, Injection site haematoma
Immediate post-injection reaction, Injection site haematoma
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patient received the vaccine flu and covid this day, the ARM where they inject the medication develo...
patient received the vaccine flu and covid this day, the ARM where they inject the medication developed hematoma immediately after the injection. This could be the needle not injected all the way thru and injected not to the muscle.
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| 2862070 | 47 | M | FL | 09/29/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
0421L20A 0421L20A 0421L20A 006M20A 006M20A 006M20A UNK UNK UNK |
Artery dissection, Blood test normal, COVID-19, Coeliac artery aneurysm, Coeliac...
Artery dissection, Blood test normal, COVID-19, Coeliac artery aneurysm, Coeliac artery occlusion; Computerised tomogram abdomen, Computerised tomogram abnormal, Flank pain, Genetic testing, SARS-CoV-2 test positive; Sexually transmitted disease test; Artery dissection, Blood test normal, COVID-19, Coeliac artery aneurysm, Coeliac artery occlusion; Computerised tomogram abdomen, Computerised tomogram abnormal, Flank pain, Genetic testing, SARS-CoV-2 test positive; Sexually transmitted disease test; Artery dissection, Blood test normal, COVID-19, Coeliac artery aneurysm, Coeliac artery occlusion; Computerised tomogram abdomen, Computerised tomogram abnormal, Flank pain, Genetic testing, SARS-CoV-2 test positive; Sexually transmitted disease test
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On 9APR2022, I felt a sharp stabbing pain in my side while I was stationed. I was diagnosed with a d...
On 9APR2022, I felt a sharp stabbing pain in my side while I was stationed. I was diagnosed with a dissection of the celiac artery and distal occlusion. I was medically discharged and received only 10% for the dissected artery even though I still today has associated pain and the location is considered inoperable. I currently have a small aneurysm of 1.3cm, but I still have low levels of pain when my heart rate goes up. eg. Cardio, stress. sex. etc. I have gone through my records and the only names I have for the treating doctors were multiple doctors at hospital, the vascular surgery clinic at hospital, a vascular surgeon, a Rheumatologist, and multiple doctors.
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โ | โ | ||||
| 2862072 | 63 | M | ME | 09/29/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0846 |
Underdose
Underdose
|
Patient received a pediatric Comirnaty 10mcg/0.3ml vaccine indicated for 5 year old to 11 year old p...
Patient received a pediatric Comirnaty 10mcg/0.3ml vaccine indicated for 5 year old to 11 year old patients instead of an adult vaccine. Upon discovery and guidance from the CDC the patient was administered a correct adult dose of Comirnaty 30mcg/0.3ml 4 days later when he was able to return to the pharmacy. The patient did not report any issues following either vaccination.
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| 2862073 | 59 | F | PA | 09/29/2025 |
UNK |
UNKNOWN MANUFACTURER |
ZOO3579 |
Erythema, Malaise, Oedema peripheral, Pyrexia, Skin warm
Erythema, Malaise, Oedema peripheral, Pyrexia, Skin warm
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The patient received the pneumococcal vaccination on Wednesday, September 3, 2025. She appears to ha...
The patient received the pneumococcal vaccination on Wednesday, September 3, 2025. She appears to have mounted a robust immunologic response with fever and malaise on the same day. Despite these symptoms, she went to her physically demanding job, which involves manual labor and sweating. Patient seen in the office on 9/8/2025 developed clinical features concerning for cellulitis localized to the left upper extremity. The erythema has been progressively spreading to the anterior, posterior, and medial aspects of the arm. The arm is warm to touch, with diffuse erythema. She denies fever, chills, or changes in mental status. On examination, the vaccination site demonstrates a circular ecchymosis without surrounding erythema or peripheral edema, making injection-site reaction less likely. The presentation is more consistent with cellulitis rather than a local vaccine reaction. Given the extent and progression of findings, I have decided to initiate broad-spectrum antibiotic therapy with Bactrim DS to provide MRSA coverage.
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| 2862074 | 31 | F | NY | 09/29/2025 |
FLU3 RSV |
SANOFI PASTEUR PFIZER\WYETH |
UT8779NA LK3779 |
Exposure during pregnancy, No adverse event, Product preparation issue; Exposure...
Exposure during pregnancy, No adverse event, Product preparation issue; Exposure during pregnancy, No adverse event, Product preparation issue
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36 week ob with EDD of 10/24/2025 was to get flu and RSV vaccine at routine office visit. RSV powder...
36 week ob with EDD of 10/24/2025 was to get flu and RSV vaccine at routine office visit. RSV powder was reconstituted with Fluzone vaccine. Patient was examined shortly after adverse event and injection site was clean/intact, no swelling or rash noted. Patient was also advised to contact the service for evaluation if any acute changes in her or fetal status occur at all. 24 hour and 72 hour follow up with the patient, doing well with no signs or symptoms of any reaction.
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| 2862075 | 83 | F | MO | 09/29/2025 |
FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8859CA U8859CA U8859CA |
C-reactive protein, Computerised tomogram head, Epistaxis, Full blood count, Hyp...
C-reactive protein, Computerised tomogram head, Epistaxis, Full blood count, Hypoaesthesia; Joint stiffness, Laboratory test, Metabolic function test, Pain in extremity, Paraesthesia; Red blood cell sedimentation rate
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Sore arm day of and after then , 3 days after stiffness of all joints, numbness tinglingly sensation...
Sore arm day of and after then , 3 days after stiffness of all joints, numbness tinglingly sensation on and off on left side of head around ear, x 1 nose bleed
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| 2862076 | 60 | F | CA | 09/29/2025 |
FLU3 |
SANOFI PASTEUR |
|
Injection site pain, Injection site rash
Injection site pain, Injection site rash
|
Shot was given in upper right arm. 3 hrs after shot placed an ice pack on to relieve soreness (appr...
Shot was given in upper right arm. 3 hrs after shot placed an ice pack on to relieve soreness (approx 2 minutes). Later on around 6pm noticed a rash around the injection site. Very tender to the touch. Went to bed and awoke with the rash still there and now darker and still very tender. I write this now approx 48 hrs after orig injection. I have gotten a flu shot yearly over the last 30 yrs and have never gotten this type of reaction before.
More
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| 2862077 | 09/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pain in extremity
Pain in extremity
|
have the arm pain that I experienced with the first dose.; This non-serious case was reported by a c...
have the arm pain that I experienced with the first dose.; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. 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 in arm (Verbatim: have the arm pain that I experienced with the first dose.). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 11-SEP-2025 The patient reported that he/she received the 2nd dose of Shingrix a few days ago and did not have the arm pain that he/she experienced with the first dose.
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| 2862078 | 70 | F | PA | 09/29/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
8146545 U8790BA |
Erythema, Pruritus; Erythema, Pruritus
Erythema, Pruritus; Erythema, Pruritus
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Patient received both vaccines - stated that the next day her husband noted that her arm appeared to...
Patient received both vaccines - stated that the next day her husband noted that her arm appeared to have a large reddened area on it - stated that it has since become very itchy
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| 2862079 | 89 | M | CA | 09/29/2025 |
RSV |
PFIZER\WYETH |
LL8396 |
Abdominal pain upper, Eye pruritus, Nasopharyngitis, Rhinorrhoea
Abdominal pain upper, Eye pruritus, Nasopharyngitis, Rhinorrhoea
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Patient reports that after receiving his RSV vaccine 8/29/25, he experienced stomach cramps, rhinorr...
Patient reports that after receiving his RSV vaccine 8/29/25, he experienced stomach cramps, rhinorrhea, cold like symptoms, itching around the eyes. Symptoms are now resolved.
More
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