| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2866132 | 73 | F | NY | 10/15/2025 |
FLU3 |
SANOFI PASTEUR |
U8881CA |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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patient was inadvertently administered the Fluzone prefilled syringe, , intramuscularly into the lef...
patient was inadvertently administered the Fluzone prefilled syringe, , intramuscularly into the left deltoid, rather than the intended Fluzone High-Dose with no reported adverse event; Initial information received on 09-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 73 years old female patient who was inadvertently administered the Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone], intramuscularly into the left deltoid, rather than the intended Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] with no reported adverse event while receiving vaccines and. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Oct-2025, the patient received 0.5mL dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine, once, Suspension for injection in pre-filled syringe (unknown strength), lot U8881CA and expiry date 30-Jun-2026 via intramuscular route in the left deltoid for immunisation rather than the intended Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation), with no reported adverse event (wrong product administered) (latency Same day). Reportedly, The patient received no concomitant vaccines. This error was the result of an order error, and not the result of confusing the two products. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2866133 | 54 | M | PA | 10/15/2025 |
FLU3 UNK |
SANOFI PASTEUR UNKNOWN MANUFACTURER |
U8767AA |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
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administration of fluzone np to a patient who was intended by the facility to receive flublok with n...
administration of fluzone np to a patient who was intended by the facility to receive flublok with no reported adverse event; Initial information along with live follow up received on 10-Oct-2025 both of which are processed together regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 54 years old male patient had administration of influenza USP trival A-B subvirion no preservative vaccine [Fluzone] who was intended by the facility to receive influenza trivalent recombinant vaccine [Flublok TIV] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2025 the patient had administration of 0.5 ml (dose 1) once of suspect influenza USP trival A-B subvirion no preservative vaccine (Suspension for injection) (lot: U8767AA; expiry date: 30-Jun-2026; strength: standard) via intramuscular route in the left deltoid for Immunization who was intended by the facility to receive influenza trivalent recombinant vaccine (Solution for Injection) with no reported adverse event (wrong product administered) (latency: same day). It was reported, "the patient has not reported any allergy to eggs." Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2866134 | F | DC | 10/15/2025 |
FLU3 |
SANOFI PASTEUR |
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Product administered at inappropriate site
Product administered at inappropriate site
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pre-assessed as an off-label use as per local labelling due to use of unapproved alternative injecti...
pre-assessed as an off-label use as per local labelling due to use of unapproved alternative injection site patient may have received possibly fluzone hd in the gluteal area before with no reported ae; Initial information received on 10-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age female patient who had use of unapproved alternative injection site patient may have received possibly influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] in the gluteal area before with no reported ae (adverse event) which was pre-assessed as an off-label use as per local labelling. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Poliomyelitis. Concomitant medications included COVID-19 vaccine for Immunisation. On an unknown date, the patient received a dose of suspect influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot number, dose, strength and expiry not reported) via unknown route in gluteal muscle as Immunization that had use of unapproved alternative injection site with no reported ae (adverse event) which was pre-assessed as an off-label use as per local labelling (off label use) (latency: same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. It was reported "A nurse is asking for guidance on administering FLUZONE HD in an alternate site to a senior resident that has Polio Syndrome, which has diminished usable tissue in the deltoid. She has been told that historically, the patient has gotten COVID and flu vaccines in the gluteal muscle instead, and they are supposed to administer FLUZONE HD next week. She is asking if they can give that injection in the gluteal muscle, and she is aware there may be an effect on a nerve. Caller mentioned that she believes the patient may have received (unspecified) COVID vaccine and possibly FLUZONE HD in the gluteal area before. There is no further information available, as she states it was in the past and at a different facility." Action taken: not applicable.
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| 2866135 | MO | 10/15/2025 |
FLU3 |
SANOFI PASTEUR |
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Incorrect dose administered
Incorrect dose administered
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45yr old patient received FLUZONE HD with no reported adverse event; Initial information received on...
45yr old patient received FLUZONE HD with no reported adverse event; Initial information received on 10-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 45 years old and unknown gender patient who received influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Influenza (Influenza immunisation) with no reported adverse event (product administered to patient of inappropriate age) (same day latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2866136 | M | CT | 10/15/2025 |
FLU3 |
SANOFI PASTEUR |
U8440AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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administration of expired dose with no reported adverse event; Initial information received on 13-Oc...
administration of expired dose with no reported adverse event; Initial information received on 13-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age male patient who had administration of expired dose with no reported adverse event of influenza trivalent recombinant vaccine [Flublok]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2025, the patient received expired 0.5 ml dose of suspect influenza trivalent recombinant vaccine (lot U8440AA, Expiry date: 30-Apr-2025, strength: standard) via intramuscular route in the arm for influenza (expired dose with no reported adverse event (expired product administered; latency: same day) Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2866137 | F | CT | 10/15/2025 |
UNK |
UNKNOWN MANUFACTURER |
U8440AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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patient received expired dose with no reported adverse event; Initial information received on 13-Oct...
patient received expired dose with no reported adverse event; Initial information received on 13-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient who received expired dose of influenza trivalent recombinant vaccine [flublok TIV] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2025, the patient received 0.5 ml of suspect influenza trivalent recombinant vaccine Solution for injection of standard strength, frequency once with lot U8440AA and expiry date 30-APR-2025 via intramuscular route in the arm NOS (Not otherwise specified) with no reported adverse event (Expired product administered) (Latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2866146 | F | MN | 10/15/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete cours...
Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete course of vaccination
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never received the second dose; The patient developed Shingles; This non-serious case was reported b...
never received the second dose; The patient developed Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and did not receive 2nd dose of Shingrix. In AUG-2025, more than 2 years after receiving Shingrix, the patient experienced shingles (Verbatim: The patient developed Shingles ). The patient experienced incomplete course of vaccination (Verbatim: never received the second dose). The outcome of the shingles was unknown and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 03-OCT-2025 The patient received the first dose of Shingrix in 2018 and never received the second dose. The patient developed Shingles in the beginning of AUG 2025. The batch number was not provided, and we are unable to contact the reporter.
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| 2866147 | MN | 10/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Missed dose; This non-serious case was reported by a consumer via call center representative and des...
Missed dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 86-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2019). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: Missed dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date:10-OCT-2025 The reporter was the patient who received her first dose of Shingrix in 2019 and did not go back for the second dose.
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| 2866148 | F | 10/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Drug dose administered interval to long; This non-serious case was reported by a consumer via call c...
Drug dose administered interval to long; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2020). 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 drug dose administration interval too long (Verbatim: Drug dose administered interval to long). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date:10-OCT-2025 The patient received the first dose of Shingrix in 2020 and the second dose on 2025.
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| 2866149 | 10/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pain in extremity
Pain in extremity
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sore arm; This non-serious case was reported by a consumer via interactive digital media and describ...
sore arm; This non-serious case was reported by a consumer via interactive digital media 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 Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was resolved. The reporter considered the pain in arm to be related to Shingrix. The company considered the pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 05-OCT-2025 This case was reported by a patient via interactive digital media. Patient received fifth booster dose. Patient believed that having sore arm this time was due to Shingrix. Patient never tested positive for Covid and never had shingles painful lesions. The batch number was not provided and unable to contact the reporter.
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| 2866151 | M | 10/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Extra dose administered
Extra dose administered
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received 3rd dose of Shingrix; This non-serious case was reported by a pharmacist via interactive di...
received 3rd dose of Shingrix; This non-serious case was reported by a pharmacist via interactive digital media and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received 3rd dose of Shingrix). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date:09-OCT-2025 This case was reported by a consumer via interactive digital media. The patient received late 2nd dose of Shingrix. Patient received a third dose of Shingrix and it was considered a non-serious case.
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| 2866154 | F | NE | 10/15/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
9PT2F |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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(Infanrix) to a 46 year old patient; This non-serious case was reported by a other health profession...
(Infanrix) to a 46 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 46-year-old female patient who received DTPa (Infanrix) (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis. On 01-OCT-2025, the patient received Infanrix. On 01-OCT-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: (Infanrix) to a 46 year old patient). The outcome of the inappropriate age at vaccine administration 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: 02-OCT-2025 Medical assistant ended up giving a vaccines for children shot for children (Infanrix) to a 46 year old patient on 01 Oct 2025.
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| 2866155 | NJ | 10/15/2025 |
MENB MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
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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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received 1st and 2nd dose at 8 and 9 years of age; Bexsero late third dose; This non-serious case wa...
received 1st and 2nd dose at 8 and 9 years of age; Bexsero late third dose; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 16-year-old patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis and Men B NVS (Bexsero) for prophylaxis. On 02-OCT-2025, the patient received the 3rd dose of Bexsero. On an unknown date, the patient received the 2nd dose of Bexsero and the 1st dose of Bexsero. On 02-OCT-2025, an unknown time after receiving Bexsero and not applicable after receiving Bexsero and Bexsero, the patient experienced drug dose administration interval too long (Verbatim: Bexsero late third dose). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: received 1st and 2nd dose at 8 and 9 years of age). The outcome of the drug dose administration interval too long and inappropriate age at vaccine administration were 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: 04-OCT-2025 The physician reported that the Patient received 1 dose of Bexsero at age 8, 1 dose at age 9 and, 1 dose at age 16. The reporter was ask should patient receive another dose of Bexsero.
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| 2866156 | 10/15/2025 |
COVID19 FLUX |
MODERNA UNKNOWN MANUFACTURER |
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Fatigue, Headache, Pain in extremity; Fatigue, Headache, Pain in extremity
Fatigue, Headache, Pain in extremity; Fatigue, Headache, Pain in extremity
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left arm is experiencing significant soreness; fatigue; Light headache; This spontaneous case was re...
left arm is experiencing significant soreness; fatigue; Light headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm is experiencing significant soreness), FATIGUE (fatigue) and HEADACHE (Light headache) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. On 09-Oct-2025 at 5:00 AM, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form. On 09-Oct-2025 at 5:00 PM, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In October 2025, the patient experienced PAIN IN EXTREMITY (left arm is experiencing significant soreness), FATIGUE (fatigue) and HEADACHE (Light headache). At the time of the report, PAIN IN EXTREMITY (left arm is experiencing significant soreness), FATIGUE (fatigue) and HEADACHE (Light headache) outcome was unknown. No concomitant medication was reported. Patent received Spikevax dose yesterday at 5 pm. Patient took it alongside the flu vaccine. patient left arm was experiencing significant soreness. Patient was also experiencing fatigue and a light headache. No treatment information was reported.
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| 2866157 | 66 | F | 10/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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Back pain, Vaccination site nodule
Back pain, Vaccination site nodule
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Local knot at site of injection 2-3 days post vaccine; Muscle pain around back that began after vacc...
Local knot at site of injection 2-3 days post vaccine; Muscle pain around back that began after vaccination and continues; This is a spontaneous report received from a Pharmacist from a sales representative. A 66-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 25Sep2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: TIRZEPATIDE. Past drug history included: Morphine, reaction(s): "Morphine: Allergy". The following information was reported: VACCINATION SITE NODULE (non-serious) with onset 26Sep2025, outcome "recovered", described as "Local knot at site of injection 2-3 days post vaccine"; BACK PAIN (non-serious) with onset 26Sep2025, outcome "not recovered", described as "Muscle pain around back that began after vaccination and continues". Therapeutic measures were not taken as a result of vaccination site nodule, back pain. Additional information: Did the patient receive any other vaccines on the same date as the vaccine(s) for which you are reporting?: No. Did the patient receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting?: No. Were you/Was the patient taking any other medications within 2 weeks of the event starting?: Yes. The reported Event: Local knot at site of injection 2-3 days post vaccine (resolved); muscle pain around back that began after vaccination and continued. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2866158 | M | 10/15/2025 |
RSV |
PFIZER\WYETH |
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Arthralgia, Pain in extremity
Arthralgia, Pain in extremity
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Knee pain that is killing him/knees are killing me, my knees and down my legs/Joint pain; This is a ...
Knee pain that is killing him/knees are killing me, my knees and down my legs/Joint pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Oct2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 11Oct2025, outcome "unknown", described as "Knee pain that is killing him/knees are killing me, my knees and down my legs/Joint pain". Additional information: caller experienced some knee pain that is killing him. It appeared after getting the RSV shot, so he'd like to know if it may be related to this vaccine. He received the RSV vaccine on Friday, and it seemed fine at first. Then, the pain appeared and it's killing him. He read the PI the pharmacist gave him, and he found that it may cause joint pain. The patient had a question, that he got that RSV shot that Pfizer makes, he got that on Friday. Saturday morning he went to get up and his knees are killing him, his knees and down his legs and he looked up some of the side effects and it says could cause joint pain. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2866159 | M | NY | 10/15/2025 |
PNC20 |
PFIZER\WYETH |
LN4928 |
Injection site cellulitis, Injection site erythema, Injection site pain, Injecti...
Injection site cellulitis, Injection site erythema, Injection site pain, Injection site rash
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Erythema to the injection site; Cellulitis at the injection site; Tenderness; Itching; Rash; This is...
Erythema to the injection site; Cellulitis at the injection site; Tenderness; Itching; Rash; This is a spontaneous report received from a Consumer or other non HCP. An 87-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4928) for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Erythema to the injection site"; VACCINATION SITE CELLULITIS (non-serious), outcome "unknown", described as "Cellulitis at the injection site"; TENDERNESS (non-serious), outcome "unknown"; PRURITUS (non-serious), outcome "unknown", described as "Itching"; RASH (non-serious), outcome "unknown". Additional information: an 87 years old patient that has a ton of medication so that's all irrelevant reactions. When probed for the Lab test and event details, reporter stated: I am just going to think it came, it happened like couple of days after the vaccine so, within 3 to 4 days, they had a reaction all 3.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500202794 same reporter/drug/event, different patient;US-PFIZER INC-202500202833 same reporter/drug/event, difference patient;
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| 2866160 | F | 10/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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Vaccination site erythema, Vaccination site pruritus
Vaccination site erythema, Vaccination site pruritus
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mild Itching and redness at the covtd shot Injection site/similar reactions with previous covid vacc...
mild Itching and redness at the covtd shot Injection site/similar reactions with previous covid vaccines; mild Itching and redness at the covtd shot Injection site/similar reactions with previous covid vaccines; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-021146 (BioNTech), 2025SA138951 (SANOFI). A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "mild Itching and redness at the covtd shot Injection site/similar reactions with previous covid vaccines". Batch/lot number is not provided, and it cannot be obtained.
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| 2866161 | 10/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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Musculoskeletal stiffness
Musculoskeletal stiffness
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The patient neck felt stiff and tight to turn it; This is a spontaneous report received from a Consu...
The patient neck felt stiff and tight to turn it; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), (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: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "The patient neck felt stiff and tight to turn it". Additional information: It was reported chat question verbatim1: Could covid vaccine have caused osteoarthritis? The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2866162 | 51 | F | PA | 10/15/2025 |
COVID19 COVID19 FLUX FLUX |
PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Body temperature increased, Chills, Fatigue, Heart rate increased, Nausea; Pain;...
Body temperature increased, Chills, Fatigue, Heart rate increased, Nausea; Pain; Body temperature increased, Chills, Fatigue, Heart rate increased, Nausea; Pain
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Addition of nausea the next morning; Within 8 hours chills, body aches and fatigue; Within 8 hours c...
Addition of nausea the next morning; Within 8 hours chills, body aches and fatigue; Within 8 hours chills, body aches and fatigue; Within 8 hours chills, body aches and fatigue; Elevated heart rate and temp at night; Elevated heart rate and temp at night; This is a spontaneous report received from a Consumer or other non HCP. A 51-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 13Oct2025 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 13Oct2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "anal cancer" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN topical; PROGESTERONE; ESTRADIOL. The following information was reported: HEART RATE INCREASED (non-serious), BODY TEMPERATURE INCREASED (non-serious) all with onset 13Oct2025 at 18:00, outcome "not recovered" and all described as "Elevated heart rate and temp at night"; CHILLS (non-serious), PAIN (non-serious), FATIGUE (non-serious) all with onset 13Oct2025 at 18:00, outcome "not recovered" and all described as "Within 8 hours chills, body aches and fatigue"; NAUSEA (non-serious) with onset 14Oct2025, outcome "not recovered", described as "Addition of nausea the next morning". Therapeutic measures were taken as a result of chills, pain, fatigue, heart rate increased, body temperature increased, nausea. Additional information: The patient received Advil as treatment for the events. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2866163 | 10/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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Eructation
Eructation
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burping; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and...
burping; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 13Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, single; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4, single; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 5, single; unknown manufacturer), for COVID-19 immunization. The following information was reported: ERUCTATION (non-serious) with onset 13Oct2025, outcome "unknown", described as "burping". Additional information: the patient took a shot yesterday (13Oct2025) and last night started burping. Patient was burping today and it's unusual because patient have never had that before. Patient have had shots previously about five times they think and never had burping problem. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2866164 | 72 | F | MD | 10/15/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2210 |
Headache, Tinnitus
Headache, Tinnitus
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had a slight headache every time; tinnitus/it gets worse every time I get a covid vaccine; This is a...
had a slight headache every time; tinnitus/it gets worse every time I get a covid vaccine; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 16Oct2024 as dose 1, 0.3 ml, single (Lot number: LM2210) at the age of 72 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, 0.3 mL, SINGLE, Lot number: FG3527, Intramuscular in the right arm), administration date: 08Nov2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "Headache", "Tinnitus"; BNT162b2 (DOSE 2, 0.3 mL, SINGLE, Lot number: GJ3277, Intramuscular in the right arm), administration date: 12Oct2022, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "Headache", "tinnitus/it gets worse every time I get a covid vaccine"; BNT162b2 (DOSE 3 (BOOSTER), 0.3 mL, SINGLE, Lot number: HG2282, Intramuscular in the left arm), administration date: 09Oct2023, when the patient was 71-year-old, for COVID-19 Immunization, reaction(s): "Headache", "tinnitus/it gets worse every time I get a covid vaccine"; BNT162b2 (DOSE 4 (BOOSTER), 0.3 mL, SINGLE, Lot number: HN0477, Intramuscular in the right arm), administration date: 24Apr2024, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "Headache", "tinnitus/it gets worse every time I get a covid vaccine". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "had a slight headache every time"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus/it gets worse every time I get a covid vaccine". Additional information: The patient experienced headache which has been her reaction to previous COVID-19 vaccines. She has a slight headache every time. Also, she experienced tinnitus and it got worse every time she gets a COVID vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500192477 same patient/suspect vaccine; different dose; similar events;
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| 2866165 | 10/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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Vaccination site pain
Vaccination site pain
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tenderness at injection site; This is a spontaneous report received from a Consumer or other non HCP...
tenderness at injection site; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789963 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "tenderness at injection site". Additional information: Consumer describes the occurrence of VACCINATION SITE PAIN (tenderness at injection site) in a patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Pfizer BioNTech COVID-19 vaccine for an unknown indication. No Medical History information was reported. No concomitant medications were reported. The patient had COVID vaccinations since they first started coming out, and probably the patient had the most recent one or something within the past year (1 year and a half or something like that). The patient had received last dose last year (2024) or two years ago (2023). The patient did not have any reactions to any of the vaccinations of any kind, particularly in relation to flu vaccines and the COVID vaccines that the patient been getting fairly frequently. Patient had tenderness at the injection site in some cases and for few times, the patient did not have any reaction. Treatment medication was not reported. Batch/lot number is not provided, and it cannot be obtained.
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| 2866166 | F | 10/15/2025 |
COVID19 FLUX VARZOS |
PFIZER\BIONTECH UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS |
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Headache, Pain; Headache, Pain; Headache, Pain
Headache, Pain; Headache, Pain; Headache, Pain
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headaches and body aches; headaches and body aches; This is a spontaneous report received from a Con...
headaches and body aches; headaches and body aches; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier(s): 2025SA281951 (Sanofi). A 65-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since 08Sep2025 at 600 mg (600 mg ( 1x)), subcutaneous for dermatitis atopic; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), PAIN (non-serious) all with onset 16Sep2025, outcome "not recovered" and all described as "headaches and body aches". The action taken for dupilumab was unknown. Additional information: On 16Sep2025 the patient developed a non-serious event "headaches and body aches" (pain) (headache) (latency: 8 days following the first dose intake of DUPILUMAB, (unknown latency Covid-19 Vaccine, Influenza Vaccine and Shingles Vaccine. (unknown batch number and expiry date for all events). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "patient reports headaches and body aches since 16Sep2025 after receiving shingles, influenza, and covid-19 vaccines, ongoing, unknown if md (medical doctor) is aware." It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Not Recovered / Not Resolved for both the events. Company causality for drug DUPIXENT and events reported as related. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2866167 | 10/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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Asthenia, Chills, Headache, Pain, Pyrexia
Asthenia, Chills, Headache, Pain, Pyrexia
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headache; chills; fever/night fever; body aches; weak; This is a spontaneous report received from a ...
headache; chills; fever/night fever; body aches; weak; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789973 (Moderna), AE-00230870 (Moderna), AE-00230887 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Nov2024, outcome "recovered", described as "body aches"; PYREXIA (non-serious) with onset Nov2024, outcome "recovered", described as "fever/night fever"; HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; ASTHENIA (non-serious), outcome "unknown", described as "weak". Additional information: Day of suspect product administration and onset date of both events (Nov2024). caller informed that had side effects from previous Pfizer OVID-19 vaccine that took last Nov2024. Caller stated that had fever and body aches on the day of vaccination. Batch/lot number is not provided, and it cannot be obtained.
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| 2866169 | 69 | F | MD | 10/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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Headache, Tinnitus
Headache, Tinnitus
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headache; tinnitus; This is a spontaneous report received from a Consumer or other non HCP. A 73-ye...
headache; tinnitus; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old female patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown". Additional information: The patient had her first covid shot on 06Apr2021 and had a slight headache every time. Also, the patient had tinnitus, and it gets worse every time she gets a covid vaccine.
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| 2866171 | 74 | M | TX | 10/15/2025 |
UNK |
UNKNOWN MANUFACTURER |
407268 |
Needle issue, Underdose
Needle issue, Underdose
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Did not receive all the dosage, he received only about half the dosage; During the vaccination the p...
Did not receive all the dosage, he received only about half the dosage; During the vaccination the product leaked from the needle; This spontaneous case, initially received on 03-Oct-2025, was reported by a health professional and concerns an elderly male patient. Concomitant medications and medical history were unknown. Administration of company suspect drug: On 03-Oct-2025, the patient received Fluad (TIV) for Immunization for the prevention of influenza disease, Dose regimen: Not reported, Route of Administration: Not Reported, Anatomical location: Not Reported, Lot number: 407268. No additional suspect drugs. Adverse reactions/events and outcomes: On 03-Oct-2025, same day of vaccination, the patient Did not receive all the dosage, he received only about half the dosage (outcome: Unknown, stop date: 03-Oct-2025), During the vaccination the product leaked from the needle (outcome: Unknown, stop date: 03-Oct-2025). The pharmacist tried to vaccinate patient with Fluad at the time of vaccination the product leaked from the needle and the patient did not receive all the dosage, he received only about half the dosage. Pharmacist reported this could happen because or needle was not well attached or it was defective. How many defective units? 1 Was the dose administered? Yes, partially Is the complaint sample available? unknown The defect was noticed during the administration. It was unknown if the plunger was depressed/not depressed. It was unknown if the needle shield was in place. The location of the leak was unknown. It was unknown if there were any signs of damage on the syringe and on the needle. The needle used was the pre-filled syringe (PFS) manufacturer. It was unknown if the needle appeared tightly attached. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter (pharmacist) did not provide a seriousness or causality assessment for events Did not receive all the dosage, he received only about half the dosage, During the vaccination the product leaked from the needle.; Reporter's Comments: Events Did not receive all the dosage, he received only about half the dosage, During the vaccination the product leaked from the needle assessed not related due to events nature (special situation).
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| 2866172 | 70 | M | CO | 10/15/2025 |
SMALLMNK SMALLMNK |
BAVARIAN NORDIC BAVARIAN NORDIC |
96868 96868 |
Arteriogram carotid, Computerised tomogram head, Condition aggravated, Diplopia,...
Arteriogram carotid, Computerised tomogram head, Condition aggravated, Diplopia, Magnetic resonance imaging head; Speech disorder, Urine analysis
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Increased speech deficit, R eye dipolopia. ER visit 10/10/25 and 10/11/25 with admission until 10/12...
Increased speech deficit, R eye dipolopia. ER visit 10/10/25 and 10/11/25 with admission until 10/12/25. Described at that time 3-4 day history of symptoms. Underwent CT head, CT angio head and neck, MRI brain, u/a. Neurology consultation (felt could be psychogenic but noted no new life stressors) vs recrudescence of prior stroke. Improvement by 10/12/25.
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| 2866173 | 57 | M | MD | 10/15/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
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Swelling face; Swelling face
Swelling face; Swelling face
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Swelling on left size of face
Swelling on left size of face
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| 2866174 | 11 | M | NY | 10/15/2025 |
FLUN3 FLUN3 |
MEDIMMUNE VACCINES, INC. MEDIMMUNE VACCINES, INC. |
YF3413B YF3413B |
Cough, Headache, Influenza, Malaise, Pyrexia; Respiratory symptom
Cough, Headache, Influenza, Malaise, Pyrexia; Respiratory symptom
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The patient developed symptoms on 10/12/2025 in the morning - fever, headache, malaise, nasal sympto...
The patient developed symptoms on 10/12/2025 in the morning - fever, headache, malaise, nasal symptoms and now a cough.
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| 2866176 | 78 | M | WA | 10/15/2025 |
PNC21 |
MERCK & CO. INC. |
Z009681 |
Dizziness, Vision blurred
Dizziness, Vision blurred
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Patient experience blurred vision and dizziness the following day. No treatment was needed.
Patient experience blurred vision and dizziness the following day. No treatment was needed.
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| 2866177 | 62 | F | AZ | 10/15/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3052731 3052731 |
Depression, Erythema, Pharyngitis, Pyrexia, Throat irritation; Tongue coated
Depression, Erythema, Pharyngitis, Pyrexia, Throat irritation; Tongue coated
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Redness spreading down from injection sit eto forearm/elbow, throat irritation/infection, tongue whi...
Redness spreading down from injection sit eto forearm/elbow, throat irritation/infection, tongue white/thrush like symptoms along with fever
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| 2866179 | 41 | F | FL | 10/15/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
tfaa2502 tfaa2502 |
Dizziness, Dysphagia, Dyspnoea, Feeling hot, Flushing; Pharyngeal swelling, Tach...
Dizziness, Dysphagia, Dyspnoea, Feeling hot, Flushing; Pharyngeal swelling, Tachycardia, Throat tightness
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The patient came into the pharmacy today and wanted to report that she had a reaction to the vaccine...
The patient came into the pharmacy today and wanted to report that she had a reaction to the vaccine on July 29, 2025. 20-30 seconds after the vaccine the patient experienced flushing, tachycardia, difficulty breathing, tightness in the throat with difficulty swallowing or swelling and feeling hot. The pharmacy called 911 and an ambulance arrived within 4-5 minutes. July 30 the patient went to her primary MD (withheld); MD (withheld) confirmed a reaction to the vaccine and sent in a prescription for an EpiPen. Finally she went to an allergist (name withheld); he confirmed her reaction. The patient still complains of tachycardia, SOB and dizziness.
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| 2866181 | 3 | F | MD | 10/15/2025 |
COVID19 |
PFIZER\BIONTECH |
na0846 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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patient got comirnaty instead of spikevax - no symptoms
patient got comirnaty instead of spikevax - no symptoms
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| 2866182 | 4 | F | MD | 10/15/2025 |
COVID19 |
PFIZER\BIONTECH |
na0846 |
Wrong product administered
Wrong product administered
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no symptoms - patient got comirnaty instead of spikevax
no symptoms - patient got comirnaty instead of spikevax
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| 2866183 | 71 | M | ID | 10/15/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
MY9550 UT8763FA |
Injection site pain, Injection site rash; Injection site pain, Injection site ra...
Injection site pain, Injection site rash; Injection site pain, Injection site rash
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Patient received the capvaxive vaccine in his right deltoid on monday 10/13. Today on 10/15 patient ...
Patient received the capvaxive vaccine in his right deltoid on monday 10/13. Today on 10/15 patient came in due to having a rash a few inches in diameter around the spot of the injection. He also noted that it is still sore. He says he is doing fine and just wanted to report the reaction.
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| 2866184 | 61 | F | MI | 10/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7YD42 |
Burning sensation, Rash, Rash pruritic
Burning sensation, Rash, Rash pruritic
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patient started getting rash on back of her neck 6-8 hours later after receiving shingles vaccine. i...
patient started getting rash on back of her neck 6-8 hours later after receiving shingles vaccine. it was burning and itching at that time. patient started using cortisone cream and it helped a lot. patient called pharmacy on Monday and her symptoms were improved. as per recent conversation on 10/15/25. patients symptoms got significantly improved. it's not burning anymore but still itching little bit. patient took benadryl. she feels it spreaded little bit around the same spot, patient thinks it might be because she was itching. no concern at pt's side at this moment. she will contact us or her dr for if she has any concern
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| 2866185 | 60 | F | VT | 10/15/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
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No adverse event, Refusal of vaccination; No adverse event, Refusal of vaccinati...
No adverse event, Refusal of vaccination; No adverse event, Refusal of vaccination
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Patient was only planning on receiving a flu vaccine while she was at the workplace clinic. There wa...
Patient was only planning on receiving a flu vaccine while she was at the workplace clinic. There was a miscommunication and provider thought that she said she was looking for both covid and flu vaccines. Covid vaccine was administered first, then when flu was prepped, the error was discovered. Patient did receive the flu vaccine as planned. Pt did not require treatment and did not have symptoms at administration. An apology was given to the patient and confirmation that she would check in if any adverse events or symptoms occurred in the following few days.
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| 2866186 | 76 | F | VA | 10/15/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052296 U8800BA |
Injection site pain, Injection site swelling; Injection site pain, Injection sit...
Injection site pain, Injection site swelling; Injection site pain, Injection site swelling
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PATIENT GOT THE COVID AND FLU VACCINES ON 09/29/25 AND 2 HOURS AFTER THE INJECTION, THE INJECTION SI...
PATIENT GOT THE COVID AND FLU VACCINES ON 09/29/25 AND 2 HOURS AFTER THE INJECTION, THE INJECTION SITE WERE SWOLLEN AND VERY PAINFUL. PATIENT HAS BEEN TRYING HEAT/COLD PATCHES ALONG WITH ALEVE, BUT IT IS STILL DID NOT HELP.
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| 2866216 | 82 | M | GA | 10/15/2025 |
FLU3 |
SANOFI PASTEUR |
U8855BA |
Injection site bruising
Injection site bruising
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PATIENT CAME BY THE PHARMACY TO INQUIRE ABOUT HIS ARM, WHICH HAD A PURPLE BRUISE AT THE INJECTION SI...
PATIENT CAME BY THE PHARMACY TO INQUIRE ABOUT HIS ARM, WHICH HAD A PURPLE BRUISE AT THE INJECTION SITE OF THE FLU VACCINE. PATIENT STATED THAT THIS STARTED TO OCCUR 2-3 DAYS AFTER RECEIVING VACCINE AND IS NOT TAKING ANY BLOOD THINNERS, AND IS NOT IN ANY PAIN.
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| 2866217 | 64 | F | SC | 10/15/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
u8790aa z010761 |
Abdominal pain, Pruritus, Pyrexia, Rash; Abdominal pain, Pruritus, Pyrexia, Rash
Abdominal pain, Pruritus, Pyrexia, Rash; Abdominal pain, Pruritus, Pyrexia, Rash
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pt said she had abdominal pain, fever, rash on left arm, and a lot of itching-fever and abdominal pa...
pt said she had abdominal pain, fever, rash on left arm, and a lot of itching-fever and abdominal pain have gone away but rash, itching is still present
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| 2866219 | 16 | F | ID | 10/15/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
na0590 tfaa2547 |
Syncope; Syncope
Syncope; Syncope
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Fainted within a few minutes of receiving vaccination. She was given water and apple juice and sat...
Fainted within a few minutes of receiving vaccination. She was given water and apple juice and sat with her father until she felt better then went home
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| 2866220 | 23 | F | CA | 10/15/2025 |
COVID19 |
MODERNA |
3052550 |
Product preparation error, Underdose
Product preparation error, Underdose
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patient was administered only half a dose because the remaining part of the dose was frozen.
patient was administered only half a dose because the remaining part of the dose was frozen.
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| 2866221 | 79 | F | CA | 10/15/2025 |
FLU3 |
SANOFI PASTEUR |
UT8763HA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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At time of scheduling patent for COVID vaccine asked POA if he wanted flu vaccine at that time must ...
At time of scheduling patent for COVID vaccine asked POA if he wanted flu vaccine at that time must have missed understood due to him saying yes, I scheduled pt reviewed PT history and did not see previous dose of HD flu given on 09/23/2025 and scheduled PT for COVID and flu vaccine, at time of administration I introduced myself and explained to PT and caregiver that I will be given two injections 1. COVID and 2. HD FLU provided education on common side effects and what to do in case of adverse effects, after receiving injections I remained with PT for 15-20mins did not observe any adverse signs or symptoms, re-enforced education previously provided thanked PT and care giver for allowing me to come in their home and the opportunity to provide care, on 10/14/2025 after being informed by my management staff I Called son POA for follow up, son states that mother was ok no adverse effects or concerns were noted at time of call, no treatments needed per son .
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| 2866222 | 64 | M | MI | 10/15/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052735 U8859CA |
Incorrect dose administered, No adverse event; Incorrect dose administered, No a...
Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event
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No Patient adverse event reported. VAERS report is being completed because the patient was not 65 ...
No Patient adverse event reported. VAERS report is being completed because the patient was not 65 at time of vaccination with Fluzone High Dose (64yr)
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| 2866223 | 45 | F | AL | 10/15/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
9FG5M |
Herpes zoster, Pain, Pyrexia, Rash
Herpes zoster, Pain, Pyrexia, Rash
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The patient started having a fever and a rash on her body on Saturday, October 2nd. The patient stat...
The patient started having a fever and a rash on her body on Saturday, October 2nd. The patient stated she was in a lot of pain. This was 2 days after she received the flu vaccine. Treatment is unknown but she did contact her doctor and the doctor stated she had shingles and it may have been brought on from receiving the flu vaccine.
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| 2866224 | 77 | F | IL | 10/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5A4XG |
Rash
Rash
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PATIENT DESCRIBES RASH COVERING RIGHT ARM AFTER VACCINATION
PATIENT DESCRIBES RASH COVERING RIGHT ARM AFTER VACCINATION
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| 2866226 | 60 | M | FL | 10/15/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4457 |
Extra dose administered
Extra dose administered
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Patient received 2 of the new covid shots in subsequent months
Patient received 2 of the new covid shots in subsequent months
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| 2866228 | 76 | F | FL | 10/15/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
bg5j4 |
Extra dose administered
Extra dose administered
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patient received 2 doses of RSV vaccine over one year apart. this is a once a lifetime vaccine
patient received 2 doses of RSV vaccine over one year apart. this is a once a lifetime vaccine
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| 2866229 | 68 | F | NC | 10/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
342xp |
Arthralgia, Pain in extremity
Arthralgia, Pain in extremity
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Patient presented to the pharmacy on 09/23/25 complaining of pain in left shoulder and arm. Patient ...
Patient presented to the pharmacy on 09/23/25 complaining of pain in left shoulder and arm. Patient stated had seen/was seeing a doctor for treatment. This was the first notification the pharmacy had received in regards to any adverse events.
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