chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: accidentally only gave the adjuvant and not the actual vaccine itself; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ3N3, expiry date 17-APR-2026) for prophylaxis.   On 19-SEP-2024, the patient received the 2nd dose of Shingrix. On 19-SEP-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: accidentally only gave the adjuvant and not the actual vaccine itself) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 20-SEP-2024 Yesterday (the day before reporting) the patient was giving a Shingrix vaccine and accidentally only gave the adjuvant and not the actual vaccine itself, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered Consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: pt got first dose of shingrix in october 2021 do they need to start over with the 2 shot series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: pt got first dose of shingrix in october 2021 do they need to start over with the 2 shot series). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 20-SEP-2024 Pharmacist reported if patient got first dose of shingrix in october 2021 do they need to start over with the 2 shot series Till the time of reporting the patient did not received 2nd dose, which led to incomplete course of vaccination. Did not consent to follow-up.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: after a week it is still sore/ it's unbearable; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in a 57-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5YB5G, expiry date 09-OCT-2026) for prophylaxis.   On 14-SEP-2024, the patient received Boostrix (right arm). In SEP-2024, an unknown time after receiving Boostrix, the patient experienced pain (Verbatim: after a week it is still sore/ it's unbearable). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the pain 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: 20-SEP-2024 The pharmacist reported a patient received a dose of Boostrix and after a week it was still sore and the pharmacist thought the placement of the dose was good, but patient was reporting as it was unbearable.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received 2 doses of Arexvy vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 77-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3372J, expiry date 17-AUG-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 08-DEC-2023).   On 17-SEP-2024, the patient received the 2nd dose of Arexvy. On 17-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received 2 doses of Arexvy vaccine). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2024 The pharmacist reported about the administration of 2 doses of Arexvy vaccine to the patient, which led to an extra dose administered. The patient mentioned not having side effects after the administration of a 2nd dose (patient was in the pharmacy and mentioned that got no fever, pain or other side effects). The pharmacist mentioned that providers should be educated on the dosing schedule to not suggest the patients to receive an extra dose. The vaccine administration facility was the same as primary reporter. This case had been linked with US2024117150, reported by the same reporter.; Sender's Comments:  US-GSK-US2024117150:DIFFERENT PT SAME REPORTER
Age: 95.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient received 2 doses of Arexvy vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 95-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3372J, expiry date 17-AUG-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 27-NOV-2023).   On 17-SEP-2024, the patient received the 2nd dose of Arexvy. On 17-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received 2 doses of Arexvy vaccine). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2024 The pharmacist reported about the administration of 2 doses of Arexvy vaccine to the patient, which led to an extra dose administered. The pharmacist mentioned that providers should be educated on the dosing schedule to not suggest the patients to receive an extra dose. The vaccine administration facility was the same as primary reporter. This case had been linked with US2024117148, reported by the same reporter.; Sender's Comments:  US-GSK-US2024117148:DIFFERENT PT SAME REPORTER
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: she did not fully administered the dose of the shingrix vaccine; she did not fully administered the dose of the shingrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) (batch number XK5HC, expiry date 16-MAY-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: she did not fully administered the dose of the shingrix vaccine) and inappropriate dose of vaccine administered (Verbatim: she did not fully administered the dose of the shingrix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-SEP-2024 The reporter was Medical Assistant. The reporter was just calling because he/she had a question, they had the Shingrix vaccine within our office, a patient came and she was only given, she did not fully administered the dose of the Shingrix vaccine; cause there were two vials, one with the powder and one with the liquid and the liquid was the only one that was given, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: She received it 2 weeks after her first dose instead of 30 days; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received HBV (Engerix B pediatric) (batch number 42b22, expiry date 07-MAR-2026) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b pediatric).   On an unknown date, the patient received the 2nd dose of Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric and not applicable after receiving Engerix b pediatric, the patient experienced drug dose administration interval too short (Verbatim: She received it 2 weeks after her first dose instead of 30 days). The outcome of the drug dose administration interval too short was unknown.   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: 20-SEP-2024 The reporter reported that the patient received the second dose of Engerix B pediatric B earlier than the recommended interval, which led to shortening of vaccine schedule. She received it 2 weeks after her first dose instead of 30 days. The case was linked with case US2023136420 reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2023136420:same reporter, different patient and product
Sex: F
Vaccine: VARZOS
Symptoms: Genital rash, Herpes zoster, Rash vesicular
Clinical narrative: diagnosed with shingles; rash with blisters in her crotch area; rash with blisters in her crotch area; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included INFLUENZA VACCINE.   On 11-SEP-2024, the patient received the 1st dose of Shingrix (left arm). On 16-SEP-2024, 5 days after receiving Shingrix, the patient experienced shingles (Verbatim: diagnosed with shingles), genital blister (Verbatim: rash with blisters in her crotch area) and genital rash (Verbatim: rash with blisters in her crotch area). The patient was treated with aciclovir (Acyclovir). The outcome of the shingles, genital blister and genital rash were not reported.   It was unknown if the reporter considered the shingles, genital blister and genital rash to be related to Shingrix.     It was unknown if the company considered the shingles, genital blister and genital rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-SEP-2024 The patient self reported this case. The patient received her Shingrix vaccine and then she noticed a rash with blisters in her crotch area.  The patient was diagnosed with shingles. The patient was prescribed Acyclovir (unknow dose/strength) for treatment of shingles.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: he has not received the 2nd 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 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about a year ago he had an episode of Shingles on the right side of the head). Previously administered products included Shingrix (on an unknown date received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: he has not received the 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 20-SEP-2024 The patient received the 1st dose of Shingrix at a local pharmacy.  The vaccine administration date was unknown.   The patient reported that it had been more than 6 months, and not received the 2nd dose, which led to incomplete course of vaccination. Patient reported he was not aware that he needed a second dose.  Patient reported that before getting his 1st dose of Shingrix, about a year ago he had an episode of Shingles on the right side of the head.  The patient reported that the Shingles condition invaded his right eye and the ophthalmologist stated that the eye had to be removed before shingles reached the brain.   No additional information was reported. Consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient was given saline in lieu of the adjuvant; Patient was given saline in lieu of the adjuvant; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: Patient was given saline in lieu of the adjuvant) and inappropriate dose of vaccine administered (Verbatim: Patient was given saline in lieu of the adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 20-SEP-2024 The patient was given saline in lieu of the adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The reporter wanted to knew if they need to re-vaccinate, the recommended timing to do so and if was safe to re-vaccinate.. Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number LY93M, expiry date 09-JUN-2026) for prophylaxis.   Concurrent medical conditions included als.   On 17-SEP-2024, the patient received the 1st dose of Shingrix. On 17-SEP-2024, less than a day after receiving Shingrix, the patient experienced pain (Verbatim: Pain). In SEP-2024, the outcome of the pain was resolved (duration 3 days).   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-SEP-2024 The pharmacist contacted GSK requesting information about the administration of the second dose of Shingrix to a patient who was suffering ALS, who received the first dose and mentioned that they presented pain for the following three days.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (sinus infection) in a 79-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Sinus infection.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AMOXCLAV [AMOXICILLIN;CLAVULANIC ACID]) for Sinus infection, at an unspecified dose and frequency and CEFUROXIME for Sinus infection, at an unspecified dose and frequency. At the time of the report, SINUSITIS (sinus infection) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if any other vaccines were given in the 4 weeks prior to COVID-19 vaccine. Patient was being on a course of Amox-Clav for a sinus infection for the next 7 days, followed by Cefuroxime for an additional 10 days. The patient inquired if it is safe to receive the Moderna Covid vaccine during this period. The patient has previously received all doses of the Moderna Covid vaccine and boosters since the initial rollout.  There were no reports of adverse reactions to the prior doses of the vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2024: Non-significant follow up added. reference number was added.
Age: 70.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Diarrhoea, Illness, Vomiting
Clinical narrative: felt violently ill; diarrhea; throw up; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (felt violently ill), DIARRHOEA (diarrhea) and VOMITING (throw up) in a 70-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for Product used for unknown indication: Flu shot (Flu shot); for COVID-19 prophylaxis: Moderna. Past adverse reactions to the above products included No adverse effect with Flu shot and Moderna.   On 21-Sep-2024 at 4:00 PM, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 21-Sep-2024, the patient experienced ILLNESS (felt violently ill), DIARRHOEA (diarrhea) and VOMITING (throw up). On 22-Sep-2024, ILLNESS (felt violently ill), DIARRHOEA (diarrhea) and VOMITING (throw up) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient had no medical history, concomitant disease or risk factor.  The patient got the Moderna Covid shot along with the high dose flu shot. About 10 hours later, the patient felt violently ill and throw up several times also diarrhea. It did not last long and felt better the next day. The patient had always gotten the Moderna Covid shot and never had a reaction before. She got the Covid shot with the flu shot and never had a reaction before. She thought it was unusual that she threw up as she never threw up and was glad that she got the shot though. The patient did not experience any additional symptoms/events. No medicine was needed after the adverse event as it was resolved. There were no lab data/results reported.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test abnormal
Clinical narrative: found an "unknown antibody"; This spontaneous case was reported by a patient and describes the occurrence of ANTIBODY TEST ABNORMAL (found an "unknown antibody") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST ABNORMAL (found an "unknown antibody"). At the time of the report, ANTIBODY TEST ABNORMAL (found an "unknown antibody") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test abnormal: found an "unknown antibody".     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that in Jan-2021 and Feb-2021, patient received two covid 19 vaccinations. In the spring donated blood and 10 days later, patient received a letter stating not to donate again as they found an unknown antibody. It was also reported that earlier this year patient requested one blood to test again, and patient received the same letter. The treatment medication was not reported by reporter.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Syringe issue
Clinical narrative: When I went to connect one of mine the connector on it was broke and so therefore the diluent when I went to put it in, leaked out/I had to throw away a vaccine because the adaptor was defective; When I went to connect one of mine the connector on it was broke and so therefore the diluent when I went to put it in, leaked out/I had to throw away a vaccine because the adaptor was defective; This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM9866, Expiration Date: 31Mar2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE LEAKAGE (non-serious), outcome "unknown" and all described as "When I went to connect one of mine the connector on it was broke and so therefore the diluent when I went to put it in, leaked out/I had to throw away a vaccine because the adaptor was defective".  Additional information: The pharmacist stated, "I am a pharmacist at a drug store, and I was giving some Abrysvo vaccines today and when I went to connect one of mine the connector on it was broke and so therefore the diluent when I went to put it in, leaked out. So, I had to throw away a vaccine because the adaptor was defective. So, I did not know if there was a way to get a replacement for that for our drug store because they are so expensive. It was in a, it comes in a box of 5 kits, it comes in a box of 5 vaccines. Each vaccine is 0.5 ml."  Causality for "when i went to connect one of mine the connector on it was broke and so therefore the diluent when i went to put it in, leaked out/i had to throw away a vaccine because the adaptor was defective" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: U
Vaccine: COVID19
Symptoms: Accident at work, Device breakage, Injury associated with device
Clinical narrative: Syringe was broken upon receipt. Nurse was cut by the glass; Syringe was broken upon receipt. Nurse was cut by the glass; Syringe was broken upon receipt. Nurse was cut by the glass; This is a spontaneous report received from a Nurse.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), (Lot number: PAA226428) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), ACCIDENT AT WORK (non-serious), INJURY ASSOCIATED WITH DEVICE (non-serious) all with onset 24Sep2024, outcome "unknown" and all described as "Syringe was broken upon receipt. Nurse was cut by the glass".  Causality for "syringe was broken upon receipt. nurse was cut by the glass" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction).  Additional information: the nurse reported that the syringe was broken upon receipt and the nurse was cut by the glass. The dose was not administered to the nurse's patient.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Hyperhidrosis, Pyrexia
Clinical narrative: Bed sweats; temperature of greater than 99F; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old male patient 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: HYPERHIDROSIS (non-serious), outcome "recovered", described as "Bed sweats"; PYREXIA (non-serious), outcome "recovered", described as "temperature of greater than 99F". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was feeling normal 24hrs after injection.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400259222 same patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Tenderness
Clinical narrative: her inner left arm feels warm; her inner left arm feels warm and has a burning sensation that extends into the armpit; feels tender and the sensation extends to the right side under her chin; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 71-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TENDERNESS (non-serious) with onset Sep2024, outcome "unknown", described as "feels tender and the sensation extends to the right side under her chin"; FEELING HOT (non-serious) with onset Sep2024, outcome "unknown", described as "her inner left arm feels warm"; BURNING SENSATION (non-serious) with onset Sep2024, outcome "unknown", described as "her inner left arm feels warm and has a burning sensation that extends into the armpit".
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dry eye, Dry mouth, Dry throat, Nasal dryness
Clinical narrative: Overnight severe onset of dry mouth and throat; Overnight severe onset of dry mouth and throat; Mild eye and nose dryness; Mild eye and nose dryness; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: FR8729) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRY EYE (non-serious), NASAL DRYNESS (non-serious) all with onset 16Apr2021, outcome "not recovered" and all described as "Mild eye and nose dryness"; DRY MOUTH (non-serious), DRY THROAT (non-serious) all with onset 16Apr2021, outcome "not recovered" and all described as "Overnight severe onset of dry mouth and throat". Therapeutic measures were not taken as a result of dry mouth, dry throat, dry eye, nasal dryness.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: rashes on my arms and legs, Some of which were itchy but mostly just random small red patches; rashes on my arms and legs, Some of which were itchy but mostly just random small red patches; This is a spontaneous report received from an Other HCP.  A 43-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Sep2024 at 08:45 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), on 25Sep2024 as dose number unknown, single), in left arm for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CEPHALEXIN [CEFALEXIN], start date: 16Sep2024, stop date: 21Sep2024; TYPHOID VACCINE taken for immunisation, on 03Sep2024 as dose number unknown, single. The following information was reported: RASH ERYTHEMATOUS (non-serious), RASH PRURITIC (non-serious) all with onset 25Sep2024 at 13:15, outcome "not recovered" and all described as "rashes on my arms and legs, Some of which were itchy but mostly just random small red patches". Therapeutic measures were not taken as a result of rash erythematous, rash pruritic.  Additional information: About four hours after vaccine administration (COVID+flu), patient developed rashes on patient arms and legs. Some of which were itchy but mostly just random small red patches. The patient was taking other medications within 2 weeks of the event starting. The patient received unspecified medication in past and experienced allergy previously.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Abdominal pain upper, Back pain, Nausea
Clinical narrative: Severe upper abdominal pain with nausea; Severe upper abdominal pain with nausea; Pain radiating into back; This is a spontaneous report received from an Other HCP.  A 33-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Sep2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 25Sep2024 as dose number unknown, single), in left arm for influenza immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Lactose intolerant/allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: BACK PAIN (non-serious) with onset 26Sep2024 at 10:00, outcome "not recovered", described as "Pain radiating into back"; ABDOMINAL PAIN UPPER (non-serious), NAUSEA (non-serious) all with onset 26Sep2024 at 10:00, outcome "not recovered" and all described as "Severe upper abdominal pain with nausea". Therapeutic measures were not taken as a result of abdominal pain upper, nausea, back pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s). The patient was not taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Vaccination site pain
Clinical narrative: shoulder mobility issues; unrelenting throbbing pain in the area of bicep insertion; unrelenting throbbing pain in the area of bicep insertion; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Hypersensitivity" (unspecified if ongoing); "Hyponatremia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Vaccination; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Vaccination; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Vaccination. The following information was reported: MOBILITY DECREASED (non-serious) with onset 22Apr2022, outcome "recovered with sequelae" (01Feb2024), described as "shoulder mobility issues"; VACCINATION SITE PAIN (non-serious), PAIN (non-serious) all with onset 22Apr2022, outcome "recovered with sequelae" (01Feb2024) and all described as "unrelenting throbbing pain in the area of bicep insertion". Therapeutic measures were taken as a result of mobility decreased, vaccination site pain, pain.  Additional information: he patient did not receive any other vaccines on the same date as the vaccine and did not receive any other vaccines within 4 weeks PRIOR to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. It was reported that about a week after patient received the booster in left arm began to have shoulder mobility issues and unrelenting throbbing pain in the area of bicep insertion. Saw shoulder surgeon he prescribed PT
Age: 59.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Cold sweat, Diarrhoea, Vomiting
Clinical narrative: cold sweats; diarrhea; vomiting; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Sep2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 25Sep2024 as dose numebr unknown, single), in left arm for immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COLD SWEAT (non-serious) with onset 29Sep2024 at 06:00, outcome "recovering", described as "cold sweats"; DIARRHOEA (non-serious) with onset 29Sep2024 at 06:00, outcome "recovering", described as "diarrhea"; VOMITING (non-serious) with onset 29Sep2024 at 06:00, outcome "recovering". Therapeutic measures were not taken as a result of cold sweat, diarrhoea, vomiting. Additional information: patient had no known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Asthma, Condition aggravated
Clinical narrative: caller mentioned that after taking the RSV vaccine her asthma got triggered and she almost died; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: ASTHMA (medically significant), outcome "unknown", described as "caller mentioned that after taking the RSV vaccine her asthma got triggered and she almost died".  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Nausea
Clinical narrative: a painful nodule under my right armpit; horrible headaches; makes me nauseous; 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 (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 2024, outcome "unknown", described as "a painful nodule under my right armpit"; HEADACHE (non-serious) with onset 2024, outcome "not recovered", described as "horrible headaches"; NAUSEA (non-serious) with onset 2024, outcome "unknown", described as "makes me nauseous".  Additional information: The patient got the updated COVID-19 vaccine on 22Sep204 and had been having horrible headaches and a painful nodule under their right armpit. The nodule didn't bother them, but the headache should have been gone by now since it had already been five days. It was so bad that it made them nauseous. The patient wanted to know how long was normal for this to last so they would know when to seek a doctor.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Ischaemic stroke, Presyncope
Clinical narrative: ischemic stroke kind of thing; where felt like was going to pass out and fall on the ground; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOC20240925000009 (MODERNA).  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 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: ISCHAEMIC STROKE (medically significant) with onset 2023, outcome "unknown", described as "ischemic stroke kind of thing"; PRESYNCOPE (medically significant) with onset 2023, outcome "unknown", described as "where felt like was going to pass out and fall on the ground". The events "ischemic stroke kind of thing" and "where felt like was going to pass out and fall on the ground" required emergency room visit. Clinical course: Moderna was not authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification. This caller did not contacted Moderna before. The caller asked if Spikevax was an MRNA vaccine. Said wanted to know because recently (about a week ago) got the new Moderna Covid19 (Spikevax) and told them that did not want an MRNA vaccine because had a previous reaction with an MRNA Covid19 vaccine from Pfizer. Then realized that the person that had gotten the Spikevax vaccine was the (no reaction reported for the spouse - no AE) and in fact received Novovax so said 'disregard everything'. Did confirm that got Pfizer vaccines 2 or 3 times and reported the reaction. Stated did have a reaction to Pfizer Covid19 vaccine 'the Bivalent one' about a year and a half ago about a week after receiving the vaccine. Said it was a 'funny reaction' which consisted in what described as 'ischemic stroke kind of thing' where felt like was going to 'pass out and fall on the ground'. Also added that had to go to the ER. Mentioned this was a 'known' allergic reaction to people over 65 and that it was on (withheld). Also mentioned that few people had reported it. Confirmed once more, has not had Moderna Covid19 vaccination.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: AF (Atrial Fibrillation); This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): NOV24-00373 (Novavax).  A female patient 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: ATRIAL FIBRILLATION (medically significant) with onset 2023, outcome "unknown", described as "AF (Atrial Fibrillation)". The event "af (atrial fibrillation)" required physician office visit. Clinical course: Per consumer phone call: "Her healthcare group were not using their vaccine although some retail outlets were. She knew that AF (Atrial Fibrillation) was a remote possibility in terms of a side effect but she had currently controlled AF, and Pfizer, last year, kicked off a week of it in a progression of AF which they had to gone back to get into control. She could see that that was a lot of data in connection between A Fib and mRNA. Consumer stated that the big group health groups around her place did not have a clue. She also stated that her two cardiologists did not pay any attention to the vaccine or any of the vaccines, so they did not have any opinion on this. Consumer stated she wants to figure out which vaccine to get. Per consumer: " If efficacy was roughly the same, then probably she would do Pfizer again, just because her doctor gives it. She would like to know in the next couple of days, because she needed to figure this out soon. " Consumer stated that her health care providers do not use this vaccine so they will not spend a nanosecond researching it. Consumer stated she had read about warnings, precautions and contraindications regarding Novavax and she does not need advice on this subject. Per consumer: "Was there anyway to know if this type of vaccine was less likely to have an inflammatory response in kick of AFib than in mRNA was. Was the risk any different of setting off A Fib with this type of vaccine than the mRNA."  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Panic attack
Clinical narrative: severe anxiety; panic attacks; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), on 23Sep2024 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: PANIC ATTACK (non-serious) with onset 25Sep2024, outcome "not recovered", described as "panic attacks"; ANXIETY (non-serious) with onset 25Sep2024, outcome "not recovered", described as "severe anxiety".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Pain
Clinical narrative: chest pain; severe are pain; 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 (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "severe are pain".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: pregnancy with no reported adverse event; Initial information received on 05-Sep-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 28 years old female pregnant patient who was exposed to influenza usp trival a-b subvirion no preservative vaccine [Fluzone] with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnancy with no reported adverse event occurred at 32 weeks of pregnancy and the patient was exposed to Fluzone at 32 weeks of pregnancy, during third pregnancy trimester.  The date of last menstrual period was reported as 27-Jan-2024. The estimated due date is 02-Nov-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Sep-2024, the patient received a dose 1 of suspect Influenza usp trival a-b subvirion no preservative vaccine (lot- 4T84235A) via intramuscular route in unknown administration site (strength and expiration date: not provided) for Immunisation and pregnancy with no reported adverse event (maternal exposure during pregnancy) (latency- same day).  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Vaccine exposure during pregnancy with no reported ae; Initial information received on 05-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 33 years adult female patient who was exposed to Vaccine Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] in context of vaccine exposure during pregnancy with no reported AE (Adverse event). The reported Vaccine exposure during pregnancy with no reported AE occurred at unknown gestation period and the patient was exposed to Influenza Usp Trival A-B Subvirion No Preservative Vaccine at 31 weeks of pregnancy, during third pregnancy trimester for INFLUENZA USP Trival A-B Subvirion No Preservative Vaccine.  The date of last menstrual period was reported as 04-Feb-2024. The estimated due date is 10-Nov-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The concomitant involved was Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid [TDAP].  On 04-Sep-2024, the patient received a dose 1 of Suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot-UT8423JA) (unknown dosage and strength) via intramuscular route in unknown administration site for immunization.  On 04-Sep-2024, the patient was exposed during pregnancy with no reported AE (Adverse event) (exposure during pregnancy) (latency-same day) following the administration of Influenza Usp Trival A-B Subvirion No Preservative Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: F
Vaccine: TDAP
Symptoms: Brain injury, Central nervous system lesion, Impaired work ability, Memory impairment
Clinical narrative: Claims brain damage has occurred after vaccination; lesions, brain damage; also forget people name; Initial information received on 16-Sep-2024 regarding an unsolicited valid serious case received from a Patient.  This case involves Adult female patient who claims brain damage has occurred after vaccination, lesions and also forget people name after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  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 suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient claims brain damage has occurred after vaccination (brain injury), lesions, brain damage (central nervous system lesion) and also forget people name (memory impairment) (latency: unknown).   Memory not what it used to be. He also forget people's names. Lesions. Brain damage. It's not really improving. It's been over a year since he've worked.  Information regarding batch number corresponding to the one at time of event occurrence is requested.  Seriousness criteria: The event Brain injury was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the events.; Sender's Comments: Sanofi company comment dated 30-Sep-2024: This case involves Adult female patient who claims brain damage has occurred after vaccination, lesions and also forget people name after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.