chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine being administered after it was no longer suitable for use due to excursion with no reported adverse event; Initial information received on 11-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4-year-old patient of unknown gender whom vaccine IPV (VERO) [IPOL] being administered after it was no longer suitable for use due to excursion 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 in 2024, the patient received a unknown dose of suspect IPV (VERO) Suspension for injection of lot W1A191M and expiry date: 16-Feb-2025 (strength, dose: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization) after it was no longer suitable for use due to excursion with no reported adverse event (poor quality product administered) (latency: on same day).  Reportedly, Caller stated that the products were involved in two separate excursions. Caller stated the the first excursion occurred on 13Jul2024 while they were doing inventory; products were out of range for 30 minutes and reached 8.28C. Caller stated that the second excursion occurred through 20Jul2024 to 23Jul2024 due to unknown cause; products were out of range for 47 hours and 30 minutes and reached 1.47C. Huma error was no. Extended stability does not cover the excursion.   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.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: used a normal sodium chloride diluent from their stock, not the one included in the vaccine and administered to a patient (with no reported adverse event); Initial information received on 20-Sep-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of unknown demographics who used a normal sodium chloride diluent from their stock, not the one included in the yellow fever vaccine - [YF-VAX] ,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 suspect Yellow Fever Vaccine - Solution for injection (strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunization and used a normal sodium chloride diluent from their stock, not the one included in the vaccine, with no reported adverse event (product preparation error) (latency: on same day).  Information regarding batch number corresponding to the one at time of event occurrence is requested.  Reportedly, Pharmacist enquired if they could use any sterile water for injection as a diluent with YF VAX or they should use the diluent comes with it.  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.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: had injection site reactions, "sore arm and red spots; had injection site reactions, "sore arm and red spots; Initial information received on 20-Sep-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases0 US-SA-2024SA285980, US-SA-2024SA285853, US-SA-2024SA286193, US-SA-2024SA286870  This case involves a 22 years old female patient who had injection site reactions, "sore arm and red spots after receiving RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Sep-2024, the patient received a dose 1 (0.1 ml) of suspect RABIES (HDC) VACCINE Powder and solvent for suspension for injection lot W1C931M expiry- 31-OCT-2025 via intramuscular route in the right arm. On 16-Sep-2024 she also received dose 2 of same vaccine for  Immunisation (strength unknown).  On an unknown date in Sep-2024 the patient had injection site reactions, "sore arm and red spots (vaccination site pain) (vaccination site erythema) (unknown latency).  Reportedly, 5 students that had potential adverse reactions from IMOVAX vaccinations  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events  At time of reporting, the outcome was Unknown for both the events; Sender's Comments:  US-SA-2024SA285980: US-SA-2024SA285853: US-SA-2024SA286193: US-SA-2024SA286870:
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: unable to receive the full dose/volume of Fluzone HD during the course of vaccine administration (due to syringe or needle malfunction) with no reported adverse event; Initial information received on 21-Sep-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was unable to receive the full dose/volume of Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] during the course of vaccine administration (due to syringe or needle malfunction) 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 suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (lot number, strength and expiry not reported) via unknown route in unknown administration site as immunization but was unable to receive the full dose/volume during the course of vaccine administration (due to syringe or needle malfunction) with no reported adverse event (incorrect dose administered) (latency: same day).   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.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Ipol was administered post excursion with no adverse event; Initial information received on 25-Sep-2024 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient who was administered IPV (VERO) [IPOL] post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Jul-2024, the patient was administered IPV (VERO) [IPOL] vaccine Suspension for injection (lot- W1B511M, Expiry date: 28-Sep-2025) (unknown strength, dosage and route) in unknown administration site for prophylactic vaccination IPOL was administered post excursion with no adverse event post (poor quality product administered) (latency-same day).  Caller reported temperature excursion for punctured ipol, Max/low temperature reached: 09Jul2024: 47.7°F Duration: 45 minutes. There was previous excursion and reporter mentioned that they've overstock their vaccines in the fridge that caused the refrigerator's temperature to be low (16Aug2024): 33.4°F; He didn't have data for the duration of the first excursion. Human error was unknown. The reporter did not have the patient information at the time of the report.  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.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: mistakenly mixed hib portion of the PENTACEL with a different diluent which is normal saline with no reported AE; mistakenly mixed hib portion of the PENTACEL with a different diluent which is normal saline with no reported AE; Initial information received on 26-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 19 months old female patient to who got mistakenly mixed HIB portion of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with a different diluent which is normal saline 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 unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (Lot UK041AA; Expiration Date :31-Aug-2025) via unknown route in unknown administration site for Immunization which was mistakenly mixed hib portion of the Pentacel with a different diluent which is normal saline with no reported adverse event (single component of a two-component product administered) (product preparation error) (same day latency).  Reporter would like to know if this would count as a valid dose and if they could salvage the IPV portion of the vaccine and administer to the patient.   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.
Sex: M
Vaccine: FLUA4
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: She said she would guess it to be like he received about half of the dose; Injection site leaking / Leaking Syringe; About half of the vaccine ran out, like down the patient's arm; This spontaneous case, initially received on 04-Oct-2024, was reported by a health professional and concerns an elderly male patient.  Administration of company suspect drug: On 04-Oct-2024, the patient received Fluad Quadrivalent for Flu immunization, Dose regimen: 0.5 ml, Route of administration, not reported. Lot number: 388494.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 04-Oct-2024, the patient experienced he received about half of the dose (outcome: Unknown), Leaking Syringe (outcome: unknown) and about half of the vaccine ran out, like down the patient's arm (outcome: unknown).  Reporter informed they had an incident that occurred while we were administering the Fluad flu vaccine, the 65 and up, the high-dose formula today. And it's something that they have not encountered before, and they weren't really sure how to handle it. So basically what happened is when the person (pharmacy technician) was giving the vaccine, the needle was not, don't know if the needle, she said it was screwed on there tightly. But whenever she went to get the vaccine, she said that where the needle meets the the medicine, like it leaked, the vaccine leaked out, like while she was giving the vaccine. She said probably she would guess that it would be about half of the vaccine ran out, like down the patient's arm, because it came out in the seal, where the needle was put on. It came out through there, but she said that the needle was screwed on really tightly. So they didn't know as far as like re-dosing the patient or, because they can't tell how much that he got. She said she would guess it to be like he received about half of the dose, but they don't really know what to do in this situation.  The defect discovered during use. No sample available or picture of complaint.  The plunger was depressed. The needle shield in place Location of the leak: Needle hub ("where the needle meets the medicine") No signs of damage on the syringe  Needle was used: 25 G x 1 in. BD PrecisionGlide  Needle. No signs of damage on the needle  The needle appear tightly attached.  Fluad Quadrivalent action taken: Not Applicable  Reporter's assessment: The reporter considered the events as non serious and did not provide causality assessment.; Reporter's Comments: The special situations are not related to Fluad Quadrivalent
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she develops a low grade fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  An elderly female patient received BNT162b2 (BNT162B2), 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: PYREXIA (non-serious), outcome "unknown", described as "she develops a low grade fever".  Additional Information: Every time she got the vaccine (COVID-19 Vaccine) she developed a low grade fever. Reported she was quite sick from it with a little bit of fever, really feeling like she was sick.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400271848 same patient, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: every time she gets the vaccine she develops a low grade fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "every time she gets the vaccine she develops a low grade fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "every time she gets the vaccine she develops a low grade fever".  Additional information: A 77-year-old patient reported that every time she received the vaccine she developed a low grade fever. Reported she quite sick from it with a little bit of fever, really feeling like she was sick.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400271848 same patient, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: develops a low grade fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "develops a low grade fever".  Additional information: A 77-year-old patient reported that every time she received the vaccine she developed a low grade fever. Reported she quite sick from it with a little bit of fever, really feeling like she was sick.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400271848 same patient, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Every time she gets the vaccine she develops a low grade fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "low grade fever"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "low grade fever"; Bnt162b2 (DOSE 3, SINGLE), for Covid-19 Immunization, reaction(s): "low grade fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time she gets the vaccine she develops a low grade fever".  Additional Information: The patient reported that every time she received the vaccine she developed a low grade fever. Reported she quite sick from it with a little bit of fever, really feeling like she was sick.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400271848 same patient, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Every time she gets the vaccine she develops a low grade fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID: .  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "low grade fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "low grade fever"; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "low grade fever"; Bnt162b2 nos (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "low grade fever"; Bnt162b2 nos (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "low grade fever".  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time she gets the vaccine she develops a low grade fever".  Additional Information: It was reported that every time she got the vaccine (COVID-19 Vaccine) she developed a low grade fever. Reported she was quite sick from it with a little bit of fever, really feeling like she was sick.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400271848 same patient, different dose and event (LOE).;
Sex: F
Vaccine: COVID19, FLUX, RSV
Symptoms: Headache, Illness, Palpitations
Clinical narrative: heart racing; sick; headache; This is a spontaneous report and received from Consumer or other non HCPs.  An adult female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 06Oct2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 06Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: past drug history: allergy. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 07Oct2024, outcome "not recovered"; PALPITATIONS (non-serious) with onset 07Oct2024, outcome "not recovered", described as "heart racing"; ILLNESS (non-serious) with onset 07Oct2024, outcome "not recovered", described as "sick". It was unknown if therapeutic measures were taken as a result of palpitations, illness, headache.  Additional information: Heart racing, sick and headache from RSV vaccine. But also said had flu and covid vaccine too.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia, Vaccination site reaction, Vaccination site swelling
Clinical narrative: mild flu symptoms that lasted for like a day and a half; the low grade fever; the chills; the injection site was warm; the injection site was raised; a residual something, it is some kind of a mole; This is a spontaneous report received from a Consumer or other non HCP.  A patient in their 60's received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "mild flu symptoms that lasted for like a day and a half"; PYREXIA (non-serious), outcome "recovered", described as "the low grade fever"; CHILLS (non-serious), outcome "recovered", described as "the chills"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "the injection site was warm"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "the injection site was raised"; VACCINATION SITE REACTION (non-serious), outcome "not recovered", described as "a residual something, it is some kind of a mole". Additional information: First covid inoculation which was in March of 2021, initial injection. The second time had an injection in the right arm, did get mild flu symptoms that lasted for like a day and a half, the low grade fever, the chills. The injection site was warm and raised. Have lived with this for a couple of years now. Went to get a booster today, the technician asked, what arm do you want this injection and the patient said they would like it in their left arm because they still have a residual something from the initial second covid booster years ago. The technician said it looks like it is some kind of a mole. It was not there prior to getting an injection.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: mild flu symptoms that lasted for like a day and a half; the low grade fever; the chills; the injection site was warm; the injection site was raised; a residual something, it is some kind of a mole; This is a spontaneous report received from a Consumer or other non HCP.  A patient in their 60's received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "mild flu symptoms that lasted for like a day and a half"; PYREXIA (non-serious), outcome "recovered", described as "the low grade fever"; CHILLS (non-serious), outcome "recovered", described as "the chills"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "the injection site was warm"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "the injection site was raised"; VACCINATION SITE REACTION (non-serious), outcome "not recovered", described as "a residual something, it is some kind of a mole". Additional information: First covid inoculation which was in March of 2021, initial injection. The second time had an injection in the right arm, did get mild flu symptoms that lasted for like a day and a half, the low grade fever, the chills. The injection site was warm and raised. Have lived with this for a couple of years now. Went to get a booster today, the technician asked, what arm do you want this injection and the patient said they would like it in their left arm because they still have a residual something from the initial second covid booster years ago. The technician said it looks like it is some kind of a mole. It was not there prior to getting an injection.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: First out break of Neonatal herpes since he was a baby; This is a spontaneous report received from an Other HCP.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose number unknown, single (Lot number: EJ1685) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HERPES SIMPLEX (non-serious) with onset 21Jan2021 at 12:00, outcome "recovering", described as "First out break of Neonatal herpes since he was a baby". Therapeutic measures were not taken as a result of herpes simplex.  Additional information: First out break of Neonatal herpes since he was a baby. Location: right shoulder.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased
Clinical narrative: high heart rate; Chest pain; This is a spontaneous report received from a Consumer or other non HCP.  A 16-year-old female patient received BNT162b2 (BNT162B2), on 12Jun2021 as dose 2, single (Lot number: EW0196) for covid-19 Immunization. The patient's relevant medical history included: "POTS" (unspecified if ongoing); "FND" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Drug Allergy". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EW0182, Location of injection/shot: Left Arm, Route of administration: Intramuscular shot), administration date: 22May2021, for Covid-19 Immunization.  The following information was reported: CHEST PAIN (non-serious) with onset 13Jun2021, outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "high heart rate". The event "chest pain" required emergency room visit.  Additional information: It was reported that patient went next day to Emergency room for chest pain. Patient was not taking any other vaccine on the same date as the Pfizer vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart trouble soon after vaccination; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-774523 (Moderna).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Sep2024 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: CARDIAC DISORDER (non-serious) with onset 29Sep2024, outcome "unknown", described as "heart trouble soon after vaccination".  Additional information: Reporter stated that a family member may have had an adverse reaction to Pfizer's COVID vaccine (heart trouble soon after vaccination).  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: the patient received multiple doses of COMIRNATY over the past years but different lot numbers. The patient was not allergic to any previous vaccination, medications, food or other products. 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-202400270616 Same patient and event, different suspect drug;
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: PT EXPIRIENCED VASOVAGEL SYNCOPE FOLLOWING GARDASIL9 VACCINATION. PT WAS UNCONCIOUS FOR APPROX 10 SECONDS. PT WAS SEATED AND DID NOT FALL OR COLLAPSE. IMMUNIZATION STAFF RECLINED PATIENT, PLACING A COLD PACK BEHIND HIS NECK, AND PROVIDED A SNACK AND WATER TO ASSIST WITH RECOVERY. PT GUARDIAN WAS NOTIFIED AND BROUGHT INTO PT ROOM. PT WAS MONITORED DIRECTLY BY STAFF FOR 15 MINUTES FOLLOWING ICIDENT AND SELF AMBULATED FROM CLINIC.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given a high dose flu shot and was to receive a regular flu shot.
Age: 13.0
Sex: F
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Too young to receive Adult Twinrix
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Heart rate increased
Clinical narrative: feeling fast heart beat after 24 hours of vaccination - took beta blocker - heart is at 118 48 hrs later
Age: 11.0
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Too young to receive Adult Twinrix
Age: 54.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives and itching to arm, neck and little rash on torso too.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Loss of consciousness
Clinical narrative: patient passed out in chair after administration --- came back before cpr administration as repositioning from falling from chair
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Patient received vaccination about 4:30 PM on 10/08/2024.  At 5:40 PM patient had symptoms of tingling and burning in arms, hands, base of neck, buttocks, lower back, upper head and ankles. Patient took a dose of Vistaril and the symptoms resolved later.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: swollen arm,chills,fever and redness
Age: 34.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: I do not have an adverse reaction to the shot (yet). My OB/GYM recommended I report this anyway because I was mistakingly given this vaccine instead of Abrysvo. I am 35 weeks pregnant and 34 years old and should not have received this vaccine. My Doctor called me to tell me that the medical technician administered the incorrect one.
Age: 68.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: Patient woke up to go to restroom, he stated he felt faint and fell and hit head
Age: 52.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Nausea
Clinical narrative: Patient reported feeling nauseated and weak about 10 minutes after receiving the 2 vaccines.  No other symptoms reported. She sat on a bench for about 20 minutes and was then feeling back to normal.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immediate post-injection reaction, Inflammatory marker increased, Joint stiffness
Clinical narrative: Rheumatoid reaction, immediate and constant joint pain and stiffness.    Possible diagnosis of Polymyalgia Rheumatica.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Rash, Urticaria
Clinical narrative: Urticarial rash noted on trunk and face. 6cm warm erythemetous induration at injection site. Treatment: Start Famotidine (20 MG Tablet) 1 tablet at bedtime as needed Once a day. Start ZyrTEC (10 MG Tablet Chewable)1 tablet Once a day.  H1 H2 blocker for several days.
Age: 35.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Brain fog, Chills, Cough, Diarrhoea, Fatigue
Clinical narrative: On Saturday, October 5, 2024, patient developed fever, chills, and diarrhea. On Sunday, patient developed aches, fatigue, and brain fog. On Monday, fatigue ended but continued with aches and developed congestion and cough. The cough has persisted until 10/10/24.
Age: 35.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: On Saturday, October 5, 2024, patient developed fever, chills, and diarrhea. On Sunday, patient developed aches, fatigue, and brain fog. On Monday, fatigue ended but continued with aches and developed congestion and cough. The cough has persisted until 10/10/24.
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Fatigue, Somnolence
Clinical narrative: dizziness, fatigue, drowsy
Age: 8.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received Flu and Covid vaccine at office visit appointment 9/20/24. Pt then arrived to drive thru event on 10/5/24 and was given another dose of each vaccine.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction has occurred, patient received a Flu HD and Flublok instead of a comirnity and flublok.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient stated warmth at the injections site and redness and swelling
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Cough
Clinical narrative: Patient began coughing a couple of days after receiving the vaccine and ultimately had to be hospitalized.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Skin discolouration
Clinical narrative: Pt described fluid filled bubbles on left shoulder day of vaccination. Now skin is discolored in spots
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Immunisation reaction, Peripheral swelling
Clinical narrative: On 09/09/2024 at 8:00 pm, patient experienced covid arm (redness and swelling) from the shoulder and past the elbow. It lasted for 3 days and then it went away. Patient states she did not take anything during the reaction. Patient did not go get medical treatment. Reaction resolved on its own
Age: 0.5
Sex: M
Vaccine: RSV
Symptoms: Irritability
Clinical narrative: Infant was given Abrysvo instead of Beyfortus by staff. He is fussy, though consolable at 48 hours after the event. He is eating well. He received other vaccines at the same time: Vaxcelis, PCV20, Fluzone.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Patient started having throbbing pain like a nerve shooting up into shoulder.  It was severe at 24 hours, but continues to be bothersome.  She said it feels like a nerve.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red rash from injection site spreading to upper arm; warm to touch
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: I adminstered Covid-19 Comirnaty 12+ to a patient who is aged 3years. There is no signs or symptoms of adverse reaction at this time
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 8.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Reported vaccine was painful, but was not upset at the time. Tenderness overnight and continued to complain today, appeared to develop erythematous swelling with delineated border approx. 3x3 cm. Area is erythematous with blanching center, firm, warm to touch. No tingling or numbness. No hives, HA, or nausea. Activity level normal. Continues to be active, using arm with coloring throughout the appt.  Numerous flu vaccines in the past, no hx of reaction. This year's flu vaccine is a different brand than previous years.
Age: 8.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Injection site warmth, Pallor, Swelling, Tenderness
Clinical narrative: Reported vaccine was painful, but was not upset at the time. Tenderness overnight and continued to complain today, appeared to develop erythematous swelling with delineated border approx. 3x3 cm. Area is erythematous with blanching center, firm, warm to touch. No tingling or numbness. No hives, HA, or nausea. Activity level normal. Continues to be active, using arm with coloring throughout the appt.  Numerous flu vaccines in the past, no hx of reaction. This year's flu vaccine is a different brand than previous years.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Patient came in to ask about normal swelling, redness after the vaccine. The rash had been getting larger each day after receiving the vaccine on 10/7/24. The rash was red, raised and warm to the touch. The patient was experiencing itching and burning around the area. The rash covered a large part of the left deltoid area. The patient is following up with the primary care physician.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: Patient came in to ask about normal swelling, redness after the vaccine. The rash had been getting larger each day after receiving the vaccine on 10/7/24. The rash was red, raised and warm to the touch. The patient was experiencing itching and burning around the area. The rash covered a large part of the left deltoid area. The patient is following up with the primary care physician.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: PT STATED SHE HAD ITCHING AND RASH FROM 9/7/24 TO A FEW DAYS AGO IN ARM THAT THEY WERE ADMINISTERED IN.  SHE STATED THEY LASTED A MONTH AND A HALF, BUT I DID ASK IF IT WAS CLEARED UP NOW AND SHE STATED IT IS.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given after "Best By" date. Patient notified. No reaction stated.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral
Clinical narrative: Approx 24 hours after dose, my right ear went deaf. Saw ENT MD on 10/8. Prescribed Prednisone. 10/10 injected steroid in ear drum. Still cannot hear out of right ear.
Age: 11.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product administration error
Clinical narrative: no adverse reaction only administration error
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Chills, Extra dose administered, Malaise
Clinical narrative: Patient has received AREXVY on 11/29/2023 and was given second dose on 9/17/2024. She called and reported the duplication on 10/1 and said she had been laid up in bed and very sick (weakness, chills) since she was given the shots. She received Fluad 65+ and COMIRNATY 24-25 at the same visit.
Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Aphthous ulcer, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms including fever, child, and body aches the night of my vaccine. Canker sores arose appeoximately 48 hours after vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Dyspnoea, Echocardiogram abnormal
Clinical narrative: woke up on December 9, 2023 with shortness of breath, unable to breath in normally, pain and tightness around entire front of chest and back (like a vice was squeezing my chest), pain when trying to breath in.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Painful respiration, Pericardial effusion, Respiration abnormal
Clinical narrative: woke up on December 9, 2023 with shortness of breath, unable to breath in normally, pain and tightness around entire front of chest and back (like a vice was squeezing my chest), pain when trying to breath in.
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Axillary pain, Blood electrolytes, Blood immunoglobulin A normal, Blood immunoglobulin E increased
Clinical narrative: Patient experienced swelling and pain in L arm, at site of injection, with development of hives around injection site, then over week following injection, pain and swelling worsened, with L subscapular pain, axillary pain and swelling, feeling of internal L sided chest pain with deep breath, rating pain 10/10 and unable to sleep
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M normal, C-reactive protein normal, Computerised tomogram thorax abnormal, Differential white blood cell count normal
Clinical narrative: Patient experienced swelling and pain in L arm, at site of injection, with development of hives around injection site, then over week following injection, pain and swelling worsened, with L subscapular pain, axillary pain and swelling, feeling of internal L sided chest pain with deep breath, rating pain 10/10 and unable to sleep
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Electrocardiogram normal, Flow cytometry, Full blood count normal, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced swelling and pain in L arm, at site of injection, with development of hives around injection site, then over week following injection, pain and swelling worsened, with L subscapular pain, axillary pain and swelling, feeling of internal L sided chest pain with deep breath, rating pain 10/10 and unable to sleep
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site urticaria, Laboratory test, Liver function test, Lymphadenopathy, Oedema peripheral
Clinical narrative: Patient experienced swelling and pain in L arm, at site of injection, with development of hives around injection site, then over week following injection, pain and swelling worsened, with L subscapular pain, axillary pain and swelling, feeling of internal L sided chest pain with deep breath, rating pain 10/10 and unable to sleep
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Painful respiration, Sleep disorder
Clinical narrative: Patient experienced swelling and pain in L arm, at site of injection, with development of hives around injection site, then over week following injection, pain and swelling worsened, with L subscapular pain, axillary pain and swelling, feeling of internal L sided chest pain with deep breath, rating pain 10/10 and unable to sleep
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Abdominal pain upper, Burning sensation, Diarrhoea, Headache
Clinical narrative: Took the Fluad 2024-2025 0.5 MI injection Influenza Type A&B on 10/08/24.  After the injection, I felt a burning sensation in my left arm.  Within a couple of hours I had a horrible headache.  I vomited twice and had diarrhea and sharp pains in my stomach. Today is 10-1024 and my stomach is still upset.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Took the Fluad 2024-2025 0.5 MI injection Influenza Type A&B on 10/08/24.  After the injection, I felt a burning sensation in my left arm.  Within a couple of hours I had a horrible headache.  I vomited twice and had diarrhea and sharp pains in my stomach. Today is 10-1024 and my stomach is still upset.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm, Urticaria
Clinical narrative: pt received shingrix on 10/07/24 around 2PM.  She states 2-3 hours later she noticed her arm had a baseball sized welt (approximately 5"x2").  It was red, round, and hot to the touch. The pt came in to the pharmacy on 10/9/24 and showed the pharmacy manager.  She advised the pt to apply a cold compress and take tylenol if needed for the pain. I followed up with the patient 10/10/24 around 6 PM.  She states the swelling has gone down but it is still sore.  Other than showing her son who is a paramedic and the pharmacist, she did not seek medical attention.  I advised her to continue cold compress and tylenol prn.  If symptoms worsen or do not continue to get better, she should seek medical care.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Swelling, hives, itching at injection site, complete redness and warmth on right side of face.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to device use error, Injection site laceration
Clinical narrative: Patient moved the left arm which resulted cutting of the skin of injection site.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside "Best By" date. Patient notified. No reaction stated.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside "Best By" date. Patient notified. No reaction stated.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 40.0
Sex: M
Vaccine: COVID19, FLU3, HEP, TDAP
Symptoms: Balance disorder, Electrocardiogram abnormal, Fall, Heart rate decreased
Clinical narrative: AFTER RECEIVING ALL OF THE VACCINES, PATIENT SUDDENLY LOST BALANCE AND FELL OFF THE CHAIR ON THE FLOOR. THE PATIENT WAS LAYING DOWN ON THE FLOOR AND BACK TO NORMAL IN A FEW MINUTES. CALLED 911 AND EKG WAS MEASURED HIS HEART RATE WAS AS LOW AS 20 BPM AFTER RECEIVING THE VACCINE.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Pain in extremity
Clinical narrative: left arm sored after receiving shot arm got. hot later in the evening. Redness and hotness radiated down arm and had to visit urgent care.