chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Tetanus, Trismus
Clinical narrative: Seizures; Vomiting; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in 2021 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: SEIZURE (disability, medically significant) with onset 2021, outcome "not recovered", described as "Seizures"; VOMITING (non-serious) with onset 2021, outcome "unknown". The event "seizures" required physician office visit. Therapeutic measures were taken as a result of seizure. Additional information: The patient reported that he was experiencing seizures and it seems like he was vomiting while he's call was on hold with the agent. The patient stated that he's nearly dying as a result of Pfizer utilizing him/her and his/her body for medical research for the company (in regards to the vaccination). It was between 2021 and 2022, over several months. The patient was trying to get his/her seizure medication Gabapentin (clarified as Pfizer medication as the patient knows) and he's almost "dying" without it. His/her primary care physician was aware that she was prescribing Gabapentin for the treatment of seizure disorder. The patient stated that he/she was dying due to the company and he/she was actively having seizures while he/she was on the phone with the agent. He/she also mentioned that he/she was disabled.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: no adverse event; Product preparation error; This spontaneous report was received from medical assistant and refers to a 4-year-old female patient. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-AUG-2023, the patient received a dose with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), along with of 0.5 ml (Frequency: twice) dose 1 of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine of standard strength suspension for injection (lot: UJ8768A, Expiry date: 19-Mar-2024) via intramuscular route in left administration site for Immunization (product preparation error). Concurrently with no reported adverse event.
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Neurological examination, Syncope
Clinical narrative: patient fainted and hit the head after receiving GARDASIL 9; patient fainted and hit the head after receiving GARDASIL 9; This spontaneous report was received from medical assistant and refers to a adolescent male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2023, reported as in the last few weeks, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for HPV prevention (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2023, after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient fainted and hit the head, it was stated that the patient received unspecify treatment for the events, he was checked by the physician's assistant who did a neurological check and referred the patient to the emergency room for further evaluation, then the patient went to the hospital for a neurological exam and hospital visit exam (no hospital admission was performed). The outcome of the event was not reported.  The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.   Upon internal review, the event syncope was determined to be medically significant.  This is one of 2 cases from the same reporter.; Sender's Comments:  US-009507513-2310USA003339:
Age: 12.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD was administered after it experienced a supported temperature excursion; No side effects/No additional AE; This spontaneous report was received from a nurse referring to a 12 year old patient of unknown gender. The patients concurrent conditions, medical history and concomitant medications were not provided.    On 11-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, route, frequency, were not provided) 0.5 mL for prophylaxis; Lot No. X009734 has been verified to be a valid lot number for [Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live], expiration date reported as 30-SEP-2024, and upon internal validation established as the same.  It was stated that no lot information was provided for properly stored sterile diluent used to reconstitute the improperly store vaccine.  The nurse reporting that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was administered after it experienced a supported temperature excursion (incorrect product storage). The vaccine presented a temperature excursion with a temperature of -9 degrees Celsius, with a time frame of 4 hours, 30 minutes. There were no previous temperature excursion. Moreover, it was stated that the sterile diluent that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. No side effects were reported and no additional adverse event (AE). No additional information was provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE and no PQC; 32 year old patient received their second GARDASIL 9 dose late. The first dose was on 09/28/20222 and the second dose was on 07-SEP-2023; This spontaneous report has been received from  a physician and refers to a 32-year-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 28-SEP-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, and on 09-SEP-2023, the patient was vaccinated with the second dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered for prophylaxis (inappropriate schedule of product administration) (strength, lot #, expiry date, and route of administration were not provided). No adverse events were reported for this patient.
Sex: U
Vaccine: RSV
Symptoms: Device issue, Syringe issue
Clinical narrative: Not able to use one of the syringes because it was leaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "Not able to use one of the syringes because it was leaking".  Additional information: caller received five doses of the Abrysvo vaccine but was not able to use one of the syringes because it was broken and leaking. It was confirmed that this dose was not administered to any patients (they were unable to put the diluent with the vaccine to use this)  Causality for "not able to use one of the syringes because it was leaking" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Hypersensitivity
Clinical narrative: Have extreme allergic reactions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "allergic to mercury" (unspecified if ongoing); "allergic to soy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Have extreme allergic reactions".  Additional information: The patient stated that she has extreme allergic reactions. By recommendation of pharmacist and doctor, the patient was questioning the Prevnar 20 ingredients. The patient was allergic to soy and mercury, so was asking if Prevnar has these.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Sex: F
Vaccine: FLUX, RSV
Symptoms: Dizziness, Dysphagia, Hypersensitivity, Swelling
Clinical narrative: she couldn't swallow the pill; swelling; dizziness; allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 78-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 07Sep2023 as dose number unknown, single (Batch/Lot number: unknown); influenza vaccine live reassort 4v (INFLUENZA VACCINE LIVE REASSORT 4V), on 07Sep2023 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DYSPHAGIA (non-serious), outcome "unknown", described as "she couldn't swallow the pill"; SWELLING (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysphagia, swelling, dizziness, hypersensitivity.  Causality for "she couldn't swallow the pill", "swelling", "dizziness" and "allergic reaction" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Immune system disorder, Immunisation reaction
Clinical narrative: Slightly heightened (for a few days) immune system reactions; Somewhat more uncomfortable post-vaccine time; Normal post-vaccine reactions (a few days only each time); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL3247) at the age of 59 years intramuscular, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Multiple chemical sensitivities" (unspecified if ongoing); "Graves' disease" (unspecified if ongoing), notes: in remission. The patient's concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "recovered", described as "Slightly heightened (for a few days) immune system reactions"; DISCOMFORT (non-serious), outcome "unknown", described as "Somewhat more uncomfortable post-vaccine time"; IMMUNISATION REACTION (non-serious), outcome "recovered", described as "Normal post-vaccine reactions (a few days only each time)". Additional information: The patient reported that overall she had normal immune system reactions to COVID-19 vaccines. She had nothing relevant to family medical history other than slightly heightened (for a few days) immune system reactions - no follow-up care needed from any medical facility or physician. She has multiple chemical sensitivities and Grave's disease (in remission). Over reactive immune system in general. Probably contributed to a somewhat more uncomfortable post-vaccine time. She had normal post-vaccine reactions (a few days only each time), each of the 4 times she was vaccinated against COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201279899 same patient, vaccine, and event; different dose;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: chills; terrible aches and pains; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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: CHILLS (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "terrible aches and pains"; HEADACHE (non-serious), outcome "unknown". Therapeutic measures were taken as a result of chills, pain.  Additional Information: Caller stated that she was pleased to report her side effect that lasted for less than 48 hours. Caller added that the patient had shot on, guess Thursday, and by Saturday was okay actually. Patient never took temperature but had chills, but the patient had terrible aches and pains, but they all vanished. Caller mentioned "Two other people that had very similar side effects just like her, the patient had all the other shots and never had any reaction. That was the first time to have a reaction. The patient never had any reaction and that was the first one to  have a reaction to but that seemed to be common among the elderly. Two friends of mine reported the same thing and they never had the same response like that before. So the patient did not knowthat are they supposed to take Tylenol afterwards, patient did take Tylenol and maybe that helped." Caller said that she had side effects after taking the covid vaccine. Caller did not attempt to take temperature but experienced chills and a headache. Caller would like to know how long  she would be having the side effects and she wanted to know if she could take aspirin. Caller did not attempt to take temperature but experienced chills and a headache.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Ear swelling, Swelling, Swelling face
Clinical narrative: swelling back of ear and neck, around the facial area; swelling back of ear and neck, around the facial area; swelling back of ear and neck, around the facial area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 06Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), SWELLING (non-serious), SWELLING FACE (non-serious) all with onset 06Oct2023, outcome "unknown" and all described as "swelling back of ear and neck, around the facial area".  Additional Information: The patient received the vaccine on 06Oct2023 around 11:30am or 12:00pm. At 5:00pm the patient called the pharmacy and notified that she experienced swelling at the back of her ear and neck, like around the facial area, but not inside her throat.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 30Sep2023 to 04Oct2023 as Treatment of COVID-19. Patient did not had Known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300322291 same patient, different drug/event;
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Choking, Cough, Erythema, Pruritus
Clinical narrative: choking; tight chest; coughing; Face turned red; itchiness; whole body rash; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 52-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "thyroid problem" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; METFORMIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: CHOKING (medically significant), outcome "unknown"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "tight chest"; COUGH (non-serious), outcome "unknown", described as "coughing"; ERYTHEMA (non-serious), outcome "unknown", described as "Face turned red"; PRURITUS (non-serious), outcome "unknown", described as "itchiness"; RASH (non-serious), outcome "unknown", described as "whole body rash".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: On the basis of the limited information available in this report, a medically meaningful assessment of the case cannot be made. Details regarding the drug-event temporal relationship and clinical course are not provided. However on conservative basis, the possible causality cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: choking; tight chest; coughing; Face turned red; itchiness; whole body rash; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 52-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "thyroid problem" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; METFORMIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: CHOKING (medically significant), outcome "unknown"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "tight chest"; COUGH (non-serious), outcome "unknown", described as "coughing"; ERYTHEMA (non-serious), outcome "unknown", described as "Face turned red"; PRURITUS (non-serious), outcome "unknown", described as "itchiness"; RASH (non-serious), outcome "unknown", described as "whole body rash".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: On the basis of the limited information available in this report, a medically meaningful assessment of the case cannot be made. Details regarding the drug-event temporal relationship and clinical course are not provided. However on conservative basis, the possible causality cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 18:00 as dose 1, single (Lot number: HF9275) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 30Sep2023 to 04Oct2023. Clinical Course: Patient had no Known allergies.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300322558 same patient, different drug/AE (Paxlovid case);
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 18:00 as dose 1, single (Lot number: HF9275) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 30Sep2023 to 04Oct2023. Clinical Course: Patient had no Known allergies.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300322558 same patient, different drug/AE (Paxlovid case);
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: Husband tested positive for Covid/ feeling awful, achy all over, nauseous, coughing; they both got really sick; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Medical Information Team.  An adult male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as DOSE 1, SINGLE (lot number: HG4680) for COVID-19 immunization; for COVID-19 immunization. The patient's relevant medical history included: "exposed to a friend with Covid", start date: 05Oct2023, stop date: 05Oct2023, notes: on Thurs (the day before Covid shot). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 07Oct2023, outcome "unknown" described as "they both got really sick"; COVID-19 (non-serious) with onset 09Oct2023, outcome "unknown" described as "Husband tested positive for Covid/ feeling awful, achy all over, nauseous, coughing." Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter (patient's wife) and her husband were exposed to a friend with Covid on Thursday (05Oct2023).  They got the Covid shot the next day on Friday (06Oct2023).  They usually get Moderna, but they were out of Moderna, so they got the Pfizer Covid vaccine.  Then they both got really sick, Saturday (07Oct2023).  Her husband tested positive for Covid this morning (09Oct2023).  She has taken two home Covid test and has been negative twice.  She was feeling as awful as he was, achy all over, nauseous, coughing. Reporter asked, "Is coughing a side effect of the Comirnaty 12+ 2023-2024 vaccine?"   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: hardly a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 101-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Lot number: HG4659), in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (A couple of weeks before both of them had got the flu vaccine), for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "hardly a sore arm". Additional information: This report is for caller's mother. Calling about new booster, the latest one. Caller clarified she is calling about the Corona booster vaccine. On vaccine card they wrote the number H64659 unless it a G. Caller is looking at her mom's, because she had it too. The girl didn't have good printing on the vaccine card. Caller clarified the number on the vaccine card is HG4659. On the 01Oct caller and her 101 year old mother went and had the booster. A couple of weeks before both of them had got the flu vaccine at the same location which was (name withheld) in (city withheld). Neither of them had a problem with the flu vaccine. Caller had the Corona virus booster on 01Oct2023 in right arm. Right away that day caller started to get bruising. It was sore. 8 or 9 days later and caller's arm is more sore and hurts when she lifts it. Her mom that is 101 and thin with sensitive skin that bruises easily didn't get bruise or hardly a sore arm.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Product use issue, Vaccination site pruritus
Clinical narrative: Flu vaccine 06Oct2023 / Pfizer 06Oct2023; Flu vaccine 06Oct2023 / Pfizer 06Oct2023; Extreme itchiness at injection site; major body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 13:00 as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 06Oct2023 as dose number, unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3 ; Manufacture Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2 ; Manufacture Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1 ; Manufacture Unknown), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 06Oct2023, outcome "unknown" and all described as "Flu vaccine 06Oct2023 / Pfizer 06Oct2023"; VACCINATION SITE PRURITUS (non-serious) with onset Oct2023, outcome "recovering", described as "Extreme itchiness at injection site"; PAIN (non-serious) with onset Oct2023, outcome "recovering", described as "major body aches". It was unknown if therapeutic measures were taken as a result of vaccination site pruritus, pain.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Non Hodgkin lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Malaise
Clinical narrative: haven't been feeling well; I feel so tired all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 89-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "haven't been feeling well"; FATIGUE (non-serious), outcome "unknown", described as "I feel so tired all the time".  Additional information: She hadn't been feeling well that past 10 days. She felt so tired all the time she did not feel that way. She asked what is happening to her and what they suggest. She also asked if she should take the pneumonia vaccine now or wait.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v has been requested and will be submitted if and when received.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Psoriatic arthropathy
Clinical narrative: Psoriasis symptoms; severe psoriatic arthritis affecting the right wrist; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old male patient received bnt162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: EN6203) at the age of 26 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot number: EL9264, Dose vaccine location: Right arm), administration date: 09Feb2021, when the patient was 26-year-old, for COVID-19 immunization. The following information was reported: PSORIASIS (hospitalization, disability) with onset May2021, outcome "recovered with sequelae", described as "Psoriasis symptoms"; PSORIATIC ARTHROPATHY (medically significant) with onset May2021, outcome "recovered with sequelae", described as "severe psoriatic arthritis affecting the right wrist". The patient was hospitalized for psoriasis (hospitalization duration: 4 day(s)). The events "psoriasis symptoms" and "severe psoriatic arthritis affecting the right wrist" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of psoriasis, psoriatic arthropathy.  Additional information: Psoriasis symptoms beginning in months after vaccine completed. No prior history, no abnormal life events. Psoriasis continued to get worse, with severe psoriatic arthritis affecting the right wrist. Emergency surgery in Jan2022, with ongoing therapy and treatment for psoriasis with COSENTYX to retain functionality. The patient had no covid prior to vaccination. The patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I have been getting all the vaccines from Pfizer and I have got sick each time; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 10Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 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: ILLNESS (non-serious), outcome "unknown", described as "I have been getting all the vaccines from Pfizer and I have got sick each time".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: got a double dose/The patient received  it on 9/28 and just received another one now; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An elderly female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "nervous person to begin with" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE), administration date: 28Sep2023, for COVID-19 immunisation. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 10Oct2023, outcome "unknown", described as "got a double dose/The patient received  it on 9/28 and just received another one now".  Additional information: The pharmacist reported an inadvertent administration of the Comirnaty 12 years and up formulation to a patient over 70 years old. It was administered last 28Sep and today 10Oct. She's asking for further guidance or recommendation. On 10Oct2023, pharmacist stated that the patient has no side effects at the moment but has anxiety about it and causing the pharmacist to have anxiety. Pharmacist is freaking out that something is going to happen to the patient but feels that the patient is going to be fine. Pharmacist needs information to be able to assure the patient in some way. Patient doesn't feel bad and is just a nervous nelly, stating patient is a nervous person to begin with. Pharmacist feels horrible it happened but caller doesn't know why caller's system didn't catch it to see patient already received one.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.  Follow-up (10Oct2023): This is a spontaneous follow-up report received from a contactable Pharmacist reported for the patient, Program ID: 004756.  Updated information: Patient's gender, relevant medical history (nervous), and further clinical details  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: she was pregnant and had a very rare miscarriage; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001230 (Novavax).  A female patient (pregnant) received bnt162b2 (BNT162B2 NOS), 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. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "she was pregnant and had a very rare miscarriage".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt pretty bad a couple days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 6 (booster), single (Lot number: GH9694) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Takes small dose blood pressure pill" (unspecified if ongoing); "allergy shots" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: bnt162b2 (1st dose, left upper arm, Batch/Lot number: EL3248), administration date: 16Jan2021, when the patient was 77-year-old, for Covid-19 Immunization; bnt162b2 (2nd dose, left upper arm, Batch/Lot number: EN9581), administration date: 06Feb2021, when the patient was 77-year-old, for Covid-19 Immunization; bnt162b2 (3rd dose, left upper arm, Batch/Lot number: FE3592), administration date: 24Sep2021, when the patient was 78-year-old, for Covid-19 Immunization; bnt162b2 (4th dose, left upper arm, Batch/Lot number: FM9992), administration date: 14Apr2022, when the patient was 79-year-old, for Covid-19 Immunization; Bnt162b2 (5th dose, left upper arm), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt pretty bad a couple days".
Age: 38.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Lymph node pain, Lymph nodes scan abnormal, Lymphadenopathy
Clinical narrative: Swelling/pain of underarm lymphnodes on R side (same side as COVID vaccine administration).; Swelling/pain of underarm lymphnodes on R side (same side as COVID vaccine administration).; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 16:30 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), on 09Oct2023 at 16:30 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer biontech (DOSE 2, SINGLE), administration date: Apr2021, when the patient was 36 years old, for Covid-19 immunization; Pfizer biontech (DOSE 1, SINGLE), administration date: Mar2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 10Oct2023, outcome "not recovered" and all described as "Swelling/pain of underarm lymphnodes on R side (same side as COVID vaccine administration).   ". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: The patient did not have covid prior to vaccination, and covid was not test post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cefaclor, reaction: "Drug allergy". Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3 (booster), Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos syndrome" (unspecified if ongoing); "POTS" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid on 02Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.