chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive. Her only symptom is post-nasal drip. However a home test kit tested her positive for COVID-19.; tested positive. Her only symptom is post-nasal drip. However a home test kit tested her positive for COVID-19.; The initial case was missing the following minimum criteria: Other-Non Pfizer product. Upon receipt of follow-up information on 19Dec2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: NIFEDIPINE. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer, ), for Covid-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacturer, ), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (booster); unknown manufacturer, ), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (booster); unknown manufacturer, ), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Dec2023, outcome "recovering" and all described as "tested positive. Her only symptom is post-nasal drip. However a home test kit tested her positive for COVID-19.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Dec2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: They tested (name withheld) after my daughter tested positive. Her only symptom is post-nasal drip. However, a home test kit tested her positive for COVID-19. No covid prior vaccination. It was Comirnaty that was administered. (name withheld) and reporter and also both received Comirnaty. Reporter was confused on the reporting form and did not understand that Comirnaty is not the same thing as "bivalent".   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Product contamination microbial, Product quality issue
Clinical narrative: there might be mold or something white floating in the bottom of the Prevnar 20 syringe; This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GT6701, Expiration Date: Oct2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT CONTAMINATION MICROBIAL (medically significant), outcome "unknown", described as "there might be mold or something white floating in the bottom of the Prevnar 20 syringe". Additional information: Calling about a product concern involving Prevnar 20. Went to go give a vaccine and looks like there might be mold or something white floating in the bottom of the Prevnar 20 syringe. Caller went to grab a 2nd Prevnar 20 and that Prevnar 20 had the same concern, confirmed 2 Prevnar 20 syringes had what looks like there might be mold or something white floating in the bottom of the Prevnar 20 syringes. Caller stated these were the last 2 Prevnar 20s in the box. Caller is not sure if there is a log to keep track of lot numbers in regard to this or if caller can get a replacement. Asked if they should keep the vaccines in the fridge in the meantime. Confirmed no patients involved with the 2 Prevnar 20s that had the quality concern. Product strength and count size dispensed: Comes with 10 per box, confirmed the 2 Prevnar 20s that had the concern came from the same box. Confirmed both Prevnar 20 vaccines that had the quality concern have the same NDC, lot, and expiry. Confirmed no additional NDC numbers, lots, or expiration dates to provide. Causality for "there might be mold or something white floating in the bottom of the prevnar 20 syringe" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein)  will be requested and submitted if and when received.; Sender's Comments: White floating and mold found in the bottom of PREVNAR 20 syringe with no patient involved is due to product contamination associated with the medical device constituent part of the combination vaccine PREVNAR 20  not related to the drug part for the vaccine
Age: 79.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Brain fog, Confusional state, Gait disturbance
Clinical narrative: feel quite confused (brain fog); feel quite confused (brain fog); unsteady on his feet; This is a spontaneous report received from a Consumer or other non HCP and a Nurse.  A 79-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 09Nov2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years for immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Nov2023 as dose number unknown, single) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BRAIN FOG (non-serious), CONFUSIONAL STATE (non-serious) all with onset 15Nov2023, outcome "recovering" and all described as "feel quite confused (brain fog)"; GAIT DISTURBANCE (non-serious) with onset 15Nov2023, outcome "recovering", described as "unsteady on his feet". The events "feel quite confused (brain fog)" and "unsteady on his feet" required physician office visit. Therapeutic measures were not taken as a result of brain fog, confusional state, gait disturbance.  Additional information: Caller stated that he called about Abrysvo (RSV), a Pfizer product. On 09Nov2023 he went into (name withheld) and they did his Covid and RSV shots and within a day or so he was starting to feel quite confused (brain fog) and  unsteady on his feet that continued until last Thursday (14Dec2023). Now he feels fine. Had Moderna Covid shot. Had talked with the nurse at the (name withheld) before they called Pfizer and she told them that the Covid shot was Moderna. Later clarified that (name withheld) was for (name withheld). Attempted to capture outcome: stated that there are still some iffy spots but much better.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia
Clinical narrative: his shoulder hurt continuously; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jul2023 as dose numner unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset Jul2023, outcome "not recovered", described as "his shoulder hurt continuously".  Additional information: the caller has a concern about the vaccine he took 6 months before (in Jul2023) for pneumonia for the Prevnar 20 vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Biopsy skin normal, Body temperature decreased, Chills, Feeling cold, Injection site pain
Clinical narrative: She is experiencing chills after receiving the vaccine; When she has given it to me it hurt like hell/ the shot hurt like the devil/ sore arm; Her temperature was below normal; I was freezing, like shivering, my teeth were shattering. My nose was cold; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 79-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "Ulcer" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pneumonia shot, for immunization; Flu shot (inaudible) (Flu shot (inaudible)), for immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "She is experiencing chills after receiving the vaccine"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "When she has given it to me it hurt like hell/ the shot hurt like the devil/ sore arm"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "Her temperature was below normal"; FEELING COLD (non-serious), outcome "unknown", described as "I was freezing, like shivering, my teeth were shattering. My nose was cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain. Additional information: Caller mentions that she is experiencing chills after receiving the vaccine. Caller would like to know whether chills is associated with the vaccine. Caller mentions, "when she has given it to me it hurt like hell, she says it's gonna hurt, I never screamed like anything and she said you might have a soreness where the injection was and chills, some people get chills I went shopping after getting it, and my arm wasn't hurting yet."  Caller added "I was freezing, like shivering, my teeth were shattering. My nose was cold. My arm was one thing, I was putting ice on it for like half an hour." Caller added, 'Since I have the sore arm and the chills"  Caller confirmed that she didn't have a fever. Caller would like to know how long will her side effects last. Caller mentioned that her temperature was below normal. Caller added that she doesn't feel sick and her arms kills her. Caller mentioned that she got the pneumonia shot, Flu shot (inaudible) and RSV is the last one. Caller stated that have ulcer. Caller mentioned that her doctor took a biopsy from her ulcer and the results indicated that it was fine.  Caller added that her chills come and go and currently, she is not experiencing it. Caller added that the shot hurt like the devil.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  will be requested and submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Vaccination site pain
Clinical narrative: pain in the injection site that he developed after getting the vaccine; arm hurts / arm pain / ever since then his arm had been giving him pain; he could hardly at times pick up a cup of coffee and in different positions it hurt worse than others; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 82-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Nov2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "arm hurts / arm pain / ever since then his arm had been giving him pain"; MOBILITY DECREASED (non-serious) with onset 2023, outcome "unknown", described as "he could hardly at times pick up a cup of coffee and in different positions it hurt worse than others"; VACCINATION SITE PAIN (non-serious) with onset 2023, outcome "not recovered", described as "pain in the injection site that he developed after getting the vaccine". Therapeutic measures were not taken as a result of pain in extremity. Additional information: the patient had been having pain in his arm near where the shot was put in and it had gotten so bad he could hardly at times pick up a cup of coffee and in different positions it hurt worse than others and if he did not move it, it did not hurt. No other vaccines were administered in 4 weeks  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: RSV
Symptoms: Device breakage, Device leakage
Clinical narrative: Reconstitution; plastic adapter the tip thing broke off as we were in the middle of doing it and then all the liquid squirted out of the side; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HH2495, Expiration Date: Mar2025) 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 "Reconstitution; plastic adapter the tip thing broke off as we were in the middle of doing it and then all the liquid squirted out of the side".  Causality for "reconstitution; plastic adapter the tip thing broke off as we were in the middle of doing it and then all the liquid squirted out of the side" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: Pharmacy stated that there was a defect on the Abrysvo vaccines regrading the reconstitution, when they opened the first box and use the vaccines, the real plastic on it went off and it start squirting all the way. So, they have wasted two of the doses for the vaccines. When paraphrased the concern: Reporter stated, "We had two doses and we have been doing the RSV vaccines since August. So we are all our pharmacists are pretty well versed in how to do it, but the first two doses that we opened in this new box, the plastic adapter, the tip thing broke off as we were in the middle of doing it and then all the liquid squirted out of the side. So, anyway I do not know if it was just a bad LOT or so we had to be very careful on the last one to do is to make sure it does not break. Obviously with the expensive involved of wasting two doses of RSV vaccine, that's pretty significant." When probed if defective vaccines given to any patient: Reporter stated, "No, we just, the first one we threw away, we discarded. Second one I saved, I have right here next to me. So, we said we do not give it to, we only made a new one and ended up wasting a couple of doses. Last night, we discarded that one, in this morning the first one we did, that's why I decided to call and report it because having two in the same box, I have saved that one." NDC number of Abrysvo: 00069020701.
Age: 68.0
Sex: F
Vaccine: 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 Consumer or other non HCP from product quality group.  A 68-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 14:00 as dose 1, single (Lot number: HD9835) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing), notes: Sulfa drugs, like the ones given for UTIs. Concomitant medication(s) included: RALOXIFENE, start date: Feb2021, stop date: Dec2023; LOSARTAN, start date: May2023, stop date: Dec2023. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number=EL1283, vaccine location=Left arm), administration date: 20Jan2021, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number=EN5318, vaccine location=Left arm), administration date: 10Feb2021, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number=FD8448, vaccine location=Left arm), administration date: 26Aug2021, when the patient was 66-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number=FK9893, vaccine location=Left arm), administration date: 11Apr2022, when the patient was 67-year-old, for Covid-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Lot number=GH9702, vaccine location=Left arm), administration date: 16Sep2022, when the patient was 67-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" (Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for 9 days; negative, notes: negative for 2 day. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 17Dec2023 to 19Dec2023.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Ear pain, Oropharyngeal pain, Pain
Clinical narrative: sore throat/throat is super sore; her ears hurt.; was coughing; In the middle of the night, aches/Body aches and was pretty bad, lasted for a probably about 30 hours; shivering/extreme chills; she developed pain in the injection site/arm started hurting; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 55-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Caller stated that on the evening on 23Dec2023 when she received the vaccine everything was fine then her arm started hurting, she developed pain in the injection site, then on Sunday (24Dec2023), the middle of the night, she started getting shivering/ extreme chills and aches/ body aches and was pretty bad and it was crazy and that lasted for a probably about 30 hours and she took Tylenol (Intent: Treatment) which seems to help and made it just so she was felt like she was not going to die and but then yesterday on 26Dec2023 she developed sore throat and her ears hurt. Caller stated she started coughing it sounded, it felt like it was from her lungs, her throat was not sore. Now she was kind of stop coughing and her throat was super sore. Caller added that the coughing came first then the sore throat comes next. Therapeutic measures were taken as a result of pain, vaccination site pain. The outcome of event Pain, Chills, Vaccination site pain and Cough was recovered in Dec2023. The outcome of the other events was unknown.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore throat/throat is super sore; her ears hurt.; was coughing; In the middle of the night, aches/Body aches and was pretty bad, lasted for a probably about 30 hours; shivering/extreme chills; she developed pain in the injection site/arm started hurting; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 55-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Caller stated that on the evening on 23Dec2023 when she received the vaccine everything was fine then her arm started hurting, she developed pain in the injection site, then on Sunday (24Dec2023), the middle of the night, she started getting shivering/ extreme chills and aches/ body aches and was pretty bad and it was crazy and that lasted for a probably about 30 hours and she took Tylenol (Intent: Treatment) which seems to help and made it just so she was felt like she was not going to die and but then yesterday on 26Dec2023 she developed sore throat and her ears hurt. Caller stated she started coughing it sounded, it felt like it was from her lungs, her throat was not sore. Now she was kind of stop coughing and her throat was super sore. Caller added that the coughing came first then the sore throat comes next. Therapeutic measures were taken as a result of pain, vaccination site pain. The outcome of event Pain, Chills, Vaccination site pain and Cough was recovered in Dec2023. The outcome of the other events was unknown.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: I developed Neuropathy; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 2023, outcome "unknown", described as "I developed Neuropathy". The event "i developed neuropathy" required physician office visit. Clinical course: After getting the first two shots of the Pfizer Covid vaccine patient developed Neuropathy. Patient's Neurologist told patient that patient wasn't the only one.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 19:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BMI" (unspecified if ongoing), notes: Over 50, high BMI; "strawberries" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug allergies: Codeine"; Prednisone, reaction(s): "Drug allergies: Prednisone". Vaccination history included: BNT162b2 ({Vaccine brand=Pfizer / Biontech, Vaccine brand unknown=False, Vaccine administration date=17Nov2022, Vaccine administration time=05:00 PM, Vaccine lot unknown=true, Vaccine lot unknown reason=unable to locate or Read the details, Vaccine dose number unknown=true, Vaccine dose number unknown reason=unknown, Vaccine location=left arm}]), administration date: 17Nov2022, when the patient was 58-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) Over 50, high BMI, notes: Over 50, high BMI; SARS-CoV-2 test: (2023) negative, notes: previously had tested negative on two consecutive tests 48 hours aparrt.; (2023) positive, notes: Tested positive again on at home test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received anti viral covid 19 treatment with paxlovid from 15Dec2023 to 20Dec2023.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Dose 2/Dose 1:Pfizer;Dose 5/Dose 4/Dose 3:Moderna; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 09May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Oct2021 as dose 3 (booster), single), in right arm, on 03Oct2022 at 12:00 as dose 4 (booster), single), in right arm and on 20Oct2023 at 17:30 as dose 5 (booster), single), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "sulfa-based antibiotics allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Oct2021, outcome "recovered", described as "Dose 2/Dose 1:Pfizer;Dose 5/Dose 4/Dose 3:Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Dec2023, outcome "recovered" (10Dec2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2023) Positive; (10Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Initial covid symptoms began on 02Dec2023. Tested positive on 04Dec2023. Started Paxlovid midday on 04Dec2023 and completed the full 5 days in the evening on 08Dec2023. Symptoms were flu-like and not serious enough for hospital visit. Began to wane on 09Dec2023 and were mostly clear on 10Dec2023. Negative test on 10Dec2023.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 28 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2023) Negative; (27Dec2023) Negative; (27Dec2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid treatment from 21Dec2023 to 25Dec2023. Two days after finishing Paxlovid he took 3 COVID tests with 2 being negative and 1 being positive. He was unsure if this was just a false positive or not but he was concerned.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Nurse.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single). The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing); "Gluten intolerance" (unspecified if ongoing); "Dairy intolerance" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Dec2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative; (Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid treatment start date 18Dec2023, stop date 22Dec2023 for COVID-19. Tested negative at days 6, 7 and positive on days 8, 9 (today). Runny nose but otherwise no additional symptoms. Known allergies: Gluten and dairy intolerance not true allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported Drug ineffective /COVID-19 cannot be ruled out.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to raw onions, scallions, garlic" (unspecified if ongoing), notes: Cooked was ok, but raw caused nausea. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose number unknown, single, Vaccine location: Left arm), administration date: 05Jun2023, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID from 18Dec2023 to 23Dec2023.  The information on the batch/lot number for BNT162B2 OMI XBB.1.5 been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Drug ineffective, Electrocardiogram
Clinical narrative: I have had eight of the Pfizer COVID shots; I got COVID; I have had eight of the Pfizer COVID shots; I got COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Mounjaro for Diabetes. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "Arterial occlusion", "heart failure", "Triple vessel bypass graft", "Feeling bad", "heart attack"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "Arterial occlusion", "heart failure", "Triple vessel bypass graft", "Feeling bad", "heart attack"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 6 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 7 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "I have had eight of the Pfizer COVID shots; I got COVID". The patient underwent the following laboratory tests and procedures: Computerised tomogram: unknown; Electrocardiogram: abnormal. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Consumer (patient) stated that he had eight of the Pfizer COVID shots, eight of them and unfortunately, his friend and he got COVID about 2-3 days ago (Further information was not available over the call about friend). So, anyway his doctor prescribed Paxlovid from Pfizer for him and he got it today, well, yesterday and he took it at 3 PM and then he just took it now at 3 AM and he was looking at these pills, the pills that they gave him, these pills are already expired. COVID Vaccine details: Consumer stated that he didn't have it handy but his most recent shot because all she had gotten almost 3 years ago. He only used Pfizer.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300456937 Same patient, different dose and different event.;
Sex: U
Vaccine: COVID19
Symptoms: Kyphosis, Malaise, Myocardial infarction, Myocardial injury, Vaccination site discolouration
Clinical narrative: Mild heart attack, 5% damage; Mild heart attack, 5% damage; Hunch in the back; I am not feeling real well; Arm went dead; My arm went dead, turned black on me; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: MYOCARDIAL INFARCTION (medically significant), MYOCARDIAL INJURY (medically significant), outcome "unknown" and all described as "Mild heart attack, 5% damage"; KYPHOSIS (non-serious), outcome "unknown", described as "Hunch in the back"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling real well"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm went dead"; VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown", described as "My arm went dead, turned black on me".  Clinical course: Consumer stated, I got some real concerns, when I got your Pfizer shot when this whole started, I had a mild heart attack, 5% damage and hunch in the back of that night. I do not know which one, it is the COVID shot. I do not know what to say. It might be me because I am not feeling really well because I think I got it again and I am really scared to go, get another shot and I do not want another heart attack. Consumer stated, I got the COVID shot. I had a mild heart attack that night that I got it, 5% damage in my heart. My arm went dead, turned black on me and I felt like shit ever since. I am trying to get across.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild heart attack, 5% damage; Mild heart attack, 5% damage; Hunch in the back; I am not feeling real well; Arm went dead; My arm went dead, turned black on me; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: MYOCARDIAL INFARCTION (medically significant), MYOCARDIAL INJURY (medically significant), outcome "unknown" and all described as "Mild heart attack, 5% damage"; KYPHOSIS (non-serious), outcome "unknown", described as "Hunch in the back"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling real well"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Arm went dead"; VACCINATION SITE DISCOLOURATION (non-serious), outcome "unknown", described as "My arm went dead, turned black on me".  Clinical course: Consumer stated, I got some real concerns, when I got your Pfizer shot when this whole started, I had a mild heart attack, 5% damage and hunch in the back of that night. I do not know which one, it is the COVID shot. I do not know what to say. It might be me because I am not feeling really well because I think I got it again and I am really scared to go, get another shot and I do not want another heart attack. Consumer stated, I got the COVID shot. I had a mild heart attack that night that I got it, 5% damage in my heart. My arm went dead, turned black on me and I felt like shit ever since. I am trying to get across.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 62.0
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 Nurse.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 at 14:00 as dose 3 (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) and as dose 2, single) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment includes paxloid started on 16Dec2023 and stopped on 21Dec2023. It was reported that there was no other medication in 2 weeks and no known allergies reported.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported events Drug ineffective and COVID-19 cannot be ruled out, based on the limited information currently available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster); unknown manufacture), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Dec2023 to 21Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 62.0
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 Nurse.  A 62-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "known allergies: Nickel" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid from 26Dec2023 to 27Dec2023 for the treatment of COVID-19.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the known the information available the Causal relation between the events Vaccination failure, Covid 19 and suspect drug cannot be excluded completely
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Both she and her father contracted COVID-19 and had recently received booster shots; Both she and her father contracted COVID-19 and had recently received booster shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Both she and her father contracted COVID-19 and had recently received booster shots". However, she clarified that while she followed her doctor's prescription for a different medication.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300209800 same reporter/product/event, different patient;
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ipf" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Condition aggravated, Fatigue
Clinical narrative: she was a little more fatigued; she was a little more fatigued; This is a spontaneous report received from an Other HCP.  A 71-year-old female patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), in 2023 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), FATIGUE (non-serious) all with onset 2023, outcome "recovering" and all described as "she was a little more fatigued". Additional information: Patient reported after having the flu, pneumonia, and respiratory syncytial virus (rsv) vaccines (recently) she was a little more fatigued, but now feeling much better (unknown if ongoing)/MD aware.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v , pneumococcal 13-val conj vac (dipht CRM197 protein), pneumococcal 13-val conj vac (dipht CRM197 protein)  will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Myocarditis
Clinical narrative: myocarditis; symptoms similar to the flu; Fell Ill during the week of 20Dec2021; This is a spontaneous report received from a Lawyer from legal division. Other Case identifier(s): (Court Case number), (Court Case number).  A 14-year-old 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: MALAISE (medically significant) with onset Dec2021, outcome "unknown", described as "Fell Ill during the week of 20Dec2021"; MYOCARDITIS (death), outcome "fatal"; INFLUENZA LIKE ILLNESS (medically significant), outcome "unknown", described as "symptoms similar to the flu". The events "myocarditis" and "fell ill during the week of 20dec2021" required emergency room visit. The event "symptoms similar to the flu" required physician office visit and emergency room visit. The patient date of death was 25Dec2021. Reported cause of death: "myocarditis". It was not reported if an autopsy was performed. Clinical course: Plaintiff alleged his 14-year-old daughter died from Comirnaty vaccine-induced myocarditis on 25Dec2021 on Christmas Day in 2021. PRIVACY was a healthy 14-year-old girl who loved her family, loved to play basketball, and who was a straight. A student at PRIVACY school in PRIVACY. Because Of the pressure from PRIVACY, PRIVACY took the first dose Of Pfizer's vaccine. She took the second dose three weeks later. She fell ill during the week of 20Dec2021. She sought medical attention for symptoms similar to the flu. Although she was alert and some symptoms had subsided, her family debated taking her to the emergency room on 24Dec2021.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: myocarditis