chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Quality of life decreased, Stent placement, Vasospasm, X-ray
Clinical narrative: Chest pain, difficulty swallowing, choking sensation, stomach and abdominal pain.  Heart stent Oct 5, 2022. Heart stent April 26, 2023. Medication for esophageal spasms. I continue to have constant stomach and abdominal pain and cramping, causing difficulty sleeping and ruining normal life. I had never had GI problems of any kind my entire life until September, 2022. The two heart stents seem to have been effective, though test show it is likely that I had irreversible heart damage between October and April.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Impaired work ability, Migraine, Mobility decreased, Pain
Clinical narrative: Within 24 hours, developed fever 101 degrees and body aches that lasted for 3 days. I was unable to get up and move around due to body aches and fever, even while taking my ibuprofen prescription (600 mg) every six hours.  I missed 3 days of work. On the 4th day, fever subsided but migraine persisted for 3 more days. This migraine was unresponsive to my migraine medicines (Triptans ) I have never had side effects from any vaccine before (other than a sore arm).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Within 24 hours, developed fever 101 degrees and body aches that lasted for 3 days. I was unable to get up and move around due to body aches and fever, even while taking my ibuprofen prescription (600 mg) every six hours.  I missed 3 days of work. On the 4th day, fever subsided but migraine persisted for 3 more days. This migraine was unresponsive to my migraine medicines (Triptans ) I have never had side effects from any vaccine before (other than a sore arm).
Age: 23.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Was supposed to give Tdap, but gave DTaP by mistake. Dr checked with the CDC, which said that DTaP given to people age 11 or greater should count as Tdap vaccine.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Used past refrigration date / administrative error
Age: 82.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Dizziness, Hypertension
Clinical narrative: Caller mentions she was administered the vaccine on 08 Aug 2023 and had a severe reaction to it. She was sent to the hospital; severe chest pains; very high blood pressure; cardiac exacerbations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 08Aug2023 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years, in right arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Chronic kidney disease stage 4" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Mitral valve prolapse" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (medically significant), outcome "recovered", described as "Caller mentions she was administered the vaccine on 08 Aug 2023 and had a severe reaction to it. She was sent to the hospital"; CHEST PAIN (medically significant), outcome "recovered", described as "severe chest pains"; HYPERTENSION (medically significant), outcome "recovering", described as "very high blood pressure"; CARDIAC DISORDER (medically significant), outcome "unknown", described as "cardiac exacerbations". The events "caller mentions she was administered the vaccine on 08 aug 2023 and had a severe reaction to it. she was sent to the hospital", "severe chest pains" and "very high blood pressure" required emergency room visit. The consumer stated, "I was just in the emergency room, I was not admitted to the hospital but I was, the doctor send me to the emergency room on 08Aug2023 and they kept me there until yesterday 09Aug2023, I was there for two days in the emergency room." The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) very high, notes: I had very high blood pressure I do not know what it is today I did not check it yet but when they discharged, me it had come down for over 200 over a 105, it come down to I think around 160 something it is improved and I have to follow up and check it at home today; Blood test: (08Aug2023) Unknown Results, notes: I did blood work in the hospital on the 8th and 9th they did blood work every few hours; (09Aug2023) Unknown Results, notes: I did blood work in the hospital on the 8th and 9th they did blood work every few hours; Haemoglobin: (03Aug2023) Normal.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 82.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Blood pressure increased, Blood test, Cardiac disorder, Chest pain, Dizziness
Clinical narrative: Caller mentions she was administered the vaccine on 08 Aug 2023 and had a severe reaction to it. She was sent to the hospital; severe chest pains; very high blood pressure; cardiac exacerbations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 08Aug2023 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years, in right arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Chronic kidney disease stage 4" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Mitral valve prolapse" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (medically significant), outcome "recovered", described as "Caller mentions she was administered the vaccine on 08 Aug 2023 and had a severe reaction to it. She was sent to the hospital"; CHEST PAIN (medically significant), outcome "recovered", described as "severe chest pains"; HYPERTENSION (medically significant), outcome "recovering", described as "very high blood pressure"; CARDIAC DISORDER (medically significant), outcome "unknown", described as "cardiac exacerbations". The events "caller mentions she was administered the vaccine on 08 aug 2023 and had a severe reaction to it. she was sent to the hospital", "severe chest pains" and "very high blood pressure" required emergency room visit. The consumer stated, "I was just in the emergency room, I was not admitted to the hospital but I was, the doctor send me to the emergency room on 08Aug2023 and they kept me there until yesterday 09Aug2023, I was there for two days in the emergency room." The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) very high, notes: I had very high blood pressure I do not know what it is today I did not check it yet but when they discharged, me it had come down for over 200 over a 105, it come down to I think around 160 something it is improved and I have to follow up and check it at home today; Blood test: (08Aug2023) Unknown Results, notes: I did blood work in the hospital on the 8th and 9th they did blood work every few hours; (09Aug2023) Unknown Results, notes: I did blood work in the hospital on the 8th and 9th they did blood work every few hours; Haemoglobin: (03Aug2023) Normal.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 82.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Haemoglobin normal, Hypertension
Clinical narrative: Caller mentions she was administered the vaccine on 08 Aug 2023 and had a severe reaction to it. She was sent to the hospital; severe chest pains; very high blood pressure; cardiac exacerbations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 82-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 08Aug2023 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years, in right arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Chronic kidney disease stage 4" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Mitral valve prolapse" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (medically significant), outcome "recovered", described as "Caller mentions she was administered the vaccine on 08 Aug 2023 and had a severe reaction to it. She was sent to the hospital"; CHEST PAIN (medically significant), outcome "recovered", described as "severe chest pains"; HYPERTENSION (medically significant), outcome "recovering", described as "very high blood pressure"; CARDIAC DISORDER (medically significant), outcome "unknown", described as "cardiac exacerbations". The events "caller mentions she was administered the vaccine on 08 aug 2023 and had a severe reaction to it. she was sent to the hospital", "severe chest pains" and "very high blood pressure" required emergency room visit. The consumer stated, "I was just in the emergency room, I was not admitted to the hospital but I was, the doctor send me to the emergency room on 08Aug2023 and they kept me there until yesterday 09Aug2023, I was there for two days in the emergency room." The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) very high, notes: I had very high blood pressure I do not know what it is today I did not check it yet but when they discharged, me it had come down for over 200 over a 105, it come down to I think around 160 something it is improved and I have to follow up and check it at home today; Blood test: (08Aug2023) Unknown Results, notes: I did blood work in the hospital on the 8th and 9th they did blood work every few hours; (09Aug2023) Unknown Results, notes: I did blood work in the hospital on the 8th and 9th they did blood work every few hours; Haemoglobin: (03Aug2023) Normal.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: M
Vaccine: HPV9
Symptoms: Therapeutic response unexpected
Clinical narrative: Merck Vaccine Representative called on behalf of Nurse Practitioner. Merck Vaccine Representative stated that the Nurse Practitioner mentioned that they know someone who had warts on his hands, not on his genitals, who received GARDASIL 9 and some ti; This spontaneous report was received from a Nurse and refers to a male patient of unknown age. The patient's concurrent conditions included wart on hands (not genital). His medical history, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, strength, dose, route of administration, anatomical location not provided) as prophylaxis.   On an unknown date, after vaccination, the warts that the patient had on his hands were gone (therapeutic response unexpected). Outcome of the event was unknown.   Causality assessment between the therapeutic response unexpected and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was considered as related.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Product was administered to three different patients post TE.; No additional AE/no PQC; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was vaccinated with an inappropriate stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, lot number 1968382 with expiration date 21-MAY-2024, administered as prophylaxis (dosage regimen was not provided) (Product storage error). No additional adverse events were reported (No adverse event).   This is one of three cases from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; improperly stored administered PROQUAD; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 26-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliters (ml) for prophylaxis, lot# reported as X01111 (this is an invalid lot number for varicella [oka-merck] virus vaccine live [PROQUAD]), expiration date reported as 18-JUL-2024 (dose, anatomical location, and route of administration were not reported). The vaccine was stored at a temperature of -14.23 Celsius (C) degrees (-14 C up to -10 C) for 0 hours, 15 minutes, 0 seconds (product storage error). No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: Patient's spouse calling to state that his wife, who was 7 months pregnant, was administered GARDASIL-9 instead of TDAP.; Patient's spouse calling to state that his wife, who was 7 months pregnant, was administered GARDASIL-9 instead of TDAP.; No AE; This spontaneous report was received from patient's spouse and refers to a 7-month pregnant female of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, frequency, strength, lot #, expiry date, anatomical location, and route of administration were not provided) instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (Exposure during pregnancy) (Wrong product administered). No additional adverse events were reported.
Age: 0.42
Sex: M
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: Caller reporting that after administering a dose of VAXNEUVANCE that the syringe experienced a break. He laid the syringe on the exam table gently after administration- vaccine was still in tact- and "2 seconds later the glass popped and broke.; Caller reporting that after administering a dose of VAXNEUVANCE that the syringe experienced a break. He laid the syringe on the exam table gently after administration- vaccine was still in tact- and "2 seconds later the glass popped and broke.; This spontaneous report was received from a nurse and refers to a 5-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-AUG-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, valid lot #X005583, expiration date: 10-DEC-2024, administered intramuscularly for prophylaxis (strength was not provided) (Poor quality device used). Then, nurse stated that after administration of vaccine, he placed the safety on the needle. He laid the syringe on the exam table gently after administration (vaccine was still intact) and "2 seconds" later the glass popped and broke. The break occurred distal to the barrel of the syringe. The entire syringe tip/luer lock broke/snapped off into separate 2 pieces (Syringe issue). No additional information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received dose of vaccine from vial punctured on 8/3/23, administered on 8/5/23 (52 hours later). Patient reports no symptoms. Additional doses are not indicated.
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Product closure issue
Clinical narrative: Patient received dose of vaccine from vial punctured on 8/3/23, administered on 8/5/23 (52 hours later). Patient reports no symptoms. Additional doses are not indicated.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Presents to the ER with concern for shortness of breath, vomiting, and chest tightness.  Covid-19:  symptoms started on 1/13, start on remdesivir given.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Multiple organ dysfunction syndrome, Septic shock, Urinary tract infection
Clinical narrative: Admitted w/septic shock with multiorgan failure, UTI, COVID-19, possible RUL pna and C.diff infection. Tx w/abx, steroids, O2, zinc; poor prognosis, palliative care consulted; pt transitioned to hospice
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chills, Dyspnoea, Hypoxia, Productive cough
Clinical narrative: Pt w/shortness of breath, fever, chills and productive cough for 1-2 weeks prior to arrival and found to be hypoxemic and confirmed COVID-19 pneumonia. Tx w/abx, steroids, O2, remdesivir, Vit C; dc'd to LTAC d/t persistent need for high O2 levels.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pt w/shortness of breath, fever, chills and productive cough for 1-2 weeks prior to arrival and found to be hypoxemic and confirmed COVID-19 pneumonia. Tx w/abx, steroids, O2, remdesivir, Vit C; dc'd to LTAC d/t persistent need for high O2 levels.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Respiratory distress, SARS-CoV-2 test positive
Clinical narrative: Admitted for respiratory distress; Patient tested positive for COVID-19; tx w/remdesivir, steroids, O2; dc'd to SNF on O2
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Death, Dyspnoea, Immunoglobulin therapy, Mental status changes
Clinical narrative: Presented to the hospital with complaints of altered mental status and shortness of breath. COVID-19+ w/pna; tx w/remdesivir, abx, Vit C, steroids, O2, IGG, zinc, O2; did not improve w/ tx; DNR status confirmed w/comfort care & pt expired.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Presented to the hospital with complaints of altered mental status and shortness of breath. COVID-19+ w/pna; tx w/remdesivir, abx, Vit C, steroids, O2, IGG, zinc, O2; did not improve w/ tx; DNR status confirmed w/comfort care & pt expired.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Confirmed with caller no other AE occurred; The caller said the patient received their first dose on 11/26/2022, but missed their second dose that was scheduled to be administered a month later (date unknown).; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 26-NOV-2022, the patient was vaccinated the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date in December 2022, the patient missed their second dose that was scheduled to be administered a month later (date unknown) (Product dose omission issue). Confirmed with caller no other AE occurred (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse reported AE related to improperly stored and administered PROQUAD.; This spontaneous report was received from a licensed practical nurse (LPN) referring to a patient of unknown gender and age. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (1 dose, lot # X002292, expiration date was reported as 21-JUN-2024, but upon internal review was established as 21-JUL-2024, strength and route of administration were not reported) for prophylaxis.  On 12-JUL-2023, the vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was improperly stored at temperature of 6.93 F, the time frame was 1 hour and 13 minutes, and the vaccine was administered to the patient (product storage error). There was also a previous temperature excursion on unknown dates that the vaccines were stored at 52.01 F for 2 hours and 6 minutes and stored at 9.74 F for 4 hours and 34 minutes. No additional AE/no PQC (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a customer (reported as type "other") and referred to a patient of unspecified age and gender. Information of the patient's  pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 11-JUL-2023, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid (2 milliliter (ml), lot# 1968385, expiration date upon internal review was established as 22-MAY-2024, strength was not reported) orally for prophylaxis (product storage error).  It was stated that the vaccine had the following temperature excursions: 34.9 degree Fahrenheit (F) with a time frame of 6 hours and 34 minutes (on 20-JUN-2023); 51.4 F with a time frame of 7 hours and 33 minutes (on 03-JUL-2023); 51.1 F with a time frame of 24 hours (on 04-JUL-2023); and 50.7 F with a time frame of 9 hours and 27 minutes (on 05-JUL-2023).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009885: US-009507513-2307USA009292:Original Case # (no patient identifiers)
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Expired PROQUAD U022983 / 07/22/2023 was administered 07/27/2023; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot number was reported as U022983 but upon internal validation it was not valid, expiration date: 22-JUL-2023, administered for prophylaxis (dose, strength and route of administration were not provided) (Expired product administered). Patient denies signs/symptoms of adverse effects. No additional adverse event (AE) (No adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient does not report signs/symptoms of adverse effects; Vaccine was administered post expiration date; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 31-JUL-2023, the patient was vaccinates with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, expiration date: 13-JUL-2023, administered for prophylaxis (strength, lot # and route of administration were not provided). The patient did not report signs/symptoms of adverse effects (no adverse event).
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: serious neurological reaction; 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), 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: NEUROLOGICAL SYMPTOM (medically significant), outcome "unknown", described as "serious neurological reaction". The event "serious neurological reaction" required physician office visit. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300012028 same patient, different dose/events;US-PFIZER INC-202300012027 same patient, different dose/events;US-PFIZER INC-PV202300005067 same patient, different dose/events;
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cognitive disorder, Dyspnoea, Loss of personal independence in daily activities, Pleural effusion
Clinical narrative: fluid around heart; hard time breathing; Chest pain; unable to perform as well; lack of cognitive focus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 20-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (dose number: 1), for COVID-19 immunization. The following information was reported: PLEURAL EFFUSION (disability), outcome "unknown", described as "fluid around heart"; DYSPNOEA (disability), outcome "unknown", described as "hard time breathing"; CHEST PAIN (disability), outcome "unknown"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability), outcome "unknown", described as "unable to perform as well"; COGNITIVE DISORDER (disability), outcome "unknown", described as "lack of cognitive focus". The events "fluid around heart", "hard time breathing", "chest pain", "unable to perform as well" and "lack of cognitive focus" required physician office visit. Therapeutic measures were taken as a result of pleural effusion, dyspnoea, chest pain, loss of personal independence in daily activities, cognitive disorder. Clinical course: Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Interchange of vaccine products
Clinical narrative: he has had both the Pfizer and Moderna vaccine; asthma; 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 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), 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: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "he has had both the Pfizer and Moderna vaccine"; ASTHMA (non-serious), outcome "unknown".  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: M
Vaccine: COVID19
Symptoms: Disease recurrence, Muscle disorder, Musculoskeletal disorder, Nerve injury, Paraesthesia
Clinical narrative: Damaged the nerves; Tingling in his arm; Arm went out; couldn't use his left arm; relapse in his arm; Arm went out; couldn't use his left arm; relapse in his arm; Muscle was gone in the back of the left arm; This is a spontaneous report received from a contactable consumer (patient's spouse) from medical information team.  A male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 2, single (Lot number: EN6207; 59267-1000 or 1080-1) for COVID-19 immunisation. The patient's relevant medical history included: "Couldn't use his left arm" (unspecified if ongoing); "Surgeries on his neck", start date: 1998 (unspecified if ongoing), notes: 25 years ago; two titanium plates in his neck from C3-C7; "Stint" (unspecified if ongoing); "BBB" (unspecified if ongoing). Concomitant medication(s) included: IVERMECTIN. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EN6200 (59267-1000-1)), administration date: 02Feb2021, for COVID-19 immunization, reaction(s): "Never had a reaction to the shot at all and he never did have any problems". The following information was reported: NERVE INJURY (medically significant), outcome "unknown", described as "Damaged the nerves"; PARAESTHESIA (medically significant), outcome "unknown", described as "Tingling in his arm"; MUSCULOSKELETAL DISORDER (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Arm went out; couldn't use his left arm; relapse in his arm"; MUSCLE DISORDER (medically significant), outcome "unknown", described as "Muscle was gone in the back of the left arm". The patient was in the early part of the clinical trial and was taking ivermectin at this time. The patient's spouse asked could the relapse in his arm be related to getting the vaccines. The patient had two surgeries on his neck within 3 days of each other, which was repeat of a surgery he had 25 years ago. It damaged the nerves and all of a sudden there was a tingling in his arm and his arm went out. His arm went bad again and he couldn't use his left arm. His muscle was gone in the back of the left arm. He had to start steroid shots. He has two titanium plates in his neck from C3-C7. Therapeutic measures were taken as a result of nerve injury, paraesthesia, musculoskeletal disorder, disease recurrence, muscle disorder which included two surgeries in Feb2023. The patient's spouse assessed the case as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Psoriasis, SARS-CoV-2 test
Clinical narrative: Psoriasis; 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), on 24Apr2021 as dose 2, single (Lot number: EW0172) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "severe pain", start date: Jan2021 (unspecified if ongoing), notes: I have been in severe pain with this disease since that time, Jan2021 /Feb2021; "Obstuctive Sleep Apnea" (unspecified if ongoing), notes: Other medical history: Obstuctive Sleep Apnea; "Anti-Body Thyroid Disease" (unspecified if ongoing), notes: Other medical history: Anti-Body Thyroid Disease. Concomitant medications included thyroid meds and a statin. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Right), administration date: 02Apr2021, when the patient was 62-year-old, for COVID-19 immunization. The following information was reported: PSORIASIS (disability) with onset 15Nov2021, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Biopsy: (Nov2022) Unknown Results, notes: biopsy was done in Nov2022 and diagnosed as a rare form of Psoriasis; SARS-CoV-2 test: (06Jun2022) Negative, notes: Covid test type post vaccination=Nasal Swab. Clinical course was reported as follows. A patch of discolored skin developed on her right ankle area in Nov2021, as well as discolored skin on her left lower leg area. The skin developed in a red rash over a few months and burning stinging ensued. She stated she never had any skin issues ever. She was misdiagnosed for nearly a year as 'fungal' a biopsy was done in Nov2022 and diagnosed as a rare form of Psoriasis. She had been in severe pain with this disease since that time, Jan2021 /Feb2021. There are others who have reported similarly, never having this until the vaccine/boosters for COVID. Therapeutic measures taken as a result of psoriasis included ointments, steroid shots, and photo light therapy. The event psoriasis results in doctor office/clinic visit and was considered serious (disability or permanent damage).
Sex: M
Vaccine: COVID19
Symptoms: Congenital tracheomalacia, Laryngomalacia, Maternal exposure during pregnancy, Vascular compression
Clinical narrative: Maternal exposure during pregnancy; Laryngomalacia/omega epiglottis; Tracheomalacia; Arterial compression on his epiglottis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A neonate male patient was exposed to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), transplacental, administration details for the mother: as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (life threatening), outcome "unknown"; LARYNGOMALACIA (life threatening), outcome "unknown", described as "Laryngomalacia/omega epiglottis"; CONGENITAL TRACHEOMALACIA (life threatening), outcome "unknown", described as "Tracheomalacia"; VASCULAR COMPRESSION (life threatening), outcome "unknown", described as "Arterial compression on his epiglottis". Therapeutic measures were taken as a result of vascular compression.   Additional information: Reporter on the line calling with a question asking if Pfizer has done any research into possible birth defects with the covid vaccine. The reporter explained he had to watch them run a code on his 2.5 week old son and do CPR. He was born with several airway defects. Reporter clarified that before his son was born, both his son's mother and he (the reporter) received the covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300275193 Maternal case;
Age: 76.0
Sex: M
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 at 13:00 as dose 4 (booster), single (Lot number: GJ6739) at the age of 76 years, in right arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Heart patient" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: 15Nov2000; TAMSULOSIN, start date: 01Oct2010; ESCITALOPRAM, start date: 01Mar2017. Past drug history included: Morphine, reaction(s): "Drug allergy". 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: (unspecified date) Positive, notes: Treatment of COVID-19; (10Aug2023) negative, notes: tested negative on the 7th day; (11Aug2023) positive, notes: tested positive in the morning of the 8th day. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: the patient took Paxlovid for 5 days, started feeling better on the 3rd day, and tested negative on the 7th day. He tested positive on the morning of the 8th day, not feeling well again. He had the same symptoms prior to taking Paxlovid.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 55.0
Sex: M
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 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13May2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm 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: "Depression" (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 "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. 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.
Age: 48.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Nov2021 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: "Asthma exercise induced" (unspecified if ongoing); "Known allergies : Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY, start date: 01Jan2015; FLONASE ALLERGY RELIEF, start date: 01Jan2015; ALBUTEROL SULFATE HFA, start date: 01Jan2015. 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 as patient took Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 66 years, in right arm 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: "hypercholesterolemia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: eggs" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE HCL, start date: 01May2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures included Paxlovid from 05Aug2023 to 09Aug2023 were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 at 13:30 as dose 4 (booster), single (Lot number: GJ6738) at the age of 68 years, in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD s/9 6 vessel CABG" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (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 "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment was Paxlovid.
Age: 32.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Peanuts" (unspecified if ongoing), notes: Known allergies: Peanuts and tree nuts; "tree nuts" (unspecified if ongoing), notes: Known allergies: Peanuts and tree nuts. The patient's concomitant medications were not reported. No other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 03Aug2023 to 07Aug2023, for Treatment of COVID-19. The patient has not recovered from rebound COVID from 12Aug2023.  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.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Feb2023 as dose 5 (booster), single at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm 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) and as dose 3 (booster), 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: 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 from 04Aug2023 to 08Aug2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Feb2023 as dose 5 (booster), single at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm 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) and as dose 3 (booster), 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: 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 from 04Aug2023 to 08Aug2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures taken as a result of drug ineffective, covid-19 included PAXLOVID from 25Jul2023 to 30Jul2023.  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.