chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Ejection fraction, Electrocardiogram, Magnetic resonance imaging, Myocarditis
Clinical narrative: acute myocarditis 4 days after 2nd dose,chest pain; Fever on day 1; This is a literature report.  A 21-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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered", described as "acute myocarditis 4 days after 2nd dose,chest pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever on day 1". The patient underwent the following laboratory tests and procedures: C-reactive protein: 4.6; Ejection fraction: 54 %, notes: inferior and posterolateral hypokinesia; Electrocardiogram: results below, notes: Diffuse ST-segment elevation; Magnetic resonance imaging: results below, notes: Edema, delayed enhancement, pericardial effusion, pericardial edema; SARS-CoV-2 test: negative; Troponin: 1.4; 1164. Therapeutic measures were taken as a result of myocarditis, pyrexia.  Clinical course: 2 days in intensive care; no inotropes or mechanical circulatory support; NSVT episode; discharged stable.  SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event myocarditis  and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Troponin
Clinical narrative: acute myocarditis 4 days after 2nd dose,chest pain; Fever on day 1; This is a literature report.  A 21-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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered", described as "acute myocarditis 4 days after 2nd dose,chest pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever on day 1". The patient underwent the following laboratory tests and procedures: C-reactive protein: 4.6; Ejection fraction: 54 %, notes: inferior and posterolateral hypokinesia; Electrocardiogram: results below, notes: Diffuse ST-segment elevation; Magnetic resonance imaging: results below, notes: Edema, delayed enhancement, pericardial effusion, pericardial edema; SARS-CoV-2 test: negative; Troponin: 1.4; 1164. Therapeutic measures were taken as a result of myocarditis, pyrexia.  Clinical course: 2 days in intensive care; no inotropes or mechanical circulatory support; NSVT episode; discharged stable.  SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event myocarditis  and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 32 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 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 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: contacted COVID/Nasal Swab Positive; contacted COVID/Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 04Mar2021 at 13:00 as dose 1, single (Lot number: EN6205), in left arm and on 26Mar2021 at 14:00 as dose 2, single (Lot number: ER8733) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No covid prior vaccination. No known allergy.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, outcome "unknown" and all described as "contacted COVID/Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300300687 same patient/vaccine, different events;
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test positive
Clinical narrative: Increase fatigue.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 8.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events and patient's mother not concerned that vaccine is indicated for 18 and older
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Confusional state, Laboratory test normal
Clinical narrative: Vaccine administered in retail environment so above manufacturer information is not accurate.  Hours after receiving  RSV and flu vaccine together she experienced an acute confusional episode.  Went to ER and had negative workup after which her mentation cleared.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: D#1 (9/11/23)  - fever/shaking chills, pain at injection site; fever lasted about 24hours; pain at injection site lasted 2-3days. D#4 (9/15/23) - I woke up with my L upper arm (lateral and spreading lower than at the injection site) with  pain and swelling.  Also a red, itchy rash developed in this same area. The area is hot to touch. No other symptoms of fever or chills
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sleep disorder, Tremor
Clinical narrative: D#1 (9/11/23)  - fever/shaking chills, pain at injection site; fever lasted about 24hours; pain at injection site lasted 2-3days. D#4 (9/15/23) - I woke up with my L upper arm (lateral and spreading lower than at the injection site) with  pain and swelling.  Also a red, itchy rash developed in this same area. The area is hot to touch. No other symptoms of fever or chills
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: The patient said that the shingrix shot is causing him sleep disturbances. He said it started right after he got the shot and that he wakes in the middle of the night. He said nothing else has changed other then receiving the vaccine
Age: 45.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dysphagia, Dyspnoea, Erythema, Paraesthesia oral
Clinical narrative: Patient received Vaqta and Typhim-Vi IM in R arm at 3:05 pm. At 3:17 pm client reported feeling "tingling" on her tongue, a moment later reported difficulty swallowing. Emergency protocol initiated and first dose of epinephrine given at 3:21 pm, improvement of symptoms noted by patient following that dose. EMS called 3:27 pm.  BP 116/88 in L arm, HR 54 bpm, RR 22. Client reported return of difficulty swallowing and tingling at 3:30 pm with red/splotchy patches on arms and chest noted, client taking labored deep breaths. 2nd dose epi given at 3:31 followed benadryl at 3:35, BP 125/78 HR 94 RR 16. Redness improved and client reported ease in breathing again. 3:42 pm client began to report same tingling in mouth/tongue and stated she was having trouble swallowing again. Final dose epi given 3:45 pm, BP 136/86 HR 93 RR 15. EMS arrived 3:48 pm and client left clinic to hospital 16:02 with husband following by car.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Decreased appetite, Headache, Nausea, Pain
Clinical narrative: Received flu vaccine the day before. 4 hrs after rsv injection arm was sore, had chills, headache, body aches, nausea, strange brief shooting pains anywhere on body ie; pinky finger. Symptoms continued though lessened for next two days, chills continued during the night, Today nausea was worse and vomiting occurred, chills started earlier today. No appetite since injection. Saw my dr the day after the injection. I don?t know which rsv vaccine it was.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Received flu vaccine the day before. 4 hrs after rsv injection arm was sore, had chills, headache, body aches, nausea, strange brief shooting pains anywhere on body ie; pinky finger. Symptoms continued though lessened for next two days, chills continued during the night, Today nausea was worse and vomiting occurred, chills started earlier today. No appetite since injection. Saw my dr the day after the injection. I don?t know which rsv vaccine it was.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient presented to pharmacy with hives and welts only on right arm that she said began last night.  She was seeking a remedy to control the rash and itch.  It started 6 days after vaccine was adminstrated.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site rash, Tenderness
Clinical narrative: Pt said after the vaccine, was fine for 24 hours then on day 2,3,4 she had a red rash at site of injection. a little tender to the touch. she did not take any tylenol or contact md/pharmacy regarding adverse event.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Headache
Clinical narrative: Severe headache after vaccine; required evaluation  at ER . Headache improved with oral analgesic nlgesic
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Hypotension, Malaise, Syncope
Clinical narrative: Vasovagal syncope. After sitting for a few moments on the exam table after the immunization (none other given today), patient stood to walk out of exam room. She reported to her mother that she did not feel well and then fainted. Mother reported catching her so patient did not injure herself on the floor. She quickly recovered but had low blood pressure (normalized within 10 minutes) and normal blood sugar.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Adnexa uteri pain, Feeling abnormal, Gastrointestinal pain, Impaired work ability
Clinical narrative: This was the 2nd of the Moderna shots, taken exactly 12 weeks after the first shot.  push out the protection. Received it around the 5pm hour Sunday 11/21/2023, then woke up the next day Monday morning, felt like I got hit by a mac truck or train. Several hours of waves of pains. I had to take the rest of the day off at work at about 11am that morning. I got into the bathtub, Epsom salt trying to relieve pain. Could not go get my childrenfrom school, laid in bed for most of the day, waves of pains. eventually felt like my ovaries and stomach intestines were being ripped out of me. I felt like I was in labor, pulsating waves of pains would come every few minutes. felt like I was going to have a baby, and i have had two child prior to this shots. Because of this reaction, I will never be getting any other Flu/Covid-19 boosters ever again. I am a healthy woman still currently and I keep good care of myself, and am not at high risk for death from Covid-19 which I've had most likely more than once since those shots. I was still messed up, and not 100% for several days, and even several weeks. Not everyone needed to take these shots, I had no co-morbidities.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain, Suspected COVID-19
Clinical narrative: This was the 2nd of the Moderna shots, taken exactly 12 weeks after the first shot.  push out the protection. Received it around the 5pm hour Sunday 11/21/2023, then woke up the next day Monday morning, felt like I got hit by a mac truck or train. Several hours of waves of pains. I had to take the rest of the day off at work at about 11am that morning. I got into the bathtub, Epsom salt trying to relieve pain. Could not go get my childrenfrom school, laid in bed for most of the day, waves of pains. eventually felt like my ovaries and stomach intestines were being ripped out of me. I felt like I was in labor, pulsating waves of pains would come every few minutes. felt like I was going to have a baby, and i have had two child prior to this shots. Because of this reaction, I will never be getting any other Flu/Covid-19 boosters ever again. I am a healthy woman still currently and I keep good care of myself, and am not at high risk for death from Covid-19 which I've had most likely more than once since those shots. I was still messed up, and not 100% for several days, and even several weeks. Not everyone needed to take these shots, I had no co-morbidities.
Age: 66.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Back pain, Chills, Headache, Nausea, Pain
Clinical narrative: Initially nausea, followed by headache, low grade fever, body aches, back ache, chills
Age: 66.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Pyrexia
Clinical narrative: Initially nausea, followed by headache, low grade fever, body aches, back ache, chills
Age: 78.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Injection site pain, Malaise, Nausea, Vertigo
Clinical narrative: Felt lightheaded as if room was swirling.....lasting only a second or two and then left. I had to grab onto something to steady myself. This was 20 min after RSV vaccination. Experienced nausea and a feeling of being unwell.....very unpleasant......this lasted for another day and then left (today) by 6pm. Injection site tenderness.x 3 days. I know this was an RSV vaccine......but don't know manufacturer or lot number or which RSV type it was. I had an influenza 2023 vaccine on 9/4/23 with no ill effects.
Age: 86.0
Sex: M
Vaccine: FLU4, PNC20, RSV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Patient states left upper arm swelling starting a few days post injection. Growing swelling into the forearm area. No redness, itching, temperature change, fever. Patient has done no self care. Just calling pharmacy to report swelling. Patient did not express any concerns for life-threatening symptoms. Referred patient to contact primary care physician or immediate care clinic as soon as possible.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test positive, Allergy to plants, Bacterial test negative, Pruritus, Seasonal allergy
Clinical narrative: A month or two later I started to become itchy, mainly in the vaginal area.  After seeing my gynecologist who could find no reason (infection or otherwise) as to why I was itchy, he sent me to a dermatologist who then sent me to an allergist.  No doctor could find a reason for the itching or why it was worse some times than others.  Two years later I determined that the itching got worse with the more gluten I ate.  I have never had an issue with gluten (no sensitivity at all) or any other food in my life.  Ever since I got my first Johnson & Johnson Covid vaccine, this issue started shortly after with no other changes in my life to potentially cause it.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Viral test negative, Vulvovaginal pruritus
Clinical narrative: A month or two later I started to become itchy, mainly in the vaginal area.  After seeing my gynecologist who could find no reason (infection or otherwise) as to why I was itchy, he sent me to a dermatologist who then sent me to an allergist.  No doctor could find a reason for the itching or why it was worse some times than others.  Two years later I determined that the itching got worse with the more gluten I ate.  I have never had an issue with gluten (no sensitivity at all) or any other food in my life.  Ever since I got my first Johnson & Johnson Covid vaccine, this issue started shortly after with no other changes in my life to potentially cause it.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Death
Clinical narrative: Patient expired 9/13/2023.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: No adverse events noted. See explanation on Continuation Page
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: the patient in question received their first dose of VAQTA in 2017 and did not receive a booster as recommended by the prescribing information; No adverse event; This spontaneous report was received from a pharmacist and refers to a 55-year-old patient. Information regarding the patient medical history, concomitant medications, drug allergies or reactions was not provided.      On an unspecified day in  2017,  the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) dose 1 for prophylaxis (dose, strength, administration route, lot number and expiration date were not provided.).    It was mention that the patient did not received the recommended booster by the prescribing information(vaccine dose omission). Pharmacist stated that the patient came into the pharmacy and received a dose of hepatitis A combination (TWINIRIX) on 17-AUG-2023. No adverse events were reported.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported/no vaccine reaction; The healthcare worker is reporting that a patient received improperly stored vaccine/power outage; This spontaneous report has been received from a healthcare worker and refers to a 4-year-old male patient. His current conditions included tie tong and disorder of speech. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 17-AUG-2023, the patient was vaccinated at the private doctor's office/hospital with public funds with 1 dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection in the left arm (lot number x000996 has been verified to be valid, expiration date 08-JUL-2024); which was previously improperly stored at a temperature of 29 Fahrenheit (F) during 4 hours and 30 minutes. The power outage occurred at 5:49 am (product storage error). Additionally, it was reported that the vaccine had no previous temperature excursion and no additional adverse events or vaccine reactions were reported. Digital Data Logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2308USA007442: US-009507513-2308USA007540: US-009507513-2308USA007507:
Age: 13.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No additional adverse event reported; The patient was administered PROQUAD and VARIVAX the same time instead of MMR II and VARIVAX; The patient was administered PROQUAD and VARIVAX the same time instead of MMR II and VARIVAX; This initial spontaneous report was received from a nurse concerning a 13-year-old male patient.  The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported.   On 26-AUG-2023, the patient was vaccinated with an unspecified dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, Lot #, expiry date, and route of administration were not provided) and at the same time (overdose) he was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, both administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX). No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: calling to report the administration of an expired dose of a PNEUMOVAX 23 VIAL to a patient on 09/01/2023.  No symptoms or further details reported.  No other AE and no PQC; calling to report the administration of an expired dose of a PNEUMOVAX 23 VIAL to a patient on 09/01/2023.  No symptoms or further details reported.  No other AE and no PQC; Information has been received from an unspecified reporter, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-SEP-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 2,5 ml/ five dose vial, lot # U025499 and expiration date 07-AUG-2023 (administration route was not provided) for prophylaxis. No adverse effects were reported.
Age: 56.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; A patient received a inadvertent administration of an expired dose of PNEUMOVAX 23; This spontaneous report was received from a nurse and refers to a 56-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications, concurrent conditions and drug reactions/allergies were not reported.  On 07-SEP-2023, the patient was inadvertent vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection, vial, 0.5 milliliter, lot number: U025499 with expiry date reported as 07-AUG-2023, (route of administration and anatomical location were not provided) as prophylaxis. No additional adverse events (AEs) reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE; 36 year old patient had a delay in receiving their second GARDASIL 9 Vaccine at 6 months instead of 2 months; This spontaneous report was received from a pharmacist and refers to a 36-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications, concurrent conditions and drug reactions/allergies were not reported.  On 12-SEP-2023, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, (dose, strength, lot number, expire date, route of administration and anatomical location were not provided) as prophylaxis. Furthermore, it was reported that the patient had a delay in receiving their second dose at six months instead of 2 months. No additional adverse events (AEs) reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects were reported; expired dose of MMR-II that was administered to an adult patient; expired dose of MMR-II that was administered to an adult patient; This spontaneous report was received from a nurse and refers to an adult patient of unknown gender and age.The patient's pertinent medical history, concomitant medications, concurrent conditions and drug reactions/allergies were not reported.  On 12-SEP-2023, the adult patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) Subcutaneous Injection, first dose given subcutaneously, lot number: W011885 and expiration date was reported as 04-SEP-2023, (dose, strength and anatomical location were not provided) as prophylaxis (product administered to patient of inappropriate age and expired product administered). No additional adverse events (AEs) reported and no adverse effects were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: dose number: 1, brand other: Janssen ; dose number: 2, brand: Pfizer / BioNTech; 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 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 30Dec2021 at 15:15 as dose 2 (booster), single (Lot number: FL3197) at the age of 59 years, in left arm for covid-19 immunisation; covid-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 21Mar2021 as dose 1, single (Lot number: 1808609), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Known allergies: Sulfa quinolones (antibiotics)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "dose number: 1, brand other: Janssen ; dose number: 2, brand: Pfizer / BioNTech"; 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. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 19Aug2023 to 22Aug2023.
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Stomatitis
Clinical narrative: Upper lip localized angioedema; oral mucositis; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 16-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2023 as dose 3 (booster), 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: bnt162b2 (Dose Number: 1; Batch/Lot No: not known), administration date: 21Feb2022, when the patient was 14-year-old, for Covid-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 2; Batch/Lot No: not known), for Covid-19 Immunization. No other vaccine in four weeks, no other medications in two weeks. No known allergies. None other medical history. Unknown if covid prior vaccination and no covid tested post vaccination. The following information was reported: ANGIOEDEMA (medically significant) with onset 09Sep2023 at 19:00, outcome "recovering", described as "Upper lip localized angioedema"; STOMATITIS (non-serious) with onset 09Sep2023 at 19:00, outcome "recovering", described as "oral mucositis". The events "upper lip localized angioedema" and "oral mucositis" required physician office visit. Therapeutic measures were taken as a result of angioedema, stomatitis. HSV testing.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2, bnt162b2 omi ba.4-5 and the reported event "Upper lip localized angioedema". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Food intolerance, Immune system disorder
Clinical narrative: caused my immune system to react to food that I could normally eat before; caused my immune system to react to food that I could normally eat before; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: 301458A), in left arm for covid-19 immunisation. The patient had no relevant medical history. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks/medications in two weeks. There were no concomitant medications. Past drug history included: Macrodantin, reaction(s): "known allergies: Macrodantin". Vaccination history included: bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Ek4176, Location of injection: Arm Right), administration date: 18Jan2021, for Covid-19 Immunization; bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EH9899, Location of injection: Arm Right), administration date: 28Dec2020, for Covid-19 Immunization. The following information was reported: IMMUNE SYSTEM DISORDER (medically significant), FOOD INTOLERANCE (medically significant) all with onset 22Feb2022, outcome "unknown" and all described as "caused my immune system to react to food that I could normally eat before". The vaccine has caused my immune system to react to food that I could normally eat before. So I am no longer able to eat wheat, dairy, pork. Therapeutic measures were not taken as a result of immune system disorder, food intolerance.; Sender's Comments: Based on the available information, a causal relationship between the reported events immune system disorder, food intolerance and suspect product cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 67 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6203), on 18Mar2021 as dose 2, single (Lot number: ER2613), on 04Nov2021 as dose 3 (booster), single (Lot number: FF2590) and on 29Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Concomitant medication(s) included: BUPROPION; CITALOPRAM; GLUCOSAMINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" 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; (27Sep2022) Positive, notes: Rebound COVID 4 days after last dose. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 77-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 76 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 02Jun2022 as dose 4 (booster), single (Lot number: FM0173) 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: "Poly chondritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codine, reaction(s): "Drug allergy: Codine".The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 (BNT162B2 NOS), on 26Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years, in left arm 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 31Aug2023 at 20:00, outcome "recovered" (09Sep2023) and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from 02Sep2023 to 07Sep2023 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Aug2023 at 20:00 as dose 6 (booster), single (Lot number: GL2042) at the age of 72 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Lot number: 030L20A), on 04Mar2021 as dose 2, single (Lot number: 029A21A), on 17Nov2021 as dose 3 (booster), single (Lot number: 034F21A), on 04Apr2022 as dose 4 (booster), single (Lot number: 002M21A) and on 29Sep2022 as dose 5 (booster), single (Lot number: 027E22A) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Cypro antibiotic, reaction(s): "Known allergies: Cypro antibiotic". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Aug2023 at 20:00, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99.0, notes: Since then highest fever is 99.0; (01Sep2023) 100.1, notes: Highest fever was 100.1 on 01Sep; SARS-CoV-2 test: (01Sep2023) positive, notes: My initial positive test was that morning; (04Sep2023) negative, notes: tested negative on 04Sep and 07Sep; (07Sep2023) negative, notes: tested negative on 04Sep and 07Sep; (10Sep2023) positive, notes: I tested positive with no initial symptoms on 10Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken as treatment for COVID-19 from 01Sep2023 to 06Sep2023
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown), as dose number unknown (booster), single (Batch/Lot number: unknown) and 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient reported that the patient received the vaccines at privacy, then 2 boosters. Then, the patient got COVID. For behtelovimab infusion, the patient fell out of the chair, had fractured hip then underwent bone surgery and rehab and received another vaccine on 23Jan. The patient had fatigue, diarrhea, brain fog, etc. Granted that the patient was 86 but had none of this and other health issues prior.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: severe constipation problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), on 28May2021 as dose 1, single (Lot number: Ew0180) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONSTIPATION (hospitalization) with onset 2021, outcome "unknown", described as "severe constipation problems". The patient was administered with 2 doses of the Pfizer COVID-19 Vaccine: Dose 1 on 28May2021 (Pfizer Ew0180) and Dose 2 on 21Jun2021 (Pfizer Ew0181) at pharmacy. Since immediately after he was administered the first dose of Pfizer vaccine, he was hospitalized in view of severe constipation problems.
Sex: U
Vaccine: COVID19
Symptoms: Pemphigoid
Clinical narrative: Bullous Pemigoid/blistering itching skin reaction/rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 immunization. The following information was reported: PEMPHIGOID (medically significant), outcome "recovered", described as "Bullous Pemigoid/blistering itching skin reaction/rash". The event "bullous pemigoid/blistering itching skin reaction/rash" required physician office visit. Therapeutic measures were taken as a result of pemphigoid. Clinical details: Patient's first Pfizer shot for Covid was fine. After second shot and got a blistering itching skin reaction about two months after the shot. After visiting several Dermatologist, patient was referred to (withheld) and was diagnosed with Bullous Pemigoid. It took a few months of dupixant treatment for the rash and itching to go away. Patient never had it prior to Covid shot.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue
Clinical narrative: Flu Vaccines received were in transit too long due to delayed delivery with no adverse event; Initial information received on 08-Sep-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 9 months old female patient and the flu vaccines received were in transit too long due to delayed delivery with no adverse event for influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient had no medical history, concomitant disease or risk factor.The patient's medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 ml of suspect influenza quadrival A-B vaccine, single dose pre-filled syringe lot UT8040KA via intramuscular route in unknown administration site for flu prevention(strength, expiry date: unknown), flu vaccines received were in transit too long due to delayed delivery with no adverse event (poor quality product administered) (latency same day). There were no lab data/results available.  Reportedly, the Flu Vaccines received were in transit too long due to delayed delivery therefore they were considered ineffective. Vaccine had been administered prior to getting this information. There have been no signs or symptoms of any type of reaction to the adverse event  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: fainted day after vaccination; dizziness; Initial information received on 07-Sep-2023 regarding an unsolicited valid serious courtesy case received from other health professional.  This case involves Adult and unknown gender patient who had fainted day after vaccination and dizziness after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had No allergy. At the time of the event, the patient had ongoing Blood pressure high and High cholesterol.  Concomitant medications included Lisinopril; Alendronate Sodium (alendronate); and Atorvastatin for Product used for unknown indication.  On 3-Sep-2023, the patient received unknown dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation, batch number and expiry date) via unknown route in Right arm for prophylactic vaccination (immunization).  On 04-Sep-2023 at 10:30 hours, the patient had dizziness and fainted day after vaccination (syncope) (latency: 1 day 10 hrs 30 min) following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (dizziness, fainted day after vaccination).  At time of reporting, the outcome was Recovered / Resolved on 04-Sep-2023 for both the events.   Seriousness criteria: The event fainted day after vaccination (syncope) was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 15-Sep-2023: This case involves Adult and unknown gender patient who had fainted day after vaccination and dizziness after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent]. Based on the information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information regarding past medical treatment(s), family history information precludes comprehensive case assessment.
Age: 0.75
Sex: F
Vaccine: TD
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 9 month old patient was administered TENIVAC with no reported adverse event; Initial information received on 07-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves 9-month-old patient was administered diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Sep-2023, the patient received a dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection lot U7745AA expiry date: 20-May-2025 via unknown route in the right thigh for immunization and 9 month old patient was administered tenivac with no reported adverse event (product administered to patient of inappropriate age) on the same day following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 9 month old patient was administered tenivac with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.