chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, White blood cell count
Clinical narrative: rotator cuff repair infection; This is a literature report for the following literature source Adverse events following mRNA vaccine administration from a busy orthopedic practice: A series of four cases.  Follow up (17Feb2022): This is a literature report for the following literature source entitled Adverse events following mRNA vaccine administration from a busy orthopedic practice: A series of four cases , JSES Reviews, Reports, and Techniques, 2022; [DOI: 10.1016/j.xrrt.2021.12.003]. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.  The initial case was missing the following minimum criteria: Unspecified event. Upon receipt of follow-up information on (17Feb2022), this case now contains all required information to be considered valid.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "arthroscopic rotator cuff repair", start date: Mar2020 (unspecified if ongoing); "fall" (unspecified if ongoing); "hypercholesterolemia" (ongoing); "hypertension" (ongoing); "left shoulder rotator cuff tear" (unspecified if ongoing), notes: 4.5 years ago; "right shoulder pain", start date: Feb2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 Immunization.  The following information was reported: INFECTIVE TENOSYNOVITIS (medically significant), outcome "recovering", described as "rotator cuff repair infection". The patient underwent the following laboratory tests and procedures: c-reactive protein (normal high range 0.9): 2.2; culture: negative, notes: The cultures were held for 21 days, the final gram stain; diagnostic aspiration: unknown results; magnetic resonance imaging: a full-thickness supraspinatus tear was confirmed; demonstrated a large  loculated fluid collection, notes: in the subacromial space with disruption of the rotator cuff repair and lucency  around the previously placed anchors; red blood cell sedimentation rate (0-15): 45; white blood cell count (5.7-10.5): 7.2. Therapeutic measures were taken as a result of infective tenosynovitis; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event, infective tenosynovitis cannot be completely ruled out. 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.,Linked Report(s) : US-PFIZER INC-202200301423 Same article/ drug and different patient/event
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Contusion, Lymphoedema, Swelling
Clinical narrative: swelling; bruising; like there is a pocket of fluid in my underarm/ armpit area; her armpit is sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jan2022 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date Dec2021. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot: ER8781), administration date: 21Apr2021, when the patient was 46 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Lot: ER8730), administration date: 31Mar2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 27Jan2022, outcome "not recovered", described as "swelling"; CONTUSION (non-serious) with onset 27Jan2022, outcome "not recovered", described as "bruising"; LYMPHOEDEMA (non-serious) with onset 27Jan2022, outcome "not recovered", described as "like there is a pocket of fluid in my underarm/ armpit area"; AXILLARY PAIN (non-serious) with onset 27Jan2022, outcome "not recovered", described as "her armpit is sore".   Additional information: The patient not received additional vaccine on the same date of Pfizer vaccine. The patient received flu vaccine within four weeks prior to administration. she received her PBCV booster dose on 26Jan2022. On 27Jan2022, the patient has experienced swelling, bruising and "like there was a pocket of fluid in my underarm/ armpit area. She states it was not hot, not discolored on the pocket and her armpit was sore. Also, the swelling was not changing. Caller states she was looking at the Pamphlet they gave her after her shot. Caller states she had the shot on Wednesday and her arms feel sore like they would with a Tetanus shot but she considered that to be normal. Treatment received none, going to ice later.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Pityriasis rubra pilaris, Psoriasis
Clinical narrative: psoriasis; PRP; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I had RA prior to all this" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "psoriasis"; PITYRIASIS RUBRA PILARIS (non-serious), outcome "unknown", described as "PRP". The events "psoriasis" and "prp" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional info: Patient stated, Mar of last year I received the two doses of vaccine. At that time I had two places on my face that were I saw my dermatologist about. Some cream was given. In Apr a month later saw the doctor again the places were spreading across my face. In Aug I got the booster. This dermatitis spread across my body like a fire. After testing, I had psoriasis , PRP. I believe the vaccines help push this on me.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Axillary lymph vessels under left armpit swollen 5 cm and tender Cervical lymph nodes nodule swollen 2 cm and tender; Axillary lymph vessels under left armpit swollen 5 cm and tender. Cervical lymph nodes nodule swollen 2 cm and tender; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Feb2022 10:15 (Lot number: FK9896) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EJ1686, Location of injection: Arm Left, Vaccine Administration Time: 12:00, Route of Administration: Intramuscular), administration date: 04Feb2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Arm Left, Vaccine Administration Time: 03:15 PM, Route of Administration: Intramuscular), administration date: 14Jan2021, when the patient was 45 years old, for COVID-19 immunization.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 04Feb2022 12:15, outcome "recovering", described as "Axillary lymph vessels under left armpit swollen 5 cm and tender Cervical lymph nodes nodule swollen 2 cm and tender"; LYMPH NODE PAIN (non-serious) with onset 04Feb2022 12:15, outcome "recovering", described as "Axillary lymph vessels under left armpit swollen 5 cm and tender. Cervical lymph nodes nodule swollen 2 cm and tender". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.  Additional information: The patient had no other vaccine in four weeks. No other medications in two weeks. The patient received no covid prior vaccination and was not tested for covid post vaccination. The patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: chronic migraine/persistent headache/migraines; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 03Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 01, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: MIGRAINE (non-serious) with onset Nov2021, outcome "not recovered", described as "chronic migraine/persistent headache/migraines".  Additional information: The patient has had chronic migraine after 2nd dose of vaccine on 03Nov2021, seeing neurologist for persistent headache/migraines through 02Feb2022. Optional Information was not applicable. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Actually after the first dose I had called because my kids they were just tired the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Jul2021 10:30 (Lot number: ER8731) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 17Jul2021, outcome "unknown", described as "Actually after the first dose I had called because my kids they were just tired the next day".  Additional information: The patient took dose 2 on 06Aug2021 approximately 11AM on right arm (Batch/lot number: EW0171) and dose 3 on 14Jan2022 approximately 10.30AM on right arm (Batch/lot number: FF2589). The vaccine facility type was public health clinic/ Veterans administration facility. Vaccine was not administered at Facility. No prior vaccinations were done vaccinations within four weeks prior to the first administration date of the suspect vaccines. No medications were taken within two weeks before the event onset. Patient has no medical history. No relevant test (specific) was done.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: Taste became more acute/aversion to the taste; my sense of smell became more acute/ aversion to the smell; 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) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: TASTE DISORDER (non-serious), outcome "unknown", described as "Taste became more acute/aversion to the taste"; PAROSMIA (non-serious), outcome "unknown", described as "my sense of smell became more acute/ aversion to the smell ".  Additional information: The patient had COVID-19 vaccine doses 1 and 2 and a booster. Within 2 days of booster, the patient's sense of smell and taste became more acute. 60-70% of typical daily diet was needed to change because of aversion to the taste and smell of dairy products, foods cooked in oils like sunflower seeds and roasted nuts, coffee (that the patient love to drink), chocolate, wine, the list goes on.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Epistaxis, Paranasal sinus haemorrhage
Clinical narrative: blood coming out of sinuses; still getting blood out of nose; everything tastes salty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient in his 60's received bnt162b2 (BNT162B2), administered in arm, administration date 20Jan2022 11:45 (Lot number: FD0810) at the age of 7 decade as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ex-tobacco user" (unspecified if ongoing), notes: I've quit smoking late it now. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Time (24hr): 9:00 AM, Anatomical Site of injection: Shoulder, Batch/Lot number: ER8734), administration date: 20Mar2021, for COVID-19 immunization, reaction(s): "I got covid", "sinus infection", "hard time breathing"; Bnt162b2 (Dose: 2nd, Time (24hr): 11:00 AM, Anatomical Site of injection: Shoulder, Batch/Lot number: EW0153), administration date: 20Apr2021, for COVID-19 immunization, reaction(s): "I got covid", "sinus infection", "hard time breathing".  The following information was reported: PARANASAL SINUS HAEMORRHAGE (non-serious), outcome "not recovered", described as "blood coming out of sinuses"; EPISTAXIS (non-serious), outcome "not recovered", described as "still getting blood out of nose"; DYSGEUSIA (non-serious), outcome "unknown", described as "everything tastes salty".  Additional Information: Patient age at time of vaccination was reported as 60 and 61 years. Booster dose administered due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Patient did not receive prior vaccinations with four weeks. There are no family history relevant to the adverse events. There are no relevant tests or specific relevant test for thromboembolic events with thrombocytopenia. Eight months after the second dose, four days from getting the booster, patient got covid, probably omicron and sinus infection on top of it. Patient has very hard time breathing for first 3 days. Patient thought he was going to have a heart attack. Thirty days later and after getting the booster, patient is till getting blood out of nose and sinuses stuff the size of quarters, looking like blood clots everything tastes salty. Only good thing is patient quite smoking late it now. Patient is worried about Blood coming out of sinuses reminds him of distemper his dog died of years ago. Patient is also somewhat familiar w/mRNA and crisper.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: sick 11Feb ST body aches and fever and then a positive test but not sure when; sick 11Feb ST body aches and fever and then a positive test but not sure when; sick 11Feb ST body aches and fever and then a positive test but not sure when; sick 11Feb ST body aches and fever and then a positive test but not sure when; sick 11Feb ST body aches and fever and then a positive test but not sure when; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 41 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 20May2021 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single and administration date 30Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "sick 11Feb ST body aches and fever and then a positive test but not sure when"; ILLNESS (non-serious), PAIN (non-serious), PYREXIA (non-serious) all with onset 11Feb2022, outcome "unknown" and all described as "sick 11Feb ST body aches and fever and then a positive test but not sure when". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, illness, pain, pyrexia.  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 information provided, a causal association between reported events and the suspect BNT162B2 is possible.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: sick 11Feb ST body aches and fever and then a positive test but not sure when; sick 11Feb ST body aches and fever and then a positive test but not sure when; sick 11Feb ST body aches and fever and then a positive test but not sure when; sick 11Feb ST body aches and fever and then a positive test but not sure when; sick 11Feb ST body aches and fever and then a positive test but not sure when; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 41 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 20May2021 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single and administration date 30Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "sick 11Feb ST body aches and fever and then a positive test but not sure when"; ILLNESS (non-serious), PAIN (non-serious), PYREXIA (non-serious) all with onset 11Feb2022, outcome "unknown" and all described as "sick 11Feb ST body aches and fever and then a positive test but not sure when". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, illness, pain, pyrexia.  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 information provided, a causal association between reported events and the suspect BNT162B2 is possible.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia streptococcal, SARS-CoV-2 test
Clinical narrative: She is seeing people get streptococcal pneumonia right after the shots. They are saying its COVID but they do extensive testing and see its either a bacteria pneumonia or streptococcal pneumonia; This is a spontaneous report received from a contactable reporter (Other HCP).  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA STREPTOCOCCAL (medically significant), outcome "unknown", described as "She is seeing people get streptococcal pneumonia right after the shots. They are saying its COVID but they do extensive testing and see its either a bacteria pneumonia or streptococcal pneumonia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: nobody comes back positive for COVID. The nurse stated that this has been going on in the hospital and now it's family members and coworkers. She stated her mother and boyfriend are reports.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Event PNEUMONIA STREPTOCOCCAL  represents an intercurrent medical condition and unrelated to bnt162b2 .  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.,Linked Report(s) : US-PFIZER INC-202200276393 Same reporter, drug and event and different patient;US-PFIZER INC-202200276328 Same reporter, drug and event and different patient
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Mass, Pain in extremity, Parkinsonism
Clinical narrative: lump in arm that was hard; body was shaking, could not sleep; body was shaking, could not sleep; arm really sore; she said she felt pressured to get it.; Shaking like Parkinson's type of shaking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: EL9265, Expiration Date: May2021) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TREMOR (non-serious) with onset 12Feb2021 01:00, outcome "unknown", PAIN IN EXTREMITY (non-serious) with onset 11Feb2021, outcome "unknown" and all described as "arm really sore"; MASS (non-serious) with onset 12Feb2021 15:00, outcome "unknown", described as "lump in arm that was hard"; INSOMNIA (non-serious) with onset 12Feb2021, outcome "unknown", described as "body was shaking, could not sleep"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "she said she felt pressured to get it."; PARKINSONISM (non-serious) with onset 2021, outcome "recovered" (2021), described as "Shaking like Parkinson's type of shaking".  Additional information: The patient did not receive any additional vaccines on same date. No AE required to visit emergency room or physician office, and patient messaged her doctor but her doctor said it would go away. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Patient has completed the 2 doses of Covid shots, and she is currently pregnant in her 1st trimester, she had Covid in mid-January.  Conclusion: investigation results: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL9265 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EL9265. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: lump in arm that was hard; body was shaking, could not sleep; body was shaking, could not sleep; arm really sore; she said she felt pressured to get it.; Shaking like Parkinson's type of shaking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: EL9265, Expiration Date: May2021) at the age of 31 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TREMOR (non-serious) with onset 12Feb2021 01:00, outcome "unknown", PAIN IN EXTREMITY (non-serious) with onset 11Feb2021, outcome "unknown" and all described as "arm really sore"; MASS (non-serious) with onset 12Feb2021 15:00, outcome "unknown", described as "lump in arm that was hard"; INSOMNIA (non-serious) with onset 12Feb2021, outcome "unknown", described as "body was shaking, could not sleep"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "she said she felt pressured to get it."; PARKINSONISM (non-serious) with onset 2021, outcome "recovered" (2021), described as "Shaking like Parkinson's type of shaking".  Additional information: The patient did not receive any additional vaccines on same date. No AE required to visit emergency room or physician office, and patient messaged her doctor but her doctor said it would go away. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Patient has completed the 2 doses of Covid shots, and she is currently pregnant in her 1st trimester, she had Covid in mid-January.  Conclusion: investigation results: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL9265 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EL9265. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Interchange of vaccine products, Off label use, Psoriatic arthropathy
Clinical narrative: The patient received COVID-19 Vaccine manufactured by Moderna.; The patient received COVID-19 Vaccine manufactured by Moderna.; Recurrent psoriatic arthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4158756-00 (Pharmaceutical Company).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Oct2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Route of Administration: Intramuscular, High blood pressure - Recovering/resolving), administration date: 01Apr2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "High blood pressure", "Arthritis in hands"; Bnt162b2 (Dose 1, Route of Administration: Intramuscular, High blood pressure - Recovering/resolving), administration date: 01Mar2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "High blood pressure", "Arthritis in hands". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "The patient received COVID-19 Vaccine manufactured by Moderna."; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Recurrent psoriatic arthritis". The patient underwent the following laboratory tests and procedures: blood pressure measurement: high.  Clinical course: Causality as per reporter (Drug/Vaccine) for the event recurrent psoriatic arthritis (Psoriatic arthropathy) was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out after the first COVID vaccination; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jul2021 13:30 (Lot number: EM0179) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Sinusitis" (unspecified if ongoing). Concomitant medication included: ADVAIR. Past drug history included: Augmentin, reaction: "Allergy". The patient has not had other vaccine in four weeks.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovering", described as "passed out after the first COVID vaccination".   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: she mentioned that her  Father, as soon as he got the COVID vaccine, he passed away shortly after; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 89 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 19May2021, outcome "fatal", described as "she mentioned that her  Father, as soon as he got the COVID vaccine, he passed away shortly after". The patient date of death was 19May2021. The reported cause of death was "she mentioned that her  Father, as soon as he got the COVID vaccine, he passed away shortly after". The reporter mentioned that the patient was not in good health. He was on hospice. The reported does not have the manufacturer, lot or expiration. She believes it was the Pfizer, but was not sure. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Event unknown cause of death is assessed as related until sufficient information is available to confirm an unrelated cause of death. 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.; Reported Cause(s) of Death: she mentioned that her  Father, as soon as he got the COVID vaccine, he passed away shortly after
Sex: U
Vaccine: COVID19
Symptoms: Oral disorder
Clinical narrative: I had weird feeling in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Jun2021 15:00 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  Vaccination history included: Flu shot (I got flu shot in Nov2020), administration date: Nov2020, for Immunization.  The following information was reported: ORAL DISORDER (non-serious), outcome "recovered", described as "I had weird feeling in my mouth". Additional information: The first COVID shot I had weird feeling in my mouth the hospital had me stay longer to keep an eye on me. Prior Vaccinations (Within 4 weeks) was none.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Myocarditis
Clinical narrative: myocarditis; irregular heart beats; This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer-sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, lot number unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "irregular heart beats". The patient underwent the following laboratory tests and procedures: heart rate: irregular. Clinical course: The patient reported having irregular heartbeats after the booster shot and the patient was scared asking what to do about it. The patient also mentioned reading about this on a social media app as myocarditis. The patient asked for help as it occurs off and on, mostly at night.  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Headache, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: joint pain; muscle pain; chest pain; muscle twitching; headaches; stiffness; 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), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "muscle pain"; CHEST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "chest pain"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "not recovered", described as "muscle twitching"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headaches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "not recovered", described as "stiffness".  Clinical course: The patient is having an adverse reaction to Pfizer COVID vaccine for months now.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: joint pain; muscle pain; chest pain; muscle twitching; headaches; stiffness; 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), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "muscle pain"; CHEST PAIN (non-serious) with onset 2021, outcome "not recovered", described as "chest pain"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "not recovered", described as "muscle twitching"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headaches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "not recovered", described as "stiffness".  Clinical course: The patient is having an adverse reaction to Pfizer COVID vaccine for months now.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Allergic reaction to excipient, Anaphylactic reaction, Skin test
Clinical narrative: Pruritic symptoms, facial urticaria, tongue swelling, wheezing progressed to full body hives and difficulty breathing/occurring within 30 minutes after first dose/Anaphylactic reaction; Pruritic symptoms, facial urticaria, tongue swelling, wheezing progressed to full body hives and difficulty breathing/occurring within 30 minutes after first dose/Anaphylactic reaction; This is a literature report for the following literature source(s): "Diagnostic challenge in evaluating the risk and management of allergic reaction(s) to sars-cov-2 vaccines", Annals of Allergy, Asthma and Immunology, 2021;.  A 49 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "Atopic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), ALLERGIC REACTION TO EXCIPIENT (medically significant), outcome "recovering" and all described as "Pruritic symptoms, facial urticaria, tongue swelling, wheezing progressed to full body hives and difficulty breathing/occurring within 30 minutes after first dose/Anaphylactic reaction". The patient underwent the following laboratory tests and procedures: skin test: negative, notes: to PEG; negative, notes: to JNJ-78436735 (Johnson and Johnson); positive, notes: to polysorbate 80; ngative, notes: to BNT 162B2; negative, notes: to PEG; negative, notes: to JNJ-78436735 (Johnson and Johnson); negative, notes: to polysorbate 80; negative, notes: to BNT 162B2. Therapeutic measures were taken as a result of anaphylactic reaction, allergic reaction to excipient. Anaphylactic reaction to BNT162B2 vaccine occurred within 30 minutes after the first dose, following treatment with epinephrine, IV diphenhydramine, and IV steroids, her symptoms improved.  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 Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. 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: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive with Covid-19, physician suggested Paxlovid. She asked where she can get the medication. she was fully immunized, boosted with Pfizer Covid19 Vaccine; she tested positive with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "tested positive with Covid-19, physician suggested Paxlovid. She asked where she can get the medication. she was fully immunized, boosted with Pfizer Covid19 Vaccine"; COVID-19 (medically significant), outcome "unknown", described as "she tested positive with Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROXYCHLOROQUINE; LEVOTHYROXINE; LISINOPRIL; HYDROCHLOROTHIAZIDE; PRILOSEC [OMEPRAZOLE MAGNESIUM]; VITAMIN D [COLECALCIFEROL]; FISH OIL; SPIRONOLACTONE; AMETHYST; METHOTREXATE. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", COVID-19 (medically significant) with onset Jan2022, outcome "recovered" (2022) and all described as "COVID".It was reported that patient stated she had covid on or about 15Jan2022. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Zpak, reaction(s): "Drug Allergy", notes: Known allergies: zpak. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "Covid test resultPositive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: covid test type post vaccination other.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had a mild case of omicron; Had a mild case of omicron; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had a mild case of omicron".  Clinical course: Caller was a physician residing in withheld. He wants to know when the vaccine will be approved. He also mentioned that he has a friend who was a doctor as well and had a lecture. He mentioned that his friend has had the Covid vaccine and the booster but the friend has had a mild case of omicron. He stated that his daughter got vaccinated and yesterday was tested positive. She was trying to find out if it was Omicron or something else. He basically wants to know when the vaccine will be available (approved). He also stated that he heard that they have started human trials but he was not interested in participating in the Covid trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202200295286 same reporter/patient/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 cases with onset from 7 days through 6 months post-dose 2 in BNT162b2 vaccine recipients; This case has been considered invalid as the event was outcome study.
Sex: U
Vaccine: COVID19
Symptoms: Breast tenderness
Clinical narrative: breast tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST TENDERNESS (non-serious), outcome "unknown", described as "breast tenderness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Nasal congestion, SARS-CoV-2 test
Clinical narrative: congestion; She got sick; She then tested positive for COVID-19 on November; She then tested positive for COVID-19 on November; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PAXLOVID taken for illness, stop date: 05Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "She then tested positive for COVID-19 on November"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; ILLNESS (non-serious) with onset 27Jan2022, outcome "recovered" (28Jan2022), described as "She got sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive; (Jan2022) positive; (Jan2022) negative. Therapeutic measures were taken as a result of illness.  The lot number for bnt162b2 was not provided and will be requested during follow up.