chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site bruising
Clinical narrative: pain; Depression; I have had to drop from working fulltime to parttime; When I first got the Vaccine I had a lot of bruising; so I had muscle aches / I have been super tired with muscle ache on and off since; I had muscle aches and fatigue/ I have been super tired with muscle ache on and off since/ have had to drop from working fulltime to parttime/ I am extremely weak after a few hours of work; extremely weak after a few hours of work; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (extremely weak after a few hours of work), PAIN (pain), DEPRESSION (Depression), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I have had to drop from working fulltime to parttime) and VACCINATION SITE BRUISING (When I first got the Vaccine I had a lot of bruising) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058G21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-Feb-2022, the patient experienced ASTHENIA (extremely weak after a few hours of work), MYALGIA (so I had muscle aches / I have been super tired with muscle ache on and off since) and FATIGUE (I had muscle aches and fatigue/ I have been super tired with muscle ache on and off since/ have had to drop from working fulltime to parttime/ I am extremely weak after a few hours of work). On an unknown date, the patient experienced PAIN (pain), DEPRESSION (Depression) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I have had to drop from working fulltime to parttime). an unknown date, the patient experienced VACCINATION SITE BRUISING (When I first got the Vaccine I had a lot of bruising). The patient was treated with DULOXETINE for Pain and Depression, at a dose of 20 milligram once a day. At the time of the report, ASTHENIA (extremely weak after a few hours of work), MYALGIA (so I had muscle aches / I have been super tired with muscle ache on and off since) and FATIGUE (I had muscle aches and fatigue/ I have been super tired with muscle ache on and off since/ have had to drop from working fulltime to parttime/ I am extremely weak after a few hours of work) had not resolved, PAIN (pain), DEPRESSION (Depression) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I have had to drop from working fulltime to parttime) outcome was unknown and VACCINATION SITE BRUISING (When I first got the Vaccine I had a lot of bruising) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient reported that bruising continued for few weeks.Within 2 months or so she had muscle aches and fatigue. It was unknown if the patient experienced any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 03-Jan-2023; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018c22a) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 03-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023).    No concomitant medications were reported.  It was reported that 2 patients of age 6 Years received expired dose of vaccine. Monovalent vaccines of vial size 2.5 ml from carton 4 were administered. The vial was initially stored in the refrigerator on 03-Jan-2023. Beyond use date was reported as 01-Feb-2023 The vial did not undergo any temperature excursion.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-709273 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-709273:2nd patient
Sex: U
Vaccine: COVID19-2
Symptoms: Medication error, No adverse event
Clinical narrative: A pharmacist called in to report a drug error related to MODERNA vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of MEDICATION ERROR (A pharmacist called in to report a drug error related to MODERNA vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MEDICATION ERROR (A pharmacist called in to report a drug error related to MODERNA vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, MEDICATION ERROR (A pharmacist called in to report a drug error related to MODERNA vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MEDICATION ERROR (A pharmacist called in to report a drug error related to MODERNA vaccine).    No concomitant medication was reported.  A pharmacist called in to report a drug error related to Moderna vaccine. Verified with the caller that the vaccine was not related to any Moderna clinical trial.  No treatment information was provided.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; instead of shingles vaccine (Shingrix) and the pharmacist in shift administered Moderna Bivalent COVID vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (instead of shingles vaccine (Shingrix) and the pharmacist in shift administered Moderna Bivalent COVID vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Feb-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (instead of shingles vaccine (Shingrix) and the pharmacist in shift administered Moderna Bivalent COVID vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (instead of shingles vaccine (Shingrix) and the pharmacist in shift administered Moderna Bivalent COVID vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (instead of shingles vaccine (Shingrix) and the pharmacist in shift administered Moderna Bivalent COVID vaccine).    No concomitant medications were reported. On 10Feb2023, patient came to receive the second dose of the shingles vaccine (Shingrix) and the pharmacist in shift administered Moderna Bivalent COVID vaccine.  The patient had already received this vaccine on Sep2022. No treatment medications were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient has not reported any AE; inadvertently administered the 2nd dose of the Moderna vaccine which was beyond the BUD to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered the 2nd dose of the Moderna vaccine which was beyond the BUD to a patient) and NO ADVERSE EVENT (Patient has not reported any AE) in a 74-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered the 2nd dose of the Moderna vaccine which was beyond the BUD to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (Patient has not reported any AE). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered the 2nd dose of the Moderna vaccine which was beyond the BUD to a patient) and NO ADVERSE EVENT (Patient has not reported any AE) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (Patient has not reported any AE) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered the 2nd dose of the Moderna vaccine which was beyond the BUD to a patient).    No concomitant medications were provided. The vaccine was initially stored in the refrigerator on 26-Oct-2022.  No treatment medications were provided.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series) and NO ADVERSE EVENT (No adverse event) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: flu vaccine. Past adverse reactions to the above products included No adverse event with flu vaccine.    On 07-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series).    No concomitant medications were provided. No treatment medications were provided.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series for 6 to 11 years old at the; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series for 6 to 11 years old at the) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 07-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series for 6 to 11 years old at the). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series for 6 to 11 years old at the) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (child was suppose to receive the Moderna bivalent booster but instead they got the Moderna primary series for 6 to 11 years old at the).    The patient receives other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications was reported. Dose of Moderna vaccine was reported as 0.25 dose. No treatment medications was reported.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphagia, Dyspnoea, Urticaria
Clinical narrative: difficulty swallowing; difficulty breathing; urticaria/Hives; This spontaneous case was reported by a patient and describes the occurrence of DYSPHAGIA (difficulty swallowing), DYSPNOEA (difficulty breathing) and URTICARIA (urticaria/Hives) in a 45-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 microgram. On 13-Dec-2022, the patient experienced DYSPHAGIA (difficulty swallowing), DYSPNOEA (difficulty breathing) and URTICARIA (urticaria/Hives). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (difficulty swallowing), DYSPNOEA (difficulty breathing) and URTICARIA (urticaria/Hives) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  It was reported that patient had urticaria full body reaction 1 week post injection. Hives are dermographic and has caused in the beginning difficulty swallowing and breathing. Patient had to use an inhaler for a week every morning.  Patient was treated with prednisone and antihistamines as well as topicals. no relief and is still present as of 2/10/23. It is unknown if the patient experienced any additional symptoms/events.
Sex: U
Vaccine: COVID19-2
Symptoms: Abdominal pain lower, Hepatic enzyme abnormal, Hepatic enzyme increased, Vomiting
Clinical narrative: my liver enzymes are high; my lower right side is hurting constantly making it hard to keep food down etc.; hard to keep food down; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (my liver enzymes are high), ABDOMINAL PAIN LOWER (my lower right side is hurting constantly making it hard to keep food down etc.) and VOMITING (hard to keep food down) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (my liver enzymes are high), ABDOMINAL PAIN LOWER (my lower right side is hurting constantly making it hard to keep food down etc.) and VOMITING (hard to keep food down). At the time of the report, HEPATIC ENZYME INCREASED (my liver enzymes are high), ABDOMINAL PAIN LOWER (my lower right side is hurting constantly making it hard to keep food down etc.) and VOMITING (hard to keep food down) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme abnormal: liver enzymes are high.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. The patient stated that the other two boosters was fine. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2023: Live Significant Follow up appended - event, Narrative updated
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was administer vaccine 4 days after BUD date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administer vaccine 4 days after BUD date) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 31-Jan-2023,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administer vaccine 4 days after BUD date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administer vaccine 4 days after BUD date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administer vaccine 4 days after BUD date).    Concomitant products were not reported.  It was reported that patient was administered with vaccine four days after the BUD date which was 27-Jan-2023. Patient previous vaccination details was first dose on 30-Aug-2022, Lot number AS1412B. Second dose on 27-Sep-2022, Lot number AR9236B.  Treatment medications were not reported.
Sex: U
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: 1 dose that was broken, the syringe; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 30Jan2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: FN5555, Expiration Date: 31Jul2024) for immunisation, Device Lot Number: FN5555, Device Expiration Date: 31Jul2024. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "1 dose that was broken, the syringe".  Additional information: NDC number of Prevnar 13: 0005197101. According to the nurse, the received a Prevnar 13, 1 dose that was broken, the syringe. They received a damaged box, just 1 syringe was damaged in the shipment. When probed if the syringe was used on any patient: Nurse stated, "No".
Sex: U
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: when it was dropped on the floor it broke; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 27Jan2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 26Jan2023 as dose number unknown, 0. 5 ml, single (Lot number: FY2475, Expiration Date: Dec2024) for immunisation, Device Lot Number: FY2475, Device Expiration Date: Dec2024. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious) with onset 26Jan2023, outcome "unknown", described as "when it was dropped on the floor it broke".  Additional information: There were two syringes have broken. According to the reporter no patient got the broken vaccines. The second one broke on 26Jan2023, when it was dropped on the floor it broke.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300046183 same reporter/drug/event, different patient;
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Migraine, SARS-CoV-2 test
Clinical narrative: ongoing recurrent migraine headaches and vascular swelling in the head; ongoing recurrent migraine headaches and vascular swelling in the head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8733) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillins" (unspecified if ongoing), notes: known allergies: penicillins; "dairy allergy" (unspecified if ongoing), notes: dairy allergy. There were no concomitant medications. Past drug history included: Neosporin, reaction(s): "known allergies: neosporin", notes: known allergies: neosporin. The following information was reported: ANGIOEDEMA (medically significant), MIGRAINE (non-serious) all with onset 24Mar2021, outcome "not recovered" and all described as "ongoing recurrent migraine headaches and vascular swelling in the head". The events "ongoing recurrent migraine headaches and vascular swelling in the head" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: covid test type post vaccination=Other. Therapeutic measures were taken as a result of angioedema, migraine. Clinical course: Patient did not take any other vaccine in four weeks and any other medications in two weeks. Patient took meloxicam as treatment. Patient had no Covid prior vaccination. Patient was tested for Covid post vaccination. other medical history none. Patient took dose 2 on 13Apr2021 (Lot number: EW0169) right arm, dose 3 on 12Nov2021, (Lot number: FG3527) left arm and dose 4 on 27May2022 (Lot Number: FN2908) right arm all Pfizer Covid-19.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid test date=08Feb2023, Covid test result=Positive.; Covid test date=08Feb2023, Covid test result=Positive.; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Feb2023, outcome "not recovered" and all described as "Covid test date=08Feb2023, Covid test result=Positive.". The event "covid test date=08feb2023, covid test result=positive." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Unknown exposure symptoms high fever 101.3 cough sneezing; fatigue then tested positive on 08Feb2023, adverse event start date: 06Feb2023. Patient had Covid tested post vaccination.  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 in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300062309 same patient different dose/drug/event;
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: She was diagnosed with Covid on board a ship and the next day her symptoms got worse. She was given Paxlovid; She was diagnosed with Covid on board a ship and the next day her symptoms got worse. She was given Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 25Feb2021 as dose 2, single (Lot number: CH6200), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 14Apr2022 as dose 4 (booster), single (Lot number: FS4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme disease" (ongoing), notes: Has had 2 exacerbations since being diagnosed with Lyme disease. Was diagnosed in May2015 or May2016. Concomitant medication(s) included: ATOVAQUONE oral taken for lyme disease (ongoing); AZITHROMYCIN taken for lyme disease (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jan2023, outcome "not recovered" and all described as "She was diagnosed with Covid on board a ship and the next day her symptoms got worse. She was given Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jan2023) Positive; (01Feb2023) Negative; (02Feb2023) Negative; (03Feb2023) Positive, notes: Weak positive; (08Feb2023) Positive, notes: Strong positive; Weight: (unspecified date) 137-138 lbs. Therapeutic measures were taken as a result of vaccination failure, covid-19 included PAXLOVID from 26Jan2023 to 31Jan2023.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (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) all with onset Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Feb2023) Positive, notes: Still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Vaccine. Other medication in 2weeks was received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunodeficiency, Interchange of vaccine products, Lung transplant
Clinical narrative: received 1 dose of primary monovalent Pfizer in the past but started to receive Evusheld; immunocompromised; lung transplant; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "received 1 dose of primary monovalent Pfizer in the past but started to receive Evusheld"; LUNG TRANSPLANT (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events interchange of vaccine products, immunodeficiency . 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: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypoglycemia" (unspecified if ongoing); "Leaky Gut" (unspecified if ongoing); "Muscle Spasms" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Antibiotics-cillians, reaction(s): "Allergy", notes: Name of Drug as Reported: Antibiotics-cillians, Reaction: Allergy. The following information was reported: COVID-19 (medically significant) with onset Jan2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Jan2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient received any other medications (Larin Fe 1.5/30 MG-MCG TAB) within 2 weeks of vaccination. Patient took Paxlovid (lot no. GE3014) antiviral COVID 19 treatment form 29Jan2023 to 02Feb2023. Felt very good until about 8pm Friday. Exhaustion hit. Slept almost all of Saturday and Sunday. Cold like symptoms started Monday - throat and nose. Continued progression. Lots of sneezing currently (Thursday 09Feb), fatigue, exhaustion, chest pain, shortness of breath. Symptoms have increased each day.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230208000141 (Moderna).  An adult male patient received BNT162b2 (BNT162B2 NOS), 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), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID".  Clinical Course: Caller stated that they all had COVID in May2022 as well. Him and his wife have received the Pfizer COVID-19 vaccine so far but his son has received the Moderna COVID-19 vaccine with his most recent booster shot in Feb2022. Caller states that this was his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023. Consent for Safety follow up was not obtained during this call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300062513 same reporter/product/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-MODERNATX-MOC20230208000141 (Moderna).  A female patient received BNT162b2 (BNT162B2 NOS), 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), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID". Clinical information: Reporter states that they all had COVID in May2022 as well. Him and his wife have received the Pfizer COVID-19 vaccine so far but his son has received the Moderna COVID-19 vaccine with his most recent booster shot in Feb2022. Reporter that this was his son's second time getting COVID, with the first one in May2022 and the second one in Jan2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300062512 same reporter/product/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Cough, Myalgia, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sore throat; muscle aches; dry hacking cough; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: Mar2021, for COVID-19 IMMUNIZATION. The following information was reported: COUGH (non-serious) with onset 08Feb2023, outcome "not recovered", described as "dry hacking cough"; MYALGIA (non-serious) with onset 08Feb2023, outcome "not recovered", described as "muscle aches"; OROPHARYNGEAL PAIN (non-serious) with onset 08Feb2023, outcome "not recovered", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oropharyngeal pain, myalgia, cough.  Additional information: No Known allergies, No other vaccine in four weeks. No covid prior vaccination, Patient had covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300064596 same patient, different dose and event;
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Antiviral Product for COVID 19 Treatment which included Paxlovid from 31Jan2023 till 05Feb2023. Vaccine lot unknown reason stated as unable to locate or read the details. Other medication in 2weeks at the time of Paxlovid treatment included sertraline and bupropion for unspecified reason. Had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 at 12:00 as dose 1, single (Lot number: EL3246), on 16Feb2021 at 13:00 as dose 2, single (Lot number: EL3246), on 13Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 11Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I took a Covid  test that was again positive; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient treatment of Paxlovid started on 25Jan2023 and stopped on 30Jan2023, lot number: GF3965. No known allergies.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I began to experience Pulsatile Tinnitus in my right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Nov2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Convergence insufficiency" (unspecified if ongoing); "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "known allergies: Clindamycin", notes: known allergies: Clindamycin. Vaccination history included: Covid-19 vaccine (Dose number: 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number: 2, Manufacturer: Unk2own), for COVID-19 immunization; Covid-19 vaccine (Dose number: 3, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 22Nov2022 at 12:00, outcome "not recovered", described as "I began to experience Pulsatile Tinnitus in my right ear". The event "i began to experience pulsatile tinnitus in my right ear" required physician office visit. Therapeutic measures were not taken as a result of tinnitus. Additional information: The patient had COVID prior vaccination. The patient had not COVID tested post vaccination.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination site hypoaesthesia, Vaccination site pain, Vaccination site warmth
Clinical narrative: I feel off like I'm not sick but I feel sick; numb in the arm I got the shot; I feel hot; sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2023 as dose 1, single (Batch/Lot number: unknown) at the age of 24 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE WARMTH (non-serious) with onset 08Feb2023, outcome "recovering", described as "I feel hot"; MALAISE (non-serious) with onset 08Feb2023, outcome "recovering", described as "I feel off like I'm not sick but I feel sick"; VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 08Feb2023, outcome "recovering", described as "numb in the arm I got the shot"; VACCINATION SITE PAIN (non-serious) with onset 08Feb2023, outcome "recovering", described as "sore". Therapeutic measures were not taken as a result of malaise, vaccination site hypoaesthesia, vaccination site warmth, vaccination site pain. Additional information: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient did not received a COVID-19 Vaccine previously. No treatment for AE. No covid tested post vaccination. No covid prior vaccination: Patient felt off like he is not sick but felt sick, numb in the arm he got the shot and felt hot and sore. Patient not aware of any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Bronchospasm, SARS-CoV-2 test
Clinical narrative: bronchial spasms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes; "known allergies: Dairy" (unspecified if ongoing), notes: known allergies: Dairy. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Is bivalent=False, Prev dose lot unknown=True, Prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, Prev dose number=1, Prev dose vaccine location=Right arm, My doctor called them bronchial spasms. I had them for up to a year after. The worst was 24 hours after 1st dose.), for COVID-19 IMMUNIZATION, reaction(s): "bronchial spasms/worst was 24 hours after 1st dose". The following information was reported: BRONCHOSPASM (non-serious) with onset 16Mar2021, outcome "recovered with sequelae", described as "bronchial spasms". The event "bronchial spasms" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of bronchospasm.  Additional information: Patient did not receive other vaccine in four weeks. No prior COVID vaccination. The patient received other medications in 2 weeks. Patient had bronchial spasms for up to a year after. The worst was 24 hours after 1st dose. It was horrifying. I'll never get any version of this type of shot again. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient had diagnosed with COVID-19 and since the vaccination, the patient had tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300064610 same patient, different dose and event;