chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; Product Storage Error; experienced excursion, from 13SEP2022 until end of NOV2022. Temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Product Storage Error), PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Concomitant products included mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    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) .5 mL/min. On 12-Sep-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Temperature excursion). On 12-Dec-2022, the patient experienced PRODUCT STORAGE ERROR (Product Storage Error). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). In November 2022, PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Temperature excursion) outcome was unknown. At the time of the report, PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 assessments were provided for PRODUCT STORAGE ERROR (Product Storage Error) and PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Temperature excursion).    Moderna is authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification. Storage condition at the time of the excursion was Frozen storage They are stored and returned to the freezer and some vials were used.  No Treatment Medication was provided by reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event; Patient received moderna covid-19 vaccine bivalent by subQ injection; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient received moderna covid-19 vaccine bivalent by subQ injection) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose), PFIZER BIONTECH COVID-19 VACCINE (booster dose) and PFIZER BIONTECH COVID-19 VACCINE (2nd dose). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 13-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Subcutaneous) .5 milliliter. On 13-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient received moderna covid-19 vaccine bivalent by subQ injection). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient received moderna covid-19 vaccine bivalent by subQ injection) 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)) (Subcutaneous), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient received moderna covid-19 vaccine bivalent by subQ injection).    No concomitant medication was provided.  It was reported that error occurred because the wrong sized needle was used for the injection.  Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Caller mentions they got three shots in their body and it still hurts.; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Caller mentions they got three shots in their body and it still hurts.) 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 VACCINATION SITE PAIN (Caller mentions they got three shots in their body and it still hurts.). At the time of the report, VACCINATION SITE PAIN (Caller mentions they got three shots in their body and it still hurts.) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   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.   Concomitant products were not reported.  Treatment medications were not reported.   Reporter did not allow further contact
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient was administered a dose of the Moderna COVID-19 vaccine from a lot number that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 vaccine from a lot number that was expired) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Nov-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 vaccine from a lot number that was expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 vaccine from a lot number that was expired) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (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 administered a dose of the Moderna COVID-19 vaccine from a lot number that was expired).    Concomitant medication was not reported.  The patient was administered COVID-19 vaccine from a lot number that was expired. The patient has not reported any adverse reactions to this dose. No treatment medication was reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dizziness, Feeling abnormal, Hot flush
Clinical narrative: Death; dizziness; hot flashes; felt like I was dying; This spontaneous case was reported by a nurse and describes the occurrence of DEATH (Death) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001B22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bladder infection and Open heart surgery. Concomitant products included CEFALEXIN (CEPHALEXINE), ATENOLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), ALLOPURINOL, VALSARTAN, HYDROCHLOROTHIAZIDE, MELATONIN and VITAMINS NOS for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced DIZZINESS (dizziness), HOT FLUSH (hot flashes) and FEELING ABNORMAL (felt like I was dying). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (dizziness), HOT FLUSH (hot flashes) and FEELING ABNORMAL (felt like I was dying) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported.  Very limited information regarding this event/s has been provided at this time.   This case was linked to US-MODERNATX, INC.-MOD-2021-095209, US-MODERNATX, INC.-MOD-2021-094933 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Upon internal review on 08-DEC-2022 non-significant corrections performed to update "case received from field" to blank On 28-May-2021: attached. Patient died.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. US-MODERNATX, INC.-MOD-2021-095209: US-MODERNATX, INC.-MOD-2021-094933:; Reported Cause(s) of Death: unknown cause of death
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis; Was tired for a day; extreme pain in joints,hands,wrist,both knees/ debilitating pain in joints; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included HYDROXYCHLOROQUINE, PREDNISONE and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced ARTHRALGIA (extreme pain in joints,hands,wrist,both knees/ debilitating pain in joints). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis) (seriousness criterion medically significant) and FATIGUE (Was tired for a day). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis), ARTHRALGIA (extreme pain in joints,hands,wrist,both knees/ debilitating pain in joints) and FATIGUE (Was tired for a day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported/unknown. Patient reported that March, April and May was horrible, nothing worked heat, ice. Patient was put on steroid were reported.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Arthralgia and fatigue are consistent with the product known safety profile   This case was linked to MOD-2021-216022 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up contains secondary reporter details, patient demographic details and additional concomitant medication. On 10-Jun-2021: Upon internal review on 08-DEC-2022 non-significant correction performed to update "case received from  field" to blank.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Arthralgia and fatigue are consistent with the product known safety profile
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: Heartburn; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heartburn) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included LEVOTHYROXINE, BUPROPION HCL and LIOTHYRONINE SODIUM (LIOTHYRONINE [LIOTHYRONINE SODIUM]) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced DYSPEPSIA (Heartburn). The patient was treated with ESOMEPRAZOLE MAGNESIUM at a dose of 40 milligram once a day; PANTOPRAZOLE at a dose of 40 milligram once a day and OMEPRAZOLE at a dose of 20 milligram twice a day. At the time of the report, DYSPEPSIA (Heartburn) outcome was unknown.            Patient suffered with an events that includes an upper GI and after 2 nd shot had heartburn but cannot find reason. Safety to follow-up with patient and health care provider provided and contacted with the patient through mail.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Upon internal review on 08-Dec-2022 non-significant correction performed to update "case received from  field" to blank.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Dose 1 administered on 13-Apr-2022 and dose 2 administered on 25-Apr-2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 13-Apr-2022 and dose 2 administered on 25-Apr-2022) and NO ADVERSE EVENT (no adverse event) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 13-Apr-2022 and dose 2 administered on 25-Apr-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 13-Apr-2022 and dose 2 administered on 25-Apr-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 13-Apr-2022 and dose 2 administered on 25-Apr-2022).    No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-675263 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; patient received first moderna dose on 04-MAR-2021 and second dose on 26-SEP-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first moderna dose on 04-MAR-2021 and second dose on 26-SEP-2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 021821A, 012H21B and 056A22A) for COVID-19 prophylaxis.     The patient's past medical history included High cholesterol. Concurrent medical conditions included Drug allergy (Unspecified drug). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) from an unknown date to 30-Nov-2022 for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first moderna dose on 04-MAR-2021 and second dose on 26-SEP-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first moderna dose on 04-MAR-2021 and second dose on 26-SEP-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            On 24-Sep-2022, Patient received fifth dose of Moderna COVID-19 Vaccine (unknown route) in left arm and batch number was A57145B.  On 30-Nov-2022, patient received Paxlovid medication with last administration date on 01-Dec-2022 for treatment of COVID-19.  On 30-Nov-2022, patient experienced nausea and acid reflux. It dramatically improved if patient ate a meal before patient took the medication and if patient sat upright for at least 45 minutes after taking the medication.   It was reported patient started taking Paxlovid the 2nd day of Covid symptoms. 2 days after taking Paxlovid patient tested negative. 4 days after taking Paxlovid patient developed symptoms again. Patient had a runny nose, congestion, low grade fever, and headache. patient tested positive. patient still had symptoms and patient still testing positive. It was 7 days after finishing Paxlovid. It was 12 days after developing symptoms.   No treatment medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: ache in the arm; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (ache in the arm), CHILLS (chills) and HEADACHE (headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050D22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE for an unknown indication.    Interstial Lung disease related to Rheumatoid Arthritis Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 on 14-Jan-2022. Previously administered products included for COVID-19 vaccination: COVID-19 vaccine (1st dose) and COVID-19 vaccine (2nd dose). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine and COVID-19 vaccine. Concurrent medical conditions included Rheumatoid arthritis-associated interstitial lung disease and Interstitial lung disease.   On 07-Dec-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient received dose of COVID-19 VACCINE (unknown route) 1 dosage form. On 11-Dec-2022, the patient experienced MYALGIA (ache in the arm), CHILLS (chills) and HEADACHE (headache). At the time of the report, MYALGIA (ache in the arm), CHILLS (chills) and HEADACHE (headache) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received  two COVID vaccines previously. On 12-Dec-22, five days later, patient woke up to extreme chills and had to put on extra layers to warm up. That day had an extreme headache, diminished after 7 hours. Patient had the same chill before but they were within 24 hours of injection. The patient did not experience any additional symptoms/events. No treatment medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 24Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: It was reported that patient got COVID 19 and for that Paxlovid treatment was given from 25Nov2022 to 29Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Aching all over, in a lot of pain; fever; feel very sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 at 12:00 as dose 3 (bivalent), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Dieabates" (unspecified if ongoing); "Known allergies: Sulfer" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid 19 immunization.  The following information was reported: PAIN (non-serious), outcome "not recovered", described as "Aching all over, in a lot of pain"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; MALAISE (non-serious), outcome "not recovered", described as "feel very sick". Therapeutic measures were not taken as a result of pain, pyrexia, malaise.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known allergies : erythromycin", notes: Known allergies : erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received. No other medication in 2 weeks was noted. Covid-19 treatment was noted as Paxlovid. Treatment start date was noted as 28Nov2022 and treatment stop date was noted as 03Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted 5 days after booster.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2022 at 14:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) or other medication in two weeks included: AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM; LISINOPRIL. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin"; Visipaque, reaction(s): "Known allergies: visipaque". Vaccination history included: BNT162b2 (Dose 3, Lot number: EW0170, Location of injection: Arm right, Vaccine administration time: 12:00 pm), administration date: 03Sep2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot number: El9265, Location of injection: Arm left, Vaccine administration time: 14:00 pm), administration date: 01Feb2021, when the patient was 67-year-old, for COVID-19 immunization; Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 2022, outcome "unknown", described as "Fainted 5 days after booster". The event "fainted 5 days after booster." required emergency room visit. Therapeutic measures were not taken as a result of syncope. The facility where the most recent vaccine was administered was Pharmacy or drug store. The patient did not receive any other vaccine in four weeks. The patient did not receive any other vaccine on the same date.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autonomic nervous system imbalance, Biopsy skin, Chest pain, Dysphagia, Hyperhidrosis
Clinical narrative: covid home antigen test: Positive; covid home antigen test: Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EK9231), on 09Feb2021 as dose 2, single (Lot number: EN9581) and on 07Sep2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 38 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing), notes: other medical history: Rheumatoid Arthritis; "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Allergies" (unspecified if ongoing), notes: other medical history: Allergies; "Hypothyroid" (unspecified if ongoing), notes: other medical history: Hypothyroid. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "covid home antigen test: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: Nasal Swab.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-biontech covid-19 vaccine lot EK9231 and EN9581 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. The final scope included the reported finished goods lot EK9231 and EN9581, fill lot EK9229 and EN9580, and the formulated drug product lot EK9226 and EL9245. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: The reported COVID-19 positive after properly spaced BNT162b2 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202201358783 Same reporter/patient, same drug, different AEs;
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Paraesthesia, Photophobia, SARS-CoV-2 test, Small fibre neuropathy
Clinical narrative: covid home antigen test: Positive; covid home antigen test: Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EK9231), on 09Feb2021 as dose 2, single (Lot number: EN9581) and on 07Sep2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 38 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing), notes: other medical history: Rheumatoid Arthritis; "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Allergies" (unspecified if ongoing), notes: other medical history: Allergies; "Hypothyroid" (unspecified if ongoing), notes: other medical history: Hypothyroid. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "covid home antigen test: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: Nasal Swab.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-biontech covid-19 vaccine lot EK9231 and EN9581 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. The final scope included the reported finished goods lot EK9231 and EN9581, fill lot EK9229 and EN9580, and the formulated drug product lot EK9226 and EL9245. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: The reported COVID-19 positive after properly spaced BNT162b2 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202201358783 Same reporter/patient, same drug, different AEs;
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine flow decreased, Visual impairment
Clinical narrative: covid home antigen test: Positive; covid home antigen test: Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EK9231), on 09Feb2021 as dose 2, single (Lot number: EN9581) and on 07Sep2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 38 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing), notes: other medical history: Rheumatoid Arthritis; "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Allergies" (unspecified if ongoing), notes: other medical history: Allergies; "Hypothyroid" (unspecified if ongoing), notes: other medical history: Hypothyroid. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "covid home antigen test: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: Nasal Swab.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-biontech covid-19 vaccine lot EK9231 and EN9581 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. The final scope included the reported finished goods lot EK9231 and EN9581, fill lot EK9229 and EN9580, and the formulated drug product lot EK9226 and EL9245. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: The reported COVID-19 positive after properly spaced BNT162b2 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202201358783 Same reporter/patient, same drug, different AEs;
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid home antigen test: Positive; covid home antigen test: Positive; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EK9231), on 09Feb2021 as dose 2, single (Lot number: EN9581) and on 07Sep2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 38 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing), notes: other medical history: Rheumatoid Arthritis; "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "Allergies" (unspecified if ongoing), notes: other medical history: Allergies; "Hypothyroid" (unspecified if ongoing), notes: other medical history: Hypothyroid. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "covid home antigen test: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive, notes: Nasal Swab.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-biontech covid-19 vaccine lot EK9231 and EN9581 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. The final scope included the reported finished goods lot EK9231 and EN9581, fill lot EK9229 and EN9580, and the formulated drug product lot EK9226 and EL9245. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: The reported COVID-19 positive after properly spaced BNT162b2 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202201358783 Same reporter/patient, same drug, different AEs;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid (anti viral) as COVID 19 Treatment from 26Nov2022 to 01Dec2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events and The suspected drug cannot be ruled out.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Aug2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "VCD (Vocal Cord Dysfunction)" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2022) Positive; (04Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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: COVID-19, Drug ineffective
Clinical narrative: Received 4doses of Pfizer BioNtech Covid-19 vaccine before, now Has Covid; Received 4doses of Pfizer BioNtech Covid-19 vaccine before, now Has Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (172086). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "Received 4doses of Pfizer BioNtech Covid-19 vaccine before, now Has Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Received 4 doses of Pfizer BioNtech Covid-19 vaccine before, now Has Covid. Caller also misses doses from Paxlovid packs. States he took the Paxlovid treatment since saturday 03Dec2022 and took the last remaining dose this AM 07Dec2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 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 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right 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 was not reported. Concomitant medication(s) included: LEXAPRO. Past drug history included: Ibuprofen, reaction(s): "Allergy: Ibuprofen", notes: Known allergies: Ibuprofen; Naproxen, reaction(s): "Allergy: naproxen", notes: Known allergies: naproxen; Aspirin, reaction(s): "Allergy: aspirin", notes: Known allergies: aspirin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received paxlovid (Lot number- Ge3011) for COVID 19 treatment from Dec2022 till Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral coldness
Clinical narrative: Cold feet; Pounding headache; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 at 10:00 as dose 3 (booster), single (Lot number: GJ6742) at the age of 39 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anaemia" (unspecified if ongoing), notes: Other medical history: Anemia; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin, Sulfur drugs. There were no concomitant medications. Past drug history included: Sulfur drugs, reaction(s): "known allergies: Sulfur drugs", notes: Known allergies: Penicillin, Sulfur drugs. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular, Facility type vaccine: Workplace clinic), administration date: 22Feb2021, when the patient was 37-year-old, for covid-19 immunization; BNT162b2 (Dose 2, Single, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 15Mar2021, when the patient was 37-year-old, for covid-19 immunization. The following information was reported: PERIPHERAL COLDNESS (non-serious) with onset 07Dec2022, outcome "recovered" (07Dec2022 at 08:00), described as "Cold feet"; HEADACHE (non-serious) with onset 07Dec2022, outcome "recovered" (07Dec2022 at 08:00), described as "Pounding headache". Therapeutic measures were taken as a result of peripheral coldness, headache.  Additional information: Patient is a Pfizer employee and registered nurse (DNP). Patient received her COVID-19 booster shot yesterday morning and around 12am this morning she experienced extremely cold feet and a pounding headache. The events resolved as of 8am this morning. AE treatment was took Motrin for the headache. Patient did not received other vaccine in four weeks and other medication in two weeks. Patient did not had covid Prior vaccination and was not tested for covid post vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03May2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 21Jun2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing), notes: high cholesterol under control with meds; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex allergies-rash/hives/itching; "rash" (unspecified if ongoing), notes: known allergies: Latex allergies-rash/hives/itching; "hives" (unspecified if ongoing), notes: known allergies: Latex allergies-rash/hives/itching; "itching" (unspecified if ongoing), notes: known allergies: Latex allergies-rash/hives/itching. The patient took concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Nov2022, outcome "unknown", described as "COVID 19 Treatment"; VACCINATION FAILURE (medically significant) with onset Nov2022, outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid from 28Nov2022 to 03Dec2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.