chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female 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 12-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 12-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) 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 (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    No concomitant medications were reported.  The patient didn't received second dose of vaccine. No adverse effect noted in patient. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:MAster case
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 214K22A and 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 22-May-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. On 21-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) 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 (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    Concomitant medications were not reported.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:
Age: 0.58
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated ) and NO ADVERSE EVENT (No adverse event) in a 7-month-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 27-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 27-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated ) 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 (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated ).    Concomitant medications were not reported.   Patient had dose 1 Moderna (Monovalent ) 25 mcg on 19 Apr 2023 (Lot number - AS1903B).  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:
Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and AS7643A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 27-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 25 microgram. On 26-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated) 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 (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated).    No concomitant medication information was reported.  No adverse effects were noted. Appropriate vaccine was scheduled or given as indicated by the CDC.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No Adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 01-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. On 04-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) 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 (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    No concomitant medications were reported. The patient didn't received third dose. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune type issues; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (autoimmune type issues) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. GH9693) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (autoimmune type issues) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (autoimmune type issues) had not resolved.            No concomitant medication information was provided.    It was unknown if the patient experienced any additional symptoms/events.  No treatment drug information was provided. Company comment- This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the unexpected and serious (medically significant) event of autoimmune disorder. A dose of mRNA-1273 vaccine, given as a fourth dose of COVID-19 vaccine schedule, was administered. Onset date of the event was not provided; hence, latency cannot be assessed. It was reported patient had autoimmune type issues. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chest X-ray, Pneumonia
Clinical narrative: Pneumonia; COVID on April 2nd, 2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PNEUMONIA (Pneumonia) in an 83-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Apr-2023, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and COVID-19 (COVID on April 2nd, 2023). On 26-May-2023, PNEUMONIA (Pneumonia) had resolved. At the time of the report, COVID-19 (COVID on April 2nd, 2023) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2023, Chest X-ray: still showed pneumonia. On 26-May-2023, Chest X-ray: that showed he was cleared of the pneumonia..     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 medication details not reported by the reporter. It was reported that patient got exposed to COVID on 30-MAR-2023 and got COVID on 02-APR-2023 during a trip. Pneumonia was diagnosed. It was reported that after four antibiotics patient got over it by 26-MAY-2023.  Company comment:  This is a spontaneous case concerning a 83-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant)  event of Pneumonia and non-serious event of COVID-19. The events occurred about 7 months after the administration of mRNA-1273 BIVALENT .222 vaccine, used as a fifth dose. Two chest x-Rays were done with about one month in between showing current and posterior resolution of the pneumonia. It was not reported if pneumonia was secondary to current COVID-19 infection. No further information on clinical course or treatment received was available in the report. The benefit-risk relationship of mRNA-1273 BIVALENT .222 Vaccine is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: She reported the arm she received the injection often goes out while driving .; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (She reported the arm she received the injection often goes out while driving .) in a 54-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (She reported the arm she received the injection often goes out while driving .). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (She reported the arm she received the injection often goes out while driving .) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  It is unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  Treatment Medication use information was not provided by reporter.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 04-Aug-2023.; no adverse event; Expired vaccine was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered), PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 04-Aug-2023.) and NO ADVERSE EVENT (no adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Aug-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 04-Aug-2023.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered), PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 04-Aug-2023.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) and PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-23 and was stored in the refrigerator since. Pharmacist was unaware that vaccine could only be refrigerated for 30 days. Expired vaccine was administered on 04-Aug-2023.).    Concomitant medication not reported.   Treatment medication not reported.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; DOSE 5 (BOOSTER); 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 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known Allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; IMMUNISATION (medically significant), outcome "unknown", described as "DOSE 5 (BOOSTER)". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 14Feb2021 as dose 2, single (Lot number: EM9810, Expiration Date: 30Jun2021) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Comments: Breast cancer had breast cancer like 7 years ago. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9262, Expiry date: 31May2021), administration date: 24Jan2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "tenderness", "Chills". The following information was reported: TENDERNESS (non-serious), outcome "unknown".  Additional information: Patient did not have any significant reaction to any of her Pfizer covid vaccines and stated that she had no reactions just some local arm tenderness and one time that she can't tell when it was she had some chills but no fever at night. She thinks the tenderness of the arm she had that from all of the Pfizer Covid vaccines and the chills might have been from the first dose but she cannot remember.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300271774 Same reporter/patient, same drug/different dose, different AE.;
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immune system disorder, Induration, Nasopharyngitis, Pain in extremity
Clinical narrative: Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high; Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days; Arm had a massive [hard painful] swelling for days; Arm had massive hard [painful swelling] for days/ Induration; Chronic fatigue; wiped out for a couple of days; wiped out for a month; Cold; Knocked my immune system off/ Immune system disorder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "Chronic fatigue; wiped out for a couple of days; wiped out for a month", "Knocked my immune system off", "Arm had massive hard [painful swelling] for days", "Cold", "Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days", "Arm had a massive [hard painful] swelling for days", "Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Arm had a massive [hard painful] swelling for days"; INDURATION (non-serious), outcome "unknown", described as "Arm had massive hard [painful swelling] for days/ Induration"; FATIGUE (non-serious), outcome "unknown", described as "Chronic fatigue; wiped out for a couple of days; wiped out for a month"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Knocked my immune system off/ Immune system disorder". Relevant laboratory tests and procedures are available in the appropriate section.  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: Linked Report(s) : US-PFIZER INC-PV202300137387 same patient/event, different vaccine dose (dose 2);
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high; Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days; Arm had a massive [hard painful] swelling for days; Arm had massive hard [painful swelling] for days/ Induration; Chronic fatigue; wiped out for a couple of days; wiped out for a month; Cold; Knocked my immune system off/ Immune system disorder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "Chronic fatigue; wiped out for a couple of days; wiped out for a month", "Knocked my immune system off", "Arm had massive hard [painful swelling] for days", "Cold", "Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days", "Arm had a massive [hard painful] swelling for days", "Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Little fever; fever was too high for even the thermometer to pick up; fever was 101 it was lower than the night before but still pretty high"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore but not terrible; arm had a [massive hard] painful [swelling] for days"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Arm had a massive [hard painful] swelling for days"; INDURATION (non-serious), outcome "unknown", described as "Arm had massive hard [painful swelling] for days/ Induration"; FATIGUE (non-serious), outcome "unknown", described as "Chronic fatigue; wiped out for a couple of days; wiped out for a month"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "Cold"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Knocked my immune system off/ Immune system disorder". Relevant laboratory tests and procedures are available in the appropriate section.  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: Linked Report(s) : US-PFIZER INC-PV202300137387 same patient/event, different vaccine dose (dose 2);
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS-MANUFACTURER UNKNOWN), 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: THROMBOSIS (medically significant), outcome "unknown".; Sender's Comments: Based on the  information provided, a causal association between reported event thrombosis and suspect BNT162B2 cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300137572 Same article/drug/event or different patient;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Country: Language:  Reporting type: AE Report about covid treatment: Yes  Reporter type: Patient Age group: Elderly (65+ Years) Current age: 65 Current age unit: Years Gender: Female Is pregnant: Not Pregnant Patient occupation: Nurse  If vaccine received: Yes Other medication in 2weeks: No Anti viral details: Product=COVID 19 Treatment Brand=paxlovid Treatment start date=31Jul2023 Treatment stop date=04Aug2023 Indication=Treatment of COVID-19  Covid vaccine details: Vaccine brand=Pfizer/BioNTech Vaccine brand unknown=False Vaccine administration date=04May2023 Vaccine lot number=GH9702 Vaccine lot unknown=False Vaccine dose number=6 Vaccine dose number unknown=False  Adverse event: symptoms started 3 days after finishing Paxlovid. Have nasal congestion and sneezing, head fog and mild headache. Adverse event country:  Adverse event start date: 07Aug2023 Ae resulted in: None of the above If patient recovered: Not recovered  Known allergies: penicillin Other medical history: Migraines; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of post viral acute disseminated encephalomyelitis" (unspecified if ongoing); "chronic residual neurological symptoms" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nitrofurantoin, reaction(s): "Known allergies:  nitrofurantoin". Vaccination history included: Covid vaccine (Dose number unknown, single), for Covid-19 Immunization, reaction(s): "Known allergies: COVID vaccine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (08Aug2023) positive, notes: by antigen. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Jul2023 to 03Aug2023.  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 available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6200), in left arm and on 17Mar2021 as dose 2, single (Lot number: EN6200) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 12Oct2021 at 16:00 as dose 3 (booster), single (Lot number: 1822809), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Aug2022 as dose 4 (booster), single (Lot number: 011B22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Oct2021 at 16:00, outcome "recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive; (2023) Negative, notes: COVID-19 rebound eight days from being negative from first infection. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 27Jul2023 to 31Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272575 Same patient, different product, different event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37-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) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: nsaids, reaction(s): "Known allergies: NSAIDS". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 31Jul2023 to 05Aug2023. The patient experienced rebound COVID-19 on 08Aug2023 at 1:00 PM treated with Mucinex.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, SARS-CoV-2 test
Clinical narrative: migraine daily; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 15:00 as dose 2, single (Lot number: F48027) at the age of 40 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Drug Allergy". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: 301458A, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 30Sep2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 10Dec2021 at 15:00, outcome "not recovered", described as "migraine daily". The event "migraine daily" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine.  Additional information: Patient presents with migraine daily since 10Dec2021. Has seen multiple physicians and specialists for follow up and no relief.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 31Jul2023 to 04Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272598 Same patient/reporter, different drug/ event;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer, Dose Number: 1, 2, 3, 4 / Moderna, Dose Number: 5; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), on 20Apr2021 as dose 2, single (Lot number: EW0170), on 16Nov2021 as dose 3 (booster), single (Lot number: FG3527) and on 06May2022 as dose 4 (booster), single (Lot number: Fm9992) at the age of 64 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 31Oct2022 as dose 5 (booster), single (Lot number: 05202217), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Oct2022, outcome "unknown", described as "Pfizer, Dose Number: 1, 2, 3, 4 / Moderna, Dose Number: 5"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Postive, notes: COVID 19 Treatment; (09Aug2023) Postive, notes: 09Aug2023 my head cold is worse and I am still testing positive for Covid; (Aug2023) Postive, notes: Still testing positive for Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 28Jul2023 to 01Aug2023 (Lot: GG0067).  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna, Vaccine administration date=25Feb2021 / Vaccine brand=Pfizer / BioNTech, Vaccine administration date=05Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jan2021 as dose 1, single (Lot number: 037K20A), in left arm, on 25Feb2021 as dose 2, single (Lot number: 002A21A), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Nov2021, outcome "unknown", described as "Vaccine brand other=Moderna, Vaccine administration date=25Feb2021 / Vaccine brand=Pfizer / BioNTech, Vaccine administration date=05Nov2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: He experienced some adverse events affecting his hearing/ My apparatus; it's very thin; I could bare my hearing is not great; one or two occasions, it's extremely bright; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "He experienced some adverse events affecting his hearing/ My apparatus; it's very thin; I could bare my hearing is not great; one or two occasions, it's extremely bright". Therapeutic measures were taken as a result of hypoacusis.   Additional information: The caller received the Pfizer Covid Vaccines, two Covid Vaccines and two Boosters and he mentioned and he experienced some adverse events affecting his hearing. Patient apparatus was very, he just got apparatus in, it was very thin. Patient could barely see it. Patient could bare hearing was not great but he liked, He did not know if it was the bandwidth issue or about two Boosters and two Vaccines and then two Boosters, He did not know if it was the bandwidth issue. Patient did not know what the 'deal' was but it was very thin, patient was seeing, as he spoke, but sometimes it was there, sometimes it was not, hardly visible and in one or two occasions, it was extremely bright. He had been told that he had the very best available, patient was looking to get clarity of the audio and video to begin with.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; received BNT162B2, BNT162B2 OMI BA.4-5 and Moderna covid-19 vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 19:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 67 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jan2021 at 15:00 as dose 1, single (Lot number: 039K20A), in left arm, on 06Feb2021 at 15:00 as dose 2, single (Lot number: 029K20A), in left arm and on 13Sep2021 as dose 3 (booster), single (Lot number: 004F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Sep2021, outcome "unknown", described as "received BNT162B2, BNT162B2 OMI BA.4-5 and Moderna covid-19 vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 31Jul2023 to 05Aug2023.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test
Clinical narrative: Sense of taste is still off. I can barely taste my food until it hits my throat but not my taste buds; 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), on 14Dec2022 as dose 1, single (Lot number: FP7138) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "Herniated disk c4-c5" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious) with onset 16Dec2022, outcome "not recovered", described as "Sense of taste is still off. I can barely taste my food until it hits my throat but not my taste buds". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ageusia.  Additional information: Patient also received BNT162b2 (BNT162B2), on 06Jan2023 as dose 2, single (Lot number: FP7138) in right arm for covid-19 immunisation. Patient had no known allergies. No other vaccine in four weeks was administered. Other medications in two weeks: Not applicable. COVID prior vaccination: No