chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Total of 168 doses/vials were given for LOT  048C21A.  The vial did not undergone to any temperature excursions. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non significant information
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses. Expiration date was reported as 09-Nov-2021.  Dates of administration of vaccine were reported as 10-Nov-2021 and 11-Nov-2021.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up recieved contains non-significant information.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Drug ineffective, Suspected COVID-19
Clinical narrative: Solicited report from a consumer of a 40 year old male with events of non-serious thumb arthritis and COVID-19 with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced thumb arthritis. In 2022, the patient experienced COVID-19. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of thumb arthritis was not provided. The reporter's causality for the event(s) of Covid-19 with Humira (Adalimumab) was a reasonable possibility. Suspect Drug(s) Information: Suspect Drug(s): Humira (Solution for injection in pre-filled pen) (Adalimumab) Route of administration: Subcutaneous Indications for use: Psoriatic Arthritis Therapy Dates: Unknown - Discontinued Causality: Finger arthritis (Arthritis) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A Covid-19 (Covid-19) Action(s) taken with drug: Drug discontinued Outcome after reintroduction of dose: Not applicable Causality as per reporter (Drug/Vaccine): Probable Dechallenge: Yes Rechallenge: No challenge Seq. No: 2 Suspect Drug(s): Pfizer BIONTECH Covid-19 vaccine (Tozinameran) (Tozinameran), Unknown, Unknown, Unknown Daily dose:  1) 1st dose 2) 2nd dose 3) 3rd dose Route of administration: 1) Intra-Muscular 2) Intra-Muscular 3) Intra-Muscular  Indications for use: Covid-19 Vaccination Therapy dates (from/to):  1) 24Jun2021 - 24Jun2021 2) 14Jul2021 - 14Jul2021 3) 14Jan2022 - 14Jan2022 Causality: Finger arthritis (arthritis) Action(s) taken with drug: not applicable Causality as per reporter (Drug/Vaccine): Possible Dechallenge: N/A. Covid-19 (Covid-19) Action(s) taken with drug: Not applicable Causality as per reporter (Drug/Vaccine): Probable Dechallenge: N/A Did event abate after stopping drug: NA. Concomitant drugs and dates of administration (Exclude those used to treat event): Concomitant Drugs Not Reported. Other relevant history: Not reported. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. Based on the limited information provided, causal relationship cannot be clearly established and cannot be excluded for BNT162B2 in onset of the reported arthritis. Start date of Arthritis was not provided. Case will be reassessed upon receipt of additional information.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First Booster dose: Arm hurt/Second Booster Dose: Arm hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 45 years, in right arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (First dose: 20Mar2021, lot: ER2613, NDC: Unknown , expiration: unknown, route of administration: upper right arm), administration date: 20Mar2021, when the patient was 44-year-old, for COVID-19 Immunization; BNT162b2 (second dose: 10Apr2021 , lot: ER8731, NDC: unknown, expiration: unknown , route of administration: upper right arm), administration date: 10Apr2021, when the patient was 44-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "First Booster dose: Arm hurt/Second Booster Dose: Arm hurting".  Additional information: it was noted that after the second booster dose, the arm hurt; it barely hurt as of the reporting, however  if  the shoulder is raised up, the arm pain would be felt. Otherwise, it was not bothersome. If moves arm really high would only be doing it to find out if arm hurts or not. Arm hurting was improving.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Recently he tested positive for COVID-19; Recently he tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: BN5318), on 03Mar2021 as dose 2, single (Lot number: EN6202), on 18Aug2021 as dose 3(booster), single (Lot number: FC3180) and on 16Mar2022 as dose 4(booster), single (Lot number: FJ6369) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Recently he tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: He has continued to test positive for the 20th consecutive day for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient reported as he received 4 doses of Pfizer-BioNTech COVID-19 Vaccine, the last dose was on 16Mar2022. Recently he tested positive for COVID-19 and took Paxlovid from 12May2022 to 16May2022. It has been 20 days since he originally tested positive for COVID-19 and he still has not tested negative said that this is a rebound effect.He took Simvastatin, one 40 mg daily.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6202, lot FC3180 and lot FC3180 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 EN6202, fill lot EN5334, and the formulated drug product lot EN5323. The final scope included the reported finished goods lot FC3180, fill lot EY546, and bulk formulation lot EP8650. The final scope included the reported finished goods lot FC3180, fill lot EY546, and bulk formulation lot EP8650. 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: achy; Fatigue; lymph node swelling under her right armpit (side of injection), as well as lymph node discomfort in her bilateral groin area. lymph node swelling under her right armpit (side of injection), as well as lymph node discomfort in her bilateral groin area.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (COMIRNATY), on 22May2022 as dose 2, single (Lot number: FM7553), in right arm for covid-19 immunization. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: she only take a prescription for high blood pressure. She has been on it for a long time and is still taking it. Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: BNT162b2 (Dose 1, Manufacturer: Pfizer, Date: 05Feb2021, NDC: unknown, LOT: EL9264, EXP: unknown, Dose and Route: unknown), administration date: 05Feb2021, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose 2, Manufacturer: Pfizer, Date: 02Mar2021, NDC: unknown, LOT: hard to read caller thinks it says GN6202, handwritten on the card, EXP: unknown, Dose and Route: unknown), administration date: 02Mar2021, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose 3, Manufacturer: Pfizer, Date: 12Oct2021, NDC: unknown, LOT: 320308D, EXP: unknown, Dose and Route: unknown), administration date: 12Oct2021, for COVID-19 immunization, reaction(s): "COVID-19"; tetanus (Vaccine Name: Tetanus , Manufacturer: not provided, Lot Number: unknown, Route, Anatomical Location: left arm, No. of Previous Doses: not provided, Date: 19May2022), administration date: 19May2022. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 23May2022, outcome "recovering" and all described as "lymph node swelling under her right armpit (side of injection), as well as lymph node discomfort in her bilateral groin area."; PAIN (non-serious), outcome "unknown", described as "achy"; FATIGUE (non-serious), outcome "unknown".  Additional information: patient received her second booster dose of Comirnaty on Sunday, 22May2022, and on Monday, noticed lymph node swelling under her right armpit (side of injection), as well as lymph node discomfort in her bilateral groin area. She described it as worrisome and uncomfortable. The patient had received the second booster in her right arm on a Sunday afternoon;  Sunday night, it was fine. Monday as the day wore on, she started getting achy and had fatigue. She took a nap. Since then, under her right arm, the lymph node was swollen. She felt discomfort in the lymph node area in left and right groin. She has been taking Tylenol and drinking water.  Under her right arm, the lymph node was swollen; the swelling has gone down a bit, but still visibly swollen. She had reactions to 3 out of the 4 Covid vaccines.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 at 10:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm, on 17Feb2021 at 09:30 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 28Jan2022 at 09:30 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29May2022 at 13:15, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) negative; (29May2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: The patient received no other medications in two weeks, had no known allergies. He received anti-viral treatment of Paxlovid for Covid-19 from 17May2022 to 22May2022 for five days, thereafter he tested negative on 26May2022, and on 29May2022 he has again tested positive at home testing.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Disturbance in attention, Feeling abnormal, Pain in extremity, Road traffic accident
Clinical narrative: First dose: he felt out of it; First dose: Weakness; First dose: Pain in the arms; First dose: kind of fuzzy mind; First dose: car accident; First dose: he was not as focused, it took him a long time to focus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 25Aug2021 at 15:00 as dose 1, single (Lot number: EWQ171) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "First dose: he felt out of it"; ASTHENIA (non-serious), outcome "recovered", described as "First dose: Weakness"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "First dose: Pain in the arms"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "First dose: kind of fuzzy mind"; ROAD TRAFFIC ACCIDENT (non-serious), outcome "recovered", described as "First dose: car accident"; DISTURBANCE IN ATTENTION (non-serious), outcome "recovered", described as "First dose: he was not as focused, it took him a long time to focus".  Additional information: Patient felt out of it, pain in the arms, 2 weeks of kind of feeling general kind of weakness, kind of fuzzy mind, and that was the first time he had a car accident. He was walking outside, he has a farm, and he was not as focused, it took him a long time to focus. Outcome of these events as far as he knows he recovered completely from them all, but who knows, he could have just gotten used to it.  Patient did not had any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. He never had any side effects prior to vaccination, the area hurts a little after but he never remembers anything else. All of his family had the same Pfizer Covid Vaccines, like 4 of them and none of them had any major side effects besides some weakness, like feeling like getting a little bit sick the day after as far as they told him.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: I am having diarrhea ; even after I eat or drink something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 IMMUNIZATION; Covid-19 vaccine (first booster, COVID-19 VACCINE [unknown manufacturer]), for COVID-19 IMMUNIZATION. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "I am having diarrhea; even after I eat or drink something". Additional information Reporter stated, I do not want to leave my name but I just wanted to be calling about my side effect that I had from my 2nd booster. So, I have my 2nd booster on May 11th and couple days later I am having diarrhea I still have the once even after I eat or drink something. The first booster did not cause that I don't know why and I take anti- viral (Further clarification unknown hence, captured as unspecified medication) at night so I don't know if that's related to that. Reporter stated, I take it every night anti-viral but the first booster did not do that. So, I don't know why 2nd have like this because doctors aren't really helping me so I thought I am calling you guys may be you guys can explain it to me better.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 33 years 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). The patient's relevant medical history included: "Eosinophilic esophagitis" (unspecified if ongoing); "allergies: Wheat and dairy" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28May2022, outcome "not recovered" and all described as "Treatment of COVID-19/Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, Covid-19. Clinical Course: Tested positive for COVID-19 after taking Paxlovid and recovering. Tested positive on 29May, 10 days after completing Paxlovid. Patient received Multivitamin- other medication in 2 weeks after vaccination. Anti-viral details: product-COVID 19 Treatment from 14May2022 to 19May2022. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FH8027 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8027, fill lot FH4340, and the bulk formulated drug product FH4348. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: achy and fatigue; achy and fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9264) at the age of 66 years for COVID-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medications included: LISINOPRIL taken for blood pressure increased. Vaccination history included: TETANUS VACCINE (Manufacturer: not provided, Lot Number: unknown, Route, Anatomical Location: left arm, No. of Previous Doses: not provided), administration date: 19May2022, for Immunisation. The following information was reported: PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "achy and fatigue". Therapeutic measures were taken as a result of pain.  Additional information: the patient had reactions to three out of the four Covid vaccines. After the first dose, the patient she was achy, and had fatigue; therefore, she took a nap.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: a baseball size lymphadenopathy/ left axilla swollen lymph node; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 2, single (Lot number: EK9231, Expiration Date: 30Apr2021) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: covid-19 vaccine (Covid-19 Vaccine , First dose: , Date: 22Dec2020, Lot: EL0140, Exp: 31Mar2021), administration date: 22Dec2020, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "a baseball size lymphadenopathy/ left axilla swollen lymph node".  Additional information: She previously reported that she experienced at approximately 10 pm the day of her Covid-19 injection that she had a baseball size lymphadenopathy on the same side of the shot. She said that she could call it a left axilla swollen lymph node. It was only after her second dose of the Covid-19 vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Recent gout diagnosis." (unspecified if ongoing). Concomitant medication(s) included: NASACORT, start date: 01Mar2022; MOTRIN [NAPROXEN], start date: 15May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Apr2022 at 20:00, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID on day 10. Therapeutic measures were taken as a result of Covid-19. Clinical course: Patient received antiviral treatment for COVID-19 from 18May2022 to 23May2022. Patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 28Feb2021 at 03:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 12Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 16May2022 at 09:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "Heart attack", start date: 2019 (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL, start date: Mar2009; METFORMIN, start date: May2014. Past drug history included: No, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29May2022 at 08:00, 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, notes: I was symptoms free and tested negative; (29May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, Covid-19. Clinical course: Adverse event: Patient taken Statin from unknown date in Nov2019 to 20May2022. On day 8 after starting Paxlovid I was symptoms free and tested negative. On day 10, today 29May2022 I developed a sore throat and tested positive. Other medication in 2 weeks: Yes Anti-viral details: product: COVID-19 Treatment, Brand: Paxlovid Treatment start date: 20May2022, Treatment start date: 25May2022, Indication: Treatment of COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: 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 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EZ9264), in right arm, on 18Feb2021 as dose 2, single (Lot number: EN6200), in right arm and on 28Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 76 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2005, stop date: 2005; "Total knee replacement", start date: 2021, stop date: 2021. Concomitant medication(s) included: PRAVASTATIN, start date: Sep2016; ALENDRONATE SODIUM, start date: Sep2020. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, latency 1 year 3 months 7 days after the suspect product(s) administration, outcome "recovering" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Clinical course: The patient had no known allergies. On an unspecified date in May2022, the patient experienced suspected COVID-19 and led to drug ineffective. From 20May2022 to 25May2022, the patient received unspecified treatment for COVID-19 (lot number: GA1190). As part of the simplification process, the following Complaint Records were classified as Product Use Attributes / Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in UNKNOWN. Refer to the below table for details. The complaint for Lack of Effect of the PFIZER/BIONTECH COVID-19 VACCINE lot FF2589 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 FF2589, fill lot FF2558, and the bulk formulated drug product lot FE5318 and the final scope included the reported finished goods lot EN6200; fill lot EN5332, and the formulated drug product lot EN5321. 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. No follow-up attempts were possible. No further information was expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacture), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "not recovered" and all described as "Rebound COVID with worst symptoms than first time, But still mild". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: unknown. 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Negative, notes: I tested negative on the last day of my medication 26May; (30May2022) Positive, notes: I started feeling like I had a cold and I tested positive on 30May. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient not received other medication in 2 weeks. The patient received anti viral treatment on 21May2022 and stop on 26May2022 for treatment of COVID-19. She tested negative on the last day of my medication 26May, she started feeling like she had a cold on 30May2022 12:00 PM and she tested positive on 30May2022. She had no any known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 41-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 27Nov2021 at 14:00 as dose 3 (booster), 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 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: "obese" (unspecified if ongoing); "Irritable bowel syndrome" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19. The patient received Paxlovid to treated drug ineffective, Covid-19. Treatment start date: 31May2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Vertigo
Clinical narrative: experienced vertigo in early Feb; Contracted Covid in late Jan2022; Contracted Covid in late Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 52 years, in left leg, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: STATIN [NYSTATIN]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "recovered" and all described as "Contracted Covid in late Jan2022"; VERTIGO (non-serious) with onset Feb2022, outcome "recovered", described as "experienced vertigo in early Feb". The events "contracted covid in late jan2022" and "experienced vertigo in early feb" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jan2022) Positive, notes: Covid test post vaccination: covid test type Post vaccination: Nasal Swab, Covid test date: 20Jan2022, Covid test result: Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, vertigo.  Clinical course: Facility type vaccine was pharmacy or drug store. He received no other vaccine in four weeks. He received Statin and blood pressure medications in two weeks. He had no Covid prior to vaccination. He was covid tested post vaccination. He had no known allergies. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EM9809 and EN6203 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 EN6198, fill lot EM9809, and the formulated drug product lot EM9809. 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: dizziness; fever 100; chills; body aches; nausea; fatigue; pain at injection site; swelling in neck; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 23May2022, outcome "recovered" (2022), described as "body aches"; CHILLS (non-serious) with onset 23May2022, outcome "recovered" (2022); DIZZINESS (non-serious) with onset 23May2022, outcome "recovered" (2022); FATIGUE (non-serious) with onset 23May2022, outcome "recovered" (2022); PYREXIA (non-serious) with onset 23May2022, outcome "recovered" (2022), described as "fever 100"; HEADACHE (non-serious) with onset 23May2022, outcome "recovered" (2022); NAUSEA (non-serious) with onset 23May2022, outcome "recovered" (2022); VACCINATION SITE PAIN (non-serious) with onset 23May2022, outcome "recovered" (2022), described as "pain at injection site"; SWELLING (non-serious) with onset 23May2022, outcome "recovered" (2022), described as "swelling in neck". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, pyrexia, chills, pain, nausea, fatigue, vaccination site pain, swelling, headache.  Additional information: It was reported that patient did not receive any vaccine and any other medication in 2weeks. The patient had no other medical history and no known allergies. The events did not result in emergency room, physician office visit or intensive care unit. The patient experienced these side effects from her second booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Swelling, Vaccination site pain
Clinical narrative: dizziness; fever 100; chills; body aches; nausea; fatigue; pain at injection site; swelling in neck; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 23May2022, outcome "recovered" (2022), described as "body aches"; CHILLS (non-serious) with onset 23May2022, outcome "recovered" (2022); DIZZINESS (non-serious) with onset 23May2022, outcome "recovered" (2022); FATIGUE (non-serious) with onset 23May2022, outcome "recovered" (2022); PYREXIA (non-serious) with onset 23May2022, outcome "recovered" (2022), described as "fever 100"; HEADACHE (non-serious) with onset 23May2022, outcome "recovered" (2022); NAUSEA (non-serious) with onset 23May2022, outcome "recovered" (2022); VACCINATION SITE PAIN (non-serious) with onset 23May2022, outcome "recovered" (2022), described as "pain at injection site"; SWELLING (non-serious) with onset 23May2022, outcome "recovered" (2022), described as "swelling in neck". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, pyrexia, chills, pain, nausea, fatigue, vaccination site pain, swelling, headache.  Additional information: It was reported that patient did not receive any vaccine and any other medication in 2weeks. The patient had no other medical history and no known allergies. The events did not result in emergency room, physician office visit or intensive care unit. The patient experienced these side effects from her second booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, COVID-19, Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. An 11-year-old male patient received BNT162b2 (BNT162B2), on 19Dec2021 at 13:00 as dose 2, single (Lot number: FK5127) at the age of 10 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Time: 13.00, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: FK5127), administration date: 28Nov2021, for COVID-19 immunization, reaction(s): "armpit swollen", "Armpit swollen and pain", "lump under armpit". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 22May2022, outcome "recovered" (2022), described as "Armpit swollen"; AXILLARY PAIN (non-serious) with onset 22May2022, outcome "recovered" (2022), described as "Armpit swollen and pain"; AXILLARY MASS (non-serious), outcome "unknown", described as "Lump under armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, axillary pain with Tylenol and Advil. Additional information : No prior Vaccinations within 4 weeks of vaccination. The same AEs were occurred at 1 and 2nd dose, but less severe.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Caller's legs have been cramping since caller got the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER6213) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "Caller's legs have been cramping since caller got the vaccine". The event "caller's legs have been cramping since caller got the vaccine" required physician office visit. Therapeutic measures were taken as a result of muscle spasms.  Additional information: Patient took blood thinners, Xarelto, for 6 months until Nov2021; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200794186 same patient, different vaccine dose/events.;US-PFIZER INC-202200794187 same patient, different vaccine dose/events.
Age: 102.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An 102-year-old male patient received BNT162b2 (BNT162B2), on 24Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 102 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: DIGOXIN, start date: 01Jan2021, stop date: 02Jun2022; LEXAPRO, start date: 01Jan2021, stop date: 02Jun2022; PRAVASTATIN, start date: 01Jan2021, stop date: 02Jun2022; ALPRAZOLAM, start date: 01Jan2021, stop date: 02Jun2022; METOPROLOL TARTRATE, start date: 01Jan2021, stop date: 02Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28May2022, outcome "not recovered", COVID-19 (medically significant) with onset 28May2022 at 11:00, outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient had no known allergies. Patient had received medication in 2 weeks. Anti-viral details: Product: COVID-19 Treatment, Treatment start date: 28May2022 and Treatment stop date:31May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.