chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: this time both arms and hands are numb,started dropping things; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (this time both arms and hands are numb,started dropping things) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A, 060H21A, 019B21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Neuropathy (Neuropathy feet and legs, from kneed down) in 2012. Concurrent medical conditions included Drug allergy (Aspirin) and Type II diabetes mellitus. Concomitant products included GABAPENTIN and INSULIN ASPART (NOVOLOG) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (this time both arms and hands are numb,started dropping things). At the time of the report, HYPOAESTHESIA (this time both arms and hands are numb,started dropping things) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Patient received Mylan 26 Units once a day. It was reported that patient wanted to inform that  his pneumonia shot the same day as the booster shot, but in opposite arms. Symptoms were slowly Worsened. No treatment drug were reported.   This case was linked to MOD-2022-648104 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever of 102.6; Nausea; Tired; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever of 102.6), NAUSEA (Nausea) and FATIGUE (Tired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Patient had no allergies. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever of 102.6), NAUSEA (Nausea) and FATIGUE (Tired). In March 2021, PYREXIA (Fever of 102.6), NAUSEA (Nausea) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: Fever of 102.6.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  On 05-Mar-2021 night, the patient had fever of 102.6, nausea and was tired. The symptoms lasted for 36 to 48 hours.  Treatment information was not provided.   This case was linked to MOD-2022-648152, MOD-2022-648153, MOD-2022-648157, MOD-2022-648275 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102.6; Nausea; Tired; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever of 102.6), NAUSEA (Nausea) and FATIGUE (Tired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Patient had no allergies. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever of 102.6), NAUSEA (Nausea) and FATIGUE (Tired). In March 2021, PYREXIA (Fever of 102.6), NAUSEA (Nausea) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: Fever of 102.6.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  On 05-Mar-2021 night, the patient had fever of 102.6, nausea and was tired. The symptoms lasted for 36 to 48 hours.  Treatment information was not provided.   This case was linked to MOD-2022-648152, MOD-2022-648153, MOD-2022-648157, MOD-2022-648275 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Fever of 102.6; Nausea; Tired; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever of 102.6), NAUSEA (Nausea) and FATIGUE (Tired) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Patient had no allergies. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever of 102.6), NAUSEA (Nausea) and FATIGUE (Tired). In March 2021, PYREXIA (Fever of 102.6), NAUSEA (Nausea) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: Fever of 102.6.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  On 05-Mar-2021 night, the patient had fever of 102.6, nausea and was tired. The symptoms lasted for 36 to 48 hours.  Treatment information was not provided.   This case was linked to MOD-2022-648152, MOD-2022-648153, MOD-2022-648157, MOD-2022-648275 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pyrexia
Clinical narrative: On 02May2022, Light fever for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (On 02May2022, Light fever for 24 hours) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 065F21A, 020B21A and 029A21A) for COVID-19 vaccination.     Patient had no known allergies. Patient never had COVID positive  test or diagnosis. Patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (On 02May2022, Light fever for 24 hours). On 02-May-2022, PYREXIA (On 02May2022, Light fever for 24 hours) had resolved.            No concomitant medications were reported. No treatment  medications were reported. It was reported that the patient's symptoms were less and less with each dose, the first dose he had a fever of 102.6 and with this last dose, nothing. He thought that his body was used to get it.   This case was linked to MOD-2022-648153, MOD-2022-648106, MOD-2022-648152, MOD-2022-648157 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: On 02May2022, Light fever for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (On 02May2022, Light fever for 24 hours) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 065F21A, 020B21A and 029A21A) for COVID-19 vaccination.     Patient had no known allergies. Patient never had COVID positive  test or diagnosis. Patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (On 02May2022, Light fever for 24 hours). On 02-May-2022, PYREXIA (On 02May2022, Light fever for 24 hours) had resolved.            No concomitant medications were reported. No treatment  medications were reported. It was reported that the patient's symptoms were less and less with each dose, the first dose he had a fever of 102.6 and with this last dose, nothing. He thought that his body was used to get it.   This case was linked to MOD-2022-648153, MOD-2022-648106, MOD-2022-648152, MOD-2022-648157 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: On 02May2022, Light fever for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (On 02May2022, Light fever for 24 hours) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 065F21A, 020B21A and 029A21A) for COVID-19 vaccination.     Patient had no known allergies. Patient never had COVID positive  test or diagnosis. Patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (On 02May2022, Light fever for 24 hours). On 02-May-2022, PYREXIA (On 02May2022, Light fever for 24 hours) had resolved.            No concomitant medications were reported. No treatment  medications were reported. It was reported that the patient's symptoms were less and less with each dose, the first dose he had a fever of 102.6 and with this last dose, nothing. He thought that his body was used to get it.   This case was linked to MOD-2022-648153, MOD-2022-648106, MOD-2022-648152, MOD-2022-648157 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Pyrexia
Clinical narrative: On 15Nov2021, he reported having a Light fever which lasted for 24-36 hours.; Receive 0.5ml Booster Dose; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (On 15Nov2021, he reported having a Light fever which lasted for 24-36 hours.) and ACCIDENTAL OVERDOSE (Receive 0.5ml Booster Dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 020B21A and 029A21A) for COVID-19 vaccination.     Patient had no known allergies. Patient never had COVID positive  test or diagnosis. Patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Nov-2021, the patient experienced PYREXIA (On 15Nov2021, he reported having a Light fever which lasted for 24-36 hours.) and ACCIDENTAL OVERDOSE (Receive 0.5ml Booster Dose). In November 2021, PYREXIA (On 15Nov2021, he reported having a Light fever which lasted for 24-36 hours.) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (Receive 0.5ml Booster Dose) outcome was unknown.            No concomitant medications were reported. No treatment details were reported. It was reported that the Symptom was lasted for 24-36 hours.   This case was linked to MOD-2022-648152, MOD-2022-648106, MOD-2022-648157, MOD-2022-648275 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: They were sick for two days when receiving the vaccines; side effects too awful/ they experienced terrible side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (They were sick for two days when receiving the vaccines) and FEELING ABNORMAL (side effects too awful/ they experienced terrible side effects) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient experienced allergies (medications, food and other products). The patient did not tested or diagnosed with COVID-19. It was unknown if the history was related to mentioned event and both Acute and Chronic illnesses at the time of vaccination. It was unknown if patient received other vaccines within 1 month prior to Moderna COVID-19 vaccine.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ILLNESS (They were sick for two days when receiving the vaccines) and FEELING ABNORMAL (side effects too awful/ they experienced terrible side effects). On 09-Apr-2021, ILLNESS (They were sick for two days when receiving the vaccines) and FEELING ABNORMAL (side effects too awful/ they experienced terrible side effects) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown that patient had prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination or at the time of adverse event.  Patient had received dose 2 on 05-May-2021, Body site right arm and experienced the same events started on 05-May-2021 and recovered on 07-May-2021.  It was reported that the patient experienced terrible side effetcs and was sick for two days when receiving the vaccines and side effects too awful and would not get another one.  It was reported that the adverse event did not cause patient to seek medical care and there were no other potential causes.   It was reported that the patient did not experienced similar event in past.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-640217 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Viral test
Clinical narrative: Drug ineffective; SARS-CoV-2 Infection; This is a literature report.  A 55-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), 5 months after the suspect product(s) administration, outcome "unknown"; COVID-19 (medically significant), 5 months after the suspect product(s) administration, outcome "unknown", described as "SARS-CoV-2 Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: PCR Ct greater than equal to 30; SARS-CoV-2 test (normal high range 30): Symptomatic, positive antigen test, notes: day 0; Symptomatic, positive antigen test, notes: day 6; Asymptomatic or negative test result, notes: day 8; Symptomatic, positive antigen test, notes: day 11; 17.2, notes: day 12, Symptomatic, positive antigen test; 22.9, notes: day 14, Symptomatic, positive antigen test; 29.9, notes: day 16, Symptomatic, positive antigen test; Asymptomatic or negative test result, notes: day 18; Asymptomatic or negative test result, notes: day 20; were obtained through Laboratories, notes: Laboratories; Unknown Result; Viral test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-PV202200065235 Same article/ drug/event and different patient:;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: SARS-CoV-2 Infection; SARS-CoV-2 Infection; This is a literature report.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 2, booster dose, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 1 month after the suspect product(s) administration, outcome "recovered" and all described as "SARS-CoV-2 Infection". The patient underwent the following laboratory tests and procedures: diagnostic testing: Positive, notes: day 0; Polymerase chain reaction: Unknown results; SARS-CoV-2 test: Positive, notes: on days 9 through 15, remained positive for 2 to 7 days; Negative, notes: day 22; Unknown results; Negative, notes: day 0; Negative, notes: day 1; Positive, notes: day 2; Positive, notes: day 5; Positive, notes: day 6; Negative, notes: day 8; Negative, notes: day 9; Positive, notes: day 11; Positive, notes: day 12; Positive, notes: day 13; Positive, notes: day 14; Positive, notes: day 15; Positive, notes: day 16; Mild, notes: day 17; Negative, notes: day 18. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that all the patients had been fully vaccinated and had received at least one dose of a messenger RNA booster 0.5 to 7 months before diagnosis. None of the patients had any known immunocompromising conditions, and all recovered without additional antiviral treatment. It was reported that patient received second booster 1 month before diagnosis.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-PV202200065235 Same article/ drug/event and different patient:;
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: first booster it was a terrible headache that went on for longer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "occipital neuralgia" (unspecified if ongoing), notes: She had preexisting conditions prior to the Covid vaccines and that condition is occipital neuralgia. The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (Caller had a mixture of both Pfizer and Moderna. Caller has filed VAERS on Moderna.), for Covid-19 Immunization; Bnt162b2 (Caller had a mixture of both Pfizer and Moderna. Caller has filed VAERS on Moderna.), for Covid-19 Immunization.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "first booster it was a terrible headache that went on for longer".  Additional information: The patient reported that she had a really horrible reaction to the last booster of the Pfizer COVID-19 vaccine (gray, monovalent).  She reported a history of "occipital neuralgia" which she had before receiving any covid vaccines.  She stated that it felt permanent, like a worsening of the occipital neuralgia noting it starts days after the vaccine. I think this last time it started 5 days... but before that with each vaccine. She had occipital neuralgia and she didn't get it from the vaccine, but originally, she just had a terrible headache for a few days, the second one she had a terrible headache for like 2 weeks, then the first booster it was a terrible headache that went on for longer, and this last one just killed me, it just killed me.  She noted, "I haven't gotten over that one yet and that was almost 2 months ago, maybe I'll never get over it, I don't know".  She also said, "I don't think this last vaccine did anything for BA4 &5, everyone I know who's also worn a mask, has gotten it, and they all got pretty sick, too."  She also stated that she would not be taking another booster "until 6 months go by". She does report having a mixed series, "I had a combination of both Pfizer and Moderna trying to see if one worked. " and "I think I did a VAERS on the Moderna".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspareunia, Haemorrhage, Intermenstrual bleeding, Vaginal haemorrhage
Clinical narrative: after intercourse she hurts in the morning with abdominal cramps and bleeding; after intercourse she hurts in the morning with abdominal cramps and bleeding; after intercourse she hurts in the morning with abdominal cramps and bleeding; bleeding, spotting; bleeding, spotting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 29-year-old female patient received BNT162b2 (BNT162B2), in Jul2021 as dose 1, 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: HAEMORRHAGE (medically significant), DYSPAREUNIA (non-serious), ABDOMINAL PAIN (non-serious), outcome "unknown" and all described as "after intercourse she hurts in the morning with abdominal cramps and bleeding"; INTERMENSTRUAL BLEEDING (non-serious), VAGINAL HAEMORRHAGE (non-serious), outcome "unknown" and all described as "bleeding, spotting". Clinical Course: Her Daughter in law got the initial covid 19 vaccine in Jul or original dose. Her Daughter in law is trying to have a child with her husband. Before the vaccine her period was every 40 days, but after the vaccine in Jul she began hurting the next morning after intercourse and having abdominal cramps and bleeding. Her Daughter in law thinks its just spotting but her Daughter in law is healthy. Caller clarified her Daughter in law's Initial Dose was Jul2021. Caller again asks that she just wanted to know if this was experienced. The previous agent (withheld) spoke about periods being longer and spaced out but not if this was a side effect. Caller states that she just doesn't know. Caller states that she thinks the second dose was spaced 3 months after the first she is not sure. Furthermore, reporter stated, "I am calling about my daughter in law because she had the Pfizer vaccine (Later confirmed as  Pfizer COVID 19 vaccine) before she married my son like in last Nov, the wedding was in Sep. So, she had the vaccine in probably like Jul I think she had it in Jul and then she got the next vaccine by Pfizer, prior to that she had regular periods coming every 40 days okay. So, then after having the vaccination and the second one she is been having pain after she has intercourse. I mean it doesn't hurt, it is cramps. It is the day after and she has cramps and then she bleeds a little bit after the day after. Isn't it crazy, have you heard anything from other people. She wanted to get child, she want to get pregnant."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201170253 same reporter/patient/vaccine, different doses/events;
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Off label use, Vertigo
Clinical narrative: queasiness in stomach; vertigo; Dose Number 5; Dose Number 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 14:15 as dose 5 (booster), single (Lot number: GJ2524) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; FOLBIC. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (BOOSTER), SINGLE; manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (BOOSTER), SINGLE; manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 15Sep2022 at 14:15, outcome "unknown" and all described as "Dose Number 5"; NAUSEA (non-serious) with onset 17Sep2022 at 03:30, outcome "recovering", described as "queasiness in stomach"; VERTIGO (non-serious) with onset 17Sep2022 at 03:30, outcome "recovering". Therapeutic measures were not taken as a result of nausea, vertigo. Additional information: After 36 hours woke up to use bathroom had severe vertigo on left side used furniture and walls for support to get into bathroom. Sat on toilet for about 5 minutes felt queasiness in stomach. Went back to bed used support but severe vertigo had subsided. Slept additional 3 hours vertigo had passed but still felt queasiness.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Have the Pfizer vaccine just tested positive for COVID-19 last night.; Have the Pfizer vaccine just tested positive for COVID-19 last night.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6-year-old female patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 1, single (Lot number: FK5127), in arm, on 01Dec2021 as dose 2, single (Lot number: FL0007), in arm and on 09Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 6 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Sep2022, outcome "unknown" and all described as "Have the Pfizer vaccine just tested positive for COVID-19 last night.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical information: Reporter was a Pfizer employee and she was trying to report on the website and just could not. Her two kids who have the Pfizer vaccine just tested positive for COVID-19 last night. Her children received two dose plus a booster. Her Husband also tested positive and he had received the Pfizer booster. Reporter confirmed she was reporting on her children and husband.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Menstruation delayed
Clinical narrative: my cycle was delayed; sharp pain in my stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 21Sep2021, outcome "not recovered", described as "my cycle was delayed"; ABDOMINAL PAIN UPPER (non-serious) with onset 21Sep2021, outcome "not recovered", described as "sharp pain in my stomach". The events "my cycle was delayed" and "sharp pain in my stomach" required physician office visit. Therapeutic measures were not taken as a result of menstruation delayed, abdominal pain upper.  Additional information: It was reported that, the patient used to have regular menstruation before the Pfizer vaccine and after the Pfizer vaccine her cycle was delayed for the first time in her life. She also experienced a sharp pain in her stomach after the vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. The patient did not receive any other medications in 2 weeks. No known allergies were reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site bruising, Vaccination site pain
Clinical narrative: Arm pain (feels like bruising) in general area of injection; Arm pain (feels like bruising) in general area of injection; Armpit pain (axillary region) on the same side; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2022 at 18:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 48 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing), notes: other medical history: Hashimoto's thyroiditis; "degenerative joint disease" (unspecified if ongoing), notes: other medical history: degenerative joint disease; "fibroids" (unspecified if ongoing), notes: other medical history: fibroids; "endometriosis" (unspecified if ongoing), notes: other medical history: endometriosis; "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "known allergies: latex" (unspecified if ongoing), notes: known allergies: latex; "known allergies: adhesives" (unspecified if ongoing), notes: known allergies: adhesives. Concomitant medication(s) included: SYNTHROID; FAMOTIDINE; FISH OIL; VITAMIN D3; FLUOCINONIDE topical. Past drug history included: Sporanox, reaction(s): "known allergies: sporanox", notes: known allergies: sporanox; Celebrex, reaction(s): "known allergies: celebrex", notes: known allergies: celebrex; Macrobid, reaction(s): "known allergies: macrobid", notes: known allergies: macrobid. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious) all with onset 17Sep2022 at 07:00, outcome "not recovered" and all described as "Arm pain (feels like bruising) in general area of injection"; AXILLARY PAIN (non-serious) with onset 17Sep2022 at 07:00, outcome "not recovered", described as "Armpit pain (axillary region) on the same side". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site bruising, axillary pain.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid 19 positive; Covid 19 positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Sep2022, outcome "unknown" and all described as "Covid 19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Sep2022) Positive, notes: Covid 19 positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Thank you for your email. Patient directly reported me the event, patient/reporter refused to be contacted for follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: Testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient didn't receive any other medication in 2weeks. Patient received Paxlovid for COVID 19 Treatment. Treatment start date was 8Sep2022 and stop date was 13Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid Rebound after treatment.; Covid Rebound after treatment.; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 at 16:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 22Jan2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 29Nov2021 at 12:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. There were no concomitant medications. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Covid Rebound after treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment included Paxlovid (treatment start date= 13Sep2022, treatment stop date= 17Sep2022).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Vaccination failure and Covid-19  cannot be completely excluded.
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; METFORMIN; FAXIGEN XL. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about Covid treatment was Yes. If vaccine received reported as Yes. Other medications in 2 weeks reported as Yes. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 16Sep2022, Lot number: GE4518, 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.; Sender's Comments: Based on the available information in the case, the causal association between the events Drug ineffective, COVID-19, interchange of vaccine products and the suspect drug BNT162B2 cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, 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 Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive other medication in 2 weeks. No known allergies reported. The patient received paxlovid from 10Sep2022 to 14Sep2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0162), in right arm, on 29Oct2021 as dose 3 (booster), single (Lot number: FD0809) and on 29Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: TOPIRAMATE; LAMOTRIGINE; ESTRADIOL; ESTRING; PANTOPRAZOLE; LEVOTHYROXINE; SIMVASTATIN; ARMODAFINIL. Past drug history included: Wellbutrin, reaction(s): "Known allergies: wellbutrin", notes: Known allergies: wellbutrin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2022) Positive, notes: Positive home test 18Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient received other medication in 2 weeks.Last dose of Paxlovid was 11Sep2022.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "severe headache". The event "severe headache" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of headache.  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Testing as COVID positive as of 18Sep2022; Testing as COVID positive as of 18Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 3-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), on 25Jun2022 at 10:15 as dose 1, single (Lot number: FT9142), in right arm, on 16Jul2022 at 10:15 as dose 2, single (Lot number: FT9142), in right arm and on 10Sep2022 at 09:45 as dose 3 (booster), single (Lot number: FT9142) at the age of 3 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. No Covid prior vaccination. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Sep2022 at 07:00, outcome "not recovered" and all described as "Testing as COVID positive as of 18Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 29Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years, in left arm for covid-19 immunisation; 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: "Known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medications included: ODACTRA; GRASTEK. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 30 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: "High Blood Pressure" (unspecified if ongoing); "bicuspid aortic valve" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Reoccurrence/rebound of Covid symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.