chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain
Clinical narrative: insomnia; severe chills; bodyaches; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 47-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 3 (booster), single (Lot number: FL3197) at the age of 47 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247, Route of Administration: Intramuscular, Manufacturer: Pfizer), administration date: 23Feb2021, when the patient was 46-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Route of Administration: Intramuscular, Manufacturer: Pfizer), administration date: 03Feb2021, when the patient was 46-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 12Apr2022, outcome "unknown", described as "bodyaches"; INSOMNIA (non-serious) with onset 12Apr2022, outcome "unknown"; CHILLS (non-serious) with onset 12Apr2022, outcome "unknown", described as "severe chills". It was unknown if therapeutic measures were taken as a result of insomnia, chills, pain.  Additional information: Patient had vaccine at workplace clinic. He did not take other vaccine in four weeks. He was not tested covid positive prior to vaccination and was not tested positive after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Slight cold symptoms 13Apr2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 64 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 13Mar2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 22Feb2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 13Apr2022, outcome "unknown", described as "Slight cold symptoms 13Apr2022". It was unknown if therapeutic measures were taken as a result of nasopharyngitis.  Additional information: It was reported that COVID was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Type of dose gave after expiration date and date second booster; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 70-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (Dose number: 2, Moderna 17Jul2021, with lot number 092E21A,), administration date: 17Jul2021, when the patient was 69-year-old, for Covid-19 immunization; Bnt162b2 (Dose number: 1, first dose Pfizer), for Covid-19 immunization; Covid-19 vaccine (Dose number: 3 (Booster), first booster on (state name) not in the system), for Covid-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 07Apr2022, outcome "unknown", described as "Type of dose gave after expiration date and date second booster". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Type of dose gave after expiration date and date second dose 07Apr2022; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 41-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, on 07Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose number: 01, Manufacturer: Pfizer), administration date: 10Mar2022, when the patient was 40-year-old, for Covid-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Type of dose gave after expiration date and date second dose 07Apr2022". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood creatine phosphokinase, Chest pain, Fatigue, HIV antigen
Clinical narrative: So sick after each vaccine; Chest pain; fatigue; difficulty going up and down the stairs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 22Jun2021 as dose 1, single (Lot number: EW175) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "So sick after each vaccine"; CHEST PAIN (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "difficulty going up and down the stairs". The events "so sick after each vaccine", "chest pain", "fatigue" and "difficulty going up and down the stairs" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Movement disorder, Polymerase chain reaction
Clinical narrative: So sick after each vaccine; Chest pain; fatigue; difficulty going up and down the stairs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 22Jun2021 as dose 1, single (Lot number: EW175) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "So sick after each vaccine"; CHEST PAIN (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "difficulty going up and down the stairs". The events "so sick after each vaccine", "chest pain", "fatigue" and "difficulty going up and down the stairs" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out; MARKETING PROGRAM NAME NOT AVALIABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4351305-00 (AbbVie).  A 73-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), at citrate free, subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First Dose, Route of Admin: Intramuscular), administration date: 20Feb2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (Second Dose, Route of Admin: Intramuscular), administration date: 12Mar2021, when the patient was 72-year-old, for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 02Apr2022, outcome "unknown", described as "Passed out". The action taken for adalimumab was unknown.  Additional information: Patient stated that he was not drinking enough water and went out into the heat. He went to sit and instead fell backwards and scraped his head. He was taken to the emergency room and told he was dehydrated. He adds, because he took his 4th Pfizer booster the day before he was told the booster might have played a role in his fainting. After getting fluids in the hospital he reported feeling good. The reporters causality for the event of passed out was not reported.  Abbvie's opinion is that there is no reasonable possibility that the event of passed out, unknown onset related to Humira (ADALIMUMAB).  The reporter's assessment of the causal relationship of "passed out" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vomiting
Clinical narrative: ill for 4 days after, completely wiped out: No fever, no nothing, just throwing up, so sick; Clarifies with the 2nd dose she had severe vomiting, 8 hours of vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 23Apr2021 as dose 2, single (Lot number: ER8755) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "had very like indigestion" (unspecified if ongoing), notes: Prior to getting the vaccine caller had very like indigestion. There were no concomitant medications. Vaccination history included: BNT162b2 (Pfizer COVID-19 vaccine, 1st dose:, Date: 02Apr2021, NDC number: unknown, Lot number: EP7533, Expiration date: unknown), administration date: 02Apr2021, when the patient was 40-year-old, for COVID-19 Immunization. The following information was reported: VOMITING (non-serious) with onset 23Apr2021, outcome "recovered" (Apr2021), described as "Clarifies with the 2nd dose she had severe vomiting, 8 hours of vomiting"; ILLNESS (non-serious) with onset 24Apr2021, outcome "recovered" (2021), described as "ill for 4 days after, completely wiped out: No fever, no nothing, just throwing up, so sick".  Additional information: Caller had a little bit of a reaction with the 2nd dose, but that is not why she is calling. Clarifies with the 2nd dose she had severe vomiting, 8 hours of vomiting: Stop date: Probably a week later started feeling better again. COVID-19 vaccine, 2nd dose: ill for 4 days after, completely wiped out: No fever, no nothing, just throwing up, so sick. Sick as heck and that lasted 4 days. Stop date: Probably a week later started feeling better again.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient stated that she got COVID-19 infection while being fully vaccinated, but patient stated that she "did not have it too bad".; Patient stated that she got COVID-19 infection while being fully vaccinated, but patient stated that she "did not have it too bad".; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Patient stated that she got COVID-19 infection while being fully vaccinated, but patient stated that she "did not have it too bad".". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course: It was unknown facility type vaccine and unknown for if other vaccine in four weeks. Adverse event Patient stated that she got COVID-19 infection while being fully vaccinated, But patient stated that she did not have it too bad. No covid prior vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rheumatoid arthritis
Clinical narrative: occasional flares of Rheumatoid arthritis; sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4351745-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years, all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "occasional flares of Rheumatoid arthritis"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". The action taken for upadacitinib was dosage permanently withdrawn.  Clinical course: It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's assessment of the causal relationship of "occasional flares of rheumatoid arthritis" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "sore arm" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Lymphadenitis, Night sweats
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 63 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "sarcoidosis lungs" (unspecified if ongoing), notes: Other medical history: sarcoidosis lungs; "Arthritis" (unspecified if ongoing), notes: Other medical history: Arthritis; "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "Fever"; PAIN (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "body aches"; FATIGUE (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "extreme fatigue"; CHILLS (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "full body convulsive chills"; LYMPHADENITIS (non-serious) with onset 12Apr2022 at 06:00, outcome "not recovered", described as "inflamed lymph nodes left neck and chest"; NIGHT SWEATS (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022); DYSPNOEA (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "shortness of breath"; PAIN IN EXTREMITY (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity, chills, pyrexia, pain, dyspnoea, night sweats, fatigue, lymphadenitis. Additional information: Adverse event: 12 hrs. post injection, sore arm, full body convulsive chills 45 minutes. Fever and body aches, shortness of breath 6hrs., night sweats, extreme fatigue, and full body aches 24 hrs., inflamed lymph nodes left neck and chest, ongoing. Patient did not receive any other vaccine in four weeks. Patient received other medication in two weeks. Patient did not receive any treatment. Patient not tested Covid prior and post vaccination. Patient had no known allergies.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 63 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "sarcoidosis lungs" (unspecified if ongoing), notes: Other medical history: sarcoidosis lungs; "Arthritis" (unspecified if ongoing), notes: Other medical history: Arthritis; "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "Fever"; PAIN (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "body aches"; FATIGUE (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "extreme fatigue"; CHILLS (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "full body convulsive chills"; LYMPHADENITIS (non-serious) with onset 12Apr2022 at 06:00, outcome "not recovered", described as "inflamed lymph nodes left neck and chest"; NIGHT SWEATS (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022); DYSPNOEA (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "shortness of breath"; PAIN IN EXTREMITY (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity, chills, pyrexia, pain, dyspnoea, night sweats, fatigue, lymphadenitis. Additional information: Adverse event: 12 hrs. post injection, sore arm, full body convulsive chills 45 minutes. Fever and body aches, shortness of breath 6hrs., night sweats, extreme fatigue, and full body aches 24 hrs., inflamed lymph nodes left neck and chest, ongoing. Patient did not receive any other vaccine in four weeks. Patient received other medication in two weeks. Patient did not receive any treatment. Patient not tested Covid prior and post vaccination. Patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "unknown".  Additional Information: The caller stated that, with the first two doses had some headaches and the normal things that were told she would have.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis symptoms worsened; rheumatoid arthritis symptoms worsened; uncomfortable; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: (141003).  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 59 years 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 , Manufacturer Unknown), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), RHEUMATOID ARTHRITIS (medically significant), outcome "unknown" and all described as "rheumatoid arthritis symptoms worsened"; MALAISE (non-serious), outcome "unknown", described as "uncomfortable".  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, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Rheumatoid arthritis and Rheumatoid arthritis aggravated which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Migraine, Pain
Clinical narrative: I noticed throughout the first month or two after getting each shot, I would get more migraine headache than I am having; the second booster/I always get a little chills and aches some days after; the second booster/I always get a little chills and aches some days after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism; LIOTHYRONINE taken for hypothyroidism. Vaccination history included: Bnt162b2 (Dose Number: Booster 1 [Dose 03], Lot no.: FH8027), for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Lot no.: EN6207), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Lot no.: EW0158), for Covid-19 Immunization.  The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "I noticed throughout the first month or two after getting each shot, I would get more migraine headache than I am having"; CHILLS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "the second booster/I always get a little chill and aches some days after". Therapeutic measures were taken as a result of migraine.  Additional information: Patient stated that patient just got second booster, the first two Pfizer and the third booster. patient noticed throughout the first month or two after getting each shot, patient would get more migraine headache than patient having. So, patient guessed finally, just got the booster, the second booster last Friday, 5 days ago and always get a little chill and aches some days after. It's just finally normal thought then sort of okay but then start getting headaches, they did go now for another month or two on and off and just wanted to report it. Patient stated typically they start like later in the afternoon and they usually have to take migraine medicine and then sometimes and patient wake up with it and take my migraine medicine and they will go away, when sleep in patient will be okay but then it will come back again that evening. So it happens for a couple of days in a row and then patient was fine for a while and then the same thing repeats and it goes usually a couple of days in a row and it's more so than patient would normally have my migraines. Patient took the medication Imitrex for Migraine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Migraine
Clinical narrative: I noticed throughout the first month or two after getting each shot, I would get more migraine headache than I am having; I always get a little chills and aches some days after; typically they start like later in the afternoon; I take my migraine medicine and they will go away, when I sleep in I'll be okay but then it will come back again that evening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0158), as dose 2, single (Lot number: EN6207) and as dose 3 (booster), single (Lot number: FK9895) for covid-19 immunisation. The patient's relevant medical history included: "low thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; LIOTHYRONINE taken for hypothyroidism. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "I noticed throughout the first month or two after getting each shot, I would get more migraine headache than I am having"; CHILLS (non-serious), outcome "unknown", described as "I always get a little chills and aches some days after"; MIGRAINE (non-serious), outcome "unknown", described as "typically they start like later in the afternoon; I take my migraine medicine and they will go away, when I sleep in I'll be okay but then it will come back again that evening".  Additional Information: Consumer stated, "And typically they start like later in the afternoon and they usually I have to take my migraine medicine and then sometimes I wake up with it I take my migraine medicine and they will go away, when I sleep in I'll be okay but then it will come back again that evening. So it happens for a couple of days in a row and then I'm fine for a while and then the same thing repeats and it goes usually a couple of days in a row and it's more so than I would normally have my migraines."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Helicobacter infection, SARS-CoV-2 test, Therapeutic product effect decreased
Clinical narrative: Helicobacter pylori infection; Drug effect decreased; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4356088-00.  A 20-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for hidradenitis; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Oct2021, outcome "recovered" and all described as "COVID-19"; HELICOBACTER INFECTION (non-serious), outcome "unknown", described as "Helicobacter pylori infection"; THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "unknown", described as "Drug effect decreased". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter considered "covid-19", "helicobacter pylori infection" and "drug effect decreased" related to BNT162b2.  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, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID - 19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Lung disorder
Clinical narrative: heart problems including 5 bypass surgeries; lung problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (medically significant), outcome "unknown", described as "heart problems including 5 bypass surgeries"; LUNG DISORDER (non-serious), outcome "unknown", described as "lung problems". Clinical course: Patient has health issues including heart problems including 5 bypass surgeries, lung problems and a pacemaker.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Endoscopy, Gastrooesophageal reflux disease
Clinical narrative: after my booster shot I experienced heartburn; GERD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 02Feb2022 at 10:00 as dose 3 (booster), single (Lot number: FK9729) at the age of 66 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia", start date: 1991 (ongoing); "Chronic fatigue syndrome", start date: 1991 (ongoing); "Osteoporosis", start date: 2016 (ongoing); "IBS", start date: 2009 (ongoing); "Post-Concussion Syndrome", start date: 2020, stop date: 2021. Concomitant medication(s) included: AMITRIPTYLINE oral taken for fibromyalgia (ongoing); CLONAZEPAM oral taken for anxiety, sleep disorder (ongoing); METOPROLOL [METOPROLOL TARTRATE] oral taken for tachycardia (ongoing); NABUMETONE oral taken for fibromyalgia (ongoing). Vaccination history included: BNT162b2 (Dose 1, Batch number: FA6780, Anatomical Location: Left arm, Route of administration: Intramuscular, Vaccination time: 15:30), administration date: 10Aug2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Batch number: FC3182, Anatomical Location: Left arm, Route of administration: Intramuscular, Vaccination time: 11:00), administration date: 31Aug2021, when the patient was 65-year-old, for COVID-19 immunization. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 02Feb2022 at 10:20, outcome "not recovered", described as "GERD"; DYSPEPSIA (non-serious) with onset 02Feb2022 at 10:20, outcome "not recovered", described as "after my booster shot I experienced heartburn". The events "after my booster shot i experienced heartburn" and "gerd" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspepsia, gastrooesophageal reflux disease.  Additional information: After 1st and 2nd covid dose , experienced severe flare up of my fibromyalgia. Fatigue, muscle pain, burning nerve pain. Eventually recovered. After my booster shot patient experienced heart burn and GERD. It happened to minutes after booster shot. Patient never had those symptoms before. It is still an ongoing issue. Patient was currently on meds for this and will undergo an endoscopy in one week. The patient was on NSAIDS, so was at higher risk for upper digestive issue. Endoscopy was performed on 06Aug2022 for Gastritis. Fibro flare-up for 7 days with onset Date: 31Aug2021, 10Aug2021 (not serious).  AE Outcome: Recovered Specific relevant test for thromboembolic events with thrombocytopenia: None     No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Endoscopy upper gastrointestinal tract, Fibromyalgia, Gastritis
Clinical narrative: after my booster shot I experienced heartburn; GERD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 02Feb2022 at 10:00 as dose 3 (booster), single (Lot number: FK9729) at the age of 66 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia", start date: 1991 (ongoing); "Chronic fatigue syndrome", start date: 1991 (ongoing); "Osteoporosis", start date: 2016 (ongoing); "IBS", start date: 2009 (ongoing); "Post-Concussion Syndrome", start date: 2020, stop date: 2021. Concomitant medication(s) included: AMITRIPTYLINE oral taken for fibromyalgia (ongoing); CLONAZEPAM oral taken for anxiety, sleep disorder (ongoing); METOPROLOL [METOPROLOL TARTRATE] oral taken for tachycardia (ongoing); NABUMETONE oral taken for fibromyalgia (ongoing). Vaccination history included: BNT162b2 (Dose 1, Batch number: FA6780, Anatomical Location: Left arm, Route of administration: Intramuscular, Vaccination time: 15:30), administration date: 10Aug2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Batch number: FC3182, Anatomical Location: Left arm, Route of administration: Intramuscular, Vaccination time: 11:00), administration date: 31Aug2021, when the patient was 65-year-old, for COVID-19 immunization. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious) with onset 02Feb2022 at 10:20, outcome "not recovered", described as "GERD"; DYSPEPSIA (non-serious) with onset 02Feb2022 at 10:20, outcome "not recovered", described as "after my booster shot I experienced heartburn". The events "after my booster shot i experienced heartburn" and "gerd" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspepsia, gastrooesophageal reflux disease.  Additional information: After 1st and 2nd covid dose , experienced severe flare up of my fibromyalgia. Fatigue, muscle pain, burning nerve pain. Eventually recovered. After my booster shot patient experienced heart burn and GERD. It happened to minutes after booster shot. Patient never had those symptoms before. It is still an ongoing issue. Patient was currently on meds for this and will undergo an endoscopy in one week. The patient was on NSAIDS, so was at higher risk for upper digestive issue. Endoscopy was performed on 06Aug2022 for Gastritis. Fibro flare-up for 7 days with onset Date: 31Aug2021, 10Aug2021 (not serious).  AE Outcome: Recovered Specific relevant test for thromboembolic events with thrombocytopenia: None     No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Breast enlargement, Depression, Fatigue, Heavy menstrual bleeding
Clinical narrative: suicidal tendencies; severe  depression; extremely enlarged breasts; Prolonged period; extreme fatigue; severe hormonal acne outbreak waist up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 at 13:45 as dose 1, single (Lot number: FC3594) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thoracic Outlet Syndrome" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; TESTOSTERONE CIPIONATE. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid"; Darvocet, reaction(s): "Known allergies: Darvocet"; Doxycycline, reaction(s): "Known allergies: Doxycycline"; Z-pak, reaction(s): "Known allergies: z-pak". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "Prolonged period"; FATIGUE (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "extreme fatigue"; BREAST ENLARGEMENT (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "extremely enlarged breasts"; DEPRESSION (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "severe  depression"; ACNE (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "severe hormonal acne outbreak waist up"; SUICIDAL IDEATION (medically significant) with onset 10Dec2021 at 12:00, outcome "unknown", described as "suicidal tendencies". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Feb2022) Negative, notes: Nasal swab. Therapeutic measures were not taken as a result of suicidal ideation, depression, breast enlargement, heavy menstrual bleeding, fatigue, acne.  Additional information: No other vaccine in four weeks. No covid prior vaccination.  Follow-up (18Apr2022): Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suicidal ideation
Clinical narrative: suicidal tendencies; severe  depression; extremely enlarged breasts; Prolonged period; extreme fatigue; severe hormonal acne outbreak waist up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 at 13:45 as dose 1, single (Lot number: FC3594) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thoracic Outlet Syndrome" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; TESTOSTERONE CIPIONATE. Past drug history included: Macrobid, reaction(s): "Known allergies: Macrobid"; Darvocet, reaction(s): "Known allergies: Darvocet"; Doxycycline, reaction(s): "Known allergies: Doxycycline"; Z-pak, reaction(s): "Known allergies: z-pak". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "Prolonged period"; FATIGUE (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "extreme fatigue"; BREAST ENLARGEMENT (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "extremely enlarged breasts"; DEPRESSION (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "severe  depression"; ACNE (non-serious) with onset 10Dec2021 at 12:00, outcome "unknown", described as "severe hormonal acne outbreak waist up"; SUICIDAL IDEATION (medically significant) with onset 10Dec2021 at 12:00, outcome "unknown", described as "suicidal tendencies". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Feb2022) Negative, notes: Nasal swab. Therapeutic measures were not taken as a result of suicidal ideation, depression, breast enlargement, heavy menstrual bleeding, fatigue, acne.  Additional information: No other vaccine in four weeks. No covid prior vaccination.  Follow-up (18Apr2022): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Pfizer/ BioNTech: 04Oct2021, Dose Number: 3; Paxlovid: Treatment of COVID-19, 12Apr2022; Pfizer/ BioNTech: 04Oct2021, Dose Number: 3; Paxlovid: Treatment of COVID-19, 12Apr2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; SYMBICORT. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for Covid-19 Immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 13Apr2022, outcome "not recovered" and all described as "Pfizer/ BioNTech: 04Oct2021, Dose Number: 3; Paxlovid: Treatment of COVID-19, 12Apr2022". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Patient took Anti-viral for Covid-19 Treatment, Paxlovid from 12Apr2022, lot Number (FY4445).   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive for COVID-19 on Sunday; she tested positive for COVID-19 on Sunday; 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 female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "she tested positive for COVID-19 on Sunday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Details:  Product: PAXLOVID Question: Caller just wanted to compliment and thank Pfizer because she tested positive for COVID-19 on Sunday, then started treatment with Paxlovid on Monday and today being Thursday she is already fine. Caller then mentioned to have all the 3 COVID-19 vaccines including the booster from Pfizer. She then stated being a big Pfizer fan.  potential Pfizer COVID-19 Vaccine AE E-transmitting to Safety, noticed during post-call documentation.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Vaccination site pain
Clinical narrative: chills in middle of the night; pain where the injection is; feel kind of weak; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing), notes: Had Covid 2 years ago; "he almost died from it.", start date: 2020 (unspecified if ongoing); "ventilator for 17 days", start date: 2020 (unspecified if ongoing), notes: He had Covid 2 years ago and was on a ventilator for 17 days.; "He lost 35 pounds", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single), for COVID-19 immunization; Covid-19 vaccine (Dose 3(Booster dose), single), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset Apr2022, outcome "unknown", described as "chills in middle of the night"; ASTHENIA (non-serious) with onset Apr2022, outcome "unknown", described as "feel kind of weak"; VACCINATION SITE PAIN (non-serious) with onset Apr2022, outcome "unknown", described as "pain where the injection is". Additional information Reporter states he had the second Pfizer Booster shot yesterday. Clarified that he is referring to the Pfizer Covid-19 vaccine, second booster shot. Dentist who received the booster dose of Pfizer-BioNTech COVID-19 Vaccine yesterday (13Apr2022). He states, he had chills in the middle of the night. He has pain where the injection is and feels kind of weak. He had Covid 2 years ago and was on a ventilator for 17 days. He lost 35 pounds and almost died but he is alive now. His daughter had a 5-week baby and they are going to visit him. Is there any possible potential infection from getting the second Pfizer Booster, for the new baby. Clarified that his question is regarding him getting the second booster and how it will affect the baby. He asks it is ok from him to be near the baby, given the problems he has had. He can live with the pain and discomfort. He states he has a pretty tight schedule and does not like people calling out of the blue   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.