chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got vaccinated and yesterday was tested positive; Got vaccinated and yesterday was tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single 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 16Feb2022, outcome "unknown" and all described as "Got vaccinated and yesterday was tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Feb2022) positive. Additional information: Caller wants to know when the vaccine will be approved. He also mentioned that he has a friend who was a doctor as well and has a lecture. He mentioned that his friend has had the Covid vaccine and the booster but the friend has had a mild case of omicron. He stated that his daughter got vaccinated and yesterday was tested positive. She was trying to find out if it was Omicron or something else. He basically wants to know, when the vaccine will be available (approved). He also stated that he heard that they have started human trials but he was not interested in participating in the Covid trial.  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-202200295239 same reporter/patient/drug/AE, different patient
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: Generalized fatigue and severe back pain lasted for more than 72 hours.; Generalized fatigue and severe back pain lasted for more than 72 hours.; I developed a severe headache; Spiked a fever of 104 approximately 10 hours after third dose infusion. I continued to run a fever between 100 and 104 for 48 hours.; This is a spontaneous report from a contactable reporter (healthcare professional). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 12Feb2022 at 10:15 (Lot number: FM0698) at the age of 57 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa medications. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EK9231), administration date: 27Dec2020, when the patient was 56 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EL3248), administration date: 17Jan2021, when the patient was 56 years old, for COVID-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 12Feb2022, outcome "recovering", described as "I developed a severe headache"; PYREXIA (non-serious) with onset 12Feb2022, outcome "recovering", described as "Spiked a fever of 104 approximately 10 hours after third dose infusion. I continued to run a fever between 100 and 104 for 48 hours"; FATIGUE (non-serious) with onset 12Feb2022 at 22:00, outcome "recovered" (an unknown date in Feb2022), described as "Generalized fatigue and severe back pain lasted for more than 72 hours"; BACK PAIN (non-serious) with onset 12Feb2022 at 22:00, outcome "recovered" (an unknown date in Feb2022), described as "Generalized fatigue and severe back pain lasted for more than 72 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia, fatigue and back pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the 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.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: drug ineffective; I just tested positive.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single 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", described as "drug ineffective"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "I just tested positive.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical Course: It was reported that, Customer Verbatim: I had both doses (Mar and Apr2021) and the booster in October. But, I just tested positive. What the?   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Beginning day after dose 1, patient experienced diarrhea.; This is a spontaneous report from a contactable reporter (Consumer or other non HCP).   A 11-year-old male patient received bnt162b2 (BNT162B2), administration date 16Feb2022 (Lot number: unknown) at the age of 11 years as dose 1 (tris), single for COVID-19 immunisation. It was unknown whether the patient had any relevant medical history and it was unknown whether the patient was receiving concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 17Feb2022, outcome "unknown", described as "Beginning day after dose 1, patient experienced diarrhea". It was unknown whether therapeutic measures were taken as a result of diarrhoea.  Additional information: It was unknown whether the patient had any known allergies. It was unknown whether the patient had received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Immunodeficiency
Clinical narrative: However, for the booster dose, she said that she was so depleted that she can't get out of bed. She also mentioned that she is immunocompromised.; However, for the booster dose, she said that she was so depleted that she can't get out of bed. She also mentioned that she is immunocompromised.; she was depleted; 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) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Caller has the 2 Pfizer COVID-19 vaccines and she said that she had no problems except for a slightly sore arm.), for Covid-19 immunization, reaction(s): "slightly sore arm"; Bnt162b2 (Dose 1, Caller has the 2 Pfizer COVID-19 vaccines and she said that she had no problems except for a slightly sore arm.), for Covid-19 immunization, reaction(s): "slightly sore arm". The following information was reported: IMMUNODEFICIENCY (medically significant), BEDRIDDEN (disability), outcome "unknown" and all described as "However, for the booster dose, she said that she was so depleted that she can't get out of bed. She also mentioned that she is immunocompromised."; ASTHENIA (non-serious), outcome "unknown", described as "she was depleted".  Clinical course: It was reported that, patient has the 2 Pfizer COVID-19 vaccines and she said that she had no problems except for a slightly sore arm. However, for the booster dose, she said that she was so depleted that she can't get out of bed. She also mentioned that she was immunocompromised. She wanted to know if the formulation for the first 2 dose, 4th dose, and the booster dose have the same formulation. She also mentioned that she know other people who didn't have a problem with the first and second dose. They were so chill and under covers. For some reason, the booster shot was not good because she had a reaction to that.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: slight fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 11:20 (Lot number: EN6202) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 Diabetes", start date: 1990 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single at 10:00 , Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Batch/Lot number: EL9269), administration date: 05Feb2021, when the patient was 71 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 27Feb2021, outcome "recovered", described as "slight fatigue". Therapeutic measures were not taken as a result of fatigue. Additional information: Prior Vaccinations (within 4 weeks) was reported as none.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: The vaccine triggered diabetes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162B2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. Family history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COMIRNATY (dose 1, single; lot number: unknown), for COVID-19 immunization. The following information was reported: DIABETES MELLITUS (disability, medically significant, life threatening), outcome "not recovered", described as "The vaccine triggered diabetes". Therapeutic measures were taken as a result of diabetes mellitus. Clinical course: The vaccine triggered diabetes in the patient. There is a family history of diabetes but the patient had no symptoms or pre-diabetes before getting the second dose. The patient was on insulin at the time of the report.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (Lot number: EW0191) as dose 3 (booster), single, administration date 06Mar2021 (Lot number: EN6198) as dose 2, single and administration date 13Feb2021 (Lot number: EN6201) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), ASYMPTOMATIC COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: got Covid, will call the doctor after this phone call to ask if they should be retested. The patient and his wife got both Covid shots and their boosters and they both still got Covid, but only his wife has symptoms. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), on Apr 6, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient developed fatigue/experienced a really bad fatigue, onset Apr 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 79.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Back pain, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got Covid with symptoms; got Covid with symptoms; back pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP,). The reporter is patient's husband.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 (Lot number: EW0191) at the age of 79 years as dose 3 (booster), single, administration date 06Mar2021 (Lot number: EN6198) as dose 2, single and administration date 13Feb2021 (Lot number: EN6201) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII) (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing). There was no Family Medical History Relevant to AE(s). Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM] taken for thyroid disorder (ongoing). The patient did not receive prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). There was no AE(s) following prior vaccinations. No sample of the product was available to be returned, if requested.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Feb2022, outcome "unknown" and all described as "got Covid with symptoms"; BACK PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "back pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: got Covid-19, will call the doctor to ask if they should be retested. The patient took Paxlovid as treatment for COVID-19 from 14Feb2022 night. The reporter asked if patient can take Ibuprofen, because patient had back pain from the covid and coughing a lot. The reporter clarified that patient's back pain started with the cough from the Covid, and then patient started taking the Paxlovid after the cough started. The reporter stated that he and his wife(patient) got both Covid shots and their boosters and they both still got Covid, but only his wife(patient) had symptoms. The reporter would call the doctor after this phone call to ask if they should be retested.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: Soreness in arm 4 months out from vaccination date; Was too sick after shot to work for 2 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: dairy" (unspecified if ongoing); "COVID prior vaccination" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Comirnaty (First dose, MANUFACTURER UNKNOWN, vaccine location: Right arm), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Oct2021, outcome "recovered with sequelae", described as "Soreness in arm 4 months out from vaccination date"; ILLNESS (non-serious) with onset 21Oct2021, outcome "recovered with sequelae", described as "Was too sick after shot to work for 2 days.". Therapeutic measures were not taken as a result of pain in extremity, illness. Additional information: no other vaccine in four weeks and no other medications in two weeks.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: This "vaccine" caused about 60% of my hair to fall out.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 27Aug2021 at 17:00 (Lot number: FC3182) at the age of 41 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medication included: WELLBUTRIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0169, Anatomical Location: Left arm, Time of administration: 17:00), administration date: 06Aug2021, when the patient was 41 years old, for COVID-19 immunisation.  The following information was reported: ALOPECIA (non-serious) with onset 04Nov2021 at 21:00, outcome "not recovered", described as "This "vaccine" caused about 60% of my hair to fall out". Therapeutic measures were not taken as a result of alopecia.  Additional Information: It was reported that the patient never had a hair loss issue in her life before this vaccine triggered massive hair loss. The patient stated that she got both shots of "poison" in August and her hair began falling out November 4th. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: itching; developed rash/ He said that he has rashes in his ankles.; and hives for about a month already/ hives in his ankles./ he has hives in his chest and in the back.; "reddish patches, pretty good size, about a couple of inches, kinda flat, spots, and they are itchy."; non-severe allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumeror other non HCP) from medical information team. The reporter is the patient.   An 82 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Unknown manufacturer, Primary Immunization completed), for Covid-19 Immunization, reaction(s): "did not experience any side effects"; Covid-19 vaccine (Dose: 2, Unknown manufacturer, Primary Immunization completed), for COVID-19 Immunization, reaction(s): "did not experience any side effects". The following information was reported: PRURITUS(Medically Significant), outcome "unknown", described as "itching"; RASH(non-serious), outcome "unknown", described as "developed rash/ He said that he has rashes in his ankles."; URTICARIA(non-serious), outcome "unknown", described as "and hives for about a month already/ hives in his ankles./ he has hives in his chest and in the back."; RASH ERYTHEMATOUS(non-serious), outcome "unknown", described as "reddish patches, pretty good size, about a couple of inches, kinda flat, spots, and they are itchy."; HYPERSENSITIVITY(non-serious), outcome "unknown", described as "non-severe allergic reaction ". Therapeutic measures were taken as a result of pruritus. The case was reported as non-serious. Caller stated that he already received the first two doses of the vaccine and did not experience any side effects. He said that when he received the booster dose, he developed rash and hives for about a month already. He said that he has rashes and hives in his ankles. He also stated that he has hives in his chest and in the back. He described the rash and hives as "reddish patches, pretty good size, about a couple of inches, kinda flat, spots, and they are itchy." He was also aware that rashes and hives are signs non-severe allergic reaction from the vaccine. He mentioned that his daughter gave him ketoconazole and hydrocortisonefor the itching which helped a little.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After the second shot, I have started experiencing short randomly and intermittently dizzy spells similar to Vertigo; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2022 at 09:00 (Lot number: FL3196) at the age of 51 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: FL3197, Anatomical location: Left arm, Administration time: 09:00, Route of administration: Unspecified), administration date: 20Jan2022, when the patient was 51 years old, for COVID-19 immunisation.  The following information was reported: DIZZINESS (non-serious) with onset 12Feb2022 at 17:00, outcome "not recovered", described as " After the second shot, I have started experiencing short randomly and intermittently dizzy spells similar to vertigo". Therapeutic measures were not taken as a result of dizziness.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Mild - moderate pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2021 19:30 (Batch/Lot number: unknown) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "BP" (unspecified if ongoing), notes: BP; "mild prediabetic" (unspecified if ongoing), notes: mild prediabetic; "artritis of knee" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 12Jan2021, outcome "unknown", described as "Mild - moderate pain". It was unknown if therapeutic measures were taken as a result of pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID19. No allergies to medications, food, or other products. Patient did not require a visit to Emergency room/Physician office. No antipyretic use (around date(s) of Vaccination).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Rash papular, SARS-CoV-2 test, Urticaria
Clinical narrative: 15 hrs later, woke with horrible itchy bumps all over my legs, hips and back. Then went away; 8 days later they came back - huge welts across my legs (depending on the day, front and back) buttocks, hips, thighs, stomach, arms, face, LIPS! - large welts; Horrible breath taking heartburn; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jan2022 at 10:00 (Lot number: 33030BD) at the age of 59 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: PCN and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medications included: TYLENOL; VIT D3; VITAMIN K2 and B COMPLEX. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: UNKNOWN; Anatomical Location: Left arm; Administration time: 10:00), administration date: 07Aug2021, when the patient was 59 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: FD8448; Anatomical Location: Left arm; Administration time: 10:00), administration date: 28Aug2021, when the patient was 59 years old, for COVID-19 immunisation.  The following information was reported: RASH PAPULAR (non-serious) with onset 26Jan2022 at 04:00, outcome "not recovered", described as "15 hrs later, woke with horrible itchy bumps all over my legs, hips and back. Then went away"; URTICARIA (non-serious) with onset 26Jan2022 at 04:00, outcome "not recovered", described as "8 days later they came back - huge welts across my legs (depending on the day, front and back) buttocks, hips, thighs, stomach, arms, face, LIPS! - large welts"; DYSPEPSIA (non-serious) with onset 26Jan2022 at 04:00, outcome "not recovered", described as "Horrible breath taking heartburn". The events "15 hrs later, woke with horrible itchy bumps all over my legs, hips and back. Then went away", "8 days later they came back - huge welts across my legs (depending on the day, front and back) buttocks, hips, thighs, stomach, arms, face, LIPS! - large welts" and "Horrible breath taking heartburn" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash papular, urticaria and dyspepsia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Treatment for the reported events included Xyzal, Benadryl, Steroids, Pepcid, Singular, Hydroxyzine. Since the vaccination, the patient had been tested for COVID-19.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dental caries, Drug ineffective, Hyperaesthesia teeth, SARS-CoV-2 test
Clinical narrative: Tooth decay; Sensitivity of teeth; Tooth infection; COVID-19; drug ineffective; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4282918-00.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Aug2021 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single, intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at single (unk, single) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 28Jan2022, outcome "recovered" (2022), described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 28Jan2022, outcome "unknown", described as "drug ineffective"; DENTAL CARIES (non-serious), outcome "unknown", described as "Tooth decay"; HYPERAESTHESIA TEETH (non-serious), outcome "unknown", described as "Sensitivity of teeth"; TOOTH INFECTION (non-serious), outcome "unknown", described as "Tooth infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Jan2022) positive. The action taken for adalimumab was unknown. Clinical course:On unknown dates, the patient experienced thought had an infection due to sensitive space on a decaying tooth at the gum line. On 28Jan2022, the patient experienced COVID-19. It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for BNT162B2: The reporter considered "Sensitivity of teeth", "Tooth decay", "Tooth infection", and "COVID-19" related (reported as possible) to bnt162b2.  The reporter's causality for the event(s) of thought had an infection due to sensitive space on a decaying tooth at the gym line unknown onset and COVID-19 with Humira (Adalimumab) was no reasonable possibility.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, a casual association between the suspect product BNT162B2 and the reported events cannot be totally excluded.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Tooth decay; Sensitivity of teeth; Tooth infection; COVID-19; drug ineffective; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4282918-00.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Aug2021 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single, intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at single (unk, single) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 28Jan2022, outcome "recovered" (2022), described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 28Jan2022, outcome "unknown", described as "drug ineffective"; DENTAL CARIES (non-serious), outcome "unknown", described as "Tooth decay"; HYPERAESTHESIA TEETH (non-serious), outcome "unknown", described as "Sensitivity of teeth"; TOOTH INFECTION (non-serious), outcome "unknown", described as "Tooth infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Jan2022) positive. The action taken for adalimumab was unknown. Clinical course:On unknown dates, the patient experienced thought had an infection due to sensitive space on a decaying tooth at the gum line. On 28Jan2022, the patient experienced COVID-19. It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for BNT162B2: The reporter considered "Sensitivity of teeth", "Tooth decay", "Tooth infection", and "COVID-19" related (reported as possible) to bnt162b2.  The reporter's causality for the event(s) of thought had an infection due to sensitive space on a decaying tooth at the gym line unknown onset and COVID-19 with Humira (Adalimumab) was no reasonable possibility.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information, a casual association between the suspect product BNT162B2 and the reported events cannot be totally excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm has been sore and hurting for the past 4 months in area of injection.; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 31-year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administered in left arm, administration date 01Jul2021 at 12:00 (Lot number: unknown) at the age of 31 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Aspirin, reactions: "Drug allergy". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN; Anatomical Location: Left arm; Administration time: 12:00), administration date: 10Jun2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Oct2021 at 14:00, outcome "not recovered", described as "Left arm has been sore and hurting for the past 4 months in area of injection". It was unknown whether any therapeutic measures were taken as a result of vaccination site pain.  Additional information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Dizzy/ Lightheaded; Sore arm; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 21Feb2022 at 17:00 (Lot number: FJ6369) at the age of 20 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: PROZAC; HYDROXYZINE and GLYCOPYRROLATE.  The following information was reported: DIZZINESS (non-serious) with onset 21Feb2022 at 17:15, outcome "not recovered", described as "Dizzy/ Lightheaded"; PAIN IN EXTREMITY (non-serious) with onset 21Feb2022 at 17:15, outcome "not recovered", described as "Sore arm". Therapeutic measures were taken as a result of the pain in extremity.   Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the 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. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment included tylenol for pain in extremity.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, SARS-CoV-2 test
Clinical narrative: High blood pressure; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 at 08:00 (Batch/Lot number: unknown)at the age of 61 Year(s) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: UNKNOWN; Route of administration: Unspecified; Anatomical location: Left Arm; Administration time: 08:00), administration date: 19Jan2021, when the patient was 61 years old, for COVID-19 immunisation. The following information was reported: HYPERTENSION (non-serious) with onset an unknown date in Aug2021, outcome "not recovered", described as "High blood pressure". The event "High blood pressure" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension.  Additional Information: The patient had no known allergies. The patient did not receive any 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 been tested for COVID-19. Treatment taken as a result of hypertension included lisinopril 10 mg. The patient also received bnt162b2 (BNT162B2), administered in left arm, administration date 14Oct2021 at 14:45 (Lot number: unknown) at the age of 62 years as dose 3 (booster), single for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 6 out of 10 got COVID; 6 out of 10 got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose number unknown (booster), single 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 but unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "6 out of 10 got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2022) positive.  Comments/Narrative: After receiving booster sat Christmas dinner and 6 out of 10 and 5 children got covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 6 out of 10 got COVID; 6 out of 10 got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "6 out of 10 got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: got covid.  Clinical information: After receiving booster- sat at dinner and 6 out 10 & 5 children got Covid. I was told later by specially Pharmacist. Humira weakens effectiveness. I should have been told soon I would have suspend Humira immediately. I am 65 w/COPD + Psoriatic arthritis.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 6 out of 10 got COVID; 6 out of 10 got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "6 out of 10 got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 6 out of 10 got COVID; 6 out of 10 got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "6 out of 10 got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Got Covid.  After receiving booster-sat at dinner and 6 out 10 & 5 children got Covid. I was told later by specially Pharmacist. Humira weakens effectiveness. I should have been told soon I would have suspend Humira immediately. I am 65 w/COPD + Psoriatic arthritis.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 6 out of 10 got COVID; 6 out of 10 got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). This is the sixth out of 6 cases.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single 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 but unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "6 out of 10 got COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical information: After receiving booster- sat at Christmas dinner and 6 out 10 & 5 children got Covid.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscular weakness, Pain in extremity, Paralysis
Clinical narrative: paralyzing effects of their muscles; aching arm; muscles gave out which continued until Oct of last year/muscle weakness; started laying down a lot and noticed it when I put the dog out for a walk and couldn't walk very longer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: EM6203) as dose 1, single and administered in arm right, administration date 09Apr2021 (Lot number: ER8727) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disorder" (unspecified if ongoing), notes: Autoimmune disorder resulted from an exposure to chemicals. Concomitant medication(s) included: THYROXIN taken for autoimmune disorder, start date: 19May2018. The following information was reported: PARALYSIS (medically significant) with onset Oct2021, outcome "recovering", described as "paralyzing effects of their muscles"; PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "unknown", described as "aching arm"; MUSCULAR WEAKNESS (non-serious) with onset 21Mar2021, outcome "recovering", described as "muscles gave out which continued until Oct of last year/muscle weakness"; GAIT DISTURBANCE (non-serious) with onset 21Mar2021, outcome "recovering", described as "started laying down a lot and noticed it when I put the dog out for a walk and couldn't walk very longer". The patient had very little side effects other than pain in arm for first two doses. A few days after, she mentioned her muscles gave out and this persisted or continued until Oct2021. By Oct2021, it started getting better. She mentioned she got another two extra shots, so 4 shots in total of the Pfizer COVID 19 vaccine. She also ended up sick again on Dec2021, due to COVID, and described symptoms as being massively bad. He thinks she is referring to the COVID. She also mentioned that her main concern was weakening of muscles. She, as well as associates, were self quarantining and could hardly go to the bathroom due to the paralyzing effects of their muscles. She had been given astronomic amounts of magnesium and plenty of potassium as a muscle relaxant. She also had a COVID virus. She later stated that she caught COVID virus in 01Jan2022. At the end of Oct2021, 2 days after, it looks like she started feeling sweating and muscle tightening. After she came down with COVID virus, she said she can hardly walk from her apartment to her car. Therapeutic measures were taken as a result of paralysis, pain in extremity, muscular weakness, gait disturbance.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia, Immunisation, Nausea, Off label use
Clinical narrative: Off label use; Booster, dose 4; Blood in stool; Nausea; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4097881.  A 41 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis, uveitis, psoriasis, colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. Vaccination history included: Bnt162b2 (First dose), administration date: 01Mar2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Colitis ulcerative aggravated", "Blood in stool", "Flare ups increased to once a week", "Sickness", "Nauseous", "Diarrhea", "sore arm on covid vaccine shot", "Upset stomach", "Headache", "Fever", "Flair ups diarrhea"; Bnt162b2 (Second dose), administration date: 01Apr2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "nausea", "headache", "Diarrhea"; Bnt162b2 (Third dose), administration date: 01Dec2021, when the patient was 41 years old, for Covid-19 immunization, reaction(s): "Blood in stool", "Diarrhea", "Nausea", "Headache". The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster, dose 4"; HAEMATOCHEZIA (medically significant), outcome "not recovered", described as "Blood in stool"; NAUSEA (non-serious), outcome "recovered", described as "Nausea"; DIARRHOEA (non-serious), outcome "recovered", described as "Diarrhea". The action taken for adalimumab was dosage permanently withdrawn.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.