chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Thumb sucking
Clinical narrative: Right armpit lymph nodes swollen; Right thumb, pointer finger, tingling and swollen, swelling inside forearm.; Soreness, right arm; Right thumb, pointer finger, tingling and swollen, swelling inside forearm.; Right thumb, pointer finger, tingling and swollen, swelling inside forearm.; the swelling is ongoing on the thumb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jan2022 18:00 (Lot number: FJ6396) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Covid vaccine: 17Mar2021, Lot Number / Expiry Date: EN6208, Route, Anatomical Location: left arm), administration date: 17Mar2021, when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Second Covid vaccine, Lot Number / Expiry Date: EW0150, Route, Anatomical Location: left arm , No. of Previous Doses: one, Date: 07Apr2021), administration date: 07Apr2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 28Jan2022, outcome "unknown", described as "Right armpit lymph nodes swollen"; SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 28Jan2022, outcome "recovering" and all described as "Right thumb, pointer finger, tingling and swollen, swelling inside forearm."; PAIN IN EXTREMITY (non-serious) with onset 28Jan2022, outcome "recovered" (28Jan2022), described as "Soreness, right arm"; PARAESTHESIA (non-serious) with onset 28Jan2022, outcome "recovered" (30Jan2022), THUMB SUCKING (non-serious) with onset Jan2022, outcome "not recovered" and all described as "the swelling is ongoing on the thumb".  Additional Information: Vaccine Administered at Military Facility: No. Any AE(s) require a visit to Emergency Room: No and Physician Office: No. No prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). No AE(s) following prior vaccinations. No relevant tests were performed.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Psychotic symptom
Clinical narrative: now after getting the second shot she had antipsychotic symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administration date 26Jan2022 (Batch/Lot number: unknown) at an unspecified age as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, 1st Dose), for COVID-19 Immunization. The following information was reported: PSYCHOTIC SYMPTOM (medically significant) with onset Jan2022, outcome "unknown", described as "now after getting the second shot she had antipsychotic symptoms". Additional information: the patient stopped the medication of antipsychotic drugs for 9 months. After getting the second dose of Pfizer COVID-19 vaccine, the patient had antipsychotic symptoms. They were still waiting to hear from the patient's doctor. Now, the reporter was asking for any drug interactions for antipsychotics and Pfizer COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Diarrhoea, Pyrexia
Clinical narrative: Saturday, 29Jan2022, started violently vomiting; diarrhea; teeth were chattering; Friday night, 28Jan2022, started coughing a lot; Had normal onset of fever; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FL3209) at the age of 41 years as dose 3 (booster) single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1; lot: EK5730;  single; Route of administration: left arm), administration date: 18Dec2020, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2; lot: EL3246; single; Route of administration: left arm), administration date: 08Jan2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: COUGH (medically significant) with onset 28Jan2022, outcome "recovered" (31Jan2022), described as "Friday night, 28Jan2022, started coughing a lot"; PYREXIA (disability) with onset 28Jan2022, outcome "unknown", described as "Had normal onset of fever"; VOMITING (disability) with onset 29Jan2022, outcome "unknown", described as "Saturday, 29Jan2022, started violently vomiting"; DIARRHOEA (disability) with onset 29Jan2022, outcome "unknown", described as "diarrhea"; CHILLS (non-serious) with onset 28Jan2022, outcome "unknown", described as "teeth were chattering". The patient underwent the following laboratory tests and procedures: body temperature: (28Jan2022) 102 Fahrenheit. Therapeutic measures were taken as a result of pyrexia.  Clinical course details: The patient's teeth were chattering and had completely like fever like symptoms. Couldn't get out of bed 29Jan2022 or Sunday, 30Jan2022, pretty bad. The patient took Tylenol for fever.  Reaction assessed: Diarrhea, Cough, Vomiting, Fever Source of assessment: Primary Source Reporter    Method of assessment: Global Introspection    Drug related: Related; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Saturday, 29Jan2022, started violently vomiting; diarrhea; teeth were chattering; Friday night, 28Jan2022, started coughing a lot; Had normal onset of fever; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FL3209) at the age of 41 years as dose 3 (booster) single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1; lot: EK5730;  single; Route of administration: left arm), administration date: 18Dec2020, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2; lot: EL3246; single; Route of administration: left arm), administration date: 08Jan2021, when the patient was 39 years old, for COVID-19 immunization. The following information was reported: COUGH (medically significant) with onset 28Jan2022, outcome "recovered" (31Jan2022), described as "Friday night, 28Jan2022, started coughing a lot"; PYREXIA (disability) with onset 28Jan2022, outcome "unknown", described as "Had normal onset of fever"; VOMITING (disability) with onset 29Jan2022, outcome "unknown", described as "Saturday, 29Jan2022, started violently vomiting"; DIARRHOEA (disability) with onset 29Jan2022, outcome "unknown", described as "diarrhea"; CHILLS (non-serious) with onset 28Jan2022, outcome "unknown", described as "teeth were chattering". The patient underwent the following laboratory tests and procedures: body temperature: (28Jan2022) 102 Fahrenheit. Therapeutic measures were taken as a result of pyrexia.  Clinical course details: The patient's teeth were chattering and had completely like fever like symptoms. Couldn't get out of bed 29Jan2022 or Sunday, 30Jan2022, pretty bad. The patient took Tylenol for fever.  Reaction assessed: Diarrhea, Cough, Vomiting, Fever Source of assessment: Primary Source Reporter    Method of assessment: Global Introspection    Drug related: Related; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Decreased appetite, Dry skin, Feeling cold
Clinical narrative: hair loss; very dry wrinkled skin to her arms and legs; loss of appetite; feeling very cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 23Jun2021 (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: TOPROL XL taken for hypertension, start date: May2021. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "hair loss"; DRY SKIN (non-serious) with onset 2021, outcome "unknown", described as "very dry wrinkled skin to her arms and legs"; DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "loss of appetite"; FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "feeling very cold". Therapeutic measures were not taken as a result of alopecia, dry skin.  Additional information: Caller said these began shortly after her first shot. She said they began last summer, her first dose was in Jun, so she knew it was during last summer. She clarified that her first side effect was heavy hair loss, and said the other came later, which was very dry wrinkled skin to her arms and legs. She said she had done no treatment for those. She said she also has had loss of appetite and feeling very cold. She said she knew immediate side effects, but these were very long range. She said she wore 2-3 layers of clothing, and that side effect was not usual, that she had heard about. She said she wanted to know for her other question: has there been any interaction reported with blood pressure medicine she took which was Toprol XL. Toprol XL: Caller said she began taking this May2021, so she is interested if there could be any interaction with COVID vaccine. She said her Toprol XL came in an orange pharmacy bottle with NDC/LOT/EXP: Unknown, and provides manufacturer: Aralez/New Amer. She took this for her high blood pressure, but her high blood pressure is not related to when she started taking it, she started taking the blood pressure medicine then about 3 weeks after that she got the shot.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she got the vaccine back in Mar2021, but has not gotten the booster, she contracted the covid virus this past Jan2022; she got the vaccine back in Mar2021, but has not gotten the booster, she contracted the covid virus this past Jan2022; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "she got the vaccine back in Mar2021, but has not gotten the booster, she contracted the covid virus this past Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) contracted; (Feb2022) negative twice, notes: asymptomatic. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: received the call from (Name withheld) with DSU NTID:# rep# (Withheld) (call was transferred from (Name withheld) with Covax support) Caller is a retired physician working for a dance company. He is asking on behalf of a 42-year-old female who received the doses of Pfizer BioNtech Covid vaccine on Mar2021. However she has contracted the Covid infection on Jan2022. She was not treated with any antibody or steroids during her infection. currently she has tested negative twice and is asymptomatic. Caller would like to know when would be the best time to receive the booster dose of Pfizer BioNtech vaccine, should they wait 90 days given that she had the infection on Jan2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events drug ineffective and COVID-19 cannot be totally excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Feeling abnormal, Fibrin D dimer
Clinical narrative: Shortness of breath; Palpitations; it has been really tough for me to resume with my normal self/got weird toes; D-dimers elevated; Pains to arm; got weird toes, feel exhausted often despite being off work.; Bit of fever; Chills; Pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "menopausal hormonal rollercoaster" (unspecified if ongoing), notes: No known health problems other than the rocking menopausal hormonal rollercoaster.; "Interchange of vaccine products" (unspecified if ongoing), notes: Pfizer after 2 Astra Zeneca. The patient took concomitant medications. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (non-serious), outcome "not recovered", described as "Palpitations"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it has been really tough for me to resume with my normal self/got weird toes"; FIBRIN D DIMER INCREASED (non-serious), outcome "unknown", described as "D-dimers elevated"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pains to arm"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "Bit of fever"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Pain at the injection site"; FATIGUE (non-serious), outcome "unknown", described as "got weird toes, feel exhausted often despite being off work.". The events "shortness of breath", "palpitations" and "pains to arm" 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 feeling abnormal, fibrin d dimer increased.  Additional information: 13 days later, she visited her GP for shortness of breath, palpitations and pains to arm. D-dimers elevated, 5 days of blood thinners. Her GP thought of long covid but for the last 20 months she tested regularly (school teacher) and never had a positive or doubting result.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Pain in extremity, Palpitations, Pyrexia, SARS-CoV-2 test
Clinical narrative: Shortness of breath; Palpitations; it has been really tough for me to resume with my normal self/got weird toes; D-dimers elevated; Pains to arm; got weird toes, feel exhausted often despite being off work.; Bit of fever; Chills; Pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "menopausal hormonal rollercoaster" (unspecified if ongoing), notes: No known health problems other than the rocking menopausal hormonal rollercoaster.; "Interchange of vaccine products" (unspecified if ongoing), notes: Pfizer after 2 Astra Zeneca. The patient took concomitant medications. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (non-serious), outcome "not recovered", described as "Palpitations"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it has been really tough for me to resume with my normal self/got weird toes"; FIBRIN D DIMER INCREASED (non-serious), outcome "unknown", described as "D-dimers elevated"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pains to arm"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "Bit of fever"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Pain at the injection site"; FATIGUE (non-serious), outcome "unknown", described as "got weird toes, feel exhausted often despite being off work.". The events "shortness of breath", "palpitations" and "pains to arm" 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 feeling abnormal, fibrin d dimer increased.  Additional information: 13 days later, she visited her GP for shortness of breath, palpitations and pains to arm. D-dimers elevated, 5 days of blood thinners. Her GP thought of long covid but for the last 20 months she tested regularly (school teacher) and never had a positive or doubting result.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Shortness of breath; Palpitations; it has been really tough for me to resume with my normal self/got weird toes; D-dimers elevated; Pains to arm; got weird toes, feel exhausted often despite being off work.; Bit of fever; Chills; Pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "menopausal hormonal rollercoaster" (unspecified if ongoing), notes: No known health problems other than the rocking menopausal hormonal rollercoaster.; "Interchange of vaccine products" (unspecified if ongoing), notes: Pfizer after 2 Astra Zeneca. The patient took concomitant medications. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (non-serious), outcome "not recovered", described as "Palpitations"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it has been really tough for me to resume with my normal self/got weird toes"; FIBRIN D DIMER INCREASED (non-serious), outcome "unknown", described as "D-dimers elevated"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pains to arm"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "Bit of fever"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Pain at the injection site"; FATIGUE (non-serious), outcome "unknown", described as "got weird toes, feel exhausted often despite being off work.". The events "shortness of breath", "palpitations" and "pains to arm" 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 feeling abnormal, fibrin d dimer increased.  Additional information: 13 days later, she visited her GP for shortness of breath, palpitations and pains to arm. D-dimers elevated, 5 days of blood thinners. Her GP thought of long covid but for the last 20 months she tested regularly (school teacher) and never had a positive or doubting result.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Leukaemia
Clinical narrative: Leukemia; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 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: Bnt162b2 (dose 1), for COVID-19 immunization; Bnt162b2 (dose 2), for COVID-19 immunization. The following information was reported: LEUKAEMIA (medically significant), outcome "unknown", described as "Leukemia". The patient underwent the following laboratory tests and procedures: antibody test: negative. Therapeutic measures were taken as a result of leukaemia. Caller said that he had all the 3 doses of the Pfizer covid-19 vaccine and got negative antibody response. Caller mentioned that he is currently at clinical trial at (name) for leukemia. Caller asked if he can get a prescription for Paxlovid even though he is not covid-19 positive. Caller also said that he is taking Ibrutinib, and he know that the said drug has interaction to Paxlovid, he said that if ever, he knows that he need to stop his current medication as he takes Paxlovid.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known disease pathophysiology, the event of leukemia is assessed as not related to BNT162B2, and more likely an intercurrent medical condition.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Arthralgia, Bone pain, Fatigue, Gingival pain
Clinical narrative: agitation; bone pain in both legs and arms; Gums swelled; Internal inflammation bones; Gums - still painful; extreme fatigue; knee pain; headache for two weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Oct2021 23:00 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Epstein-Barr virus" (ongoing); "Asthma" (ongoing), notes: Teens; "Graves Disease" (ongoing), notes: Onset date: 17Apr, managed with acupuncture no results; "Thyroid" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Anatomical location:  Right arm, Route of administration: Intramuscular, Batch/Lot Number: Unable to Locate or Read the Details, Vaccination Time : 2:00 PM), administration date: 07Apr2021, when the patient was 54 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Anatomical location:  Left arm, Vaccination Time : 2:00 PM, Batch/Lot Number: Unable to Locate or Read the Details), administration date: 27Apr2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "extreme fatigue"; AGITATION (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "agitation"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "knee pain"; BONE PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "bone pain in both legs and arms"; HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "headache for two weeks"; GINGIVAL SWELLING (non-serious) with onset Oct2021, outcome "recovering", described as "Gums swelled"; OSTEITIS (non-serious) with onset Oct2021, outcome "unknown", described as "Internal inflammation bones"; GINGIVAL PAIN (non-serious) with onset Oct2021, outcome "not recovered", described as "Gums - still painful". Additional information: Vaccination facility type was Pharmacy or Drug store. No vaccinations Prior (within 4 weeks). Specific relevant test for thromboembolic events with thrombocytopenia and Relevant tests was None. Oct booster extreme fatigue & agitation for a month- Knee pain, bone pain in both legs + arms, headache for two weeks. Gums swollen + red-dentist said due to internal inflammation Bones - hurt 3 months- 90% better Gums - still painful -50% better. I'm afraid of another booster at this point  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Headache, Osteitis
Clinical narrative: agitation; bone pain in both legs and arms; Gums swelled; Internal inflammation bones; Gums - still painful; extreme fatigue; knee pain; headache for two weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Oct2021 23:00 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Epstein-Barr virus" (ongoing); "Asthma" (ongoing), notes: Teens; "Graves Disease" (ongoing), notes: Onset date: 17Apr, managed with acupuncture no results; "Thyroid" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Anatomical location:  Right arm, Route of administration: Intramuscular, Batch/Lot Number: Unable to Locate or Read the Details, Vaccination Time : 2:00 PM), administration date: 07Apr2021, when the patient was 54 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, Anatomical location:  Left arm, Vaccination Time : 2:00 PM, Batch/Lot Number: Unable to Locate or Read the Details), administration date: 27Apr2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "extreme fatigue"; AGITATION (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "agitation"; ARTHRALGIA (non-serious) with onset Oct2021, outcome "unknown", described as "knee pain"; BONE PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "bone pain in both legs and arms"; HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "headache for two weeks"; GINGIVAL SWELLING (non-serious) with onset Oct2021, outcome "recovering", described as "Gums swelled"; OSTEITIS (non-serious) with onset Oct2021, outcome "unknown", described as "Internal inflammation bones"; GINGIVAL PAIN (non-serious) with onset Oct2021, outcome "not recovered", described as "Gums - still painful". Additional information: Vaccination facility type was Pharmacy or Drug store. No vaccinations Prior (within 4 weeks). Specific relevant test for thromboembolic events with thrombocytopenia and Relevant tests was None. Oct booster extreme fatigue & agitation for a month- Knee pain, bone pain in both legs + arms, headache for two weeks. Gums swollen + red-dentist said due to internal inflammation Bones - hurt 3 months- 90% better Gums - still painful -50% better. I'm afraid of another booster at this point  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Drug ineffective, Myalgia, Pyrexia, Suspected COVID-19
Clinical narrative: she had COVID; she had COVID; fever; muscle aches; very weak.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization, reaction(s): "fever". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she had COVID"; PYREXIA (medically significant), outcome "unknown", described as "fever"; MYALGIA (medically significant), outcome "unknown", described as "muscle aches"; ASTHENIA (medically significant), outcome "unknown", described as "very weak.". Therapeutic measures were taken as a result of suspected covid-19, pyrexia, myalgia, asthenia with steroids and antibiotics.  Clinical course: Reporter does have vaccines she gets worse things, her sister experienced the same thing. Her sister had 2 doses of the Pfizer COVID vaccine and she had COVID and was more sick than ever. It was a miracle that her sister didn't go to the hospital.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Sedation
Clinical narrative: sore arm; Nausea; Sedation; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 31Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Feb2022, outcome "unknown", described as "sore arm"; NAUSEA (non-serious) with onset 01Feb2022, outcome "unknown", described as "Nausea"; SEDATION (non-serious) with onset 01Feb2022, outcome "unknown", described as "Sedation"; FATIGUE (non-serious) with onset 01Feb2022, outcome "unknown", described as "Fatigue". It was unknown if therapeutic measures were taken as a result of pain in extremity, nausea, sedation, fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid after having been vaccinated; tested positive for covid after having been vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 10 years 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) all with onset 01Feb2022, outcome "unknown" and all described as "tested positive for covid after having been vaccinated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Feb2022) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid test date=Dec2021, covid test result=Positive; covid test date=Dec2021, covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Lot number: ew0182) at the age of 41 years as dose 2, single and administered in arm left, administration date Apr2021 (Lot number: ew0158) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "covid test date=Dec2021, covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive.  Clinical course: lot number=33025b1, administration date=Jan2022, administration time=10:30 AM, dose number=3, vaccine location=Left arm  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use, Rash
Clinical narrative: Rash all over body; off label use; Dose number=1: Moderna/Dose number=2: Moderna/Dose number=3: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jan2022 10:30 (Lot number: Fl3198) at the age of 23 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: BACTRIM. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: Ohob21a, Location of injection: Arm Right), administration date: 12May2021, when the patient was 22 years old, for Covid-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: Oloa21a, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 22 years old, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 30Jan2022 10:30, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 30Jan2022 10:30, outcome "unknown", described as "Dose number=1: Moderna/Dose number=2: Moderna/Dose number=3: Pfizer"; RASH (non-serious) with onset 01Feb2022, outcome "recovering", described as "Rash all over body". The event "rash all over body" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of rash. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have known allergies and other medical history. Treatment received for the adverse event were Shot & pills of prednisone. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Inappropriate schedule of product administration, Pain, Pruritus
Clinical narrative: numbness from shoulder to elbow; Sinuses have been an issue too; Pain in my left shoulder  to my elbow; Inject site swelled about 5 inches around, red and itchy; Inject site swelled about 5 inches around, red and itchy; Inject site swelled about 5 inches around, red and itchy; Inject site swelled about 5 inches around, red and itchy; sever itching from left shoulder  to my elbow; Pain in my left shoulder  to my elbow; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 17:00 (Lot number: fj5682) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfa and narcotics, reaction(s): "Allergy"; Narcotics, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Product=COVID 19, Brand= Pfizer, Lot number=fj5682, administration time=10:30 AM, dose number=1, vaccine location=Left arm), administration date: 03Jan2022, when the patient was 53 years old, for COVID-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Jan2022, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE REACTION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 19Jan2022 12:00, outcome "not recovered" and all described as "Inject site swelled about 5 inches around, red and itchy"; PRURITUS (non-serious) with onset 19Jan2022 12:00, outcome "not recovered", described as "sever itching from left shoulder to my elbow"; ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 19Jan2022 12:00, outcome "not recovered" and all described as "Pain in my left shoulder to my elbow"; HYPOAESTHESIA (non-serious) with onset 19Jan2022 12:00, outcome "not recovered", described as "numbness from shoulder to elbow"; SINUS DISORDER (non-serious) with onset 19Jan2022 12:00, outcome "not recovered", described as "Sinuses have been an issue too". Therapeutic measures were not taken as a result of inappropriate schedule of product administration, vaccination site swelling, vaccination site reaction, vaccination site erythema, vaccination site pruritus, pruritus, arthralgia, pain, hypoaesthesia. Therapeutic measures were taken as a result of sinus disorder.  Additional Information: The patient was not tested for Covid post vaccination. The patient did not take any other vaccine in four weeks and no other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: numbness from shoulder to elbow; Sinuses have been an issue too; Pain in my left shoulder  to my elbow; Inject site swelled about 5 inches around, red and itchy; Inject site swelled about 5 inches around, red and itchy; Inject site swelled about 5 inches around, red and itchy; Inject site swelled about 5 inches around, red and itchy; sever itching from left shoulder  to my elbow; Pain in my left shoulder  to my elbow; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 17:00 (Lot number: fj5682) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfa and narcotics, reaction(s): "Allergy"; Narcotics, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Product=COVID 19, Brand= Pfizer, Lot number=fj5682, administration time=10:30 AM, dose number=1, vaccine location=Left arm), administration date: 03Jan2022, when the patient was 53 years old, for COVID-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 17Jan2022, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE REACTION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 19Jan2022 12:00, outcome "not recovered" and all described as "Inject site swelled about 5 inches around, red and itchy"; PRURITUS (non-serious) with onset 19Jan2022 12:00, outcome "not recovered", described as "sever itching from left shoulder to my elbow"; ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 19Jan2022 12:00, outcome "not recovered" and all described as "Pain in my left shoulder to my elbow"; HYPOAESTHESIA (non-serious) with onset 19Jan2022 12:00, outcome "not recovered", described as "numbness from shoulder to elbow"; SINUS DISORDER (non-serious) with onset 19Jan2022 12:00, outcome "not recovered", described as "Sinuses have been an issue too". Therapeutic measures were not taken as a result of inappropriate schedule of product administration, vaccination site swelling, vaccination site reaction, vaccination site erythema, vaccination site pruritus, pruritus, arthralgia, pain, hypoaesthesia. Therapeutic measures were taken as a result of sinus disorder.  Additional Information: The patient was not tested for Covid post vaccination. The patient did not take any other vaccine in four weeks and no other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective
Clinical narrative: post covid pneumonia; having the covid virus; having the covid virus; 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 62 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 62 years as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogren's" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. The following information was reported: COVID-19 PNEUMONIA (hospitalization, medically significant) with onset May2021, outcome "unknown", described as "post covid pneumonia"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "having the covid virus". The patient was hospitalized for covid-19 pneumonia (hospitalization duration: 7 day(s)). Patient had post covid pneumonia over the last year on an unknown date in May2021 and had 3 vaccinations and still has no antibodies. She got the booster which was some time on an unknown date in the end of Jul2021. Serious reported as: Yes. Investigation Assessment: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for Covid 19 on 1Feb22.; I tested positive for Covid 19 on 1Feb22.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Mar2021 (Lot number: EP6955) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; PANTOPRAZOLE; TRIAMTERENE HYDROCHLORIDE. Vaccination history included: Bnt162b2 (Dose: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 05Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 01Feb2022, outcome "recovering", VACCINATION FAILURE (medically significant) with onset 02Feb2022, outcome "recovering" and all described as "I tested positive for Covid 19 on 1Feb22.". The event "i tested positive for covid 19 on 1feb22." and "i tested positive for covid 19 on 1feb22." was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Sep2021) negative; (01Feb2022) positive. Therapeutic measures were taken as a result of covid-19, vaccination failure. Fluticasone propionate (nasal spray), drink fluids, rest were taken as treatment.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19 positive, Headache, sore throat, chills, congestion; Covid-19 positive, Headache, sore throat, chills, congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 28Oct2021 (Batch/Lot number: unknown) at the age of 32 years as dose 3 (booster), single, administration date 23Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date 01Mar2021 (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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Feb2022, outcome "unknown" and all described as "Covid-19 positive, Headache, sore throat, chills, congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.