chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Full blood count, Haemoglobin, Immunology test, Investigation
Clinical narrative: swollen testicles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Mar2021 15:00 (Lot number: EN6207) at the age of 60 years as dose 2,single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing); "seperated adenoma of colon", start date: 14Jul2014 (ongoing); "spondylosis of lumbar region", start date: 12Sep2021 (ongoing); "asthma", start date: 11Nov2005 (ongoing). Concomitant medication(s) included: HYDROCODONE; MORPHINE. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE, time-15:00, lot number-EN6201, route-intramuscular, anatomical site-left arm), administration date: 18Feb2021, when the patient was 60 years old, for COVID-19 immunization; Influenza (lot number-UT7336NA, anatomical site-Left deltoid, no.of previous dose-3, route-intramuscular), administration date: 29Sep2021, when the patient was 60 years old. The following information was reported: TESTICULAR SWELLING (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "swollen testicles". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101308295 same patient/drug, different dose/event
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Lipids, Metabolic function test, Polymerase chain reaction, SARS-CoV-2 test, Testicular swelling
Clinical narrative: swollen testicles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Mar2021 15:00 (Lot number: EN6207) at the age of 60 years as dose 2,single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing); "seperated adenoma of colon", start date: 14Jul2014 (ongoing); "spondylosis of lumbar region", start date: 12Sep2021 (ongoing); "asthma", start date: 11Nov2005 (ongoing). Concomitant medication(s) included: HYDROCODONE; MORPHINE. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE, time-15:00, lot number-EN6201, route-intramuscular, anatomical site-left arm), administration date: 18Feb2021, when the patient was 60 years old, for COVID-19 immunization; Influenza (lot number-UT7336NA, anatomical site-Left deltoid, no.of previous dose-3, route-intramuscular), administration date: 29Sep2021, when the patient was 60 years old. The following information was reported: TESTICULAR SWELLING (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "swollen testicles". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101308295 same patient/drug, different dose/event
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Thyroid function test
Clinical narrative: swollen testicles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Mar2021 15:00 (Lot number: EN6207) at the age of 60 years as dose 2,single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing); "seperated adenoma of colon", start date: 14Jul2014 (ongoing); "spondylosis of lumbar region", start date: 12Sep2021 (ongoing); "asthma", start date: 11Nov2005 (ongoing). Concomitant medication(s) included: HYDROCODONE; MORPHINE. Vaccination history included: Bnt162b2 (DOSE 1,SINGLE, time-15:00, lot number-EN6201, route-intramuscular, anatomical site-left arm), administration date: 18Feb2021, when the patient was 60 years old, for COVID-19 immunization; Influenza (lot number-UT7336NA, anatomical site-Left deltoid, no.of previous dose-3, route-intramuscular), administration date: 29Sep2021, when the patient was 60 years old. The following information was reported: TESTICULAR SWELLING (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "swollen testicles". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101308295 same patient/drug, different dose/event
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 06Feb2021 15:00 (Lot number: EM9810) at the age of 82 years as dose 2, single and intramuscular, administered in arm, administration date 01Jan2021 14:00 (Lot number: EL3249, Expiration Date: 31May2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Jan2021, outcome "recovered" (Feb2021), described as "sore arm".  Additional information: Patient reported she got her the first and the second and she had almost no reaction just a little bit sore arm(dates were unspecified). Consumer stated, "Is this the right number to report side effects from the Pfizer drug?". In the past January and February she got her first and the second and almost had no reaction just a little bit sore arm, but this booster shot was totally different. Consumer was informed about the role of Pfizer Drug Safety Department. Consumer stated, "My height is 5'6 I think." and "Oh I don't know I am not over weight, lets see I haven't weight myself from a long time I am not over weight, I don't know." Expiration date: "31May2021 oh boy it was expired so they shouldn't be given to me right." (further confirmed the expiration date was for the first shot and for the booster it was not provided on the card) Consumer stated, "And lot# you asked me about LOT# EL3249. Ok hang on this may be the previous one it may be previous I don't know, the date on 15 that was the first one I got. But I don't have an expiration date for what I got yesterday." The reporter was a researcher. Consumer stated, "I was very surprised I didn't get the barely any reaction in Jan and Feb and this was quite a reaction I got, I was surprise". There was no prior vaccinations, Concomitant drugs, patient's medical history (including any illness at time of Vaccination) or relevant tests done for the patient. Onset date the event after dose 1 was 15Jan2021 and after dose 2 06Feb2021. Patient stated am feeling ok again. Specific relevant test for thromboembolic events with thrombocytopenia: None  Follow-up attempts are completed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypokinesia, Nervousness
Clinical narrative: but it was like two weeks that she could not practically moved,; nervous; extreme fatigue; 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 87 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 15:10 (Lot number: EW0168) at the age of 87 years as dose 1, 0.3ml single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOKINESIA (non-serious), outcome "unknown", described as "but it was like two weeks that she could not practically moved,"; FATIGUE (non-serious) with onset Sep2021, outcome "recovering", described as "extreme fatigue"; NERVOUSNESS (non-serious), outcome "unknown", described as "nervous".  Additional information: The patient did not take second dose yet, due on 28Oct2021, but was nervous to get it. She still golfs, walked 2 miles a day 5 days a week,She just recently letting up. She was grateful that it leveled off but it was like two weeks that she could not practically moved.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: 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 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 09:00 (Lot number: 3014JRA) at the age of 75 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY taken for hypersensitivity; ROSUVASTATIN taken for hypercholesterolaemia; AMLODIPINE taken for blood pressure measurement. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT# EL9266., Caller states that after receiving the first two shots of the vaccine, she had no problem), administration date: 17Feb2021, when the patient was 74 years old, for Covid-19 Immunization, reaction(s): "After receiving the first two shots of the vaccine, she had no problem"; Bnt162b2 (DOSE 2, SINGLE, LOT# EN6208., Caller states that after receiving the first two shots of the vaccine, she had no problem), administration date: 10Mar2021, when the patient was 74 years old, for Covid-19 Immunization, reaction(s): "After receiving the first two shots of the vaccine, she had no problem". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Sep2021, outcome "recovered" (03Oct2021), described as "her entire arm ached, all down to her fingers. Her arm was "very very sore from Thursday up to Sunday.""; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Under her arm, her lymph nodes are swollen"; LYMPH NODE PAIN (non-serious) with onset 02Oct2021, outcome "unknown", described as "lymph nodes under my arm was very, very sore". Additional Information: Reporter stated that after receiving the first two shots of the vaccine, she had no problem. The reporter stated that she had a mammogram was scheduled on 04OCT2021 and caller found out on 04OCT2021 that shouldn't have a mammogram after having the Pfizer BioNTech Vaccine for at least 6 weeks. Caller wants to know if the swollen lymph nodes she has could generate other side effects and questioning the location of the nodes. No follow-up attempts are possible. No further information is expected. Follow up (02Oct2021): This is a follow up spontaneous report from a contactable consumer. Updated information was added and narrative updated. Follow-up attempts are completed. No further information is expected. Follow up (04Oct2021): This is a follow up spontaneous report from a contactable consumer. Updated information was added and narrative updated. Follow-up attempts are completed. No further information is expected. Follow-Up (11Oct2021): Follow-up attempts are completed. No further information is expected. Updated information was added and narrative updated. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Inflammation of sinuses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUSITIS (non-serious), outcome "unknown", described as "Inflammation of sinuses".  Additional information: Caller's Pfizer booster shot appointment is tomorrow and she was prescribed with high dosage steroids for inflammation of sinuses (has not started yet taking it yet). Asking how long she should take this after getting her booster dose tomorrow. she has a caller on the line that has an appointment for the Pfizer Covid vaccine booster tomorrow and she has a prescription for steroids that she has not started yet. Agent relays the caller is asking should she wait to start the steroids until after the booster. Agent relays she is transferring to medical facility since the caller needed steroids after both doses of the Pfizer Covid vaccine. Caller declines to make a report, states it has nothing to do with the Covid vaccine, nothing. States she has inflammation of her sinuses and it's nothing to do with Covid vaccine. Caller states she doesn't want to do anything to screw up the booster. Caller clarifies she has not started taking the steroids yet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Fatigue, Pain
Clinical narrative: she started feeling not clear-headed; achy; tired; 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 patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Sep2021 (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 (1st dose), for COVID-19 Immunization; Bnt162b2 (2nd dose), for COVID-19 Immunization. The following information was reported: DISORIENTATION (non-serious) with onset 29Sep2021, outcome "unknown", described as "she started feeling not clear-headed"; PAIN (non-serious) with onset 29Sep2021, outcome "unknown", described as "achy"; FATIGUE (non-serious) with onset 29Sep2021, outcome "unknown", described as "tired".  Additional information: Caller states it was the Pfizer 3rd dose and the name should be on the card she was given, caller confirms it was the Covid vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: produced tingling and numbness on the left side of the jaw and arm; produced tingling and numbness on the left side of the jaw and arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (163738).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Sep2021 (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: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "produced tingling and numbness on the left side of the jaw and arm".  Additional information: It was reported that , I am a pharmacist that administered a first dose of Pfizer Covid vaccine 21 days ago to a patient and it produced tingling and numbness on the left side of the jaw and arm. It last approximately 24 hours . Patient has no history of Bell's Palsey or any type of facial paralysis. Can you provide guidance on it to administer the 2nd dose or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Granuloma
Clinical narrative: developed side effect of granuloma post vaccination with Pfizer Covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) 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: GRANULOMA (non-serious), outcome "unknown", described as "developed side effect of granuloma post vaccination with Pfizer Covid-19 Vaccine".  Additional information: Reporter wanted to know if Granuloma has been reported post vaccination. Reporter called on behalf of a patient who developed side effect of granuloma post vaccination with Pfizer Covid-19 Vaccine.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Spinal pain
Clinical narrative: the back of her neck hurts and when she turns her head from side to side; pain goes down her spine which is a sharp pain; 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 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 09:00 (Lot number: FC3184) at the age of 47 years as dose 2, 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, SINGLE, Date: 10Sep2021, Time: 10-11 am, Anatomical location: left arm , Lot: FC3184, No NDC , Expiry: known.), administration date: 10Sep2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: NECK PAIN (non-serious) with onset 03Oct2021, outcome "not recovered", described as "the back of her neck hurts and when she turns her head from side to side"; SPINAL PAIN (non-serious) with onset 03Oct2021, outcome "not recovered", described as "pain goes down her spine which is a sharp pain". Therapeutic measures were taken as a result of neck pain, spinal pain.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Malaise
Clinical narrative: Chills; Severe headache; Vomiting; Diarrhea; Fatigue; Nausea; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Sep2021 (Lot number: FF8839) at the age of 68 years 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 Number: 2, Batch/Lot No: EN6205, Location of injection: Arm , Route of administration: Intramuscular, Vaccine Administration Time: AM), administration date: 03Mar2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "Headache", "Fatigue"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Route of administration: Intramuscular, Location of injection: Arm, Vaccine Administration Time: AM), administration date: 10Feb2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "Headache", "Fatigue". The following information was reported: CHILLS (non-serious) with onset 30Sep2021 15:00, outcome "recovered with sequelae" (10Oct2021), described as "Chills"; HEADACHE (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (10Oct2021), described as "Severe headache"; VOMITING (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (10Oct2021), described as "Vomiting"; DIARRHOEA (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (10Oct2021), described as "Diarrhea"; FATIGUE (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (10Oct2021), described as "Fatigue"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Nausea"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Malaise". Therapeutic measures were not taken as a result of chills, headache, vomiting, diarrhoea, fatigue.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID. Since vaccination the patient was not tested for COVID. Booster headache fatigue nausea diarrhoea chills malaise lasted 9 days.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Chills; Severe headache; Vomiting; Diarrhea; Fatigue; Nausea; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Sep2021 (Lot number: FF8839) at the age of 68 years 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 Number: 2, Batch/Lot No: EN6205, Location of injection: Arm , Route of administration: Intramuscular, Vaccine Administration Time: AM), administration date: 03Mar2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "Headache", "Fatigue"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Route of administration: Intramuscular, Location of injection: Arm, Vaccine Administration Time: AM), administration date: 10Feb2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "Headache", "Fatigue". The following information was reported: CHILLS (non-serious) with onset 30Sep2021 15:00, outcome "recovered with sequelae" (10Oct2021), described as "Chills"; HEADACHE (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (10Oct2021), described as "Severe headache"; VOMITING (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (10Oct2021), described as "Vomiting"; DIARRHOEA (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (10Oct2021), described as "Diarrhea"; FATIGUE (non-serious) with onset 30Sep2021 15:00, outcome "recovered" (10Oct2021), described as "Fatigue"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Nausea"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Malaise". Therapeutic measures were not taken as a result of chills, headache, vomiting, diarrhoea, fatigue.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not receive any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID. Since vaccination the patient was not tested for COVID. Booster headache fatigue nausea diarrhoea chills malaise lasted 9 days.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). Other Case identifier(s): US-PFIZER INC-202101313990 (Pfizer).  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 number: 1), for COVID-19 immunization; Bnt162b2 (Dose number: 2), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes".  Additional information: Patient didn't have any side effects after the first two dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node left underarm; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 13:30 (Lot number: 30145BA) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type one diabetes" (unspecified if ongoing), notes: Type one diabetes; "Fibromyalgia" (unspecified if ongoing), notes: Fibromyalgia. Concomitant medication(s) included: METFORMIN; HUMALOG; CELEXA [CELECOXIB]; TRAMADOL. Vaccination history included: Bnt162b2 (Dose Number: 1, product=COVID 19, brand=Pfizer, Batch/Lot No: EH9899, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 18Dec2020, when the patient was 32 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, product=COVID 19, brand=Pfizer, Batch/Lot No: EL1284, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM), administration date: 06Jan2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 02Oct2021, outcome "not recovered", described as "Swollen lymph node left underarm". The event "swollen lymph node left underarm" was evaluated at the physician office visit. Additional Information- Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with covid-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Feb 2021; both single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced lymphadenopathy (swollen lymph nodes), onset 2021, with outcome of not recovered. Additional information: Patient's 3rd dose, the booster shot of Pfizer COVID-19 vaccine scheduled on Wednesday, Oct 6, 2021. She wanted to check if it was or not recommended to get the booster shot with her still having ongoing swollen lymph nodes. She never had swollen lymph nodes prior to getting the Pfizer COVID-19 vaccine doses. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Vaccination site pain
Clinical narrative: Injection site pain - Moderate; Heavy fatigue; Chills; Very Cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 14:00 (Lot number: FF3398) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Secondary diabetes" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; INVOKAMET XR; ATORVASTATIN. Vaccination history included: Bnt162b2 (DOSE 1, Batch/Lot No: el3302, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 19Mar2021, for Covid-19 Immunization; Bnt162b2 (DOSE 2, Batch/Lot No: fw015, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 07Apr2021, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Sep2021 22:00, outcome "recovered" (03Oct2021), described as "Injection site pain - Moderate"; FATIGUE (non-serious) with onset 30Sep2021 22:00, outcome "recovered" (Oct2021), described as "Heavy fatigue"; CHILLS (non-serious) with onset 30Sep2021 22:00, outcome "recovered" (Oct2021), described as "Chills"; FEELING COLD (non-serious) with onset 30Sep2021 22:00, outcome "recovered" (Oct2021), described as "Very Cold". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills, feeling cold.  Additional information: The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No hospitalization. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date Oct2021 (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 (prev dose product COVID 19,, prev dose brand Pfizer,, prev dose lot number Unknown, prev dose administration date: Mar2021, prev dose: dose number 2.), administration date: Mar2021, for covid-19 immunization; Bnt162b2 (prev dose product COVID 19,, prev dose brand Pfizer,, prev dose lot number Unknown,, prev dose administration date: Feb2021, prev dose: dose number 1.), administration date: Feb2021, for covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Nausea"; DIARRHOEA (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Diarrhea". Therapeutic measures were not taken as a result of nausea, diarrhoea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diplopia, Headache
Clinical narrative: headache; double vision in his left eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 (Lot number: 30145BA) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: OLMESARTAN taken for hypertension; AMLODIPINE taken for hypertension. Vaccination history included: Bnt162b2 (Dose 1), when the patient was 64 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2), when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; DIPLOPIA (non-serious), outcome "unknown", described as "double vision in his left eye". The events "headache" and "double vision in his left eye" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, diplopia.  Additional information: Patient didn't have any other vaccine (within 4 weeks) before Pfizer Covid 19 vaccine (Captured as suspect) until now after the 2 first Pfizer shots.   Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Influenza, Influenza A virus test, Influenza B virus test, SARS-CoV-2 test
Clinical narrative: cold sweat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 17:00 (Lot number: 30130RA) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FA7485, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 21Aug2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: COLD SWEAT (non-serious) with onset 18Sep2021, outcome "not recovered", described as "cold sweat". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of cold sweat.  Additional information:Patient did not received any other vaccines within 4 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. No known allergies. Device Date was 04Oct2021. No Prior vaccinations.    No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Post concussion syndrome, Vaccination site discomfort
Clinical narrative: Discomfort at injection site; Persistent Confusion; similar to what is observed post-concussion; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Sep2021 (Lot number: Ff8839) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Moderate asthma" (unspecified if ongoing), notes: Moderate asthma. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1, single, lot number: El1283,), administration date: 21Jan2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose2, single, lot number=En5318,), administration date: 24Feb2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 30Sep2021, outcome "recovering", described as "Discomfort at injection site"; CONFUSIONAL STATE (non-serious) with onset 30Sep2021, outcome "recovering", described as "Persistent Confusion"; POST CONCUSSION SYNDROME (non-serious) with onset 30Sep2021, outcome "recovering", described as "similar to what is observed post-concussion". Therapeutic measures were not taken as a result of vaccination site discomfort, confusional state, post concussion syndrome.  Additional information: Patient past drug event included BO and experienced allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Malaise, Tremor
Clinical narrative: mild injection site pain began approx 4-6hrs post dose and lasted 1-2days; chills; shaking began approx 14hrs post dose and lasted 3-4hours; flu-like body aches; general ill-feeling began 14hrs post does and lasted 1.5days; headache began 14hrs post dose and lasted 2.5days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 48-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 09:30 (Lot number: EW0217) at the age of 48 years as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Relevant medical history included: "Factor V LEIDEN blood clotting mutation" (unspecified if ongoing), notes: Factor V LEIDEN blood clotting mutation. Concomitant medication(s) included: ELIQUIS. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 17Feb2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EV3247), administration date: 27Jan2021, for Covid-19 immunization; Flu shot (Anatomical site: left arm), administration date: 21Sep2021, for Influenza Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "mild injection site pain began approx 4-6hrs post dose and lasted 1-2days"; CHILLS (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "chills"; TREMOR (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "shaking began approx 14hrs post dose and lasted 3-4hours"; INFLUENZA LIKE ILLNESS (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "flu-like body aches"; MALAISE (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "general ill-feeling began 14hrs post does and lasted 1.5days"; HEADACHE (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "headache began 14hrs post dose and lasted 2.5days". Therapeutic measures were not taken as a result of vaccination site pain, chills, tremor, influenza like illness, malaise, headache.  Additional Information: Patient had mild injection site pain began approx 4-6hrs post dose and lasted 1-2days; chills and shaking began approx 14hrs post dose and lasted 3-4hours; flu-like body aches and general ill-feeling began 14hrs post does and lasted 1.5days; headache began 14hrs post dose and lasted 2.5days. Other medications the patient received within 2 weeks of vaccination: ELIQUIS (2.5mg BID). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild injection site pain began approx 4-6hrs post dose and lasted 1-2days; chills; shaking began approx 14hrs post dose and lasted 3-4hours; flu-like body aches; general ill-feeling began 14hrs post does and lasted 1.5days; headache began 14hrs post dose and lasted 2.5days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 48-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 09:30 (Lot number: EW0217) at the age of 48 years as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Relevant medical history included: "Factor V LEIDEN blood clotting mutation" (unspecified if ongoing), notes: Factor V LEIDEN blood clotting mutation. Concomitant medication(s) included: ELIQUIS. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 17Feb2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EV3247), administration date: 27Jan2021, for Covid-19 immunization; Flu shot (Anatomical site: left arm), administration date: 21Sep2021, for Influenza Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "mild injection site pain began approx 4-6hrs post dose and lasted 1-2days"; CHILLS (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "chills"; TREMOR (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "shaking began approx 14hrs post dose and lasted 3-4hours"; INFLUENZA LIKE ILLNESS (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "flu-like body aches"; MALAISE (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "general ill-feeling began 14hrs post does and lasted 1.5days"; HEADACHE (non-serious) with onset 30Sep2021, outcome "recovered" (2021), described as "headache began 14hrs post dose and lasted 2.5days". Therapeutic measures were not taken as a result of vaccination site pain, chills, tremor, influenza like illness, malaise, headache.  Additional Information: Patient had mild injection site pain began approx 4-6hrs post dose and lasted 1-2days; chills and shaking began approx 14hrs post dose and lasted 3-4hours; flu-like body aches and general ill-feeling began 14hrs post does and lasted 1.5days; headache began 14hrs post dose and lasted 2.5days. Other medications the patient received within 2 weeks of vaccination: ELIQUIS (2.5mg BID). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Visual impairment, Vitreous floaters
Clinical narrative: walked out of the building got into my car and noticed floaters in my left eye; see streaks of light in the corners of both eyes that I never had prior to the vaccine; black spots at times that are floaters in my eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 12:00 (Lot number: EW0161) as dose 2, single and administered in arm left, administration date 25Mar2021 12:00 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID. The following information was reported: VITREOUS FLOATERS (non-serious) with onset 25Mar2021 12:00, outcome "not recovered", described as "walked out of the building got into my car and noticed floaters in my left eye"; EYE DISORDER (non-serious) with onset 25Mar2021 12:00, outcome "not recovered", described as "see streaks of light in the corners of both eyes that I never had prior to the vaccine"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "not recovered", described as "black spots at times that are floaters in my eyes". Therapeutic measures were not taken as a result of vitreous floaters, eye disorder, visual impairment. Additional information: Clinical course includes After Patient received first vaccine she walked out of the building got into the car and noticed floaters in left eye. She thought it was a hair in her eye but it was not.  From that point on She see streaks of light in the corners of both eyes that she never had prior to the vaccine. She also now have black spots at times that are floaters in her eyes.Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/Military facility. Prior to 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. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Poor quality product administered, Product temperature excursion issue
Clinical narrative: The second shot they (administered) passed the 14 days window and that supposed to get rid of it/ they didn't move it to the freezer into the time; The second shot they (administered) passed the 14 days window and that supposed to get rid of it/ they didn't move it to the freezer into the time; My wife is very "early pregnant"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "The second shot they (administered) passed the 14 days window and that supposed to get rid of it/ they didn't move it to the freezer into the time"; EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "My wife is very "early pregnant"". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Context: When probed for the concern, reporter stated, "I am calling for my wife (consumer), she got her second dose Pfizer vaccine at withheld near my house and the Pharmacist just called and told her that the second shot they (administered) passed the 14 days window and that supposed to get rid of it. I guess Pharmacist said it comes from a truck from Pfizer and it didn't meet within that 14 days under and then they are not supposed to give it to her. I guess it passed that 14 days window and they gave it to her. They are checking the freezer too long, they didn't move it to the freezer into the time. They did not move it to the freezer in that time, so it passed the time. My wife is very "early pregnant" (further not clarified), they didn't know what are the side effects maybe. We are hoping to talk to somebody who would know because withheld Pharmacist didn't know anything, so we don't know if any technical adverse side effects, she is kind of nervous because they had a mistake. Is that makes sense?" As reporter was not willing to proceed the call. Product details (LOT#, expiration date, NDC# and UPC#) and Pharmacy details could not be probed over the call. Limited information available over the call.  Follow-up (01Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: It made my blood sugar level rise above the normal.; This is a spontaneous report received from a contactable reporter(s) (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 30Sep2021 14:30 (Lot number: FF2588) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Allergy: Egg yolks" (unspecified if ongoing), notes: Allergy: Egg yolks. The patient took concomitant medications. The following information was reported: Blood glucose increased(non-serious) with onset 30Sep2021 19:00, outcome "recovered" (2021), described as "It made my blood sugar level rise above the normal.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.