chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Investigation, Malaise, Nausea
Clinical narrative: Nausea like he wants to throw up but nothing comes up, like a pump is sucking water out but the water isn''t coming up; Cramps in Stomach; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Nov2021 15:20 (Lot number: 32030BD) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 08Nov2021, outcome "recovered" (15Nov2021), described as "Cramps in Stomach"; NAUSEA (non-serious) with onset 09Nov2021 12:00, outcome "recovered" (15Nov2021), described as "Nausea like he wants to throw up but nothing comes up, like a pump is sucking water out but the water isn''t coming up"; MALAISE (non-serious) with onset Nov2021, outcome "unknown", described as "Not feeling well". The events "cramps in stomach", "nausea like he wants to throw up but nothing comes up, like a pump is sucking water out but the water isn''t coming up" and "not feeling well" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea.  Additional information: Caller states the Doctor at the Urgent Care couldn't find anything wrong and all of the tests were normal so he gave him something for nausea, Omeprazole. It is unknown for history of all previous immunization with the Pfizer vaccine considered as suspect. It is unknown if any Additional Vaccines Administered on Same Date of the Pfizer Suspect and no prior vaccinations within 4 weeks. It is unknown for patient medical history including any illness at time of vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Illness
Clinical narrative: she got sick for 12 hours; Part of her body was hot and part was cold.; Part of her body was hot and part was cold.; 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 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose of covid vaccine, Covid-19 First dose: , Lot: EL9265, Expiry date: 31May2021, Dose Unknown, injection in the left arm for all 3 doses.), administration date: 05Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "Caller said that with the first dose she had nothing". The following information was reported: FEELING HOT (non-serious), FEELING COLD (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Part of her body was hot and part was cold."; ILLNESS (non-serious) with onset 26Feb2021, outcome "recovered" (26Feb2021), described as "she got sick for 12 hours". Therapeutic measures were taken as a result of feeling hot, feeling cold.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Even with all his COVID vaccinations, he only had a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) for a Pfizer sponsored program. The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shot (He believes he got the flu shot before the vaccinations, and they weren't even close together.). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Even with all his COVID vaccinations, he only had a sore arm".  Additional information: NDC number and Expiry Date of Pfizer BioNTech COVID-19 vaccine was unknown. No Other Products were there. Lot Number / Expiry Date: EP7534 or ED7534, the caller (patient) stated the second letter could either be a P or D, it doesn't look clear/ Expiry date unknown. Route, Anatomical Location: Left arm (he remember since it was at the fairground, he rolled down his driver's side window, and didn't really have a choice for which arm; This was dose 1. No Investigation Assessment was there.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: General malaise; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  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: MALAISE (non-serious), outcome "unknown", described as "General malaise". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 18:00 (Lot number: FK5127) 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: MIGRAINE (non-serious) with onset 09Nov2021 06:00, outcome "not recovered", described as "migraine". Therapeutic measures were not taken as a result of migraine.  No follow-up attempts are possible. No further information is expected.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that one of the kids had a fever, vomiting, nausea for a week. another one of the kids had a few migraines, third child had migraine as well for one day as of right now. The patient was neither diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 Since the vaccination. Vaccine Facility information, ethnicity and race information was available.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101609878 same reporter/drug/AE with different patient
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: experienced "Covid Toes" in which they had blisters on their toes. They experienced these blisters for about 5 days after dose #2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast Cancer" (unspecified if ongoing), notes: several years ago (20+ years ago) ; "Chemotherapy" (unspecified if ongoing); "Mastectomy" (unspecified if ongoing); "Neuropathy of Feet and Hands" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Feb2021, for COVID-19 immunization. The following information was reported: BLISTER (non-serious) with onset Feb2021, outcome "recovered", described as "experienced "Covid Toes" in which they had blisters on their toes. They experienced these blisters for about 5 days after dose #2". Therapeutic measures were not taken as a result of blister.  Additional information: No covid prior vaccination. Not covid tested post vaccination. Patient underwent chemotherapy several years ago (20+ years ago) for breast cancer and as a result experiences neuropathy in their feet. After receiving the Pfizer Covid Vaccine dose #2 and #3, they experienced "Covid Toes" in which they had blisters on their toes. They experienced these blisters for about 5 days after dose #2 and then experienced milder blisters for just a couple of days after dose #3.  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: Illness
Clinical narrative: She said that she did ok with the first 2 doses and only felt sick for a couple of days afterward.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (Lot number: ER8727) at the age of 32 years as dose 1, single and administration date 15May2021 (Lot number: EW0168) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "She said that she did ok with the first 2 doses and only felt sick for a couple of days afterward.".  Additional information: Prior Vaccinations patient did not had any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Rhinorrhoea
Clinical narrative: cold symptoms; nasal drip; congestion; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (051529).  A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 48 years 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: NASOPHARYNGITIS (non-serious), outcome "recovered", described as "cold symptoms"; RHINORRHOEA (non-serious), outcome "recovered", described as "nasal drip"; NASAL CONGESTION (non-serious), outcome "recovered", described as "congestion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: ER2613) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Low back arthritis" (unspecified if ongoing), notes: Other medical history: Low back arthritis; "SI joint inflammation" (unspecified if ongoing), notes: other medical history: SI joint inflammation; "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose brand unknown: False,, Prev dose lot number: EN6203, Prev dose lot unknown: False, Prev dose number:1,, Prev dose vaccine location: Left arm), administration date: 03Mar2021, when the patient was 56 years old, for COVID-19 Immunization, reaction(s): "Extreme low back pain", "worsening of joint inflammation", "worsening of joint inflammation"; Bnt162b2, administration date: 03Mar2021, when the patient was 56 years old, for COVID-19 immunization, reaction(s): "3 episodes of recurrent injection site pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered with sequelae", described as "injection site pain". It was unknown if therapeutic measures were taken as a result of vaccination site pain.  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 diagnosed with COVID. Since vaccination the patient had not been tested for COVID.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Lung hyperinflation
Clinical narrative: inflated in the pectoral area; Discomfort; pain in his joints, pains in his knees and shoulder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Lot number: FF2587) at the age of 41 years 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: LUNG HYPERINFLATION (non-serious) with onset 27Oct2021, outcome "not recovered", described as "inflated in the pectoral area"; DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Discomfort"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "pain in his joints, pains in his knees and shoulder".  Additional information included: He doesn't have health insurance or primary doctor. Would like to know what the next step is if this inflammation doesn't go away or gets worse. It has been more than 72 hours since he got the shot and had the swelling. It has not gone. He is a really healthy man. He doesn't do drugs or drink. He has a good diet and is healthy. He has no underlying conditions. This happening is worse with the second dose. That area is still swelling. Thinks it is the lymphatic that they were reading about in the brochure. He is in the country under Visa. He doesn't have PCP or medical physician if he needs to go to the Emergency Room. He is not looking for dollars. He enquired weather he needs to go to ER because of swollen lymph nodes. The report is for statistics and he wants to be transferred for his concerns.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Abnormal faeces, Diarrhoea, Flatulence
Clinical narrative: Loose and smelly stools/ Occasional diarrhea; Loose and smelly stools; Occasional stomach pain; flatulence; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.   A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 14:45 (Lot number: Fc3180) at the age of 38 years as dose 1, single and administered in arm left, administration date 25Aug2021 14:45 (Lot number: FC3182) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DIARRHOEA (non-serious) with onset 05Aug2021, outcome "not recovered", described as "Loose and smelly stools/ Occasional diarrhea"; ABNORMAL FAECES (non-serious) with onset 05Aug2021, outcome "not recovered", described as "Loose and smelly stools"; ABDOMINAL PAIN UPPER (non-serious) with onset 05Aug2021, outcome "not recovered", described as "Occasional stomach pain"; FLATULENCE (non-serious) with onset 05Aug2021, outcome "not recovered", described as "flatulence". Therapeutic measures were not taken as a result of diarrhoea, abnormal faeces, abdominal pain upper, flatulence.   Additional information: Product=COVID 19, brand=Pfizer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The patient had no known allergies. 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: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: upset stomach with diarrhea; upset stomach with diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Nov2021 (Lot number: FK5127) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), DIARRHOEA (non-serious) all with onset 18Nov2021, outcome "not recovered" and all described as "upset stomach with diarrhea". Therapeutic measures were not taken as a result of abdominal discomfort, diarrhoea.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for Covid-19. The patient received other medications in two weeks: Zyrtec and flonase spray over the counter. The patient had allergies was none. On 18Nov2021, the patient experienced adverse event:18 hours post first dose of Covid vaccine, 8-year-old female patient has upset stomach with diarrhea. No other symptoms to report. The patient was not received treatment. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Paraesthesia
Clinical narrative: 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 left, administration date 24Oct2021 (Lot number: 32030BD) at the age of 45 years as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset Nov2021, outcome "not recovered", described as "Pins and needles all through body". The event "pins and needles all through body" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia. Additional information included: The report was not related to a study or programme. Caller stated that, she was calling regarding the Pfizer shot, the first shot. She stated that it was mandatory for her job. Clarified that she was referring to the Pfizer Covid-19 vaccine. She was wondering why she had the shot 3 weeks ago and was put in the hospital because she was having pins and needles all through her body after the first shot. Pins and needles all through body: Caller states that it occurred 3 weeks after she got the first shot. She stated that, she was still experiencing it and it has stayed the same. Clarified that she was in the hospital for 4 hours on Saturday and it was clarified that she was referring to this past Saturday, 13Nov2021. Clarified that she was not admitted to the hospital overnight, that she was in the emergency room for 4 or 5 hours. Treatment: No, they did not give her anything in the hospital. She states that they did blood work. She stated that, she has had no other medications for treatment for the pins and needles. She visited to physician Office, right after the next day. Time of Vaccination Was Given: around 3:30 or 4:00 in the afternoon. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as no. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as no. The patient did not receive any vaccine prior to Covid-19 vaccine. Family Medical History Relevant to AE(s) was given as No. Relevant Tests: None. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Had same kind of headache with first vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Apr2021 10:30 (Lot number: EP8834) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Jan2021 (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 11Oct2021. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Had same kind of headache with first vaccination".  Additional information: On 16Nov2021 at 18:00, the third dose resulted in right axillary lymph node swelling and pain, which continues 48 hours, still very sore/swollen. The patient experienced 30 hours headache (stingy like a migraine), fatigue, malaise. The patient had same kind of headache with the first vaccination. The patient experienced almost nothing with second dose. Armpit swelling and pain was unique to the third shot. On 16Nov2021 at 09:30, the patient received the third dose of BNT162B2 (Batch/Lot number: FH8030) at the age of 49 years, via unspecified route of administration in right arm. The patient was not pregnant at the time of third dose. On 28Apr2021 at 12:00, the patient received the second dose of BNT162B2 (Batch/Lot number: EW0172) at the age of 48 years, via unspecified route of administration in right arm. Facility where the most recent (third dose) of COVID-19 vaccine was administered reported as pharmacy or drug store. On 11Oct2021, the patient received FLU vaccines within 4 weeks prior to the COVID vaccine. Dose 3 adverse events was not resulted in emergency room or physician office visit. Dose 3 events outcome reported not recovered. The patient was not received treatment for dose 3 events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the third dose of vaccination, the patient was not tested for COVID-19. The patient had no known allergy. Other medical history reported as no.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Pain assessment, Vaccination site pain
Clinical narrative: Soreness at injection site (4 on pain scale 1-10); body aches (3-4 on pain scale); sore throat (2 on pain scale); nausea (occasional); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 50 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 was not reported. Concomitant medication(s) included: FLU VACCINE VII. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at injection site (4 on pain scale 1-10)"; PAIN (non-serious), outcome "unknown", described as "body aches (3-4 on pain scale)"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat (2 on pain scale)"; NAUSEA (non-serious), outcome "unknown", described as "nausea (occasional)". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain assessment, Vaccination site pain
Clinical narrative: Soreness at injection site (3 on pain scale of 1-10); body aches (2 on pain scale); headache (3 on pain scale); tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 17:15 (Lot number: FH8030) at the age of 47 years as dose 3(booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), intramuscular, administered in arm right, administration date 16Nov2021 17:15 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Date: 16Mar2021, Site of Injection: Left upper arm, Lot: EP6955(Pfizer)), administration date: 16Mar2021, when the patient was 47 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2, Date: 06Apr021, Site of Injection: Left upper arm, Lot: EP0955(Pfizer)), administration date: 06Apr2021, when the patient was 47 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Soreness at injection site (3 on pain scale of 1-10)"; PAIN (non-serious) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "body aches (2 on pain scale)"; HEADACHE (non-serious) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "headache (3 on pain scale)"; FATIGUE (non-serious) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Therapeutic measures were taken as a result of pain, headache. Additional information: Concomitant Drugs; List below concomitant drugs taken within two weeks before the event onset. Exclude all drugs only administered more than two weeks before the event, and any drug used to treat the event or taken after event onset: was not provided. Patient's Medical History (including any illness at time of vaccination) was not provided. Family Medical History Relevant to AE (s) was not provided. RELEVANT TESTS List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebro-spinal fluid culture, pleural fluid culture, urine culture, diagnostic imaging, (e.g., chest  X-ray, MRI).  If COVID-19 testing has been conducted, provide test dates and results was not provided. Specific relevant test for Thromboembolic event with Thrombocytopenia was not provided.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: experienced the vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: VERTIGO (non-serious), outcome "unknown", described as "experienced the vertigo".  Additional Information: Reporter stated that dads wife being a nurse and even she said her co-workers who are nurses as well said they experienced the vertigo. I guess the vertigo is common.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 71-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6207), at the age of 71, in left arm, on Mar 15, 2021, single dose, for COVID-19 immunization. Medical history included psoriasis (unspecified if ongoing); and psoriatic arthritis (unspecified if ongoing). Concomitant medications not reported. The patient had influenza-like illness (flu-like symptoms), onset 2021, with outcome of recovered (2021). Additional information: Prior to the vaccination, patient not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. First only flu-like symptoms for a couple days. Psoriasis became much more severe. Psoriatic arthritis more intense. No follow-up attempts possible. No further information expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single and administration date Apr2021 (Batch/Lot number: unknown) 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: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "tinnitus". The event "tinnitus" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 with unknow results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 19:45 (Lot number: FKS127) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VOMITING (non-serious) with onset 18Nov2021 20:15, outcome "unknown", described as "Vomiting". Therapeutic measures were not taken as a result of vomiting.  Additional Information: The patient was a child. The patient had no known allergies. The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had no other medical history. The patient not received other medications in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Pain in left axilla.Swelling in left axilla; Pain in left axilla.Swelling in left axilla; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 17:00 (Lot number: FF2593) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN.  The following information was reported: LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset 17Nov2021 03:00, outcome "unknown" and all described as "Pain in left axilla. Swelling in left axilla". Therapeutic measures were not taken as a result of lymphadenopathy, axillary pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination Olmesartan. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Irritability, Nervousness, Psychomotor hyperactivity
Clinical narrative: grumpy; fidgety; jittery; nervous; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Lot number: ZTL5384026) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing), notes: She can only have left because of her breast cancer.; "Blood pressure high" (unspecified if ongoing); "Restless" (unspecified if ongoing); "lymphedema" (unspecified if ongoing), notes: The therapy is since she got the vaccine.; "blood clots", start date: 2009 (unspecified if ongoing), notes: She has been taking it for 9 years, She had blood clots in 2009. Concomitant medication(s) included: ELIQUIS taken for thrombosis; LOSARTAN taken for hypertension; CARVEDILOL taken for hypertension; SERTRALINE taken for restlessness. Vaccination history included: Bnt162b2 (dose 1, single, Lot ZTC2948, Expiration is unknown., Injected in left arm., Batch/lot number: FD0809), administration date: 16Mar2021, when the patient was 77 years old, for COVID-19 Immunization.  The following information was reported: IRRITABILITY (non-serious) with onset Apr2021, outcome "unknown", described as "grumpy"; PSYCHOMOTOR HYPERACTIVITY (non-serious) with onset Apr2021, outcome "unknown", described as "fidgety"; FEELING JITTERY (non-serious) with onset Apr2021, outcome "unknown", described as "jittery"; NERVOUSNESS (non-serious) with onset Apr2021, outcome "unknown", described as "nervous".  Additional information: Dates for Concomitant Products Losartan: (Start: Unspecified Stop: Unspecified). Additional Information for Concomitant Products Losartan: Started it about 5 years ago. Dates for Concomitant Products Carvedilol: (Start: Unspecified Stop: Unspecified). Additional Information for Concomitant Products Carvedilol: Started it about 5 years ago. Dates for Concomitant Products Sertraline: (Start: Unspecified Stop: Unspecified) Additional Information for Concomitant Products Sertraline: Started back again about 1 month ago. Previously 5 years ago. She is grumpy and short. She is fidgety, nervous, and jittery. It looks like everything started around the same time right after, or 2-3 days after she got second dose. She noticed the changes in her body.     No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: dose 1 administerd on 02May2021 and dose 2 on 03May2021; A Little Soreness at Injection Site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02May2021 10:00 (Lot number: EWD162) at the age of 69 years as dose 1, single and administration date 03May2021 10:00 (Lot number: EWD162) as dose 2 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: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "dose 1 administerd on 02May2021 and dose 2 on 03May2021"; VACCINATION SITE PAIN (non-serious) with onset 02May2021 11:00, outcome "recovered", described as "A Little Soreness at Injection Site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: Patient was non pregnant. No other vaccine was taken in four week. Event reported was A Little Soreness at Injection Site for 12 hours or so. No Covid reported prior vaccination. No Covid tested post vaccination. No Known allergies was reported. No Other medical history was reported.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Panic reaction
Clinical narrative: He was more than frustrated and he was panicking.; He was more than frustrated and he was panicking.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FRUSTRATION TOLERANCE DECREASED (non-serious), PANIC REACTION (non-serious), outcome "unknown" and all described as "He was more than frustrated and he was panicking."  Additional information: He added, "There's so many complications with this trial". He was more than frustrated and he was panicking. He wants to talk to the authority or someone in a higher position. The caller was using profanity at the onset of the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Illness, Retching, Vomiting
Clinical narrative: dry heat; sick; throwing up; Dry heaves; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the parent.  A 6-year-old female patient received bnt162b2 (BNT162B2), administered in thigh right, administration date 17Nov2021 14:30 (Lot number: FK5618, Expiration Date: 19Jan2022) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Flu shot (She had a flu shot in August. Caller doesn't have NDC, lot, and expiry for the flu shot.), administration date: Aug2021. The following information was reported: BODY TEMPERATURE ABNORMAL (non-serious), outcome "unknown", described as "dry heat"; ILLNESS (non-serious), outcome "unknown", described as "sick"; VOMITING (non-serious) with onset 18Nov2021, outcome "unknown", described as "throwing up"; RETCHING (non-serious) with onset 18Nov2021, outcome "unknown", described as "Dry heaves". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: it was reported that the patient got the vaccine on 17Nov2021 after getting the pfizer covid 19 vaccine presented throwing up, and dry heat. She does not want to get another shot. are there any problems by skipping the second dose? The patient further reported that she got the first shot on Wednesday and it made her sick. Yesterday morning, she was throwing up and had dry heaves. She doesn't want to go get the follow up shot. Will there be a problem with skipping the second one? Event Details: at about 4 in the morning, she started being sick with throwing up and dry heaving. It has cleared up and she went to school today. She was pretty adamant that she doesn't want another shot. Prior Vaccinations (within 4 weeks) was none within 4 weeks. Patient had a flu shot in August. Reporter doesn't have NDC, lot, and expiry for the flu shot. AE prior to vaccination was none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller mentions that she had no side effects from the vaccines, other than her arm being sore.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Lot number: EW0169) as dose 2, single and administration date 15Apr2021 (Lot number: EW0169) 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), outcome "unknown", described as "Caller mentions that she had no side effects from the vaccines, other than her arm being sore.".  Additional information: Reporter states that she was calling about the Pfizer Product:  Covid 19 Vaccine.  Weight:  Reported by the caller as 140-145 pounds. Reporter denies any other medications, medical conditions, labs, testing or treatments relevant to report. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine: None. No AE(s) following prior vaccinations. Patient had no medical History (including any illness at time of vaccination). Family Medical History Relevant to AE(s): Not Provided. Relevant Tests: None  Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dry skin, Pain in extremity, Productive cough
Clinical narrative: Productive cough; Dry skin in hands and feet; Pain in hands and feet; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4159996-00 (Agency).  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Oct2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous from 2020 (Batch/Lot number: unknown) to 2020 at 150 mg (150 mg, 1 in 1-2) for psoriasis. Relevant medical history included: "Alcohol Use: Whiskey or screw drivers every night", start date: 1969 (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "L4 and L5 was Broken" (unspecified if ongoing); "Broken Wrist" (unspecified if ongoing); "Fell" (unspecified if ongoing); "Non-Smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Humira, notes: Patient was on Humira previously. The following information was reported: PRODUCTIVE COUGH (non-serious) with onset 28Oct2021, outcome "recovering", described as "Productive cough"; DRY SKIN (non-serious) with onset 28Oct2021, outcome "recovering", described as "Dry skin in hands and feet"; PAIN IN EXTREMITY (non-serious) with onset 28Oct2021, outcome "recovering", described as "Pain in hands and feet". The action taken for risankizumab was temporarily withdrawn on 2020. Therapeutic measures were taken as a result of productive cough.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of PRODUCTIVE COUGH, DRY SKIN IN HANDS AND FEET and PAIN IN HANDS AND FEET with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Vax 2 - Normal (flu-type) symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 10:00 (Lot number: ER8736) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE; AMLODIPINE BESILATE. Past drug history included: No. Vaccination history included: Bnt162b2 (dose 1,single, Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 10:00), administration date: 01Apr2021, when the patient was 55 years old, for Covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Vax 2 - Normal (flu-type) symptoms".  Additional Information: If Covid prior vaccination was reported as Unknown. If Covid tested post vaccination was reported as No. Known allergies was reported as No. If other vaccine in four weeks was reported as No.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: lightheadedness; feeling drained/Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 18:00 (Lot number: 30155BA) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Repeating Node Relevant past drug history: , Name of Drug as Reported: no, Reaction: Allergy , . Concomitant medication(s) included: FLU taken for immunisation. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: 3248, Location of injection: Arm Left, Vaccine Administration Time: 13:00 PM), administration date: 23Mar2021, when the patient was 39 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 13:00 PM), administration date: 02Mar2021, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 19Nov2021 06:00, outcome "not recovered", described as "lightheadedness"; FATIGUE (non-serious) with onset 19Nov2021 06:00, outcome "not recovered", described as "feeling drained/Fatigue". Therapeutic measures were not taken as a result of dizziness, fatigue.  Additional information: Other medications the patient received within 2 weeks of vaccination included Flu Shot Quad. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No treatment was received.  Follow-up attempts are completed. No further information is expected.