chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Influenza like illness, Nausea, Retching
Clinical narrative: flu-like symptoms; diarrhea; nausea; dry heaves; could not eat nor drink; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu-like symptoms"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; RETCHING (non-serious), outcome "unknown", described as "dry heaves"; DECREASED APPETITE (non-serious), outcome "unknown", described as "could not eat nor drink".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite
Clinical narrative: Tick bite; 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).  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EM9809) at the age of 64 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: ARTHROPOD BITE (non-serious) with onset 22Mar2021, outcome "unknown", described as "Tick bite". The event "tick bite" was evaluated at the physician office visit. Therapeutic measures were taken as a result of arthropod bite. Additional information: The patient was scheduled for her 2nd dose of the covid vaccine on 31Mar2021. On Monday, 22Mar2021, the patient had a tick bite. The tick was discovered on Monday, 22Mar2021. Reporter tried to get the tick out of the patient but could not get it all. Patient went to a walk-in clinic, and the doctor there took all of the tick out. The doctor prescribed her doxycycline to take for 14 days. The doctor at the walk-in clinic suggested that the patient should delay her second dose of the covid vaccine until 5 days after she has completed the doxycycline. The doctor at the walk-in clinic made it seem like she did not think the doxycycline would hurt the second dose of the covid vaccine, but the doctor believes that patient could possibly have more symptoms after the second dose of the covid vaccine. Clarified as, that the patient may experience stronger or negative side effects from the second dose of the covid vaccine. Reporter was querying about this. The reporter would also like to know if there was an interaction between the covid vaccine and Doxycycline, an antibiotic.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in her feet, fingertips, lower arm and calves of her legs; 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 58 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 29Jan2021 (Lot number: EL9265) at the age of 58 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Cancer", start date: Apr2020 (ongoing); "Chemo" (unspecified if ongoing), notes: she finished chemo in Oct and cut chemo short a couple of rounds because of issues with neuropathy; "Radiation" (unspecified if ongoing), notes: radiation in Jan for 6 weeks & half way through she got her 1st  dose of the vaccine on 29Jan2021; "For bones" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D taken for bone disorder, start date: 11Jan2021 (ongoing); COD-LIVER OIL taken for bone disorder, start date: 11Jan2021.  The following information was reported: PARAESTHESIA (non-serious), outcome "not recovered", described as "Tingling in her feet, fingertips, lower arm and calves of her legs". Therapeutic measures were taken as a result of paraesthesia. The patient stated that the events started after the first dose and has been ongoing. She said that she was in the middle of radiation treatment and was no longer on chemotherapy. She had neuropathy symptoms in Oct2020 during her treatment with chemotherapy. She said that it had been improving and she had not had any tingling in her back or upper arms and that type of a thing. It was more in the feet, calves, hands, and lower arms she did have from the chemo.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Widespread flu like aches; Exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 09:15 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies_PCN" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose number 1, Product: COVID 19, lot number: unknown, Administration date: 01Mar2021, Administration time: 09:15 AM, vaccine location: Left leg), administration date: 01Mar2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "No reaction". The following information was reported: PAIN (non-serious) with onset 25Mar2021, outcome "recovering", described as "Widespread flu like aches"; FATIGUE (non-serious) with onset 25Mar2021, outcome "recovering", described as "Exhaustion". Therapeutic measures were not taken as a result of pain, fatigue.  Additional information: The patient did not receive any other medications within 2 weeks. The patient did not receive any other vaccine in four weeks of covid-19 vaccine. Prior to vaccine, the patient did not have covid-19 and since vaccination the patient has not been tested for covid-19. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Patient received the vaccine at Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The Pfizer Drug safety unit recently received the attached report submitted by you via pfizersafetyreporting.com. Please help to confirm the date that you became aware of the adverse events in this report as these effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Disease recurrence
Clinical narrative: started having shoulder issues the past 2 days; started having shoulder issues the past 2 days; 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "shoulder issues" (unspecified if ongoing), notes: preexisting condition/issue; hasn't occurred in several years; reoccurs every 2 years. The patient's concomitant medications were not reported. Past drug history included: Cortisone injection for shoulder issues. The following information was reported: ARTHROPATHY (non-serious), DISEASE RECURRENCE (non-serious) all with onset 23Mar2021, outcome "unknown" and all described as "started having shoulder issues the past 2 days". Additional information: The patient was due to get his second shot on 05Apr2021 and was asking if he can get a cortisone injection on 06Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Illness, Nausea, Vomiting
Clinical narrative: extremely sick; the second he got up he got horribly dizzy; dizziness; felt like he was going to throw up; throw up; 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 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 10:00 (Lot number: EN6204) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure", start date: 2012 (ongoing). The patient took concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 09Mar2021, outcome "unknown", described as "extremely sick"; DIZZINESS POSTURAL (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "the second he got up he got horribly dizzy"; DIZZINESS (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "dizziness"; NAUSEA (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "felt like he was going to throw up"; VOMITING (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "throw up". Therapeutic measures were taken as a result of dizziness postural, dizziness, nausea.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. It was further reported that he had no effects at all and he did fine for the fifteen minutes. He states he barely even felt the shot, he went out and then came home, worked all day and went to bed and did fine. The patient got up the next morning and was fine. After lunch, he got up and he got horribly dizzy. His wife got him to the bedroom and he felt like he was going to throw up. Patient stated that his wife brought him some bismuth subsalicylate (PEPTO BISMOL; equate version; lot number: CJ07849 and expiration date: Apr2022), and immediately after he took 30 mL dosage, he started to throw up "yellow" (everything that had gone down). He stated that this was 25-26 hours after first dose, and he doesn't know if it was due to the shot. The event "the second he got up he got horribly dizzy", "dizziness", "felt like he was going to throw up" and 'throw up"  persisted about 12 hours and was resolved. The patient next shot was scheduled on Monday, 29Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Influenza like illness, Lacrimation increased, Nasal congestion
Clinical narrative: flu like side effects; chills (hot/cold); chills (hot/cold); congestion; watery eyes; scratchy throat; terrible nausea (cannot eat or drink, only ginger ale); 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 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Mar2021 (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: INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "flu like side effects"; CHILLS (non-serious), FEELING OF BODY TEMPERATURE CHANGE (non-serious) all with onset Mar2021, outcome "unknown" and all described as "chills (hot/cold)"; NASAL CONGESTION (non-serious) with onset Mar2021, outcome "unknown", described as "congestion"; LACRIMATION INCREASED (non-serious) with onset Mar2021, outcome "unknown", described as "watery eyes"; THROAT IRRITATION (non-serious) with onset Mar2021, outcome "unknown", described as "scratchy throat"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "terrible nausea (cannot eat or drink, only ginger ale)". Additional information: The patient wanted to know what she can do about the side effects and if she could take paracetamol (TYLENOL).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Throat irritation
Clinical narrative: flu like side effects; chills (hot/cold); chills (hot/cold); congestion; watery eyes; scratchy throat; terrible nausea (cannot eat or drink, only ginger ale); 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 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Mar2021 (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: INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "flu like side effects"; CHILLS (non-serious), FEELING OF BODY TEMPERATURE CHANGE (non-serious) all with onset Mar2021, outcome "unknown" and all described as "chills (hot/cold)"; NASAL CONGESTION (non-serious) with onset Mar2021, outcome "unknown", described as "congestion"; LACRIMATION INCREASED (non-serious) with onset Mar2021, outcome "unknown", described as "watery eyes"; THROAT IRRITATION (non-serious) with onset Mar2021, outcome "unknown", described as "scratchy throat"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "terrible nausea (cannot eat or drink, only ginger ale)". Additional information: The patient wanted to know what she can do about the side effects and if she could take paracetamol (TYLENOL).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dehydration, Headache, Insomnia, Malaise
Clinical narrative: bad headache; memory loss; not feeling good; couldn't sleep; very dehydrated feeling; 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 26 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 22Mar2021 15:50 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "vitamin d deficiency", start date: 2019 (ongoing). Concomitant medication(s) included: VITAMIN D2 taken for vitamin d deficiency, start date: 2019 (ongoing). Vaccination history included: BNT162B2 (at 12:45), administration date: 01Mar2021, when the patient was 26 years old, for COVID-19 immunisation, reaction(s): "very mild soreness". The following information was reported: AMNESIA (medically significant) with onset 23Mar2021, outcome "recovering", described as "memory loss"; MALAISE (non-serious) with onset 22Mar2021 (late at night), outcome "recovering", described as "not feeling good"; INSOMNIA (non-serious) with onset 22Mar2021 (late at night), outcome "recovering", described as "couldn't sleep"; HEADACHE (non-serious) with onset 24Mar2021, outcome "not recovered", described as "bad headache"; DEHYDRATION (non-serious) with onset Mar2021, outcome "not recovered", described as "very dehydrated feeling". Clinical course: Patient stated she was having a memory loss and can not remember things she used or seen everyday like her street address, debit card pin and computer password. On 23Mar2021 (Tuesday), the patient had memory loss. It was at the beginning of her day and she really did not notice it. She said that she uses her work computer 5 days a week for the last 3 years and said she doesn't know her computer password, she had to get it out of her phone. The patient kept asking her coworker what she was doing, she doesn't know what she was doing. The patient had to go home as she was not feeling good. She needed gas and went to gas station. She was putting the wrong PIN in and it kept declining her card. It got to the point where she went back to her car and cried because she never has not known her debit card PIN. She called the bank because maybe somebody hacked her, but she was not hacked, the bank said that her PIN number has not changed and she locked her account up by putting in the wrong PIN. The patient said it was serious. The patient had appointment scheduled for her cellphone company and has tried to do business but she doesn't know her street address. She knew the street name but, she doesn't know the digits. The patient has no family history relevant to the events. The patient's doctor will be sending her to a specialist.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Glycosylated haemoglobin
Clinical narrative: Higher then normal morning glucose reading/Blood sugar levels spiking; 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 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 12:45 (Batch/Lot number: unknown) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 07Mar2021, outcome "not recovered", described as "Higher then normal morning glucose reading/Blood sugar levels spiking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose increased.  Additional information: There are no known allergies.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. patient had nor received any other medication within 2 week of vaccination as reported.Reporter reporting an increase in blood glucose after the covid vaccine. Patient had his first dose on 04Mar2021 and his 2nd shot 25Mar2021. Starting on 07Mar2021 and on, it has been spiking about 25 points higher than than normal. The glucose level went up after the second shot 20-25 points. Patient said it is unusual for it to go up, His previous Internist that retired told him that he would have times during the year like Christmas and holidays that he would see his levels go up. He was advised to increase his Metformin 1000 mg dose and add 1/2 tablet daily to help correct the increase. Patient normally takes 1000mg twice daily for a total of 2000mg. With the increase the total dose is 2500mg daily Reporter confirmed that he is adding 1/2 tablet of Metformin daily since 07Mar2021.Caller confirmed total daily dose as 2500 mg per day. Caller has seen that a fever and the rest of the stuff could happen, but it not that. Caller is asking could the spiking be caused by the Pfizer injection?Pharmacy bottle not available to Report at the time of the report for lot, and exp.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Nausea, Wrong technique in product usage process
Clinical narrative: Diarrhea; Feeling more nauseous every day- very mild nausea, started with the first dose, but got worse with the second; Did not take the vaccine from the vial, but had syringes laying on the table already filled up; 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 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 15:00 (Lot number: EN6201) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Microscopic colitis" (unspecified if ongoing), notes: Verbatim: Microscopic colitis; "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease (ongoing). The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 24Feb2021, outcome "unknown", described as "Did not take the vaccine from the vial, but had syringes laying on the table already filled up"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Feeling more nauseous every day- very mild nausea, started with the first dose, but got worse with the second". Relevant laboratory tests and procedures are available in the appropriate section. Additional information- It was reported that patient  received her first does of Pfizer's COVID vaccine on 24Feb2021 and they did not take the vaccine from the vial, but had syringes laying on the table already filled up. She  is concerned with the stability of the vaccine. she stated for her second shot, they took it out of the vial  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Malaise
Clinical narrative: postpone her schedule with the 2nd dose; not been feeling very well due to her other health conditions; 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). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (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: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "postpone her schedule with the 2nd dose"; MALAISE (non-serious), outcome "unknown", described as "not been feeling very well due to her other health conditions". The patient vaccine scheduled (26Mar2021) and had some medical issues and not feeling well. Her doctor told her it may be related to thyroid but still unsure. She called in to ask how long she can postpone her second dose. She had her first dose 05Mar2021. Cold transfer and created Manual AE form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: nausea; pain in the arm; 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), administration date 10Mar2021 (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: NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "nausea"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "pain in the arm".  Additional information: It was reported that nausea was experienced 12 hours after vaccination and that she was still experiencing the event over 2 weeks now (day of report). Patient stated that pain in the arm went away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Cold sweat, Eye pain, Fatigue
Clinical narrative: fatigue/Tired/wiped out; brain fog; weak; clammy; headache; eye pain; racing heartbeat; feelings of anxiety; tenderness at injection area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from AE Reporting, Adverse Event Report.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 10:30 (Lot number: EP7534) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "obese, possibly other comorbid conditions" (unspecified if ongoing), notes: obese, possibly other comorbid conditions. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 25Mar2021, outcome "not recovered", described as "fatigue/Tired/wiped out"; FEELING ABNORMAL (non-serious) with onset 25Mar2021, outcome "not recovered", described as "brain fog"; ASTHENIA (non-serious) with onset 25Mar2021, outcome "not recovered", described as "weak"; COLD SWEAT (non-serious) with onset 25Mar2021, outcome "not recovered", described as "clammy"; HEADACHE (non-serious) with onset 25Mar2021, outcome "not recovered", described as "headache"; EYE PAIN (non-serious) with onset 25Mar2021, outcome "not recovered", described as "eye pain"; HEART RATE INCREASED (non-serious) with onset 25Mar2021, outcome "not recovered", described as "racing heartbeat"; ANXIETY (non-serious) with onset 25Mar2021, outcome "not recovered", described as "feelings of anxiety"; VACCINATION SITE PAIN (non-serious) with onset 25Mar2021, outcome "not recovered", described as "tenderness at injection area". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccine Facility information was Pharmacy or Drug Store. Allergies to medications, food, or other products was unknown. The patient had not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination were unknown. Reportedly, serious: no.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Heart rate, Heart rate increased, Vaccination site pain
Clinical narrative: fatigue/Tired/wiped out; brain fog; weak; clammy; headache; eye pain; racing heartbeat; feelings of anxiety; tenderness at injection area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from AE Reporting, Adverse Event Report.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 10:30 (Lot number: EP7534) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "obese, possibly other comorbid conditions" (unspecified if ongoing), notes: obese, possibly other comorbid conditions. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 25Mar2021, outcome "not recovered", described as "fatigue/Tired/wiped out"; FEELING ABNORMAL (non-serious) with onset 25Mar2021, outcome "not recovered", described as "brain fog"; ASTHENIA (non-serious) with onset 25Mar2021, outcome "not recovered", described as "weak"; COLD SWEAT (non-serious) with onset 25Mar2021, outcome "not recovered", described as "clammy"; HEADACHE (non-serious) with onset 25Mar2021, outcome "not recovered", described as "headache"; EYE PAIN (non-serious) with onset 25Mar2021, outcome "not recovered", described as "eye pain"; HEART RATE INCREASED (non-serious) with onset 25Mar2021, outcome "not recovered", described as "racing heartbeat"; ANXIETY (non-serious) with onset 25Mar2021, outcome "not recovered", described as "feelings of anxiety"; VACCINATION SITE PAIN (non-serious) with onset 25Mar2021, outcome "not recovered", described as "tenderness at injection area". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccine Facility information was Pharmacy or Drug Store. Allergies to medications, food, or other products was unknown. The patient had not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination were unknown. Reportedly, serious: no.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Myalgia, Retching
Clinical narrative: chills; not feeling well; vomiting/throwing up; dry heaves; headache; muscle 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 15:00 (Lot number: EN6204) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY taken for diabetes mellitus; METFORMIN taken for diabetes mellitus. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; VOMITING (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "vomiting/throwing up "; RETCHING (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "dry heaves"; HEADACHE (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "headache"; MYALGIA (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "muscle pain"; MALAISE (non-serious), outcome "unknown", described as "not feeling well".  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: chills; not feeling well; vomiting/throwing up; dry heaves; headache; muscle 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 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 15:00 (Lot number: EN6204) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY taken for diabetes mellitus; METFORMIN taken for diabetes mellitus. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; VOMITING (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "vomiting/throwing up "; RETCHING (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "dry heaves"; HEADACHE (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "headache"; MYALGIA (non-serious) with onset 25Mar2021 04:00, outcome "not recovered", described as "muscle pain"; MALAISE (non-serious), outcome "unknown", described as "not feeling well".  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: sore armpit that started on evening of 2nd vaccination and still hurts today 1 day later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (BNT162B2), administration date 24Mar2021 10:00 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 24Mar2021 19:00, outcome "not recovered", described as "sore armpit that started on evening of 2nd vaccination and still hurts today 1 day later". It was unknown if therapeutic measures were taken as a result of axillary pain.  Additional information: Serious: No, Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. It was unknown whether patient 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 was Unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was unknown. Since the vaccination, has the patient been tested for COVID-19 was unknown. Allergies to medications, food, or other products was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Feeling abnormal, Influenza
Clinical narrative: having a bad case of the flu; light headed; chills; effected his vision; Kind of clammy today too; feels horrible, feels like he got hit by a truck; 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 male patient of an unspecified age (Age: 59 Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "light headed", "his Right arm hurt where the injection was".  The following information was reported: DIZZINESS (non-serious) with onset 24Mar2021, outcome "unknown", described as "light headed"; CHILLS (non-serious) with onset 24Mar2021, outcome "unknown", described as "chills"; VISUAL IMPAIRMENT (non-serious) with onset 24Mar2021, outcome "unknown", described as "effected his vision"; INFLUENZA (non-serious) with onset 25Mar2021, outcome "unknown", described as "having a bad case of the flu"; COLD SWEAT (non-serious) with onset Mar2021, outcome "unknown", described as "Kind of clammy today too"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "feels horrible, feels like he got hit by a truck".  Additional information: The patient would like to know how long would side effects last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: having a bad case of the flu; light headed; chills; effected his vision; Kind of clammy today too; feels horrible, feels like he got hit by a truck; 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 male patient of an unspecified age (Age: 59 Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "light headed", "his Right arm hurt where the injection was".  The following information was reported: DIZZINESS (non-serious) with onset 24Mar2021, outcome "unknown", described as "light headed"; CHILLS (non-serious) with onset 24Mar2021, outcome "unknown", described as "chills"; VISUAL IMPAIRMENT (non-serious) with onset 24Mar2021, outcome "unknown", described as "effected his vision"; INFLUENZA (non-serious) with onset 25Mar2021, outcome "unknown", described as "having a bad case of the flu"; COLD SWEAT (non-serious) with onset Mar2021, outcome "unknown", described as "Kind of clammy today too"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "feels horrible, feels like he got hit by a truck".  Additional information: The patient would like to know how long would side effects last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache was starting to feel more like a migraine; 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 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:30 (Lot number: EN6200) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: she was diagnosed with migraines 31 years ago. The patient's concomitant medications were not reported. Past drug history included: Fiorinal for Migraine, notes: Fiorinal 325/25/40mg capsule; Naproxen for Migraine, notes: Naproxen 500mg tablet; Metoclopramide for Migraine, notes: Metoclopramide 5mg. Vaccination history included: Bnt162b2 (1st dose, Lot Number: EN6198, Route of administration: Intramuscular, Anatomical location: Left arm), administration date: 03Mar2021, when the patient was 61 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 25Mar2021, outcome "not recovered", described as "headache was starting to feel more like a migraine". Therapeutic measures were not taken as a result of headache.  Additional information: The patient had no additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior vaccination. The event did not result to ER visit or physician office visit. The patient was asking if it is okay to take her prescriptions for her Migraine (Fiorinal, Naproxen and Metoclopramide) for the reported event headache was starting to feel more like a migraine.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: numbness in left leg; soreness in the left arm; soreness in the left arm was reported as worsened; rush down to her toes on her left side; tingling sensation all the way to my toes; 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 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 13:20 (Batch/Lot number: unknown, Expiration Date: Jul2021) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: verbatim: Caller states she did have Covid in November. The patient's concomitant medications were not reported.  The following information was reported: PARAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "tingling sensation all the way to my toes"; HYPOAESTHESIA (non-serious) with onset 24Mar2021, outcome "not recovered", described as "numbness in left leg"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "not recovered", described as "soreness in the left arm"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "soreness in the left arm was reported as worsened"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "rush down to her toes on her left side".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea, Sinusitis
Clinical narrative: little soreness at the injection site; feeling like I was coming down with a sinus infection; sore throat; runny nose; felt stopped up; 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 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "little soreness at the injection site"; SINUSITIS (non-serious), outcome "unknown", described as "feeling like I was coming down with a sinus infection"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt stopped up"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". Therapeutic measures were taken as a result of vaccination site pain. Additional information: The patient took acetylsalicylic acid (ASPIRIN) as a treatment for the little soreness at the injection site. Patient denied having fever. He was scheduled to take the second dose on 26Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little soreness at the injection site; feeling like I was coming down with a sinus infection; sore throat; runny nose; felt stopped up; 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 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "little soreness at the injection site"; SINUSITIS (non-serious), outcome "unknown", described as "feeling like I was coming down with a sinus infection"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt stopped up"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". Therapeutic measures were taken as a result of vaccination site pain. Additional information: The patient took acetylsalicylic acid (ASPIRIN) as a treatment for the little soreness at the injection site. Patient denied having fever. He was scheduled to take the second dose on 26Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Dental discomfort
Clinical narrative: circumstance or information capable of leading to medication error; had a bad tooth; 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. Other Case identifier(s): US-PFIZER INC-2021335707 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunisation.  The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "she received her second dose of the Pfizer BioNTech COVID-19 vaccine today and may possibly be started on antibiotics soon for a dental procedure. She would like to know if this will affect the vaccine."; DENTAL DISCOMFORT (non-serious), outcome "unknown", described as "had a bad tooth".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.