chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Weakness; Loss of balance; Nausea at very little; Fell on bathroom floor; Could not get up; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Feb2021 (Batch/Lot number: unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing); "ulcerative colitis" (ongoing); "Crohns" (ongoing); "Pulmonary Embolism" (ongoing). Concomitant medications included: MERCAPTOPURINE taken for crohn's disease, colitis ulcerative, start date: Feb1993 (ongoing); ELIQUIS taken for pulmonary embolism, start date: Jan2016 (ongoing); PAROXETINE HCL taken for depression (ongoing); BUPROPION HCL taken for depression (ongoing). Vaccination history included: BNT162B2 (Dose 1, single (Lot Number: Not provided)), administration date: 25Jan2021, when the patient was 81 years old, for COVID-19 immunisation, reactions: "Sick with diarrhea", "Dry heaves", "She went to living room and fell", "Couldn't get up", "Tiredness", "She has a sore throat", "Fever blister on her mouth", "Severe headache", "Muscle pain in back of her neck and back", "Violent chills", "Almost 10 pounds in the two and half weeks with all this stuff", "Nausea", "weakness", "loss of balance". The following information was reported: NAUSEA (non-serious) with onset 18Feb2021, outcome "recovered" (21Feb2021), described as "Nausea at very little"; VOMITING (non-serious) with onset 22Feb2021 12:00, outcome "unknown", described as "Vomiting"; ASTHENIA (non-serious) with onset 22Feb2021 12:00, outcome "unknown", described as "Weakness"; BALANCE DISORDER (non-serious) with onset 22Feb2021 12:00, outcome "unknown", described as "Loss of balance"; FALL (non-serious) with onset 2021, outcome "unknown", described as "Fell on bathroom floor"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Could not get up".  Additional Information: On 18Feb2021 to 21Feb2021, the patient experienced nausea at very little and on 22Feb2021 at 12:00PM, she experienced vomiting, weakness, and loss of balance. The patient fell on bathroom floor, could not get up, and slept on the floor for about 3 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148886 Same patient and drug; Different dose and events
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vitamin B12 deficiency" (unspecified if ongoing); "Parkinson's disease" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE ~Lot no: unknown), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Fatigue". Therapeutic measures were not taken as a result of fatigue. Additional information: The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested for COVID-19 since having the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; Soreness in left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 98 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 09:00 (Lot number: EN6202) at the age of 98 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic / chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Kidney disease" (unspecified if ongoing); "Atrial Fibrillation" (unspecified if ongoing); "Barrett's disease" (unspecified if ongoing); "height, he stated he has shrunk some" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Mar2021, outcome "unknown", described as "Soreness in left arm"; HEADACHE (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Headache".  Additional information: Patient did not receive additional vaccines on same date of the Pfizer Suspect. Patient had no history of previous immunization with Pfizer vaccine as suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had first vaccine 2 1/2 weeks ago. A day or two after, he started to get a headache and it continued every day for 2 weeks. It stopped and he was ok for a few days and yesterday they came back. Yesterday and today, he still has it. He would like to know how long might this continue and will it affect in any way as he was getting the second shot in 3 days. Patient also reported soreness in left arm in the afternoon on the day of vaccination. Events did not result to urgent care or physician office visit.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 14:30 (Lot number: EN6198) at the age of 71 years as dose 1, single and administered in arm left, administration date 18Mar2021 15:30 (Lot number: EN6206) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; LEVOTHYROXINE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient experienced sore arm on 26Feb2021 after the first dose and on 19Mar2021 after the second dose. Event did not result to urgent care and physician office visit.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (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: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache". Additional information: The patient was asking if she can take aspirin to treat her headache since she had a headache since after getting the Pfizer covid-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Vertigo
Clinical narrative: Vertigo and plugging of left ear; Vertigo and plugging of left ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 17:00 (Lot number: En6199) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Festival cancer in 1999", start date: 1999 (unspecified if ongoing), notes: Festival cancer in 1999. No known allergies. No covid prior vaccination. Concomitant medication(s) included: ERYTHROMICIN; LIPITOR [ATORVASTATIN]. No in other vaccine in four weeks. The following information was reported: VERTIGO (non-serious), EAR DISCOMFORT (non-serious) all with onset 06Mar2021 02:00, outcome "recovering" and all described as "Vertigo and plugging of left ear". The event "vertigo and plugging of left ear" and "vertigo and plugging of left ear" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo, ear discomfort. Additional information: Covid was not tested post vaccination. AE treatment: Neti pot, nasal spray and prednizone. Second dose is scheduled on 25Mar2021 and was asking if it is okay to get the second dose.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: pains in his stomach; 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 male patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "wound on his leg thats oozing" (unspecified if ongoing), notes: His doctor prescribed Cephalexin 500 mg for a wound on his leg that's oozing. Concomitant medication(s) included: CEPHALEXINE. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Mar2021, outcome "unknown", described as "pains in his stomach".  Additional Information: HIs doctor prescribed Cephalexin 500mg for a wound on his leg that was oozing.  Can he take vaccine along with antibiotic?  HCP was unsure.  He does not want to mess up the vaccine from working.    No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: her arm was sore / injection site still sore; injection site redness; injection site little swollen; Injection site has heat/ feels warmer to touch than any other part of the arm; injection site inflammation; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 (Lot number: EN6198, Expiration Date: Jun2021) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2002 (unspecified if ongoing), notes: had a left lumpectomy; "left lumpectomy with 3 nodes resected" (unspecified if ongoing), notes: all negative; "Lymphoma", start date: Dec2020 (unspecified if ongoing), notes: it was 2021 before results of biopsies were in and they started on treatment; "removed left side lymph nodes" (unspecified if ongoing); "she was very anemic" (unspecified if ongoing), notes: when she was diagnosed with lymphoma but almost back to normal now. Concomitant medication(s) included: TRUXIMA [RITUXIMAB], start date: 28Jan2021 (ongoing). Vaccination history included: Pfizer covid-19 vaccine (dose 1, single, lot number: EN6201, Expiration date: Jun2021, Administration site: right arm), administration date: 23Feb2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "her arm was sore / injection site still sore"; VACCINATION SITE ERYTHEMA (non-serious) with onset Mar2021, outcome "unknown", described as "injection site redness"; VACCINATION SITE SWELLING (non-serious) with onset Mar2021, outcome "unknown", described as "injection site little swollen"; VACCINATION SITE WARMTH (non-serious) with onset Mar2021, outcome "unknown", described as "Injection site has heat/ feels warmer to touch than any other part of the arm"; VACCINATION SITE INFLAMMATION (non-serious) with onset Mar2021, outcome "unknown", described as "injection site inflammation".  Additional Information: The patient had no other recent vaccinations and the only other new medication she started was a lymphoma treatment. She said her first dose of Rituximab was 28Jan2021, which she has had a dose every Thursday except the 18th which was cancelled due to a snow storm. She said she will be getting her last dose of  this Thursday (as reported) which was given via IV infusion, the first dose takes a lot longer, it takes about 3 hours. The patient mentioned that she knew that arm soreness happens with vaccine. She expected the injection site soreness but not the redness, swelling, inflammation and it feels warmer to touch than any other part of my arm. She did not know whether she should be concerned or not.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; slight fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 13:45 (Lot number: EL3247) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination. Concomitant medication(s) included: WELLBUTRIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Mar2021 13:45, outcome "recovering", described as "Sore arm"; FATIGUE (non-serious) with onset 03Mar2021 13:45, outcome "recovering", described as "slight fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional Information: The vaccine was given in a workplace clinic. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit sore in his 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 (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset 22Mar2021, outcome "unknown", described as "little bit sore in his arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Night sweats, Pain
Clinical narrative: body aches; night sweats; lymphnodes on my clavicle are very swollen and slightly painful; lymphnodes on my clavicle are very swollen and slightly painful; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Mar2021 09:15 (Lot number: EN6202) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: TRAMADOL; MELOXICAM; HUMIRA. Past drug history included: Doxycyclene, reaction(s): "Allergy", notes: Allergies to medications, food, or other products:Doxycyclene. Vaccination history included: Bnt162b2 (Dose 1, Single (lot# not provided)), for COVID-19 Immunisation, reaction(s): "swollen lymphomas". The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered with sequelae", described as "body aches"; NIGHT SWEATS (non-serious) with onset 2021, outcome "recovered with sequelae", described as "night sweats"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "recovered with sequelae" and all described as "lymphnodes on my clavicle are very swollen and slightly painful". Therapeutic measures were not taken as a result of pain, night sweats, lymphadenopathy, lymph node pain. Additional Information: After first shot the patient had some swollen lymphomas and one on his left clavicle never went down. After the 2nd shot he had body aches on and off for a few days and night sweats. He also experienced the lymph nodes on his clavicle were very swollen and slightly painful. 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 and has not been tested for COVID-19 since the vaccination.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021320016 same reporter/patient, different vaccine dose number and different event.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis
Clinical narrative: sick; had a cold when she went back for the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (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: ILLNESS (non-serious), outcome "unknown", described as "sick"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "had a cold when she went back for the second dose".  Additional Information: The reporter was the patient's daughter. The patient had a cold when she went back for the second dose. The community center where she went to get the vaccine wouldn't let her get it. They also wouldn't reschedule the vaccine until she gets over the cold. The reporter was asking how does she reschedule for her mother.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia
Clinical narrative: severe reaction to it, he is dizzy and he can't stand up; severe reaction to it, he is dizzy and he can't stand up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: DIZZINESS (non-serious), DYSSTASIA (non-serious), outcome "unknown" and all described as "severe reaction to it, he is dizzy and he can't stand up".  Additional Information: The reporter was asking if the events was normal or will it go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Euphoric mood
Clinical narrative: felt high immediately after receiving each of the doses; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Mar2021 08:45 (Lot number: EN6202) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Redundant Colon" (unspecified if ongoing); "Known Allergies- Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "allergy". The following information was reported: EUPHORIC MOOD (non-serious), outcome "recovering", described as "felt high immediately after receiving each of the doses". Therapeutic measures were not taken as a result of euphoric mood. Additional information: The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: The patient's age was reported as 71, no unit provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 11:00 (Lot number: EL3249) at the age of 58 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL3249; Vaccine location: Left arm; Administration time: 12:00 PM), administration date: 22Jan2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Nasal Swab Positive". The following information was reported: HEADACHE (non-serious) with onset 24Feb2021, outcome "not recovered", described as "Constant headache". The event "constant headache" 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 headache. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Ringing in ears". The event "ringing in ears" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: Treatment for the event ringing in ears included injection in ear. The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swollen hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (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: PERIPHERAL SWELLING (non-serious) with onset 16Mar2021, outcome "unknown", described as "swollen hands".  Additional information: Event was experienced 2 days after receiving his first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Presyncope
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Mar2021 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 62 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Tylenol, reaction(s): "it makes me go to sleep". The following information was reported: DIZZINESS (non-serious), PRESYNCOPE (non-serious) all with onset 17Mar2021, outcome "not recovered" and all described as "had several dizzy stuff where I almost passed out". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, presyncope. Additional information: The patient take tonic medications and free to susceptible when she take medications. When she tool Tylenol, it made her to go to sleep. Her body did not do well with stuff. Anyways, since she had her COVID shot, she had several dizzy stuff where she almost passed out. The event was persisting. It was not constant but it happens 2 -3 times a day and she was trying to make herself very aware what she was doing when it happens and what was happening to her while it was going on. The patient had not taken anything for it other than she was making herself drink more water but that did not feel to making a difference.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site lymphadenopathy
Clinical narrative: Very swollen lymph node in left arm; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 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 was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (administration time=10:00 AM, vaccine location =Left arm, dose number =1), administration date: 02Mar2021, when the patient was 43 years old, for COVID 19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 24Mar2021 10:00, outcome "recovering", described as "Headache"; VACCINATION SITE LYMPHADENOPATHY(non-serious) with onset 25Mar2021 09:00, outcome "recovering", described as "Very swollen lymph node in left arm". Therapeutic measures were not taken as a result of headache, lymphadenopathy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain in extremity
Clinical narrative: woke up in a pool of sweat; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 10:15 (Lot number: EN6207) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure/Blood Pressure" (ongoing). Concomitant medication(s) included: RAMIPRIL taken for hypertension (ongoing); NIFEDIPINE taken for hypertension (ongoing); CLONIDINE taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "recovering", described as "sore arm"; NIGHT SWEATS (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "woke up in a pool of sweat".  Additional information: Patient did not receive additional vaccines on same date of the Pfizer suspect. Patient had no history of previous immunization with Pfizer vaccine as suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient said that she got the vaccine in the morning and her arm got sore later in the evening. She said that something happened in the middle of the night, around 3-4am on 22Mar2021, she said that she woke up in a pool of sweat and never had that before. She takes something to sleep and for her to wake up was unusual. She did not feel warm or like she had a fever, and the heat was not on. It was a lot of sweat and she was concerned about this. She said that she did not typically get sweaty. She said that she was hoping her body was fighting things and it was just because of that. She does not sleep in a warm room at all. She also said that her arm was still sore today, but it was better than last night. Events did not result to emergency room and physician office visit.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "sore throat".  Additional information: The patient was currently scheduled for the second dose of the Pfizer COVID 19 vaccine on Wednesday (22Mar2021) but still has a sore throat, the patient was asking if he should get the second dose with a sore throat.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm right, administration date 12Mar2021 09:00 (Lot number: EP6955) at the age of 79 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Time: 9:00 AM, Anatomical Site of injection: Left arm Shoulder, Route of administration: Intramuscular, Batch/Lot number: EL9261), administration date: 12Feb2021, when the patient was 79 years old, for covid-19 immunisation, reaction(s): "Sleepy". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021 13:00, outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity. Additional information: The vaccine was administered on the right arm shoulder. The patient had no prior vaccinations. The event was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: bad sore throat; runny nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (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: OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "bad sore throat"; RHINORRHOEA (non-serious) with onset Mar2021, outcome "not recovered", described as "runny nose".  Additional information: Patient was scheduled to receive the second dose tomorrow, 23Mar2021 but she developed a bad sore throat and runny nose. Patient was asking whether she should proceed with the second dose as scheduled.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This is a spontaneous report received from contactable reporters (Consumer or other non HCP) from a sales representative.  A 17-year-old male patient received BNT162B2 (BNT162B2), administration date 20Mar2021 (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: HEADACHE (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "headache"; FATIGUE (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "Fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in deltoid left, administration date 18Feb2021 09:30 (Lot number: EL9265) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension", start date: 2006 (ongoing), notes: Controlled; "GERD", start date: 2014 (ongoing), notes: Controlled; "Hiatal Hernia" (unspecified if ongoing); "Fluid retention" (unspecified if ongoing). Concomitant medications included: PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE] taken for hiatus hernia, start date: 2014 (ongoing); LOSARTIN taken for hypertension, start date: 2013 (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension, fluid retention, start date: 2013 (ongoing). Vaccination history included: BNT162B2 (Dose 1, Single, Time: 14:15, Anatomical Site of injection: Lt Deltoid, Route of Administration: Intramuscular, Batch/Lot Number: EL3249), administration date: 28Jan2021, when the patient was 67 years old, for Covid-19 immunisation, reaction(s): "Injection Site Pain", "Joint pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Feb2021 12:00, outcome "recovered" (2021), described as "Injection site pain". Additional Information: The patient received dose 1 on 28Jan2021. The patient experienced injection site pain on 28Jan2021, 22:00, not serious, recovered without receiving treatment. On 30Jan2021, the patient experienced joint pain (bilateral hands), not serious, not recovered and has not received treatment. No relevant tests were done. The patient has no prior vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Pain
Clinical narrative: Body soreness; Muscle fatigue; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN6205, Expiration Date: Jun2021) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Lot Number: EN6200, Expiration Date: Jun2021 MUSC), for covid-19 immunization, reaction: "hive on upper torso, neck and chin". The following information was reported: PAIN (non-serious), outcome "unknown", described as "Body soreness"; MUSCLE FATIGUE (non-serious), outcome "unknown", described as "Muscle fatigue".  Additional information: Shot number 1 adverse event was hive on upper torso, neck and chin. No breathing problems. Shot number 2 adverse events included body soreness and muscle fatigue on 3rd day after shot. No hives.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021196639 Same patient, same drug, different dose, different events
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter (Other Healthcare Professional). The reporter is the patient. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 20Jan2021 09:00 (Lot number: EK9231) at the age of 39 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: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "sore left arm". Additional Information: The patient experienced sore left arms for 24 hours. The patient did not receive any vaccines prior vaccination within 4 weeks. No relevant test was done. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2021145143 same patient/drug, different dose/AE.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild-moderate left arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 15:15 (Batch/Lot number: unknown) at the age of 16 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: VACCINATION SITE PAIN (non-serious) with onset 22Mar2021 22:00, outcome "recovering", described as "Mild-moderate left arm pain". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: a little tired; This is a spontaneous report received from a contactable consumer.  A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 21Mar2021 (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, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "a little tired".  Additional information: The reporter (daughter) stated that her parents are both really healthy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Bottom side of lower arm turned blue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID=19 mRNA VACCINE, solution for injection) (Lot number: EN6200) 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: SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "Bottom side of lower arm turned blue".  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: woke up sick to her stomach and threw up three to four times/nauseated; woke up sick to her stomach and threw up three to four times/nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 22Mar2021 15:00 (Lot number: EN9809) at the age of 60 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Type 2 Diabetic", start date: 2016 (ongoing), notes: Diagnosed about 5 years ago. There were no concomitant medications. The following information was reported: VOMITING (non-serious), NAUSEA (non-serious) all with onset 23Mar2021, outcome "recovered" (23Mar2021) and all described as "woke up sick to her stomach and threw up three to four times/nauseated".  Additional information: The patient had no relevant family medical history. The patient had no history of previous immunization with Pfizer vaccine considered as suspect. The patient had no additional vaccines administered on same date of the Pfizer suspect. The vaccine was administered in a hospital. The events onset time was 03:30-04:00. The patient had no prior vaccinations (within 4 weeks). The events did not require a visit to emergency room or physician office.  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 (Lot number: EN620) at the age of 86 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 1, Batch/Lot number: EL9262, Site and route of Injection: Left arm), administration date: 01Feb2021, when the patient was 85 years old, for covid-19 immunisation, reaction(s): "had no reaction at all not even a sore arm". The following information was reported: FATIGUE (non-serious) with onset 25Feb2021, outcome "unknown", described as "very tired". Additional information: It was reported that the second shot was uneventful. The 2nd day after the shot, in the late afternoon, the patient felt very tired and not sure if it had anything to do with the shot. The patient has had no problem since then.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 13Mar2021 (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: DIARRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "Diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 09:30 (Lot number: EN6202) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1; Batch/lot number: EN6202; anatomical location: left arm), administration date: 27Feb2021, when the patient was 51 years old, for COVID-19 IMMUNISATION, reaction(s): "tinnitus, ringing in her left ear and it hasn't gone away", "slight loss of hearing in her left ear". The following information was reported: FATIGUE (non-serious) with onset 21Mar2021, outcome "unknown", described as "tired". Additional information: The patient was reported to be perfectly healthy and doesn't take anything. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional administered vaccines administered on same date with the Pfizer vaccine considered as suspect. It was reported that the patient's primary care doctor gave her a prescription for prednisone for 5 days to take after getting the Covid 19 vaccine. The patient didn't want to take the prednisone. She thought it was too soon. Her doctor told her to start it 24 hours after she received the vaccine. She still hasn't started taking it yet. She wanted to give her body more time. She didn't want anything else in her body. This past Sunday and Monday she's been tired.  She has not started the prednisone yet.   No follow-up attempts are possible. No further information is expected.