chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: is not in good health; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 85 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood thinner" (unspecified if ongoing), notes: He's on Coumadin a blood thinner. Concomitant medication(s) included: COUMADIN taken for anticoagulant therapy. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "is not in good health".  Additional information: Reporter explained she was calling on behalf of her 85-year-old father whose second dose of the Pfizer-BioNTech COVID-19 vaccine was scheduled this Friday. She added her father was not in good health and had a nose surgery scheduled this Wednesday on 10Mar2021. Reporter stated her dad was having nose surgery on 10Mar2021 and was going to receive his 2nd Pfizer vaccine 12Mar2021. His surgery was scheduled 2 days before his second dose. She asked if the surgery interfere with the vaccine's effectiveness. Reporter asked if the surgery cause my father to have different/worst side effects to the Pfizer-BioNTech COVID-19 vaccine. He's on Coumadin a blood thinner.  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, Feeling abnormal, Headache, Lethargy
Clinical narrative: lethargic; cloudiness in the head; fatigue; 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 45 year-old male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as 1st dose, single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 06Mar2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 06Mar2021, outcome "unknown", described as "headache"; LETHARGY (non-serious), outcome "unknown", described as "lethargic"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "cloudiness in the head".  Additional info- It was reported that patient got vaccine first dose on Friday 05Mar2021  and after he felt lethargic, run down, cloudiness in the head and with a slight headache. He had no fever slight. He wants to know if these are normal side effects.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Oxygen saturation, Vital signs measurement
Clinical narrative: She had "a burning sensation, not quite a headache" in her head; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: ACTEMRA, start date: 12Feb2021, stop date: 12Feb2021. The following information was reported: BURNING SENSATION (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "She had "a burning sensation, not quite a headache" in her head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was  interested in the data for antibody testing around vaccination, especially because she is on an immunosuppressive agent. She was wondering if the Actemra and vaccine has interaction or the effectiveness will decrease. She was supposed to inject herself with Actemra but she skipped (drug holiday) her dose because this might have an effect on the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Movement disorder, Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A male 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 "Second dose is scheduled 15 days after first dose"; PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "unknown", described as ""arm is very sore", it "hurts real bad""; MOVEMENT DISORDER (non-serious) with onset 09Mar2021, outcome "unknown", described as "he "can't raise his arm""; MYALGIA (non-serious) with onset 09Mar2021, outcome "unknown", described as "muscle pain". Therapeutic measures were taken as a result of pain in extremity, movement disorder, myalgia. Additional information: The patient was scheduled to have his second dose on 20Mar2021 explained to caller was earlier than the recommended period of 3 weeks between doses. He reported that 4 days after the first dose on 05Mar2021 his whole arm is sore. He is concerned about what to do, if he needs to take the second dose of the vaccine or not. He also wanted to know how long the sore arm is going to last. He says he put some ice on it. He will be seeing his doctor on Monday. He said that he can hardly move his arm. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was sore at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 11:00 (Lot number: EL3247) 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) with onset 08Mar2021 14:00, outcome "recovering", described as "Arm was sore at injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nauseous; Emesis/threw 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 parent.  A 21 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Lot number: EN6199) 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), outcome "not recovered", described as "Nauseous"; VOMITING (non-serious), outcome "unknown", described as "Emesis/threw up".  Additional information: Reporter stated, "Her daughter got the vaccine on Saturday. And yesterday, she woke up and was nauseous and threw up. And today, she was also nauseous. And she want to know if that was a normal reaction?".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Pain, Pharyngeal erythema
Clinical narrative: sore throat; congestion; feels like has a mild cold; achiness; throat red; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (158559). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "feels like has a mild cold"; PAIN (non-serious), outcome "unknown", described as "achiness"; PHARYNGEAL ERYTHEMA (non-serious), outcome "unknown", described as "throat red". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Warm transfer from (name). Agent states she has a caller on the line that is scheduled for her 2nd dose today, 9Mar2021 and she had felt a mild sore throat and congestion and wanted to know if it is still safe to take the 2nd dose. Agent states she had not told caller that she is coming to make a report and states from here she can be sent to (name). Stated if she doesn't take the second dose today she couldn't get another for 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: sore throat; congestion; feels like has a mild cold; achiness; throat red; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (158559). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "feels like has a mild cold"; PAIN (non-serious), outcome "unknown", described as "achiness"; PHARYNGEAL ERYTHEMA (non-serious), outcome "unknown", described as "throat red". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Warm transfer from (name). Agent states she has a caller on the line that is scheduled for her 2nd dose today, 9Mar2021 and she had felt a mild sore throat and congestion and wanted to know if it is still safe to take the 2nd dose. Agent states she had not told caller that she is coming to make a report and states from here she can be sent to (name). Stated if she doesn't take the second dose today she couldn't get another for 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Insomnia, Restlessness
Clinical narrative: she felt restless like she had drank a bunch of coffee. Felt "racy".; anxious; difficulty sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for hypersensitivity; BENADRYL taken for hypersensitivity.  The following information was reported: RESTLESSNESS (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "she felt restless like she had drank a bunch of coffee. Felt "racy"."; ANXIETY (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "anxious"; INSOMNIA (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "difficulty sleeping". The patient had the Pfizer shot and everything was fine maybe about 8, 10 hours later she started feeling very restless like she had 10 cups of coffee, kept awake a little bit. Felt "racy".  It wasn't noticeable during the day so much as it was at night.  It lasted two nights in a row, difficulty sleeping. She was restless and anxious maybe about first 48 hours then she laid down.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021259135 (RA). An 84-year-old female patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Parkinson's disease" (unspecified if ongoing), notes: Verbatim: Parkinson's disease. The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Flu like symptoms"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "soreness at the injection site". Additional information: The patient stated that she had a mild reaction at first with soreness at the injection site and flu like feeling like she'd rather go lay on the couch for 2 days than do anything else, type symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Joint injury, Joint swelling, Pain
Clinical narrative: has an intermittent knee issue, it pops up every so often / Knee started on Saturday before the 2nd dose / last night very painful could hardly walk; knee swell; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 14Feb2021 (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: JOINT INJURY (non-serious), outcome "unknown", described as "has an intermittent knee issue, it pops up every so often / Knee started on Saturday before the 2nd dose / last night very painful could hardly walk"; JOINT SWELLING (non-serious), outcome "unknown", described as "knee swell"; PAIN (non-serious), outcome "unknown", described as "Pain". Additional information: Caller states, the patient got his first Pfizer vaccine on 14Feb2021, second one the other day 07Mar2021. He was done, no side effects, did very well, very happy with Pfizer. He had an intermittent knee issue, it pops up every so often, and he went to orthopedic doctor, they drain and give a cortisone shot, he's been out of work for two days, the Knee started on Saturday before the 2nd dose, by Sunday, it was really big, Made appt. on Monday to see the Doctor, he was able to drain the fluid and not able to give the cortisone, and he told him that because you have to wait 2 weeks after Pfizer vaccine before you can get a steroid. On Sunday, or Saturday, the knee was starting to swell and the patient knew it was going to get worse.  By Sunday night, the knee was really swollen and the patient could hardly walk, and the caller means that. The caller thinks the patient has to wait 2 weeks after the Covid shot before he can take a steroid, the caller thinks that's the rule. The only thing the orthopedic doctor could do was drain the patient's knee and took out a lot of fluid and couldn't give the cortisone because the patient just had the covid two days ago.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site warmth
Clinical narrative: discoloration at the injection site; little warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from information team. The reporter is the patient.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 87 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious) with onset Mar2021, outcome "not recovered", described as "discoloration at the injection site"; VACCINATION SITE WARMTH (non-serious) with onset Mar2021, outcome "not recovered", described as "little warm". Therapeutic measures were not taken as a result of vaccination site discolouration, vaccination site warmth.  Additional Information: The Patient had her Pfizer covid vaccine on 01Mar and now has a discoloration at the injection site that is about 1 inch long, felt a little warm and it's not really bothering her, just discolored like a black and blue discoloration. The Patient wanted to know if this is common or should she be worried. The Patient had a little side effect, didn't know if she had to report that or not. It was Pfizer, it's at the site of the injection. The patient reported start date of the event as maybe the 3rd or 4th Mar 2021. The outcome of the event was reported as the same, maybe improved, the patient was not sure, it's yellow on the outside, like around the circle. The patient did not receive any treatment. The patient reported that she was taking Thyroid medications. The Patient wanted to know if it was normal what she had.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Illness, Nausea, Pain in extremity
Clinical narrative: vomiting; A lot of Fatigue; stomach pain; nausea; sick for about a week now; sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (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 25Feb2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset 25Feb2021, outcome "unknown", described as "fatigue"; ABDOMINAL PAIN UPPER (non-serious) with onset 03Mar2021, outcome "unknown", described as "stomach pain"; NAUSEA (non-serious) with onset 03Mar2021, outcome "unknown", described as "nausea"; ILLNESS (non-serious) with onset 03Mar2021, outcome "unknown", described as "sick for about a week now"; VOMITING (non-serious) with onset 07Mar2021, outcome "unknown", described as "vomiting"; FATIGUE (non-serious) with onset 03Mar2021, outcome "unknown", described as "A lot of Fatigue".  Additional information: Reason for no lot number of Pfizer-BioNTech COVID-19 Vaccine was reported as Caller unwilling to complete the report. Patient gender was referred to as female during this report, but gender not verified with caller who was unwilling to complete report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; A lot of Fatigue; stomach pain; nausea; sick for about a week now; sore arm; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (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 25Feb2021, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset 25Feb2021, outcome "unknown", described as "fatigue"; ABDOMINAL PAIN UPPER (non-serious) with onset 03Mar2021, outcome "unknown", described as "stomach pain"; NAUSEA (non-serious) with onset 03Mar2021, outcome "unknown", described as "nausea"; ILLNESS (non-serious) with onset 03Mar2021, outcome "unknown", described as "sick for about a week now"; VOMITING (non-serious) with onset 07Mar2021, outcome "unknown", described as "vomiting"; FATIGUE (non-serious) with onset 03Mar2021, outcome "unknown", described as "A lot of Fatigue".  Additional information: Reason for no lot number of Pfizer-BioNTech COVID-19 Vaccine was reported as Caller unwilling to complete the report. Patient gender was referred to as female during this report, but gender not verified with caller who was unwilling to complete report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction, Pain in extremity
Clinical narrative: Will the IBG infusion interfere with the second dose of the vaccine; little sore 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 68 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Low immune system" (unspecified if ongoing), notes: Takes IBG infusion monthly. She has to take a steroid, Tylenol and Benadryl along with infusions. The patient's concomitant medications were not reported. The following information was reported: POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "Will the IBG infusion interfere with the second dose of the vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little sore arm".  Additional information included: The patient would receive the next IBG infusion on 12Mar2021 and would take steroid, Tylenol and Benadryl along with infusion. Her second dose of vaccination would be on 17Mar2021. She wanted to know if that will interfere with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vomiting
Clinical narrative: Vomiting; muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 18 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: VOMITING (non-serious) with onset 25Feb2021, outcome "recovered", described as "Vomiting"; MYALGIA (non-serious) with onset 25Feb2021, outcome "recovered", described as "muscle aches". Therapeutic measures were taken as a result of vomiting, myalgia.  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. Ibuprofen was received as treatment for the events. Events did not result to physician office visit and emergency room visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: nausea; diarrhea; headache; dizziness; fatigue; I've been sleeping a lot / she is really tired, she is falling asleep all the time; feeling bad; 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 76 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EN6206) dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: NAUSEA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "nausea"; DIARRHOEA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "diarrhea"; HEADACHE (non-serious) with onset 05Mar2021, outcome "not recovered", described as "headache"; DIZZINESS (non-serious) with onset 05Mar2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 05Mar2021, outcome "unknown", described as "fatigue"; SOMNOLENCE (non-serious) with onset 05Mar2021, outcome "unknown", described as "I've been sleeping a lot / she is really tired, she is falling asleep all the time"; FEELING ABNORMAL (non-serious) with onset 05Mar2021, outcome "unknown", described as "feeling bad".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: nausea; diarrhea; headache; dizziness; fatigue; I've been sleeping a lot / she is really tired, she is falling asleep all the time; feeling bad; 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 76 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EN6206) dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: NAUSEA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "nausea"; DIARRHOEA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "diarrhea"; HEADACHE (non-serious) with onset 05Mar2021, outcome "not recovered", described as "headache"; DIZZINESS (non-serious) with onset 05Mar2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 05Mar2021, outcome "unknown", described as "fatigue"; SOMNOLENCE (non-serious) with onset 05Mar2021, outcome "unknown", described as "I've been sleeping a lot / she is really tired, she is falling asleep all the time"; FEELING ABNORMAL (non-serious) with onset 05Mar2021, outcome "unknown", described as "feeling bad".  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysstasia, Illness
Clinical narrative: sick; can't stand up by himself; dizziness; weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Feb2021 (Lot number: EM9810) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes; "Arthritis" notes: Verbatim: Arthritis; "Cirrhosis liver" (unspecified if ongoing), notes: Verbatim: Cirrhosis liver; "pain" (unspecified if ongoing); "He got Corona Virus and he got through that." (unspecified if ongoing); "he had fluid in the stomach" (unspecified if ongoing); "he had ammonia in his brain" (unspecified if ongoing); "he couldn't talk or speak" (unspecified if ongoing); "About two or three days after surgery he couldn't speak" (unspecified if ongoing); "He could use the walker to go to the bathroom by himself." (unspecified if ongoing). Concomitant medication(s) included: RIFAXIMIN; SPIRONOLACTONE; FUROSEMIDE; SERTRALINE; ENULOSE; FAMOTIDINE; CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; NOVOLOG taken for diabetes mellitus; LANTUS taken for diabetes mellitus; LIDOCAINE; VOLTAREN [DICLOFENAC SODIUM] taken for arthritis, pain; DICLOFENAC SODIUM; OXYCODON.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; DIZZINESS (non-serious) with onset 28Feb2021, outcome "not recovered", described as "dizziness"; ASTHENIA (non-serious) with onset 28Feb2021, outcome "not recovered", described as "weakness"; DYSSTASIA (non-serious), outcome "unknown", described as "can't stand up by himself".  Additional information: Patient got dizziness and weakness 3 days after the vaccine and it is ongoing.  Patient was scheduled to receive second dose of vaccine on 15Mar2021. He took Oxycodone about 20 years. He had to give up Oxycodone because his liver is not working right now. He tries not to take Oxycodone.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Fatigue
Clinical narrative: abdominal pain; fatigue; stomach issues; 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 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 11:00 (Lot number: EN6205, Expiration Date: 06Mar2021) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing), notes: This was diagnosed when he was 42, so 22 years ago or so.; "Heart disease, unspecified" (unspecified if ongoing), notes: This was diagnosed when he was 40, 21 years ago. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 07Mar2021, outcome "unknown", described as "abdominal pain"; FATIGUE (non-serious) with onset 07Mar2021, outcome "unknown", described as "fatigue"; ABDOMINAL DISCOMFORT (non-serious) with onset 07Mar2021, outcome "unknown", described as "stomach issues".  Additional information: Consumer reported that he got his first dose of the Pfizer COVID-19 vaccine Saturday and they gave him a paper and he was reading side effects and he doesn't had a lot on there but he had a couple things that are not on there and he wants to query for if they are common. He reported that he had stomach issues and pain. reporter stated that his vaccine card was printed by a computer with typed in information. He reported that it had a MRN number, his name, date of birth, male, and a sticker on there with the LOT. He reported that it was Sunday night when the stomach pain and stomach issues started, which had stayed about the same with no treatment done.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Vaccination site pain
Clinical narrative: When she received the shot she had pain in the injection site; Tired some days; This morning she had a lot of stomach pain; Very watery diarrhea; 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) (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 (First dose), for Covid-19 Immunisation. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 09Mar2021, outcome "unknown", described as "This morning she had a lot of stomach pain"; DIARRHOEA (non-serious) with onset 09Mar2021, outcome "unknown", described as "Very watery diarrhea"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "When she received the shot she had pain in the injection site"; FATIGUE (non-serious), outcome "unknown", described as "Tired some days".  Additional information: Patient received the second dose of the vaccine on Saturday, this morning she had a lot of stomach pain and very "watery" diarrhea, when she received the shot she had pain in the injection site and she felt tired some days, she did not have chills or fever.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Vaccination site paraesthesia, Vaccination site pruritus
Clinical narrative: Tingling and throbbing from the injection site; Tingling and throbbing from the injection site; Itching at injection site; feels kind of like her arm fell asleep; 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 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 (Lot number: EN6202) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic kidney disease stage 3" (unspecified if ongoing), notes: Verbatim: Chronic kidney disease stage 3; "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure; "Cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol abnormal (ongoing); IRBESARTAN/HCTZ GA taken for blood pressure abnormal. The following information was reported: VACCINATION SITE PARAESTHESIA (non-serious), PAIN (non-serious) all with onset 03Mar2021, outcome "not recovered" and all described as "Tingling and throbbing from the injection site"; VACCINATION SITE PRURITUS (non-serious) with onset 03Mar2021, outcome "recovering", described as "Itching at injection site"; FEELING ABNORMAL (non-serious) with onset 03Mar2021, outcome "unknown", described as "feels kind of like her arm fell asleep".  Additional information: Caller was a consumer. She reports she received her first covid vaccine exactly a week ago, on 2Mar2021. She initially stated that she developed tingling, but later clarified she also feels throbbing from the injection site, all the way down to her fingertips: feels kind of like her arm fell asleep. She reports this has been going on since the day after the vaccine,3Mar2021. Caller reports it comes and goes maybe about 6-7 times an hour. Caller stated that she does not know if he hit a nerve when he gave her injection or if this is from the vaccine itself. She thinks a week is long enough to worry. Reports it itches at the injection site and it improved slightly. Caller stated the Bottle number/Lot number is EN6202. It is hard to read his writing, but she thinks that is an N. Caller stated the person who gave her the vaccine told her he gets 6 doses out of a bottle. She sees a date of 03Sep2020, on the bottom of the card, that is the only date she sees.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She got sick; 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) (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.  The seriousness of the event was reported as non-serious. The reporter reported that she got sick but it had nothing to do with the COVID shot.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Mydriasis, Night blindness, Ocular discomfort
Clinical narrative: Vision is Very Blurry/eyesight got blurry; Hard to Read in Small Print; looked at her pupils, one was huge and one was small; felt like something was in her eye; at night time she can't see with the street lights and lights from the cars are blinding.  They only way she can see things is in the sunlight; Lost Part of Eye Sight; 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 83 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 13:00 (Lot number: EN6200) at the age of 83 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Shingles vaccine, administration date: Jan2021, when the patient was 83 years old, for immunisation. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 15Feb2021, outcome "not recovered", described as "Lost Part of Eye Sight"; VISION BLURRED (non-serious) with onset 27Feb2021, outcome "not recovered", described as "Vision is Very Blurry/eyesight got blurry"; VISUAL IMPAIRMENT (non-serious) with onset 27Feb2021, outcome "not recovered", described as "Hard to Read in Small Print"; MYDRIASIS (non-serious) with onset 27Feb2021, outcome "unknown", described as "looked at her pupils, one was huge and one was small"; OCULAR DISCOMFORT (non-serious) with onset 27Feb2021, outcome "unknown", described as "felt like something was in her eye"; NIGHT BLINDNESS (non-serious) with onset 27Feb2021, outcome "not recovered", described as "at night time she can't see with the street lights and lights from the cars are blinding.  They only way she can see things is in the sunlight". The events "vision is very blurry/eyesight got blurry", "hard to read in small print", "looked at her pupils, one was huge and one was small", "felt like something was in her eye" and "at night time she can't see with the street lights and lights from the cars are blinding.  they only way she can see things is in the sunlight" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She mentioned that she has already seen her ophthalmologist and a retinal specialist, states they didn't give her any medicine and said it would resolve in 6-8 weeks but she doesn't know. She was really upset about it and she considers this very serious. She fears she might go blind and was weary of taking the 2nd dose. Additional vaccines administered on same date of the Pfizer Suspect was reported as none.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Vision is Very Blurry/eyesight got blurry; Hard to Read in Small Print; looked at her pupils, one was huge and one was small; felt like something was in her eye; at night time she can't see with the street lights and lights from the cars are blinding.  They only way she can see things is in the sunlight; Lost Part of Eye Sight; 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 83 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 13:00 (Lot number: EN6200) at the age of 83 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Shingles vaccine, administration date: Jan2021, when the patient was 83 years old, for immunisation. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 15Feb2021, outcome "not recovered", described as "Lost Part of Eye Sight"; VISION BLURRED (non-serious) with onset 27Feb2021, outcome "not recovered", described as "Vision is Very Blurry/eyesight got blurry"; VISUAL IMPAIRMENT (non-serious) with onset 27Feb2021, outcome "not recovered", described as "Hard to Read in Small Print"; MYDRIASIS (non-serious) with onset 27Feb2021, outcome "unknown", described as "looked at her pupils, one was huge and one was small"; OCULAR DISCOMFORT (non-serious) with onset 27Feb2021, outcome "unknown", described as "felt like something was in her eye"; NIGHT BLINDNESS (non-serious) with onset 27Feb2021, outcome "not recovered", described as "at night time she can't see with the street lights and lights from the cars are blinding.  They only way she can see things is in the sunlight". The events "vision is very blurry/eyesight got blurry", "hard to read in small print", "looked at her pupils, one was huge and one was small", "felt like something was in her eye" and "at night time she can't see with the street lights and lights from the cars are blinding.  they only way she can see things is in the sunlight" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She mentioned that she has already seen her ophthalmologist and a retinal specialist, states they didn't give her any medicine and said it would resolve in 6-8 weeks but she doesn't know. She was really upset about it and she considers this very serious. She fears she might go blind and was weary of taking the 2nd dose. Additional vaccines administered on same date of the Pfizer Suspect was reported as none.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Headache; Nausea; Soreness; Exhaustion; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 12:00 (Lot number: EN6202) at the age of 22 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: HEADACHE (non-serious) with onset 05Mar2021 12:45, outcome "recovered" (Mar2021), described as "Headache"; NAUSEA (non-serious) with onset 05Mar2021 12:45, outcome "recovered" (Mar2021), described as "Nausea"; PAIN (non-serious) with onset 05Mar2021 12:45, outcome "recovered" (Mar2021), described as "Soreness"; FATIGUE (non-serious) with onset 05Mar2021 12:45, outcome "recovered" (Mar2021), described as "Exhaustion"; CHILLS (non-serious) with onset 05Mar2021 12:45, outcome "recovered" (Mar2021), described as "Chills". Therapeutic measures were not taken as a result of headache, nausea, pain, fatigue, chills. Additional information: Facility type vaccine where patient received vaccine reported as Pharmacy or Drug Store. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. No known allergies reported.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vital capacity
Clinical narrative: dizzy spells; 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 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer in lymph nodes", start date: 2015 (unspecified if ongoing), notes: She had cancer in her Lymph nodes, but she is in remission.; "swollen lymph nodes" (unspecified if ongoing), notes: She has had cancer and swollen lymph nodes from that; "lymph nodes removed" (unspecified if ongoing), notes: The took 8 of the lymph nodes out.; "high blood pressure" (ongoing), notes: about 7 years ago; "Schizophrenia", start date: 1989 (ongoing); "Asthma" (ongoing), notes: 3 years ago. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 07Mar2021, outcome "not recovered", described as "dizzy spells". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dysstasia, Fatigue, Feeling abnormal, Thinking abnormal
Clinical narrative: problems with balance; tired; couldn't think and ended falling asleep; did not feel great; trouble standing; 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 57 year-old female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) at the age of 57 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 BALANCE DISORDER (non-serious) with onset 08Mar2021, outcome recovering; FATIGUE (non-serious) with onset Mar2021, outcome recovering; THINKING ABNORMAL (non-serious) with onset Mar2021, outcome recovering; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome recovering; DYSSTASIA (non-serious) with onset Mar2021, outcome recovering.  Patient received her first Pfizer Covid 19 vaccination yesterday (08Mar2021) and had some reactions to it. She was ok when she left but about 1 hour later, she had problems with balance, had to sit down, got really tired, and couldn't think and ended falling asleep. she could not stand so had to sit down. She woke up this morning, felt a little better, did not feel great, but went to work anyway. She had to go sit down at work too because she was having trouble standing up because tired and could not balance. She feel better today as the day progressed. She was concerned about the second dose and planned to discuss this further with her physician.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.