chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Headache, Pyrexia, Swelling
Clinical narrative: She said she had headache most of the day, most notably when she stood up.; She also had a fever of 99.9 degrees; Complained of swelling and pain under her armpit.; Pain under her armpit; This is a spontaneous report from a contactable reporter (Pharmacist). The reporter is the parent.  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 10Dec2021 at 16:45 (Lot number: FK5618) at the age of 7 years as dose 2 (tris), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE, Lot Number: FK5618, Anatomical Location: Left arm, Route of Administration: Intramuscular, Administration time: 16:45), administration date: 20Nov2021, when the patient was 7 years old, for COVID-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 11Dec2021 at 08:00, outcome "recovered" (an unknown date in Dec2021), described as "She said she had headache most of the day, most notably when she stood up"; PYREXIA (non-serious) with onset 11Dec2021 at 08:00, outcome "recovered" (an unknown date in Dec2021), described as "She also had a fever of 99.9 degrees"; SWELLING (non-serious) with onset 11Dec2021 at 08:00, outcome "recovered" (an unknown date in Dec2021), described as "Complained of swelling and pain under her armpit"; AXILLARY PAIN (non-serious) with onset 11Dec2021 at 08:00, outcome "recovered" (an unknown date in Dec2021), described as "Pain under her armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia, swelling and axillary pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Palpitations
Clinical narrative: Dose received: 3; Heart palpitations; This is a spontaneous report received from contactable reporter (Nurse).  A male patient received bnt162b2 (BNT162B2), administration date an unknown date in 2021 (Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine manufacture unknown (DOSE 1, SINGLE, Lot Number: UNKNOWN), for COVID-19 immunisation and Covid-19 vaccine manufacture unknown (DOSE 2, SINGLE, Lot Number: UNKNOWN), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Dose received: 3"; PALPITATIONS (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Heart palpitations". The event "Heart palpitations" was evaluated at the emergency room visit. It was unknown whether any therapeutic measures were taken as a result of the event PALPITATIONS.  Additional Information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was reported that while on a vendor call one of the vendors mentioned in passing that he had received the Pfizer booster and had to go to the ER for heart palpitations, but no further information was provided.  The lot number for BNT162b2 was not provided and will be requested during follow up.
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) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), intramuscular, administration date 30Jan2021 (Lot number: EL3247) as dose 1, single and administration date 23Feb2021 (Lot number: EL6201) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: sore throat; She is not feeling too good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A 99-year-old female patient received bnt162b2 (BNT162B2) solution for injection, dose 1 (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), outcome "unknown", described as "sore throat"; MALAISE (non-serious), outcome "unknown", described as "She is not feeling too good".  Additional information: reporter mentioned that his Mother-in-law is scheduled to receive the second dose of the Pfizer-BioNTech COVID-19 Vaccine today, but she is "not feeling the greatest, woke up with a sore throat and no fever". Can she get the shot today. Potential AE realized after call (possible underlying disease), e-transmitting for review (99 years old, Female). Reporter stated, our mother here is 99 years old, she is due for her second Pfizer shot today. She is not feeling too good, she has got a sore throat. Is it safe to get her the shot today. Reporter stated, can you transfer me. Reporter was provided with the number as (Contact number) (Option 3) and was informed about the timings as 8 AM-8 PM Monday to Sunday as per EST. In response to further probing, Reporter stated, no, its not a good time, no. LOT#: Reporter stated, no, we dont have it right now. Limited information was available over the call as the reporter was not willing to proceed with the questions.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the site of application; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at the site of application". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: After the first dose, the patient felt some soreness at the site of application on the first day, she put some ice and the next day she felt better. She thought the nurse "put it so high", where the clavicular bone meets her arm, an inch below that, she thinks its a little high for the vaccine. The patient (Retired Registered Nurse) is scheduled for a colonoscopy had the procedure to be done by gastro-endocrinologist (further clarification unknown). It will be on March 18th on 9am at the clinic or hospital, she don't know. On the 19Mar, the next day at 12noon, the patient was scheduled for second dose of Covid Vaccine. It was reported LOT# and Expiration date: Nurse stated, "It was lost." Asking was the vaccine administered on the deltoid muscle? and can she get the vaccine after the 21 days?.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Pain
Clinical narrative: collarbone pain; hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Lot number: EM9809) at the age of 79 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "autoimmune disease" (unspecified if ongoing). Concomitant medication(s) included: URSODIOL. Vaccination history included: Bnt162b2 (Batch/Lot number: EL9262), administration date: 03Feb2021, for Covid-19 Immunization.  The following information was reported: PAIN (non-serious), outcome "Not recovered", described as "collarbone pain"; ALOPECIA (non-serious), outcome "Not recovered", described as "hair loss". Therapeutic measures were not taken as a result of pain, alopecia.  Additional Information: Consumer stated, she just want to report possible side effects, she got post her shot. start date of experiencing the problems, consumer stated, She had two problems one was the pain in the collar bone and the other was hair loss, her hair was coming out. Consumer further added, she got her First shot on February 3, she was just giving you the estimate, she was not a 100% sure. She would say in the middle of February, She was not sure 100%. When probed for the doctor details, consumer stated, she will you her regular doctor. When probed for the facility details, consumer stated, "The vaccine was administered at (Address). When probed for the number of facility, consumer stated, she had no idea. When probed for the expiration date, consumer stated, "she don't have an expiration date. When probed for the NDC, consumer stated, "she don't see a bar code. When probed for the dose, consumer stated, she don't have either. When probed for route of administration, consumer stated, she don't have anything other than what she gave u. Concomitant medications: Consumer stated, yes, but she was on all those medications from last 1 year. When probed if the event was worsened, improved or persisting, consumer stated, She still have it. Consumer stated, She just want to know how long it is going to last. Consumer was provided with the number of Pfizer Medical Information.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dizziness postural, Fatigue, Headache
Clinical narrative: headache; Injection site pain; dizziness; fatigue; dizziness is so strong that he cannot stay stand up; feeling with little energy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (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) with onset 03Mar2021, outcome "recovered" (2021), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "Injection site pain"; DIZZINESS (non-serious) with onset 03Mar2021, outcome "unknown", described as "dizziness"; FATIGUE (non-serious) with onset 03Mar2021, outcome "not recovered", described as "fatigue"; DIZZINESS POSTURAL (non-serious) with onset 03Mar2021, outcome "unknown", described as "dizziness is so strong that he cannot stay stand up"; ASTHENIA (non-serious) with onset 03Mar2021, outcome "unknown", described as "feeling with little energy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: headache; Injection site pain; dizziness; fatigue; dizziness is so strong that he cannot stay stand up; feeling with little energy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (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) with onset 03Mar2021, outcome "recovered" (2021), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "Injection site pain"; DIZZINESS (non-serious) with onset 03Mar2021, outcome "unknown", described as "dizziness"; FATIGUE (non-serious) with onset 03Mar2021, outcome "not recovered", described as "fatigue"; DIZZINESS POSTURAL (non-serious) with onset 03Mar2021, outcome "unknown", described as "dizziness is so strong that he cannot stay stand up"; ASTHENIA (non-serious) with onset 03Mar2021, outcome "unknown", described as "feeling with little energy". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema
Clinical narrative: painful raised red patch at the injection site, it hurt; painful raised red patch at the injection site, it hurt; 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 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Feb2021 13:55 (Lot number: EN6202) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer", start date: 2016 (unspecified if ongoing), notes: Verbatim: Cancer; "a-fib", start date: 2020 (unspecified if ongoing), notes: Verbatim: a-fib. There were no concomitant medications. The following information was reported: PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 01Mar2021, outcome "not recovered" and all described as "painful raised red patch at the injection site, it hurt". Therapeutic measures were not taken as a result of pain, vaccination site erythema.  Additional Information: Patient is 80 years old, she got the first dose of Pfizer's COVID-19 vaccine on 28Feb, two days later she had a painful raised red big patch at the injection site, it hurt and she still has it. Caller says they have not had any other recent vaccinations or started any new medications.  No follow up attempts are possible. No further information is expected.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Sat out in the sun 04MAR2021.Now has blisters./a couple big blisters on her left knee and a couple small blisters above her left knee; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 91 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 09:30 (Lot number: EL1284) at the age of 91 years as 1st dose, single for covid-19 immunisation. Relevant medical history included: "sarcoidosis" (unspecified if ongoing); "stool softener" (unspecified if ongoing); "Bladder" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN (ongoing); SOLIFENACIN taken for bladder disorder (ongoing); HYDROCODONE/PARACETAMOL (ongoing); DOCUSATE SODIUM taken for faeces soft (ongoing).The following information was reported: BLISTER (non-serious) with onset 04Mar2021, outcome "not recovered", described as "Sat out in the sun 04MAR2021. Now has blisters./a couple big blisters on her left knee and a couple small blisters above her left knee".  Additional Information for Concomitant Products hydrocodone-acetaminophen: Makes her sleep a lot, so she only takes a half a tablet when she needs it, which isn't often. No Lot/NDC/Expiry on the pharmacy bottle. Caller is calling about her sister, (name). States that she got the BioNtech Covid 19 vaccine on 02Mar2021 and did well at 91 years old. Her sister went out yesterday and sat out in the sun. States that parts of her left leg were in the sun, and this morning she has blisters on those same parts of her left leg. Have there been any reports of anyone blistering after getting the vaccine? States that she got the vaccine in her left arm. She has no blisters anywhere else. She has a couple big blisters on her left knee and a couple small blisters above her left knee, but she doesn't know if it was the from the sun or if the shot had anything to do with it. States that her sister used to have psychodosis, but is no longer on medication for that. Call handler attempted to clarify, but caller did not know what psychodosis was and she didn't know how to spell it. Psychodosis in this report is spell as pronounced by the caller. States that her sister slept late today and is eating now. She noticed the blisters when she got up today and showered. They have not used any kind of treatment for the blisters. Caller states that her sister got the blisters yesterday, 04Mar2021, but didn't notice them until today, 05Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Insomnia, Myalgia, Pain in extremity
Clinical narrative: arm is sore was reported as worsened; arm is keeping her up at night; it hurts, it's like a muscle pain; 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 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 14:00 (Lot number: EN6201) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "thyroid" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Feb2021, outcome "not recovered", described as "arm is sore was reported as worsened"; INSOMNIA (non-serious) with onset 17Feb2021, outcome "unknown", described as "arm is keeping her up at night"; MYALGIA (non-serious) with onset 17Feb2021, outcome "unknown", described as "it hurts, it's like a muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, insomnia, myalgia.  Additional information: It was reported that patient administered flu shot every year, her arm might be sore for a day or two at the most, but patient did not remember it being sore hardly at all. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations were not available were none. Vaccination Facility Type at Pharmacy and Grocery Store. There were no relevant test. The patient did not received any vaccine within 4 weeks prior vaccinations. Patient did not administered vaccines on same date with the Pfizer vaccine considered as suspect. Concomitant Medications, History and Investigations: Caller has, and takes medicine for high blood pressure, cholesterol and her thyroid medicine. She took all those medicines. She's had her normal yearly Blood test. She did not feel they are relevant to this report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: extreme pain around his hips, hollering out in pain that he cannot move them /he couldn't hardly stand the pain around his lower waist, by his hips; 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 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: Jul2020, stop date: Jul2020; "Broken Left Leg/broke his right leg up by where the bone connects to the hip/broken both legs", start date: Jul2020 (unspecified if ongoing), notes: her husband has broken both legs since July and is recovering; "has multiple stents" (unspecified if ongoing); "had open heart surgery" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; XARELTO.  The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "extreme pain around his hips, hollering out in pain that he cannot move them /he couldn't hardly stand the pain around his lower waist, by his hips".  Additional information: Caller states that she and her husband received the first pfizer coivd 19 vaccine on Tuesday 2Mar2021. Her husband was okay Tuesday. His physical therapist came that day and he was fine. On Wednesday, he couldn't hardly stand the pain around his lower waist, by his hips. States that he couldn't move his hips due to the pain, and he just hollers when he tries to move them. Caller states that he has fought 2 injuries since Jul2020. He broke his left leg, and then broke his right leg up by where the bone connects to the hip. So, he's been in therapy. States that he was in a rest home for 3 months, and he has been home for 4 months; and has home physical therapy and a home care nurse that comes. At first they thought that the pain may have just been from the physical therapy on Wednesday, but when the in home nurse came on Thursday, she said that therapy wouldn't have done that and she thought it was a side effect of the vaccine. The nurse also said that her dad complained of the same thing after getting the vaccine. Caller asks, have there been any complaints of hip pain before? How long has it lasted? And what can they do? Caller wanted to know what she can do to help the hip pain her husband is having States that he has a lot of medical conditions. He is on the blood thinner Xarelto; he's a diabetic and takes insulin; he has major heart conditions. It was reported that Patient Age was 78.   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-2021259635 same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated
Clinical narrative: back pain/ pain across his back in his lower part that fades away after he gets up; Before vaccination he already had back pain, but it got worse after vaccination; 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. Other Case identifier(s): US-PFIZER INC-2021244788 (Pfizer).  A 85 year-old male patient received bnt162b2 (BNT162B2), administration date 20Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "had back pain" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 30Jan2021, for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "recovering", described as "back pain/ pain across his back in his lower part that fades away after he gets up"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "Before vaccination he already had back pain, but it got worse after vaccination".  Additional information: He mentioned that reports of back pain associated to the COVID-19 vaccine have been mentioned on TV news. Caller mentions that he called earlier and wanted to know if there were reports about back pain. He says that he got the 2 doses of the Pfizer-BioNTech covid 19 vaccine; the first dose he got it on 30Jan and the second on 20Feb. He has some pain across his back in his lower part that fades away after he gets up. He says that he has back pain before getting the vaccines (the 2 doses of the covid vaccine) and thought it was due to an old mattress he had. Now he has changed his mattress for a new one and says that the pain is in the lower part of his back. Was tried to get an agent but there was 34 calls ahead. caller did not want to wait and give his consent to be contacted, however he wanted to be contacted around 5pm because he has to go. AE duplicate.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: This is a spontaneous report received from a contactable other HCP (patient), via a Pfizer sponsored program (159558). The reporter is the patient. A 72-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Feb 26, 2021, single dose, for COVID-19 immunisation. The patient's medical history not reported. The patient took concomitant medications. The patient had fatigue/felt tired the next day, onset Feb 27, 2021, with outcome of unknown, and malaise, with outcome of unknown. Additional information: The patient reported that, after getting first dose injection, it was weird. She did not feel like anything went in there. She felt tired the next day. She took medications that made her feel tired, but this was different. She believed she may had gotten malaise. But was not sure. She wanted to know if she had no antibodies, what should she do. She was scheduled for the second dose on Mar 19, 2021. Patient needed physiological tests and antibodies tests to get done so that she could know. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information  expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Chills, Dizziness, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose number unknown, single dose for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 04Mar2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 04Mar2021, outcome "unknown", described as "chills"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 04Mar2021, outcome "unknown", described as "temperature"; DIZZINESS (non-serious) with onset 05Mar2021, outcome "unknown", described as "dizziness"; FATIGUE (non-serious) with onset 05Mar2021, outcome "unknown", described as "fatigue"; NAUSEA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "nausea". 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (consumer or other non-HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose number unknown, single dose for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 04Mar2021, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 04Mar2021, outcome "unknown", described as "chills"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 04Mar2021, outcome "unknown", described as "temperature"; DIZZINESS (non-serious) with onset 05Mar2021, outcome "unknown", described as "dizziness"; FATIGUE (non-serious) with onset 05Mar2021, outcome "unknown", described as "fatigue"; NAUSEA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "nausea". 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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: body aches; chills; 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 62 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "felt horrible after", start date: 2020 (unspecified if ongoing), notes: after he received his Shingles vaccines he "felt horrible after". The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered", described as "body aches"; CHILLS (non-serious), outcome "recovered", described as "chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Malaise
Clinical narrative: he's not feeling well; diarrhea; feeling weak; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 04Feb2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: ATEZOLIZUMAB, start date: 25Feb2021. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "he's not feeling well"; DIARRHOEA (non-serious) with onset 04Mar2021, outcome "unknown", described as "diarrhea"; ASTHENIA (non-serious) with onset 04Mar2021, outcome "unknown", described as "feeling weak". Additional information: Patient received his first shot on 04Feb2021 and scheduled to get his 2nd dose on 26Feb2021 however his appointment was cancelled because he's not feeling well. He tried to reschedule his 2nd dose again and was scheduled today 04Mar2021. However, the caller said he is not feeling well today.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: it was extremely painful; I was unable to move my arm for several days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 27 year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 21Jan2021 17:45 (Lot number: EL3247) at the age of 27 years as dose 1, single for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: MURO 128. The following information was reported: PAIN (non-serious) with onset 23Jan2021, outcome "recovered", described as "it was extremely painful"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 23Jan2021, outcome "recovered", described as "I was unable to move my arm for several days". Therapeutic measures were not taken as a result of pain, joint range of motion decreased. Additional information: The patient had no other vaccine in four weeks. The patient had no prior vaccination, did not have COVID test post vaccination and had no known allergies. Other medication in two weeks included MURO 128 eye ointment. The patient reported that with the first vaccine it was extremely painful and was unable to move her arm for several days.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: pain and discomfort under the left armpit; lymph node that is irritated; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 (Lot number: EN6200) at the age of 31 years as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: AXILLARY PAIN (non-serious) with onset 03Mar2021, outcome "not recovered", described as "pain and discomfort under the left armpit"; LYMPHADENOPATHY (non-serious) with onset 03Mar2021, outcome "not recovered", described as "lymph node that is irritated".  Additional information: the patient said that he received the vaccine on Tuesday 02Mar2021 and he started to notice the pain on 03Mar2021 and it was worse today 04Mar2021. He said that he was fine before the vaccine and his arm was fine. He said that if he tries to make a fist it is uncomfortable and to flex his muscles in his arm. He did say that he was doing some heavy lifting the day that he received the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Received Pfizer COVID vaccine. Got sick. Got better.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 65 years 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: ILLNESS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "Received Pfizer COVID vaccine. Got sick. Got better.". Therapeutic measures were not taken as a result of illness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: arm was a little sore; a little tired for a day or two; This is a spontaneous report received from a contactable reporter (Consumer).  A female patient of an unspecified age received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single; both via an unspecified route of administration on an unspecified date 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 "arm was a little sore"; FATIGUE (non-serious), outcome "unknown", described as "a little tired for a day or two". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: showed antibodies. 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-2021240087 same reporter/drug, different patient, similar events
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Her arm is still swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 23Feb2021 (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: PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "Her arm is still swollen".  No follow-up attempts are possible. information about lot/batch number cannot been obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Tremor
Clinical narrative: I have a tremor in my right hand; My ears just got totally clogged up and I am very uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 13:30 (Lot number: EN6205) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for Covid-19 immunisation. The following information was reported: EAR DISCOMFORT (non-serious) with onset 04Mar2021, outcome "unknown", described as "My ears just got totally clogged up and I am very uncomfortable"; TREMOR (non-serious), outcome "unknown", described as "I have a tremor in my right hand".  No follow-up attempts are possible. No further information is expected.
Age: 74.0
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).  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Feb2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "past stroke" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (the first dose), for covid19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 01Mar2021, outcome "recovered" (2021), described as "headache". Therapeutic measures were taken as a result of headache included some ibuprofen.  Additional Information: the patient is the reporter mother. No other vaccine in four weeks. No covid prior to vaccination and no covid test post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2021 09:15 (Lot number: EL8982) at the age of 72 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: PAIN IN EXTREMITY (non-serious) with onset 20Jan2021, outcome "recovered" (21Jan2021), described as "Arm soreness".  Additional Information: No treatment received, no covid prior to vaccination and no covid test post vaccination. No known allergies and other medical history. No other vaccine in four weeks and no other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "past stroke" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's 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 is the reporter mother. No other vaccine in four weeks. No covid prior to vaccination and no covid test post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test, Seasonal allergy
Clinical narrative: seasonal allergy; sore throat; 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. Other Case identifier(s): US-PFIZER INC-2021360431 (Pfizer).  A male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.  Relevant medical history included: "Chronic Bronchitis" (unspecified if ongoing), notes: diagnosed with Chronic Bronchitis prior to getting the 1st dose of the Covid-19 vaccine. The patient's concomitant medications were not reported.  The following information was reported: SEASONAL ALLERGY (non-serious) with onset Mar2021, outcome "unknown", described as "seasonal allergy"; OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He is asking if he can take the 2nd dose today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: seasonal allergies; 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 (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: SEASONAL ALLERGY (non-serious), outcome "unknown", described as "seasonal allergies".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Food allergy
Clinical narrative: an hour ago food allergy reaction; 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) (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: FOOD ALLERGY (non-serious), outcome "unknown", described as "an hour ago food allergy reaction". 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, Food allergy
Clinical narrative: 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. 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 "missed second dose of Covid Vaccine"; FOOD ALLERGY (non-serious), outcome "unknown", described as "developed food allergy". Additional information: Consumer missed second dose of covid vaccine because of newly developed food allergy after first dose. He was delayed by one week. A consumer missed his second dose, he didn't give a reason, he went back yesterday to get his second dose, but he developed food allergies, so didn't get his second dose. His second dose was on 28Apr2021. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Sick; Initial information was received on 07-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had sick (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got sick for three days from the senior one so I get the regular flu shot"  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: terrible hives; Initial information was received on 07-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient who experienced terrible hives (urticaria), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious terrible hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.