chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: the nurse gave the vaccine in the arm (left deltoid) and it hurts since then; Hurts when rising the left arm up and down (worsened); This is a spontaneous report received from a contactable reporter(s) (nurse). The reporter is the patient.  A 69 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in left deltoid, administration date 12Feb2021 (Lot number: EL9267) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 2001 (ongoing); "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: SYNJARDY XR taken for diabetes mellitus (ongoing); TOUJEO MAX SOLOSTAR taken for diabetes mellitus (ongoing); HYDROXYCHLOROQUINE SULFATE taken for rheumatoid arthritis (ongoing); METHOTREXATE SODIUM taken for rheumatoid arthritis (ongoing); FOLIC ACID. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EL8982)), administration date: 22Jan2021, when the patient was 68 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "the nurse gave the vaccine in the arm (left deltoid) and it hurts since then; Hurts when rising the left arm up and down (worsened)". Therapeutic measures were taken as a result of vaccination site pain. Additional information: Treatment included: Paracetamol (TYLENOL) 500 mg 2 tablets (2-3 times a day).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Little bit pain in her entire body and today is Wednesday and the pain is very is a lot never seen that before; body ache; 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 VACICNE), administration date 20Mar2021 (Lot number: EN6203) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Dementia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Little bit pain in her entire body and today is Wednesday and the pain is very is a lot never seen that before; body ache".  Additional information: The patient was 83 (unit not reported). The patient had the shot given to her this past Saturday, which was 20Mar2021, Saturday, on 21Mar2021 she was completely fine, 22Mar2021 she was feeling a little bit pain in her entire body and today was Wednesday and the pain was very was a lot never seen that before. The patient did not have fever, she did not have any other symptoms it was just a body ache and it was her first shot not the second. She was 83 she had dementia (captured as history) so we talk to the doctor and doctor said to get the shot.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: body aches all over her body/everything hurt/Felt like she got hit by a truck after the first shot, achy all over; general malaise/she didn't feel like doing anything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 (Lot number: EL8982) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rotator Cuff Tear" (unspecified if ongoing), notes: happened before the she got the shots, Old injury coupled with a new injury (6-8 months ago); "Rheumatoid Arthritis" (unspecified if ongoing); "headaches and aches and pains" (unspecified if ongoing); "headaches and aches and pains" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for rheumatoid arthritis, start date: 03Mar2021 (ongoing); ADVIL [IBUPROFEN] taken for headache, pain; TUMS ANTACID. Past drug history included: Keflex, reaction(s): "Allergy to Keflex", notes: had an unusual rash, in a prickly heat type of rash over her body (1982-1983 after a mischarge). Vaccination history included: Flu shot (got it along time ago before she got married), for immunization, reaction(s): "got deathly ill". The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches all over her body/everything hurt/Felt like she got hit by a truck after the first shot, achy all over"; MALAISE (non-serious), outcome "unknown", described as "general malaise/she didn't feel like doing anything". Additional information: Patient had no Prior Vaccinations (within 4 weeks). Patient said that she was told not to take a anti-inflammatory even though you feel like crap and you want to. She said that she just kind of laid there and just binged watched some TV.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021340952 same patient/SD/event, different dose
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt tired for about two days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6205) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Felt tired for about two days". Additional Information: The patient felt tired for about two days, the 13th and 14th. Concomitant medication of the patient included Unspecified B12 Shot. The patient got a first vaccine shot on Friday and it was reported that she gets a B12 shot (Unspecified B12 shot) every now and then and she wanted to get her B12 shot and the reporter thought she got the first vaccine two days ago, so, maybe she should wait until she gets the second one. The reporter was querying if there was any information whether it was best for the patient to take that B12 shot.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Lot number: ER26198) at the age of 32 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 20Mar2021, outcome "recovered" (22Mar2021), described as "a sore arm".  Additional information: The patient after her first vaccine literally had no issues, barely a sore arm.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, SARS-CoV-2 test
Clinical narrative: Intense migraines; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 (Lot number: EN6199) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic migraines" (unspecified if ongoing), notes: on botox treatment every 3 months. Concomitant medication(s) included: BOTOX taken for migraine. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number: EL1283, Anatomical site: Left arm), administration date: 16Feb2021, when the patient was 26 years old, for COVID-19 immunisation, reaction(s): "Arm soreness". The following information was reported: MIGRAINE (non-serious) with onset 09Mar2021, outcome "not recovered", described as "Intense migraines"; NAUSEA (non-serious) with onset 09Mar2021, outcome "not recovered", described as "nausea". The events "intense migraines" and "nausea" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, nausea.  Additional Information: It was reported that the patient's medical history chronic migraines was treated with botox every 3 months which largely eradicated it and typically only gets mild migraines as the botox wears off. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The treatment for event migraine included gabapentin for 5 days.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Has been nauseated and throwing up; Has been nauseated and throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), VOMITING (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "Has been nauseated and throwing up".  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: a little bit of soreness in the area of injection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "a little bit of soreness in the area of injection".  Additional information: The patient's age was reported as 27, no unit provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: worsening terrible tinnitus after dose 2 (has been 3 weeks and it has not decreased); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 03Mar2021 15:15 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin, Bactrim, Cipro, Macrobid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (in left arm, at 03:15 PM)), administration date: 10Feb2021, when the patient was 46 years old, for COVID-19 immunisation, reaction(s): "Terrible tinnitus". The following information was reported: TINNITUS (non-serious) with onset 19Mar2021, outcome "not recovered", described as "worsening terrible tinnitus after dose 2 (has been 3 weeks and it has not decreased)". Therapeutic measures were not taken as a result of tinnitus. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Fatigue, Headache, Pain
Clinical narrative: Body aches; Fatigue; got a headache which lasted for 13 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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: HEADACHE (non-serious), outcome "recovered", described as "got a headache which lasted for 13 days"; PAIN (non-serious), outcome "unknown", described as "Body aches"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue". The events "got a headache which lasted for 13 days", "body aches" and "fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Clinical course: The patient had a 13 days reaction. The patient had to get a CT scan on my head because the headache was so severe. It was like patient could not let head up until yet and the headache last for 13 days. The patient got the first shot and had a terrible reaction that the patient needed medical care. It started with body aches, then got a headache which lasted for 13 days. Also was actually fatigue for 10 of those 13 days. The patient went to the doctor.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Retching
Clinical narrative: complete liquid diarrhea / diarrhea is that bad, it's just complete liquid; chills; I am not throwing up but I do have nausea; hot flush type thing; I 'haven't thrown' 3 times, it's just like a dry heave or just a bit of saliva; it is taking every ounce of energy I have to hold this phone; I can't even work; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: ER2613) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "menopause" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 22Mar2021 09:30, outcome "not recovered", described as "complete liquid diarrhea / diarrhea is that bad, it's just complete liquid"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "I am not throwing up but I do have nausea"; HOT FLUSH (non-serious) with onset Mar2021, outcome "unknown", described as "hot flush type thing"; RETCHING (non-serious) with onset Mar2021, outcome "unknown", described as "I 'haven't thrown' 3 times, it's just like a dry heave or just a bit of saliva"; ASTHENIA (non-serious) with onset Mar2021, outcome "not recovered", described as "it is taking every ounce of energy I have to hold this phone"; IMPAIRED WORK ABILITY (non-serious) with onset Mar2021, outcome "not recovered", described as "I can't even work". Therapeutic measures were not taken as a result of diarrhoea, chills, nausea, hot flush, retching, asthenia.  Additional information: It was further reported that the patient got her shot on Thursday morning (18Mar2021) and she was fine after that and didn't have any problems. Patient usually don't have any vaccines since she was not just 'here there' going out in public other than going to get her shot. On Monday (22Mar2021) started about 9:30 in the morning, the patient had complete liquid diarrhea and was still experiencing it. The patient had chills and she was not throwing up but she do have nausea. She had a hot flush type thing even though she was already menopause. Patient was not throwing up anything, when she 'haven't thrown' 3 times, it's just like a dry heave or just a bit of saliva. The patient just wanted to know if this was normal, she read online (not on Pfizer site) but she read that many people are experiencing diarrhea and that sometimes side effects can take up to 7 days to show and then can last for several days. Patient stated that it was huge for her, that she was concerned not only now but for her second dose too (on 08Apr2021). The patient said that this was bad since she can't even work. The patient was asking why severe diarrhea has not been on the sheet as one of the issues.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 46 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), outcome "unknown", described as "Arm pain". Additional information: The patient had no additional administered vaccines, administered on same date with the Pfizer vaccine considered as suspect. The patient had no prior vaccinations within 4 weeks.  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: Burning sensation, Feeling abnormal, Skin burning sensation
Clinical narrative: He is miserable; Got burning sensation under his breast area, under his skin and it is under his armpits and down to the side of his body upper, torso area and down his back; underneath burning, it was his skin is burning or underneath the skin was burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2021 (Lot number: EN6200) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication(s) included: PREDNISONE (ongoing); CAPSAICIN; OZEMPIC; JARDIANCE.  The following information was reported: BURNING SENSATION (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Got burning sensation under his breast area, under his skin and it is under his armpits and down to the side of his body upper, torso area and down his back"; SKIN BURNING SENSATION (non-serious) with onset 25Feb2021, outcome "not recovered", described as "underneath burning, it was his skin is burning or underneath the skin was burning"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "He is miserable". The events "got burning sensation under his breast area, under his skin and it is under his armpits and down to the side of his body upper, torso area and down his back" and "underneath burning, it was his skin is burning or underneath the skin was burning" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of burning sensation, skin burning sensation.  Additional information: The patient called his primary doctor and gave him 10 days of prednisone. He went and took some of prednisone and still taking but it was not helping. He went to the emergency room and was told that he have sore muscles and gave him Capsaicin cream to put on it and according to the patient his muscles are not sore, it is underneath burning, it was his skin is burning or underneath the skin was burning.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ear discomfort, Oropharyngeal pain
Clinical narrative: I started feel like my ears, feel like, it just starts off the plane; Throat sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (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: EAR DISCOMFORT (non-serious) with onset 22Mar2021, outcome "unknown", described as "I started feel like my ears, feel like, it just starts off the plane"; OROPHARYNGEAL PAIN (non-serious) with onset 22Mar2021, outcome "unknown", described as "Throat sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: had some swelling of the arm; This is a spontaneous report received from a contactable consumer.  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, 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 "unknown", described as "had some swelling of the arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: sore throat; not feeling 100%; 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 male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "sore throat"; MALAISE (non-serious) with onset 24Mar2021, outcome "unknown", described as "not feeling 100%".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Jan2021 12:00 (Lot number: EL3246) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN; LEVOTHYROXINE; PROGESTERONE. Past drug history included: Doxicycline, reaction(s): "Allergy". The following information was reported: FATIGUE (non-serious) with onset 08Jan2021, outcome "unknown", described as "Fatigue". Therapeutic measures were not taken as a result of fatigue.  Additional information: Concomitant medications also included unspecified multivitamin. The patient had not been diagnosed with COVID-19 prior vaccination and not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itchiness around the COVID-19 vaccination site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown, Expiration Date: May2021) 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, SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Itchiness around the COVID-19 vaccination site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills
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 72-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "disabled" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "No symptoms". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills". Additional information: The patient called in to check on the status of an order for the medication Toviaz and mentioned that he/she received the vaccine and was very pleased about it. The only thing the patient had with the second shot was chills and no symptoms from the first dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus
Clinical narrative: soreness to her left arm.; feeling itchiness around the injection site; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness to her left arm."; VACCINATION SITE PRURITUS (non-serious), outcome "recovered", described as "feeling itchiness around the injection site".  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, Nasal congestion, Pain
Clinical narrative: body ache; chills; little congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (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 (non-serious) with onset 23Mar2021, outcome "unknown", described as "body ache"; CHILLS (non-serious) with onset 23Mar2021, outcome "unknown", described as "chills"; NASAL CONGESTION (non-serious) with onset 23Mar2021, outcome "unknown", described as "little congestion".  Additional Information: The patient wanted to know if this was normal and how long would it take to subside.  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: Chills
Clinical narrative: had a little bit of chills; This is a spontaneous report received from contactable consumer. The reporter is the patient.  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 04Feb2021 (Lot number: EH9809) at the age of 80 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COPD", start date: 2005 (unspecified if ongoing), notes: diagnosed 20 years prior (as reported); "sleep difficulty" (unspecified if ongoing), notes: alprazolam helps her sleep; "smoker for a long time" (unspecified if ongoing), notes: quit about 20 years prior. Concomitant medications included: ANORO taken for chronic obstructive pulmonary disease, start date: 02Feb2021 (ongoing); ALBUTEROL [SALBUTAMOL] taken for chronic obstructive pulmonary disease (ongoing); ALPRAZOLAM EXTENDED RELEASE taken for insomnia, start date: 2005 (ongoing); ATORVASTATIN. Vaccination history included: Flu shot, administration date: Oct2020, for immunisation, reactions: "chills", "didn't feel good", "low grade fever"; Old shingles shot, administration date: Oct2020, for immunisation, reactions: "chills", "didn't feel good", "low grade fever". The following information was reported: CHILLS (non-serious) with onset 05Feb2021, outcome "recovered" (05Feb2021), described as "had a little bit of chills".  Additional information: The chills lasted for 5 minutes. The lot number was reported as EH9809, but it was also stated that it could be EM or EN, and the vaccine was administered at 2:15 pm or 2:30 pm. The events did not result to emergency room or physician office visit. The patient did not have prior vaccinations within four weeks. The patient stated she stopped taking umeclidinium bromide, vilanterol trifenatate (ANORO) on 10Feb2021 due to heartburn, and started using again on 19Mar2021; said she might stop using it again. She also stated her temperature was higher than normal when not taking the umeclidinium bromide, vilanterol trifenatate.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (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 28Mar2021, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset 28Mar2021, outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: has a migraine after receiving first dose of Pfizer Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient in her 30's received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "has a migraine after receiving first dose of Pfizer Covid vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Condition aggravated, Stress
Clinical narrative: glucose was at 125; glucose was at 125; lot of stress lately; 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 75-year-old male patient received BNT162B2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN. Vaccination history included: Bnt162b2 (dose 1), when the patient was 75 years old, for Covid-19 immunisation, reaction(s): "glucose levels are usually between "95-105", but now they have been around "130, 140, and 150"". The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "glucose was at 125"; STRESS (non-serious), outcome "unknown", described as "lot of stress lately". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He got the first dose of the Pfizer-BioNTech COVID-19 vaccine "on the 4th, and on the 7th " he "started getting rising numbers of [his] glucose in the morning". He mentioned his glucose levels are usually between "95-105", but now they have been around "130, 140, and 150". He explained his "old internist" mentioned to add "half a pill" when his glucose level rise, therefore instead of taking 2000 mg of Metformin/2 pills he has been taking 2500 mg. He added he received his second dose of the vaccine yesterday, and this morning his "glucose was at 125", but he said he still takes 2500 mg of Metformin. He asked could the vaccine cause a rise in the blood glucose level.  He then added he also had a "lot of stress lately", which could have also "caused" the higher blood sugar levels.    No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Breast induration, Breast pain, Mammogram, Physical examination, Ultrasound scan
Clinical narrative: Hardness of right breast; Deep-deep burning in my right breast / pain in my breast / burning pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Lot number: EH6206) at the age of 84 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2005 (unspecified if ongoing); "Cancer surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BREAST PAIN (non-serious) with onset 09Mar2021 05:00, outcome "recovered" (Mar2021), described as "Deep-deep burning in my right breast / pain in my breast / burning pain"; BREAST INDURATION (non-serious) with onset 11Mar2021, outcome "recovered" (Mar2021), described as "Hardness of right breast". The events "deep-deep burning in my right breast / pain in my breast / burning pain" and "hardness of right breast" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of breast pain.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This is a spontaneous report received from a contactable reporter (Consumer).  An 18 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing), notes: Patient is healthy young man but is overweight. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Extreme fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness".  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: Very mild pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Very mild pain at the injection site". No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache
Clinical narrative: Extreme fatigue; terrible headache; Felt very warm but no fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 23Mar2021 (Batch/Lot number: unknown) at the age of 34 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: FATIGUE (non-serious) with onset 24Mar2021, outcome "unknown", described as "Extreme fatigue"; HEADACHE (non-serious) with onset 24Mar2021, outcome "unknown", described as "terrible headache"; FEELING HOT (non-serious) with onset 24Mar2021, outcome "unknown", described as "Felt very warm but no fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, Pain in extremity
Clinical narrative: Lethargic; Body aches; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: LETHARGY (non-serious), outcome "unknown", described as "Lethargic"; PAIN (non-serious), outcome "unknown", described as "Body aches"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: dizziness; soreness at injection site; This is a spontaneous report received from a contactable reporter consumer or other non HCP.  A 37 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 25Mar2021 11:00 (batch/lot number: unknown) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient, prior to vaccination, was not diagnosed with COVID-19. Concomitant medications included: HCG. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: DIZZINESS (non-serious) with onset 25Mar2021 11:30, outcome "recovering", described as "dizziness"; VACCINATION SITE PAIN (non-serious) with onset 25Mar2021 11:30, outcome "recovering", described as "soreness at injection site". The patient, since the vaccination, has not been tested for COVID-19. Therapeutic measures were not taken as a result of dizziness, vaccination site pain.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Therapeutic response unexpected
Clinical narrative: Left hand got hot and hurt; Left hand got hot and hurt; cerebral palsy in his left hand and now it's better /had a better brain hand connection. He was not able before the shot to pick up small things. Now he can; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cerebral palsy" (unspecified if ongoing), notes: in his left hand. The patient's concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Left hand got hot and hurt"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "cerebral palsy in his left hand and now it's better /had a better brain hand connection. He was not able before the shot to pick up small things. Now he can".  Additional information: It was further reported that left hand got hot and hurt, 2 days after the shot. He stretched it and worked it out and then he had a better brain and hand connection. The patient was not able to pick up small things prior the shot and now he can and has now muscle control. Patient had cerebral palsy in his left hand and now it's better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: soreness of arm; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "allergies" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness of arm"; HEADACHE (non-serious), outcome "unknown", described as "headache".  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
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 female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 22Mar2021 13:30 (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: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort
Clinical narrative: Teeth keep on bothering her; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "Knee replacement" (unspecified if ongoing), notes: Years ago. The patient's concomitant medications were not reported. The following information was reported: DENTAL DISCOMFORT (non-serious), outcome "unknown", described as "Teeth keep on bothering her".  Additional Information: The patient wants to set an appointment with her dentist because her teeth keep on bothering her. The patient was asking if this is possible. The patient had a knee replacement surgery years ago and will need to take antibiotics prior and after her dental appointment (dental appointment not yet filed, she is asking first if possible). The patient will also undergo another knee replacement on 25May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm sore; 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 female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (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 26Mar2021, outcome "unknown", described as "arm sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.