chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Limb mass, Pain, Pain in extremity
Clinical narrative: chills; sore arm; body aches; feverish; small lump in the arm pit; headaches; This is a spontaneous report from a contactable consumer or other non hcp. A male unspecified age (45 units not reported) patient received bnt162b2 (Pfizer covid vaccine, Formulation: Solution for injection in pre-filled syringe, Batch/lot number : Unknown), dose 1 via an unspecified route of administration on 23Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 23Mar2021, patient received Pfizer covid vaccine. On 24Mar2021, patient reported he experienced chills, sore arm, body aches, feverish, small lump in the arm pit and now headaches. The outcome for all the events was unknown. No follow-up attempts are Possible.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; sore arm; body aches; feverish; small lump in the arm pit; headaches; This is a spontaneous report from a contactable consumer or other non hcp. A male unspecified age (45 units not reported) patient received bnt162b2 (Pfizer covid vaccine, Formulation: Solution for injection in pre-filled syringe, Batch/lot number : Unknown), dose 1 via an unspecified route of administration on 23Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 23Mar2021, patient received Pfizer covid vaccine. On 24Mar2021, patient reported he experienced chills, sore arm, body aches, feverish, small lump in the arm pit and now headaches. The outcome for all the events was unknown. No follow-up attempts are Possible.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: mosquito bite appeared on my body;clear and itchy; appear around my elbow and my, around my armpit area and my thighs.; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 03Mar2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had called to report side effects of Pfizer vaccine. On an unspecified date, after the patient got the first dose of Pfizer vaccine, things began on third day, there were mosquito bites appeared on the patient's body. It just looked like mosquito bite, clear and itchy and it was not a lot but to the point the patient noticed that they were. It usually appeared around the patient's elbow and around armpit area and thighs. It was still going on till that day and the patient was supposed to get second dose of Pfizer vaccine that day. The patient wanted to know if it would be okay to get the second dose of vaccine or was there any data about those symptoms. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Eye swelling, Headache, Lymphadenitis
Clinical narrative: Eye swelling right under my eyebrow on both sides, more pronounced on the right side.; inflamed lymph node left armpit area; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my  psoriasis flare was barely noticeable; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my  psoriasis flare was barely noticeable; Sore arm; body aches; headache; 100.3 temperature; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 23Mar2021 13:00 as dose 2, single for COVID-19 immunization (at the age of 38-year-old). Medical history included psoriasis and underactive thyroid. Concomitant medications included vitamin d3 and vitamin b12 nos (other medications in two weeks). No known allergies. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 02Mar2021 13:15 as dose 1, single for COVID-19 immunization (at the age of 38-year-old). The patient did not took any other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. On 23Mar2021 23:00, the patient experienced sore arm, body aches, headache and 100.3 temperature. On 24Mar2021, the patient experienced inflamed lymph node left armpit area, have mild psoriasis on his forehead. He noticed that a day after the vaccination and the redness of his psoriasis flare was barely noticeable. On 27Mar2021 07:00, the patient experienced eye swelling right under his eyebrow on both sides, more pronounced on the right side. The patient did not received any treatment for adverse events. On 23Mar2021, the patient underwent lab tests and procedures which included body temperature: 100.3. The outcome of the event eye swelling right under his eyebrow on both sides, more pronounced on the right side was not recovered and for all other events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Psoriasis, Pyrexia
Clinical narrative: Eye swelling right under my eyebrow on both sides, more pronounced on the right side.; inflamed lymph node left armpit area; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my  psoriasis flare was barely noticeable; I have mild psoriasis on my forehead. I noticed that a day after the vaccination, the redness of my  psoriasis flare was barely noticeable; Sore arm; body aches; headache; 100.3 temperature; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 23Mar2021 13:00 as dose 2, single for COVID-19 immunization (at the age of 38-year-old). Medical history included psoriasis and underactive thyroid. Concomitant medications included vitamin d3 and vitamin b12 nos (other medications in two weeks). No known allergies. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in arm left on 02Mar2021 13:15 as dose 1, single for COVID-19 immunization (at the age of 38-year-old). The patient did not took any other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. On 23Mar2021 23:00, the patient experienced sore arm, body aches, headache and 100.3 temperature. On 24Mar2021, the patient experienced inflamed lymph node left armpit area, have mild psoriasis on his forehead. He noticed that a day after the vaccination and the redness of his psoriasis flare was barely noticeable. On 27Mar2021 07:00, the patient experienced eye swelling right under his eyebrow on both sides, more pronounced on the right side. The patient did not received any treatment for adverse events. On 23Mar2021, the patient underwent lab tests and procedures which included body temperature: 100.3. The outcome of the event eye swelling right under his eyebrow on both sides, more pronounced on the right side was not recovered and for all other events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Oropharyngeal pain, Pain
Clinical narrative: I haven't felt better, I still have the reaction of the vaccine; Body ache; Sore throat; Headache; Fever; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 20Mar2021 (at the age of 53-year-old) as dose 1, single for covid-19 immunization. The patient medical history reported as none. The patient's concomitant medications included levothyroxine sodium (SYNTHROID) Once a day, oral and Vitamins. The patient reported that I had vaccine, Saturday on 20Mar2021 and till today I haven't felt better, I still have the reaction of the vaccine. I had body ache, sore throat, headache, fever 102.1, I took Tylenol to control the fever and the symptoms I had, I took Tylenol (later clarified as treatment) every 4 hours, because I can't take these symptoms, I wasn't getting concerned but now since it has got two days from the vaccine, all I hear is the first dose, it should be very mild, it's the second dose that is difficult. Patient stated I called to make sure if the symptoms that I am feeling are safe or not, is it usual to feel this or not. Patient stated since I got the vaccine, symptoms mostly I started that night, but I truly felt that on 21Mar2021, and still experiencing the symptoms. The patient also stated that he was due to receive second shot, after 21 days, which was scheduled in April. The patient underwent lab tests and procedures which included body temperature: 102.1 on an unspecified date. Therapeutic measures were taken as a result of the events with Tylenol every 4 hours. The outcome of the events was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I haven't felt better, I still have the reaction of the vaccine; Body ache; Sore throat; Headache; Fever; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 20Mar2021 (at the age of 53-year-old) as dose 1, single for covid-19 immunization. The patient medical history reported as none. The patient's concomitant medications included levothyroxine sodium (SYNTHROID) Once a day, oral and Vitamins. The patient reported that I had vaccine, Saturday on 20Mar2021 and till today I haven't felt better, I still have the reaction of the vaccine. I had body ache, sore throat, headache, fever 102.1, I took Tylenol to control the fever and the symptoms I had, I took Tylenol (later clarified as treatment) every 4 hours, because I can't take these symptoms, I wasn't getting concerned but now since it has got two days from the vaccine, all I hear is the first dose, it should be very mild, it's the second dose that is difficult. Patient stated I called to make sure if the symptoms that I am feeling are safe or not, is it usual to feel this or not. Patient stated since I got the vaccine, symptoms mostly I started that night, but I truly felt that on 21Mar2021, and still experiencing the symptoms. The patient also stated that he was due to receive second shot, after 21 days, which was scheduled in April. The patient underwent lab tests and procedures which included body temperature: 102.1 on an unspecified date. Therapeutic measures were taken as a result of the events with Tylenol every 4 hours. The outcome of the events was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: he has a cough, he is coughing; he develop side effects with the first vaccine a day after the vaccination; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter mentioned I have a question which I could not find it anywhere on internet and I am very good at research. What happened was my whole family got vaccinated but my brother, he did not have one of those significant medical condition and he is under 60 so he just got vaccinated, his first vaccine, Pfizer vaccine with facility and then he develop side effects with the first vaccine a day after the vaccination. The side effects were similar to what I experienced when I got my second vaccine of Moderna but the only difference is that he has a cough, he is coughing and I could not find that as a side effect on any of the websites like. I looked everywhere and I got worried about it and I just wanted to know if anyone have reported having cough as the side effect from the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: muscle pain in arm, shoulder and scapula; tightness of neck; some tingling in arm, all on left side; This is a spontaneous report from a contactable patient.   A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 14:30 (at the age of 54 year old) as dose 1, single for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) and mitral valve prolapse from an unknown date. Concomitant medications included ergocalciferol (VITAMIN D); and topical minoxidil (ROGAINE FOR WOMEN) both for an unspecified indication. The patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Prior vaccination, patient did not receive any other vaccines within four weeks and was not diagnosed with COVID 19.  On 23Mar2021 02:00, the patient experienced muscle pain in arm, shoulder and scapula, tightness of neck, and some tingling in arm, all on left side. Since the vaccination patient took COVID-19 test (Nasal swab) on 10Mar2021, where result was negative. No treatment was received in response to the events. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: rash on his arms; kinda itchy; little red rash in his elbow; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored Program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced rash on his arms, little red rash in his elbow and kind of itchy on an unspecified date. The outcome of the events was unknown.    Follow-up (23Mar2021/24Mar2021): new information received from same contactable consumer includes: New event details (little red rash in his elbow and kind of itchy).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Histamine level, Paraesthesia oral, SARS-CoV-2 test
Clinical narrative: slight tingling on the tongue; This is a spontaneous report from a contactable Consumer or other non-health professional (patient).  A 28-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot number: EN6206) via an unspecified route of administration in deltoid left on 09Mar2021 14:00 (at the age at vaccination of 28-year-old) as dose 1, single for CVOID-19 immunization. Patient's relevant medical history included ongoing Asthma which was recently diagnosed, and concomitant medications included ongoing Montelukast sodium (MONTELUKAST SODIUM) taken for asthma from an unspecified start date and ongoing Tiotropium bromide (TIOTROPIUM BROMIDE) taken for asthma symptoms from an unspecified start date. Patient had historical vaccine of booster shot of for the flu in Nov2020. He was mostly taking supplements and allergy medications. Family Medical History Reported as Maternal Grandfather had heart problems. History of all previous immunizations with the Pfizer vaccine considered as suspect were reported as None and no additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations taken within 4 weeks and no AE were reported following prior vaccinations. On 09Mar2021, patient experienced a slight tingling on the tongue that he had right after his Covid vaccination that subsided after 5 minutes or so. He has been exposed directly, more than likely and got a test kit on 24Mar2021 (reported as today) and he do not know whether or not he was positive for another few days for the virus and he said he got his first dose of the vaccine just over two weeks ago. Also, he went to the doctor recently and found out he was Asthmatic and he was referred to a pulmonologist in April. And his histamine levels were pretty high, that was out of blood work he had a month or so ago, it has been a consistent issue for the last year to him and his doctor have been trying their best to get this level down. Adverse event did not require visit to emergency room and physician office. Patient said he got his first dose of the vaccine just over two weeks ago. Also stated if his test comes back positive does he have to start the vaccination process over again and what are his options. The patient underwent lab tests and procedures which included on an unspecified date in 2021, histamine level was pretty high and on 24Mar2021, COVID test and results was unknown. Outcome of the event was recovered on 09Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate, Heart rate increased, Palpitations
Clinical narrative: Chest discomfort; Heart palpitations; Elevated heart rate; This is a spontaneous report from a contactable Consumer. This Consumer reported for a 43-year-old male patient (Husband) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7534) via an unspecified route of administration on 19Mar2021 at 11:00 hours (at 43-year-old) on left arm as dose 1, single for COVID-19 immunization. No prior vaccinations (within 4 weeks) and other products were received, no investigation assessment was done, no events were reported following prior vaccinations and no family medical history was reported relevant to events. The relevant tests and medical history were reported as none. On 20Mar2021 the patient had chest discomfort, heart palpitations and an elevated heart rate since receiving the first dose of the Pfizer Covid-19 vaccine. Caller reported that the patient was considering going to the emergency room since he had been experiencing side effects. Caller reported that the patient described the event as it feels like there was something weird in his chest and described it as a strange sensation. Caller reported that the patient had no history of heart problems and was not on any medications. The patient spoke with the callers cardiologist and urgent care. Caller reported that the physician and urgent care staff informed patient that if the chest discomfort, heart palpitations, and elevated heart rate continue to go to the emergency room. The patient did not require emergency room and physician office visit. The patient had not recovered.  No follow-up attempts were possible. No further information was expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Eye contusion, Eye swelling, Swelling face
Clinical narrative: Facial swelling; eye actually swelled up; looked like a black eye; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).  A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 at 09:45 (Age at vaccination was 31 years) as dose 1, single for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. No other vaccinations within four weeks prior administration date of the suspect vaccine. On 19Mar2021 after the first dose of the COVID 19 vaccine patient experienced some side effects and the most concerning was facial swelling and her eye actually swelled up and looked like she had a black eye and wondering if it would be safe for her to get the 2nd dose. She did not have a doctor. The patient took Benadryl as therapeutic measures. The outcome of events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Oropharyngeal pain, Swollen tongue
Clinical narrative: Sore throat; tongue felt fat and it hurt/her tongue still hurts /feels like her tongue is a little swollen; tongue felt fat and it hurt/her tongue still hurts /feels like her tongue is a little swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6207), via an unspecified route of administration, administered in arm left on 18Mar2021 as dose 1, single for COVID-19 immunization (at the age of 57-year-old). Medical history included ongoing high blood pressure, ongoing type 2 diabetes mellitus, ongoing hypothyroidism, ongoing chronic depression, ongoing uric acid high, gout and severe reaction to sulfa drugs. Concomitant medications included oral levothyroxine sodium (L-THYROXINE) 50mcg once a day by mouth) for Hypothyroidism, bupropion hydrochloride (WELLBUTRIN) 450mg one time a day for Depression, metoprolol (50mg one time a day) for high blood pressure, allopurinol (300mg one time a day) for gout prevention, linagliptin (TRADJENTA) (5mg one time a day) for type 2 diabetes. On 23Mar2021 (5 days after the vaccination), the patient experienced tongue felt fat and it hurt, just feels like her tongue is a little swollen. On 24Mar2021 (6 days after the vaccination), the patient experienced sore throat. Stated today her tongue still hurts. it just feels like her tongue is a little swollen, says she cannot tell if it is swollen when she looks at it, it just feels that way. Patient stated they monitored her after her dose for 30 minutes instead of 15. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; light fever; extreme fatigue; whole body soar; This is a spontaneous report from a contactable consumer, the mother.   A 19-years-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE formulation: solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single (age at vaccination 19 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms, whole body soar, light fever and extreme fatigue on an unknown date. It was reported that the patient does not take any medications and was a healthy young man and that event took place after use of product. The patient lab data included light fever. The reason for it being past the 24 hours was because it was my son. The reporter was the one observing him and the symptoms lasted more than two days. She thought it would be normal for him to have some symptoms so that was why she didn't report it right away. The patient received the vaccine on a Tuesday and then missed three days of work. By that Saturday he was back to normal. The outcome of the events was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dry mouth, Dyspnoea, Sleep apnoea syndrome
Clinical narrative: Had like an episode of sleep apnea; My mouth was real dry; I was sleeping and it was like I couldn't breathe; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced like an episode of sleep apnea, mouth was real dry and patient stated that she was sleeping and it was like she couldn't breathe. Patient stated, "I am going to take the second vaccine today from the Pfizer for the COVID and I don't know, I had not reported this but before, like I said I don't know if this is the side effect or not of the first one but after I took the first one, maybe about a week later or so I had like an episode of sleep apnea and my mouth was real dry, I was sleeping and it was like I couldn't breathe you know and I had that in the past a long time ago and stuff. It happened twice." The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Nodule, Pain in extremity, SARS-CoV-2 test
Clinical narrative: bruise showed up on the calf muscle of the back of her left leg and oddly enough it showed up after the vaccine; feels like knot is in that left leg and it is painful; feels like knot is in that left leg and it is painful; This is a spontaneous report from a contactable consumer or other non hcp. This report is in reference to the reporter's mother. This is report 2 of 2.  A 64-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EN6207, Expiry Date: unknown), via an unspecified route of administration, administered in Arm Left on 19Mar2021 13:00 (at the age of 64-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No prior vaccinations within 4 weeks. On 20Mar2021 the patient experienced bruise showed up on the calf muscle of the back of her left leg and oddly enough it showed up after the vaccine, feels like knot is in that left leg and it is painful. On 15Mar2021, the patient underwent lab tests and procedures which included Covid 19 virus test, sars-cov-2 test: Negative. The outcome of events recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Insomnia, Restlessness
Clinical narrative: restless; inability to sleep; chest pains; she was tossing and turning and had a poor nights rest; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (mother) that:   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 25Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took historical vaccine bnt162b2 dose 1, single for covid-19 immunisation. On Mar2021, the patient experienced restless, inability to sleep, chest pains and she was tossing and turning and had a poor nights rest. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. .
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Rash
Clinical narrative: I am breaking out a rash; This is a spontaneous report from a contactable consumer (Patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6198) via an unspecified route of administration, administered in the right arm on 04Mar2021 (at the age of 70-years-old) as dose 1, single for COVID-19 immunization. Medical history was not reported. Concomitant medications were reported as, patient was on just one medication (not specified, Other Products: Yes). Patient took the first dose of vaccine about 3 or 4 weeks ago (at the time of report) and she was breaking out a rash on an unspecified date in 2021 after vaccination. Patient haven't seen a doctor for it but was going to. Patient would like to know that can she take the second shot. The patient underwent lab tests and procedures which included blood test with unknown results 2 days ago (at the time of report) on an unspecified date in 2021. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Urticaria
Clinical narrative: hives all over [her] arms and legs/woke up with hives again; fever; aches; This is a spontaneous report from a non-contactable consumer. A 4-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient developed huge hives all over arms and legs 5 days after her second dose of the Pfizer covid vaccine. On 24Mar2021, the patient experienced fever and aches, and woke up with hives again. It was reported that, the patient would be seeing her doctor on 25Mar2021 (reported as today). The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Night sweats; couldn't sleep; really tired; severe headache; body aches and pain; Fever; sweaty; feels super cold; feels bad; she was unable to move; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613, age at vaccination 30 years), via an unspecified route of administration, administered in Arm Left on 23Mar2021 as DOSE 2, SINGLE for Covid protection. The patient medical history was not reported. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for vitamin d decreased at a dose of 10,000 units weekly, from an unspecified start date and ongoing (has been taking for maybe 6 months); hydrocodone at a dose of 10mg twice daily taken for pain and back problems, start and stop date were not reported (has been taking for a couple of years for back problems). The patient previously took first dose of bnt162b2 (Lot: EN6205) via an unspecified route of administration, administered in arm on 02Mar2021 as DOSE 1, SINGLE for covid-19 immunisation and received a Vitamin b12 injection the day before in the same arm. The patient experienced severe headache, body aches and pain, fever, couldn't sleep, really tired on 23Mar2021, night sweats on 24Mar2021, sweaty, feels super cold, feels bad, she was unable to move on an unspecified date in 2021. It was reported that, the patient received the vaccine and was having bad reactions. She wanted to see if this was normal and why her body was acting like this. She had a severe headache, body aches and pain that was like being beat so hard all over, fever and night sweats, sweaty and cold really bad, could not sleep, was really tired, started feeling most of these last night, reporter still felt bad this morning. Took Children's Tylenol because her fever was going up, also taken some Aleve. Did not have a fever right now, but she felt super cold and sweaty, fever went down and was unable to move. Therapeutic measures taken as a result of the events included Children's Tylenol (Children's Tylenol liquid acetaminophen. Confirmed the brand name. Strength 160mg/5ml, Lot: SFM002, Expiry May2022) because her fever was going up. She also took some Aleve. No AE(s) required a visit to: Emergency Room, physician Office. The outcome of the events of headache and fever was recovering, the outcome of rest of the events was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Movement disorder, Night sweats, Pain, Pyrexia
Clinical narrative: Night sweats; couldn't sleep; really tired; severe headache; body aches and pain; Fever; sweaty; feels super cold; feels bad; she was unable to move; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613, age at vaccination 30 years), via an unspecified route of administration, administered in Arm Left on 23Mar2021 as DOSE 2, SINGLE for Covid protection. The patient medical history was not reported. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for vitamin d decreased at a dose of 10,000 units weekly, from an unspecified start date and ongoing (has been taking for maybe 6 months); hydrocodone at a dose of 10mg twice daily taken for pain and back problems, start and stop date were not reported (has been taking for a couple of years for back problems). The patient previously took first dose of bnt162b2 (Lot: EN6205) via an unspecified route of administration, administered in arm on 02Mar2021 as DOSE 1, SINGLE for covid-19 immunisation and received a Vitamin b12 injection the day before in the same arm. The patient experienced severe headache, body aches and pain, fever, couldn't sleep, really tired on 23Mar2021, night sweats on 24Mar2021, sweaty, feels super cold, feels bad, she was unable to move on an unspecified date in 2021. It was reported that, the patient received the vaccine and was having bad reactions. She wanted to see if this was normal and why her body was acting like this. She had a severe headache, body aches and pain that was like being beat so hard all over, fever and night sweats, sweaty and cold really bad, could not sleep, was really tired, started feeling most of these last night, reporter still felt bad this morning. Took Children's Tylenol because her fever was going up, also taken some Aleve. Did not have a fever right now, but she felt super cold and sweaty, fever went down and was unable to move. Therapeutic measures taken as a result of the events included Children's Tylenol (Children's Tylenol liquid acetaminophen. Confirmed the brand name. Strength 160mg/5ml, Lot: SFM002, Expiry May2022) because her fever was going up. She also took some Aleve. No AE(s) required a visit to: Emergency Room, physician Office. The outcome of the events of headache and fever was recovering, the outcome of rest of the events was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; chills; fatigue; fever; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced headache, chills, fatigue, fever. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: Dizziness; nausea; body aches; fever; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: not reported, Expiration Date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history included seasonal allergy. The patient concomitant medications were not reported. The patient experienced dizziness, nausea, body aches, fever on an unspecified date. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: a bad headache; a fever of 101.1; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 22Mar2021 (at the age of 47-years-old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism and mood disorder. The patient was in excellent health. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism; bupropion taken for mood disorder. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced a bad headache and a fever of 101.1 on 23Mar2021. It was reported that headache lasted for 24 hours. The fever gradually fell throughout the day and returned to normal 98.2 by 6 p.m. Outcome of events was resolved on 24Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: I just have a tiny bruise; This is a spontaneous report from a contactable consumer (patient) reporting for herself.  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on 24Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, patient reported that When they got it they did not have any soreness in our arm. She just had a tiny bruise on an unspecified date in 2021, but her husband got the bunch of side effects and that was a day later. Patient enquired do they need to continue that shot as her husband didn't want to take that shot. They cancelled the shot as they do not want to continue because we do not want that to happen again. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Pain in extremity, Swollen tongue
Clinical narrative: tongue swelling; sore arm; dehydration; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer Sales Representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that after receiving the first dose of the Pfizer COVID-19 vaccine, she had tongue swelling, dehydration for approximately 45 minutes, and a sore arm. Patient reported being fine after this. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Tremor, Vomiting
Clinical narrative: Headache; Low grade fever; Vomiting; Tremors; This is a spontaneous report from a contactable consumer or other non hcp (Patient mother).  A 22-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration on 23Mar2021 (Age at vaccination: 22-years-old) as unknown dose single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included thioridazine (THIORIDAZINE), omeprazole (OMEPRAZOLE), propranolol (PROPRANOLOL), folic acid (FOLIC ACID), methotrexate (METHOTREXATE), ethinylestradiol, ferrous fumarate, norethisterone (KAITLIB FE), aripiprazole (ARIPIPRAZOLE), escitalopram oxalate (ESCITALOPRAM [ESCITALOPRAM OXALATE]), adalimumab (HUMIRA) all taken for an unspecified indication, start and stop date were not reported. It was reported as 25Mar2021 morning patient had a reaction from the Pfizer vaccine she was vaccinated on Tuesday afternoon. she had a headache, low grade fever, vomiting and tremors. Patient received treatment for the events with Tylenol. The patient underwent lab tests and procedures which included body temperature: seems to be fine. The outcome for the events was reported as resolved on 25Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: slight chills; fever, maybe a degree; Muscle ache; Joint ache; she ached all over; Headache; Nausea; she sleeping around the clock. She would wake up and fall back asleep; felt tired/Exhaustion; This is a spontaneous report from a contactable nurse (Patient).  A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6200, expiration date: not reported) via an unspecified route of administration, administered in left arm on 02Mar2021 at 09:15 (at the age of 77-years-old) as dose 2, single for covid-19 immunization. Medical history included Chronic Lyme disease, she got it again in 2018 she thinks, she had it in 2017. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EL9264, expiry date: not reported), via an unspecified route of administration on unspecified date (at the age of 77-years-old) as a single dose for COVID-19 immunization and she takes a flu vaccine every and it's fine. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for chronic lime disease, start and stop date were not reported. On 18Mar2021, patient experienced slight chills, fever, maybe a degree, muscle ache, joint ache, exhaustion, headache, nausea, she sleeping around the clock. she would wake up and fall back asleep and felt tired. Patient took ibuprofen for events chills and fever maybe a degree. On 18Mar2021, patient underwent lab tests and procedures which included body temperature resulted fever maybe a degree. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Somnolence
Clinical narrative: slight chills; fever, maybe a degree; Muscle ache; Joint ache; she ached all over; Headache; Nausea; she sleeping around the clock. She would wake up and fall back asleep; felt tired/Exhaustion; This is a spontaneous report from a contactable nurse (Patient).  A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6200, expiration date: not reported) via an unspecified route of administration, administered in left arm on 02Mar2021 at 09:15 (at the age of 77-years-old) as dose 2, single for covid-19 immunization. Medical history included Chronic Lyme disease, she got it again in 2018 she thinks, she had it in 2017. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EL9264, expiry date: not reported), via an unspecified route of administration on unspecified date (at the age of 77-years-old) as a single dose for COVID-19 immunization and she takes a flu vaccine every and it's fine. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for chronic lime disease, start and stop date were not reported. On 18Mar2021, patient experienced slight chills, fever, maybe a degree, muscle ache, joint ache, exhaustion, headache, nausea, she sleeping around the clock. she would wake up and fall back asleep and felt tired. Patient took ibuprofen for events chills and fever maybe a degree. On 18Mar2021, patient underwent lab tests and procedures which included body temperature resulted fever maybe a degree. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: slight chills; fever, maybe a degree; Muscle ache; Joint ache; she ached all over; Headache; Nausea; she sleeping around the clock. She would wake up and fall back asleep; felt tired/Exhaustion; This is a spontaneous report from a contactable nurse (Patient).  A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6200, expiration date: not reported) via an unspecified route of administration, administered in left arm on 02Mar2021 at 09:15 (at the age of 77-years-old) as dose 2, single for covid-19 immunization. Medical history included Chronic Lyme disease, she got it again in 2018 she thinks, she had it in 2017. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE; Lot Number: EL9264, expiry date: not reported), via an unspecified route of administration on unspecified date (at the age of 77-years-old) as a single dose for COVID-19 immunization and she takes a flu vaccine every and it's fine. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for chronic lime disease, start and stop date were not reported. On 18Mar2021, patient experienced slight chills, fever, maybe a degree, muscle ache, joint ache, exhaustion, headache, nausea, she sleeping around the clock. she would wake up and fall back asleep and felt tired. Patient took ibuprofen for events chills and fever maybe a degree. On 18Mar2021, patient underwent lab tests and procedures which included body temperature resulted fever maybe a degree. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.