chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: Vertigo/room spinning; Blurry vision; General "fuzzy" head feeling; Headache going from back of head (left side) to the front.; Had a small rash that has since turned into the bruise; Had a small rash that has since turned into the bruise; Bruised knot at injection site still hasn't cleared; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0196) via an unspecified route of administration, in the left arm on 01Jul2021 (at the age of 28-years-old) as dose 1, single for COVID-19 immunization at pharmacy or drug store. The patient medical history included covid-19 from an unknown date and unknown if ongoing. Concomitant medication within 2 weeks of vaccination included ESTRADIOL, 0.5mg once daily taken for an unspecified indication, start and stop date were not reported. Allergies to medications, food, or other products included dilaudid and lortab. Prior to vaccination patient was diagnosed with COVID-19 and did not received any other vaccines within 4 weeks. Since the vaccination, the patient had not been tested for COVID-19. On 01Jul2021, the patient experienced headache going from back of head (left side) to the front started within an hour of receiving the vaccine and hadn't stopped since, and Still ongoing; and also had Bruised knot at injection site still hadn't cleared and had a small rash that has since turned into the bruise. On 03Jul2021, on day 3 after vaccine patient had Vertigo including blurry vision, room spinning, and general fuzzy head feeling started and lasted until day 7. The reporter assessed the events as non-serious The patient did not receive any treatment for the event. Outcome of the events vertigo, blurry vision and general fuzzy head feeling was recovered on 07Jul2021 and outcome of other events was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling face, Tinnitus
Clinical narrative: continuing tinnitus in left ear; Swelling of the face; swelling of the lymph nodes in the jaw; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3247, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 09Feb2021 11:30 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Medical history included penicillin and sulfa drug allergy from an unknown date. Concomitant medications included losartan (LOSARTAN) taken for an unspecified indication, from an unknown start date, levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, from an unknown start date. On 09Feb2021 12:15, the patient experienced continuing tinnitus in left ear with swelling of the face, swelling of the lymph nodes in the jaw. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the events were resolved with sequelae.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initially typical sore arm, low fever,  then worsened to higher fever, cough, pounding heart, trouble breathing, stiff neck and shoulder, chills
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Initially typical sore arm, low fever,  then worsened to higher fever, cough, pounding heart, trouble breathing, stiff neck and shoulder, chills
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: About a week after receiving the vaccine, I noted that I seemed to have some loss hearing.  It has not improved as of yet.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Inflammation
Clinical narrative: Caller stated she heard of two people under 30 that got this side effect from the Pfizer covid 19 vaccine/ Caller stated she heard one of the side effects is a heart defect.; Kid across the street got the Pfizer vaccine and he is about 18 years old and had that heart inflammation; This is a spontaneous report from a contactable nurse from a Pfizer sponsored program. A 18-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single (at the age of 18-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that reporter heard of two people under 30 that got side effect from the Pfizer covid 19 vaccine and heard one of the side effects is a heart defect. On an unknown date, the patient (Kid/Neighbor across the street) got the Pfizer vaccine and had heart inflammation and heart defect. Reporter wanted to know how many days after, would be seeing these side effects of heart inflammation. The outcome of events was unknown.  Information on batch/lot number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chest X-ray, Decreased appetite, Fatigue, Headache
Clinical narrative: loss of appetite; loss of taste; headaches; fatigue; This is a spontaneous report received from a contactable consumer or other non hcp (patients son). This consumer reported for mother. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) (age at vaccination was reported as 77 years) via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number not reported) as single dose for covid-19 immunization. Patient's Medical History including any illness at time of vaccination was reported as none. The patient's concomitant medications were not reported. The patient experienced loss of appetite, loss of taste, headaches, fatigue on an unspecified date. Additional context reported as report that his 78-year-old mother experienced side effects after administration of the fist dose of Pfizer Covid-19 Vaccine. The patient has already gone to the physician for the management of the symptoms. The patient was dosed with first dose of Pfizer Covid-19 Vaccine less than 2 weeks ago but does not have the actual date of administration or the Pfizer Covid-19 Vaccine Lot and things like that. The patient underwent lab tests and procedures which included chest x-ray: not have pneumonia on 09Jul2021. She does not have pneumonia. The clinical outcome of the events was not recovered.  Information on the lot/batch number has been requested
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: On 03Jul2021, I contracted Covid, delta, variant; On 03Jul2021, I contracted Covid, delta, variant; This is a spontaneous report from a contactable nurse (Patient). A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL9262 and Expiry date was not reported) dose 2 via an unspecified route of administration in arm Left on 23Jan2021 09:00 (age at vaccination was 53-year-old) and dose 1 (Lot number: EL3246 and Expiry date was not reported) via an unspecified route of administration in right arm on31Dec2020 13:15 as single dose for covid-19 immunisation. The patient had no known allergies. Medical history included Hypothyroid, PFO, HCP from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had tested for COVID-19. Concomitant medications in two weeks were included levothyroxine sodium (SYNTHROID), asa (ASA), riboflavin (RIBOFLAVIN), ergocalciferol, retinol (VITAMIN A + D), zinc (ZINC), magnesium (MAGNESIUM), topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. The patient was hospice that continues to take masking precautions, hand hygiene. On 03Jul2021 16:00 she contracted covid, variant. Due to events patient visited Emergency room/department or urgent care. Treatment received for the events was Promethazine, Albuterol inhaler, Tessalon pearls. The patient underwent lab tests and procedures which included PCR nasal Swab positive on 03Jul2021. The outcome of the event was recovering.; Sender's Comments: Based on the information in the case report, a possible causal relationship between events Covid-19 and suspect drug BNT162B2 cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Muscle twitches in lower legs; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: FR28744), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 1, single for COVID-19 immunization at other. The patient medical history included COVID-19. Concomitant medication(s) included losartan (LOSARTAN). The patient previously took Aleve. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13Apr2021, patient experienced muscle twitches in lower legs. It was reported that no therapeutic measures were taken for the events experienced. The clinical outcome of event was not recovered.  Follow-up attempts are needed. Information on the lot/batch available.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Lacrimation increased, Pain in extremity, Rhinorrhoea, Sneezing
Clinical narrative: Arm pain; Runny nose; Watery eyes; Sneezing; Allergy; This is a spontaneous report from a contactable consumer (reported for self).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/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. On an unspecified date, the consumer stated that he went to get Pfizer Covid Vaccine on Tuesday evening around 6 o'clock and he just had like normal arm pain but probably on Thursday he started having like runny nose kind of like allergy running nose, watery eyes and he have been having and it's not improving it is getting worse. He has been getting runny nose, watery eyes and also sneezing. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Body height decreased, Bone density abnormal, Headache, Osteopenia
Clinical narrative: Osteopenia; Have lost lot of height because of the osteoporosis; Had Ibuprofen but I don't take Ibuprofen because it is harder on stomach; Have lost lot of height because of the osteoporosis; Terrible headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number EW176), via an unspecified route of administration on 08Jul2021, 3:00 (age at the vaccination 71-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included haemorrhoids from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrocortisone acetate (HYDROCORTISONE ACETATE) 25mg, taken for haemorrhoids, start and stop date were not reported. The patient experienced osteopenia on an unspecified date, have lost lot of height because of the osteoporosis on an unspecified date, terrible headache on 09Jul2021. The patient underwent lab tests and procedures which included bone density abnormal: osteoporosis on Jun2021. Therapeutic measures were taken as a result of osteopenia, have lost lot of height because of the osteoporosis. Treatment for Osteoporosis and Osteopenia consumer stated, its Vitamin D and calcium; had Ibuprofen but don't take Ibuprofen because it is harder on stomach. The outcome of events was persisting (not recovered) for Osteoporosis and Osteopenia; lost lot of height and terrible headache was unknown.   Information on the lot/batch number has been requested
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Osteoporosis
Clinical narrative: Osteopenia; Have lost lot of height because of the osteoporosis; Had Ibuprofen but I don't take Ibuprofen because it is harder on stomach; Have lost lot of height because of the osteoporosis; Terrible headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number EW176), via an unspecified route of administration on 08Jul2021, 3:00 (age at the vaccination 71-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included haemorrhoids from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrocortisone acetate (HYDROCORTISONE ACETATE) 25mg, taken for haemorrhoids, start and stop date were not reported. The patient experienced osteopenia on an unspecified date, have lost lot of height because of the osteoporosis on an unspecified date, terrible headache on 09Jul2021. The patient underwent lab tests and procedures which included bone density abnormal: osteoporosis on Jun2021. Therapeutic measures were taken as a result of osteopenia, have lost lot of height because of the osteoporosis. Treatment for Osteoporosis and Osteopenia consumer stated, its Vitamin D and calcium; had Ibuprofen but don't take Ibuprofen because it is harder on stomach. The outcome of events was persisting (not recovered) for Osteoporosis and Osteopenia; lost lot of height and terrible headache was unknown.   Information on the lot/batch number has been requested
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone densitometry, Headache, Migraine, Nausea, Pain
Clinical narrative: Osteopenia; Have lost lot of height because of the osteoporosis; Had Ibuprofen but I don't take Ibuprofen because it is harder on stomach; Have lost lot of height because of the osteoporosis; Terrible headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number EW176), via an unspecified route of administration on 08Jul2021, 3:00 (age at the vaccination 71-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included haemorrhoids from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrocortisone acetate (HYDROCORTISONE ACETATE) 25mg, taken for haemorrhoids, start and stop date were not reported. The patient experienced osteopenia on an unspecified date, have lost lot of height because of the osteoporosis on an unspecified date, terrible headache on 09Jul2021. The patient underwent lab tests and procedures which included bone density abnormal: osteoporosis on Jun2021. Therapeutic measures were taken as a result of osteopenia, have lost lot of height because of the osteoporosis. Treatment for Osteoporosis and Osteopenia consumer stated, its Vitamin D and calcium; had Ibuprofen but don't take Ibuprofen because it is harder on stomach. The outcome of events was persisting (not recovered) for Osteoporosis and Osteopenia; lost lot of height and terrible headache was unknown.   Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not provided), via an unspecified route of administration, on an unspecified date as dose 2, single and bnt162b2 (formulation: Solution for injection, Lot number and expiry date was not provided), via an unspecified route of administration, on an unspecified date as dose 1, single, for covid-19 immunization (had both doses of the vaccine). The reason for no lot number was stated as the complainant did not have the product with them at the time of call. The patient medical history and concomitant medications were not reported. It was stated that, the reporter met a younger man that also developed shingles on an unspecified date, after the Pfizer covid vaccine. The reporter said that her husband had a lot more shingles compared to the young man (husband case of shingles was a lot worse). Reportedly, the man had pictures of his shingles. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on her arms, torso, and thighs; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient. A female patient of an unspecified age 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 number unknown, single for COVID-19 immunization.The patient's medical history and concomitant medications were not reported. Report was not related to a study or programme. On an unknown date, after taking the vaccine, the patient experienced hives.  It was reported that she googled Covid vaccine and hives.  was the first thing that popped up with 9 people. There was this woman that said she took Pfizer COVID and had hives. On the second day she got hives on her arms, torso, and thighs. They told the woman  to take an antihistamine and then moved on to next call. Caller stated she didn't have information for that woman and did not wish to do a report for her. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: face swelled; Rash; This is a spontaneous report received from contactable consumer (the patient). A patient of unspecified age and gender received the received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date, patient experienced face swelled and rash. Patient stated that, i was calling to reaction because I had been having reaction to Pfizer and I just want to know how proceed with my second shot, my second shot is 19 of this month 19Jul2021 (Further clarification unknown) and doctor had helped me with that so much so my face swelled and had a bad rash, my doctor put in for it. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Tension headache
Clinical narrative: I have body ache and headache; It's almost like a tension headache on top of my head.; I have body ache and headache; This is a spontaneous report from contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was not reported), via an unspecified route of administration on 07Jul2021 at 05:00 PM (48 hours ago on Wednesday at 5pm) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient experienced body ache and headache the 1st 24 hours. Patient had a very bad headache. It was almost like a tension headache on top of the head. Patient wanted to know if that was normal. The outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Secretion discharge
Clinical narrative: Throat Hurts and he has a lot of yellow mucus; Throat Hurts and he has a lot of yellow mucus; This is a spontaneous report from a contactable consumer. This contactable consumer (Patient's Parent) reported for a 24 years old male patient that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC Number, UPC Number: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE (at the age of 24 years old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. He had Pfizer COVID shot a little over 2 weeks ago and he said his throat really hurts and he had a lot of yellow mucus. He wondered whether it was a known side effect or it could be just a cold and he wanted to know whether anyone reported such side effect. The outcome of all events were unknown.   Information on Lot/Batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Fatigue, Laboratory test, Pyrexia
Clinical narrative: Had fever of 102.6 for 3 days and then the fever drop down to 100; He'd work a little bit and then had to lay down and take a nap; This is a spontaneous report from a contactable consumer, the patient. This consumer reported for a male patient (husband). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: Unknown), via an unspecified route of administration in right arm on an unknown date in Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history was not reported. The patient's concomitant medications included aspirin and Tamasol which was a blood thinner. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Feb2021 for COVID-19 immunization. The second shot was 2 weeks later, now she could not remember the date on that. It was the beginning of Mar (about 3 weeks ago) and he had no reaction to the injection or the injection site. Patient had fever of 102.6 for 3 days and then the fever dropped down to 100 and then slowly after the second for two weeks, patient had fever and fatigue. Patient would work a little bit and then had to lay down and took a nap, he had been to the doctor 4 different times and they ran all kinds of test and they never came up with anything. Chest X-rays were done to make sure there was nothing going on with his chest. They checked him mosquito bites and all kinds of different diseases and stuff and nothing, absolutely nothing showed up. The patient did not receive any treatment. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: Aching/Sore; Very sick; This is a spontaneous report from a contactable consumer. This consumer (Patient Husband) reported for a female patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not 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. On an unspecified date, the patient experienced aching/sore, very sick. Reporter is very sick right now by the aching and sore. So, we are trying to see how long is it supposed to last, whether she needs to go to the emergency room now what she needs to do. Reporter stated, I am calling because me and my wife couldn't get our second round of the vaccine (unspecified vaccine) yesterday (split not made). Reporter was informed that Pfizer Medical Information is the right department to answer this question and informed about the role of Pfizer Drug Safety. Further probing could not be done as the reporter hung up the call abruptly. Hence limited information available over the call. The outcome of the events was unknown.   QR Comment: Split to be made which was not made by the Call handler.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extremely tired; This is a spontaneous report from a contactable physician (reporter's wife). A female patient of an un-specified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number/ expiry date not reported), via an unspecified route of administration on unspecified date in 2021 at dose 2, single for covid-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number/ expiry date: not reported), via an unspecified route of administration on unspecified date for covid-19 immunization. On an unspecified date in Feb2021 patient felt extremely tired the whole day. Reporter stated that he did have was one week after the second shot he and his wife both felt extremely tired the whole day. Patient vaccination was a week ahead of his. She only had the tiredness for 24 hours. The report was not related to any study or pro-gram. The outcome of event was recovered on an unspecified date in Feb2021.  Information on Lot/Batch number has been requested
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Having just little mild ache at, where the shot was given; It is just mild pain; This is a spontaneous report from a contactable consumer (patient, self-reported). A 73-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0198 and expiry date was not reported), via an unspecified route of administration, on 10Jul2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that just had his first Pfizer shot this afternoon and he did not see anything in papers he got with that whether alcohol affects it. The patient reported that on 10Jul2021, he having just little mild ache at, where the shot was given; It was just mild pain. When clarified the concern consumer stated he had his first Pfizer shot this afternoon he did not see anything about if there was any interaction of alcohol with it. Outcome of the event was unknown.  Follow-up attempts are needed. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: He is running a low grade temperature; This is a spontaneous report from a contactable consumer (reporter's husband). A male patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, he was running a low grade temperature. The patient's wife (reporter) asked should she be alarmed about it or should she be worried, and Should she take him to the emergency room because he was running a low-grade temperature. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report from a contactable consumer reported for a patient. A 15-years-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 09Jul2021 (age at vaccination was unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chest pain. The reporter stated, the patient got the vaccine 24 hours ago and he just mentioned he has little side effect, pain the chest pain and asked what he could do. The reporter was informed about Pfizer drug safety. The reporter was informed about the Pfizer Medical Information Department. The outcome of the event was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable nurse reported for herself. A 56-year-old female nurse (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration, administered in left arm on 09Jul2021 (at age of 56-years-old) as dose 1, single for COVID-19 Immunization. Patient medical history includes Multiple sclerosis, Asthma, Hypothyroidism. Patient concomitant medications include formoterol fumarate dihydrate (4.5 ug) used for unspecified indication from unknown date and unknown ongoing, interferon beta-1b (BETASERON [INTERFERON BETA-1B]) used for multiple sclerosis from unknown date and unknown ongoing, budesonide, formoterol fumarate(SYMBICORT) used for asthma from unknown date and unknown ongoing, Levothyroxine used for Hypothyroidism from unknown date and unknown ongoing, Budesonide(160 microgram) used for unspecified indication from unknown date and unknown ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Jul2021 (one day after vaccination), patient experienced Fever. Nurse stated, she just have a quick question what is a normal fever that you can get, she stated that she called to local hospital, they do not give her any information. The fever she get the vaccine yesterday and her fever is at a 100 and she just want to make sure that its okay. Reason for no lot number was Nurse stated, PF12GR and then below that there is a R2W0181. The Reaction assessed for fever through source of assessment was primary source reporter and method of assessment was global Introspection as drug result was related. For Causality as Nurse stated, is it because of it, she believe so, yes. The patient underwent lab test and procedures include body temperature was 100 on 10Jul2021. The Outcome of event was Unknown.  Information on the lot/batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: a skin rash appeared on all extremities and trunk of body as well as neck. Rash in the form of welts. Very itchy.; a skin rash appeared on all extremities and trunk of body as well as neck. Rash in the form of welts. Very itchy.; Rash in the form of welts. Very itchy.; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 12-years-old male patient received second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: Ew0181), via an unspecified route of administration in left arm on 06Jul2021 (at the age of 12-years-old) at 14:30 as dose 2, single for COVID-19 Immunization. Facility the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unspecified), via an unspecified route of administration on an unspecified date as historical vaccine as dose 1, single for COVID-19 Immunization. On 11Jul2021 at 21:30, the patient experienced 5 days after 2nd dose, a skin rash appeared on all extremities and trunk of body as well as neck. Rash in the form of welts. Very itchy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not received treatment for the adverse event. The outcome of the adverse event was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain, Poor quality sleep, Visual impairment
Clinical narrative: I didn't sleep well; Pain; Every joint and muscle in my body is on fire; Every joint and muscle in my body is on fire; Vision is terrible; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) 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. On an unspecified date the patient experienced I didn't sleep well, pain, every joint and muscle in my body is on fire, every joint and muscle in my body is on fire, vision is terrible. The outcome of the events poor quality sleep, pain, arthralgia, myalgia, visual impairment was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: Tongue is swollen; tongue is little swollen; Throat is swollen; This is a spontaneous report from a contactable consumer(patient). An unspecified age and gender patient received BNT162B2(Pfizer-Biontech Covid-19 Vaccine, Solution for injection, batch/lot number not provided), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tongue is swollen; tongue is little swollen, Throat is swollen. Patient stated that I am having a problem. Concern: Consumer stated, my tongue is swollen, I took a shot my tongue is little swollen, what do I need to do, My tongue is swollen right now. When confirmed that the side effect came after taking Pfizer COVID 19 Vaccine, the reporter stated, "I don't know what it is, I just took the shot couple of days ago, the reporter called in about this and my tongue is swollen now, what do I need to, I am calling you and that's why I am calling, the patient had the COVID shot yes, and her throat was swollen. Patient was informed about the role of Pfizer Medical Information and offered the number. The Patient was suggested to visit Emergency room in case of emergency. The outcome of the events were unknown.  Information on the lot/batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Loosing hair; This is a spontaneous report from a contactable consumer or other non hcp.   A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8735; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 17May2021 (at the age of 12-years-old) as DOSE 1, SINGLE, and second dose via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number and Expiration date was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. The patient experienced loosing hair on an unspecified date. Reporter was calling because her son got the vaccine the first dose on 17May2021(confirmed) had been noticing that he was losing hair, and didn't know if this might a be side effect of the vaccine, planning to take him to the doctor and calling on Monday to schedule an appointment but just wanted to ask if it could be a side effect of the vaccine. The suspect product was confirmed as Pfizer COVID-19 Vaccine. Reporter stated, thought the patient height was about 4 feet 9 inches. Reporter didn't know an exact date of event because reporter just noticed after patient took (incomplete sentence), not the exact date but reported as about a week. On the week of this report, reporter noticed after the shower and saw a lot of hair on the mat. For facility name, reporter stated, could not find the card right now but it was a hospital in. Anatomical site where COVID-19 vaccine was administered reported as right arm for both the shot. No treatment received in response to event. Reporter just noticed and was wondering that's why called to see if it might be a side effect a reaction to the vaccine. It was concerning, yesterday after patient took a bath, reporter noticed a lot of hair and that's not normal and will call the doctor to schedule an appointment but again wanted to call to ask. Patient took no other vaccine prior to the first dose. Reporter stated, it just if patient passes the comb through his hair you know the hair will come off and it's a lot of hair it's not one or two hair it's several, and stated reporter did not know the time event started. Clinical outcome of the event was unknown.  Information on the lot/batch number has been requested. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had a rash on her legs, by her lower heals and ankles/ also had a rash on her arm; This is a spontaneous report from a contactable other health care professional (Nurse) patient. A 51-years-old female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 24May2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Second dose administered on 14Jun2021 at 13:00 in left arm. Medical history included covid-19 in Mar2021, pneumonia, anaphylactic shock four times. Chronic allergies. Nothing was working for her. She survived on Vicks. Concomitant medication(s) included vitamin b complex (VITAMIN B), cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID), hydrocodone bitartrate, paracetamol (NORCO) taken for neck pain She can take it four times daily as needed for pain. She takes it a minimum of one tablet every 12 hours. The patient previously took sulfa 12 for hypersensitivity and experienced hypersensitivity. On 24May2021 (within eight hours post vaccination) patient experienced had a rash on her legs, by her lower heals and ankles/ also had a rash on her arm. She did not have a fever or anything like that. There Is a Product Complaint that she takes for her neck, the pain does not go away. The outcome of event rash was recovered (within 24 hours) on an unspecified date in 2021.   Follow-up attempts are needed. Further information is requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood iron, Blood test, Headache, Lipids
Clinical narrative: had a short pain in my armpit in the one that, in the arm that I got the vaccine; mild Headache; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on 29May2021 (at the age of 20-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anaemia (low iron). Concomitant medication(s) included ferrous sulphate taken for an unspecified indication, start and stop date were not reported. The patient that after the 1st dose, I had short pain in my armpit in the arm that I got my shot in, this is the few days after and then I had mild headache after that too on an unspecified date of 2021. Reporter seriousness for both events was unspecified. The patient underwent lab tests and procedures which included blood iron: unknown results, blood test: unknown, lipids: unknown results, metabolic function test: unknown results on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number is requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test
Clinical narrative: had a short pain in my armpit in the one that, in the arm that I got the vaccine; mild Headache; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on 29May2021 (at the age of 20-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included anaemia (low iron). Concomitant medication(s) included ferrous sulphate taken for an unspecified indication, start and stop date were not reported. The patient that after the 1st dose, I had short pain in my armpit in the arm that I got my shot in, this is the few days after and then I had mild headache after that too on an unspecified date of 2021. Reporter seriousness for both events was unspecified. The patient underwent lab tests and procedures which included blood iron: unknown results, blood test: unknown, lipids: unknown results, metabolic function test: unknown results on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Pain
Clinical narrative: chest hurt; dizzy; body aches; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. This report was received via a sales representative. A 15-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 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 had experienced chest hurt, dizzy and body aches on an unspecified date. The outcome of all the events was unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Aches and pains on ours hands and our legs and sometime we cannot even close our fist; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown, Expiration date was not reported), dose 2 via an unspecified route of administration on 31Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (COMIRNATY) 1st dose on an unknown date for COVID-19 immunisation. Reporter stated, calling to see if there is anybody has had, because he had the Pfizer, his 2nd shot he had it at the end of March this year and his wife had it at the same time. He was just wondering if anybody else called and have this complaint at all. The patient experienced aches and pains on our hands and our legs and sometimes we cannot even close our fist on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) as same reporter/drug/event, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; This is a spontaneous report from a non-contactable consumer (patient's mother). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 15Jun2021 as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported that last week (Jun2021), the patient started coughing and reported that this might be a problem after taking the first dose of Pfizer COVID-19 vaccine. The consumer cancelled the appointment for the 2nd dose due to cough which the patient was supposed to get on 06Jul2021. The patient just had cough a little bit now. The consumer wanted to know if it was safe to go if he was coughing. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Energy increased, Insomnia, Irritability
Clinical narrative: pulmonary embolism; injection was very painful; left arm weakness/can't move arm; insomnia; irritability; high energy level; leg and calf pain with severe right calf pain; pain worsening from the injection area to the back of his ear and shoulder; pain worsening from the injection area to the back of his ear and shoulder; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on 15Jun2021 (at 11 AM) as single dose for covid-19 immunization. The patient medical history included allergy (he also states that he is allergic to "all the antibiotics" but does not specify which ones). The patient's concomitant medications were not reported. He reports a history of pulmonary embolism (prior to the vaccine). He states he has had ongoing side effects after the first dose of the vaccine and he wants to know if it's recommended that he get the second dose. He reports that his ability to swallow has improved. On an unspecified date in Jun2021, the patient experienced pulmonary embolism, injection was very painful, left arm weakness/can't move arm, insomnia, irritability, high energy level, leg and calf pain with severe right calf pain, and pain worsening from the injection area to the back of his ear and shoulder. The outcome of all the events was unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Pulmonary embolism, Vaccination site pain
Clinical narrative: pulmonary embolism; injection was very painful; left arm weakness/can't move arm; insomnia; irritability; high energy level; leg and calf pain with severe right calf pain; pain worsening from the injection area to the back of his ear and shoulder; pain worsening from the injection area to the back of his ear and shoulder; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on 15Jun2021 (at 11 AM) as single dose for covid-19 immunization. The patient medical history included allergy (he also states that he is allergic to "all the antibiotics" but does not specify which ones). The patient's concomitant medications were not reported. He reports a history of pulmonary embolism (prior to the vaccine). He states he has had ongoing side effects after the first dose of the vaccine and he wants to know if it's recommended that he get the second dose. He reports that his ability to swallow has improved. On an unspecified date in Jun2021, the patient experienced pulmonary embolism, injection was very painful, left arm weakness/can't move arm, insomnia, irritability, high energy level, leg and calf pain with severe right calf pain, and pain worsening from the injection area to the back of his ear and shoulder. The outcome of all the events was unknown.  Information on the lot/ batch number has been requested.