chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: Headache/Sharp stabbing pains in head as well as muscles; cough; cold chills; hot flashes; fever; muscle and joint pain/Sharp stabbing pains in head as well as muscles; muscle and joint pain; fatigue; Loss of appetite; Brain fog; Some sinus pressure; flushed cheeks; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL9265) via an unspecified route of administration on 04Feb2021 at 08:30 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. It was reported that the patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (other medications in two weeks) included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), zinc and multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: 9L3246) via an unspecified route of administration on 07Jan2021 at 18:45 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. On 04Feb2021 at 20:30 the patient experienced headache, cough, cold chills, hot flashes, fever, muscle and joint pain, sharp stabbing pains in head as well as muscles, fatigue, loss of appetite, brain fog, some sinus pressure and flushed cheeks. The patient did not require treatment for the events. The clinical outcome of the events headache, cough, cold chills, hot flashes, fever, muscle and joint pain, sharp stabbing pains in head as well as muscles, fatigue, loss of appetite, brain fog, some sinus pressure and flushed cheeks were recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Headache, Hot flush, Myalgia
Clinical narrative: Headache/Sharp stabbing pains in head as well as muscles; cough; cold chills; hot flashes; fever; muscle and joint pain/Sharp stabbing pains in head as well as muscles; muscle and joint pain; fatigue; Loss of appetite; Brain fog; Some sinus pressure; flushed cheeks; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL9265) via an unspecified route of administration on 04Feb2021 at 08:30 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. It was reported that the patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (other medications in two weeks) included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), zinc and multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: 9L3246) via an unspecified route of administration on 07Jan2021 at 18:45 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. On 04Feb2021 at 20:30 the patient experienced headache, cough, cold chills, hot flashes, fever, muscle and joint pain, sharp stabbing pains in head as well as muscles, fatigue, loss of appetite, brain fog, some sinus pressure and flushed cheeks. The patient did not require treatment for the events. The clinical outcome of the events headache, cough, cold chills, hot flashes, fever, muscle and joint pain, sharp stabbing pains in head as well as muscles, fatigue, loss of appetite, brain fog, some sinus pressure and flushed cheeks were recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Pyrexia
Clinical narrative: Headache/Sharp stabbing pains in head as well as muscles; cough; cold chills; hot flashes; fever; muscle and joint pain/Sharp stabbing pains in head as well as muscles; muscle and joint pain; fatigue; Loss of appetite; Brain fog; Some sinus pressure; flushed cheeks; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL9265) via an unspecified route of administration on 04Feb2021 at 08:30 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. It was reported that the patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (other medications in two weeks) included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), zinc and multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: 9L3246) via an unspecified route of administration on 07Jan2021 at 18:45 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. On 04Feb2021 at 20:30 the patient experienced headache, cough, cold chills, hot flashes, fever, muscle and joint pain, sharp stabbing pains in head as well as muscles, fatigue, loss of appetite, brain fog, some sinus pressure and flushed cheeks. The patient did not require treatment for the events. The clinical outcome of the events headache, cough, cold chills, hot flashes, fever, muscle and joint pain, sharp stabbing pains in head as well as muscles, fatigue, loss of appetite, brain fog, some sinus pressure and flushed cheeks were recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash macular, Tenderness
Clinical narrative: swelling; red spots; tenderness on my right big toe and the toe next to it; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot #: EL3247) via an unspecified route of administration on 19Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies. The patient did not receive any other medications within two weeks prior to the vaccination and did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021 the patient experienced swelling, red spots and tenderness on my right big toe and the toe next to it. The clinical course was reported as follows: "two weeks after my COVID-19 vaccination I noticed swelling, red spots, and tenderness on my right big toe and the toe next to it. I visited my podiatrist who recommended NSAIDs for a week. Today, my sister in law who is a nurse said it looked like COVID toes. When I googled an image of COVID toes, the spots looked identical to my own." The adverse events required a physician office visit. The patient received treatment for the events which included NSAIDs. The clinical outcomes of the events swelling, red spots and tenderness on my right big toe and the toe next to it were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19; COVID-19 exposure; This is a spontaneous report from a contactable physician (patient). A non-pregnant 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EK5730) on 21Dec2020 at 18:15 (at the age of 51-years-old) intramuscularly in the right arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL1283) on 15Jan2021 at 12:00 (at the age of 51-years-old) intramuscularly in the left arm, both as a single dose for COVID-19 immunization. Medical history was reported as none. It was reported that the patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (other medications in two weeks) were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination.The patient experienced COVID-19 exposure on 01Feb2021, COVID-19 confirmed by positive COVID-19 test and COVID-19, both on 06Feb2021. It was reported that the patient "had close contact with COVID-19 positive son on 01Feb21. Now the patient had tested positive for COVID-19 with mild symptoms. The patient became infected more than 2 weeks after the second dose was administered." The patient was tested for COVID-19 post vaccination on 06Feb2021 and was positive via a rapid antigen nasal swab. It was reported that the patient did not receive treatment for the adverse event. The clinical outcomes of the events COVID-19 confirmed by positive COVID-19 test and COVID-19 exposure were both recovering/resolving.; Sender's Comments: Based on the available information, a causal relationship between events Vaccination failure / COVID-19 and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)  cannot be completely excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Next day repeated sneezing all day every 5 minutes 2 sneezes; This is a spontaneous report from a contactable consumer  (the patient).  A non-pregnant 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration, in the right arm on 05Feb2021 at 10:00 AM (at the age of 62-years) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus.  The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included liraglutide (VICTOZA), metformin, lisinopril, bupropion hydrochloride (WELLBUTRIN), rosuvastatin calcium (COLESTRAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021, the next day after vaccination, at 2:30 PM, the patient had repeated sneezing all day every 5 minutes 2 sneezes. No treatment was given. The clinical outcome of the sneezing was not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis
Clinical narrative: Laryngitis; This is a spontaneous report from a contactable consumer (the patient). A female patient (Age: 68, Units: unspecified) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she was scheduled to receive her second shot of the Pfizer vaccine on Thursday. She has laryngitis and received prednisone today. She asked if that was ok to take. She stated it had been two weeks since her first dose, so she didn't think it was because of that. The clinical outcome of laryngitis was unknown.  Information on the lot number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of laryngitis. The reported event likely represent intercurrent medical condition.   There is limited information provided in this report. T his case will be reassessed upon receipt of follow-up information.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). This 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via unspecified route of administration in the left arm on 06Feb2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization. The patient had no medical history, had not been diagnosed with COVID prior to vaccination, and had no known allergies. Concomitant medications included cetirizine hydrochloride (ALLERTEC) from an unknown date for an unknown indication; ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE) from an unknown date for an unknown indication; and ascorbic acid, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iron, lycopene, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium molybdate, sodium selenite, thiamine mononitrate, zinc oxide (ONE A DAY MEN'S 50+ HEALTHY ADVANTAGE) from an unknown date for an unknown indication. The patient had not received any other vaccines in the four weeks prior to administration. On 07Feb2021 at 10:00 the patient experienced nausea and vomiting. No treatment was provided for the events. The clinical outcomes of nausea and vomiting were recovering. It was also reported that the patient had not been tested for COVID since vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: SARS-Covid -2 Ab IGG and it turned negative; This is a spontaneous report from a contactable physician (patient). This female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 11Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 immunization on an unspecified date. The patient reported completing her vaccination with the two doses on 11Jan (2021). She had blood drawn for annual exam and requested to add SARS-COVID-2 "Ab IGG" and it turned negative. She further reported understanding that she had not developed antibodies. The physician inquired if she should repeat the test, how she should interpret the results, and if there were any recommendations or suggestions as she was concerned she may be vulnerable. Laboratory tests and procedures on an unspecified date indicated SARS-COVID -2 "Ab IGG" negative. The clinical outcome of SARS-COVID-2 "Ab IGG" and it turned negative was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: HIV test, HIV test false positive, Maternal exposure timing unspecified
Clinical narrative: my daughter is in labor and they are talking about having to give her a C-section because of, what I believe is a false positive HIV test; had the Covid vaccine last week and she is now in labor; This is a spontaneous report from a contactable consumer (patient's parent). This consumer reported information for both mother and fetus. This is the maternal report.   A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. Medical history included having a baby two years ago (2019). The patient's concomitant medication was reported as none. The patient received the COVID vaccine on 03Feb2021 and was now (08Feb2021) in labor. The hospital protocol was that they do a rapid HIV test in which the patient has tested positive for, which was further clarified as false positive. They gave her a bag of ATZ (also reported as AVT), an antiretroviral intravenously, tested her again, and was talking about taking the baby by C-section if the rapid test comes back positive again. She was in labor and they have slowed down her labor. They were currently waiting for test results for the other HIV test. The patient has no other risk factors for HIV. Her doctor did not do a routine HIV testing during the pregnancy. She had a baby two years ago and she had an HIV testing done which was negative on an unspecified date. They were trying to find out before they cut her open for no reason. The consumer asked if there has been any information on false positive HIV testing and if the COVID vaccine could possibly cause it as the patient had the COVID vaccine last week. That way, they may less likely to cut the patient open. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021149068 fetal case
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Pain
Clinical narrative: headache; body ache; fatigue; armpit ache; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable other health care professional (patient). A female patient of an unspecified age received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the second dose of the Covid19 vaccine on 05Feb2021 and was having symptoms such as headache, body ache, fatigue and armpit ache on unknown date in Feb2021. She wanted to know if she can take acetaminophen (TYLENOL). Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Pain in extremity, Suspected COVID-19
Clinical narrative: suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; sore arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-Sponsored Program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 01Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that she "had a sore arm, and today she was experiencing all the symptoms of COVID-19". The clinical outcomes of the events sore arm and suspected COVID-19 with symptoms were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program. A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 01Feb2021 (at the age of 79-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. The patient experienced pain (reported as not related to the vaccine) on 01Feb2021. The clinical outcome of the event pain was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in her left arm where the shot was given; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 23Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the vaccine on 23Jan2021 and still had pain in her left arm where the shot was given. The patient's second dose will be on 18Feb2021. The clinical outcome of pain in her left arm where the shot was given was not recovered.   Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache
Clinical narrative: light headache; back pains; This is a spontaneous report from a Pfizer-sponsored program. A contactable Consumer reported similar events for 2 patients. This is 2nd of 2 reports. A male patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 as a single dose for covid-19 immunization.  Medical history and concomitant medications were not reported. On an unspecified date, she experienced light headache and back pains and would like to know if she can take Tylenol. The clinical outcome of the events headache and back pain was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021144697 same reporter, case for Wife
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the injection; I have a slight fever of a 100; I feel I am cold, I have the chills; Headache; joint pain; muscle pain unbelievable; nauseous; I was sick all day; symptoms felt like when you are getting the flu and when you get the flu vaccine; tiredness; sweating; This is a spontaneous report from a contactable consumer, the patient. This 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1, single dose via an unspecified route of administration on 05Feb2021 (at the age of 73 years-old) for COVID-19 vaccination. Medical history included Parkinson's disease, bulging disc in the back and shoulder, anxiety, thyroid, had very bad case of, was in the hospital for 12 days and they were just supposed to put her on the ventilator, but then started to recover a little bit, was hesitating on taking the shot. But when she called the doctors they said no you can take it, even the neurologist said that you can take it because she had this disease and should be taking it. Historical vaccine included unspecified reaction from an unspecified flu vaccine on an unknown date. Concomitant medications included dexlansoprazole (DEXILANT), levothyroxine, paroxetine for anxiety, carbidopa, levodopa for Parkinson's disease, metoprolol succinate (METOPROLOL ER ACTAVIS) 25 mg, one a day and vitamin D NOS. On 05Feb2021, the patient experienced slight fever of a 100, felt cold, chills, headache, joint pain, muscle pain unbelievable,  nauseous and was sick all day. On 06Feb2021, the patient's arm was very sore in the spot where they gave the injection and has no rash, it's not red in that area or any place else, It's just very sore and it hurts in the muscle, this is very sore in the spot where they gave the injection. On an unknown date in 2021, symptoms felt like when you are getting the flu and when you get the flu vaccine just a little more tiredness. Treatment to reduce the fever included acetaminophen (TYLENOL) and is sweating. Treatment was received for chills. The clinical outcome of slight fever of a 100, felt cold, chills was recovered on an unknown date. The clinical outcome of arm very sore in the spot where they gave the injection, headache, joint pain, muscle pain unbelievable, nauseous, sick all day, symptoms felt like when you are getting the flu and flu vaccine, tiredness and sweating was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Malaise, Myalgia, Nausea
Clinical narrative: Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the injection; I have a slight fever of a 100; I feel I am cold, I have the chills; Headache; joint pain; muscle pain unbelievable; nauseous; I was sick all day; symptoms felt like when you are getting the flu and when you get the flu vaccine; tiredness; sweating; This is a spontaneous report from a contactable consumer, the patient. This 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1, single dose via an unspecified route of administration on 05Feb2021 (at the age of 73 years-old) for COVID-19 vaccination. Medical history included Parkinson's disease, bulging disc in the back and shoulder, anxiety, thyroid, had very bad case of, was in the hospital for 12 days and they were just supposed to put her on the ventilator, but then started to recover a little bit, was hesitating on taking the shot. But when she called the doctors they said no you can take it, even the neurologist said that you can take it because she had this disease and should be taking it. Historical vaccine included unspecified reaction from an unspecified flu vaccine on an unknown date. Concomitant medications included dexlansoprazole (DEXILANT), levothyroxine, paroxetine for anxiety, carbidopa, levodopa for Parkinson's disease, metoprolol succinate (METOPROLOL ER ACTAVIS) 25 mg, one a day and vitamin D NOS. On 05Feb2021, the patient experienced slight fever of a 100, felt cold, chills, headache, joint pain, muscle pain unbelievable,  nauseous and was sick all day. On 06Feb2021, the patient's arm was very sore in the spot where they gave the injection and has no rash, it's not red in that area or any place else, It's just very sore and it hurts in the muscle, this is very sore in the spot where they gave the injection. On an unknown date in 2021, symptoms felt like when you are getting the flu and when you get the flu vaccine just a little more tiredness. Treatment to reduce the fever included acetaminophen (TYLENOL) and is sweating. Treatment was received for chills. The clinical outcome of slight fever of a 100, felt cold, chills was recovered on an unknown date. The clinical outcome of arm very sore in the spot where they gave the injection, headache, joint pain, muscle pain unbelievable, nauseous, sick all day, symptoms felt like when you are getting the flu and flu vaccine, tiredness and sweating was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the injection; I have a slight fever of a 100; I feel I am cold, I have the chills; Headache; joint pain; muscle pain unbelievable; nauseous; I was sick all day; symptoms felt like when you are getting the flu and when you get the flu vaccine; tiredness; sweating; This is a spontaneous report from a contactable consumer, the patient. This 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1, single dose via an unspecified route of administration on 05Feb2021 (at the age of 73 years-old) for COVID-19 vaccination. Medical history included Parkinson's disease, bulging disc in the back and shoulder, anxiety, thyroid, had very bad case of, was in the hospital for 12 days and they were just supposed to put her on the ventilator, but then started to recover a little bit, was hesitating on taking the shot. But when she called the doctors they said no you can take it, even the neurologist said that you can take it because she had this disease and should be taking it. Historical vaccine included unspecified reaction from an unspecified flu vaccine on an unknown date. Concomitant medications included dexlansoprazole (DEXILANT), levothyroxine, paroxetine for anxiety, carbidopa, levodopa for Parkinson's disease, metoprolol succinate (METOPROLOL ER ACTAVIS) 25 mg, one a day and vitamin D NOS. On 05Feb2021, the patient experienced slight fever of a 100, felt cold, chills, headache, joint pain, muscle pain unbelievable,  nauseous and was sick all day. On 06Feb2021, the patient's arm was very sore in the spot where they gave the injection and has no rash, it's not red in that area or any place else, It's just very sore and it hurts in the muscle, this is very sore in the spot where they gave the injection. On an unknown date in 2021, symptoms felt like when you are getting the flu and when you get the flu vaccine just a little more tiredness. Treatment to reduce the fever included acetaminophen (TYLENOL) and is sweating. Treatment was received for chills. The clinical outcome of slight fever of a 100, felt cold, chills was recovered on an unknown date. The clinical outcome of arm very sore in the spot where they gave the injection, headache, joint pain, muscle pain unbelievable, nauseous, sick all day, symptoms felt like when you are getting the flu and flu vaccine, tiredness and sweating was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: COVID drug reaction with shingles.; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported for self that the patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced covid drug reaction with shingles on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Headache, Herpes zoster
Clinical narrative: more symptoms and her right eye is more closed; more pain in her head; shingles; This is spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (Wife) with unknown age (85; Unit: Unknown) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included shingles 4 years before unspecified date and since has neuropathy on head and right eye. The concomitant medications were not reported.Patient had the first dose of the vaccine on 25Jan2021 and are tentatively scheduled for the second dose 24Feb2021, 30 days apart. Patient may have had a reaction to the first dose but it may not be related. Patient experienced shingles in Feb2021. The vaccine seemed to more symptoms and her right eye is more closed and there is more pain in her head in Feb2021. The caller stated they are seriously considering cancelling their second dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of     headache and eye disorder due to temporal relationship. Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of shingles, which may likely represent intercurrent medical condition.  There is limited information provided in this report.  This case will be reassessed once additional information is available.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient's child) reported a male patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date a week after receiving BNT162B2, the patient tested positive for COVID-19. The patient had been symptom free for 6 to 7 days at the time of the report. The patient's child wanted to know if it was okay for the patient to get dose 2 of BNT162B2 as he was supposed to get it "tomorrow." The outcome of tested positive for COVID-19 was unknown.  No follow-up attempts are possible; Information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm is sore; arm is swollen; This is a spontaneous report from a contactable consumer (the patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EU283), via an unspecified route of administration on an unknown date as a single dose in the right arm for COVID-19 immunization. Medical history included lung cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unknown date. The patient experienced my arm is still sore, it is swollen on an unknown date stating it is all day, yesterday and the night. The patient treated the arm is sore and swollen with putting an ice pack on it. The clinical outcome of the pain in extremity and peripheral swelling was not recovered.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Pain at the injection site; Body aches; Low grade fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration in the left shoulder area, on 03Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included multivitamin, losartan, eye vitamin and Garlic. The patient previously received first dose of BNT162B2 (lot number: EL3248) on 13Jan2021 for COVID-19 immunization. On an unspecified date, the patient experienced pain at the injection site, body aches, low grade fever, and chills. The patient took ibuprofen as treatment. The events did not require emergency room/ physician visit. Outcome of the events was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Just my arm, it itches and it is red and got a little fever in it; Just my arm, it itches and it is red and got a little fever in it; Just my arm, it itches and it is red and got a little fever in it; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from an unspecified date (at the age of 83 years old) at SINGLE DOSE for COVID-19 immunization, The patient's medical history was not reported.  Concomitant medication included unspecified medications but none of them is bothering her. The patient reported that she was not sick, was not running a fever, but her arm is itching and it is red and "got a little fever in it" on unspecified date.  The consumer inquired "Should I take some diphenhydramine (BENADRYL) or what should I do? Is that a reaction to the vaccine?". Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain
Clinical narrative: Soft lump on left side clavicle. Very sore; Soft lump on left side clavicle. Very sore; This is a spontaneous report from a contactable consumer, the patient. A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL5248, second dose) solution for injection intramuscular in the left arm on 16Jan2021 at 11:00 (at the age of 83-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included macular degeneration, glaucoma, and allergies: dairy products, penicillin and sulfa antibiotics. Concomitant medications included ascorbic acid/betacarotene/cupric oxide/tocopheryl acetate/zinc oxide (PRESERVISION), calcium, fish oil and vitamin D. Historical vaccine included BNT162B2 (Lot EL0140, first dose) for COVID-19 vaccination on 26Dec2020 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Feb2021 at 10:00, the patient felt a soft lump on left side clavicle very sore. No treatment was provided for the events sore and lump. The outcome of the events sore and lump was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: Bicep tendinitis; This is spontaneous report from a non-contactable health professional, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the left arm on an unspecified date (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history was none, and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date (within 4 weeks of the second vaccination) for COVID-19 immunization. On 05Feb2021, the patient experienced bicep tendinitis with severe shooting sharp pain when extending the arm and bending over 150 degrees as well as pain which also worsened when twisting the wrist from the facing leg toward the sky. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of bicep tendinitis was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills; nausea; intense headache; severe fatigue; muscle pain; joint pain; This is a spontaneous report from a non-contactable nurse (the patient). A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the right arm on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the right arm on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unspecified date, the patient experienced chills, nausea, intense headache, severe fatigue, muscle and joint pain that started around 10 following injection and was the worst 24 hours to about 48 hours following injection. Now 53 hours post injection, the patient was feeling close to normal. No treatment was received for the events. The clinical outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.    No follow up attempts are possible; information about the lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Chills; nausea; intense headache; severe fatigue; muscle pain; joint pain; This is a spontaneous report from a non-contactable nurse (the patient). A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the right arm on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the right arm on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unspecified date, the patient experienced chills, nausea, intense headache, severe fatigue, muscle and joint pain that started around 10 following injection and was the worst 24 hours to about 48 hours following injection. Now 53 hours post injection, the patient was feeling close to normal. No treatment was received for the events. The clinical outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.    No follow up attempts are possible; information about the lot number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Chills; Headache; Muscle aches; This is a spontaneous report from a contactable pharmacist. A 72-year-old non-pregnant female patient (reporter's mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 05Feb2021 at 08:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, fibromyalgia, sleep apnea. The patient was not diagnosed with COVID prior to the vaccination. The patient had no known allergies. Concomitant medications included hydrochlorothiazide/valsartan, celecoxib, duloxetine. There were no other vaccines administered within 4 weeks of the vaccination. On 06Feb2021 at 06:00, the morning after the vaccination, the patient experienced chills, headache, and muscle aches. The patient was treated for the events with 600 mg of ibuprofen and the symptoms subsided. Since the vaccination, the patient was not tested for COVID. The clinical outcome of chills, headache, and muscle aches was resolving.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cold sweat, Hyperhidrosis, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: hot cold sweat; hot cold sweat; colds; losing voice; throat is sore; This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On unspecified date, the patient experienced colds that results to hot cold sweat and losing voice as her throat is sore. She was due for the second dose on 25Feb2021. The consumer was asking if she could get the second dose of the vaccine on 25Feb2021. She has a terrible cold and is not still over yet. She wanted to get the 2nd dose until she feels better. Outcome of colds was not recovered.  Outcome of hot cold sweat, losing voice, throat is sore was unknown.  Information on the Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive between doses 1 and 2 of the vaccine; tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable pharmacist.  This pharmacist reported similar events for 6 patients. This is the 6th of 6 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The pharmacist reported that 6 patients tested positive between doses 1 and 2 of the vaccine, in which the pharmacist was giving Covid vaccinations in a nursing home. It was reported that the patient was tested positive between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home. Those patients were tested every day. The pharmacist started administering the second doses. One patient was administered the second dose and then somebody said, "Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, we're under the impression you wait 90 days if they've been given antibodies after that to give the second dose. One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest who were hospitalized did not receive their second injection. Caller asked, "What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported testing with a positive viral load based on the known safety profile. ,Linked Report(s) : US-PFIZER INC-2021199894 same drug/reporter/event, different patient;US-PFIZER INC-2021222955 same drug/reporter/event, different patient;US-PFIZER INC-2021222956 same drug/reporter/event, different patient;US-PFIZER INC-2021222953 same drug/reporter/event, different patient;US-PFIZER INC-2021222954 same drug/reporter/event, different patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tongue discomfort
Clinical narrative: Tongue heaviness and lightheadedness, given Benadryl 25 mg PO.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: I developed pain and tingling (pins and needles sensation) in my hands and feet the day after receiving the vaccine.  The pain initially interfered with my ability to type and use my hands for normal activity. The pain and tingling has subsided in severity, but continues to occur sporadically.  Now, approximately 4 weeks later, I still experience occasional tingling/pin and needles sensation in my arms, hands, legs and feet. I have spoken with my primary care doctor and decided to delay and possibly skip the second dose.  My PCP has also referred me to a neurologist.