chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade temp; arm sore; fatigue; fever/temp above 100.3; bad headache; her back, neck, shoulder and hips are gone; This is a spontaneous report from a contactable nurse (patient). A (Age: 65; Unit: Unknown) female patient received second dose of 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 a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced low grade temp, arm sore, fatigue, fever/temp above 100.3, bad headache, and her back, neck, shoulder and hips are gone. On an unspecified date, the patient underwent lab tests and procedures which included Body temperature: 100.3. Caller wanted to know what test she can do that can tell if she has any protection after the second dose. The outcome of the event low grade temp, sore arm was recovered on an unspecified date; and all other events were unknown.  No follow up attempts are possible. Information about lot/batch number cannot be requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 08Mar2021, as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After first dose, the patient experienced rashes on an unspecified date in 2021.The patient was prescribed to take cephalexin. The patient will be taking his 2nd dose on 29Mar2021. The outcome of the event was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient's daughter). A 62-year-old male patient (reporter's father) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date: not reported), via an unspecified route of administration, on Mar 21, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On Mar 29, 2021, patient experienced chills and mild fever/100.1ºF. The reporter asked if a patient who received the first dose of the Pfizer-BioNTech COVID-19 vaccine will experience chills and a mild fever. Was it possible to experience those symptoms 8 days after getting the vaccine? The reporter stated these symptoms and timeframe were experienced by her father. The patient underwent lab tests/procedures, which included body temperature of 100.1ºF on an unspecified date in 2021. The outcome of the events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: Rash; Breathing problems; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash, breathing problems. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pruritus
Clinical narrative: Itch; Pain in her shoulder; This is a spontaneous report received from a contactable consumer or other non-healthcare professional. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunisation. Medical history included hypertension (takes Metoprolol for her hypertension), blood pressure, pain from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) taken for pain, ibuprofen (ADVIL 12 HOUR) taken for pain, metoprolol (METOPROLOL) taken for blood pressure, hypertension, plantago ovata (METAMUCIL [PLANTAGO OVATA]) taken for blood pressure, digestion, start and stop date were not reported. The patient got her first dose on 26Mar. She had pain in her shoulder on 26Mar2021. The next day (27Mar), the pain went down and she felt well. She regularly takes Metoprolol for her hypertension, however, On 28Mar2021, she started to itch on her body. She wanted to know if this is normal and if she can take Benadryl. She also takes Metamucil for her digestion. She wanted to know if it's safe for her to get the second dose. Caller mentioned that there was no mark on her injection site. She mentioned that this has not happened before and was not normal. The outcome of the event arthralgia was reported as recovered on 27Mar2021 and pruritus was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure fluctuation, Dizziness, Feeling abnormal, Feeling cold
Clinical narrative: fluctuations of blood pressure; aches and pains/achy; sore joints; sore ribcage; feeling cold; dizzy; not feeling like herself; This is a spontaneous report from a contactable consumer. This 80-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6207) via an unspecified route of administration on 22Mar2021 (at 80-year-old), as dose 1, single on left arm for COVID-19 immunization. The patient's medical history included high blood pressure, caller says that this was diagnosed 12-15 years ago, maybe longer. The said that she had not had any other recent vaccinations or started any new medications, but she was prescribed something a couple weeks ago that she took one of and did not like how she felt so she had not taken any more of that, which was at least three weeks ago. Caller provides no further details about this medication. On an unknown date in Mar2021 after she had received the first dose of Pfizer's COVID vaccine she experienced fluctuations of blood pressure, which she does take medication for blood pressure. She stated that she had aches and pains and sore joints, sore ribcage which she says was very unusual, and she felt like she had reached for something and twisted or pulled a muscle or something, she felt cold, She asked if she should be concerned about her next injection. She stated she felt achy and dizzy. She says that she was advised by her doctor's office since she felt she had some kind of reaction to let Pfizer know. She says two or three days after getting the injection she started not feeling like herself, she was achy and her joints in her hands ached which was not usual and then she felt it in her shoulders. She says her blood pressure fluctuated more than usual, which she does have high blood pressure that was well controlled by medication, at least the last 5 months since her husband passed away. She says she went through a lot of stress, and it has not been an issue, then it kind of fluctuated a lot last week. She mentioned that her height was 5 feet 8 inches, and when she was last measured she was 5 feet 7.5 inches, she shrunk half an inch before she got the vaccine, which she knows because she had a bone scan a couple months ago. She says she was quite active, she lives alone and does housework and drives. She says she has not treated the achiness, though she had considered taking Tylenol if she couldn't sleep but she did sleep. The event outcome was unknown.  No follow-up attempts were possible. No further information was expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pain
Clinical narrative: fluctuations of blood pressure; aches and pains/achy; sore joints; sore ribcage; feeling cold; dizzy; not feeling like herself; This is a spontaneous report from a contactable consumer. This 80-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6207) via an unspecified route of administration on 22Mar2021 (at 80-year-old), as dose 1, single on left arm for COVID-19 immunization. The patient's medical history included high blood pressure, caller says that this was diagnosed 12-15 years ago, maybe longer. The said that she had not had any other recent vaccinations or started any new medications, but she was prescribed something a couple weeks ago that she took one of and did not like how she felt so she had not taken any more of that, which was at least three weeks ago. Caller provides no further details about this medication. On an unknown date in Mar2021 after she had received the first dose of Pfizer's COVID vaccine she experienced fluctuations of blood pressure, which she does take medication for blood pressure. She stated that she had aches and pains and sore joints, sore ribcage which she says was very unusual, and she felt like she had reached for something and twisted or pulled a muscle or something, she felt cold, She asked if she should be concerned about her next injection. She stated she felt achy and dizzy. She says that she was advised by her doctor's office since she felt she had some kind of reaction to let Pfizer know. She says two or three days after getting the injection she started not feeling like herself, she was achy and her joints in her hands ached which was not usual and then she felt it in her shoulders. She says her blood pressure fluctuated more than usual, which she does have high blood pressure that was well controlled by medication, at least the last 5 months since her husband passed away. She says she went through a lot of stress, and it has not been an issue, then it kind of fluctuated a lot last week. She mentioned that her height was 5 feet 8 inches, and when she was last measured she was 5 feet 7.5 inches, she shrunk half an inch before she got the vaccine, which she knows because she had a bone scan a couple months ago. She says she was quite active, she lives alone and does housework and drives. She says she has not treated the achiness, though she had considered taking Tylenol if she couldn't sleep but she did sleep. The event outcome was unknown.  No follow-up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: not tasting; not smelling; This is a spontaneous report from a contactable female consumer via Pfizer-sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown), unspecified route of administration, administered on 13Apr 2021 as Dose 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced not tasting and smelling. The patient wanted to know if it was okay to take second shot. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Discomfort, Dizziness, Dyspepsia
Clinical narrative: I felt very fatigue; Terrible headache / Symptoms are back again and terrible heavy headache; Very little dizzy; Chills; Stuffed nose; Discomfort; discomforted throat; Little cough; muscle pain / muscle back pain; runny nose; Stomach acid influx; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 13Mar2021 (at the age of 63 year old) as dose 1, singe for COVID-19 immunisation. The patient medical history included runny nose: allergy to cold. The patient's concomitant medications were not reported. After received the vaccine on 13Mar2021, on next day evening she felt very fatigue and terrible headache and sometimes very little dizzy, had chills, stuffed nose, discomfort, discomforted throat and a little cough, but no fever. She also had back muscle pain. The next day evening all this symptoms were gone except discomfort and stuffed nose. But two days later all this symptoms are back again. She specified the headaches were her most severe symptom while the other ones were mild. Next day she started to take Tylenol for pain relief. She continued to take pain relievers /Tylenols 500 mg for 5 days for headache. And after the fifth day of medication the headache was better, where she stop taking the medicine. It was reported that she was a person who easily gets cold and has to take medicine for 1-2 week before she can recover. She mentioned that she also had a runny nose, which was the allergy to cold and thus had a runny nose everyday in this past winter. Also, had stomach acid influx that hurts her throat, therefore she always had an unclear throat. Until the time of report, she still has headache and back muscle pain. The outcome of the events headache and back muscle pain was not recovered and of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nasal congestion, Oropharyngeal discomfort
Clinical narrative: I felt very fatigue; Terrible headache / Symptoms are back again and terrible heavy headache; Very little dizzy; Chills; Stuffed nose; Discomfort; discomforted throat; Little cough; muscle pain / muscle back pain; runny nose; Stomach acid influx; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 13Mar2021 (at the age of 63 year old) as dose 1, singe for COVID-19 immunisation. The patient medical history included runny nose: allergy to cold. The patient's concomitant medications were not reported. After received the vaccine on 13Mar2021, on next day evening she felt very fatigue and terrible headache and sometimes very little dizzy, had chills, stuffed nose, discomfort, discomforted throat and a little cough, but no fever. She also had back muscle pain. The next day evening all this symptoms were gone except discomfort and stuffed nose. But two days later all this symptoms are back again. She specified the headaches were her most severe symptom while the other ones were mild. Next day she started to take Tylenol for pain relief. She continued to take pain relievers /Tylenols 500 mg for 5 days for headache. And after the fifth day of medication the headache was better, where she stop taking the medicine. It was reported that she was a person who easily gets cold and has to take medicine for 1-2 week before she can recover. She mentioned that she also had a runny nose, which was the allergy to cold and thus had a runny nose everyday in this past winter. Also, had stomach acid influx that hurts her throat, therefore she always had an unclear throat. Until the time of report, she still has headache and back muscle pain. The outcome of the events headache and back muscle pain was not recovered and of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: I felt very fatigue; Terrible headache / Symptoms are back again and terrible heavy headache; Very little dizzy; Chills; Stuffed nose; Discomfort; discomforted throat; Little cough; muscle pain / muscle back pain; runny nose; Stomach acid influx; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 13Mar2021 (at the age of 63 year old) as dose 1, singe for COVID-19 immunisation. The patient medical history included runny nose: allergy to cold. The patient's concomitant medications were not reported. After received the vaccine on 13Mar2021, on next day evening she felt very fatigue and terrible headache and sometimes very little dizzy, had chills, stuffed nose, discomfort, discomforted throat and a little cough, but no fever. She also had back muscle pain. The next day evening all this symptoms were gone except discomfort and stuffed nose. But two days later all this symptoms are back again. She specified the headaches were her most severe symptom while the other ones were mild. Next day she started to take Tylenol for pain relief. She continued to take pain relievers /Tylenols 500 mg for 5 days for headache. And after the fifth day of medication the headache was better, where she stop taking the medicine. It was reported that she was a person who easily gets cold and has to take medicine for 1-2 week before she can recover. She mentioned that she also had a runny nose, which was the allergy to cold and thus had a runny nose everyday in this past winter. Also, had stomach acid influx that hurts her throat, therefore she always had an unclear throat. Until the time of report, she still has headache and back muscle pain. The outcome of the events headache and back muscle pain was not recovered and of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis; This is a spontaneous report from a Pfizer-sponsored Program, regulatory authority from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 22Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop dates were not reported. The patient experienced arthritis on an unspecified date. The clinical course was as follows: She called to say how long she needed to wait to take ibuprofen for her arthritis from the date she got the vaccine. She received the 1st dose on 22Mar2021. She mentioned that she took acetaminophen (TYLENOL) after the 1st dose. Therapeutic measures were taken as a result of arthritis. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Diarrhoea, Headache, Insomnia, Pain
Clinical narrative: intense sensations; achy; fever; diarrhea; headache; difficulty sleeping; This is a spontaneous report from a contactable Nurse. This is 1st of two reports. A 62-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Feb2021 (Batch/Lot Number: EN6205) as dose 1, single (at the age of 62 year) for covid-19 immunisation. Medical history included covid-19 from Oct2020. The patient's concomitant medications was not reported. After receiving the first dose of the Pfizer Covid Vaccine on 28Feb2021 the reaction was very achy, some fever. She had some diarrhea, but it was not intense diarrhea. It was one episode of diarrhea and a big headache after receiving the first dose of Pfizer Covid Vaccine. She reported difficulty sleeping and says the most intense sensations started the morning after on 01Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Oct2020. Outcome of the events was unknown  No follow-up attempts are possible; no further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: intense sensations; achy; fever; diarrhea; headache; difficulty sleeping; This is a spontaneous report from a contactable Nurse. This is 1st of two reports. A 62-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Feb2021 (Batch/Lot Number: EN6205) as dose 1, single (at the age of 62 year) for covid-19 immunisation. Medical history included covid-19 from Oct2020. The patient's concomitant medications was not reported. After receiving the first dose of the Pfizer Covid Vaccine on 28Feb2021 the reaction was very achy, some fever. She had some diarrhea, but it was not intense diarrhea. It was one episode of diarrhea and a big headache after receiving the first dose of Pfizer Covid Vaccine. She reported difficulty sleeping and says the most intense sensations started the morning after on 01Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Oct2020. Outcome of the events was unknown  No follow-up attempts are possible; no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Influenza like illness, Pyrexia
Clinical narrative: flu-like aches; mild fever (100.3); exhaustion; headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot was not reported), via an unspecified route of administration, administered anatomical location not reported, on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date (event took place after use of product), the patient experienced flu-like aches, mild fever (100.3), exhaustion, headache. On an unspecified date, the patient underwent lab tests and procedures which included body temperature: 100.3 Fahrenheit. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Gastrointestinal disorder, Migraine, Muscle spasms
Clinical narrative: extreme muscle and joint pain; extreme muscle and joint pain; unable to walk for an hour; spasms in hands, feet and legs.; experienced migraine 35 hours after injection; Migraine accompanied by severe GI symptoms; vomiting; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8730), via an unspecified route of administration on 24Mar2021 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had extreme muscle and joint pain that evening, unable to walk for an hour and had spasms in hands, feet and legs. These symptoms passed after one hour. The next day the patient experienced migraine (35 hours after injection). Migraine was accompanied by severe GI symptoms and vomiting, which concluded after 2 hours. It was reported that event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vomiting
Clinical narrative: extreme muscle and joint pain; extreme muscle and joint pain; unable to walk for an hour; spasms in hands, feet and legs.; experienced migraine 35 hours after injection; Migraine accompanied by severe GI symptoms; vomiting; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8730), via an unspecified route of administration on 24Mar2021 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had extreme muscle and joint pain that evening, unable to walk for an hour and had spasms in hands, feet and legs. These symptoms passed after one hour. The next day the patient experienced migraine (35 hours after injection). Migraine was accompanied by severe GI symptoms and vomiting, which concluded after 2 hours. It was reported that event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Body aches; Headache; Sore throat; Slight fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (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's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced body aches, headache, sore throat and slight fever. It was reported that event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Feeling hot
Clinical narrative: Right shoulder pain at injection sight; Joint aches; chills; hot; headaches; tired no energy; swollen lymph node under right arm; tired no energy; 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: EK5730, expiration date was not reported) via an unspecified route of administration, in right arm, on 23Mar2021 08:15 (at the age of 55-years-old), at dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included esomeprazole; adalimumab (HUMIRA); atorvastatin calcium (LIPITOR).  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EJ1685, expiration date was not reported) via an unspecified route of administration, in right arm, on 02Mar2021 08:15 (at the age of 55-years-old), at dose 1, single for covid-19 immunization. The patient experienced right shoulder pain at injection sight, joint aches, chills, hot, headaches, tired no energy, swollen lymph node under right arm on 23Mar2021 20:00. The outcome of the events was recovering.    Follow-up #1 (30Mar2021): New information received from the same contactable consumer includes: confirmed the events awareness date on 23Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Vaccination site pain
Clinical narrative: Right shoulder pain at injection sight; Joint aches; chills; hot; headaches; tired no energy; swollen lymph node under right arm; tired no energy; 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: EK5730, expiration date was not reported) via an unspecified route of administration, in right arm, on 23Mar2021 08:15 (at the age of 55-years-old), at dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included esomeprazole; adalimumab (HUMIRA); atorvastatin calcium (LIPITOR).  Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EJ1685, expiration date was not reported) via an unspecified route of administration, in right arm, on 02Mar2021 08:15 (at the age of 55-years-old), at dose 1, single for covid-19 immunization. The patient experienced right shoulder pain at injection sight, joint aches, chills, hot, headaches, tired no energy, swollen lymph node under right arm on 23Mar2021 20:00. The outcome of the events was recovering.    Follow-up #1 (30Mar2021): New information received from the same contactable consumer includes: confirmed the events awareness date on 23Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: Chills; Body aches/sore; fatigue; Headache; Loss if appetite; Fever; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 23Mar2021 15:00 (at the age of 43-year-old), as dose 2, single, for COVID-19 immunisation in  clinic. Patient was not pregnant at the time of vaccination. Patient had no allergies to medications, food, or other products. Medical history included obesity. Concomitant medications included probiotics and multivitamins [vitamins nos]. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:15 (at the age of 43-year-old), as dose 1, single, for COVID-19 immunisation in  clinic and experienced swelling at injection site, redness at injection site and pain at injection site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills, body aches/sore, fatigue, headache (feels like a sinus headache) that presents when stand up or move, loss of appetite, and fever on 24Mar2021 08:00 AM. No treatment was received for the events. The outcome for the events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Body aches/sore; fatigue; Headache; Loss if appetite; Fever; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 23Mar2021 15:00 (at the age of 43-year-old), as dose 2, single, for COVID-19 immunisation in  clinic. Patient was not pregnant at the time of vaccination. Patient had no allergies to medications, food, or other products. Medical history included obesity. Concomitant medications included probiotics and multivitamins [vitamins nos]. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:15 (at the age of 43-year-old), as dose 1, single, for COVID-19 immunisation in  clinic and experienced swelling at injection site, redness at injection site and pain at injection site. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills, body aches/sore, fatigue, headache (feels like a sinus headache) that presents when stand up or move, loss of appetite, and fever on 24Mar2021 08:00 AM. No treatment was received for the events. The outcome for the events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Peripheral swelling, Pruritus, Rash, Swelling
Clinical narrative: I could barely walk on my feet due to the swelling and my hand were also swollen; I could barely walk on my feet due to the swelling and my hand were also swollen; 'pink palm' started to itch and swell; Woke in the morning with a rash and itch on the right foot between the toes; Woke in the morning with a rash and itch on the right foot between the toes; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 04Mar2021 13:14 at the age of 77-year-old as dose 1, single for covid-19 immunisation. Medical history included blood pressure. Concomitant medications included irbesartan, levothyroxine sodium, acetylsalicylic acid (BABY ASPIRIN), calcium and fish oil all taken for an unspecified indication, start and stop date were not reported. On 05Mar2021, patient woke in the morning with a rash and itch on the right foot between the toes. On 06Mar2021 woke to a rash and itch on the left foot between the toes, right foot has now a rash on top of foot. On 07Mar2021 she woke in the morning in right foot both rash and itching on toes, on top of toes, ankles and arch. A rash and itching around ankle, tried the medication the calamine lotion (treatment). On 09Mar2021 she woke with the bottom of the foot starting to swell, she noted rash starting on the top of the thumb, joint and took aleve and benadryl (treatment) to sleep, then on 10Mar2021 the 'pink palm' started to itch and swell. Patient called the primary care physician he told that he is unable to see on the Thursday or Friday that was the reaction due to COVID Vaccine, he told me to get an appointment to dermatologist within 3 to 4 weeks if the symptoms continue then patient  reach out the emergency care center, next days she called the urgent care and  got a five days prescription for Prednisone 20 mg (treatment) and that night she felt a lot better. Patient tried things but nothing worked like 'Cortizone-10' (not clarified, hence suspect captured as Unspecified Medication) and she tried resting. Then, on Saturday patient could barely walk on feet due to the swelling and hand were also swollen, no fever or pain just swelling rash and itching, examined by a nurse practitioner stated that she is unable to determine the cause of the reaction. By 6 o'clock that evening she could feel the relieve from itching and swelling. Patient still have the rash going on. The patient was going to get a second injection next day. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES).  A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:15 (lot number: EL3247; expiry date: unknown) at the age of 53-years-old, as dose 2, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Mar2021 at 21:30 (lot number: EL3247) in arm left for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccine was administered in a workplace clinic. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with Covid-19 prior vaccination. The patient has not been tested for Covid-19 post vaccination. On 25Mar2021 23:30, the patient experienced chills and fever. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mass, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: throat was all big, hard; Sore throat; gland is swelling looking like a lump, its a lot, its big; gland is swelling looking like a lump, its a lot, its big; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER2613, expiration date was not reported) via an unspecified route of administration, in left arm, on 24Mar2021 11:00 (at the age of 83-years-old), at dose 1, single for covid-19 immunization. Medical history included COPD (chronic obstructive pulmonary disease) from 2017 and ongoing; used oxygen and allergic to penicillin and sulfa. Concomitant medication included oxygen taken for COPD from 2019 and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. There were no events prior to vaccination and no additional vaccines administered on same date of vaccination. On 25Mar2021, the patient experienced gland is swelling looking like a lump; it is a lot and big, on 25Mar2021 12:00, sore throat and on 25Mar2021 20:00, her throat was all big and hard. There were no investigation assessments. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Eye pain, Headache
Clinical narrative: Headache; Pain like body aches and pains; all meshed up; Chills; Nausea; Diarrhea; A low grade fever like 101 got highest; Eye pain; Nervous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6207, expiration date was not reported) via an unspecified route of administration, in left arm, on 21Mar2021 (at the age of 61-years-old), at dose 2, single for covid-19 immunization. Medical history included diabetes, blood pressure high, anxiety, depression, diuretic therapy; took a medication just a water pill Chlorthalidone. Concomitant medications included glipizide taken for diabetes; insulin glargine (LANTUS) taken for diabetes; metformin hydrochloride (METFORMIN ER) taken for diabetes; losartan taken for blood pressure high; atorvastatin; chlorthalidone taken for blood pressure high; loxapine taken for anxiety, depression; escitalopram oxalate (LEXAPRO) taken for anxiety, depression; lorazepam taken for anxiety. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6203, expiration date was not reported) via an unspecified route of administration, on 29Feb2021 (at the age of 61-years-old), at dose 1, single for covid-19 immunization. The patient experienced headache, pain like body aches and pains; all meshed up, chills, nausea, diarrhea, a low-grade fever like 101 got highest, eye pain and nervous on 21Mar2021. The patient underwent lab tests and procedures which included body temperature: 101 on 21Mar2021. The outcome of the events was recovered on 23Mar2021.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345936 Same reporter/drug & different patient/ events
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nervousness, Pain, Pyrexia
Clinical narrative: Headache; Pain like body aches and pains; all meshed up; Chills; Nausea; Diarrhea; A low grade fever like 101 got highest; Eye pain; Nervous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6207, expiration date was not reported) via an unspecified route of administration, in left arm, on 21Mar2021 (at the age of 61-years-old), at dose 2, single for covid-19 immunization. Medical history included diabetes, blood pressure high, anxiety, depression, diuretic therapy; took a medication just a water pill Chlorthalidone. Concomitant medications included glipizide taken for diabetes; insulin glargine (LANTUS) taken for diabetes; metformin hydrochloride (METFORMIN ER) taken for diabetes; losartan taken for blood pressure high; atorvastatin; chlorthalidone taken for blood pressure high; loxapine taken for anxiety, depression; escitalopram oxalate (LEXAPRO) taken for anxiety, depression; lorazepam taken for anxiety. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6203, expiration date was not reported) via an unspecified route of administration, on 29Feb2021 (at the age of 61-years-old), at dose 1, single for covid-19 immunization. The patient experienced headache, pain like body aches and pains; all meshed up, chills, nausea, diarrhea, a low-grade fever like 101 got highest, eye pain and nervous on 21Mar2021. The patient underwent lab tests and procedures which included body temperature: 101 on 21Mar2021. The outcome of the events was recovered on 23Mar2021.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345936 Same reporter/drug & different patient/ events
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fatigue; Muscle soreness; Low-grade fever; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK5730), via an unspecified route of administration in left arm on 24Mar2021 11:30 (at the age of 63-years-old) as dose 2, single for COVID-19 immunization. Medical history included none. Concomitant medication included multivitamin [vitamins nos]. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration in left arm on 03Mar2021 13:45 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not having allergies to medications, food, or other products. The patient experienced fatigue, muscle soreness, and low-grade fever on 24Mar2021 20:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of events was resolving.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Eye pain, Headache
Clinical narrative: Headache; Pain like body aches and pains; all meshed up; Chills; Nausea; Diarrhea; A low grade fever like 101 got highest; Eye pain; really got sick; cramping; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date, after the second dose of vaccine, patient was really sick for couple of days, as like reporter's signs and symptoms (headache, pain, body aches, chills, nausea, a little diarrhea and a low grade fever of 101 and eye pain). She also had cramping, but was worst than reporter had. At the time of report, she is good. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345894 Same reporter/drug/, different patient/similar events
Sex: F
Vaccine: COVID19
Symptoms: Illness, Muscle spasms, Nausea, Pain, Pyrexia
Clinical narrative: Headache; Pain like body aches and pains; all meshed up; Chills; Nausea; Diarrhea; A low grade fever like 101 got highest; Eye pain; really got sick; cramping; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. On an unspecified date, after the second dose of vaccine, patient was really sick for couple of days, as like reporter's signs and symptoms (headache, pain, body aches, chills, nausea, a little diarrhea and a low grade fever of 101 and eye pain). She also had cramping, but was worst than reporter had. At the time of report, she is good. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345894 Same reporter/drug/, different patient/similar events
Sex: F
Vaccine: COVID19
Symptoms: Application site bruise, Vaccination site rash
Clinical narrative: Rash on arm of injection site; non-itchy, non-painful; Over the course of 3 weeks appeared more bruise-like; This is a spontaneous report from a contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced rash on arm of injection site; non-itchy, non-painful, over the course of 3 weeks appeared more bruise-like on 05Mar2021. The patient did not receive treatment for the events. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.