chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Pain in extremity, Pyrexia
Clinical narrative: fever; headache; It was extremely uncomfortable and I was non functioning; body aches; This is a spontaneous report from a non-contactable consumer (patient) reporting herself.  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9269), via unspecified route of administration in the left arm, on 12Feb2021 at 02:00 (At the age of 48-year-old), as dose 2, single for COVID-19 Immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient was not a pregnant at the time of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL3247), via unspecified route of administration in the left arm, on 22Jan2021, as dose 1, single for COVID-19 Immunization. The patient had no covid prior vaccination and not tested for covid post vaccination. It was reported that, on 13Feb2021 at 02:00 AM, the patient experienced fever, body aches and headache, and the events were lasted for 24 hours. The patient did not take any pain reliever, but it was extremely uncomfortable, and he was non-functioning. Even 10 days later, she still has headache. The outcome of the events was recovered with lasting effects.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Fever of 101.3; chills; This is a spontaneous report from a contactable consumer or other non hcp.  A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on 21Feb2021 15:30 (age at the time of vaccination 68-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient took other medications in two weeks. The patient had Covid prior vaccination. The patient did not Covid tested post vaccination. There were no known allergies. On 22Feb2021 16:45, the patient experienced fever of 101.3, chills. Therapeutic measure was taken as no. The patient underwent lab tests and procedures which included body temperature was 101.3. The outcome of event was recovering.  Information on lot number/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Very bad headaches in the back of her head; This is a spontaneous report from a contactable consumer, reported for a female patient (mom) that. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the reporter called and reported on behalf their mother who had Covid 19 vaccine the before day. She was having side effects which were expected like fever, body aches but especially very bad headaches in the back of her head. As Tylenol was advised to take for the symptoms, Is it okay to take Aspirin or is Aspirin not recommended reporter questioned. No other medical information was provided. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Pruritus, Rash erythematous, Stress
Clinical narrative: Red rash from my top under my chin down to my chest; It has been itching and just making me crazy; deep itching; Penicillin allergy; I'm in a very uptight state of mind because my husband is dying, it could be nerves because I'm under a lot of stress right now; This is a spontaneous report from a contactable consumer (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), via intramuscular route in the right shoulder muscle on 11Feb2021 (age at vaccination: 76 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included diabetic and drug hypersensitivity to penicillin. Concomitant medication(s) included insulin. On an unknown date, the patient experienced red rash from my top under my chin down to my chest, it has been itching and just making me crazy; deep itching, penicillin allergy, she is in a very uptight state of mind because her husband was dying, it could be nerves because she is under a lot of stress right now. The patient took Benadryl as treatment to see if that would maybe help with these deep itching and everything. She did see rash as one of the things on the paper work that they gave her on 11Feb2021 (Thursday). She don't have any known allergies except to Penicillin. She did not take second shingles shot, because she didn't wanted to and couldn't have it within 30 days of the vaccine. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Body ache; Fever; Chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer- A 45-year-old male patient received First dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN5318 and Expiration Date: 31May2021), via an unspecified route of administration on 05Feb2021 as DOSE 1 SINGLE for covid-19 immunization.  Medical history and concomitant medications were none. Patient was calling because after he got the first dose of the vaccine, the COVID Vaccine. He is experiencing body ache, fever and chills on 10Feb2021. He wanted to know if that is coming from the Pfizer first dose of the vaccine or it was symptom of the COVID virus. Patient stated the chills he do not have that much, the body ache was only when patient stressed and fever went down a little bit, it was 101.7 yesterday and about 100.1 about half an hour ago. The event outcome was unknown.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: I started to have sneezing fits like sneeze 2 or 3 times in a row; My nose is still running, I still have a tickle in my nose that sensation that you want to sneeze; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EI9266) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced I started to have sneezing fits like sneeze 2 or 3 times in a row, and my nose is still running, I still have a tickle in my nose that sensation that you want to sneeze. The patient when probed reported of having first dose (Clarified as COVID-19 vaccine Pfizer) several hours ago and as was leaving the centre. The patient started to have sneezing fits like sneeze 2 or 3 times in a row and then may be not for couple of minutes and then again, a couple of times in a row and that went on for about an hour and it was subsided at the time of report. But the patient's nose was still running, the patient still had a tickle in nose reported as that sensation that you want to sneeze. The patient just really wanted to know whether it starts up again and could the patient take something for it. The patient queried whether could take a Benadryl or something or could use Neti pot to send it out. The patient recovered from the event I started to have sneezing fits like sneeze 2 or 3 times in a row. The clinical outcome for the other event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Feeling hot, Migraine
Clinical narrative: whole body shivers; feeling freezing cold; Stuffy nose; Nausea; migraine; exhaustion; hives; tightness in chest; achey; going between being very hot; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 21-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 01:00 (at the age of 21-year-old) (Batch/Lot Number: EL2202) as dose 2, single for covid-19 immunisation. Medical history included chronic migraine, history of inflammatory arthritis and ANA titer, Thin basement membrane disease, exercise induced asthma, eczema and Penicillin allergies. Concomitant medication included diclofenac potassium (CAMBIA), ondansetron (ZOFRAN [ONDANSETRON]), salbutamol (ALBUTEROL HFA) and drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for an unspecified indication, start and stop date were not reported. The patient had not received other vaccine in four weeks. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). dose 1 via an unspecified route of administration, administered in Arm Left on 25Jeb2021 11:15 AM. (Batch/Lot Number: GL9262) as dose 1, single for covid-19 immunization and experienced crying spell. On 11Feb2021, 03:00, the patient reported that going between being very hot and having whole body shivers and feeling freezing cold, nausea, stuffy nose, achey, migraine, exhaustion, hives and tightness in chest. The patient was not received treatment for the events. The clinical outcome of the events were recovering.  Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Nausea, Pain, Urticaria
Clinical narrative: whole body shivers; feeling freezing cold; Stuffy nose; Nausea; migraine; exhaustion; hives; tightness in chest; achey; going between being very hot; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 21-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 01:00 (at the age of 21-year-old) (Batch/Lot Number: EL2202) as dose 2, single for covid-19 immunisation. Medical history included chronic migraine, history of inflammatory arthritis and ANA titer, Thin basement membrane disease, exercise induced asthma, eczema and Penicillin allergies. Concomitant medication included diclofenac potassium (CAMBIA), ondansetron (ZOFRAN [ONDANSETRON]), salbutamol (ALBUTEROL HFA) and drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for an unspecified indication, start and stop date were not reported. The patient had not received other vaccine in four weeks. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). dose 1 via an unspecified route of administration, administered in Arm Left on 25Jeb2021 11:15 AM. (Batch/Lot Number: GL9262) as dose 1, single for covid-19 immunization and experienced crying spell. On 11Feb2021, 03:00, the patient reported that going between being very hot and having whole body shivers and feeling freezing cold, nausea, stuffy nose, achey, migraine, exhaustion, hives and tightness in chest. The patient was not received treatment for the events. The clinical outcome of the events were recovering.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dizziness, Rash
Clinical narrative: dizzy; Full body rash; This is a spontaneous report from a contactable consumer reported for a male patient. A male patient of unspecified age received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: Unknown), via an unspecified route on 13Feb2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Co-suspect medication included diphenhydramine hydrochloride (BENADRYL) on 13Feb2021. On 14Feb2021 after 24hours of covid shot, patient developed a rash, like a full body rash. He didn't get it immediately after the vaccine, he got it now 24 hours into it. Reporter gave him some Benadryl and he seems to be okay with the Benadryl but he's gotten very dizzy, he is kind of like almost tripped little dizzy. He says he feels fine. Reporter was wondering if that is something common or should she take him to the emergency room should we sit it out with the Benadryl to see if it gets better with that. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pharyngeal swelling
Clinical narrative: Headache; Swollen throat; This is a spontaneous report from a non-contactable consumer (patient). This 33-year-old non-pregnant female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6201) via an unspecified route of administration on 11Feb2021 at 04:00 PM (at 33-year-old) on left arm as dose 1, single for COVID-19 immunization. The medical history of the patient included latex allergy, nickel allergy, Gluten intolerance and dairy intolerance. The patient received other medications in two weeks. It was mentioned that patient had no other vaccine in four weeks, patient did not have COVID prior vaccination and was not tested for covid post vaccination. On 13Feb2021 at 07:30 AM the patient experienced headache, sore/swollen throat (two days after injection). It was unknown if any treatment was received for event. The event outcome was unknown.  No follow-up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: high fever; Nausea; Headache; Dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient husband). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included previously they both had covid last year (2020). The patient's concomitant medications were not reported. The patient took the first dose of the covid vaccine on Saturday. The patient had reactions of high fever, some nausea, and headaches and then that passed. The patient had been experiencing dizziness and weakness. The reporter was asking what she can do about it and how long it would last for her. Outcome of events fever, nausea, headaches was recovered; dizziness, weakness was unknown.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Rash
Clinical narrative: Under the site where I was given a shot above that I have a rash; Flu like symptoms; Fever; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN5813) via an unspecified route of administration on 10Feb2021 Wednesday (at the age of 67-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and had no reaction. On 11Feb2021, Thursday, patient experienced flu like symptoms, and had little bit of fever, that day and went away yesterday on 12Feb2021. At night on 12Feb2021, patient noticed that not directly, under the site where she was given a shot above that she had a rash and that was her concern, but it was not all over her body just under my arms not directly below the site but below it. Patient was taking Benadryl in response to the event rash. Outcome of the event flu and fever was resolved on 12Feb2021 and for rash was unknown.   Follow-up attempts completed. No further information expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood test, Dizziness, Feeling abnormal, Illness
Clinical narrative: Throwing up; Fever; Sleeping all day; Just miserable; Very dizzy; Little off balance; Sick; This is a spontaneous report from a contactable consumer or other non hcp. An 86-year-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in Arm Left on 14Feb2021 (age at the vaccination 86-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient Medical history and concomitant medication were none. The patient experienced very dizzy on 14Feb2021, and on 15Feb2021 throwing up, fever, sleeping all day, just miserable. little off balance and sick on an unspecified date in Feb2021. Today is the first day because he just got the injection yesterday. She waited an hour for someone to answer. This department must be understaffed. The doctor said cold compresses so that is what she is doing for him right now. He was a little off balance last night and slept all night. Patient was never sick at 86 so it is troublesome to her to see him sick. They both knew it could happen, but it is worth it. She will not go around and tell people not to get it. She wants people to get it. She was going to keep pushing fluids and try to get him to take Tylenol. The patient underwent lab tests and procedures which included blood test: good and investigation: they were well on an unspecified date. The outcome of the event very dizzy, throwing up, fever, sleeping all day, just miserable was not recovered and other events was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pyrexia, Sleep disorder, Vomiting
Clinical narrative: Throwing up; Fever; Sleeping all day; Just miserable; Very dizzy; Little off balance; Sick; This is a spontaneous report from a contactable consumer or other non hcp. An 86-year-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in Arm Left on 14Feb2021 (age at the vaccination 86-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient Medical history and concomitant medication were none. The patient experienced very dizzy on 14Feb2021, and on 15Feb2021 throwing up, fever, sleeping all day, just miserable. little off balance and sick on an unspecified date in Feb2021. Today is the first day because he just got the injection yesterday. She waited an hour for someone to answer. This department must be understaffed. The doctor said cold compresses so that is what she is doing for him right now. He was a little off balance last night and slept all night. Patient was never sick at 86 so it is troublesome to her to see him sick. They both knew it could happen, but it is worth it. She will not go around and tell people not to get it. She wants people to get it. She was going to keep pushing fluids and try to get him to take Tylenol. The patient underwent lab tests and procedures which included blood test: good and investigation: they were well on an unspecified date. The outcome of the event very dizzy, throwing up, fever, sleeping all day, just miserable was not recovered and other events was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Diarrhoea, Headache
Clinical narrative: Fever; headache; chills; diarrhea; stomach cramps; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-years-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid 19, formulation: solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 18Feb2021 14:00 (at the age of 50-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EL3247), via an unspecified route of administration in Arm left on 28Jan2021 11:30AM as dose 1, single for COVID-19 immunization. On 19Feb2021 04:00, the patient experienced fever, headache, chills, diarrhea, stomach cramps. The patient underwent lab tests and procedures which included body temperature: 100 fahrenheit on an unspecified date. Patient did not received treatment for adverse events. The outcome of the events was recovered on an unspecified date of 2021.  Follow-up (17Jun2021): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; headache; chills; diarrhea; stomach cramps; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-years-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid 19, formulation: solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 18Feb2021 14:00 (at the age of 50-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EL3247), via an unspecified route of administration in Arm left on 28Jan2021 11:30AM as dose 1, single for COVID-19 immunization. On 19Feb2021 04:00, the patient experienced fever, headache, chills, diarrhea, stomach cramps. The patient underwent lab tests and procedures which included body temperature: 100 fahrenheit on an unspecified date. Patient did not received treatment for adverse events. The outcome of the events was recovered on an unspecified date of 2021.  Follow-up (17Jun2021): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Biliary colic, Blood pressure abnormal, Blood pressure measurement, Investigation
Clinical narrative: Got sick to my stomach; real bad pain in gallbladder area had to go to ER after six hours of nonstop pain; BP was 205/118 normal is 140/73; This is a spontaneous report from a contactable consumer, the patient. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in the arm left on 05Feb2021 14:00 as dose 1, single (at the age of 70-years-old) for covid-19 immunization. The patient medical history was not reported. Concomitant medications included naproxen sodium (ALEVE) and paracetamol (TYLENOL). On 06Feb2021, the patient got sick to stomach and real bad pain in gallbladder area. The patient had to go to ER after six hours of nonstop pain. All test on gallbladder came back negative. Blood was good. BP was 205/118, normal was 140/73. The patient took shot for pain and after a few hours everything started back to normal. The patient was sent home and he was good now. After leaving ER, the patient had great concerns about getting second shot and if this was a reaction to the vaccine. The patient received pain nausea medication. The patient performed full blood work up and ultrasound for the events. The patient did receive any other vaccine in four weeks. The patient did not have a covid-19 prior to vaccination. The patient did not test for covid-19 post vaccination. The outcome of the events was recovered.   Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Got sick to my stomach; real bad pain in gallbladder area had to go to ER after six hours of nonstop pain; BP was 205/118 normal is 140/73; This is a spontaneous report from a contactable consumer, the patient. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in the arm left on 05Feb2021 14:00 as dose 1, single (at the age of 70-years-old) for covid-19 immunization. The patient medical history was not reported. Concomitant medications included naproxen sodium (ALEVE) and paracetamol (TYLENOL). On 06Feb2021, the patient got sick to stomach and real bad pain in gallbladder area. The patient had to go to ER after six hours of nonstop pain. All test on gallbladder came back negative. Blood was good. BP was 205/118, normal was 140/73. The patient took shot for pain and after a few hours everything started back to normal. The patient was sent home and he was good now. After leaving ER, the patient had great concerns about getting second shot and if this was a reaction to the vaccine. The patient received pain nausea medication. The patient performed full blood work up and ultrasound for the events. The patient did receive any other vaccine in four weeks. The patient did not have a covid-19 prior to vaccination. The patient did not test for covid-19 post vaccination. The outcome of the events was recovered.   Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain, Pyrexia
Clinical narrative: Hurt all over; every muscle in my body, every joint hurt; Fever; I was weak; Tired; This is a spontaneous report from a contactable consumer reported that. A 77-years-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot Number: EN6201) as DOSE 2 SINGLE for covid-19 immunization. The patient past Medical history included liver disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included ursodeoxycholic acid (URSODIOL) taken for an unspecified indication. The patient reported after the dose of vaccine she had very slight reaction like the soreness in the arm and maybe a little headache but then this past Thursday and after the second dose of vaccine the patient experienced quite a bit more of a reaction she had a fever, its hurt all over, had a (word incomprehensible) 'like I was on fire almost' (not clarified further) and of course she was weak, tired, well anyway it was, every muscle in my body, every joint hurt on an unspecified date in Feb2021. The patient is treated with Advil. The event outcome was Unknown.  No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Terrible headache could not even move my head for whole day; Muscle ache; Site pain; Fever 101 and up; This is a spontaneous report received from a non-contactable nurse (Patient). A 36-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, intramuscular, administered in Arm Left on 04Feb2021 18:00 (at the age of 36-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 05Feb2021, the patient experienced terrible headache could not even move my head for whole day, muscle ache, site pain and fever 101 and up. The patient underwent lab tests and procedures which included body temperature: 101 and up on 05Feb2021. Patient received Tylenol as a therapeutic measure to treat adverse events. The events were recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: patch on her back; red welt the size of a quarter; A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ENS318; Expiration Date: May2021), via an unspecified route of administration in Arm Left on 22jan2021 (11:00) as a DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was Dry Skin and scratching her back were reported. Concomitant medications included: VITAMIN C [ASCORBIC ACID], Colecalciferol (VITAMIN C [ASCORBIC ACID]), MAGNESIUM, TURMERIC [CURCUMA LONGA RHIZOME], Calcium taken for an unspecified indication, start and stop date were not reported. The reporter stated after her first shot on 22jan2021, and the second dose February 12th, each injection was given in her left arm at about 11:00AM on those days. She got her first shot and then a couple days later on 23Jan2021 she had a patch on her back with a red welt the size of a quarter, which she thought could be from scratching her back during the winter due to dry skin. It was reported that her welts have stayed about the same, she hasn't gotten any more, it is the same basic ones. Patient said that the first one looks like it is going away, and the others are smaller that appeared after the second dose, they are the size of a dime. She was applied Aloe Vera Clear Gel on it since it is unscented and has no smell or nothing. She stated that this product is an old one, but is still clear and didn't turn colours or anything. Aloe Vera Clear Gel UPC # LOT/EXP: Unknown, caller stated this product doesn't have this information to provide. Patient said the bottle says healing therapy, apply liberally to sunburn or irritated skin as needed. The patient was concerned because her sister looked at the welts and asked her if she thought she got shingles from it, and she was like no, it doesn't burn, though once in a while it does, and sometimes it doesn't itch, it is not something that bothers her, it's just there. The clinical outcome of the events were unknown. Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Ear pain, Paraesthesia, SARS-CoV-2 antibody test
Clinical narrative: Total loss of taste; pain in ear; tingling in face; This is a spontaneous report from a contactable (patient herself). A 61-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN9581; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on Feb2021 10:00 (at age of 61-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Patient had not known allergies. Other medical history was none. Patient did not receive any other vaccines within 4 weeks of COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that, on an unspecified date in on Feb2021 patient experienced total loss of taste, pain in ear and tingling in face. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test which was negative; (Nasal Swab) post the vaccination on an unspecified date inFeb2021. The outcome of all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Blood test, Chills, Fatigue
Clinical narrative: Constant migraine; severe joint aches; extreme fatigue; upset stomach; chills; aches at injection site; This is a spontaneous report from a contactable consumer. A 39 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration on an unspecified date (39-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Vaccination facility type was reported as other. The patient was not received any other vaccine within four weeks prior vaccination. The patient was not diagnosed with Covid prior to vaccination. On an unknown date, the patient had experienced constant migraine, severe joint aches, extreme fatigue, upset stomach, chills, ache at injection site. The patient underwent lab test and procedure which included blood test: result was pending and Covid test (post vaccination): results unknown at home on 05Feb2021: result was pending. No treatment medications received for the resulted events. The outcome of the events was unknown.  The reporter allowed to contact and agreed for explicit consent. Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Constant migraine; severe joint aches; extreme fatigue; upset stomach; chills; aches at injection site; This is a spontaneous report from a contactable consumer. A 39 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration on an unspecified date (39-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Vaccination facility type was reported as other. The patient was not received any other vaccine within four weeks prior vaccination. The patient was not diagnosed with Covid prior to vaccination. On an unknown date, the patient had experienced constant migraine, severe joint aches, extreme fatigue, upset stomach, chills, ache at injection site. The patient underwent lab test and procedure which included blood test: result was pending and Covid test (post vaccination): results unknown at home on 05Feb2021: result was pending. No treatment medications received for the resulted events. The outcome of the events was unknown.  The reporter allowed to contact and agreed for explicit consent. Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Headache, Nausea
Clinical narrative: I started feeling extremely tired like absolutely no energy; Headache; Nausea; Low grade fever; loss of energy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that on an unspecified date of 2021 the patient started feeling extremely tired like absolutely no energy and felt like that way for three days. Beside the loss of energy and extremely tired, patient had a headache and some nausea, it was not there all the time and a low-grade fever like about 99. The patient underwent lab tests and procedures which included body temperature: about 99 on an unspecified date of 2021. The outcome of events feeling extremely tired like absolutely no energy, headache, nausea, low grade fever, loss of energy was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I started feeling extremely tired like absolutely no energy; Headache; Nausea; Low grade fever; loss of energy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that on an unspecified date of 2021 the patient started feeling extremely tired like absolutely no energy and felt like that way for three days. Beside the loss of energy and extremely tired, patient had a headache and some nausea, it was not there all the time and a low-grade fever like about 99. The patient underwent lab tests and procedures which included body temperature: about 99 on an unspecified date of 2021. The outcome of events feeling extremely tired like absolutely no energy, headache, nausea, low grade fever, loss of energy was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain
Clinical narrative: chills; trouble sleeping; feeling general body aches; This is a spontaneous report from a non-contactable consumer received via COVID-19 Vaccine Adverse Event Reporting System. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 12Feb2021 (Lot Number unknown, at the age of 82 years old) as dose 2, single for COVID-19 immunisation. The vaccine was received in a hospital facility. The patient's medical history and concomitant medications were not reported. She was not pregnant at the time of vaccination and she did not receive any other vaccines within four weeks prior to vaccination. The patient previously received first dose of BNT162B2 on 22Jan2021 (Lot Number: EL3247, at the age of 82 years old) for COVID-19 immunisation. On 13Feb2021, the patient described chills and trouble sleeping the day after receiving her vaccination, as well as feeling general body aches. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the events. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: nausea; minor soreness; This is a spontaneous report received from a contactable Nurse. This Nurse reported for a 91-Year-old female patient that:  A 91-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced Nausea, Minor Soreness on an unspecified date. The outcome of event was unknown.   Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, Insomnia, Pain in extremity
Clinical narrative: immediately felt soreness in her left arm and also there was pain if she tried to raise her arm; developed a low grade fever, up 1 degree from her usual temperature; became dizzy; extremely tired; slept off and on; had a heavy head; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 68-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot number was not reported) via an unspecified route of administration, administered in left arm on an unspecified date in Feb2021 at 10:45 AM (at the age of 68-years-old) as dose 1, single dose for covid-19 immunisation. The patient's medical history included type 2 diabetes mellitus, sulfa drugs allergy and shellfish allergy from an unknown date and unknown if ongoing. The patient previously took codeine and experienced bad reaction to codeine. The patient's concomitant medications were not reported. Patient didn't got covid prior to vaccination. Patient not tested for covid-19 post vaccination. On unspecified date in Feb 2021 at 10:45 AM, after receiving the shot patient immediately felt soreness in her left arm and also there was pain if she tried to raise her arm. Approximately 9-10 hours after receiving the shot patient became dizzy, extremely tired, slept off and on and during the third day, patient developed a low-grade fever, up 1 degree from her usual temperature and on fourth day patient had a heavy head. Patient also reported that she was not as tired, the left arm soreness was all but gone, and she was no longer dizzy. soreness in her left arm, and all of these symptoms lasted for 72 hours. The patient did not receive any treatment for the adverse events. The outcome of all events was recovered on unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: immediately felt soreness in her left arm and also there was pain if she tried to raise her arm; developed a low grade fever, up 1 degree from her usual temperature; became dizzy; extremely tired; slept off and on; had a heavy head; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 68-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot number was not reported) via an unspecified route of administration, administered in left arm on an unspecified date in Feb2021 at 10:45 AM (at the age of 68-years-old) as dose 1, single dose for covid-19 immunisation. The patient's medical history included type 2 diabetes mellitus, sulfa drugs allergy and shellfish allergy from an unknown date and unknown if ongoing. The patient previously took codeine and experienced bad reaction to codeine. The patient's concomitant medications were not reported. Patient didn't got covid prior to vaccination. Patient not tested for covid-19 post vaccination. On unspecified date in Feb 2021 at 10:45 AM, after receiving the shot patient immediately felt soreness in her left arm and also there was pain if she tried to raise her arm. Approximately 9-10 hours after receiving the shot patient became dizzy, extremely tired, slept off and on and during the third day, patient developed a low-grade fever, up 1 degree from her usual temperature and on fourth day patient had a heavy head. Patient also reported that she was not as tired, the left arm soreness was all but gone, and she was no longer dizzy. soreness in her left arm, and all of these symptoms lasted for 72 hours. The patient did not receive any treatment for the adverse events. The outcome of all events was recovered on unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vaccination site pain
Clinical narrative: dizziness; sore arm at injection site; nausea; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9265, Expiration date was not reported) via an unspecified route of administration, administered in the left arm on 12Feb2021 13:45 (at the age of 31-years-old), as dose 1, single for COVID-19 immunization. Patient had no relevant medical history. The patient's has no concomitant medications. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced dizziness, sore arm at injection site, and nausea on 12Feb2021. No treatment was received as result of the events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: someone who has gotten the rash after the COVID shot, but it was after the second shot; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter mentioned that week she has talked to a couple of people and they indicate they know someone who has gotten the rash after the COVID shot, but it was after the second shot on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urticaria
Clinical narrative: bad headache; Hives in left side on neck; This is a spontaneous report from a contactable consumer (Patient). A 50-years-old non-pregnant female patient received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Arm Left on 08Feb2021 11:15 (at the age of 50-years-old) as dose 1, single for COVID-19 immunization. Patient was not pregnant. Medical history was reported as none. No other vaccine was given in four weeks. No known allergies were reported. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 09Feb2021 07:00 the patient experienced bad headache and hives in left side on neck. The patient did not receive any treatment for the events. The outcome of the events was recovered on unspecified date in 2021.  Information on the Lot/Batch number has been requested.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.