chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, X-ray
Clinical narrative: heart started pounding out of chest; blood pressure was high; Cough; ended up in ER with tachycardia; Anemic; lightheaded, foggy, kind of disconnected; lightheaded, foggy, kind of disconnected; chest got tight; hard time of breathing; chills and body aches; chills and body aches; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration on Left arm on 21Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. It was reported that she was sick in October, she was exposed to COVID, but tested negative, she got sick. She got the vaccine on 21Jan2021, she started having about 4 hours after, chills and body aches, which is normal, then her heart started pounding out of chest, her chest got tight and she had a hard time of breathing. It lasted a couple minutes, the pounding of her heart, but it slowed down, it was fast but not as bad, and she took some Benadryl and after a half hour things settled down, her breathing went back to normal. She contacted her doctor who said to let him know if it happened again, and the next day (22Jan2021) she was kind of out of it, lightheaded, foggy, kind of disconnected, almost like a hangover feeling, just yucky and ran down, Saturday she was feeling a little better, then had 2 more episodes of heart pounding and continued shortness of breath. She ended up in the ER with tachycardia on23Jan2021. She is still having problems. In ER, they found out she was anemic on 23Jan2021.On 23Jan2021 they did bloodwork that day, she had an X-ray and EKG. EKG showed fast rate, normal rhythm, appeared to be no damage to heart. Her blood pressure was high and X-ray of lungs was clear, she had another X-ray this morning, since she developed a cough on 30Jan2021, a barky cough, is coughing up phlegm, Cough started on Saturday, this past Saturday, and is ongoing and worsening, it turned into a cough with a whistle into a barky cough, they are thinking it is connected to asthma response. She is supposed to have pulmonary function tests on the 19th and on the 15th, and endoscope and colonoscope due to anemia to ensure no bleed anywhere. They did another X-ray (on 04Feb2021) this morning and it was clear. They only thing they found is she is anemic, and her doctor is wondering if it is underlying asthma or long haul COVID or a combination of anemia and the shot kicked up stuff. It was reported that she had some asthma like symptoms, which were fully resolving, but kicked back up again since the shot. The events were considered as non-serious. The outcome of the event was chills and body aches was recovered, outcome of the event cough was not recovered and outcome of other events was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 81-years-old female patient started to receive bnt162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection)via an unspecified route of administration from 03Feb2021 to 03Feb2021 at SINGLE DOSE for covid-19 immunisation .Medical history included thrombosis from Feb2020 to an unknown date Verbatim: blood clots.  Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]).  The patient previously took eliquis for thrombosis.  The patient experienced sore arm  on 03Feb2021 and The patient underwent lab tests and procedures which included investigation was unknown results  and Consumer calling about Pfizer COVID-19 vaccine who says she just had a question since she had the first dose of the vaccine yesterday. She says that the first dose went fine, and she had no ill effects at all other than a sore arm, but she didn't know that Ibuprofen shouldn't be taken before getting the vaccine and she takes low dose Aspirin every day. She says yesterday she took her dose of Aspirin, and she doesn't know should if she should continue to take her low dose Aspirin. and Caller took a low dose aspirin before taking the first dose. She is asking if that is okay.   .
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Urinary incontinence
Clinical narrative: LOSS OFBLADDER CONTROL; IRREGULAR HEARTBEAT; This is a spontaneous report from a contactable other hcp. A 56-year-old female patient started to receive bnt162b2 (BNT162B2, Solution for injection, Lot # EL9261), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Jan2021, the patient experienced loss of bladder control, irregular heartbeat. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: One of vials was accidentally diluted with 2mL of diluent; One of vials was accidentally diluted with 2mL of diluent; This is a spontaneous report from a contactable pharmacist via Medical Information Team. This pharmacist reported similar events for two patients. This is the second of two reports.   A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported, NDC number: 59267100001), intramuscularly on 03Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), intramuscularly on an unspecified date at a single dose for COVID-19 immunization. The patient did not receive additional vaccines on same date of vaccination. The pharmacist reported that one of the vials was accidentally diluted with 2mL of diluent. Instead of 1.8mL, he used a whole 2mL and the patient was vaccinated with it on 03Feb2021. The reporter assessed the events as serious, medically significant.  Information on lot/batch number has been requested.; Sender's Comments: The company deems there is not a reasonable possibility that the reported event is related to suspect product BNT162b2. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021121778 same drug/reporter/different patient
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash appeared along a scar line and her belly button; This is an initial spontaneous report from a contactable consumer. A 79-year-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot: unknown) in right arm via an unspecified route of administration on 27Jan2021 09:15 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus Verbatim: Diabetic, High blood pressure, hernia repair, big huge scar, had MRSA, tummy tuck. He had a hernia repair and a big huge scar because it went and had MRSA. He had Hernia repair and tummy tuck in England 17 years ago. Concomitant medication included insulin (INSULIN). On 28Jan2021 rash appeared along a scar line and her belly button. Scar was 10 inches long. Rash won't go away, but it was not itching. Rash was not lumpy, but different spots all over. It did not itch. Thought it might be fading, but not sure. Outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Nausea
Clinical narrative: light headed; nausea; chills; still a little "off"; This is a spontaneous report from a contactable consumer who reported for himself. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Feb2021 (batch/lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of Pfizer's COVID vaccine and everything was fine for the first hour or two. A few hours later on 11Feb2021, he went to work and he got lightheaded and it just would not go away. He started to get a little bit of chills and maybe a touch of nausea. He went work and slept the whole day and night and felt a little better but was still a little "off". Patient wondered if this was normal and if he should receive the second dose. On an unspecified date, he was feeling maybe a little bit better, that maybe he did not have quite as much lightheadedness, but he still had some chills. He reported that he does not have any allergies so he was not concerned about going into anaphylactic shock or anything like that. He stated that it just seemed like it hit him out of nowhere. Patient was wondering if these are known side effects of the product. He was due for his second dose in a few weeks, on 03Mar2021, and he is wondering what the recommendations are for getting the second dose, following having the symptoms that he had. This case was reported as non-serious. Outcome of the event lightheadedness is recovering, of the event chills was not recovered, and of the other events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: developed a little lump after receiving the Pfizer covid vaccine; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient developed a little lump after receiving the COVID vaccine on an unspecified date. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Mouth ulceration, Pain in extremity, Swollen tongue
Clinical narrative: arm pain; mouth had ulcerations; Unusual taste sensations; tongue felt swollen; tiredness; headache/her head would be pounding; Weird coating on tongue; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318; expiration date: unknown) at 66-year-old vaccination age intramuscularly administered in the left arm on 01Feb2021 as a single dose for covid-19 immunisation. Medical history included obesity just barely qualifies under that began 6 years ago (2015), allergy to one type of Penicillin VK and blood pressure (blood pressure abnormal). The patient has no familial medical history. Concomitant medication included losartan start and stop date were unknown for blood pressure. The patient has no previous immunization with the Pfizer vaccine considered as suspect and did not have other additional vaccines administered on the same day as the covid-19 vaccine. The patient reported that he experienced mouth ulcerations, tongue swelling, arm pain, tiredness and headache. The patient further reported that for the first day or two (02Feb2021 09:00), she had tiredness and headache and that was all resolving. Then on 04Feb2021 06:00, she woke up and the rest of her mouth had ulcerations. Her tongue felt swollen and she had a really weird coating on tongue (also reported to have started on 02Feb2021 06:00), along with really unusual taste sensations that lasted for 4 days and calmed down. It is still continuing on a very reduced level. She is still having weird problems with taste and her tongue feels different. She stated that the tiredness improved on 03Feb2021 and the headache was intermittent until 05Feb2021. The tongue swelling has not resolved all the way, it is intermittent. She will feel ok one day, and the next day, it will be back. She mentioned that the patchy white coating on tongue only lasted about a day, but she still has the feeling intermittently along with the taste sensations, but the white part is gone. The patient also stated that when she would wake up in the morning, her head would be pounding. That is the kind of symptoms she would have if she didn't take her blood pressure medication, but she did take her medication. The patient had arm pain on an unspecified date. The outcome of the event taste abnormality was not recovered, as for the event arm pain was unknown while the outcome of the other events was recovering.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Tongue coated
Clinical narrative: arm pain; mouth had ulcerations; Unusual taste sensations; tongue felt swollen; tiredness; headache/her head would be pounding; Weird coating on tongue; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318; expiration date: unknown) at 66-year-old vaccination age intramuscularly administered in the left arm on 01Feb2021 as a single dose for covid-19 immunisation. Medical history included obesity just barely qualifies under that began 6 years ago (2015), allergy to one type of Penicillin VK and blood pressure (blood pressure abnormal). The patient has no familial medical history. Concomitant medication included losartan start and stop date were unknown for blood pressure. The patient has no previous immunization with the Pfizer vaccine considered as suspect and did not have other additional vaccines administered on the same day as the covid-19 vaccine. The patient reported that he experienced mouth ulcerations, tongue swelling, arm pain, tiredness and headache. The patient further reported that for the first day or two (02Feb2021 09:00), she had tiredness and headache and that was all resolving. Then on 04Feb2021 06:00, she woke up and the rest of her mouth had ulcerations. Her tongue felt swollen and she had a really weird coating on tongue (also reported to have started on 02Feb2021 06:00), along with really unusual taste sensations that lasted for 4 days and calmed down. It is still continuing on a very reduced level. She is still having weird problems with taste and her tongue feels different. She stated that the tiredness improved on 03Feb2021 and the headache was intermittent until 05Feb2021. The tongue swelling has not resolved all the way, it is intermittent. She will feel ok one day, and the next day, it will be back. She mentioned that the patchy white coating on tongue only lasted about a day, but she still has the feeling intermittently along with the taste sensations, but the white part is gone. The patient also stated that when she would wake up in the morning, her head would be pounding. That is the kind of symptoms she would have if she didn't take her blood pressure medication, but she did take her medication. The patient had arm pain on an unspecified date. The outcome of the event taste abnormality was not recovered, as for the event arm pain was unknown while the outcome of the other events was recovering.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Pain at injection site; Fever of 102.7; Body aches; Lethargic; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EM9809) via an unspecified route of administration in the Left arm on 11Feb2021 09:45 as a single dose for COVID-19 vaccination. Medical history included allergies; Prior to vaccination, the patient was diagnosed with COVID-19. The patient concomitant medications were not reported. On 11Feb2021 17: 00, it was reported patient had pain at injection site. Fever of 102.7. Body aches. Lethargic. There was no treatment received for the adverse events. the patient not received any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The reported seriousness was non serious. The outcome of the events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: 24 hours of moderate shoulder pain on injection arm.; This is a spontaneous report from a contactable other health Care Professional for herself. A 48-years-old female patient received first dose BNT162B2 (solution for injection, Lot number: EL3247) via intramuscular route of administration on left arm on 22Jan2021 15:45 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient was not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced after first dose, 24 hours of moderate shoulder pain on injection arm, on unspecified date in Jan2021 and there was no event treatment for the event. the outcome of the event was not recovered; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194794 same reporter, patient and suspect drug; different dose and event
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Insomnia, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Swelling and irritation in my arm pit and what I guess it just probably my lymph node; Swelling and irritation in my arm pit and what I guess it just probably my lymph node; I was having hard time for sleeping; take something for the pain; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262), via an unspecified route of administration, administered in right arm on an unspecified date as single dose for COVID-19 immunization. Medical history included blood pressure high and cholesterol high both from an unknown date. Concomitant medications included furosemide, simvastatin, and olmesartan medoxomil taken for an unspecified indication, start and stop date were not reported. On an unspecified date, it was reported that patient experienced experiencing a swelling and irritation in her arm pit and what she guess it just probably her lymph node. The patient was reading the material and it said that is the potential symptom on the site and it is on the site where she got the shot but so, she is just calling to confirm that fact correct because then some of the material where she was reading said the side effect on the second shot but not on necessarily, she mean it didn't state that it was side effect on the first shot and number two it said that she probably should delay any mammogram for at least a month. The patient was as having hard time for sleeping, so she took some Acetaminophen, but not sure how long it's going to be last and being should she just continue to take something for the pain or what. The patient had blood work the day of vaccination, right before vaccination, with unknown results. The outcome of the events was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: a little bit of soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on left arm on 18Jan2021 at single dose for COVID-19 immunization and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date and ongoing at an unspecified dose and frequency for an unspecified indication. Medical history included Afib years ago, heart rate abnormal (reported as heart rate); and sleeping with oxygen but has not had any trouble breathing which was ongoing. Concomitant medications included propranolol hydrochloride (MANOPROLOL; also reported as MONOPROLOL) for Afib and unspecified medication to control heart rate. The patient reported that he got the first dose of COVID vaccine with no problems but had a little bit of soreness at the injection site the next day (19Jan2021). The patient was taking apixaban and mentioned that he did don't know if that was important or not. The action taken in response to the event for apixaban and the outcome of the event was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache; Fever with temperature of 100 [unknown unit], 102.0 [unknown unit] 99.6 [unknown unit]; body aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL3302; expiration date: May2021) at 54-year-old vaccination age via an unspecified route of administration in the left arm on 11Feb2021 10:30 AM at a single dose for covid-19 immunisation. Medical history included ongoing diabetes. Concomitant medications included dulaglutide (TRULICITY) from 11Feb2021 to an unspecified date for diabetes. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date: unknown) at 54-year-old vaccination age via an unspecified route of administration on 21Jan2021 at a single dose for covid-19 immunisation but had headache, low grade temperature and pain at the injection. The patient was reporting on the COVID vaccine which was given by her employer at her nursing home and who states she is experiencing some side effects. She mentioned that she had headache at 6:00 PM or 7:00 PM which was bad last night (11Feb2021) but now (12Feb2021), it was like it was when she first got it. She had a fever started around 7:00 PM or 8: 00 PM on 11Feb2021. She got up and started shivering with her temperature of 100 [unknown unit] then throughout the night it went up to 102.0 [unknown unit] and now (12Feb2021), it is 99.6 [unknown unit]. She also noticed when she noticed the fever. She took ibuprofen (ADVIL) and acetaminophen (TYLENOL). She also spoke to one of the girls in her doctor's office and was told to speak to the place where she got the vaccine, they would tell her what to do. It was also relayed if her fever got too high go to the ER (emergency room). The events did not require an ER or physician's office visit. The outcome of the events was not recovered.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product preparation error, Vaccination site pain
Clinical narrative: mistakenly reconstituted Pfizer COVID vaccine with sterile water as a diluent instead of the normal saline and administered; mistakenly reconstituted Pfizer COVID vaccine with sterile water as a diluent instead of the normal saline and administered; sore arm where the administration site was; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for 6 patients. This is first of 6 reports.  A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL3248, NDC number: 59267-1000-01, Expiry Date: Apr2021), via an unspecified route of administration in left arm on 03Feb2021 at 0.3 mL, single for prevention. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686, expiry date: Mar2021) at 0.3 ml by injection in left arm for COVID-19 immunization. On 03Feb2021 around 2 PM (Yesterday as reported) they mistakenly reconstituted Pfizer COVID vaccine with sterile water as a diluent instead of the normal saline and administered it to six patients. The patient experienced nothing other than a sore arm where the administration site was on 03Feb2021. The outcome of the events was unknown.  Relatedness of drug to reaction(s)/event(s): Reaction assessed: Sore arm, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, NDC number; Expiry Date: unknown), via intramuscularly in the left arm on 16Jan2021 15:15 (at the age of 25-year-old) at single dose for Prevention/COVID-19 vaccination. Medical history included Mild Scoliosis and ADHD, which were both diagnosed prior to receiving the vaccine. He had mild allergy to penicillin. He has not had since he was a kid. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Family medical history included Dementia and heart attack. Concomitant medications were none. No history of all previous immunization with the Pfizer vaccine considered as suspect. No other additional vaccines were administered on same date of the Pfizer suspect. The patient received first booster shot on 16Jan2021 15:15 and was scheduled to receive 2nd dose on 06Feb2021, but he has tested positive for COVID on 02Feb2021. No prescriber. Product strength and count size dispensed was unknown. The patient underwent lab tests and procedures which included SARS-CoV-2 test and results were positive on 02Feb2021. No ER (emergency room) or physician's office required. Adverse event following prior vaccinations was none. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased
Clinical narrative: very fatigued; It has mostly remained above 100 all day today. As I sit and type, it is currently 135, significantly higher than normal for sitting and typing.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported), via an unspecified route of administration on the right arm on 03Feb2021 08:30 at single dose for covid-19 immunisation. Medical history included ankylosing spondylitis, osteoarthritis, hypothyroidism, osteoporosis, known allergies: NSAIDs from an unknown date and unknown if ongoing. Concomitant medication included alendronate sodium (ALENDRONATE), arnica montana and thyroid (ARMOUR THYROID). The patient previously took neosporin, dolobid, diflunisal and experienced allergies. The patient was 69 years old when she received the first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899, expiry date not reported) on the right arm on 14Jan2021 08:30 for covid-19 immunisation. The patient reported that they went to bed at 10:30pm last night; very fatigued. At 4:08am on 04Feb2021, tapped them and reported that her heart rate had been above 120 for 10+ minutes while she was lying down. She checked the Heart app and it showed that her heart rate had been in excess of 120 for 2.5 hours while she slept. Her resting heart rate is normally 70 or below. She got up; the heart rate remained elevated for another hour or more, finally dropping below 120 at 5:30am. She was very fatigued (from the high heart rate?; as reported) for several more hours. It has mostly remained above 100 all day today. As she sit and type, it is currently 135, significantly higher than normal for sitting and typing. It was reported that the events occurred on 04Feb2021 at 01:30 am. No treatment was received for the events. The patient did not recover from the events.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she was tested positive for the infection after receiving the first dose; She was tested positive for the infection after receiving the first dose; This is a spontaneous report from a contactable consumer for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: positive and she was tested positive for the infection after receiving the first dose of COVID-19 vaccine. The outcome of events was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nasopharyngitis, Pain in extremity, Pyrexia
Clinical narrative: fever; joint pain; cold like symptoms; she had some pain her in arm; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 09Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her 1st dose on 09Feb2021 and after she had some pain her in arm, but then it went away. The following night on 10Feb2021 however, she developed a fever, joint pain around the area where the shot was given and cold like symptoms. She wants to know if the 2nd dose will be like this too, or is she allergic to it. Outcome of the event pain her in arm was recovered in Feb2021, while unknown for the other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 2 weeks after developed shingles /she developed shingles two weeks after receiving the first dose of the vaccine; This is a spontaneous report from a Pfizer. A contactable consumer reported that a 67-year-old female patient (consumer) received first dose BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Swap 3 weeks ago but 2 weeks after developed shingles and was asking if she got shingles from the COVAX or because she never got the vaccine for shingles. She was due for second COVAX on Sunday. Her HCP told her she should get the COVAX she was confirming. It was mentioned she developed shingles two weeks after receiving the first dose of the vaccine on an unspecified date. She wants to know if this side effect was associated with the vaccine. She mentioned it could be related to stress or the fact she have not received the shingles vaccine yet. It was asked as would her condition (shingles) have an impact on the efficacy of the vaccine. She want to be 95 % protected not less than that. Her HCP has recommended the second dose but she just want to verify this information with them. Outcome of event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Vomiting
Clinical narrative: extreme stomach pain; chills; vomiting; This is a spontaneous report from a contactable consumer received from Pfizer-. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced extreme stomach pain, chills and vomiting on an unspecified date. The outcome of the events was unknown.  Information of Lot/ Batch number have been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer sponsored program and medical information team. A contactable consumer (patient herself) reported that a 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, patient received the first dose of the vaccine on 19Jan2021 and the second one was scheduled for 09Feb2021, but she tested positive for COVID on 07Feb2021. Enquired about how long does she have to wait until she could get her second dose or how does she proceed. It was reported that, patient had question regarding the second vaccine. Patient don't know the guidance when she was supposed to get the 2nd vaccine. Enquired should she be getting the vaccine or not. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema of eyelid, Eye disorder, Eye pruritus, Eye swelling, Ocular icterus
Clinical narrative: Eyes swollen; lids puffy and red, red circles around each eye; lids puffy and red, red circles around each eye; yellow jaundice look below each eye in a little pouch filled with fluid; itchy eyes; skin on eye lids peeled off; yellow jaundice look below each eye in a little pouch filled with fluid (this jaundice look with pouch disappeared within 5 -6 days from receiving 1st shot).; This is a spontaneous report from a contactable female other healthcare professional reported for herself that 78-year-old female patient received first dose bnt162b2 (Solution for injection, pfizer (Batch/Lot Number: EL9265)) via an unspecified route of administration, administered in Arm Left on 28Jan2021, 16:45 as single dose for covid-19 immunisation. Medical history included myocardial infarction from 2014 to an unknown date In good health - Heart Attack 2014 , drug hypersensitivity from an unknown date and unknown if ongoing known_allergies: Sulfa drugs. The patient historical vaccine bnt162b2 (Solution for injection) on 28Jan2021 Start Date/Time: [Pfizer Lot EN6198] 19Feb2021 09:45 AM, left arm for covid-19 immunisation. Facility most recent COVID-19 vaccine was administeredin Doctor's office/urgent care. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021 07:00 AM, Eyes swollen, lids puffy and red, red circles around each eye, itchy eyes, skin on eye lids peeled off, yellow jaundice look below each eye in a little pouch filled with fluid (this jaundice look with pouch disappeared within 5 -6 days from receiving 1st shot). Other eye condition remains. The event Yellow ocular coloring was recovered in 2021 and other events not recovered.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Swelling of eyelid
Clinical narrative: Eyes swollen; lids puffy and red, red circles around each eye; lids puffy and red, red circles around each eye; yellow jaundice look below each eye in a little pouch filled with fluid; itchy eyes; skin on eye lids peeled off; yellow jaundice look below each eye in a little pouch filled with fluid (this jaundice look with pouch disappeared within 5 -6 days from receiving 1st shot).; This is a spontaneous report from a contactable female other healthcare professional reported for herself that 78-year-old female patient received first dose bnt162b2 (Solution for injection, pfizer (Batch/Lot Number: EL9265)) via an unspecified route of administration, administered in Arm Left on 28Jan2021, 16:45 as single dose for covid-19 immunisation. Medical history included myocardial infarction from 2014 to an unknown date In good health - Heart Attack 2014 , drug hypersensitivity from an unknown date and unknown if ongoing known_allergies: Sulfa drugs. The patient historical vaccine bnt162b2 (Solution for injection) on 28Jan2021 Start Date/Time: [Pfizer Lot EN6198] 19Feb2021 09:45 AM, left arm for covid-19 immunisation. Facility most recent COVID-19 vaccine was administeredin Doctor's office/urgent care. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021 07:00 AM, Eyes swollen, lids puffy and red, red circles around each eye, itchy eyes, skin on eye lids peeled off, yellow jaundice look below each eye in a little pouch filled with fluid (this jaundice look with pouch disappeared within 5 -6 days from receiving 1st shot). Other eye condition remains. The event Yellow ocular coloring was recovered in 2021 and other events not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 12Feb2021, the patient experienced fever and chills. The clinical outcome of fever and chills was unknown.  Information about Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report via a Pfizerfrom a contactable consumer (patient's wife). This contactable consumer reported the same events for two patients (herself and her husband). This is the second of two reports.   A 73-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Covid 19 vaccine along with his wife on an unspecified date (reported as 'Tuesday night'). The patient complained of arm soreness on an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Laziness, Muscle tightness, Pruritus, Skin lesion
Clinical narrative: elevated spots of itching and swelling on his body. He said the elevated spots didn't change color/elevated spots on his thighs and part of his back; elevated spots of itching and swelling on his body. He said the elevated spots didn't change color; swelling on his body; he doesn't know if the spots would be considered hives; Reported 1 day after getting his second COVID-19 Vaccine dose, his muscles were tight; he felt lazy when starting off, until his muscles loosened up, and then he felt better; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9810), via an unspecified route of administration, administered in left arm on 09Feb2021 at 10:25 am as single dose for COVID-19 immunization. The second dose of the vaccine was given at a hospital. The patient's medical history was not reported. No family medical history. No additional vaccines administered on the same day. No prior vaccinations within 4 weeks other than the first dose of BNT162B2 (lot number: EL3247), on 16Jan2021, intramuscularly on the left arm for COVID-19 immunization and experienced itching around his waist, spider bite, the spot on his waist looked like shingles, spot was a circle that turned black, and had a lot of dark spots, like bruises around the black circle. There were no concomitant medications. On 10Feb2021, 1 day after getting his second COVID-19 vaccine dose, his muscles were tight. He said he felt lazy when starting off, until his muscles loosened up, and then he felt better. The patient took a dose of Tylenol 325 mg caplet that night and said when he woke up the next day on 11Feb2021, he felt good. On 12Feb2021 at 03:00, the patient experienced elevated spots of itching and swelling on his body, he said the elevated spots didn't change color, elevated spots on his thighs and part of his back. He doesn't know if the spots would be considered hives. The patient reported he put rubbing alcohol and anti-itch lotion on the itchy, elevated spots on his thighs and part of his back. He said the rubbing alcohol soothed the spots for a second. He said he then he put the anti-itch cream on the elevated spots. The events did not require physician's office or emergency room visit. The outcome of the event muscles were tight and felt lazy was recovered on 11Feb2021 while for the rest of the events was recovered on 12Feb2021. Reported he had blood work done for his urologist between his first and second COVID-19 vaccine doses. He said everything was OK with his blood work, and there was nothing negative.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: elevated spots of itching and swelling on his body. He said the elevated spots didn't change color/elevated spots on his thighs and part of his back; elevated spots of itching and swelling on his body. He said the elevated spots didn't change color; swelling on his body; he doesn't know if the spots would be considered hives; Reported 1 day after getting his second COVID-19 Vaccine dose, his muscles were tight; he felt lazy when starting off, until his muscles loosened up, and then he felt better; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9810), via an unspecified route of administration, administered in left arm on 09Feb2021 at 10:25 am as single dose for COVID-19 immunization. The second dose of the vaccine was given at a hospital. The patient's medical history was not reported. No family medical history. No additional vaccines administered on the same day. No prior vaccinations within 4 weeks other than the first dose of BNT162B2 (lot number: EL3247), on 16Jan2021, intramuscularly on the left arm for COVID-19 immunization and experienced itching around his waist, spider bite, the spot on his waist looked like shingles, spot was a circle that turned black, and had a lot of dark spots, like bruises around the black circle. There were no concomitant medications. On 10Feb2021, 1 day after getting his second COVID-19 vaccine dose, his muscles were tight. He said he felt lazy when starting off, until his muscles loosened up, and then he felt better. The patient took a dose of Tylenol 325 mg caplet that night and said when he woke up the next day on 11Feb2021, he felt good. On 12Feb2021 at 03:00, the patient experienced elevated spots of itching and swelling on his body, he said the elevated spots didn't change color, elevated spots on his thighs and part of his back. He doesn't know if the spots would be considered hives. The patient reported he put rubbing alcohol and anti-itch lotion on the itchy, elevated spots on his thighs and part of his back. He said the rubbing alcohol soothed the spots for a second. He said he then he put the anti-itch cream on the elevated spots. The events did not require physician's office or emergency room visit. The outcome of the event muscles were tight and felt lazy was recovered on 11Feb2021 while for the rest of the events was recovered on 12Feb2021. Reported he had blood work done for his urologist between his first and second COVID-19 vaccine doses. He said everything was OK with his blood work, and there was nothing negative.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Somnolence
Clinical narrative: bad chills; Sleepy; Headache; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 07Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient had bad chills, was sleepy and out of it and he had a headache, it was not terrible or severe. The patient's wife wanted to know if the second dose was going to be worse. She heard that the second dose was worse than the first dose. All the people that they know that had the vaccine did not have any reactions. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Joint range of motion decreased, Laboratory test, Pain assessment, Pain in extremity
Clinical narrative: limited range of motion; pain to both arms and hands; This is a spontaneous report from a contactable nurse. A 92-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 24Jan2021 (Batch/Lot Number: EN5318) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had the first dose in left arm (LOT EJ1686) on 03Jan2021. The nurse reported that patient is in a long term care facility and began with complaints of left arm pain on 26Jan2021 then complained of pain to both arms and hands on 01Feb2021. She says the patient has limited range of motion from unknown date and still, and is complaining of pain still. She says that the patient was started on ibuprofen 600mg every 8 hours as needed by mouth, and was sent to the ER on the 10th for evaluation, where they did a CT and lab work, which came back ok, and he was sent back to the facility. The patient was not admitted when he went to the ER, he was evaluated, then sent back, he returned the same day. The reporter mentioned that it seems the events were a little more than a minor reaction. The reporter mentioned the events does not meet the VAERS criteria for a serious event, but it did disrupt the patient's ability to do normal function, as he has needed help getting dressed. At first he reported 10/10 pain and was requesting to go to the hospital, and now his right arm is much better, he says a 5/10 pain level and left an 8/10 pain level. She says that he admitted to pain this morning, but he did decline pain medication, so pain is still remaining. Outcome of pain in extremity was recovering , limited range of motion was not recovered. Therapeutic measures were taken as a result of pain in extremity.