chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: night sweats; nausea; body aches; chills; sleepiness; severe with slight fever; shakiness; brain fog; weakness; loss of weight; anxiety; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number -not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE (at 76-years age) for covid-19 immunisation. Medical history included celiacs, RA (rheumatoid arthritis), anemia, osteo-sarthritis, allergies all from an unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE), fluticasone (FLUTICASONE), lamotrigine (LAMOTRIGINE), leflunomide (LEFLUNOMIDE) all were taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number-unknown) via unspecified route of administration time in Left arm on 21Feb2021 at 06: 45 pm as DOSE 1, SINGLE for covid-19 immunization. The patient received vaccine at hospital. The patient not diagnosed with covid-19 prior to vaccination and did not tested post vaccination. The patient did not receive other vaccine in four weeks. The patient experienced night sweats, nausea, body aches, chills, sleepiness. for around 2 days after with lingering symptoms for a few days second shot, same reactions only more severe with slight fever and shakiness, have something like a brain fog, weakness, loss of weight, still experiencing symptoms but not as severe with anxiety and weakness on 23Feb2021 02:30 PM. The patient did not received treatment for all events. The outcome of all events was resolving.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dry throat, Pain
Clinical narrative: area across shoulders and down back hurts a lot, felt pressure in this area; area across shoulders and down back hurts a lot, felt pressure in this area; dry sore throat- feels like someone threw sand in her throat; Feeling achy, it was worse when she got up this morning; Feeling achy; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727) via an unspecified route of administration, administered in right arm on 22Mar2021 12:00 as dose 1, single for COVID-19 immunization (Clinic) (at the age of 29-year-old). Medical history included flu shot over six months ago from an unknown date. Family history of heart disease and dementia, Grandma and great grandma had dementia on father's side. Mother's side- grandma had heart disease. There were no concomitant medications. The patient experienced feeling achy on 22Mar2021 Around 3:00 PM or 4:00 PM (15:00 or 16:00), patient thought it was the weather, feeling achy about two or three hours after the shot, feeling achy, it was worse when she got up this morning on 23Mar2021 it was ten times worse- she had never felt like this before, area across shoulders and down back hurts a lot, felt pressure in this area, dry sore throat- felt like someone threw sand in throat both on 23Mar2021 07.30. Relevant tests were none. Patient wanted to lay down so didn't feel the pressure across shoulders and down her back. Patient scheduled to receive the second dose on 12Apr2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Muscle spasms
Clinical narrative: It has bruising on the injection site; Muscle spasm; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER2613, Expiration date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 14:00 (at the age of 42-years-old) as Dose 1, Single for Covid-19 immunization. Vaccination facility type was reported as sports facility. The patient's medical history included ongoing migraine headache. The patient's concomitant medication included brivaracetam (BRIVIACT) taken for migraine headache, start and stop date were not reported. On 22Mar2021 at 22:00, the patient experienced bruising on the injection site, it had bruise. Next day, she stated that yes bruise was lesser than yesterday. On an unspecified date in 2021, the patient had muscle spasm. It was reported that, patient had her cholesterol, blood test and calcium test 2 months ago, so nothing in the last month. Patient was taking medication of other vaccine (unspecified vaccine) and cyclobenzaprine (medication) for muscle spasm. She was concerned about her bruise and queried if she should check with her nurse or her doctor. Due date of second vaccination was reported as 12Apr2021 at 10:39 PM. Outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient, of an unspecified gender and age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Mar 17, 2021, single dose, for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, on Feb 20, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. On Mar 17, 2021, patient experienced diarrhea, headache, vomiting, muscle pain, tiredness and a little bit of fever (not much). The evening of the Mar 17, 2021, adverse events took place. The patient did not want to know anything and just wanted to inform of the adverse effects after getting the second shot. The patient just wanted to report illness/ill effects after the 2nd shot. They experienced mostly everything on list: diarrhea, vomiting, headache, muscle pain, tiredness and little bit of fever (not much). The outcome of the events: unknown. No follow-up attempts needed. Information about batch/lot number cannot be requested. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient, of an unspecified gender and age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Mar 17, 2021, single dose, for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, on Feb 20, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. On Mar 17, 2021, patient experienced diarrhea, headache, vomiting, muscle pain, tiredness and a little bit of fever (not much). The evening of the Mar 17, 2021, adverse events took place. The patient did not want to know anything and just wanted to inform of the adverse effects after getting the second shot. The patient just wanted to report illness/ill effects after the 2nd shot. They experienced mostly everything on list: diarrhea, vomiting, headache, muscle pain, tiredness and little bit of fever (not much). The outcome of the events: unknown. No follow-up attempts needed. Information about batch/lot number cannot be requested. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain in extremity, Pyrexia, Tremor
Clinical narrative: High fever; Extreme shaking; Sore arm; Extreme chills; Swollen lymph nodes under arms; This is a spontaneous report received from a contactable consumer. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 22Mar2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. It was reported that, the consumer would like to report an adverse event for the COVID-19 vaccine (dose 2). Stated that, this was reported last night by the patient to the reporter. Stated that, she did not report adverse side effects with dose 1. On 23Mar2021 (starting 24 hours after treatment), the patient experienced high fever, extreme shaking (starting 24 hours after injection, subsided after overnight rest) and sore arm, extreme chills, swollen lymph nodes under arms starting (24 hours after injection, ongoing). The outcome of the events for high fever, extreme shaking was recovered on an unspecified date in Mar2021 while for the other events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin exfoliation
Clinical narrative: Rash, palms of both hands and around fingers; Peeling of skin on palms of both hands and around fingers; Itching to palms of both hands and around fingers; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: E19269) via an unspecified route of administration in right upper arm on 16Feb2021 at 13:00 (age at vaccination 24 year) as dose 1, single for COVID-19 immunization. Vaccine was offered to her. First week at new company they offered it and she said yes. she wasn't on any medications that she wasn't already taking for years already, so no concomitant medications. Medical history was not reported. Prior Vaccinations (within 4 weeks) , AE(s) following prior vaccinations, Family Medical History Relevant to AE(s) were reported as None. On an unspecified date in Feb2021, the patient experienced rash, palms of both hands and around fingers, peeling of skin on palms of both hands and around fingers and itching to palms of both hands and around fingers. Therapeutic measures were taken as a result of rash, palms of both hands and around fingers, peeling of skin on palms of both hands and around fingers and itching to palms of both hands and around fingers. The patient went to the doctor that day who gave her a steroid cream (Triamcinolone 0.1 percent cream to use three times a day) to put on the peeling skin to help with the itching. NDC: 67877-251-30. Lot and Expiration date unknown. Patient visited physician office. The doctor was also the one who recommended that she call and report this event because it seemed related to the vaccine. she called because she just wants to report a reaction. States that when it appeared after her first vaccine she thought maybe she had gotten into something that caused it. Now that the rash has improved her skin was peeling in the area where the rash was on the palms of both hands and around the fingers. States after the first shot it was a small rash. Relevant Tests were reported as None. The outcome of the events rash, palms of both hands and around fingers and itching to palms of both hands and around fingers was recovering while the outcome of the rest of the event was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Nausea, Pain in extremity
Clinical narrative: light cough; nausea; sore arm; Headache; This is a spontaneous report from a contactable consumer or other non hcp (parent). A 16-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number EP6955, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 22Mar2021 15:45 (at the age of 16 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications and were not reported. Patient had no known allergies.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. On 23Mar2021 at 06:30, the patient experienced light cough, nausea, sore arm and headache. The reporter reported that, the patient on 23Mar2021 6:30a.m. woke up this morning with light cough, nausea and sore arm. 12pm - cough and nausea are resolved, but he has a headache. The patient did not received treatment for events. The reporter informed that the reporter became aware of the event on Tuesday, 23Mar when he awoke in the morning at approximately 6a.m. Outcome of cough and nausea was resolved on ??-???-2021 and that of other events was recovering.   Follow-up (26Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included information about date and time of vaccination and clinical information.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Diffuse bumpy intensely itchy rash on left shin and calf after first vaccine/Rash continued to spread, right leg; Diffuse bumpy intensely itchy rash on left shin and calf after first vaccine/Rash continued to spread, right leg; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; lot number: EL9269and expiration date was not reported) via an unspecified route of administration in the left arm on 15Feb2021 09:45 (at the age of 65-year-old) as dose 1, single for covid-19 immunization. Medical history included hypertension and fibromyalgia. Concomitant medication included atenolol, simvastatin and diphenhydramine Hydrochloride, all for an unknown indication. The patient had history of erythromycin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccine within four weeks. The patient was not pregnant at the time of vaccination. After taking the first dose of vaccination, on an unspecified date of Feb2021 the patient experienced diffuse bumpy intensely itchy rash on left shin and calf after first vaccine/rash continued to spread, right leg. Patient was not tested positive for COVID-19 since the vaccination. Therapeutic measures in response to the events included, topical and oral steroids. The outcome of the events was not resolved at the time of report.    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over the body/experienced this after getting the first vaccine; This is a spontaneous report from a contactable consumer (Patient) via a Pfizer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), dose 1 via an unspecified route of administration on 06Feb2021 as dose 1 single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced itching all over the body and it became worse after receiving the second dose. On an unspecified date in 2021, the patient received the second dose. She thought that it was not a side effect of the COVID vaccine. Caller was asking about the side effects of the vaccine. The clinical outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Woke up at 5:45 with a headache; intermittent fever; feeling very tired; This is a spontaneous report from a contactable Consumer or other non-HCP (Parent). A 20-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EP6955) via an unspecified route of administration, administered on Right arm on 22Mar2021 at 12 pm as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Medical history included Atopic Dermatitis. Patient had no known allergies. Concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Mar2021 at 05:45, the patient experienced "woke up at 5:45 with a headache" on 22Mar2021 at 12:00 am intermittent fever and feeling very tired. Patient did not receive any treatment for the events. Outcome of the event headache was recovered on 23Mar2021, outcome of other events was recovering.   Follow-up (24Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient included Information about adverse events.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching all over the body/experienced this after getting the first vaccine and it became worse after receiving the second dose; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program.   A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE; and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE, 2 SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient received the second dose of Covid-19 vaccine already and said she is itching all over the body. She mentioned that she experienced this after getting the first vaccine (06Feb2021) and it became worse after receiving the second dose. She thought that it was not a side effect of the Covid vaccine. The outcome of the event unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Lacrimation increased, Ocular hyperaemia, Vision blurred
Clinical narrative: watery eyes itching redness in both eyes; watery eyes itching redness in both eyes; watery eyes itching redness in both eyes; blurred vision; This is a spontaneous report received from a contactable consumer (patient's spouse) for a male patient of unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 20Mar2021 the patient experienced watery eyes itching redness in both eyes, and blurred vision. Patient started with eye drops and by Tuesday vision was restored to normal. The outcome of the event blurred vision was recovered on an unspecified date, and other events was unknown.  No follow-up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021324852 Same reporter/ drug /AE, different patient
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Skin odour abnormal
Clinical narrative: Terrible smell in nose; Had a temperature; This is a spontaneous report from a contactable consumer or other non hcp (wife of the patient).   A 75-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 10Mar2021 (at the age of 75 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cancer from an unknown date and unknown if ongoing. The patient did not have constipation. The patient's concomitant medications were not reported. The reporter reported that on an unspecified date, the patient experienced terrible smell in nose and had a temperature. The patient had not been tested COVID yet. The patient had a temperature. Also mentioned for like five days he had a smell in his nose. No other symptoms. The patient received the shot on 10Mar2021. The second vaccine would be supposed to be the following Monday on 29Mar2021. The first symptoms started on Monday. He also has chemo and radiation, and it could be related according to caller. The issue that was bothering them was the event related to the smell. He was not losing his sense of smell, he has a smell in his nose that was now less. This started on Monday. The patient underwent lab tests and procedures which included body temperature which results into had a temperature on unspecified date. The outcome for the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: arm soreness; arm swollen; rash; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer or other non hcp (Patient). A female patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number and expiration date was not reported) via an unspecified route of administration on 09Mar2021 as dose number unknown, single for COVID-19 immunization. Medical history included diabetes mellitus and she had broken blood vessels in her eye on the side that she got the vaccine. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) taken for she had broken blood vessels in her eye on the side that she got the vaccine. The patient had arm soreness and arm swollen and rash lasted few days on an unspecified date in Mar 2021. The event outcome for soreness in arm, arm swollen, and rash was reported as recovered on unspecified date of 2021.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Malaise, Myalgia, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Both hands swelled up; Hives; Lip swelled; Tongue swelled up a little; Couldn't talk; Muscle pain and aches, ached all over; Didn't feel so good; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 vaccine, Formulation: Solution for injection, Lot number: EP6955, Expiration date: unknown) via an unspecified route of administration, administered in arm left on 20Mar2021 (at the age of 67-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included COVID (patient dad died of COVID and other family members had covid) from an unknown date and unknown if ongoing. There were no concomitant medications reported. The patient had no prior vaccinations within 4 weeks. The patient did not administer any additional vaccines on same date of the pfizer suspect. Historical vaccine included flu vaccine which led to arm ached and muscle ached from an unspecified date in Sep2020 (at the age of 66-year-old). On 22Mar2021, the patient didn't feel so good. On the same day at 01:00, the patient experienced muscle pain and aches, ached all over. On 23Mar2021, she was there alone with nobody to talk to during the day. She went to facetime one of her sister's and she could hardly talk. On the same day at 10:00 in the morning, the patient's lip swelled and tongue swelled up a little. On 24Mar2021, around 8 to 9 o'clock, in the morning, the patient both hands swelled up and hives. Caller stated that on monday, she didn't feel so good, but she said that was expected. She reported on tuesday, her lip swelled up and her tongue swelled up a little. She couldn't talk in the afternoon, for some reason, her voice, she didn't know. By 5 pm, her voice got better. Yesterday, her hand swelled up, later clarified as both her hands swelled up. She also had hives. Caller asked, OK, she wanted to make sure she could get the second shot, should she be worried about getting the second shot. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative (she was pretty sure she had covid, but the test came back negative, she had all the symptoms) on an unspecified date in Dec2020. The patient did not visited emergency room and physician office for the adverse events. The patient was treated with benadryl (Lot: 1805142 & Expiration: Aug2022) last night as a therapeutic measure of hives. On 23Mar2021, the patient recovered from didn't feel so good, muscle pain and aches, ached all over, lip swelled, tongue swelled up a little and couldn't talk. The outcome of the events both hands swelled up and hives was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Swollen tongue, Urticaria
Clinical narrative: Both hands swelled up; Hives; Lip swelled; Tongue swelled up a little; Couldn't talk; Muscle pain and aches, ached all over; Didn't feel so good; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 vaccine, Formulation: Solution for injection, Lot number: EP6955, Expiration date: unknown) via an unspecified route of administration, administered in arm left on 20Mar2021 (at the age of 67-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included COVID (patient dad died of COVID and other family members had covid) from an unknown date and unknown if ongoing. There were no concomitant medications reported. The patient had no prior vaccinations within 4 weeks. The patient did not administer any additional vaccines on same date of the pfizer suspect. Historical vaccine included flu vaccine which led to arm ached and muscle ached from an unspecified date in Sep2020 (at the age of 66-year-old). On 22Mar2021, the patient didn't feel so good. On the same day at 01:00, the patient experienced muscle pain and aches, ached all over. On 23Mar2021, she was there alone with nobody to talk to during the day. She went to facetime one of her sister's and she could hardly talk. On the same day at 10:00 in the morning, the patient's lip swelled and tongue swelled up a little. On 24Mar2021, around 8 to 9 o'clock, in the morning, the patient both hands swelled up and hives. Caller stated that on monday, she didn't feel so good, but she said that was expected. She reported on tuesday, her lip swelled up and her tongue swelled up a little. She couldn't talk in the afternoon, for some reason, her voice, she didn't know. By 5 pm, her voice got better. Yesterday, her hand swelled up, later clarified as both her hands swelled up. She also had hives. Caller asked, OK, she wanted to make sure she could get the second shot, should she be worried about getting the second shot. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative (she was pretty sure she had covid, but the test came back negative, she had all the symptoms) on an unspecified date in Dec2020. The patient did not visited emergency room and physician office for the adverse events. The patient was treated with benadryl (Lot: 1805142 & Expiration: Aug2022) last night as a therapeutic measure of hives. On 23Mar2021, the patient recovered from didn't feel so good, muscle pain and aches, ached all over, lip swelled, tongue swelled up a little and couldn't talk. The outcome of the events both hands swelled up and hives was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Confusional state, Nausea, Presyncope
Clinical narrative: it was like a vagal reaction; gets confused at times; felt nauseous and wanted to vomit; Weaker; Blood pressure dropped; This is a spontaneous report from a contactable Nurse. This Nurse reported for a 90-year-old male patient (husband) that he received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation (90-years at the age of vaccination).  Medical history included ongoing diabetes mellitus Verbatim: Diabetes  Additional Information for Other Conditions: Started 30-40 years ago , ongoing hypertension Verbatim: High Blood Pressure  Additional Information for Other Conditions: Started 30-40 years ago. There were no concomitant medications.  The patient experienced felt nauseous and wanted to vomit, weaker and blood pressure dropped on 10Mar2021, it was like a vagal reaction and gets confused at times on an unspecified date. He received his first Covid shot on 10Mar2021. Reporter states five minutes after the shot the patient said he felt nauseous and wanted to vomit and his blood pressure dropped. Reporter states the patient ended up in the ER. Reporter states that the patient is on hospice at home. Reporter states they took him to the pharmacy for the first vaccine and he has another appointment to go on 31Mar2021. Reporter asks for the number of the pharmacy vaccination site to call to see if they can call and delay the second vaccine The outcome of the events felt nauseous and wanted to vomit, Blood pressure dropped was resolved on 10mar2021, Weaker was resolving and other events was Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Myalgia, Nausea
Clinical narrative: Nosebleed; nausea; muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nosebleed, nausea and muscle soreness on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Lymphadenopathy
Clinical narrative: severe headache; fever of 100.8; chills; joint aches; swollen lymph nodes on left side neck; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK5730), via an unspecified route of administration, administered in Left arm on 24Mar2021 11:15 (at the age of 58 year) as dose 2, single for COVID-19 immunisation.  Medical history included, allergies to sulpha drugs. Concomitant medications included carvedilol, losartan, and levothyroxine, all for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior vaccination, patient did not receive any other vaccines within four weeks and had not diagnosed COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EJ1685, via an unspecified route of administration in left arm, on 04Mar2021 11:00 (at the age of 58 year), as single dose for COVID-19 immunization. On 25Mar2021, patient had severe headache, fever of 100.8, chills, joint aches, and her lymph nodes on left side neck swollen. Since vaccination, patient had not been tested COVID-19. No treatment was given in response to the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: severe headache; fever of 100.8; chills; joint aches; swollen lymph nodes on left side neck; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK5730), via an unspecified route of administration, administered in Left arm on 24Mar2021 11:15 (at the age of 58 year) as dose 2, single for COVID-19 immunisation.  Medical history included, allergies to sulpha drugs. Concomitant medications included carvedilol, losartan, and levothyroxine, all for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior vaccination, patient did not receive any other vaccines within four weeks and had not diagnosed COVID-19. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EJ1685, via an unspecified route of administration in left arm, on 04Mar2021 11:00 (at the age of 58 year), as single dose for COVID-19 immunization. On 25Mar2021, patient had severe headache, fever of 100.8, chills, joint aches, and her lymph nodes on left side neck swollen. Since vaccination, patient had not been tested COVID-19. No treatment was given in response to the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: fatigue.; Fever; aches; dizzy; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on 22Mar2021, at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient experienced fatigue, fever, aches, dizzy on 23Mar2021 02:00. The outcome of the events was recovering.    Follow-up (26Mar2021): New information received from same contactable consumer includes: The event awareness date confirmed as 23Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Feeling abnormal, Malaise
Clinical narrative: feeling under the weather; has this hoarseness in her voice whenever she speaks; coughing; not feeling well during the morning; This is a spontaneous report from a contactable consumer or other non hcp (patient) from Pfizer sponsored program.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on 22Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported), via an unspecified route of administration, administered on 01Feb2021 as dose 1, single for COVID-19 immunisation. received her 1st vaccine on 01Feb2021 and her 2nd vaccine on 22Feb2021.  On 25Feb2021, the patient experienced feeling under the weather, has this hoarseness in her voice whenever she speaks, coughing. On an unspecified date in 2021,  the patient was not feeling well during the morning. However, upon talking reported that she experienced feeling under the weather after 3 days of receiving the 2nd vaccine.she was not feeling well during the morning. However, that did not last very long as she felt a little better later that afternoon. Consequently, had this hoarseness in her voice whenever she speaks accompanied by coughing. Referred to the local health authority/vaccination facility for her lost card. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Swelling face, X-ray
Clinical narrative: Developed swelling of my cheeks and under my chin; This is a spontaneous report from a contactable consumer (patient) received via program.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 05Mar2021 as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on 12Feb2021, as single dose for COVID-19 immunization. On an unspecified date, patient had developed swelling of cheeks and under the chin, looks like, chip monk cheeks. The patient saw her family doctor.  The patien underwent lab tests and procedures which included on an unspecified date, chest x-ray and x-ray, both were negative. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Swelling, Swelling face, X-ray
Clinical narrative: Developed swelling of my cheeks and under my chin; This is a spontaneous report from a contactable consumer (patient) received via program.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 05Mar2021 as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number unknown, via an unspecified route of administration on 12Feb2021, as single dose for COVID-19 immunization. On an unspecified date, patient had developed swelling of cheeks and under the chin, looks like, chip monk cheeks. The patient saw her family doctor.  The patien underwent lab tests and procedures which included on an unspecified date, chest x-ray and x-ray, both were negative. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Pruritus, Sluggishness
Clinical narrative: itching all over/I am itching/My feet itch, my leg itch, my head itch, my arm itch, and my back itch; feeling like I am itching all over; feels a little sluggish; just getting little anxious; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: ER8730 and expiry date was not reported), via an unspecified route of administration, on 25Mar2021 at 02:00 PM, as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Mar2021 the patient experience itching all over and she feels a little sluggish. It was reported that the patient felt like she was having a bit of allergic reaction or something because she was itching. The patient reported that she did not had any redness at the site or anything, but she woke up last night about at 2 o'clock and even still this morning she felt like she was having a bit of allergic reaction or something because she was itching. Reportedly her feet, leg, head, arm and back itch. The patient reported that she was feeling like she was itching all over. The patient stated that she was just getting little anxious. In response to further probing, the patient queried can you tell me are these side effects from this? The patient did not understand what they were saying. It makes her itch; The patient was just getting little anxious because she can't understand what they were asking her. She needs to know how she should know about the side effects if these are normal or not. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Pyrexia
Clinical narrative: Dry heavy cough; Fever; This is a spontaneous report from a non-contactable consumer (patient) from medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on 19Mar2021, at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient experienced dry heavy cough and fever on Mar2021. The patient underwent lab tests and procedures which included body temperature: 99.9 Fahrenheit on Mar2021. The outcome of the event was unknown.  Follow-up (26Mar2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Discomfort, Eye pain, Fatigue
Clinical narrative: joint pain; bone pain; muscle pain; tiredness; fever; feeeling of warm from inside out the body; irritation in the throat and the sensation of a foreign body in the throat; irritation in the throat and the sensation of a foreign body in the throat; nausea; headache; eye pain; general discomfort; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no, lot number and expiration date was not reported), first dose via an unspecified route of administration on 18Mar2021 (at the age of 57 year) as for covid-19 immunization. Medical history included cancer (patient was cancer survivor), ongoing osteoporosis. Concomitant medications included ergocalciferol (VIT D) and calcium taken for osteoporosis. Since vaccination, on 18Mar2021, patient has been presenting with joint pain, bone pain, muscle pain, tiredness, fever and the feeling of warm from inside out the body, throat irritation and the feeling of foreign body in the throat, nausea, headache, eyes pain and general discomfort. Patient reported she has been taking Tylenol at nights to manage the symptoms but as the evening arrives, symptoms are coming back and 8 days after vaccination has not disappeared. Patient reported she has not gone to the physician for management of prior symptoms. Therapeutic measures were taken as a result of all events and included treatment with Tylenol. The outcome of the events was unknown.   No follow-up attempts are possible;information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Myalgia, Nausea, Oropharyngeal discomfort
Clinical narrative: joint pain; bone pain; muscle pain; tiredness; fever; feeeling of warm from inside out the body; irritation in the throat and the sensation of a foreign body in the throat; irritation in the throat and the sensation of a foreign body in the throat; nausea; headache; eye pain; general discomfort; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no, lot number and expiration date was not reported), first dose via an unspecified route of administration on 18Mar2021 (at the age of 57 year) as for covid-19 immunization. Medical history included cancer (patient was cancer survivor), ongoing osteoporosis. Concomitant medications included ergocalciferol (VIT D) and calcium taken for osteoporosis. Since vaccination, on 18Mar2021, patient has been presenting with joint pain, bone pain, muscle pain, tiredness, fever and the feeling of warm from inside out the body, throat irritation and the feeling of foreign body in the throat, nausea, headache, eyes pain and general discomfort. Patient reported she has been taking Tylenol at nights to manage the symptoms but as the evening arrives, symptoms are coming back and 8 days after vaccination has not disappeared. Patient reported she has not gone to the physician for management of prior symptoms. Therapeutic measures were taken as a result of all events and included treatment with Tylenol. The outcome of the events was unknown.   No follow-up attempts are possible;information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat irritation
Clinical narrative: joint pain; bone pain; muscle pain; tiredness; fever; feeeling of warm from inside out the body; irritation in the throat and the sensation of a foreign body in the throat; irritation in the throat and the sensation of a foreign body in the throat; nausea; headache; eye pain; general discomfort; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and batch no, lot number and expiration date was not reported), first dose via an unspecified route of administration on 18Mar2021 (at the age of 57 year) as for covid-19 immunization. Medical history included cancer (patient was cancer survivor), ongoing osteoporosis. Concomitant medications included ergocalciferol (VIT D) and calcium taken for osteoporosis. Since vaccination, on 18Mar2021, patient has been presenting with joint pain, bone pain, muscle pain, tiredness, fever and the feeling of warm from inside out the body, throat irritation and the feeling of foreign body in the throat, nausea, headache, eyes pain and general discomfort. Patient reported she has been taking Tylenol at nights to manage the symptoms but as the evening arrives, symptoms are coming back and 8 days after vaccination has not disappeared. Patient reported she has not gone to the physician for management of prior symptoms. Therapeutic measures were taken as a result of all events and included treatment with Tylenol. The outcome of the events was unknown.   No follow-up attempts are possible;information about lot/batch number cannot be obtained. No further information is expected.