chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: Fever at 102; Aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 01Feb2021 at 07:15 AM, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin and diagnosed with COVID-19 prior vaccination. There were no concomitant medications. No other vaccine was administered in four weeks. The patient received the first dose of BNT162B2 on 12Jan2021 at 05:00 PM for COVID-19 immunization (in left arm). On 01Feb2021 at 05:00 PM (around 10 hours after the patient received the vaccine), the patient had symptoms including fever at 102, aches, nausea, chills, and headache. The patient was unable to go to work for 2 days. No treatment was received for the adverse events. The patient underwent COVID-19 test post vaccination that was negative on 04Feb2021. The patient recovered from the events in Feb2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever at 102; Aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 01Feb2021 at 07:15 AM, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin and diagnosed with COVID-19 prior vaccination. There were no concomitant medications. No other vaccine was administered in four weeks. The patient received the first dose of BNT162B2 on 12Jan2021 at 05:00 PM for COVID-19 immunization (in left arm). On 01Feb2021 at 05:00 PM (around 10 hours after the patient received the vaccine), the patient had symptoms including fever at 102, aches, nausea, chills, and headache. The patient was unable to go to work for 2 days. No treatment was received for the adverse events. The patient underwent COVID-19 test post vaccination that was negative on 04Feb2021. The patient recovered from the events in Feb2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, painful lymph node in left armpit 30hrs after vaccine; Swollen, painful lymph node in left armpit 30hrs after vaccine; This is a spontaneous report from a contactable nurse (patient). This 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN9581) via unspecified route of administration in the left arm on 05Feb2021 at 14:15 (at the age of 30-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to sulfa from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number EL3246) in the left arm on 15Jan2021 at 14:00 (at the age of 30-years-old) for COVID-19 immunization. On 06Feb2021 at 20:00 the patient experienced swollen, painful lymph node in left armpit 30 hours after vaccine. No treatment was provided for the events. The clinical outcomes of swollen, painful lymph node in left armpit 30 hours after vaccine were unknown. It was also reported the patient had not been COVID tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Mere stiffness of muscle/ Felt like my muscle did not want to slide in movement; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9261) via an unspecified route of administration on 05Feb2021 at 11:00 as a single dose in the right arm for COVID-19 immunization. The patient did not have any medical history ("0"). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included pantoprazole, sertraline hydrochloride (ZOLOFT), valacyclovir, and biotin from unknown dates for unknown indications. The patient did not have any known allergies. On 05Feb2021 at 22:00, the patient experienced mere stiffness of muscle that set in at 12 hours and was mostly gone at 24 hours. It felt like the muscle did not want to slide in movement. The patient reported it was not terribly severe and was really to be expected. The patient did not receive any treatment for the event. The outcome of mere stiffness of muscle was recovered. It was also reported that the patient was not tested for COVID-19 after vaccination.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Headache, Myalgia, Vaccination site pain
Clinical narrative: Muscle aches (back); Injection site pain; Headache; Flushing in face; Brain fog; This is a spontaneous report from a contactable other hcp (reporting for herself) A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration single dose on 06Feb2021 10:15 (at the age of 28) left arm  for covid-19 immunisation. The first dose (lot# EL12849) was taken on 15Jan2021 10:15 am, left arm. The patient medical history was not reported. There were no concomitant medications. No other vaccine was received in four weeks.  The patient experienced muscle aches on 06Feb2021 19:00, injection site pain on 06Feb2021 19:00, headache on 06Feb2021 19:00, flushing in face on 06Feb2021 19:00, brain fog on 06Feb2021 19:00. No treatment received. The events outcome was not recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Heart rate, Heart rate increased, Impaired work ability
Clinical narrative: My heart rate elevated to 120bpm; This side effect was unexpected, uncomfortable; This side effect was unexpected, uncomfortable and resulted in me being unable to work for the rest of the day.; This 25- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EL3247), via an unspecified route of administration, on 03Feb2021 at 1:00 PM (at the age of 25-years-old) as a single dose for COVID-19 immunization, in left arm. She has had no other vaccines in the past 4 weeks. Patient has not taken any medications in the past 2 weeks. The patient has no relevant medical history and is not taking any concomitant medications. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 03-FEB-2021 13:05, she reported: my heart rate elevated to 120bpm approximately 5 minutes after receiving the Pfizer COVID19 vaccine. This side effect was unexpected, uncomfortable and resulted in me being unable to work for the rest of the day. This side effect lasted approximately 36 hours. Patient did not receive any treatment. The outcome of the events heart rate elevated and unable to work the rest of the day was recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Headache
Clinical narrative: injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection site pain, redness, and swelling; headache; chills; muscle and joint pain; muscle and joint pain; nausea; dizziness; weakness; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9809), via an unspecified route of administration in the left arm on 06Feb2021 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included slightly elevated blood pressure, not taking medication, and COVID prior to vaccination, on an unspecified date. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included paracetamol (TYLENOL) and vitamin supplements. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Feb2021 16:00, the patient experienced injection site pain, redness, and swelling; headache, chills, muscle and joint pain, nausea, dizziness and weakness. No treatment was received for the events. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection site pain, redness, and swelling; headache; chills; muscle and joint pain; muscle and joint pain; nausea; dizziness; weakness; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9809), via an unspecified route of administration in the left arm on 06Feb2021 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included slightly elevated blood pressure, not taking medication, and COVID prior to vaccination, on an unspecified date. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included paracetamol (TYLENOL) and vitamin supplements. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Feb2021 16:00, the patient experienced injection site pain, redness, and swelling; headache, chills, muscle and joint pain, nausea, dizziness and weakness. No treatment was received for the events. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration in left arm, on 05Feb2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231) on 13Jan2021 at 01:45 PM for COVID-19 immunization (in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 06Feb2021 at 02:00 AM, the patient experienced fever ranging from 100 to 100.9 accompanied by chills and moderate headache as well. Fever subsided by the morning of 07Feb2021 and headache was mild by then. The patient also experienced soreness at site of injection on 06Feb2021 at 02:00 AM only if she touches it. No treatment was administered for the adverse events. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the events.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Very tired; headaches; This is a spontaneous report from a contactable consumer, the patient. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN5318, first dose) solution for injection intramuscular in the left arm on 29Jan2021 at 13:15 (at the age of 85-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included blood pressure and known allergies: penicillin. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 03Feb2021 at 07:00, the patient experienced very tired and headaches. No treatment was provided for the events very tired and headaches. The outcome of the events very tired and headaches was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Soreness in injection site; headache; fever like symptoms; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old male patient received second dose of BNT162B2 (brand=Pfizer), lot no. EN5318, via an unspecified route of administration (left arm) on 04Feb2021 15:15 at a single dose for COVID-19 immunization. Medical history included hereditary slightly higher blood pressure without medicine. No known allergies. No covid prior to vaccination. Concomitant medications included losartan and acetylsalicylic acid (ASPIRIN). The patient previously took first dose of BNT162B2 (brand=Pfizer) for COVID-19 immunization on 12Jan2021 04:15 PM (lot no. EL3249, left arm). No other vaccine in four weeks. On 05Feb2021 05:00 PM (as reported), the patient experienced soreness in injection site followed by headache and fever like symptoms that only lasted 12 hrs. The symptoms showed up around 24 hours after getting the second dose. No treatment received for the events. No covid test post vaccination. The patient recovered from all events on 06Feb2021 05:00.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Drenching night sweats; This is a spontaneous report from a contactable physician (patient).   An 80-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, lot # EL3249) intramuscular at single dose at left arm on 04Feb2021 08:30 for COVID-19 immunisation.  Medical history included hypertension, gout, no known allergies. The patient had not experienced COVID -19 prior vaccination. Concomitant medication in two weeks included metoprolol (manufacturer unknown), irbesartan (manufacturer unknown), allopurinol (manufacturer unknown), ASA (manufacturer unknown). The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # EK9231) intramuscular at single dose at left arm on 15Jan2021 09:00 for COVID-19 immunisation. No other vaccine received in four weeks. The patient experienced drenching night sweats on 06Feb2021 01:30. Course events was as follows. drenching night sweats 2nd and 3rd nights. This report written morning after 3rd night, so the reporter did not know if sweats will continue. No treatment received. COVID was not tested post vaccination. The outcome of event was recovered in Feb2021 at time of reporting.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (the patient).  A non-pregnant 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 02Feb2021 at 02:30 AM (at the age of 72-years) as a single dose for COVID-19 immunization. Medical history included carpal tunnel syndrome. (The patient stated she received the first dose of the vaccine a week ago. She was prescribed Methylprednisolone for her carpal tunnel problem. She stated its not due to COVID shot as she had it - carpel tunnel syndrome before. She wanted to know if there is any interaction with Methylprednisolone and COVID vaccine). The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included atenolol, cetirizine hydrochloride (CETRIZINE), pantoprazole, celecoxib (CELEXA) , vitamin b complex (VITAMIN B). The patient received other vaccines within four weeks prior to the vaccination, which included varicella zoster vaccine RGE (CHO) (SHINGRIX), dose 2 in the left arm as a single dose on 13Jan2021 for immunization. On 04Feb2021 at 10:00 AM  the patient experienced diarrhea. No treatment was given. The clinical outcome of diarrhea was not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information about lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seasonal allergy
Clinical narrative: seasonal allergies; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced seasonal allergies. Patient wanted to know if she can take pseudoephedrine for the seasonal allergies. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysphonia, Dyspnoea, Throat irritation, Wheezing
Clinical narrative: Scratchy throat; Shortness of breath; Hoarseness; Dry mouth; Wheezy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 66) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced scratchy throat, shortness of breath, hoarseness, dry mouth, and wheezy. The outcome of the events recovered on 07Feb2021.  Information on the lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Back pain, Body temperature, Feeling cold, Insomnia
Clinical narrative: wasn't able to sleep; felt like he was in a refrigerator; shaking; lower back pain; The patient reported receiving the Pfizer vaccine in his right arm; right arm/shoulder pain; right arm/shoulder pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 06Feb2021 at a single dose on the right arm for COVID-19 immunization. The patient also started to receive mirtazapine (MIRTAZAPINE, 50 mg, Capsule, soft), via an unspecified route of administration, from an unspecified date at 50 mg, once a day for sleep. Medical history included sleep (disorder). Concomitant medications included aspirin [acetylsalicylic acid], calcium, escitalopram, finasteride, lamotrigine, simvastatin, tamsulosin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), on an unspecified date for COVID-19 immunization. The patient reported receiving the Pfizer vaccine in his right arm on 06Feb2021. That evening he took his nightly medication and went to bed at 11:30 pm. He stated he wasn't able to sleep because he felt like he was in a refrigerator and he was shaking. He had lower back pain, right arm/shoulder pain, and went to the bathroom 5 times (all on an unspecified date in Feb2021), which was not normal for him. The patient added that it was the second dosage of the Pfizer (Covid-19 Vaccine) her received on 06Feb2021. And he had some negative response: a little pain in his shoulder but the worst thing that happened, he went to bed 11:30 did not sleep at all. At 11:30 night, he took his medication (Mirtazapine) and went to bed. He was shaking and he had to put another blanket on himself. Eventually, it was okay, but the problem is he was not able to sleep all night, from 11:30 to 9' O clock this morning (07Feb2021). Consumer stated, "Yesterday my wife and I had the second dose of the Pfizer and I had really strange reaction and I will tell you what it was. Last night at about 11:30 I took my night medicine (later clarified as Mirtazapine), I went to bedroom, I started shaking all over. And the worst part is from 11:30 to 10 o' clock this morning, I was not able to sleep. There is slight pain in my shoulder". When confirmed if the consumer wanted to report the same or have any questions, consumer stated, "No, we have no problem with temperature is fine, the oxygen is fine. Just I don't understand why in fact the medication (mirtazapine) is to induce sleeping, use to for sleep within half hour but it didn't help. I wanted to know what happened. So, this will eventually go away?" The action taken in response to the events for mirtazapine was unknown. Outcome of the events was unknown.  Information on batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Oxygen saturation, Tremor, Vaccination site pain
Clinical narrative: wasn't able to sleep; felt like he was in a refrigerator; shaking; lower back pain; The patient reported receiving the Pfizer vaccine in his right arm; right arm/shoulder pain; right arm/shoulder pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 06Feb2021 at a single dose on the right arm for COVID-19 immunization. The patient also started to receive mirtazapine (MIRTAZAPINE, 50 mg, Capsule, soft), via an unspecified route of administration, from an unspecified date at 50 mg, once a day for sleep. Medical history included sleep (disorder). Concomitant medications included aspirin [acetylsalicylic acid], calcium, escitalopram, finasteride, lamotrigine, simvastatin, tamsulosin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), on an unspecified date for COVID-19 immunization. The patient reported receiving the Pfizer vaccine in his right arm on 06Feb2021. That evening he took his nightly medication and went to bed at 11:30 pm. He stated he wasn't able to sleep because he felt like he was in a refrigerator and he was shaking. He had lower back pain, right arm/shoulder pain, and went to the bathroom 5 times (all on an unspecified date in Feb2021), which was not normal for him. The patient added that it was the second dosage of the Pfizer (Covid-19 Vaccine) her received on 06Feb2021. And he had some negative response: a little pain in his shoulder but the worst thing that happened, he went to bed 11:30 did not sleep at all. At 11:30 night, he took his medication (Mirtazapine) and went to bed. He was shaking and he had to put another blanket on himself. Eventually, it was okay, but the problem is he was not able to sleep all night, from 11:30 to 9' O clock this morning (07Feb2021). Consumer stated, "Yesterday my wife and I had the second dose of the Pfizer and I had really strange reaction and I will tell you what it was. Last night at about 11:30 I took my night medicine (later clarified as Mirtazapine), I went to bedroom, I started shaking all over. And the worst part is from 11:30 to 10 o' clock this morning, I was not able to sleep. There is slight pain in my shoulder". When confirmed if the consumer wanted to report the same or have any questions, consumer stated, "No, we have no problem with temperature is fine, the oxygen is fine. Just I don't understand why in fact the medication (mirtazapine) is to induce sleeping, use to for sleep within half hour but it didn't help. I wanted to know what happened. So, this will eventually go away?" The action taken in response to the events for mirtazapine was unknown. Outcome of the events was unknown.  Information on batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Pyrexia, Swelling
Clinical narrative: fever; chills; back pain; injection site redness w/ itching & heat; injection site redness w/ itching & heat; injection site redness w/ itching & heat; injection site redness w/ itching & heat; swelling under arm; head ache; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: F19264), via an unspecified route of administration on 05Feb2021 09:45 at a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism and sulfer allergy. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID) and rosuvastatin. The patient previously took the first dose of bnt162b2 (lot number: EL1283) in the right arm on 15Jan2021 at the age of 57 years old for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Feb2021 20:30, the patient experienced fever, chills, back pain, injection site redness with itching and heat, swelling under arm, and head ache. No treatment was received for the adverse events. Outcome of the events was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: fever; chills; back pain; injection site redness w/ itching & heat; injection site redness w/ itching & heat; injection site redness w/ itching & heat; injection site redness w/ itching & heat; swelling under arm; head ache; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: F19264), via an unspecified route of administration on 05Feb2021 09:45 at a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism and sulfer allergy. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID) and rosuvastatin. The patient previously took the first dose of bnt162b2 (lot number: EL1283) in the right arm on 15Jan2021 at the age of 57 years old for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Feb2021 20:30, the patient experienced fever, chills, back pain, injection site redness with itching and heat, swelling under arm, and head ache. No treatment was received for the adverse events. Outcome of the events was recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Feeling abnormal, Feeling jittery, Pain in extremity
Clinical narrative: jitteriness; Sore arm; brain fog; loss of some exercise ability; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration  (vaccine location: right arm) on 01Feb2021 09:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient medical history was not reported. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medication/other medications given within two weeks included 'Metropol.' There was no other vaccine given to the patient within four weeks. On 01Feb2021 12:00, the patient experienced sore arm, first day brain fog and loss of some exercise ability. The patient also experienced jitteriness two days after (03Feb2021). No treatment given for the adverse events. The patient was not Covid tested post vaccination. The patient recovered from the events on an unspecified date in Feb2021.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral coldness
Clinical narrative: started to feel numb on the fingertips going to the arms, hands, toes, legs/ I am experiencing numbness, my whole body is going numb; Left arm feeling frozen; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age (age: 50, unit: unknown) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient asked if it was ok to get the second dose of COVID vaccine on 10Feb2021 after experiencing side effects. The patient got the first dose 20Jan2021 and started to feel numb on the fingertips going to the arms, hands, toes, legs, and left arm was feeling frozen; she was experiencing numbness, her whole body was going numb, all on an unspecified date in 2021. She did not report the symptoms to a healthcare professional. The first day, her fingertips were going numb and it's gradually crawling up, now it's going to her hand and up to her arm. She also mentioned that in the beginning, it was her toes and now it was crawling up and when she wakes up in the morning, she has completely numb leg and arms and added that this was progressive. The patient did not receive any treatment and has not visited the emergency room or a physician in response to the events. The outcome of the events was unknown. The events were assessed as non-serious.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Pollakiuria, Rhinorrhoea
Clinical narrative: Reports nose is dripping; Nauseous; Cold; Increase in urination; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 80 [unknown unit]) received her first dose of bnt162b2 (BNT162B2 as reported PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at unknown vaccination age via an unspecified route of administration on an unspecified date at 0900 at a single dose for covid-19 immunization. Medical history included experiencing anxiety (ongoing) as her husband passed away a month ago (Jan2021). The patient's concomitant medications were not reported. The patient reported her was nose dripping, nauseous, cold and increase in urination on an unspecified date. The patient mentioned that she took ondansetron (ZOFRAN) about an hour ago. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever; swollen lymph nodes; severe headache; body aches; This is a spontaneous report from a non-contactable consumer reported for herself.  A 22-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unknown route at the left arm on 03Feb2021 15:30 (at the age of 22-years-old) for COVID-19 immunization. The patient medical history included asthma, allergies to penicillin and peanuts. The patient was not pregnant. No COVID prior vaccination. The patient had received the first dose of vaccine on 15Jan2021 03:45 PM at the left arm. The patient experienced fever that lasted 48 hours, severe headache, body aches, and swollen lymph nodes, the events occurred on 03Feb2021 11:45 PM. The outcome of the events was recovered.  The patient did not receive any treatment. Patient has not tested positive for COVID-19 since having the vaccine.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: dime size hard but mobile red on end lump under left arm pit. Hard to touch, somewhat tender, reduced in size as of Sunday but still remained; This is a spontaneous report from a contactable consumer (patient). This 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EM9810) via an unspecified route of administration in the left arm on 02Feb2021 at 15:45 at single dose for COVID-19 immunisation. Relevant medical history included sulfa allergy, diabetes mellitus and high blood pressure. Concomitant medications included metformin and metoprolol. On 04Feb2021 at 16:00, the patient noticed dime size hard but mobile red on end lump under left arm pit. Hard to touch, somewhat tender, reduced in size as of Sunday 07Feb2021 but still remained. The patient did not receive corrective treatments. The patient did not have COVID-19 prior to vaccination, and she was not tested for COVID-19 post vaccination. The patient had not recovered from the event.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), lot no. El3428, via an unspecified route of administration (right arm) on 03Feb2021 16:00 at a single dose for COVID-19 immunization. Medical history included acid reflux and known allergies to erythromycin and azithromycin (ZITHROMAX). No covid prior to vaccination. Concomitant medication included lansoprazole. The patient previously first dose of BNT162B2 (brand=Pfizer) for COVID-19 immunization on 15Jan2021 03:15 PM (lot no. El3428, right arm). No other vaccine in four weeks. On 04Feb2021 09:00 AM, the patient had fever and chills and headache on Thursday and Friday after her vaccine. No treatment received for the events. No covid test post vaccination. The patient recovered from all events on 05Feb2021.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 03Feb2021 03:00 at a single dose for COVID-19 immunization. The patient has no other medical history. The patient has no known allergies. The patient has no covid prior to vaccination. The patient has not been tested for covid post vaccination. Concomitant medications included amlodipine, clopidogrel bisulfate (PLAVIX), and an unspecified statin. On 07Feb2021 at 18:00, the patient experienced nausea and dizziness when he woke up, lasted about 5 hours. No treatment was received for the reported adverse events. The outcome of the events was recovered on 07Feb2021 at 23:00.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Urticaria
Clinical narrative: swollen eye; hives; This is a spontaneous report from a contactable Nurse, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via an unspecified route of administration on 11Jan2021 at 15:30 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included insulin resistance, vitamin D deficiency, GERD (Gastrooesophageal reflux disease) and allergy to pollen and possible allergy to cilantro. Prior to the vaccination, it was unknown if the patient was not diagnosed with COVID-19.  Concomitant medications included metformin, famotidine (PEPCID [FAMOTIDINE]), clarithromycin (CLARITIN [CLARITHROMYCIN]), topirmate, and diphenhydramine hydrochloride (BENADRYL); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took pregabalin (LYRICA) from an unknown date for an unknown indication and experienced allergy. On 01Feb2021 at 06:00, the patient experienced hives and swollen eye. The patient reported that the first vaccine was administered and the patient was fine then the patient had hives and swollen eye on the day the second dose was to be administered. The second dose of the vaccine was delayed. The events resulted in an emergency room/urgent care visit and the patient received treatment for the events with solumedrol shot and prednisone oral with benadryl/pepcid/atarax.  The patient received the second dose one week later, on Friday 05Feb2021, with prednisone on board. The clinical outcomes of the hives and swollen eye were recovering. It was also reported that since the vaccination, it was unknown if the patient had been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Hives cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: Swelling of the right foot; joint pain in the right big toe; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9265), via an unknown route of administration on 01Feb2021 at 08:30 (at the age of 76-years old) as a single dose in the right arm for COVID-19 immunization). Medical history included arthritis from an unknown date and unknown if ongoing. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications included tizanidine hydrochloride (MANUFACTURER UNKNOWN) and naproxen sodium (ALEVE) from an unknown date. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 02Feb2021, the patient experienced swelling of the right foot and joint pain in the right big toe. Therapeutic measures were not taken for the events. The clinical outcome of the events peripheral swelling and arthralgia was recovered on an unknown date in Feb2021.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Taste disorder
Clinical narrative: Loss of taste; More pronounced with salty/meaty flavors; This is a spontaneous report from a contactable consumer (patient). A 93-year-old non-pregnant female patient received first dose of BNT162B2, lot no. EL9265, via an unspecified route of administration (right arm) on 31Jan2021 14:00 at a single dose for COVID-19 immunization at an administrative office of healthcare group. Medical history included COPD, asthma, hypertension, and atrial flutter. She had no known allergies. Concomitant medications included prednisone, azithromycin, rivaroxaban (XARELTO), and 3 others. No other vaccine in four weeks. No covid prior to vaccination. The patient experienced loss of taste and more pronounced with salty/meaty flavors, sweets can still be tasted on 02Feb2021. No treatment received for the events. No covid test post vaccination. The outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid pain, Swelling of eyelid
Clinical narrative: eye lid swelling; Pain in left eyelid that felt like a bruise about 24 hours after shot; This is a spontaneous report from a contactable consumer reporting for herself.  A 43-years-old female patient received the first dose of  bnt162b2 (BNT162B2; Lot # EM9810) vaccine , via an unspecified route of administration in the left arm on 05Feb2021 14:45 at single dose for covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included doxycycline (DOXYCYCLINE), loratadine, pseudoephedrine sulfate (CLARITIN-D).  The patient experienced pain in left eyelid that felt like a bruise about 24 hours after shot  on 06Feb2021 15:00 with outcome of recovering , eye lid swelling  on 07Feb2021 02:45 with outcome of recovering. Both the events were considered non serious. The patient received Cold compress and Benadryl on advise from on call to treat the events.  Follow up information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gastrointestinal disorder, Pain in extremity
Clinical narrative: Gastrointestinal issues; Had occasional zaps of pain in toes and tiredness; Had occasional zaps of pain in toes and tiredness; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318) via an unspecified route of administration on 02Feb2021 at 16:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included pancreatic cancer. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included levothyroxine; pancreatin (CREON); famotidine; latanaprost; and calcium carbonate, vitamin b12, vitamin D (CALCE) from unknown dates for unspecified indications. The patient did not have any known allergies. On 03Feb2021 at 18:00 around dinner time, the patient started with gastrointestinal issues and also had occasional "zaps" of pain in toes and tiredness. These lasted into Saturday night (06Feb2021). The patient did not receive any treatment for the events. The outcome of gastrointestinal issues, zaps of pain in toes, and tiredness was recovering. It was also reported that the patient had not been tested for COVID-19 after the vaccination.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: I'm having flu like symptoms; headache; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A male patient of an unspecified age (reported as 43, no unit) received the first dose of BNT 162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient is having flu like symptoms and had a headache. The patient was asking if he can take Dayquil or ibuprofen, and will it affect the vaccine at all? The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Groin pain, Limb discomfort, Vaccination site pain
Clinical narrative: arm was a little sore at the injection site/injection site soreness; has muscle pain in her groin and states it has nothing to do with the vaccine; she moved her leg wrong yesterday after the vaccine; This is a spontaneous report from from a sponsored program. A contactable female consumer (patient) of an unspecified age received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Feb2021 14:30, single dose for COVID-19 immunization. The patient medical history was not reported.  Concomitant medication included acetylsalicylic acid (ASPIRIN). Patient states she takes supplements everyday at the same time and she took 81 mg of aspirin. Caller would like to know if taking 81 mg if aspirin would affect the efficacy of the vaccine. On 06Feb2021, patient's arm was a little sore at the injection site. Patient states she had muscle pain in her groin and states it has nothing to do with the vaccine. She moved her leg wrong yesterday after the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: she cannot remember much; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced she cannot remember much. The patient stated, "I don't know if its the vaccine or what?" The patient also reported that she was indicated for second dose on 17Feb2021. Asking for aid in transportation to "name" and if able to confirm appointment. The outcome of the event she cannot remember much was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Body rash starting with bright red palms and soles of feet, then spreading over entire body; This is a spontaneous report from a contactable consumer reporting for herself. A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9269/expiration date: not provided), via an unspecified route of administration, on 02Feb2021 at 11:45 as a single dose in the right arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 12Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient has a known allergies to iodine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Feb2021 at 12:00, the patient experienced body rash starting with bright red palms and soles of feet, then spreading over entire body. The patient did not receive any treatment for these events. The outcome of the event body rash starting with bright red palms and soles of feet, then spreading over entire body was unknown. Since the vaccination, the patient had not been tested for COVID-19.