chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: belly pain; fatigue; fever; arm pain; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151), via an unspecified route of administration in the left arm on 05Apr2021 at 11:45 (at the age of 42-year-old) as a single dose for COVID-19 immunization. Medical history included systemic lupus and Hashimoto's disease. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL); escitalopram oxalate (LEXAPRO); colecalciferol (VITAMIN D), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6208), via an unspecified route of administration in the left arm on 12Mar2021 at 11:45 (at the age of 42-year-old), as a single dose for COVID-19 immunization and the patent experienced back pain after 2 hours, exhausted and headache next day with still pain, itching on 3rd day on an unknown date. The patient previously received intravenous iodine and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 17:30 On 05Apr2021 at 17:30, the patient experienced stabbing belly pain within 6 hours, fatigue, fever and arm pain could barely move next day. Belly pain continued for 6 days, really exhausted and gets tired very easily usually the patient was very fit and exercise. No therapeutic measures were taken for the events. The clinical outcome of the event belly pain, fatigue, fever and arm pain was not resolved at the time of report.    No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Myalgia, Neck pain
Clinical narrative: I'm still in chronic muscle spasms as of 11Apr2021; severe neck pain; severe shoulder pain; severe pain in my trap muscles; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).   A 68-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via unspecified route of administration, administered in Right arm on an unknown date in Mar2021 (age at the vaccination 68-years-old) as dose 2, single for covid-19 immunization. Medical history was Arthritis from an unknown start and stop date. Concomitant medication included other medications the patient received within 2 weeks of vaccination was alprazolam taken for an unspecified indication, start and stop date were not reported. No Allergies to medications, food, or other products. Historical vaccine included patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no/ Lot number: not reported) via unspecified route of administration, administered in Right arm on an unknown date in Mar2021 08:45 AM (age at the vaccination 68-years-old) as dose 1, single for covid-19 immunization and experienced with sever muscle inflammation under left breast, she thought she broke a rib and intense pain. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. It was reported that Two weeks after her second shot, on an unknown date in Mar2021 patient experienced severe neck, shoulder and sever pain in her trap muscles. She went to withheld on 24Mar2021 after her second Pfizer shot and explained all of this to her doctor. Adverse event result in doctor or other healthcare professional office/clinic visit. Seriousness was reported as No. Therapeutic measures taken as results of events caused which she was prescribed with Baclofen and that has not helped her, also received Tramol. She was still in chronic muscle spasms as of 11Apr2021. Outcome of the all the events was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Diarrhoea, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 40-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0162) via an unspecified route of administration, administered in left arm on 09Apr2021 (at the age of 40-year-old) as dose 2 , single for covid-19 immunization. Medical history included asthma, high blood pressure, pulses, mitral valve prolapse from an unknown date and unknown if ongoing. Patient was allergic to mild eggs, dairy, peanuts, severe mushroom from an unknown date and unknown if ongoing. The patient did not received any other vaccines within 4 weeks. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. Concomitant medications, in two weeks included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, flecainide (FLECAINIDE) taken for an unspecified indication, valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) taken for an unspecified indication, hydrochlorothiazid (HYDROCHLOROTHIAZID) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (solution for injection, lot number: ER2613) via an unspecified route of administration, administered in left arm on 17Mar2021 (at the age of 40-year-old) as dose 1 single for COVID-19 immunization and experienced Lymphedema. On an unspecified date in Apr2021 the patient experienced with in 8 hours chills, fever, nausea, diarrhea, body muscle aches, low energy, swollen lymph node. The patient underwent lab tests and procedures which included body temperature (reported as temps): 99.1, 99.7 and 100.9 on an unspecified date in Apr2021. No treatment received for the events. Outcome of the events were resolving. No follow up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 40-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0162) via an unspecified route of administration, administered in left arm on 09Apr2021 (at the age of 40-year-old) as dose 2 , single for covid-19 immunization. Medical history included asthma, high blood pressure, pulses, mitral valve prolapse from an unknown date and unknown if ongoing. Patient was allergic to mild eggs, dairy, peanuts, severe mushroom from an unknown date and unknown if ongoing. The patient did not received any other vaccines within 4 weeks. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 since the vaccination. Concomitant medications, in two weeks included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, flecainide (FLECAINIDE) taken for an unspecified indication, valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) taken for an unspecified indication, hydrochlorothiazid (HYDROCHLOROTHIAZID) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (solution for injection, lot number: ER2613) via an unspecified route of administration, administered in left arm on 17Mar2021 (at the age of 40-year-old) as dose 1 single for COVID-19 immunization and experienced Lymphedema. On an unspecified date in Apr2021 the patient experienced with in 8 hours chills, fever, nausea, diarrhea, body muscle aches, low energy, swollen lymph node. The patient underwent lab tests and procedures which included body temperature (reported as temps): 99.1, 99.7 and 100.9 on an unspecified date in Apr2021. No treatment received for the events. Outcome of the events were resolving. No follow up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Musculoskeletal pain, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pain radiated into my scapula; started having pain/ unable to use the left arm/ arm hurt at rest and severe with movement; unable to sleep; The pain is with rotation of the left arm and lifting/ arm hurt at rest and severe with movement; Second dose was given in incorrect location, top/posterior area of left shoulder, not within the deltoid muscle.; This is a spontaneous report from a contactable other hcp.   A 34-year-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8733, expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:00 as (Age at vaccination was 34-year-old), as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included hypertension from an unknown date and unknown if ongoing. No allergies to medications, food, or other products were reported. There were no concomitant medications. The patient previously received first dose bnt162b2 (BNT162B2, solution for injection, Lot Number: EN6206, expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on Mar2021 04:00 PM as dose 1, single for COVID-19 immunization.On 01Apr2021 12:00, the patient experienced second dose was given in incorrect location, top/posterior area of left shoulder, not within the deltoid muscle, On 01Apr2021 15:00 pain radiated into my scapula, started having pain/ unable to use the left arm/ arm hurt at rest and severe with movement, unable to sleep, the pain was with rotation of the left arm and lifting/ arm hurt at rest and severe with movement. Patient received no treatment for the event. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The events were non-serous. The clinical outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Pain
Clinical narrative: severe chills; fever up to 101.7; severe body aches; joint pain (back, abdomen, hips); Pain and swelling at site injection; Pain and swelling at site injection; residual lower back pain; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 09:30 (age at vaccination: 55years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included glucose tolerance impaired and hypertension. Concomitant medication included losartan and metformin. Patient had no known allergies. Prior to vaccination, The patient was not tested positive for covid 19 and had not been tested post vaccination. Prior to 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 and received other medications 2 weeks prior to the COVID vaccine. The patient previously took dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 12Mar2021 as dose 1, single (refrigeration issue - had to have 1st shot again on 19Mar) and dose 2 (Lot number: ER2613 / EN6205) via an unspecified route of administration, administered in Arm Left on 19Mar2021 at 09:30 AM and experienced pyrexia, chills and body aches continued for another 24 hrs (back pain) for COVID-19 immunization. On 09Apr2021 at 11:00 PM, the patient experienced severe chills started about 14 hours after shot, fever up to 101.7, severe body aches and joint pain (back, abdomen, hips). Fever subsided to low grade about 30 hours after shot continued for another 24 hours. Pain and swelling at site injection, still happening nearly 72 hours after shot. some residual lower back pain as well. fever is still about 1 degree higher than normal. No treatment received for the events. The patient underwent lab tests and procedures which included body temperature: 101.7 on an unspecified date in Apr2021 fever up to 101.7. The outcome of the event pyrexia, vaccination site pain and vaccination site swelling was not recovered and other events were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: severe chills; fever up to 101.7; severe body aches; joint pain (back, abdomen, hips); Pain and swelling at site injection; Pain and swelling at site injection; residual lower back pain; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 09:30 (age at vaccination: 55years-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included glucose tolerance impaired and hypertension. Concomitant medication included losartan and metformin. Patient had no known allergies. Prior to vaccination, The patient was not tested positive for covid 19 and had not been tested post vaccination. Prior to 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 and received other medications 2 weeks prior to the COVID vaccine. The patient previously took dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 12Mar2021 as dose 1, single (refrigeration issue - had to have 1st shot again on 19Mar) and dose 2 (Lot number: ER2613 / EN6205) via an unspecified route of administration, administered in Arm Left on 19Mar2021 at 09:30 AM and experienced pyrexia, chills and body aches continued for another 24 hrs (back pain) for COVID-19 immunization. On 09Apr2021 at 11:00 PM, the patient experienced severe chills started about 14 hours after shot, fever up to 101.7, severe body aches and joint pain (back, abdomen, hips). Fever subsided to low grade about 30 hours after shot continued for another 24 hours. Pain and swelling at site injection, still happening nearly 72 hours after shot. some residual lower back pain as well. fever is still about 1 degree higher than normal. No treatment received for the events. The patient underwent lab tests and procedures which included body temperature: 101.7 on an unspecified date in Apr2021 fever up to 101.7. The outcome of the event pyrexia, vaccination site pain and vaccination site swelling was not recovered and other events were recovering.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: my upper arm is still hurting me; i could not sleep all night; there is a little swelling in that area; My upper arm is still hurting me; I could not sleep all night; There is a little swelling in that area; It is like a stinging pain; It is hurting me like the most; My upper arm is still hurting me; I could not sleep all night; There is a little swelling in that area; It is like a stinging pain; It is hurting me like the most; today, it is hurting me like the most; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Right (upper right arm) on 05Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer stated, I got my first shot on 05Apr2021, the Pfizer one (Covid Vaccine) and my upper arm is still hurting me. Last night, I could not sleep all night and when I woke up this morning, I saw that there is a little swelling in that area. How long it takes for pain to go away? It is like a stinging pain. Consumer further stated, I took two Tylenol (treatment) this morning and I am putting an ice pack right now. Today (08Apr2021), it is hurting me like the most. The outcome of event my upper arm is still hurting me and today, it is hurting me like the most was not recovered and rest all was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising; This a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on 31Mar2021 (at the age of 59 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient takes lot of concomitants but was not reported and stated that patient was not going to sort out her medications right now. On an unspecified date, the patient experienced extreme bruising. It was very unusual for her to bruise like that. No treatment was received. The outcome of the event was unknown.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: Headache; Chills; Body ache; low soreness; Fatigue; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that the patient got the first Pfizer COVID shot, Thursday and the patient had low soreness but the patient was ok for the most part and then like Saturday night the patient just got fatigue, had a headache, the patient got the chills and really been the same thing since Saturday night one thing was left was the headache. The patient was wondering how long do the side effect would last? had been so fatigued. The patient had not been able to go to work. The patient stated that last Thursday had body ache. The patient questioned Is it normal and How long is this supposed to last. Outcome of the event headache was recovered on an unspecified date in 2021 and for rest all events the outcome 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: Body temperature, Pyrexia
Clinical narrative: fever like 102-degree Fahrenheit; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date,, via an unspecified route of administration on 07Apr2021at 15:00 hours as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date,  via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. On Apr2021, patient had fever like 102-degree Fahrenheit. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Paraesthesia, Pruritus, Urticaria
Clinical narrative: I broke out in hives, my whole back had broke out and it turned really red and it has been around my back; I can feel it tingling around my neck, like I want to scratch it again; I started itching real bad; Last night it flared back up again; I broke out in hives, my whole back had broke out and it turned really red and it has been around my back; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8727 and expiry date was not reported), via an unspecified route of administration, on 30Mar2021 (age at vaccination: 60 years), as dose 1, single dose for COVID-19 immunization. The patient's medical history included blood pressure high (hypertension, high blood pressure. I take medication), herniated disc on back, and chronic obstructive pulmonary disease (COPD, I'm on oxygen). Concomitant medications included amlodipine besilate (5 mg) for blood pressure high, losartan potassium (100 mg) for Blood pressure high, iron, and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient stated that she had the Pfizer shot and yesterday on 08Apr2021, she broke out in hives. She woke up yesterday, yesterday morning with a hive, she started itching real bad and her whole back had broke out and it turned really red and it has been around her back. So, she had her niece rub some A and D ointment in order to cool it down. Then last night it flared back up again. So she was on oxygen. she took a Benadryl. She could feel it tingling around her neck, like she wanted to scratch it again. Due date of 2nd shot of COVID-19 Vaccine, patient stated, it was supposed to be on Wednesday, but she was not sure if she was getting it. On 21April2021 was the next shot. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (Wife) of unspecified age that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 08Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on unspecified date for COVID-19 immunization. On 09Apr2021, the patient experienced fever. Patient got her second shot (Pfizer, Covid-19 vaccine) yesterday and this morning she got fever, the consumer wanted to know does patient need to take Aspirin for this situation or not. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Contusion, Erythema, Headache, Pain
Clinical narrative: Body ache; Arm was a real sore and bruised; arm was swollen and red; Chills; Headache; Arm was a real sore and bruised; arm was swollen and red; Arm was a real sore and bruised; arm was swollen and red; Arm was a real sore and bruised; arm was swollen and red; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced body ache, arm was a real sore and bruised, arm was swollen and red, chills, and headache. It was reported that this is my 1st shot, and the patient was just had a little concern, she took the Pfizer vaccine 2 days ago and noticed some side-effects like headache and body ache, my arm is a real sore, and bruised. She asks if there was anything she can do, take for it. This was the second day, today, chills, headache, her arm was swollen and red, she was trying to figure out was there anything she can do or take, and how long it will last. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Body ache; Arm was a real sore and bruised; arm was swollen and red; Chills; Headache; Arm was a real sore and bruised; arm was swollen and red; Arm was a real sore and bruised; arm was swollen and red; Arm was a real sore and bruised; arm was swollen and red; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced body ache, arm was a real sore and bruised, arm was swollen and red, chills, and headache. It was reported that this is my 1st shot, and the patient was just had a little concern, she took the Pfizer vaccine 2 days ago and noticed some side-effects like headache and body ache, my arm is a real sore, and bruised. She asks if there was anything she can do, take for it. This was the second day, today, chills, headache, her arm was swollen and red, she was trying to figure out was there anything she can do or take, and how long it will last. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever; headache; body ache; This is a spontaneous report from a contactable consumer (patient) reported in response to Non- HCP Follow-up letter sent in cross referenced case. A 69-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6203), via an unspecified route, administered in arm on 01Mar2021 at 11:15 (at the age of 69 years) as dose 2, single for COVID-19 immunization at a health clinic. The patient's medical history included ongoing allergies to environmental from Jun2020. The patient's concomitant medications included allergy immunotherapy once a week injection. There were none prior vaccinations. Family medical history relevant to adverse events was none. The patient took previously first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EM9810), intramuscular, administered in arm on 08Feb2021 at 12:15 PM (at the age of 69 years) as dose 1, single for COVID-19 immunization. On 01Mar2021 at 23:23, the patient experienced fever, headache, body ache for 3 days. Relevant tests were none. The adverse event did not require the initiation of new medication / other treatment /procedure. The outcome of events was recovered on 04Mar2021.  No follow-up attempts were possible. No further information was expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Heart rate, Heart rate increased
Clinical narrative: I feel fatigued; rapid resting heart rate of 125; out of breath; dizziness; This is a spontaneous report from a contactable consumer (Patient). This 22-year-old female (non pregnant) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Unable to locate or read the details) on 14Apr2021at 08:30 via an unspecified route of administration in the left arm as DOSE 2, SINGLE for COVID-19 immunisation (age at vaccination:22-years-old).The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not have Covid prior vaccination neither Covid tested post vaccination. The patient medical history included: Asthma. Previously the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: not reported) on unspecified date via an unspecified route of administration as DOSE 1, SINGLE for COVID-19 immunisation. On 14Apr2021, after the shot the patient was fine in the morning, but later at 18:00 she had rapid resting heart rate of 125, felt fatigued, dizziness and out of breath. Treatment details was not provided. 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 23Mar2021 15:00 at the age of 59-years-old as dose 1, single for covid-19 immunisation at Hospital. Medical history included treated for breast cancer from an unspecified date in 2019. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccine in four weeks of vaccination. The patient did not receive other medications in two weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 02Apr2021 at 16:00, the patient experienced chills, body aches, low grade fever and loss of taste. The clinical course was reported as follows: After 10 days from her first vaccine, the patient had the chills, body aches, Low grade fever and the loss of taste. No treatment was received for adverse events. Adverse events resulted in none of the above. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast swelling, Breast tenderness, Lymphadenopathy, Pain in extremity
Clinical narrative: swelling and tenderness in breast on side of injection site; swelling and tenderness in breast on side of injection site; Swollen lymph nodes in neck and underarm; Intense arm pain and underarm pain; Intense arm pain and underarm pain; Swollen injection site; Rash on arm and neck near injection area; This is a spontaneous report from a non-contactable consumer (patient). This 24-year-old female patient reported for herself.  A 24-years-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration, on an unspecified date (24-year-old at the time of vaccination) as dose number unknown, single for COVID-19 immunization. Medical history included penicillin allergy and sulfonamide allergy. Concomitant medications included ethinylestradiol, desogestrel (ENSKYCE) and daily vitamins (UNSPECIFIED DRUG), received within 2 weeks of vaccination for unknown indication. The patient took Doxycycline on an unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Apr2021 the patient experienced Swollen injection site, rash on arm and neck near injection area, swollen lymph nodes in neck and underarm, intense arm pain and underarm pain, swelling and tenderness in breast on side of injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events swollen injection site, rash on arm and neck near injection area, swollen lymph nodes in neck and underarm, intense arm pain and underarm pain, swelling and tenderness in breast on side of injection site were resolving at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site swelling
Clinical narrative: swelling and tenderness in breast on side of injection site; swelling and tenderness in breast on side of injection site; Swollen lymph nodes in neck and underarm; Intense arm pain and underarm pain; Intense arm pain and underarm pain; Swollen injection site; Rash on arm and neck near injection area; This is a spontaneous report from a non-contactable consumer (patient). This 24-year-old female patient reported for herself.  A 24-years-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration, on an unspecified date (24-year-old at the time of vaccination) as dose number unknown, single for COVID-19 immunization. Medical history included penicillin allergy and sulfonamide allergy. Concomitant medications included ethinylestradiol, desogestrel (ENSKYCE) and daily vitamins (UNSPECIFIED DRUG), received within 2 weeks of vaccination for unknown indication. The patient took Doxycycline on an unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Apr2021 the patient experienced Swollen injection site, rash on arm and neck near injection area, swollen lymph nodes in neck and underarm, intense arm pain and underarm pain, swelling and tenderness in breast on side of injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events swollen injection site, rash on arm and neck near injection area, swollen lymph nodes in neck and underarm, intense arm pain and underarm pain, swelling and tenderness in breast on side of injection site were resolving at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: After the second vaccine my left eye swelled up again Going on day four now and it's not getting any better.; This is a spontaneous report from a contactable consumer (Patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Er8729, Expiry date was not reported), via an unspecified route of administration on 08Apr2021 at 15:15 (at the age of 56-year-old) in Arm Left as dose 2, single for COVID-19 immunization. Patient medical history reported as none. The Patient had no known allergies. The patient concomitant medications were not reported. Patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: En6204 and Expiry date was not reported), via an unspecified route of administration on unspecified date, (at the age of 56-year-old) in Arm right as dose 1, single for COVID-19 immunization and experienced left eyelid swelled. The Patient was not received other vaccine in four weeks. The Patient was not diagnosed with COVID-19 prior vaccination. The Patient was not tested COVID-19 post vaccination. On 09Apr2021, the patient experienced after the second vaccine his left eye swelled up again going on day four now and it's not getting any better. The Patient was not received treatment for the event. The outcome for the event was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: have been sick; My husband had a fever for 3 days and can we possibly got the Covid from it.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. This consumer reported for a patient (Husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient have been sick and had a fever for 3 days and can we possibly got the COVID from it. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021416198 Same reporter/diff patient.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: feel chilled like for 2 hours; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feel chilled like for 2 hours. The patient assessed the event as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Chest pain, Chills, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 41-year-old female patient received bnt162b2 (PFIZER COVID VACCINE, solution for injection, Lot Number: ER8737, Expiry date and NDC number: Unknown), dose 1 via an Intramuscular route of administration, administered in the Arm Left in the muscle on 10Apr2021 at 18:00 (at the age of 41-year-old), as DOSE 1, SINGLE for COVID-19 immunisation. No investigation assessment was done. Medical history included Pain in left arm from injection, family medical history: none. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the pfizer suspect. Diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was reported as none. Concomitant medication(s) included paracetamol (TYLENOL) taken for Pain in left arm from injection from 10Apr2021 to an unspecified stop date. No other vaccines were given within 4 weeks. On 10Apr2021 at 18:00, the patient experienced left arm sore. On 11Apr2021 at 08:00, the patient experienced throat hurt, chilly and cold, body achy. On 12Apr2021 at 08:00, the patient experienced chest pain, stomach pain, leg left numb. The events  Chest pain, Stomach pain, Throat hurt resulted into Physician Office Visit.The patient underwent lab tests and procedures which included blood test resulted throat hurt (Physician checked her and did blood work and said her throat hurt). Therapeutic measures were taken as a result of stomach pain, throat hurt and included with treatment Naproxen 375mg. Take 1 tablet twice daily by mouth as needed. She only took one and she had a pain in her stomach. Dicyclomine 10mg Take 1 tablet and she stopped because the pain was worse. Amoxicillin 500 mg one capsule by mouth 3 times daily. The doctor said not to stop this one, so she was still taking it. Reporter stated she has another appointment on 01May2021 to get second dose. She does not want to feel the way she felt the past couple of days. She wanted to get it but if she gets the second shot, will it be worse. She said she understood the flu shot will make you sick like the same thing. She did not have any prior flu shots and did not have a personal issue to report. The clinical outcome of the events chest pain, stomach pain, throat hurt, chilly and cold, body achy was reported as resolving and leg left numb was reported as not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 41-year-old female patient received bnt162b2 (PFIZER COVID VACCINE, solution for injection, Lot Number: ER8737, Expiry date and NDC number: Unknown), dose 1 via an Intramuscular route of administration, administered in the Arm Left in the muscle on 10Apr2021 at 18:00 (at the age of 41-year-old), as DOSE 1, SINGLE for COVID-19 immunisation. No investigation assessment was done. Medical history included Pain in left arm from injection, family medical history: none. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the pfizer suspect. Diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was reported as none. Concomitant medication(s) included paracetamol (TYLENOL) taken for Pain in left arm from injection from 10Apr2021 to an unspecified stop date. No other vaccines were given within 4 weeks. On 10Apr2021 at 18:00, the patient experienced left arm sore. On 11Apr2021 at 08:00, the patient experienced throat hurt, chilly and cold, body achy. On 12Apr2021 at 08:00, the patient experienced chest pain, stomach pain, leg left numb. The events  Chest pain, Stomach pain, Throat hurt resulted into Physician Office Visit.The patient underwent lab tests and procedures which included blood test resulted throat hurt (Physician checked her and did blood work and said her throat hurt). Therapeutic measures were taken as a result of stomach pain, throat hurt and included with treatment Naproxen 375mg. Take 1 tablet twice daily by mouth as needed. She only took one and she had a pain in her stomach. Dicyclomine 10mg Take 1 tablet and she stopped because the pain was worse. Amoxicillin 500 mg one capsule by mouth 3 times daily. The doctor said not to stop this one, so she was still taking it. Reporter stated she has another appointment on 01May2021 to get second dose. She does not want to feel the way she felt the past couple of days. She wanted to get it but if she gets the second shot, will it be worse. She said she understood the flu shot will make you sick like the same thing. She did not have any prior flu shots and did not have a personal issue to report. The clinical outcome of the events chest pain, stomach pain, throat hurt, chilly and cold, body achy was reported as resolving and leg left numb was reported as not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough
Clinical narrative: On 1& 2 dose patient had silly cough that disappeared after couple hrs; between 1 & 2, had unusual asthma attack lasting couple days; This is a spontaneous report from a contactable consumer (patient herself). A 62-years-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route, administered in Arm Left on 08Mar2021 at 16:45 (Age at vaccination 62-years-old) as dose 1, single for covid-19 immunization at hospital. Medical history included high blood pressure and borderline diabetic from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included levothyroxine (LEVOTHYROXINE), losartan (LOSARTAN), metformin (METFORMIN) and atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. On an unspecified Mar2021, the consumer stated that on 1 & 2 doses, she had silly cough that disappeared after couple hrs and between 1 & 2, had unusual asthma attack lasting couple days. The adverse event resulted in emergency room/department or urgent care. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received steroid inject, antibiotic, prednisone cough supp as treatment for the events. The second dose was schedule on 29Mar2021. The clinical outcome of the event on 1& 2 dose patient had silly cough that disappeared after couple hrs was resolved on an unspecified date in 2021 and between 1 & 2, had unusual asthma attack lasting couple days was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.