chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Myalgia
Clinical narrative: I got cramps in the right calf; muscle pain; joint pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 44-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:30 (at the age of 44-years old) as dose 2, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included ubidecarenone (Q10), ergocalciferol (VIT D), ascorbic acid (VIT C), cyanocobalamin (B12-VITAMIIN) taken for an unspecified indication, start and stop date were not reported. It was reported that she was not a pregnant at the time of vaccination. She did not take any other vaccine in four weeks prior COVID -19 vaccine. No Allergies to medications, food, or other products. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 1, single for COVID-19 immunisation. Couple days after the second shot, on an unspecified date in Apr2021 (Reported as 05Mar202116:00) in her left arm, she got cramps in the right calf and she started to had joint pain in her right elbow and muscle pain that extended down her forearm. No treatment received for the adverse event. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Epistaxis
Clinical narrative: 45 minutes after vaccine my nose started bleeding. It bled for about 15 minutes.; it was very worrisome; This is a spontaneous report from a contactable consumer (Herself). A 45-years-old non-pregnant female patient received second dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 20Apr2021 09:15 as DOSE 2, SINGLE for covid-19 immunization (at the age of 45 years). Medical history included autoimmune thyroiditis from an unknown date and unknown if ongoing. And no known allergies. There were no concomitant medications. The patient previously received first dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 22Mar2021 10:0 AM as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at time vaccination. It was reported no other vaccine received in four weeks and also no other medications in two weeks. No covid prior vaccination and also not tested covid post vaccination. The patient experienced on 20Apr2021 10:00 45 minutes after vaccine her nose started bleeding. It bled for about 15 minutes. She never got nose bleeds so it was very worrisome. The patient did not received any treatment. The clinical outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lethargy, Muscle spasms, Myalgia
Clinical narrative: Lethargy; achy joints; muscle pain/spasms; spasms; severe headache; low grade fever; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 40-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EW161), via an unknown route of administration in left arm on 17Apr2021 at 16:15 (at the age of 40-years-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient's medical history included Multiple sclerosis, Depression and anxiety. She was allergic to food allergy (beets). Concomitant medications included within 2 weeks of vaccination were vortioxetine hydrobromide (Trintellix), ocrelizumab (Ocrevus) and fexofenadine hydrochloride (Allegra 12 hour). The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EP7534), via an unknown route of administration in left arm on 25Mar2021 at 16:00 as historical vaccine as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 at 18:00, the patient experienced lethargy, achy joints, muscle pain/spasms, severe headache and low grade fever. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment received for the adverse events. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Lethargy; achy joints; muscle pain/spasms; spasms; severe headache; low grade fever; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 40-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EW161), via an unknown route of administration in left arm on 17Apr2021 at 16:15 (at the age of 40-years-old) as dose 2, single for COVID-19 immunization at pharmacy or drug store. The patient's medical history included Multiple sclerosis, Depression and anxiety. She was allergic to food allergy (beets). Concomitant medications included within 2 weeks of vaccination were vortioxetine hydrobromide (Trintellix), ocrelizumab (Ocrevus) and fexofenadine hydrochloride (Allegra 12 hour). The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EP7534), via an unknown route of administration in left arm on 25Mar2021 at 16:00 as historical vaccine as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Apr2021 at 18:00, the patient experienced lethargy, achy joints, muscle pain/spasms, severe headache and low grade fever. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment received for the adverse events. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: First, I take several more Rx than space available to tell you. My reaction occurred 3 days after the injection. I had a fine all over body rash. It was quite red. Did not itch. Took 3 days to resolve; This is a spontaneous report from a contactable consumer(patient). A 61-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EP7533), via an unspecified route of administration on 31Mar2021 at 18:15(at the age of 61-years-old) administered in Arm Right as a single dose for COVID-19 immunisation at at Pharmacy or Drug Store. Medical history included HBP, a fib, 5yr s/p breast cancer, pituitary adenoma benign; allergies to Adhesive, contrast dye (all from an unknown date and unknown if ongoing). Concomitant medication(s) included bupropion; metformin; lamotrigine; modafinil; citalopram hydrobromide (PRAM) taken for an unspecified indication, start and stop date were not reported. The patient was not Pregnant at the time of vaccination. On 03Apr2021 at 15:30, it was reported that My reaction occurred 3 days after the injection. I had a fine all over body rash. It was quite red. Did not itch. Took 3 days to resolve. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.Therapeutic measures were taken as a result of event and took 10 mg Zyrtec per day after the first day of the rash. The outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Sleep disorder, Vaccination site discomfort
Clinical narrative: Caller states that there is a bumpy redness around 4 or 5 bump; She states that the deep throb feeling did wake her up, she was sleeping.; itchy bumps on inside of lower arm; deep throb at the site; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN, G or 6, 204, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 19Mar2021 (age at vaccination 61 years) as dose 2, single, dose 1 intramuscular, administered in Arm Right on 26Feb2021 (Batch/Lot Number: EN6 or G 205) as dose 1, single for covid-19 immunisation. Medical history included None. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for Anxiety. (she does not really remember how long she has been taking the product, 8 years maybe), estradiol (ESTRADIOL) taken for hormone replacement therapy, start and stop date were not reported (taking for about 10 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not visited Emergency Room and Physician Office. It was reported Vaccine Administered at Military Facility. On 13Apr2021 03:00, the patient experienced deep throb at the site. On 13Apr2021 04:00, itchy bumps on inside of lower arm a few hours later. On an unspecified date, the patient had caller states that there is a bumpy redness around 4 or 5 bump, she states that the deep throb feeling did wake her up, she was sleeping on an unspecified date This was noticed about 3 or 4 am in the morning. Reporter stated, she felt she should report a delayed reaction to the vaccine that happened about a month after her second dose. Caller explains the throbbing lasted 10 or 20 seconds and then it was gone. It wasn't something that came and went. Topical cream on the area of the arm where the bumps are located, treatment except her fingernails. It was reported itchy bumps are different now, not as itchy and look like they have scabbed over, there is a bumpy redness around 4 or 5 bumps, and she would say they are healing since they scabbed up. They are taking their time to heal, the bumps. The outcome the event deep throb at the site was recovered on 13Apr2021 and itchy bumps on inside of lower arm was recovering and Caller states that there is a bumpy redness around 4 or 5 bump, Sleep disturbance was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Erythema, Gastrointestinal disorder, Pain in extremity
Clinical narrative: Left hand erythema/Lines in his hands seemed to be exaggerated; Left hand erythema/Lines in his hands seemed to be exaggerated; Upset stomach; Some diarrhea; Soreness in arm; His GI complaints started about maybe 2 to 3 hours after the vaccine.; Tingling in his scalp on the left side/Tingling on lateral aspect of abdominal wall; This is a spontaneous report from a contactable other hcp (patient). A 41-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0162) via an unspecified route of administration on 19Apr2021 at 10:30 (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included he has put on a few pounds from lockdown. Concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Historical vaccine reported as He has gotten flu shots.  Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. Relevant Tests reported as none. On 19Apr2021 the patient experienced left hand erythema/lines in his hands seemed to be exaggerated, tingling in his scalp on the left side/tingling on lateral aspect of abdominal wall, upset stomach, some diarrhea, soreness in arm, his gi complaints started about maybe 2 to 3 hours after the vaccine. It reported that about 4 to 6 hours later on the same side of his body that he had the shot he started having some symptoms. On his left hand he had some erythema, and the lines in his hands seemed to be exaggerated where the lines were deeper. He had tingling in his scalp on the left side. Also on the lateral aspect of his abdominal wall he had the same type of sensation. He didn't see anything on his abdominal wall and he didn't shave to see his scalp. It was reported that like his symptoms would appear and disappear over the course of a day. It was reported that 2 to 3 hours after he got the shot he had an upset stomach and some diarrhea. The patient stated that when his hand thing showed up his wife said it looked like it would be itchy. It was not itchy but he could tell it was not normal.It was not burning or itching but there was something wrong with his hand how he described. He is wondering if it is still safe to get the second shot. It was reported that the erythema was coming and going. It is weird how things were transient, and it was kind of rotating between 3 different spots. Other than the soreness everything has recovered completely. Patient not received treatment for the events. Outcome of the event soreness in arm was not recovered and other events was recovered on 19Apr2021.  No follow-up attempts are needed. No further information is expected
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Palmar erythema, Paraesthesia
Clinical narrative: Left hand erythema/Lines in his hands seemed to be exaggerated; Left hand erythema/Lines in his hands seemed to be exaggerated; Upset stomach; Some diarrhea; Soreness in arm; His GI complaints started about maybe 2 to 3 hours after the vaccine.; Tingling in his scalp on the left side/Tingling on lateral aspect of abdominal wall; This is a spontaneous report from a contactable other hcp (patient). A 41-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0162) via an unspecified route of administration on 19Apr2021 at 10:30 (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included he has put on a few pounds from lockdown. Concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Historical vaccine reported as He has gotten flu shots.  Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. Relevant Tests reported as none. On 19Apr2021 the patient experienced left hand erythema/lines in his hands seemed to be exaggerated, tingling in his scalp on the left side/tingling on lateral aspect of abdominal wall, upset stomach, some diarrhea, soreness in arm, his gi complaints started about maybe 2 to 3 hours after the vaccine. It reported that about 4 to 6 hours later on the same side of his body that he had the shot he started having some symptoms. On his left hand he had some erythema, and the lines in his hands seemed to be exaggerated where the lines were deeper. He had tingling in his scalp on the left side. Also on the lateral aspect of his abdominal wall he had the same type of sensation. He didn't see anything on his abdominal wall and he didn't shave to see his scalp. It was reported that like his symptoms would appear and disappear over the course of a day. It was reported that 2 to 3 hours after he got the shot he had an upset stomach and some diarrhea. The patient stated that when his hand thing showed up his wife said it looked like it would be itchy. It was not itchy but he could tell it was not normal.It was not burning or itching but there was something wrong with his hand how he described. He is wondering if it is still safe to get the second shot. It was reported that the erythema was coming and going. It is weird how things were transient, and it was kind of rotating between 3 different spots. Other than the soreness everything has recovered completely. Patient not received treatment for the events. Outcome of the event soreness in arm was not recovered and other events was recovered on 19Apr2021.  No follow-up attempts are needed. No further information is expected
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chest discomfort, Chills, Cough, Gingival pain
Clinical narrative: Swollen lips with blisters; Swollen lips with blisters; Sore swollen gums; Sore swollen gums; flared ms symptoms, (i.e. hand trembling and band around chest),; flared ms symptoms, (i.e. hand trembling and band around chest),; Aching body; Fever; chills; Coughing; This is a spontaneous report received from a contactable consumer (patient) reported herself that. A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: Ep7533) via an unspecified route of administration at right arm on 19Apr2021 13:00 (at the age of 53-year-old) as dose 2, single for COVID-19 immunisation. Medical history included CVID (Common variable immunodeficiency), MS (Multiple sclerosis), PE(s) (Pulmonary embolism), Allergies, Bone disease, Pacemaker, Wheelchair bound. Patient did not have covid prior to vaccination and post vaccination patient did not test COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. Patient do have allergies to medications, food and other products. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: Er8727) via an unspecified route of administration at right arm on 28Mar2021 13:00 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation. The patient experienced swollen lips with blisters, sore swollen gums, flared ms symptoms, (i.e. hand trembling and band around chest), aching body, fever, chills and coughing on 19Apr2021. Patient visit the physician office visit for the events. Outcome of all events was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Lip swelling, Pain, Pyrexia, Tremor
Clinical narrative: Swollen lips with blisters; Swollen lips with blisters; Sore swollen gums; Sore swollen gums; flared ms symptoms, (i.e. hand trembling and band around chest),; flared ms symptoms, (i.e. hand trembling and band around chest),; Aching body; Fever; chills; Coughing; This is a spontaneous report received from a contactable consumer (patient) reported herself that. A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: Ep7533) via an unspecified route of administration at right arm on 19Apr2021 13:00 (at the age of 53-year-old) as dose 2, single for COVID-19 immunisation. Medical history included CVID (Common variable immunodeficiency), MS (Multiple sclerosis), PE(s) (Pulmonary embolism), Allergies, Bone disease, Pacemaker, Wheelchair bound. Patient did not have covid prior to vaccination and post vaccination patient did not test COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks of vaccination. Patient do have allergies to medications, food and other products. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: Er8727) via an unspecified route of administration at right arm on 28Mar2021 13:00 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation. The patient experienced swollen lips with blisters, sore swollen gums, flared ms symptoms, (i.e. hand trembling and band around chest), aching body, fever, chills and coughing on 19Apr2021. Patient visit the physician office visit for the events. Outcome of all events was not recovered.  No follow-up attempts are needed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report from a contactable other hcp(nurse). A male patient of an unspecified age received bnt162b2 ((PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Batch/Lot Number: Not Provided, expiry date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced chills, and fever. Patient went to facility and is having adverse reactions to the COVID vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Hypokinesia, Lymphadenopathy, Malaise
Clinical narrative: Pain in back of chest, lung area; Pain he is experiencing in his chest is worse on the left side; Couldn't move; Felt very ill; Swollen lymph nodes on his neck; This is a spontaneous report from a contactable consumer (patient's mother). A 24-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown, expiry date and NDC number were not reported) via an unspecified route of administration on 12Apr2021 (at the age of 24-years-old) as dose 2, single for covid-19 immunisation. Medical history included ongoing asthma and he had this condition his whole life. This report was not related to a study or programme. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for asthma from an unspecified start date and ongoing. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number was not reported) on an unspecified date for covid-19 immunization. The patient took covid vaccine because he is an essential worker. On an unknown date in Apr2021 the patient experienced pain in back of chest (lung area), swollen lymph nodes on his neck, couldn't move, felt very ill, pain he was experiencing in his chest was worse on the left side, the reporter said it was the side of his body as he got the vaccine on. The patient took a dose of his Breo Inhaler thinking that it would help. He had to miss work to go to the doctor about his symptoms. No investigation assessment. The outcome of the events chest pain, and lymphadenopathy was not recovered and for all other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus
Clinical narrative: itchy and a burning sensation at the same time/ This sensation occurred with the first dose but resolved within a few days; itchy and a burning sensation at the same time/ This sensation occurred with the first dose but resolved within a few days; This is a spontaneous report from contactable consumer (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported) via intramuscular route on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included urticaria or hives from cold water from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, after first vaccination, the patient experienced itchy and a burning sensation at the same time. Reported that, the side effects were mild. The patient's lips, perioral area and eyes where one would usually apply eyeliner- though she doesn't apply make up, was itchy and a burning sensation at the same time. This sensation occurred with the first dose but resolved within a few days. The patient hypothesized that her side effects may be genetic because her brother and sister who live in other countries received Astra Zeneca and her sister developed hives and brother developed a wheel. Her 10-year-old son has also had to use an EpiPen several times. The outcome of the events were recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: i had a fever of 100.3; when i woke up i had felt super tried; body aches; my arm that received the shot was very sore; This is a spontaneous report from a contactable consumer (patient). A 35-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0170) via an unspecified route of administration in arm left on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included blood clot (other medical history: blood clot for that she was taking eliquis for). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered at school or student health clinic. Concomitant medication included apixaban (ELIQUIS) taken for thrombosis. The patient's historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0150) via an unspecified route of administration in right arm on 02Apr2021 16:30 as dose 1, single for COVID-19 immunization and experienced pain in arm. On 24Apr2021 07:30, the patient experienced fever of 100.3, when woke up, she felt super tried, body aches and her arm that received the shot was very sore. She was able to sleep it off and after 24 hours she was feeling 100 percent. On 24Apr2021 07:30, her body temperature was 100.3. No treatment was given for the events. The seriousness of the event was non-serious. On 25APR2021, the outcome of the events recovered.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Neck pain, Pain, Pain in extremity
Clinical narrative: SOB; pain in right arm that radiated to right neck and shoulder; generalized itching; pain in right arm that radiated to right neck and shoulder; pain in right arm that radiated to right neck and shoulder; pain in right arm that radiated to right neck and shoulder; This is a spontaneous report from a contactable other healthcare professional (nurse, patient). A 45-year-old non pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 19Mar2021 as dose 1, single (at the age of 45-years-old) for COVID 19 immunization (Hospital). Medical history included asthma and known allergies (both from an unknown date and unknown if ongoing) and COVID-19 (prior to vaccination) from an unknown date to unknown date. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had been tested for COVID-19, since the vaccination, via nasal swab and result was negative. On 19Mar2021 (began immediately after receiving injection), patient experienced generalized itching, shortness of breath (SOB), pain in right arm that radiated to right neck and shoulder. Events were reported to ED physician monitoring. Symptoms lasted for several days. Patient received no treatment for the events. The outcome of SOB was recovered on 23Apr2021, and rest of the events was recovered on an unspecified date in 2021.   No follow up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test
Clinical narrative: SOB; pain in right arm that radiated to right neck and shoulder; generalized itching; pain in right arm that radiated to right neck and shoulder; pain in right arm that radiated to right neck and shoulder; pain in right arm that radiated to right neck and shoulder; This is a spontaneous report from a contactable other healthcare professional (nurse, patient). A 45-year-old non pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 19Mar2021 as dose 1, single (at the age of 45-years-old) for COVID 19 immunization (Hospital). Medical history included asthma and known allergies (both from an unknown date and unknown if ongoing) and COVID-19 (prior to vaccination) from an unknown date to unknown date. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had been tested for COVID-19, since the vaccination, via nasal swab and result was negative. On 19Mar2021 (began immediately after receiving injection), patient experienced generalized itching, shortness of breath (SOB), pain in right arm that radiated to right neck and shoulder. Events were reported to ED physician monitoring. Symptoms lasted for several days. Patient received no treatment for the events. The outcome of SOB was recovered on 23Apr2021, and rest of the events was recovered on an unspecified date in 2021.   No follow up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Contusion, Hyperhidrosis, Rash
Clinical narrative: full body chills and sweating (no fever at all); full body chills and sweating (no fever at all); severe joint pain started in legs (ankles/knees) and moved up to hands. elbows, shoulders and back; bruise/rash; bruise/rash; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old non-pregnant female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EP7533) via an unspecified route of administration, administered in Arm Right on 06Apr2021 13:30 (at the age of 42 years) as dose 2 single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included type 1 diabetes mellitus, osteoarthritis, hereditary spherocytosis, blindness from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (INSULIN LISPRO); metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number: EP7534) via an unspecified route of administration, administered in Arm Right on 16Mar2021 13:30 (at the age of 42 years) dose 1 single for COVID-19 immunisation. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination she was not diagnosed with COVID-19. Since the vaccination, she has not tested for COVID-19. She was not pregnant at the time of vaccination. 3-4 hours after receiving 2nd dose of vaccine the patient experienced full body chills and sweating, severe joint pain started in legs and moved up to hands. elbows, shoulders and back which lasted about 16 hours, bruise/rash, on 06Apr2021 15:30 which appeared about 1 week after 2nd shot and was still there till 26Apr2021. No treatment taken for the adverse events. The outcome of the events was recovered on an unspecified date in Apr2021 and for events Rash and Bruise was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiolipin antibody, Dyspnoea, Migraine
Clinical narrative: migraines; shortness of breath (sob); This is a spontaneous report from a Pfizer sponsored program via contactable consumer or other non hcp (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, batch or lot number: was not reported), via an unspecified route of administration on 07Apr2021, as a single dose for COVID-19 immunization. The patient's medical history included covid 19 last year, May 2020, and had severe reactions. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced migraines, and shortness of breath (sob) and visited emergency room 2 or 3 times. On unspecified date, the patient underwent lab tests and procedures which included Antibodies, Cardiolipin antibody: Positive, Tested Positive for antibodies by her pulmonologist. Her 2nd vaccine dose was scheduled on 28Apr21, and her HCP referred her to poison control for information regarding how long she should wait to get her 2nd dose. Unaddressed medical questions referred or forwarded. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A male patient, of an unspecified age, received the 2nd dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# and expiration date: unknown), via an unspecified route of administration, on an unspecified date, for COVID-19 immunisation. The patient's medical history and concomitant medication not reported. Historical vaccine included the 1st dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# and expiration date: unknown), single dose, for COVID-19 immunization. Patient stated he received both doses Pfizer COVID-19 vaccine. The second dose was 8 days ago. 1 or 2 days after it, he had joint pain: knees, elbow, shoulders, hands and back. He usually takes naproxen for that; but the vaccination providers said he could only take Tylenol or Aspirin (has not been helping, it just slightly lessens the pain). He takes Tylenol 3 times a day. The outcome of all events: unknown.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient reported for himself). A 43-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), at the age of 43, in left arm, via an unspecified route of administration, on Apr 21, 2021, at 13:00, single dose, for COVID-19 immunization. The patient's medical history and concomitant not reported. The patient has no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Apr 23, 2021, patient experienced allergy/rash (itches around stomach and waste line area). The patient did not receive any treatment for the events reported. The outcome of the events: not recovered. This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Somnolence
Clinical narrative: I have hard breath & sleepy always please I need help in Emergency room couldn't find answer; I have hard breath & sleepy always please I need help in Emergency room couldn't find answer; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non pregnant female patient received bnt162b2 (Solution injection; Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 15Apr2021 at 12:00 (at the age of 34-years-old) as dose number unknown, single dose for COVID-19 immunisation. Medical history included food fruit allergy. There were no concomitant medications. Patient did not receive any other vaccines in four weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 15Apr2021 at 13:00, patient experienced to have hard breath and sleepy always please. Patient stated that she need help in emergency room couldn't find answer. Therapeutic measures were not taken due to the events. The outcome of the events was not recovered  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Pyrexia, Vomiting
Clinical narrative: Chest pain; Fever, of 104; Vomit; Tired and exhausted; This is a spontaneous case received from a non-contactable consumer (patient). A female patient of unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot# EW - Not legible), via an unspecified route of administration on 23Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medication was bot reported. Historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot # ER 8727), via an unspecified route of administration on 02Apr2021 as dose 1, single for COVID-19 immunisation. The patient reported that after the second dose of the Pfizer COVID vaccine on Friday, 23Apr2021, about after 12 hours she had fever of 104, after 24 hours after the second dose she began to feel chest pain that moved to the middle of her chest. The patient experienced vomiting and her whole body was tired and exhausted. The patient did not receive any treatment for the event fatigue. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Cough
Clinical narrative: Asthma exacerbation; Cough; This Case has been made valid conservatively since patient experienced adverse events with Suspect product BNT162B2 in Follow up 01. This is a spontaneous report from a contactable other health care professional and nurse via Pfizer sponsored program. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration on 21Apr2021 as dose 2, single (at the age of 17-years-old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included oral steroids for asthma. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Caller was not sure when the patient received the first dose, she did not get that date from the patient's mother. On an unspecified date, the patient experienced asthma exacerbation and cough. It was reported that he needed some oral steroids for an asthma exacerbation that had been going on for several weeks. Nurse didn't think the asthma flare up was due to the vaccine at all, but she wanted to know if there was any contradictions for giving oral steroids immediately following the second dose of vaccination. Nurse confirmed the asthma exacerbation was occurred prior to the first dose of the COVID-19 vaccine. It was not a severe exacerbation; he had been dealing with a cough for about 3 to 4 weeks. She did not believe that the cough was because of vaccine itself. The outcome of the events was unknown.  No further details were provided or obtained. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Dysphagia, Dyspnoea, Food allergy
Clinical narrative: itching; breathing difficulties/ immediate breathing problems; coughing; increased hearth rate; Overdose; Inappropriate schedule of vaccine administered; allergic reactions to food; vocal cords are limits her swallowing capacity; vocal cords are limits her swallowing capacity; This repeated and was more severe; This is a spontaneous report from a contactable female consumer (patient). A 57-year-old non-pregnant female patient received first bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 06Mar2021 at 11:30 (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EK4176) via an unspecified route of administration, administered in left arm on 06Mar2021 (at the age of 57-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history included high blood pressure from an unknown date and unknown if ongoing. The patient had known allergies. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. Facility type vaccine was mentioned as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not covid prior vaccination and covid was not tested post vaccination. On 06Apr2021, immediate reaction was itching, breathing difficulties, coughing and increased hearth rate. Events overdose and Inappropriate schedule of vaccine administered. Emergency medical technician (EMT) was involved and administered two Benadryl pills and after 45 minutes patient was back to normal. This repeated and was more severe during the second dose of the vaccine. After two weeks, on an unspecified date in Apr2021, allergic reactions to food started. She can only eat very limited amount of bread cheese, and some select fruit. All other food caused itching, breathing problem and coughing. The patient went to a specialist and was prescribed allergy medication and the situation improved little. Whenever patient eats, companions will wait with Epipen and Benadryl pills. Her vocal cords limit her swallowing capacity and immediately breathing problems starts. These episodes last only 10-15 minutes but are increasingly concerned because if she experience these without any companion. Adverse event resulted in doctor or other healthcare professional office / clinic visit and Emergency room /department or urgent care and EMT and Doctor visit. The clinical outcome of events was not recovered and the events overdose and Inappropriate schedule of vaccine administered was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Inappropriate schedule of product administration, Overdose, Pruritus, Vocal cord disorder
Clinical narrative: itching; breathing difficulties/ immediate breathing problems; coughing; increased hearth rate; Overdose; Inappropriate schedule of vaccine administered; allergic reactions to food; vocal cords are limits her swallowing capacity; vocal cords are limits her swallowing capacity; This repeated and was more severe; This is a spontaneous report from a contactable female consumer (patient). A 57-year-old non-pregnant female patient received first bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 06Mar2021 at 11:30 (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EK4176) via an unspecified route of administration, administered in left arm on 06Mar2021 (at the age of 57-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history included high blood pressure from an unknown date and unknown if ongoing. The patient had known allergies. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. Facility type vaccine was mentioned as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not covid prior vaccination and covid was not tested post vaccination. On 06Apr2021, immediate reaction was itching, breathing difficulties, coughing and increased hearth rate. Events overdose and Inappropriate schedule of vaccine administered. Emergency medical technician (EMT) was involved and administered two Benadryl pills and after 45 minutes patient was back to normal. This repeated and was more severe during the second dose of the vaccine. After two weeks, on an unspecified date in Apr2021, allergic reactions to food started. She can only eat very limited amount of bread cheese, and some select fruit. All other food caused itching, breathing problem and coughing. The patient went to a specialist and was prescribed allergy medication and the situation improved little. Whenever patient eats, companions will wait with Epipen and Benadryl pills. Her vocal cords limit her swallowing capacity and immediately breathing problems starts. These episodes last only 10-15 minutes but are increasingly concerned because if she experience these without any companion. Adverse event resulted in doctor or other healthcare professional office / clinic visit and Emergency room /department or urgent care and EMT and Doctor visit. The clinical outcome of events was not recovered and the events overdose and Inappropriate schedule of vaccine administered was unknown.    No follow-up attempts are needed. No further information is expected.