chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: breaks out in sweats.; arm is still sore today; fever, temperature 102; Cough; Sore throat; lost voice; cold chills and achy all over; cold chills and achy all over; Headache; This is a spontaneous report from a non-contactable consumer. A 56-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: EW0151), dose 1 intramuscular on 07Apr 2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccoination: 56-Year-old) The patient medical included she has asthma and has had it for most of her life. She has autoimmune deficiency and Rheumatoid Arthritis that was diagnosed in her mid-20s and she was diagnosed with diverticulosis in the last year. Concomitant medications were not reported. On 09Apr2021 the patient had lost voice, cold chills, achy all over, headache and sore throat. On 10Apr2021 the patient had fever (temperature 102) and cough. She was weird because she heard the 2nd shot is worse than the 1st.  She was fine the first day and the next day she had a few symptoms.  On Friday, she went into work and felt like a train hit her.  She lost her voice had cold chills and was achy all over. The next day, her temperature was 102degrees.  She had a cough with bright green phlegm.  She thought it was weird.  She had cold chills, headache, and was sore all over. She did not expect this. She had a fever the last 2 days, and it broke early this morning between 2 and 3am.  She knows this because she was soaked and now has no fever.  She took her temperature before she called, and it was right at normal.  She doesn't have one right now but is not sure if it will go up later or what. Her arm was still sore today, but she figured that it would be gone. The outcome of the event lost voice, cold chills and achy all over, headache, cough and sore throat was not recovered. The outcome of the event fever and temperature 102 was recovered on 13Apr2021. The outcome of the event break out in sweats and arm is still sore today was reported as unknown. No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: hives; itches so bad; body rash; Her feet hurt so bad; joint pain; This is a spontaneous report from a contactable consumer (patient, reported for herself).  A female patient of unspecified age received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via unspecified route of administration on 18Mar2021 as a dose 2, single for covid-19 immunization. The patient stated she was allergic to the Pfizer covid vaccine. The patient's medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: not reported), via unspecified route of administration on unspecified date as a dose 1, single for covid-19 immunization and experienced Few hives, swollen lip, Allergic to the Pfizer covid vaccine. On an unspecified date in 2021 she broke out in hives, with the second dose. Her doctor prescribed her steroids and the hives/rash comes back once she finishes the steroids treatment. The patient stated that it itches so bad, she has body rash, have joint pain, her feet hurt so bad. Patient queried for what she can do about her symptoms. Therapeutic measures were taken as a result of hives, itches so bad, body rash. Outcome of hives, itches so bad and body rash was not recovered and for feet hurt so bad and joint pain was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Temperature, 100.6; Aching all over; Severe headache; This is a spontaneous report from a contactable consumer (patient). A 72-years-old (73-year-old as reported) female patient  received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection,  Lot Number: EW0158, Expiration date not reported), via an unspecified route of administration, administered in left arm on 12Apr2021 at 11:30 (at the age of 72 years) as dose 1 single for covid-19 immunization. Medical history included Covid positive  (sars-cov-2 test positive on 04Jan2021) and she went to the emergency room, patient stated that she had to wait 90 days to get her vaccine. The patient's concomitant medications were not reported. Family Medical History Relevant to events reported as no. No history of all previous immunization with the pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and no additional vaccines administered on same date of the pfizer suspect no. Patient did not receive any vaccine within 4 weeks, prior vaccinations. On 12Apr2021, the patient experienced severe headache at 5 PM (5 hrs 30 min after the vaccination) and aching all over at 10 PM (10 hrs 30 min after the vaccination). On 13Apr2021 (1 day after vaccination), patient had temperature 100.6.  The patient underwent lab test included body temperature: 100.6 on13Apr2021. The outcome of all the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling jittery, Tremor
Clinical narrative: she noticed her hand trembling a little bit/shaky; she had pain on the right side of her chest on Friday; Caller states she was also jittery and shaky; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch Number: not reported), via an unspecified route of administration in left arm on 08Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 09Apr2021 she noticed her hand trembling a little bit and she had pain on the right side of her chest on Friday. She also experienced jittery and shaky. The patient was not received any treatment for events. Outcome of events was recovered on 10Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bronchitis, Chest discomfort, Cough, Malaise
Clinical narrative: She had Bronchitis like symptoms; Chest was full; Coughing, a lot; Back hurt, not like muscle pain, like her lung hurt; Felt under the weather; This is a spontaneous report from a contactable consumer or other non hcp.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient states that she called her family doctor today. patient states that she got the shot last Wednesday on 07Apr2021, and on Thursday 08Apr2021, she felt under the weather. She states that on Friday, she sort of felt alright. She states on Saturday 10Apr2021, she had bronchitis like symptoms, her chest was full, she was coughing alot and her back hurt. Caller describes her back hurting as not like muscle pain, reclarified, like her lung hurt. Caller states she was not having trouble breathing. The patient wants to know, what steps should she take. Reclarified, the patient states that should she take a COVID test, or does she have COVID. Reclarified, patient would like to know how to treat her symptoms. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes developing on her core/rashes developing around her armpit area/She says the rashes are both sides, left and right; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 24-year-old female patient 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, administered in Left Arm on 24Mar2021 12:30 (at the age of 24 years) as DOSE 1, SINGLE for covid-19 immunization. Family medical history relevant adverse event included high blood pressure (mom and dad both have high blood pressure), diabetes (mom has diabetes), and breast cancer (grandmother had breast cancer).No medical history (including any illness at time of vaccination) was reported. No Prior vaccinations (within 4 weeks). Relevant tests were none. No AE following prior vaccinations. The patient other concomitant medications was not reported. No additional vaccines administered on same date of the pfizer suspect was reported. On 10Apr2021, the patient experienced rashes developing on her core, developing around her armpit area and the rashes are both sides, left and right. On 12Apr2021, the patient experienced rashes developing on her core was reported as worsened. The caller was calling about the shot. She says she has a quick question. She asked was it safe for her to get the second shot since she has rashes developing around her core and around her armpit area. No adverse event resulted in emergency room/physician office visit. The outcome of the event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: First dose: arm of course hurt and itched; First dose: arm of course hurt and itched; This is a spontaneous report from a contactable consumer. This consumer Female (patient) reported.  A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK2176), via an unspecified route of administration on 14Jan2021 (at the age of 63-years-old) as dose, 1 single for covid-19 immunisation. The patient medical history included Alzheimer's from an unknown date and unknown if ongoing, cognitive issues from an unknown date and unknown if ongoing, Stroke (she had a stroke last year and Part of her throat is half paralyzed and even her voice dropped) from an unknown date and unknown if ongoing and COPD (chronic obstructive pulmonary disease) from an unknown date and unknown if ongoing, she also has COPD, so she had a problem breathing. The patient concomitant medications were not reported. On an unspecified date on 2021, the patient experienced first dose: arm of course hurt and itched. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Dyspnoea
Clinical narrative: I am feeling weak; I had a severe back; muscle pain; joint pain; headache; tiredness; chills; nausea; I had difficulty breathing; Arm sore; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A patient of unspecified age and gender received bnt162b2 ,( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 23Mar2021 as DOSE 2, SINGLE for Covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced i am feeling weak , i had a severe back, muscle pain, joint pain, headache, tiredness, chills, nausea, i had difficulty breathing , arm sore. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: I am feeling weak; I had a severe back; muscle pain; joint pain; headache; tiredness; chills; nausea; I had difficulty breathing; Arm sore; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A patient of unspecified age and gender received bnt162b2 ,( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 23Mar2021 as DOSE 2, SINGLE for Covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced i am feeling weak , i had a severe back, muscle pain, joint pain, headache, tiredness, chills, nausea, i had difficulty breathing , arm sore. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arm; This is a spontaneous report received from a contactable pharmacist. A 37-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208, Expiration date: 30Jun2021), via an unspecified route on 15Mar2021 (at the age of 37-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021, the patient experienced rash on arm. Reporter stated that the patient came in for the second dose of the Covid-19 vaccine and that the patient still had a red rash on her arm. Reporter reported that because the rash was still present on the patient's arm, the second dose of the Covid-19 vaccine was not administered and that he did not see the patient's rash but that he was told that the rash was still present. Reporter reported that he did not know if the rash had improved, persisted, or worsened. It was unknown that patient visited to Emergency Room or Physician Office. Reporter stated that the pharmacy on duty on 12Apr2021 instructed the patient to go see her primary care doctor and ask about the rash and see what the physician though. Reporter reported that he didn't think that the patient followed up with her physician but just called to complain. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP follow-up letter sent in cross reference case. A 79-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EL9809, expiration date: Jun 2021), at the age of 79, intramuscularly, in right arm, on Feb 17, 2021, at 15:00, single dose, for COVID-19 immunization, at a hospital. Historical vaccine included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EL8982, expiration date: May 2021), intramuscularly, in right arm, on Jan 27, 2021, at 15:00, single dose, for COVID-19 immunization and experienced projectile vomit, projectile diarrhea, high temperature, muscle fatigue and extreme tiredness. The patient's medical history and concomitant medications not reported. Prior vaccination within 4 weeks was none. The patient experienced high fever, headache, chills and arm pain on Feb 17, 2021, at 01:00. Reported serious (important medical event). The patient underwent lab tests and procedures, which included SARS-CoV-2 test: negative on Feb 10, 2021, with all the symptoms of COVID-19 except lost of taste and smell. Patient wanted to make sure she did not have COVID-19 for the sake of her husband. The patient did not received treatment for the events. The outcome of the events was recovered on an unspecified date. No follow-up attempts possible. No further information expected.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Rash
Clinical narrative: little rash on my arm/rash on left arm; unable to sleep because of the itching; unable to sleep because of the itching; This is a spontaneous report from a Pfizer sponsored program support from a contactable consumer (patient). An 89-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), via an unspecified route of administration, administered in left arm on 18Mar2021 (at the age of 89-year-old) as DOSE 2, SINGLE, for COVID-19 immunisation. The patient medical history was reported as none. Concomitant medication(s) included atenolol (MANUFACTURER UNKNOWN) taken 50 mg daily and hydrochlorothiazide (MANUFACTURER UNKNOWN) 25 mg daily; both taking for 10-15 years and taken for unsure water or blood pressure from an unspecified start date and ongoing. Patient previously 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 in left arm on 24Feb2021 (at the age of 89-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer Suspect. On an unspecified date in Mar2021, patient developed a rash after a week of getting it and it has returned. Patient was trying to find out what was happening. He was unable to figure out why or what it was. It didn't do any damage. He was unable to sleep because of the itching. The events did not result in emergency room or physician office. The seriousness of the events was reported as non-serious. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Loss of personal independence in daily activities, Pain, Swelling
Clinical narrative: gout flare up and pain; Was in so much pain; Toes are all swelled up on the right side; had to help to stand up and put leg on couch, so he could lay down; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (at the age of 65 year) as dose 2, single for COVID-19 immunisation. Medical history included gout. The patient had not been taking any medicine 2 weeks prior to the Covid 19 vaccine. No prior vaccinations within 4 weeks. Concomitant medication(s) included ongoing metformin (METFORMIN); ongoing atenolol (ATENOLOL) taken for blood pressure abnormal; ongoing lisinopril (LISINOPRIL) taken for blood pressure abnormal; ongoing atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal, all has been taking for years. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206), dose 1 via an unspecified route of administration on 03Mar2021 for COVID-19 immunisation. On 25Mar2021, Patient gout picked up tremendously right after the shot. Patient gout flare up, originally in one knee, the left, then went to the right and then to foot. Toes were all swelled up on the right side. Started the day after the second shot. Patient was in so much pain, had to help to stand up and put leg on couch, so he could lay down. Pain get better, but then worse. This week he has felt in his big toe but has now spread to other toes. Patient took gout medicine only after the flare up. Medication was Indomethacin and the dose was 50mg three times a day. Patient took on an as needed basis. Patient did not receive Emergency Room and Physician's office. The outcome of events Pain and Gout flare was not recovered while for rest events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lacrimation increased, Pruritus
Clinical narrative: Itching; Joint pain; One left eye is watery/eyes is still watery; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: EN6204), as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Blood pressure high. Concomitant medication(s) included Amlodipine taken for an unspecified indication, start and stop date were not reported and Lisinopril taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced Itching, Joint pain and one left eye is watery/eyes is still watery. Consumer stated Since she got the shot on an unspecified date Wednesday night, but she thought it was going to go away by maybe Thursday or Friday. She was talking to you, and she was still getting itchy its very itchy and eyes is still watery. Consumer asked what could do, just leave it or just, do you have anything to put on it, you say anything or what and not want itching, she meant she did not know about her eyes, they were watery. She stated she was still getting itchy. Consumer stated, she just dropped alcohol on the top of her hand. For her eye she did not put anything she just rubbed the alcohol and put it last night. The consumer stated that the events were still consistent. Consumer stated, she was caregiver. She take care of disability people. (Further not clarified, hence captured as consumer or non-health professional). (Not alpha spelled, hence not captured in tab). There was no Investigation Assessment provided. No treatment was received to treat the events. The patient outcome of the events was Not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling cold, Malaise, Pyrexia
Clinical narrative: Feeling unwell; throwing up; slight fever of 100.5 degrees Fahrenheit; feels very tired; is fully dressed and feels cold; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old male patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Batch/Lot number was not reported) an unspecified route of administration, administered in Arm Right on 12Apr2021 13:00 (at the age of 61 years) as dose 2 single for COVID-19 immunization. Medical history included ongoing diabetes mellitus Verbatim: Diabetes, renal disorder from 2020 and ongoing Verbatim: kidney disease from 2020 To Ongoing. The patient's concomitant medications were not reported. Historical vaccination included the patient received first dose BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on an unspecified date in Mar2021 as single for COVID-19 immunization and experienced soreness at injection site, had a big knot on his arm and indigestion No prior vaccination within 4 weeks. No investigation assessment was done. After receiving the second dose of COVID-19 vaccine on 12Apr2021, one day after (13Apr2021) the patient experienced feeling unwell, throwing up, he ate some saltines and ginger ale and has had no further episodes of throwing up. He doesn't feel like he needs to throw up at the moment, slight fever of 100.5-degree Fahrenheit, feels very tired, is fully dressed with a sweater, wind breaker fully and feels cold. The patient underwent lab tests and procedures which included body temperature: 100.5-degree Fahrenheit on 13Apr2021. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Feeling unwell; throwing up; slight fever of 100.5 degrees Fahrenheit; feels very tired; is fully dressed and feels cold; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old male patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Batch/Lot number was not reported) an unspecified route of administration, administered in Arm Right on 12Apr2021 13:00 (at the age of 61 years) as dose 2 single for COVID-19 immunization. Medical history included ongoing diabetes mellitus Verbatim: Diabetes, renal disorder from 2020 and ongoing Verbatim: kidney disease from 2020 To Ongoing. The patient's concomitant medications were not reported. Historical vaccination included the patient received first dose BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on an unspecified date in Mar2021 as single for COVID-19 immunization and experienced soreness at injection site, had a big knot on his arm and indigestion No prior vaccination within 4 weeks. No investigation assessment was done. After receiving the second dose of COVID-19 vaccine on 12Apr2021, one day after (13Apr2021) the patient experienced feeling unwell, throwing up, he ate some saltines and ginger ale and has had no further episodes of throwing up. He doesn't feel like he needs to throw up at the moment, slight fever of 100.5-degree Fahrenheit, feels very tired, is fully dressed with a sweater, wind breaker fully and feels cold. The patient underwent lab tests and procedures which included body temperature: 100.5-degree Fahrenheit on 13Apr2021. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Mastication disorder
Clinical narrative: Dizzy; hard to chew and talk; hard to chew and talk; Pain; Tiredness; difficult to breathe; Weakness; throat closing up; This is a spontaneous report received from contactable consumer (patient himself). A 34-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 13Apr2021 (age at vaccination: 34-years), as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route, in left arm, on 08Mar2021 (age at vaccination: 34-years) as dose 1, single for covid-19 immunisation. Patients medical history included HIV since 2015, unknown if ongoing. Concomitant medications were not reported. Patient took the vaccine on Tuesday morning, 13Apr2021, and he felt sick after it. He felt pain, was weak, and tiredness yesterday 14Apr2021. Today the caller was feeling dizzy, his throat was kind of closing up, it was hard to chew and talk, he felt he needs more air, and was very tired. Patient was at work today and when stands up he feels tired, weak and it was difficult to breathe. The outcome of events for difficult to breathe, weakness and throat closing up was not recovered, and rest was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Speech disorder, Throat tightness
Clinical narrative: Dizzy; hard to chew and talk; hard to chew and talk; Pain; Tiredness; difficult to breathe; Weakness; throat closing up; This is a spontaneous report received from contactable consumer (patient himself). A 34-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 13Apr2021 (age at vaccination: 34-years), as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2 via unspecified route, in left arm, on 08Mar2021 (age at vaccination: 34-years) as dose 1, single for covid-19 immunisation. Patients medical history included HIV since 2015, unknown if ongoing. Concomitant medications were not reported. Patient took the vaccine on Tuesday morning, 13Apr2021, and he felt sick after it. He felt pain, was weak, and tiredness yesterday 14Apr2021. Today the caller was feeling dizzy, his throat was kind of closing up, it was hard to chew and talk, he felt he needs more air, and was very tired. Patient was at work today and when stands up he feels tired, weak and it was difficult to breathe. The outcome of events for difficult to breathe, weakness and throat closing up was not recovered, and rest was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives arms legs & torso/ I had a reaction of hives on my arms and legs; Received the first vaccine and broke out in hives within two hours of the shot; This is a spontaneous report from a contactable consumer. This 56-year-old non-pregnant female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7533) via an unspecified route of administration on 01Apr2021 at 05:30 PM (at 56-year-old) on left arm, as dose 1, single for COVID-19 immunization. The patient had history of allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for covid-19 since the vaccination. No other vaccines were received within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. On 01Apr2021, within two hours of the shot the patient experienced hives arms legs & torso/ had a reaction of hives on my arms and legs. The patient received treatment with Benadryl. The patient was recovering.  No follow-up attempts were needed. No further information was expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chills, Ear pain, Eye irritation
Clinical narrative: weakness; burning sensation in face and lymph nodes; burning sensation in her eyes; intense headache; pain in ears; body aches; Chills; Fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 11Apr2021 (at the age of 40-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included endometriosis, hysterectomy, ovaries removed, surgeries (clarifies she actually had 4 total surgeries), severe allergies (had her epi pen with her at the time of the vaccination but everything was fine). The patient concomitant medication included estradiol (ESTROGEL) cream (applies cream every 2 days, intravaginally) via vaginal route taken for oestrogen replacement therapy (had endometriosis and had ovaries removed last year) from on an unspecified date in Feb2020 and ongoing. On 12Apr2021, the patient experienced body aches, chills, fever. On 14Apr2021, the patient experienced burning sensation in her eyes, intense headache, pain in ears, burning sensation in face and lymph nodes. On 15Apr2021, the patient experienced weakness. Calling because she got vaccine on Sunday, 11Apr2021, stated she has been having some reactions, wants to know how long will they last. The next day after the vaccine, she had body aches, chills, and fever. Stated the next day she started out feeling the same and then got a little better, states yesterday 14Apr2021 she had burning sensation in her eyes and lymph nodes and intense headache, stated it's not like a normal headache but it is hard to explain, stated she had pain in her ears, then felt a little better, in the evening yesterday felt the same. Cannot work due to symptoms. Product information: NDC, expiration date and dosage were unknown. Patient stated she does have severe allergies and had her epi pen with her at the time of the vaccination, but everything was fine. No further information provided. Stated previously she did have endometriosis and had ovaries removed, clarifies she actually had 4 total surgeries, had hysterectomy as well, everything prior to vaccine. The patient received acetaminophen and ibuprofen as treatment medication for all the events. Outcome of the event weakness was not recovered, and outcome of remaining events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: weakness; burning sensation in face and lymph nodes; burning sensation in her eyes; intense headache; pain in ears; body aches; Chills; Fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 11Apr2021 (at the age of 40-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included endometriosis, hysterectomy, ovaries removed, surgeries (clarifies she actually had 4 total surgeries), severe allergies (had her epi pen with her at the time of the vaccination but everything was fine). The patient concomitant medication included estradiol (ESTROGEL) cream (applies cream every 2 days, intravaginally) via vaginal route taken for oestrogen replacement therapy (had endometriosis and had ovaries removed last year) from on an unspecified date in Feb2020 and ongoing. On 12Apr2021, the patient experienced body aches, chills, fever. On 14Apr2021, the patient experienced burning sensation in her eyes, intense headache, pain in ears, burning sensation in face and lymph nodes. On 15Apr2021, the patient experienced weakness. Calling because she got vaccine on Sunday, 11Apr2021, stated she has been having some reactions, wants to know how long will they last. The next day after the vaccine, she had body aches, chills, and fever. Stated the next day she started out feeling the same and then got a little better, states yesterday 14Apr2021 she had burning sensation in her eyes and lymph nodes and intense headache, stated it's not like a normal headache but it is hard to explain, stated she had pain in her ears, then felt a little better, in the evening yesterday felt the same. Cannot work due to symptoms. Product information: NDC, expiration date and dosage were unknown. Patient stated she does have severe allergies and had her epi pen with her at the time of the vaccination, but everything was fine. No further information provided. Stated previously she did have endometriosis and had ovaries removed, clarifies she actually had 4 total surgeries, had hysterectomy as well, everything prior to vaccine. The patient received acetaminophen and ibuprofen as treatment medication for all the events. Outcome of the event weakness was not recovered, and outcome of remaining events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Plantar fasciitis, Tenderness
Clinical narrative: plantar fasciitis in his right foot and ankle area; joint pain is very isolated to his right foot and ankle area; right foot and ankle are very tender; having to walk with a limp; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch number EW0162) via an unspecified route of administration, administered in arm left on 13Apr2021 10:45 AM (age at the time of vaccination was 64 years) as dose 1, single for COVID-19 immunisation. The patients medical history included arthritis in all his joints. He received a flu vaccine in Sep2020 or Oct2020. He had a hernia surgery on 29Jan2021, and he was looking at his medical history and the doctor told him he was a healthy guy. He had a family history of cancer and heart disease. The patients concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) and Vitamin B12.The patient experienced no side effects for the first 24 hours. The patient reported about 30 hours afterwards maybe around 4:00-5:00PM the next day on 14Apr2021, tenderness in his right foot and ankle. He had been dealing with a case of plantar fasciitis in his right foot and ankle area that he thought he was over. He experienced the joint pain was very isolated to his right foot and ankle area. It was over a month ago that he had the plantar fasciitis. His doctor had prescribed an anti-inflammatory medicine and he had not been taking that medicine. He reported he and his wife were walking 4-5 miles a day and now he was back up to walking 1-3 miles a day. He was having to walk with a limp because it was so tender. There was none history of all previous immunization with the Pfizer vaccine considered as suspect and no additional administered vaccines, no any vaccine administered on same date with the pfizer vaccine considered as suspect. There was no any vaccine administered prior vaccinations (within 4 weeks) and no adverse event following prior vaccinations. There was no relevant test. The outcome of plantar fasciitis was unknown and other events was not recovered.  No follow-up attempts were needed, information about lot/batch number could not be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus
Clinical narrative: red spots and very itchy on her left arm where she got the vaccine and, on her leg/left arm and then leg and then backside and right arm and mostly in her legs/all over her body; red spots and very itchy on her left arm where she got the vaccine and, on her leg/left arm and then leg and then backside and right arm and mostly in her legs; feels like it was an allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0150, Expiration Date: 30Jul2021 and NDC number was unknown) via an unspecified route of administration, administered in left arm on 06Apr2021 as dose 1, single (at the age of 31-years-old) for COVID-19 immunization. The patient had no medical history and did not receive any concomitant medications. On 12Apr2021 (something strange a week after receiving the vaccine, Monday), patient started a weird reaction, patient had red spots and very itchy on her left arm where she got the vaccine and, on her leg/left arm and then leg and then backside and right arm and mostly in her legs. On 15Apr2021, the red spots bursted out all over her body and patient feels like it was an allergic reaction to the vaccine. Patient wanted to know what to do with her second dose and was she going to get something in the mail saying she should not get it. The outcome of feels like it was an allergic reaction to the vaccine was unknown and recovering for rest both the events.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Neck pain, Vaccination site pain
Clinical narrative: Elbow pain 20 min after injection.; Pain traveled to neck and shoulders; Injection site pain lasted 2 days; Fatigue for 3 days; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). An adult unknown pregnant female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown, Expiry date: not reported) via an unspecified route of administration on 10Apr2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown If the patient was diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, has the patient been tested for COVID-19. On 10Apr2021, the patient experienced elbow pain 20 min after injection, pain travelled to neck and shoulders and then to the site of injection, injection site pain lasted 2 days. Fatigue for 3 days. The reporter assessed the events as non-serious. It was unknown if patient received the treatment for events.: The outcome of the elbow pain 20 min after injection, pain travelled to neck and shoulders was recovered in 2021, for injection site pain lasted 2 days and fatigue for 3 days was recovered in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Epistaxis, Headache, Somnolence
Clinical narrative: headache; sleepiness; arm soreness; occasional nosebleeds; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer (patient) reported for herself. A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient previously took ibrance 125 mg orally on 27Jan2021, for breast cancer for 21 days on and off for 7 days with ongoing and previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an un-specified date as dose 1, single for Covid-19 immunisation. Concomitant medication(s) included letrozole (LETROZOLE). The patient reported that she had some sleepiness, a little headache and arm soreness yesterday on an unspecified date. The patient states she had her Covid 2 vaccination on Tuesday and believes these were side effects from that and had already resolved today. Patient also reports her oncologist had her hold her adjunct therapy of letrozole the past 2 days due to vaccination and was resuming today and she was currently on her 7 days break for her ibrance. previously mentioned, occasional nosebleeds had resolved. no other side effects reported. She reported repeat blood work on Monday. MD unaware of side effects. The outcome of events recovered on unspecified date.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Nausea
Clinical narrative: Nausea; Loss of taste; This is a spontaneous report from Pfizer Sponsored Patient Support Program regulatory authority. A contactable consumer (patient's husband) reported for patient (reporter's wife). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on 10Apr2021, as a DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on 01May2021, as a DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced nausea and loss of taste on an unspecified date. Outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021422131
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Dizziness, Headache, Insomnia
Clinical narrative: Insomnia; Headache; Left Shoulder Pain; a little dizzy; anxiety at night; This is a spontaneous report from a Regulatory Authority via medical information team. A contactable male consumer (patient) reported.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date on 2021, the patient experienced insomnia, headache, left shoulder pain, a little dizzy and anxiety. The 1st week, the patient had insomnia, Headache and left shoulder pain. "He took Naprosyn and the headache went away but he became dizzy." The 2nd week his "headache came back and also dizziness, he went to the doctor and was told he was fine." The patient asked Are these normal side effects and will my shoulder go back to normal "Is the dizziness normal and how long does it last". The patient also asked Can I take pain meds after the 2nd vaccine dose for my shoulder and anxiety at night which will help me sleep" He saw his doctor and doctor told him he was fine. The patient wanted to know if he should still get 2nd dose of vaccine." The patient took Naprosyn as therapeutic measures for event headache. The outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Lip swelling, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: More pronounced swollen lymph nodes in neck; Prominent left side of neck swelling; Rash behind ear and nape of hairline that itches; Rash behind ear and nape of hairline that itches; Swelling on left side of jaw extending to lip and down into neck, like a toothache; Swelling on left side of jaw extending to lip and down into neck, like a toothache; Aching in arm down to hand; Achy muscles on back and behind left breast; Swelling in the left breast that has not gone down; Swelling on left side of jaw extending to lip and down into neck, like a toothache; This is a spontaneous report from a contactable consumer (patient) or other non hcp via Medical Information Team.  A 74-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on 26Mar2021 as dose 1, single  for covid-19 immunization. Medical history included Swollen lymph nodes, patient had swollen lymph nodes for a year and a half or two years from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. On an unspecified date the patient experienced more pronounced swollen lymph nodes in neck, prominent left side of neck swelling, rash behind ear and nape of hairline that itches, swelling on left side of jaw extending to lip and down into neck, like a toothache, swelling on left side of jaw extending to lip and down into neck, like a toothache, aching in arm down to hand, achy muscles on back and behind left breast , swelling in the left breast that has not gone down, swelling on left side of jaw extending to lip and down into neck, like a toothache. Therapeutic measures were taken as a result of rash behind ear and nape of hairline that itches. The outcome of the all events was unknown except for the events Swelling on left side of jaw extending to lip and down into neck, like a toothache, Swelling on left side of jaw extending to lip and down into neck, like a toothache it was recovered on unspecified date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained