chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I was broke out, all over my body; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9267, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was trying to report the side effect, the patient was told to do so by emergency room, the Pfizer Covid Shot the patient had on friday and a hour and half later the patient had to go the emergency, the patient was broke out, all over her body and they told the patient to call the hotline and ask if the patient should get the second shot. The adverse event resulted in emergency room visit. Outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: My vision was fuzzy/One of my co-workers also had this happen to her.; This is a spontaneous report from a contactable other healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 03Feb2021 15:30 (Batch/Lot Number: EL9264) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Right on 14Jan2021 14:30 (Batch/Lot Number: EL3248) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included hypertension and concomitant medications were not reported. Known allergies to sulfa drugs, z pak. The patient experienced visual changes, her vision was fuzzy for a few days after receiving first and second dose of vaccine. First dose it was 2 days before vision was back to normal. After second dose, it was on the 4th day when her vision was back to normal. It took about 3-4 days before she was able to focus her vision like normal. She is normally near sighted and wear glasses. Her vision has now returned to normal. One of her co-workers also had this happen to her on an unspecified date with outcome of unknown.    Information on the lot batch number has been requested  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Under my armpit is swollen and it is a little, like it is sore; Like my lymph node area, that is what it feels like; This is a spontaneous report from a contactable consumer or other non hcp. A 48-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection (Batch/Lot Number: EN8200; Expiration Date: 30Jun2021), via an unspecified route of administration on 17Feb2021 as first dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced under my armpit is swollen and it is a little, like it is sore; like my lymph node area, that is what it feels like. The outcome of the event was unknown.   Information on lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported; expiration number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm soreness for about a day, but that was it. The outcome of the event was reported as unknown.  Information of lot number was requested. Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021213475 Same reporter/ drug/ event for different patients
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Product administered at inappropriate site
Clinical narrative: Migraine Headache; Vaccine location: Left Leg; This is a spontaneous report from a contactable nurse (patient herself). A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, in left leg on 20Feb2021 as dose 2, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Historical vaccine included first dose of BNT162B2 via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included migraine from an unspecified date and unknown if ongoing. Patient had no known allergies. Concomitant medication included Excedrin, taken for unspecified indication, start and stop date not reported, taken in two weeks. Other vaccine same date as dose number 2 of Pfizer vaccine, was administered in left arm. On 21Feb2021 12: 00 AM, patient experienced migraine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Treatment was received for the adverse event with Excedrin. The outcome of event was recovering.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Expanding redness on injection site with itching; Expanding redness on injection site with itching; This is a spontaneous report from a contactable consumer (patient). An 81-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EN6301, expiry date: unknown), via an unspecified route of administration, administered in Left arm on 16Feb2021 16:00 PM as DOSE 2, SINGLE for COVID-19 immunisation (age at vaccination: 81-years-old, non-pregnant at the time of vaccination). Medical history included coronary artery disease, hypertension, arthritis, fibromyalgia, hypothyroidism, blood cholesterol abnormal, drug hypersensitivity, and known allergies: sulfa. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EL9262, expiry date: unknown) on 28Jan2021 16:00 PM via unspecified route of administration in left arm as DOSE 1, SINGLE, for covid-19 immunization. She had not received any other vaccines in 4 weeks and, other medicines in two weeks before the vaccination. Not tested covid positive prior or post vaccination. On 19Feb2021, the patient experienced expanding redness on injection site with itching. She did not receive any treatment for the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of unspecified age reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient wanted to know if the location she got her first dose of the covid vaccine would still be giving the vaccine today due to past week of bad weather. Also wanted to know if patient would be able to take her second dose of the covid vaccine due to her having a cold due to bad weather on an unspecified date. Clarified that the patient did not have any side effects from her first dose of the covid vaccine. Faxing due to having a cold symptom after receiving the first vaccine. Outcome of the event was unknown.  Information about lot/Batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: unexpected benefit of the Pfizer COVID-19 BNT162b2 vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient reported for herself). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264; Expiration Date: May2021), first dose via an unspecified route of administration on 09Feb2021 (at the age of A 73-year-old) as dose 1, single for COVID-19 immunisation. Medical history included cough from 26Nov2020 to 09Feb2021, sinusitis from an unknown date and unknown if ongoing and always had had sinus issues that resulted in more postnasal drainage. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced unexpected benefit of the Pfizer covid-19 bnt162b2 vaccine. It was reported that, wanted to let you know there may be a serendipitous benefit to your vaccine that you can make use of to cure upper respiratory conditions. And said this in all seriousness because it cured her. Starting 3 months ago, right around Thanksgiving, she developed a very significant upper respiratory cough. She always had had sinus issues that resulted in more postnasal drainage than most people, and it was around the same time she turned on her house's heating system, and found her whole house humidifier had stopped working, Because of COVID, she did not want HVAC workers in the house, so she figured she should live without the humidifier this winter. The heat was extremely dry, and she assumed that the dryness, plus her chronic sinus issue and intermittent reflux was making her cough a lot. It seemed to come from the throat, and never from the chest. This continued every day from Thanksgiving till 09Feb2021, without any other symptoms. It did not seem to get any better or any worse, but for 2.5 months she was coughing so much on the phone with people that they were always telling her she must have Covid. But she had no other symptoms at all. Then, on 09Feb2021, I had my first Pfizer Covid vaccination, and miraculously, a couple of days later the coughing completely stopped. It did not taper down over several days; it just stopped. It was now 12 days since her shot and her cough has not returned. So, in addition to thanking, you for the vaccine, she wants to add her very sincere gratitude for stopping her cough. she thought you might not know about this benefit, but perhaps there was something in the vaccine that she stumbled on that could be isolated and used to treat coughs or other upper respiratory conditions. She had no symptoms after the shot and was scheduled for the second dose on 02Mar2021 at PRIVACY where she also had the first one. The outcome of the event was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen hand and it is the opposite arm; This is a spontaneous report from a contactable consumer (primary consumer-husband and secondary consumer-wife). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 20feb2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date in Feb2021, patient experienced swollen hand and it is the opposite arm. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report from a non-contactable consumer. This 50-year-old female consumer (patient) reported. A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Feb2021, the patient experienced injection site pain. The patient did not receive any treatment. Outcome of the event was not recovered, at the time of this report. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild soreness in left are at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: el3247), via an unspecified route of administration in left arm on 23Feb2021 at 14:15 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation at workplace clinic. Medical history and concomitant medications were not reported. The patient had known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild soreness in left are at injection site on 23Feb2021 at 20:00 with outcome of recovering. The patient did not receive any treatment for the events. The outcome of the event was reported as resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination complication
Clinical narrative: vaccine reaction; full body rash; hives; itching; This is a spontaneous report from a contactable other hcp (medical assistant calling on behalf of the nurse practitioner).   A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported; Expiry Date: unknown) via an unspecified route of administration on 19Feb2021 (at the age of 35-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No investigation assessment was provided. Two days after the second dose of vaccine, on 21Feb2021, the patient began having a full body rash, hives, itching and vaccine reaction. Therapeutic measures were taken as a result of full body rash, hives, itching and vaccine reaction. The patient was placed on 5 days of steroids which were completed on Saturday (27Feb2021) but he was still having a full body rash and was itchy and uncomfortable, the patient received IV famotidine and dexamethasone. The outcome of the events full body rash, hives and itching was not recovered. The outcome of the event vaccine reaction was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Rhinorrhoea
Clinical narrative: very bad runny nose; fever of 100°F-101°F; This is a spontaneous report from a Pfizer-sponsored program. A contactable 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Mar2021, patient began to experience a "very bad runny nose" and a fever of 100 degree F-101 degree F. She reports the symptoms are getting better but still persisting. She was concerned if that was a potential side effect or she needs to get tested for covid. On 05Mar2021, the patient underwent lab tests and procedures which included body temperature resulting 100 degree F-101 degree F. Outcome of the events were recovering/resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash on upper back area, behind ears and itching down left arm; rash on upper back area, behind ears and itching down left arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Mar2021 at 15:30 (Batch/Lot number was not reported; at the age of 54 years old) as dose 1, single for COVID-19 immunisation.  Medical history included asthma, prediabetes, and Penicillin allergy. Concomitant medications included fluticasone propionate (FLOVENT HFA) and hydrochlorothiazide. No other vaccine in four weeks. The patient experienced rash on upper back area, behind ears and itching down left arm on 04Mar2021 at 06:30 AM. The patient did not receive treatment for the events. No history of COVID prior to vaccination and has not been tested for COVID post vaccination. The patient is recovering from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pyrexia, Skin tightness, Swelling face
Clinical narrative: Face felt tight; Face felt tight, possibly slightly swollen; Slight redness in face; Was exhausted, fatigue; fever; This is a spontaneous report from a contactable consumer (patient, self-reported). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 27Feb2021 at 11:00 AM, as a single dose for COVID-19 immunization. The patient's medical history included allergies to pollen, grass, trees, mild allergy to wheat. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 27Feb2021 at 11:00 AM, the patient experienced face felt tight, possibly slightly swollen, slight redness in face, was exhausted, fatigue and possibly slight fever for 3 days following vaccination. All symptoms subsided after 72 hours. The patient received on sight EMT administered Benadryl as treatment for the events. Outcome of the events was recovered on 02Mar2021 at 11:00.  No follow-up attempts are possible; information about lot/batch number cannot be obtaine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in left arm on 03Mar2021 11:30 (at the age of 50 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma and pseudo tumor cerebi. The patient is not pregnant at the time of vaccination. Concomitant medications included azithromycin and prednisone. The patient did not receive other vaccine in four weeks and had no COVID prior to vaccination. The patient experienced itching all over on 03Mar2021 11:30. No treatment was given in response to the event. The patient was not tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Rash, Vaccination site pain
Clinical narrative: Headache; Some soreness on injection site; Temporary rash on front shoulders; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 01Mar2021 at 03:45 PM (15:45) (at the age of 45 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included allergies to certain foods and over the counter (OTC) medications; and antibiotics. The patient's concomitant medications included unspecified antibiotics. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 01Mar2021 at 07:15 PM, the patient experienced only a slight headache but very brief, some soreness on injection site for 1 day, and had temporary rash on front shoulders after shower but then it goes away. The patient was not sure if it's related. No treatment was received for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Some soreness on injection site" on 02Mar2021; and from the remaining events in Mar2021.   No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain in left hip; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in the left arm on 04Mar2021, at 14:00 (at the age of 86 years old) as dose 1, single for COVID-19 immunisation. Medical history included known allergies: crab, spinal stenosis, arthritis, and high blood pressure. The patient was not pregnant. Concomitant medications included quinapril, amlodipine, and tramadol. She did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Mar2021, at 16:00, the patient experienced joint pain in left hip. The patient was not diagnosed with COVID-19 prior to vaccination and she has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the event. The patient was recovering from joint pain in left hip.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Rash
Clinical narrative: Chills; Bad headache; Rash on her armpits and back of her neck; Lethargic; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9269), via an unspecified route of administration in left arm, on 10Feb2021 at 01:45 PM (13:45) (at the age of 69 years), as dose 2, single, for COVID-19 immunization. The patient's medical history included rheumatoid and osteoarthritis. The patient's concomitant medications included unspecified medications. The patient previously received the first dose of BNT162B2 (Lot Number: EL9262) on 20Jan2021 at 10:45 AM (at the age of 69 years) for COVID-19 immunization with no reaction at all (right arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a public health clinic or Veterans administration facility. On 11Feb2021 at 01:00 AM, the patient experienced 4 to 5 hours of chills during the night with a bad headache. On the next morning (11Feb2021), the patient had a rash on her armpits and back of her neck (chills and headache were gone) and she was lethargic all day. The patient went to work the next day. The patient was administered with the vaccine on a Wednesday (10Feb2021) and she was back to work on Friday (12Feb2021). No treatment was received for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Chills" and "Bad headache" on 11Feb2021 (unspecified time); and from the remaining events in Feb2021.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Migraine, Nausea, Pain
Clinical narrative: Severe migraine; body aches; fever; vomiting; diarrhea; nausea; exhaustion/ unable to leave bed; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6203), via an unspecified route of administration, administered in the left arm on 26Feb2021, at 11:30 (at the age of 45 years old) as dose 1, single for COVID-19 immunisation. The patient has no known allergies and other medical history. She was not pregnant at the time of report. She was not tested for COVID-19 prior to vaccination. The patient's concomitant medications were not reported. She did not receive any other vaccines within four weeks prior to the COVID vaccine and other medications in two weeks before the vaccination. On 27Feb2021, at 00:00, the patient experienced severe migraine, body aches, fever, vomiting, diarrhea, nausea, exhaustion, and unable to leave bed. The patient underwent lab tests and procedures which included nasal swab: negative on 28Feb2021. No therapeutic measures were taken as a result of the events. The patient recovered from the evens on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Severe migraine; body aches; fever; vomiting; diarrhea; nausea; exhaustion/ unable to leave bed; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6203), via an unspecified route of administration, administered in the left arm on 26Feb2021, at 11:30 (at the age of 45 years old) as dose 1, single for COVID-19 immunisation. The patient has no known allergies and other medical history. She was not pregnant at the time of report. She was not tested for COVID-19 prior to vaccination. The patient's concomitant medications were not reported. She did not receive any other vaccines within four weeks prior to the COVID vaccine and other medications in two weeks before the vaccination. On 27Feb2021, at 00:00, the patient experienced severe migraine, body aches, fever, vomiting, diarrhea, nausea, exhaustion, and unable to leave bed. The patient underwent lab tests and procedures which included nasal swab: negative on 28Feb2021. No therapeutic measures were taken as a result of the events. The patient recovered from the evens on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: tiredness; headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in the right arm on 05Mar2021, at 16:30 (at the age of 72 years old) as dose 1, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), failed back surgery, arthritis, and atherosclerotic cardiovascular disease (ASCVD). The patient has no known allergies. He did not receive other vaccines in four weeks before vaccination. The patient received other medications in two weeks prior to vaccination and he reported that they are too many to name. On 07Mar2021, at 18:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell. The patient was not diagnosed with COVID-19 prior to vaccination and he has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the events. The patient has not recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: tiredness; headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in the right arm on 05Mar2021, at 16:30 (at the age of 72 years old) as dose 1, single for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), failed back surgery, arthritis, and atherosclerotic cardiovascular disease (ASCVD). The patient has no known allergies. He did not receive other vaccines in four weeks before vaccination. The patient received other medications in two weeks prior to vaccination and he reported that they are too many to name. On 07Mar2021, at 18:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell. The patient was not diagnosed with COVID-19 prior to vaccination and he has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of the events. The patient has not recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Headache
Clinical narrative: Headache; Elevated temperatures; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in right arm, on 06Mar2021 at 12:00 PM (at the age of 32 years), as dose 1, single, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 07Mar2021 at 12:00 AM, the patient experienced headache, elevated temperatures, and joint pain. No treatment was received for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from the events in Mar2021.   No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Insomnia
Clinical narrative: severe headache; body aches; could not sleep; chills; dizziness; fever up to 104 Fahrenheit; This is a spontaneous report from a contactable nurse (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 13Jan2021 (Lot Number: EL3302; at the age of 21 years old) as dose 2, single for COVID-19 immunisation. Medical history included mononucleus on an unspecified date in 2017. The patient has no known allergies. She was not pregnant and she was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included spironolactone. She did not receive any other vaccines within four weeks prior to vaccination. The patient previously received the first dose of BNT162B2, administered in the left arm on 23Dec2020 (Lot Number: ENJ1685; at the age of 21 years old) for COVID-19 immunisation. About 12 hours after injection (on 13Jan2021, at 21:00), the patient got a severe headache, body aches, could not sleep, chills, dizziness, and fever up to 104 Fahrenheit. It was reported that the symptoms lasted for about 24 hours. The patient underwent lab tests and procedures which included body temperature: up to 104 Fahrenheit on 13Jan2021; and nasal swab, COVID test: negative on an unspecified date in 2021. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: severe headache; body aches; could not sleep; chills; dizziness; fever up to 104 Fahrenheit; This is a spontaneous report from a contactable nurse (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 13Jan2021 (Lot Number: EL3302; at the age of 21 years old) as dose 2, single for COVID-19 immunisation. Medical history included mononucleus on an unspecified date in 2017. The patient has no known allergies. She was not pregnant and she was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included spironolactone. She did not receive any other vaccines within four weeks prior to vaccination. The patient previously received the first dose of BNT162B2, administered in the left arm on 23Dec2020 (Lot Number: ENJ1685; at the age of 21 years old) for COVID-19 immunisation. About 12 hours after injection (on 13Jan2021, at 21:00), the patient got a severe headache, body aches, could not sleep, chills, dizziness, and fever up to 104 Fahrenheit. It was reported that the symptoms lasted for about 24 hours. The patient underwent lab tests and procedures which included body temperature: up to 104 Fahrenheit on 13Jan2021; and nasal swab, COVID test: negative on an unspecified date in 2021. The patient recovered from the events on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Headache, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration and administered in the right arm on 05Mar2021 at 11:00 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient had no known allergies. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. On 06Mar2021 at 09:30 the patient experienced Chills (Freezing), Low grade temperature, Body aches, Headache and Muscle aches. The patient did not receive treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration and administered in the right arm on 05Mar2021 at 11:00 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient had no known allergies. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. On 06Mar2021 at 09:30 the patient experienced Chills (Freezing), Low grade temperature, Body aches, Headache and Muscle aches. The patient did not receive treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Nausea, Nervousness
Clinical narrative: Headache; Right neck got stiff; Felt shaky; Felt little nauseous; Itchy all over; Tired; This is a spontaneous report from a contactable consumer (patient's sibling). A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 06Mar2021 (at the age of 53 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included allergies to sulpha. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. The patient was a little nervous about getting her second shot due to experienced adverse events. Probably will take off. Immediately after vaccination (06Mar2021), the patient got a headache and right neck got stiff and felt shaky. Within 15 minutes (06Mar2021), the patient felt little nauseous. The patient didn't get rash but after a few hours (06Mar2021), she started feeling itchy all over and tired. The patient also indicated that she feels fine today (08Mar2021). No treatment was received for the adverse events. The patient recovered from the events in Mar2021.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Headache; Right neck got stiff; Felt shaky; Felt little nauseous; Itchy all over; Tired; This is a spontaneous report from a contactable consumer (patient's sibling). A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 06Mar2021 (at the age of 53 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included allergies to sulpha. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. The patient was a little nervous about getting her second shot due to experienced adverse events. Probably will take off. Immediately after vaccination (06Mar2021), the patient got a headache and right neck got stiff and felt shaky. Within 15 minutes (06Mar2021), the patient felt little nauseous. The patient didn't get rash but after a few hours (06Mar2021), she started feeling itchy all over and tired. The patient also indicated that she feels fine today (08Mar2021). No treatment was received for the adverse events. The patient recovered from the events in Mar2021.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: pain around his lower waist, by his hips; pain around his lower waist, by his hips/couldn't move his hips due to the pain; This is a spontaneous report from a contactable consumer and a Non- contactable Nurse. These two reported similar events for 2 patients. This is 2nd of 2 reports. These two reported for a male patient that:  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain around his lower waist, by his hips, couldn't move his hips due to the pain. Stated that she only had a sore arm. His physical therapist came that day and he was fine. On Wednesday, he could not hardly stand the pain around his lower waist, by his hips and could not move his hips due to the pain, and he just hollers when he tried to move them. Caller states that he has fought 2 injuries since Jul2020. He broke his left leg, and then broke his right leg up by where the bone connects to the hip. So, he had been in therapy. States that he was in a rest home for 3 months and he has been home for 4 months. Patient home physical therapy and a home care nurse that comes. At first they thought that the pain may have just been from the physical therapy on Wednesday, but when the in home nurse came on Thursday, she said that therapy wouldn't have done that and she thought it was a side effect of the vaccine. The nurse also said that her dad complained of the same thing after getting the vaccine. The clinical outcome of events were unknown.   No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021244776 same reporter/drug/event, different patient
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This is a spontaneous report from a contactable other health care professional (patient). A 88-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 88-years), administered in arm left on 25Feb2021 as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism (Caller was diagnosed when she was 18 years old), high blood pressure (Caller was diagnosed in her 50s) and covid-19 from Nov2020 to an unknown date. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism as 0.150mg once daily by mouth, lisinopril (LISINOPRIL) taken for hypertension as 10mg once daily by mouth, start and stop date were not reported. The patient was taking the other products. On an unspecified date, the patient experienced hair loss. It was further stated that she was calling regarding the Pfizer BioNTech COVID Vaccine. She was having a side effect she would like to report. She stated that she did have COVID in the middle of Nov2020, but she got her first shot of the vaccine two weeks ago, and she is having hair loss. She was wondering if this is a side effect of the product. She stated that she noticed there might have been some hair loss in with the COVID Virus, when she had that back in Nov2020, but there was more with this. She had the COVID vaccine two weeks ago, and she started noticing she was having to take hair out of her brush more, and today, she went to the hairdresser and the hairdresser noticed it as well. She stated that it was just a concern of hers, that it will get worse with the second shot. The patient was taking Pfizer BioN-Tech COVID Vaccine because her doctor told her to. She stated that the lot number on her card was covered with a sticker saying Pfizer BioNTech. She wanted to know if hair loss is a reported AE associated with the Pfizer COVID-19 vaccine. If it is, how often is it reported. She had a prior COVID-19 infection and is experiencing hair loss after the first dose of the Pfizer COVID-19 vaccine. She mentioned that she had heard other people who are having this adverse event. Her friend saw on TV that a per-son was having clumps of her hair were coming out after having the COVID-19 vaccine but she was not sure which vaccine the news is pertaining to. She wanted to know if she should get the second dose of the vaccine considering her AE. Considering she had prior COIVD-19 infection and got the first dose of the Pfizer COVID-19 vaccine, how much is the protection. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. The clinical outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: knot and redness at the injection site (right arm); knot and redness at the injection site (right arm); It was extremely itchy; required icing to bring down the swelling and to make it feel less hot.; required icing to bring down the swelling and to make it feel less hot.; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on an unspecified date in Feb2021 (Batch/Lot Number: EN6198), at the age of 68 years old, as dose 2, single for covid-19 immunisation. Medical history included Type II diabetes, known allergies: sulpha drugs, shellfish. No COVID prior to vaccination and was not tested for COVID post vaccination. The patient's concomitant medications were not reported. No other vaccines in four weeks. The patient previously received dose 1 of BNT162B2 administered in left arm in Feb2021 10:45, at the age of 68 years old, for covid-19 immunisation, codeine and experienced allergy/bad reaction. On an unspecified date in Feb2021, the patient had a knot and redness at the injection site (right arm), which lasted for a week. It was extremely itchy and required icing to bring down the swelling and to make it feel less hot. The patient recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising on calf of left leg; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 14:15 (at the age of 44-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. 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. The patient experienced bruising on calf of left leg on 08Mar2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient received no treatment for the event. The outcome of the event was not recovered.    No follow-up attempts are needed. No further information is expected.