chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Lymphadenitis, Pyrexia
Clinical narrative: Temperature was 100 F. at 1:15 PM on 19Mar2021 which increased to a maximum of 101 F. at 3:15 PM on 19Mar2021; slightly tender and inflamed axillary lymph nodes on the left (vaccination side); slightly tender and inflamed axillary lymph nodes on the left (vaccination side); minor chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247, Expiration date: Not reported), via intramuscular route in left arm on 18Mar2021 at 12:30 (at the age of 57-years-old) as dose 2, single for COVID-19 immunization in a workplace clinic. Medical history included sjogren's syndrome. Concomitant medications/other medications the patient received within 2 weeks of vaccination included calcium; chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane (GLUCOSAMINE CHONDROITIN & MSM); hydroxychloroquine sulfate (PLAQUENIL S); vitamin b complex and colecalciferol (VITAMIN D 3). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247, Expiration date: Not reported), via intramuscular route in left arm on 25Feb2021 at 12:30 (at the age of 57-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient's temperature was 100 F at 13:15 on 19Mar2021 which increased to a maximum of 101 F at 15:15 on 19Mar2021 for which paracetamol (TYLENOL) 1000 mg taken once orally at 16:00. Additionally, the patient experienced slightly tender and inflamed axillary lymph nodes on the left (vaccination side), minor chills and fatigue on 19Mar2021. The outcome of these events was recovered in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Temperature was 100 F. at 1:15 PM on 19Mar2021 which increased to a maximum of 101 F. at 3:15 PM on 19Mar2021; slightly tender and inflamed axillary lymph nodes on the left (vaccination side); slightly tender and inflamed axillary lymph nodes on the left (vaccination side); minor chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247, Expiration date: Not reported), via intramuscular route in left arm on 18Mar2021 at 12:30 (at the age of 57-years-old) as dose 2, single for COVID-19 immunization in a workplace clinic. Medical history included sjogren's syndrome. Concomitant medications/other medications the patient received within 2 weeks of vaccination included calcium; chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane (GLUCOSAMINE CHONDROITIN & MSM); hydroxychloroquine sulfate (PLAQUENIL S); vitamin b complex and colecalciferol (VITAMIN D 3). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3247, Expiration date: Not reported), via intramuscular route in left arm on 25Feb2021 at 12:30 (at the age of 57-years-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient's temperature was 100 F at 13:15 on 19Mar2021 which increased to a maximum of 101 F at 15:15 on 19Mar2021 for which paracetamol (TYLENOL) 1000 mg taken once orally at 16:00. Additionally, the patient experienced slightly tender and inflamed axillary lymph nodes on the left (vaccination side), minor chills and fatigue on 19Mar2021. The outcome of these events was recovered in Mar2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus
Clinical narrative: After the 2nd shot, I have got 5 blisters near my hip and my upper left leg on the outside itches as well and it wouldn't be too much concern for me but it is so bad; After the 2nd shot, I have got 5 blisters near my hip and my upper left leg on the outside itches as well and it wouldn't be too much concern for me but it is so bad; This is a spontaneous report from a contactable consumer (patient).  A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization and experienced getting a couple of blisters on leg, near the collar bone and on the back; only 3, they were small little blisters, but they itched terribly. After the second shot, the patient had 5 blisters near the hip and upper left leg: on the outside, itches as well on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Fatigue, Lymphadenopathy, Malaise
Clinical narrative: feels somewhat nauseous; has not been feeling well; feeling feverish- does not have a fever; glands/lymph nodes are swollen; feels ungodly tired; Chills; has not been feeling well/glands/lymph nodes are swollen/feels ungodly tired; This is a spontaneous report from a contactable consumer (patient).   A 79-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EM9810; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Deltoid Left on 22Feb2021 15:30 (at the age of 79-years-old) as dose 2, single for covid-19 immunization.  Medical history included ongoing Systemic Lupus ,it was pretty bad and she had it for quite a few years; caller clarified she has had this for about thirty years. The patient's concomitant medications were not reported.  Patient historical vaccine included BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EN5318; Expiration Date: 31May2021), via an unspecified route of administration, administered in Left shoulder on 28Jan2021 (at the age of 79-years-old) as dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks and no other medications within 2 weeks. Since the vaccination, has the patient has not been tested for COVID-19. Patient was feeling unwell about a week and a half ago around 8Mar2021. She started feeling nauseous about three days ago, around 17Mar2021, and it is about the same. It was reported on 7Mar2021 or 8Mar2021, patient started feeling feverish but with no fever, her glands and lymph nodes were swollen; she started feeling ungodly tired; chills; and feeling unwell and like crap. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: feels somewhat nauseous; has not been feeling well; feeling feverish- does not have a fever; glands/lymph nodes are swollen; feels ungodly tired; Chills; has not been feeling well/glands/lymph nodes are swollen/feels ungodly tired; This is a spontaneous report from a contactable consumer (patient).   A 79-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EM9810; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Deltoid Left on 22Feb2021 15:30 (at the age of 79-years-old) as dose 2, single for covid-19 immunization.  Medical history included ongoing Systemic Lupus ,it was pretty bad and she had it for quite a few years; caller clarified she has had this for about thirty years. The patient's concomitant medications were not reported.  Patient historical vaccine included BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EN5318; Expiration Date: 31May2021), via an unspecified route of administration, administered in Left shoulder on 28Jan2021 (at the age of 79-years-old) as dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks and no other medications within 2 weeks. Since the vaccination, has the patient has not been tested for COVID-19. Patient was feeling unwell about a week and a half ago around 8Mar2021. She started feeling nauseous about three days ago, around 17Mar2021, and it is about the same. It was reported on 7Mar2021 or 8Mar2021, patient started feeling feverish but with no fever, her glands and lymph nodes were swollen; she started feeling ungodly tired; chills; and feeling unwell and like crap. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Joint swelling, Respiratory disorder
Clinical narrative: having trouble with his knee, it's been swelling; upper respiratory dryness; little flare ups here and there; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EJ6796, expiration date was not reported), via an unspecified route of administration, on an unspecified date, at dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included tofacitinib citrate (XELJANZ) from Dec2020 and ongoing; acetylsalicylic acid (ASPIRIN (E.C.)) as a BP medication. The patient previously took prednisone and experienced dryness in his throat and respiratory dryness.  After the vaccination, the patient experienced having trouble with his knee, it's been swelling, upper respiratory dryness, little flare ups here and there (described as flare up of arthritis) on an unspecified date. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: itchy red area at the injection site and a little round like a quarter size; itchy red area at the injection site; itchy red area at the injection site; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number EN6199 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 11Mar2021 10:45 (at the age of 65-year-old), as dose 2, single, for COVID-19 immunisation in hospital. Medical history included breast cancer from May2019 to Dec2019 (Currently in remission). There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number EN6201 and expiry date not reported), via an unspecified route of administration, administered in Arm Left, on 18Feb2021 (at the age of 65-year-old), as dose 1, single, for COVID-19 immunisation in hospital. Patient did not receive any other vaccinations within 4 weeks prior to COVID vaccine. On 18Mar2021 (reported as last night), injection site started itching and she did not look at it because she was in bed and on 19Mar2021 (reported as this morning), when she looked, it was kind of red at the injection site and a little round like a quarter size. Patient wanted to know if it was contraindicated to take Benadryl after receiving the Covid-19 vaccine. The patient did not visit emergency room or physician office due to the events. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; arm sore; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 2, SINGLE for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 21Jan2021, as DOSE 1, SINGLE for covid-19 immunization and experienced, fever, joint pain and armsore. After second vaccine on an unspecified date, the patient experienced fever and arm sore. The outcome of the events was recovered on an unspecified date.  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, Dyspnoea, Headache, Malaise
Clinical narrative: feeling sick; shortness of breath; headache; shoulder pain; This is a spontaneous report from a contactable consumer (patient) received from a Regulatory Authority. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, after received the vaccine, at night, patient started feeling sick, had shortness of breath, headache, and some shoulder pain. The second vaccine had been scheduled for 08Apr2021 and she want to know whether the date could be changed by a day to have a few days off, in case she feels sick again. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Pyrexia
Clinical narrative: started feeling weird like flu like symptoms; chills; fever 102.3; This is a spontaneous report from a Pfizer-sponsored program support received via a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported),  via an unspecified route of administration on 18Mar2021 as dose 2, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient started feeling weird like flu like symptoms with chills and fever 102.3 F. The patient underwent lab tests and procedures which included body temperature: 102.3 fahrenheit on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Tenderness
Clinical narrative: bruise; tenderness on the arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 04Mar2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced bruise and tenderness on the arm. The patient asked if it was a normal process from the vaccine and if she still needs to take the second dose that was scheduled on 25Mar2021. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Pyrexia
Clinical narrative: fever; fatigue; general sickness 6 days post vaccine/illness; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 10Mar2021 (at the age of 55 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if prior to vaccination, was the patient diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. On 16Mar2021 at 20:00 patient experienced fever, fatigue, illness, general sickness 6 days post vaccine. Covid test after post vaccination [covid test type post vaccination=Unknown]: Negative. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment for events. No hospitalization required. The reporter considered events as non-serious. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; body ached; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age (age 71, unit: unknown) 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 included covid-19 from 2020 to an unknown date States had SARs-COV-2 a year ago. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced fever, body ached. He is wondering if the reaction to the vaccine is different for anyone who had Covid in the past. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, SARS-CoV-2 antibody test
Clinical narrative: layed around for a day; joint pain; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6205, expiration date was not reported) via an unspecified route of administration, in left arm, on 05Mar2021 12:03 (at the age of 47-years-old), at dose 2, single for covid-19 immunization from school/student health clinic. Medical history included SARS-CoV-2 Antibody IgG: positive on 08Feb2020 and on 19Aug2020. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9267, expiration date was not reported) via an unspecified route of administration, in left arm, on 12Feb2021 09:45 (at the age of 46-years-old), at dose 1, single for covid-19 immunization and experienced exhaustion, Joint pain (Knees/ Hip) on 13Feb2021 08:00 and recovered without treatment on 15Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. After the second dose of vaccination in Mar2021, the patient layed around for a day and experienced joint pain. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 08Feb2020 and positive on 19Aug2020. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Skin exfoliation
Clinical narrative: skin flaking around hair follicles; mild headache; joint pain; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE BIONTECH, lot number: unknown) via an unknown route of administration in the left arm on 28Feb2021 at 09:15 (at the age of 35-years-old) at dose 1, single for COVID-19 immunization. Medical history included Ehlers Danlos syndrome, POTS (as reported), high blood pressure, CACS (as reported), thoracic outlet syndrome, CFS (as reported), and OA (as reported). The patient was allergic to legumes and neoprene. Concomitant medication included tylenol (PARACETAMOL), ibuprofen, hydroxychloroquine, and meloxicam.  The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since having the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced skin flaking around hair follicles; most noticeably around facial hair occurred last around three days, mild headaches lasted only one day and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events.  The clinical outcome the events was recovered on an unspecified date in 2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Lacrimation increased, Ocular hyperaemia, Vision blurred
Clinical narrative: Watery eyes; Itching and redness in both eyes; Itching and redness in both eyes; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Right, on 18Mar2021 10:00 (at the age of 75-year-old), as dose 2, single, for COVID-19 immunisation in public Health Clinic. Medical history included sulfonamide allergy. There were no concomitant medications. The patient previously took cipro and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 20Mar2021 at 09:00, the patient experienced watery eyes, itching and redness in both eyes and blurred vision. The patient took over the counter eyedrops as a therapeutic measure and by Tuesday (23Mar2021) vision was restored to normal. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the event blurred vision was recovered on 23Mar2021 while that of watery eyes, itching and redness in both eyes was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021332195 Same reporter/ drug /AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Pyrexia, Sleep disorder
Clinical narrative: Felling dizzy; Fever; She has not slept all night; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Mar2021 10:45 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, she has not slept all night on 21Mar2021, felling dizzy on 22Mar2021. Reported as, reporter and his wife both had a Pfizer shot yesterday (21Mar2021) around 10:45 in the morning and she came down with fever last night 10:30-11:00 o clock and she has not slept all night and she has a fever all night and also she was dizzy this morning. Still has a fever, fever was 102 degree. she have a reaction to a shot. The patient underwent lab tests and procedures which included body temperature: 102 degree on 22Mar2021. Outcome of the event fever was not resolved and unknown for other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Pruritus, Urticaria
Clinical narrative: itching; hives; inflammation of skin after scratching; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: not reported) via an unspecified route of administration in the left arm on 15Mar2021 at 10:45 (at the age of 33-years-old) as a single dose for COVID-19 immunization.  Medical history included obesity.  The patient's concomitant medications were not reported.  Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19. On 16March2021, after 24hrs of vaccination the patient experienced non-severe allergic reaction, such as itching, hives and inflammation of skin after scratching, lasted 4 days, stopped for two days, then reoccurred. Patient did not receive any treatment for the events. The clinical outcome of the events of itching, hives and inflammation of skin was not recovered at the time of this report.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash on stomach and back.; This is a spontaneous report from a contactable nurse. A 32-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 32-year-old), as dose number unknown, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included depression and seasonal allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 19Mar2021, the patient experienced pruritic rash on stomach and back. The event was resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures included prednisone for the reported event. The outcome of pruritic rash on stomach and back was resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid pain, Swelling of eyelid
Clinical narrative: eyelids swelling; eyelids swelling and becoming painful; This is a spontaneous report from a contactable other health professional.  A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE at the age of 55-year-old for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient started having a reaction of her eyelids swelling and becoming painful and she says she lost her memory. She says that this all started around the time she got her COVID vaccine. She says the memory loss started just before the vaccine and the swollen eyelids was after the vaccine. The outcome of the events was recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: hives all over face and body; This is a spontaneous report from a contactable other hcp. A patient of unspecified age and gender 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 an unspecified date as unknown, single for COVID-19 immunisation. hyaluronic acid (RESTYLANE), route of administration, start and stop date for an unspecified indication. Medical history and concomitant medications were not reported.The patient experienced at first didnt disclose the she took the covid-19 vaccine, SB patient came in 3 days post injection of Restylane Kysse in lips with hives all over face and body. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Removed at risk classification, and event "at first didnt disclose the she took the Covid-19 vaccine".
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Influenza like illness, Myalgia
Clinical narrative: Flu-like symptoms; muscles, joints and bones all had high levels of pain; muscles, joints and bones all had high levels of pain; muscles, joints and bones all had high levels of pain; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (at the age of 74-years-old) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) via an unspecified route of administration in left arm on 26Jan2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization. Medical history included pneumonia (had pneumonia three times as an adult, pneumonia shots 3 to 4 times), Chickenpox (Immunized as a child for chicken pox), Shingles (Two shingles shots), atrial fibrillation, fatty liver, hardening of the arteries, Chronic kidney disease stage 3, Smoker (At least one pack per day for 53 plus years), Mumps (Immunized as a child for mumps), measles (Immunized as a child for measles) and Statins allergy. Concomitant medications included atenolol; rivaroxaban (XARELTO); escitalopram; lamotrigine; omeprazole (LOSAR). The patient previously took Dimetapp and experienced drug allergy, niacin, and experienced drug allergy. Historical vaccine included Flu vaccine for influenza immunization (annual flu shot for at least 25 plus years). Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any vaccines within four weeks. The patient experienced flu-like symptoms and muscles, joints, and bones all had high levels of pain on an unspecified date, within 12 hours receiving the first shot. On 27Jan2021, the patient also experienced same events after receiving second shot. Patient received treatment with tramadol and Tylenol. The treatment alleviated only the intensity a bit, within 12 hours of onset; the pains disappeared, and his body returned to normal levels of pain. The patient had no other symptoms, no headaches, nausea, and tremors. The clinical outcome of flu-like symptoms, joints pain and bones all had high levels of pain were recovered within 12 hours. Outcome of all events was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Arthritis pain; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arthritis pain after 10 days of vaccination and for 6 days the HCP put her on methylprednisone. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity, Pruritus, Rash macular
Clinical narrative: started feeling upper arm aching/ left arm is still hurting; started feeling upper arm and shoulder aching; loss of range of motion; Itching; red and purple dots all over his; red and purple dots all over his; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 29Jan2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Feb2021, he started itching, red and purple dots all over his body. He was advised by his healthcare professional (HCP) to take Benadryl as treatment which took care of the symptoms. A week later, on 05Feb2021 he started feeling upper arm and shoulder aching and loss of range of motion. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 26Feb2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. His left arm was still hurting on the day of reporting. The patient was wondering if maybe the first dose wasn't effective and if he should get a third vaccine. The outcome of pain in arm was not recovered and outcome of all other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: started feeling upper arm aching/ left arm is still hurting; started feeling upper arm and shoulder aching; loss of range of motion; Itching; red and purple dots all over his; red and purple dots all over his; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 29Jan2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Feb2021, he started itching, red and purple dots all over his body. He was advised by his healthcare professional (HCP) to take Benadryl as treatment which took care of the symptoms. A week later, on 05Feb2021 he started feeling upper arm and shoulder aching and loss of range of motion. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 26Feb2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. His left arm was still hurting on the day of reporting. The patient was wondering if maybe the first dose wasn't effective and if he should get a third vaccine. The outcome of pain in arm was not recovered and outcome of all other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; body aches; This is a spontaneous report from a contactable consumer. This female consumer of an unspecified age reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208; Expiration Date: Jun2021, NDC Number: not provided), via an unspecified route of administration on 15Mar2021 at 11:15 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation assessment was not provided. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiration Date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunisation. The patient had a few side effects following the Covid-19 vaccine but that they occurred on 16Mar2021 at 01:15 (14 hours later after receiving the vaccine). Caller did not provide details of the side effects she experienced. The patient and her husband vaccinated the same day, the same schedule - quarantine. She mentioned that the she received the same lot/batch numbers as her husband, but she was otherwise fine. The patient experienced fever and body aches on an unspecified date and resolved within 2 day. It was spoken from information available in fact sheet that the frequencies for fever and muscle pain are from the 7 days following either dose of vaccine. Provided information on duration of injection site reaction the mean duration of pain at the injection site after dose 2 was 2.5 days (range 1 to 36 days) [LAB-1457-6.0; Revised: 25 February 2021]. Directed caller to back to HCP for treatment recommendations.The outcome of events was recovered on 18Mar2021 at 01:15.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: lip swelling; tongue swelling; This is a spontaneous report from a contactable pharmacist via Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported) via an unspecified route of administration on an unspecified date, as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after 3 weeks of vaccination, the patient experienced lip swelling and tongue swelling. The outcome of the events was unknown at time of report. The reporter didn't think that was part of the vaccine since it had been 3 weeks, but he wanted to make sure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low-grade fever; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable Male consumer (Patient) reported that:  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on 18Mar2021, as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on 25Feb2021, as a dose 1, single for COVID-19 immunization. On 19Mar2021, the patient experiences a low-grade fever. Outcome of the event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Body Aches; Fever; Mild Fatigue; This is a spontaneous report from a contactable nurse.   A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), intramuscular, administered in Right arm on 12Feb2021 11:00 (at the age of 69 year old) as dose 2, single for COVID-19 immunisation.  Medical history included latex allergy.  The patient's concomitant medications were reported as none.  Prior vaccination, the patient did not receive any other vaccines within 4 weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN3248, intramuscular, in right arm, on 15Jan2021 12:00, as single dose for COVID-19 immunization and the patient had mild sore arm; that started hurting a little bit more, and got the flu like body aches, with temperature 100 (low grade fever), and rash on chest that lasted 5 days and had fatigue. On an unspecified date, within 24 hours, the patient experienced slight body aches, mild fatigue for a day, and fever. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Headache
Clinical narrative: Headache; flushed cheeks and nose; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced Headache flushed cheeks and nose after vaccination.  The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 81-year) on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On an unspecified date the patient experienced fever, and chills. It was reported that patient stated that she got her 2nd COVID-19 vaccine, and she had some fever and chills, but she was feeling better on the day of reporting from it. The clinical outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Nausea, Pain
Clinical narrative: Headaches; chills; nausea; pain; lack of appetite; fever; This is a spontaneous report from a contactable consumer (patient) via  Sales Representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced headaches, chills, nausea, pain, lack of appetite and fever. The outcome of the events was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headaches; chills; nausea; pain; lack of appetite; fever; This is a spontaneous report from a contactable consumer (patient) via  Sales Representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced headaches, chills, nausea, pain, lack of appetite and fever. The outcome of the events was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 12Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the consumer stated that, after a few days she got fever, and she was asking if having a fever is a side effect of the covid vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (lot number not reported), as dose 1, single, for COVID-19 immunisation. Relevant medical history included seasonal allergies, cough (typically develops a cough around this time of year), osteoporosis and overweight, all from unknown dates, not reported if ongoing or not. Concomitant medications were not reported. On an unspecified date, 2 days after the first vaccination, the patient developed cough. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; headache; super tired; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date 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 the second day of vaccination, the patient experienced fever, chills, body aches, headache, super tired and took a one-hour nap at lunch and again at 7PM. On day 3, the patient had fever, chills, and nap one hour nap at 6PM. On the same day, the patient was perfectly fine, all back to normal. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: massive fever; was sick as a dog; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Formulation: solution for injection, Lot number was not reported, expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced massive fever and was sick as a dog. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.