chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Wound
Clinical narrative: Skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already.; Skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already.; Skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: ER8732) as dose 1, single and administration date 20Apr2021 (Lot number: EW0161) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), RASH (non-serious), WOUND (non-serious) all with onset 2021, outcome "not recovered" and all described as "Skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already.". The event "skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already.", "skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already." and "skin start to have rash and very itchy, and then have open wound over the rash and that would not heal for over 8 months already." was evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus, rash, wound.  Additional information:The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient was treated with Medicine and skin cream for the adverse event.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles".  Additional information: Customer Verbatim: Dear Pfizer Company, I have received your developed Covid-19 vaccine, and want to start by saying thank you for developing a vaccine that can save lives including my own. Side effects were a nuisance, including possibly contributing to shingles. I am overall glad the vaccine gives good protection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at injection site; Slight fever / fever (100.1 F); General fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2021 15:30 (Lot number: FK5127) at the age of 9 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 01Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), when the patient was 9 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Dec2021, outcome "recovered" (03Dec2021), described as "Soreness at injection site"; PYREXIA (non-serious) with onset 02Dec2021, outcome "recovered" (03Dec2021), described as "Slight fever / fever (100.1 F)"; FATIGUE (non-serious) with onset 02Dec2021, outcome "recovered" (03Dec2021), described as "General fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, pyrexia, fatigue.  Additional information: 18 hours after second shot, Patient woke up with soreness at injection site and slight fever. Was sent home from school 20 hours after 2nd injection with fever (100.1 F) and general fatigue. Fever and symptoms resolved by the following morning. Patient had no covid prior vaccination. Patient had no covid tested post vaccination. Patient had no Known allergies. The patient had received other vaccines within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lichen planopilaris, SARS-CoV-2 test
Clinical narrative: Abrupt onset of lichen planopilaris (frontal fibrosing variant); This is a spontaneous report received from a contactable reporter(s) (Physician). A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Dec2020 19:15 (Lot number: EJ1685) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune thyroid disease" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN XL. The following information was reported: LICHEN PLANOPILARIS (non-serious) with onset 06Jan2021, outcome "not recovered", described as "Abrupt onset of lichen planopilaris (frontal fibrosing variant)". The event "abrupt onset of lichen planopilaris (frontal fibrosing variant)" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lichen planopilaris.  Additional information: No other vaccine received in four weeks. The patient received treatment with intralesional triamcinolone, hydroxychloroquine, dutasteride, mycophenolate mofetil, clobetasol, tac. No covid prior vaccination and tested for covid post vaccination. No Known allergies.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I had rash on my both hands, they are not itchy but it just appears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administration date 24Nov2021 (Lot number: FF2590, Expiration Date: 30Dec2021) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "I had rash on my both hands, they are not itchy but it just appears". Therapeutic measures were not taken as a result of rash. Additional information:She had a question about the Pfizer booster, about the side effect.  So, after one week of getting Pfizer booster, she had rash on her both hands, they are not itchy, but it just appears, like clearly. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling cold, Muscle twitching, Tremor
Clinical narrative: woke freezing to the core; twitching and her arms were flopping in and out; head was shaking back and forth; breathing was auditory but she could get air; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose), for COVID-19 immunization. The following information was reported: FEELING COLD (non-serious), outcome "unknown", described as "woke freezing to the core"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching and her arms were flopping in and out"; TREMOR (non-serious), outcome "unknown", described as "head was shaking back and forth"; DYSPNOEA (non-serious), outcome "unknown", described as "breathing was auditory but she could get air".  Additional information: Caller stated that after her second dose of the Pfizer Covid Vaccine (purple label) she had an adverse event. Caller stated that 12 hours after receiving her second dose she woke but had no fever body. Caller stated that she was. Caller said that her and she could not stop it. Caller also said that her. Caller said she could not control anything, it lasted four hours and she thought she was gonna die. Caller asked should she get the booster dose. Caller said that she previously reported this adverse event to Pfizer. The Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the booster dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Tiredness; Injection site pain; Arm pain; fever at 99.4 F; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 12:45 (Lot number: FK5618) at the age of 6 years as dose 1, 0.2 ml, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 06Dec2021 21:00, outcome "unknown", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 06Dec2021 21:00, outcome "unknown", described as "Injection site pain"; PAIN IN EXTREMITY (non-serious) with onset 06Dec2021 21:00, outcome "unknown", described as "Arm pain"; PYREXIA (non-serious) with onset 06Dec2021 21:00, outcome "unknown", described as "fever at 99.4 F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional info: Patient took other vaccine on same date (06Dec2021) on Left shoulder. Facility where the most recent COVID-19 vaccine was administered: Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Gait disturbance
Clinical narrative: body aches; she could hardly walk; joint pain that was so severe; chills; fever (less than 38 degrees Celsius and just felt warmer than usual per Caller); headache; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "joint pain" (ongoing), notes: she normally has joint pain. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, she had no reactions), administration date: Feb2021, for Covid-19 immunization, reaction(s): "Had no reactions"; Flu shot (she has had a strong reaction to the flu shot (did not specify the reactions) in the past.), for Immunization, reaction(s): "a strong reaction". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "she could hardly walk"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain that was so severe"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever (less than 38 degrees Celsius and just felt warmer than usual per Caller)"; HEADACHE (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "unknown" and all described as "headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not have any known drug or food allergies. She reported that reports that she had a lot of side effects for three months afterwards.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: body aches; she could hardly walk; joint pain that was so severe; chills; fever (less than 38 degrees Celsius and just felt warmer than usual per Caller); headache; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "joint pain" (ongoing), notes: she normally has joint pain. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, she had no reactions), administration date: Feb2021, for Covid-19 immunization, reaction(s): "Had no reactions"; Flu shot (she has had a strong reaction to the flu shot (did not specify the reactions) in the past.), for Immunization, reaction(s): "a strong reaction". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "she could hardly walk"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain that was so severe"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever (less than 38 degrees Celsius and just felt warmer than usual per Caller)"; HEADACHE (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "unknown" and all described as "headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not have any known drug or food allergies. She reported that reports that she had a lot of side effects for three months afterwards.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Joint pain in the right hip; other joint; body hurting; Joint pain in the right hip; other joint; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 29Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 01Dec2021, outcome "recovering" and all described as "Joint pain in the right hip; other joint"; PAIN (non-serious) with onset 01Dec2021, outcome "recovering", described as "body hurting". Additional information: The reporter stated that he had a question regarding a patient who had got recently (incomplete sentence) he was 6 years old (reporter was unsure) the patient got his COVID vaccine on last Monday. Two days after that the patient started some (incomplete sentence). The reporter attributed that to the vaccination but the reporter just wanted to make sure because reporter had two questions based on that. So two days later the patient started off with a 'single' joint pain in the right hip and then a couple of days later the patient complained about the other joint and body hurting. The patient didn't had a fever or any others problem expect the joint pain and the patient continued to have the symptoms probably the next, suddenly like 2 days after he received the vaccine, it had continued since then. The patient symptoms getting a little bit better and we are (voice not clear) to it, so usually the reporter would expect it (incomplete sentence). The reporter did not know that COVID could be seen as a little bit of 'prolongation' symptoms. So the reporter question was there any contraindication to receiving the vaccination, the second dose for this child and how long can they expect to see these symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain, Pruritus, Rash
Clinical narrative: her face had turned bright red; She began itching; She is not sure if it was welts or what, but it was like a rash pretty much all over her body, not just at the injection site; Rash all over her body; Headache; Aches; Sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Dec2021 11:15 (Lot number: FJ8762) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Verbatim: Type I Diabetes", start date: 1980 (ongoing), notes: Verbatim: Type I Diabetes; "allergic reaction to penicillin" (unspecified if ongoing), notes: In the past, she has had an allergic reaction to penicillin and latex.; "allergic reaction to penicillin and latex." (unspecified if ongoing), notes: In the past, she has had an allergic reaction to penicillin and latex. Concomitant medication(s) included: INSULIN SHOT taken for type 1 diabetes mellitus. Vaccination history included: Bnt162b2 (dose 1, Lot no./ Expiry Date: EN6202/ Unknown, left arm), administration date: 08Mar2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (dose 2, Lot no/ Expiry Date: Unknown, thinks it was in her Left arm), administration date: 29Mar2021, when the patient was 48 years old, for COVID-19 immunization; Flu shot (had a flu shot a month before), for Immunization. The following information was reported: RASH (non-serious) with onset 07Dec2021, outcome "recovering", described as "Rash all over her body"; HEADACHE (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Aches"; SOMNOLENCE (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Sleepy"; ERYTHEMA (non-serious), outcome "unknown", described as "her face had turned bright red"; PRURITUS (non-serious), outcome "unknown", described as "She began itching"; URTICARIA (non-serious), outcome "unknown", described as "She is not sure if it was welts or what, but it was like a rash pretty much all over her body, not just at the injection site".  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Urticaria
Clinical narrative: her face had turned bright red; She began itching; She is not sure if it was welts or what, but it was like a rash pretty much all over her body, not just at the injection site; Rash all over her body; Headache; Aches; Sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Dec2021 11:15 (Lot number: FJ8762) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Verbatim: Type I Diabetes", start date: 1980 (ongoing), notes: Verbatim: Type I Diabetes; "allergic reaction to penicillin" (unspecified if ongoing), notes: In the past, she has had an allergic reaction to penicillin and latex.; "allergic reaction to penicillin and latex." (unspecified if ongoing), notes: In the past, she has had an allergic reaction to penicillin and latex. Concomitant medication(s) included: INSULIN SHOT taken for type 1 diabetes mellitus. Vaccination history included: Bnt162b2 (dose 1, Lot no./ Expiry Date: EN6202/ Unknown, left arm), administration date: 08Mar2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (dose 2, Lot no/ Expiry Date: Unknown, thinks it was in her Left arm), administration date: 29Mar2021, when the patient was 48 years old, for COVID-19 immunization; Flu shot (had a flu shot a month before), for Immunization. The following information was reported: RASH (non-serious) with onset 07Dec2021, outcome "recovering", described as "Rash all over her body"; HEADACHE (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Aches"; SOMNOLENCE (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Sleepy"; ERYTHEMA (non-serious), outcome "unknown", described as "her face had turned bright red"; PRURITUS (non-serious), outcome "unknown", described as "She began itching"; URTICARIA (non-serious), outcome "unknown", described as "She is not sure if it was welts or what, but it was like a rash pretty much all over her body, not just at the injection site".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; fever keeps going; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 05Dec2021, outcome "not recovered", described as "Fever; fever keeps going"; HEADACHE (non-serious) with onset 04Dec2021, outcome "unknown", described as "headache". Therapeutic measures were taken as a result of pyrexia, headache.  Additional information: The last Friday, the patient's parent took her to get the vaccine, she was 5 years old and she was okay on that day, the next day she said she felt lot of 'headache' and on Sunday she got fever, they only used the Tylenol and today the fever kept going.  The patient did not have any known allergies.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulder pain is expected with the injection and he has had the previous 2 shots and that is to be expected; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder pain is expected with the injection and he has had the previous 2 shots and that is to be expected". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: I had some big time nausea with that second shot on the second day; general malaise; some fever; . This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Manufacturer unknown), for COVID-19 immunization, reaction(s): "nausea". The following information was reported: NAUSEA (non-serious), outcome "recovered", described as "I had some big time nausea with that second shot on the second day"; MALAISE (non-serious), outcome "unknown", described as "general malaise"; PYREXIA (non-serious), outcome "unknown", described as "some fever".  Additional information: Caller has questions regarding allergic reaction. Caller has received the Pfizer Covid-19 booster dose and experienced pain in his shoulder blade and on his neck. Caller asked if there are similar reports of "referred pain". Caller added that he has loose bowel which is "not totally diarrhea but it's close." Caller mentioned that he got from the previous two vaccine experiences but actually he didn't have it with the first one. Caller said, "he got it on the second day of the second dose, but it was gone by the next morning then he had some of the general, some, he had some big time with that second shot on the second day." Caller stated that there's a certain amount of that which was just expected. Caller mentioned he doesn't have a major diarrhea. He was just mainly checking on the neck and shoulder blade issue if "referred pain was possible from that per se." Caller added that, He got mobility. He can swing his arm like throwing a baseball but it does hurt because he got the shot in his arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Body ache; Weakness; Chills; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Dec2021 11:00 (Lot number: FF8839) at the age of 51 years as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: XANAX. The following information was reported: PYREXIA (non-serious) with onset 07Dec2021 22:30, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 07Dec2021 22:30, outcome "recovering", described as "Body ache"; ASTHENIA (non-serious) with onset 07Dec2021 22:30, outcome "recovering", described as "Weakness"; CHILLS (non-serious) with onset 07Dec2021 22:30, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 07Dec2021 22:30, outcome "recovering", described as "Headache". Therapeutic measures were not taken as a result of pyrexia, pain, asthenia, chills, headache.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy; Severe rash, arms and back; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 13:15 (Lot number: FF8839) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: kiwi" (unspecified if ongoing), notes: known allergies: kiwi. There were no concomitant medications. The following information was reported: PRURITUS (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Itchy"; RASH (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Severe rash, arms and back". Therapeutic measures were not taken as a result of pruritus, rash.   Additional information included: After getting the Covid 19 vaccine, the patient started to develop a severe rash and her arms and back. On 08Dec, the patient had still itchy every and the rash had not gone away. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Blood test, Fatigue, Vitamin D decreased
Clinical narrative: asthma; fatigue/tiredness; low Vitamin D; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Lot number: ER8727) at the age of 48 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Mild Asthma" (unspecified if ongoing); "Heartburn" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8727), administration date: 06Apr2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: ASTHMA (non-serious) with onset 28May2021, outcome "not recovered", described as "asthma"; FATIGUE (non-serious) with onset 28May2021, outcome "not recovered", described as "fatigue/tiredness"; VITAMIN D DECREASED (non-serious) with onset 28May2021, outcome "not recovered", described as "low Vitamin D". The events "asthma", "fatigue/tiredness" and "low vitamin d" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthma, fatigue, vitamin d decreased. Additional information: Reported Event: Approximately 30 days after my second dose I noticed a marked fatigue or tiredness on a daily basis that I have never felt before in my life. It was so pronounced I went my GP. Blood tests only revealed low Vitamin D (started taking that daily). After the tiredness continued with no relief I went to cardiologist and pulmonologist ( I have mild asthma). Several blood tests indicated nothing out of the ordinary. Heart and lungs are all healthy. The only explanation I have at this point is the COVID vaccine because that is the only thing that changed around the time that this happened. I can function but I just feel tired all day long and I didn't experience this before the vaccine.  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: She has been having some flair ups and lots of inflammation in her arms and elbows; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) at the age of 76 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "She has been having some flair ups and lots of inflammation in her arms and elbows".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Feeling hot, Gastrointestinal disorder, Inflammation
Clinical narrative: diarrhea; worsening to pain in entire arm with redness and inflammation; arm was warm; GI symptoms; Golfball sized bump on arm; worsening to pain in entire arm with redness and inflammation; worsening to pain in entire arm with redness and inflammation; .This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 62 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 02Dec2021 (Lot number: FJ8757) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 03Dec2021, outcome "recovering", described as "diarrhea"; ERYTHEMA (non-serious), INFLAMMATION (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 03Dec2021, outcome "recovering" and all described as "worsening to pain in entire arm with redness and inflammation"; FEELING HOT (non-serious) with onset 03Dec2021, outcome "recovering", described as "arm was warm"; GASTROINTESTINAL DISORDER (non-serious) with onset 03Dec2021, outcome "recovering", described as "GI symptoms"; MASS (non-serious) with onset 03Dec2021, outcome "recovering", described as "Golfball sized bump on arm". The events "diarrhea", "worsening to pain in entire arm with redness and inflammation", "arm was warm", "gi symptoms", "golfball sized bump on arm", "worsening to pain in entire arm with redness and inflammation" and "worsening to pain in entire arm with redness and inflammation" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of diarrhoea, erythema, feeling hot, gastrointestinal disorder, mass, inflammation, pain in extremity.  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain in extremity, SARS-CoV-2 test
Clinical narrative: diarrhea; worsening to pain in entire arm with redness and inflammation; arm was warm; GI symptoms; Golfball sized bump on arm; worsening to pain in entire arm with redness and inflammation; worsening to pain in entire arm with redness and inflammation; .This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 62 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 02Dec2021 (Lot number: FJ8757) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 03Dec2021, outcome "recovering", described as "diarrhea"; ERYTHEMA (non-serious), INFLAMMATION (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 03Dec2021, outcome "recovering" and all described as "worsening to pain in entire arm with redness and inflammation"; FEELING HOT (non-serious) with onset 03Dec2021, outcome "recovering", described as "arm was warm"; GASTROINTESTINAL DISORDER (non-serious) with onset 03Dec2021, outcome "recovering", described as "GI symptoms"; MASS (non-serious) with onset 03Dec2021, outcome "recovering", described as "Golfball sized bump on arm". The events "diarrhea", "worsening to pain in entire arm with redness and inflammation", "arm was warm", "gi symptoms", "golfball sized bump on arm", "worsening to pain in entire arm with redness and inflammation" and "worsening to pain in entire arm with redness and inflammation" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of diarrhoea, erythema, feeling hot, gastrointestinal disorder, mass, inflammation, pain in extremity.  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: slight rash on his chest; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: RASH (non-serious) with onset 09Dec2021, outcome "unknown", described as "slight rash on his chest".  Follow-Up (21Dec2021): Follow-up attempts are completed. No further information is expected
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: the pain travels from the top of her arm to her elbow anytime she moves it; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 05Oct2021 16:30 (Lot number: EW0185) at the age of 35 years as dose 2, single for covid-19 immunisation. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, 1st dose received on: 14Sep2021, Age at Immunization if date not available: 35, Lot Number / Expiry Date: EW0191, the expiry date is unknown to the caller., Route, Anatomical Location: Injection in the left arm, Vaccine Lot Expire Date: Unknown to the caller., Time the Vaccination Was Given: 16:30 for both doses.), administration date: 14Sep2021, when the patient was 35 years old, for Covid-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Oct2021, outcome "not recovered", described as "sore arm"; ARTHRALGIA (non-serious), outcome "unknown", described as "the pain travels from the top of her arm to her elbow anytime she moves it". Therapeutic measures were taken as a result of pain in extremity. Prior to vaccination, patient did not received any other vaccine.   Clinical information:  Description of complaint: The caller took Tylenol for the soreness in her arm after receiving the COVID vaccine, but continues to have worsening pain in her left arm. She took Tylenol for the pain for one day. She doesn't like taking pills. She figured it would go away. She doesn't remember the strength. It was oral Tylenol. She does not have an NDC, LOT, or expiry date to provide for the Tylenol.  Follow-Up (17Dec2021): Follow-up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Pyrexia
Clinical narrative: fatigue.; daughter got pretty sick after receiving the 2nd dose; fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 28 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose: 1, Batch/Lot number: Unknown), for covid 19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue."; ILLNESS (non-serious), outcome "unknown", described as "daughter got pretty sick after receiving the 2nd dose"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: swelling under his armpit; Lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 07Dec2021 (Batch/Lot number: unknown) as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1), for COVID-19 Immunization; Bnt162b2 (dose:2), for COVID-19 Immunization. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "swelling under his armpit"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymphadenopathy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever; chills; body ache; sweet and headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US279225_NS.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 63 years as dose number unknown, single for covid-19 immunisation; ofatumumab (KESIMPTA) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; varicella zoster vaccine (SHINGRIX) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "body ache"; HEADACHE (non-serious), outcome "unknown", described as "sweet and headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Red and itchy face; Red and itchy face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Jun2021 15:15 (Lot number: EW0186) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Epinephrine (may be), reaction(s): "Known allergies: Epinephrine (may be)", notes: Known allergies: Epinephrine (may be). The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 23Jun2021, outcome "unknown" and all described as "Red and itchy face".  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Feeling abnormal, Movement disorder, Pain in extremity
Clinical narrative: Second Dose: left arm pain, couldn''t raise her arm; excruciating pain; felt like her arm was broken; Second Dose: extra pain in her shoulder area and forearm area that has radiated to the forearm, all on the left side. Caller states she shoulder is sore upon movement; Second Dose: forearm is almost like she has no ability to grip. Caller states like if she picks up milk, the pain shoots through her forearm, it is bizarre, she has almost no grip or strength.; movement was horrible; felt like her arm was broken; shoulder is sore upon movement; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Sep2021 10:00 (Lot number: FF2587) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot: FC3184 or FL3184, Anatomical Location: Arm left), administration date: 28Aug2021, when the patient was 47 years old, for COVID-19 Immunization, reaction(s): "First Dose: left breast swelled up horribly on the left side", "First Dose: Normal Soreness, Tiredness, and Nausea", "First Dose: Normal Soreness, Tiredness, and Nausea", "First Dose: Normal Soreness, Tiredness, and Nausea". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Second Dose: left arm pain, couldn''t raise her arm; excruciating pain; felt like her arm was broken"; ARTHRALGIA (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Second Dose: extra pain in her shoulder area and forearm area that has radiated to the forearm, all on the left side. Caller states she shoulder is sore upon movement"; ASTHENIA (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Second Dose: forearm is almost like she has no ability to grip. Caller states like if she picks up milk, the pain shoots through her forearm, it is bizarre, she has almost no grip or strength."; MOVEMENT DISORDER (non-serious) with onset 18Sep2021, outcome "not recovered", described as "movement was horrible"; FEELING ABNORMAL (non-serious) with onset 18Sep2021, outcome "not recovered", described as "felt like her arm was broken"; ARTHRALGIA (non-serious) with onset 18Sep2021, outcome "not recovered", described as "shoulder is sore upon movement". Therapeutic measures were taken as a result of pain in extremity, arthralgia, asthenia, movement disorder, feeling abnormal, arthralgia.  Additional information: Chiropractor and Stim machine hooks up to electrodes and blood flowing to that area, heat, ice. It is unknown if Additional Vaccines Administered on Same Date of the Pfizer Suspect. It is unknown if Prior Vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.