chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling, Vaccination site pain
Clinical narrative: Pain to left arm injection site; Swelling & pain to left armpit; swelling & pain to left armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 01:15 (Lot number: FH8027) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Pfizer (DOSE 2, SINGLE, Batch/Lot No: EL3246, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 09Jan2021, when the patient was 42 years old, for Covid-19 immunization; Pfizer (DOSE 1, SINGLE, Batch/Lot No: EH9899, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 19Dec2020, when the patient was 42 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Dec2021 07:00, outcome "unknown", described as "Pain to left arm injection site"; SWELLING (non-serious) with onset 09Dec2021 07:00, outcome "unknown", described as "Swelling & pain to left armpit"; AXILLARY PAIN (non-serious) with onset 09Dec2021 07:00, outcome "unknown", described as "swelling & pain to left armpit". Therapeutic measures were not taken as a result of vaccination site pain, swelling, axillary pain.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nasopharyngitis, Pain
Clinical narrative: I still kind of sore; Chills; Joint pain; I am shivering; I am cold; I am really high and my head hurts and is heavy; 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. Other Case identifier(s): US-PFIZER INC-202101766634 (Pfizer).  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 07Dec2021 14:28 (Lot number: FJ620) at the age of 18 years as dose 2, 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, Lot: FF2593), administration date: 24Nov2021, when the patient was 18 years old, for COVID-19 immunization.  The following information was reported: PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "I still kind of sore"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "Joint pain"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "I am shivering"; NASOPHARYNGITIS (non-serious) with onset Dec2021, outcome "unknown", described as "I am cold"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "I am really high and my head hurts and is heavy".  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Heart rate
Clinical narrative: chills; fever; headache; muscle ache; fatigue; nausea; racing heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Dec2021 09:30 (Lot number: ff8839) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: el3248, Location of injection: Arm Right), administration date: 26Mar2021, when the patient was 47 years old, for covid 19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en6203, Location of injection: Arm Right), administration date: 04Mar2021, when the patient was 47 years old, for covid 19 immunization. The following information was reported: CHILLS (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "muscle ache"; FATIGUE (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "fatigue"; NAUSEA (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "nausea"; PALPITATIONS (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "racing heart". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, headache, myalgia, fatigue, nausea, palpitations.  Additional Information: On the 3rd dose (yesterday)  had chills fever headache, muscle ache, fatigue, nausea and a racing heart. Started at the end of the day and got worse overnight. Still bad this morning. Not tested covid post vaccination. other vaccine in four weeks.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Palpitations, Pyrexia
Clinical narrative: chills; fever; headache; muscle ache; fatigue; nausea; racing heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Dec2021 09:30 (Lot number: ff8839) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: el3248, Location of injection: Arm Right), administration date: 26Mar2021, when the patient was 47 years old, for covid 19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en6203, Location of injection: Arm Right), administration date: 04Mar2021, when the patient was 47 years old, for covid 19 immunization. The following information was reported: CHILLS (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "headache"; MYALGIA (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "muscle ache"; FATIGUE (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "fatigue"; NAUSEA (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "nausea"; PALPITATIONS (non-serious) with onset 09Dec2021 16:30, outcome "recovering", described as "racing heart". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, headache, myalgia, fatigue, nausea, palpitations.  Additional Information: On the 3rd dose (yesterday)  had chills fever headache, muscle ache, fatigue, nausea and a racing heart. Started at the end of the day and got worse overnight. Still bad this morning. Not tested covid post vaccination. other vaccine in four weeks.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Minor itching; some minor rash, mostly on back of arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 15:00 (Lot number: fl9262) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: en6201, prev dose lot unknown: False, prev dose administration date: 24Feb2021, prev dose administration time: 02:00 PM, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 24Feb2021, when the patient was 74 years old, for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "Minor itching"; RASH (non-serious) with onset Mar2021, outcome "not recovered", described as "some minor rash, mostly on back of arms". The events "minor itching" and "some minor rash, mostly on back of arms" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus, rash.  Additional information: The patient had no known allergies. The patient did not receive any other vaccine in four weeks. Covid prior vaccination and Covid tested post vaccination was reported as no. After 2nd shot got minor itching and some minor rash, mostly on back of arms. Using anti itching creams. seems to help, but problem was still intermittent. Ae treatment was reported as anti itching cream.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia
Clinical narrative: Got first injection 15Sep2021 and had the "mother" of all flares.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Sep2021 (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: Have DX of fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: FIBROMYALGIA (non-serious) with onset 15Sep2021, outcome "not recovered", described as "Got first injection 15Sep2021 and had the "mother" of all flares.". Therapeutic measures were not taken as a result of fibromyalgia.  Additional Information: Have DX of fibromyalgia. Got first injection 15Sep2021 and had the "mother" of all flares. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Pain
Clinical narrative: Inflammation; Pain; More fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Oct2021 (Lot number: 123456) 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 Number: 1, Prev dose lot unknown reason: Unable to locate or read the details), administration date: 15Sep2021, when the patient was 78 years old, for COVID-19 Immunization, reaction(s): "Fibromyalgia".  The following information was reported: INFLAMMATION (non-serious) with onset 2021, outcome "not recovered", described as "Inflammation"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Pain"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "More fatigue".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 7-year-old female patient received bnt162b2 (COMIRNATY) (Lot number: FK5618) 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: CHEST PAIN (non-serious), outcome "unknown", described as "chest pain".  Additional information: Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hypersensitivity, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: cold; allergies; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN6203) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergic to penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose:, Lot Number: EL9669, Route, Anatomical Location: Left arm), administration date: 03Feb2021, when the patient was 77 years old, for COVID-19 immunization; Shingles vaccine (Manufacturer: UNKNOWN, Lot Number: UNKNOWN), for immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "cold"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergies"; COUGH (non-serious) with onset 2021, outcome "not recovered", described as "cough". The events "cold", "allergies" and "cough" were 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 hypersensitivity, cough.   Additional information: During the vaccine supplemental form caller provided that she had went to the doctor because she had a cold, she didn't have COVID, she was tested for that. The doctor gave her a Z-pack and something else for her allergies. This was all around the time of her last shot, the 3rd vaccine. She then went back, and she got another Z-pack because she still had a cough, and they gave her prednisone. The prednisone was just so many days and then when she went to get her vaccine, they said to wait 2 weeks, so they had rescheduled her. No history/ Investigations. She was on a medication that they had rescheduled her vaccine because of, it was an antibiotic, they wanted to make sure that it was out of her system. The AE(s) did not require a visit to emergency room and physician office.  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: it wasn't like the first or second vaccine, her arm didn't hurt; it didn't feel like a big bunch like the other 2 shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Lot number: ER2613) as dose 1, single and administration date 08Apr2021 (Lot number: ER8737) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "it wasn't like the first or second vaccine, her arm didn't hurt"; CONTUSION (non-serious) with onset 2021, outcome "unknown", described as "it didn't feel like a big bunch like the other 2 shots". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101772565 same reporter/patient, different dose/event
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Facial pain, Hypoaesthesia, Investigation, Magnetic resonance imaging
Clinical narrative: Neurological problems; Trigeminal neuralgia; Face pain; Ears hurt; his whole face tingles; Decreased sensation of the right side of his face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 29 year-old male patient received bnt162b2 (COMIRNATY), administration date 13Jan2021 (Lot number: EL3246) at the age of 28 years as dose 2, single and administration date 22Dec2020 (Lot number: EK5730) 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: NERVOUS SYSTEM DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "Neurological problems"; TRIGEMINAL NEURALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Trigeminal neuralgia"; FACIAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Face pain"; EAR PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Ears hurt"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "his whole face tingles"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "Decreased sensation of the right side of his face". The events "neurological problems", "trigeminal neuralgia", "face pain", "ears hurt", "his whole face tingles" and "decreased sensation of the right side of his face" were 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 nervous system disorder, trigeminal neuralgia, facial pain, ear pain, paraesthesia, hypoaesthesia.  Additional information: Reporter stated, "I am calling on behalf of my son. He had both Pfizer vaccines(clarified as Pfizer Covid-19 vaccine)". Reporter further stated, "He was having neurological side effects like serious one's. He had MRIs (Further not clarified). He was been through neurologist. They tried if, they tested him for MS(Further not clarified). He has done everything they don't know. Finally they said may be it was a side effect. He was also a physician assistant so he just has no idea. So I said may be we can call Pfizer and just see. Then, when you look online you see that some people (Further not clarified) have neurological problems. Reporter stated, "Absolutely main was facial pain. I am not. I had Moderna I have no side effects (Further not clarified). If you have any data on that. I don't even know". Reporter was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information was the concerned department to answer the question.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Nervous system disorder, Paraesthesia, Trigeminal neuralgia
Clinical narrative: Neurological problems; Trigeminal neuralgia; Face pain; Ears hurt; his whole face tingles; Decreased sensation of the right side of his face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 29 year-old male patient received bnt162b2 (COMIRNATY), administration date 13Jan2021 (Lot number: EL3246) at the age of 28 years as dose 2, single and administration date 22Dec2020 (Lot number: EK5730) 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: NERVOUS SYSTEM DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "Neurological problems"; TRIGEMINAL NEURALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Trigeminal neuralgia"; FACIAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Face pain"; EAR PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Ears hurt"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "his whole face tingles"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "Decreased sensation of the right side of his face". The events "neurological problems", "trigeminal neuralgia", "face pain", "ears hurt", "his whole face tingles" and "decreased sensation of the right side of his face" were 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 nervous system disorder, trigeminal neuralgia, facial pain, ear pain, paraesthesia, hypoaesthesia.  Additional information: Reporter stated, "I am calling on behalf of my son. He had both Pfizer vaccines(clarified as Pfizer Covid-19 vaccine)". Reporter further stated, "He was having neurological side effects like serious one's. He had MRIs (Further not clarified). He was been through neurologist. They tried if, they tested him for MS(Further not clarified). He has done everything they don't know. Finally they said may be it was a side effect. He was also a physician assistant so he just has no idea. So I said may be we can call Pfizer and just see. Then, when you look online you see that some people (Further not clarified) have neurological problems. Reporter stated, "Absolutely main was facial pain. I am not. I had Moderna I have no side effects (Further not clarified). If you have any data on that. I don't even know". Reporter was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information was the concerned department to answer the question.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Physical examination, Tinnitus
Clinical narrative: I got tinnitus the evening that I was dosed; I got tinnitus that evening and I still have it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Lot number: FH8020, Expiration Date: Apr2022) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII) (Batch/Lot number: unknown). Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "High cholesterol" (unspecified if ongoing), notes: Verbatim: High cholesterol. Concomitant medication(s) included: LISINOPRIL/HCTZ taken for hypertension; ATORVASTATIN taken for blood cholesterol increased. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE), administration date: 16Apr2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 02Dec2021, outcome "not recovered", described as "I got tinnitus the evening that I was dosed; I got tinnitus that evening and I still have it". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus. Additional information: Got flu shot (Unspecified flu shot) within 4 weeks of getting COVID 19 Vaccine., No, got it at so patient don't have that information. Suspected side effects from the COVID vaccine. Patient was informed about the role of Pfizer Drug Safety. Patient stated, Tinnitus, I got tinnitus the evening that I was dosed last Thursday, so week ago Thursday. It was my booster dose, 'would' be my third, and patient got tinnitus that evening and still have it. Patient stated yes, this is my booster so my previous shot was in April. Patient don't have them handy actually.  know my second one was16Apr, yeah for second, yeah 16Apr2021. Patient got it at (withheld), so don't have that information. Do you want all my medication because I am also taking, I have hypercholesterolemia, so high cholesterol. It's atorvastatin. No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: my period started a few hours after receiving the first dose, usually it takes 2 days after I stop taking the pill (birth control) for my period to start.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Oct2021 16:30 (Lot number: RF2589) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "sulfa" (unspecified if ongoing), notes: Known allergies: yes, sulfa; "Covid-19" (unspecified if ongoing), notes: prior vaccination. The patient took concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 01Oct2021, outcome "recovered", described as "my period started a few hours after receiving the first dose, usually it takes 2 days after I stop taking the pill (birth control) for my period to start.". The event "my period started a few hours after receiving the first dose, usually it takes 2 days after i stop taking the pill (birth control) for my period to start." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: No other vaccine taken in four weeks. Prescribed Medicines were taken in two weeks. The patient had covid prior vaccination. The patient was not tested for covid post vaccination  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Tachycardia, Vaccination site pain
Clinical narrative: heart was beating really fast; breathing kind of hard; tachycardia; pain at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 09Dec2021 14:15 (Lot number: FH8030) at the age of 52 years as dose 2, 0.3 ml single for Covid-19 immunization. Relevant medical history included: "Chemotherapy" (unspecified if ongoing), notes: Received chemotherapy 5 years ago for a duration of 1 year. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Route, Anatomical Location: Intramuscular; left arm, Lot Number / Expiry Date: FH8027), administration date: 18Nov2021, when the patient was 52 years old, for Covid-19 Immunization, reaction(s): "pain at the injection site".  The following information was reported: TACHYCARDIA (non-serious) with onset 11Dec2021, outcome "recovered" (11Dec2021), described as "tachycardia"; DYSPNOEA (non-serious) with onset 11Dec2021 11:30, outcome "recovered" (11Dec2021), described as "breathing kind of hard"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021, outcome "recovered" (10Dec2021), described as "pain at injection site"; HEART RATE INCREASED (non-serious) with onset 11Dec2021 16:30, outcome "recovered" (11Dec2021), described as "heart was beating really fast". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Musculoskeletal discomfort
Clinical narrative: On my shoulder is badly affected. My shoulder, I have loss of you know; It affected my shoulder, I have pain in my shoulder; vaccine is interfere with the function of my shoulder.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 04Oct2021 (Lot number: 30135BA) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "To help prevent hair on my head from falling" (unspecified if ongoing). Concomitant medication(s) included: PROPECIA taken for alopecia. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 13Sep2021, when the patient was 65 years old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "On my shoulder is badly affected. My shoulder, I have loss of you know; It affected my shoulder, I have pain in my shoulder"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "vaccine is interfere with the function of my shoulder.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, musculoskeletal discomfort.  Additional information: Any other vaccination: No, the patient didn't take any other sort of vaccine. The patient was going to Physiotherapist.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Computerised tomogram, Diarrhoea, Headache, Nausea
Clinical narrative: Headache; has been in bed; body is sore; Diarrhea; Wheezing; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 13:15 (Lot number: 3313OBA) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Headache"; BED REST (non-serious) with onset 09Dec2021, outcome "not recovered", described as "has been in bed"; PAIN (non-serious) with onset 09Dec2021, outcome "not recovered", described as "body is sore"; DIARRHOEA (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Diarrhea"; WHEEZING (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Wheezing"; NAUSEA (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Wheezing
Clinical narrative: Headache; has been in bed; body is sore; Diarrhea; Wheezing; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 13:15 (Lot number: 3313OBA) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Headache"; BED REST (non-serious) with onset 09Dec2021, outcome "not recovered", described as "has been in bed"; PAIN (non-serious) with onset 09Dec2021, outcome "not recovered", described as "body is sore"; DIARRHOEA (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Diarrhea"; WHEEZING (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Wheezing"; NAUSEA (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: extreme fatigue; chills; sweats; Diarrhea; Nausea; loss of appetite; mild temperature/ temperature spiked to 103.4/temperature hovered around 100.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Lot number: FK5618) at the age of 7 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 (Dose:1, Vaccine Name: Pfizer Covid Vaccine, Lot Number: FK5127, Expiry Date: 31Jan2022, Anatomical Location:  Left arm, Time the Vaccination Was Given: Both first and second dose appointments were at 1445.), administration date: 12Nov2021, when the patient was 7 years old, for COVID-19 Immunization, reaction(s): "AE(s) following prior vaccinations: no". The following information was reported: PYREXIA (non-serious) with onset 04Dec2021, outcome "recovering", described as "mild temperature/ temperature spiked to 103.4/temperature hovered around 100."; FATIGUE (non-serious) with onset 05Dec2021, outcome "recovered" (11Dec2021), described as "extreme fatigue"; CHILLS (non-serious) with onset 05Dec2021, outcome "recovered" (06Dec2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 05Dec2021, outcome "recovered" (06Dec2021), described as "sweats"; DIARRHOEA (non-serious) with onset 05Dec2021, outcome "recovered with sequelae" (10Dec2021), described as "Diarrhea"; NAUSEA (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "Nausea"; DECREASED APPETITE (non-serious) with onset 05Dec2021, outcome "recovered" (12Dec2021), described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was reporting her daughter received the second dose Pfizer Covid Vaccine and had a pretty severe reaction. The next day, 04Dec2021, had just a mild temperature, the temperature went down on 06Dec2021 and the temperature hovered around 100. Caller states the physician strongly encouraged the caller to report the patient's event. The caller wanted to be a good citizen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   Follow-up attempts are completed. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: extreme fatigue; chills; sweats; Diarrhea; Nausea; loss of appetite; mild temperature/ temperature spiked to 103.4/temperature hovered around 100.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Lot number: FK5618) at the age of 7 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 (Dose:1, Vaccine Name: Pfizer Covid Vaccine, Lot Number: FK5127, Expiry Date: 31Jan2022, Anatomical Location:  Left arm, Time the Vaccination Was Given: Both first and second dose appointments were at 1445.), administration date: 12Nov2021, when the patient was 7 years old, for COVID-19 Immunization, reaction(s): "AE(s) following prior vaccinations: no". The following information was reported: PYREXIA (non-serious) with onset 04Dec2021, outcome "recovering", described as "mild temperature/ temperature spiked to 103.4/temperature hovered around 100."; FATIGUE (non-serious) with onset 05Dec2021, outcome "recovered" (11Dec2021), described as "extreme fatigue"; CHILLS (non-serious) with onset 05Dec2021, outcome "recovered" (06Dec2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 05Dec2021, outcome "recovered" (06Dec2021), described as "sweats"; DIARRHOEA (non-serious) with onset 05Dec2021, outcome "recovered with sequelae" (10Dec2021), described as "Diarrhea"; NAUSEA (non-serious) with onset 05Dec2021, outcome "recovered" (10Dec2021), described as "Nausea"; DECREASED APPETITE (non-serious) with onset 05Dec2021, outcome "recovered" (12Dec2021), described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was reporting her daughter received the second dose Pfizer Covid Vaccine and had a pretty severe reaction. The next day, 04Dec2021, had just a mild temperature, the temperature went down on 06Dec2021 and the temperature hovered around 100. Caller states the physician strongly encouraged the caller to report the patient's event. The caller wanted to be a good citizen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over her body; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 23Nov2021 (Lot number: FK5127, Expiration Date: 31Aug2022) 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: URTICARIA (non-serious) with onset 24Nov2021, outcome "unknown", described as "Hives all over her body".  Additional information included: The reporter wanted to know if that was a reported reaction to 5-11 age group and if so, how they should proceed with second dose.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Hypersensitivity
Clinical narrative: if the patient has an allergies to either metamizole or marolac, the patient havent been getting covid vaccine; unknown if Covid vaccine administered  to patient having these allergies; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; metamizole (METAMIZOLE) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "if the patient has an allergies to either metamizole or marolac, the patient havent been getting covid vaccine; unknown if Covid vaccine administered  to patient having these allergies". The action taken for metamizole was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: whole body had blood red blisters and rashes; whole body had blood red blisters and rashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 15:00 (Lot number: FL0007) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. The following information was reported: BLISTER (non-serious), RASH (non-serious) all with onset 11Dec2021 06:00, outcome "recovering" and all described as "whole body had blood red blisters and rashes". The event "whole body had blood red blisters and rashes" and "whole body had blood red blisters and rashes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of blister, rash. Patient received Prednisolone for the treatment of events.  Additional info: No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.  Follow-Up (29Dec2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Body temperature, Cardiac disorder, Crying
Clinical narrative: He is saying his stomach is hurting; he has not been feeling good; He has a slight fever of 101.8 or 9; His heart seems, I can''t tell if the heart is elevated; he said he feels weakness on his legs; he is crying; he does not feel like he can walk; tried to throw up but he could not throw nothing up because he does not drink, except water; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient 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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "He is saying his stomach is hurting"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "he has not been feeling good"; PYREXIA (non-serious), outcome "unknown", described as "He has a slight fever of 101.8 or 9"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "His heart seems, I can''t tell if the heart is elevated"; ASTHENIA (non-serious), outcome "unknown", described as "he said he feels weakness on his legs"; CRYING (non-serious), outcome "unknown", described as "he is crying"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "he does not feel like he can walk"; NAUSEA (non-serious), outcome "unknown", described as "tried to throw up but he could not throw nothing up because he does not drink, except water". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated, "My son is having a, I don't know of he is having a side effect from the Pfizer. (Hence, name and telephone number is further not clarified) He is saying his stomach is hurting, he is crying, he is only 10 and he only ate nuggets today cause he has not been feeling good after he got this. He has a slight fever of 101.8 or 9. I am not sure if he is having a side effect or if this is what happens. His heart seems, I cant tell if the heart is elevated because I am putting my hand on him." He is having stomach pain, he said he feels weakness on his legs, I don't know if he is having joint pain but he says he does not feel like he can walk but he has got up to, tried to throw up but he could not throw nothing up because he does not drink, except water. I don't know if its a side effect or too much of a side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Nausea, Pyrexia
Clinical narrative: He is saying his stomach is hurting; he has not been feeling good; He has a slight fever of 101.8 or 9; His heart seems, I can''t tell if the heart is elevated; he said he feels weakness on his legs; he is crying; he does not feel like he can walk; tried to throw up but he could not throw nothing up because he does not drink, except water; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient 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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "He is saying his stomach is hurting"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "he has not been feeling good"; PYREXIA (non-serious), outcome "unknown", described as "He has a slight fever of 101.8 or 9"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "His heart seems, I can''t tell if the heart is elevated"; ASTHENIA (non-serious), outcome "unknown", described as "he said he feels weakness on his legs"; CRYING (non-serious), outcome "unknown", described as "he is crying"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "he does not feel like he can walk"; NAUSEA (non-serious), outcome "unknown", described as "tried to throw up but he could not throw nothing up because he does not drink, except water". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated, "My son is having a, I don't know of he is having a side effect from the Pfizer. (Hence, name and telephone number is further not clarified) He is saying his stomach is hurting, he is crying, he is only 10 and he only ate nuggets today cause he has not been feeling good after he got this. He has a slight fever of 101.8 or 9. I am not sure if he is having a side effect or if this is what happens. His heart seems, I cant tell if the heart is elevated because I am putting my hand on him." He is having stomach pain, he said he feels weakness on his legs, I don't know if he is having joint pain but he says he does not feel like he can walk but he has got up to, tried to throw up but he could not throw nothing up because he does not drink, except water. I don't know if its a side effect or too much of a side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: First shot - No symptoms, only slight bruise pain at injection site; First shot - No symptoms, only slight bruise pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 08:00 (Lot number: el8982) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ACCUTANE. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious) all with onset Jan2021, outcome "unknown" and all described as "First shot - No symptoms, only slight bruise pain at injection site".  Additional Information: The patient did not have covid prior vaccination The patient was not tested for covid post vaccination.The patient's other medical history was reported as none  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101796094 similar report from same reporter