chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain, Myocarditis
Clinical narrative: myocarditis; cardiac related problems; chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 20:00 (Lot number: 33036BD) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) included: PREMARIN; CELEBREX; VYVANSE; NURTEC ODT; SYNTHROID. The following information was reported: MYOCARDITIS (medically significant) with onset 10Jan2022 12:00, outcome "not recovered", described as "myocarditis"; CARDIAC DISORDER (non-serious) with onset 10Jan2022 12:00, outcome "not recovered", described as "cardiac related problems"; CHEST PAIN (non-serious) with onset 10Jan2022 12:00, outcome "not recovered", described as "chest pain". The events "myocarditis", "cardiac related problems" and "chest pain" were evaluated at the physician office visit. The patient did not receive other vaccine in four weeks. The patient was not tested for COVID-19 post vaccination. The patient has no known allergies.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Headache, Immunisation, SARS-CoV-2 test
Clinical narrative: Heart pain; Headache; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 16:00 (Lot number: FJ1614) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient experienced covid prior to vaccination. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EM9809, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 19Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 29Jan2021, for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset 18Jan2022 17:00, outcome "not recovered", described as "Heart pain"; IMMUNISATION (medically significant) with onset 17Jan2022 16:00, outcome "not recovered", described as "Booster"; HEADACHE (non-serious) with onset 18Jan2022 17:00, outcome "not recovered", described as "Headache". The events "heart pain", "booster" and "headache" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) positive; (18Jan2022) negative, notes: Nasal Swab; (20Jan2022) negative, notes: Nasal Swab; (24Jan2022) pending, notes: Nasal Swab. Therapeutic measures were not taken as a result of angina pectoris, immunisation, headache. The patient did not receive other vaccine in four weeks. There were no other medications within the past two weeks.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Swelling, Vaccination site warmth
Clinical narrative: he have a sudden swelling at the lower arm pit; He have a bump; Injection site is warm to touch; he is having a lump swollen like lump under the armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 (Lot number: SK9896) at the age of 31 years as dose number unknown (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "one double brain condition" (unspecified if ongoing), notes: We have an 'one double brain condition' (Further not clarified) but we don't know of any medication that he is taking, he just came in here to take his booster so we don't really have much information about the patient. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 24Jan2022, outcome "unknown", described as "he have a sudden swelling at the lower arm pit"; VACCINATION SITE WARMTH (non-serious) with onset Jan2022, outcome "unknown", described as "Injection site is warm to touch"; AXILLARY MASS (non-serious) with onset Jan2022, outcome "unknown", described as "he is having a lump swollen like lump under the armpit"; SWELLING (non-serious) with onset 24Jan2022, outcome "unknown", described as "He have a bump".  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: recovering from covid / had both shots/ i thought pfizer would want to know that i still got it; recovering from covid / had both shots/ i thought pfizer would want to know that i still got it; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  An 82-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "recovering from covid / had both shots/ i thought pfizer would want to know that i still got it".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Fatigue, Headache
Clinical narrative: severe chills; fever; muscle aches; headache; fatigue; intense pain near underarm and shoulder on injection site side; intense pain near underarm and shoulder on injection site side; intense pain near underarm and shoulder on injection site side; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jan2022 (Lot number: FL3209) at the age of 24 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 2, Lot EW0186, administered in right arm), administration date: 20May2021, when the patient was 23 years old, for Covid-19 immunization; Bnt162b2 (dose 1 , Lot EW0170, administered in left arm), administration date: 29Apr2021, when the patient was 23 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Jan2022, outcome "recovered", described as "severe chills"; PYREXIA (non-serious) with onset 18Jan2022, outcome "recovered", described as "fever"; MYALGIA (non-serious) with onset 18Jan2022, outcome "recovered", described as "muscle aches"; HEADACHE (non-serious) with onset 18Jan2022, outcome "recovered", described as "headache"; FATIGUE (non-serious) with onset 18Jan2022, outcome "recovered", described as "fatigue"; AXILLARY PAIN (non-serious), ARTHRALGIA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 18Jan2022, outcome "recovered" and all described as "intense pain near underarm and shoulder on injection site side". Therapeutic measures were not taken as a result of chills, pyrexia, myalgia, headache, fatigue, axillary pain, arthralgia, vaccination site pain.  Additional Information: The patient received the vaccine at a pharmacy or drug store. The patient did not received any other vaccine within four weeks of the vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: severe chills; fever; muscle aches; headache; fatigue; intense pain near underarm and shoulder on injection site side; intense pain near underarm and shoulder on injection site side; intense pain near underarm and shoulder on injection site side; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jan2022 (Lot number: FL3209) at the age of 24 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 2, Lot EW0186, administered in right arm), administration date: 20May2021, when the patient was 23 years old, for Covid-19 immunization; Bnt162b2 (dose 1 , Lot EW0170, administered in left arm), administration date: 29Apr2021, when the patient was 23 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Jan2022, outcome "recovered", described as "severe chills"; PYREXIA (non-serious) with onset 18Jan2022, outcome "recovered", described as "fever"; MYALGIA (non-serious) with onset 18Jan2022, outcome "recovered", described as "muscle aches"; HEADACHE (non-serious) with onset 18Jan2022, outcome "recovered", described as "headache"; FATIGUE (non-serious) with onset 18Jan2022, outcome "recovered", described as "fatigue"; AXILLARY PAIN (non-serious), ARTHRALGIA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 18Jan2022, outcome "recovered" and all described as "intense pain near underarm and shoulder on injection site side". Therapeutic measures were not taken as a result of chills, pyrexia, myalgia, headache, fatigue, axillary pain, arthralgia, vaccination site pain.  Additional Information: The patient received the vaccine at a pharmacy or drug store. The patient did not received any other vaccine within four weeks of the vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: Disequilibrium; Felt like she was going to fall and vertigo; Both shoulders became sore; Arm of the vaccine site became numb; Arm of the vaccine site with pins and needles; Intense dizziness; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 19-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 24Jan2022 09:15 (Batch/Lot number: unknown) at the age of 19 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Birth control" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Diagnosed prior to vaccination. Concomitant medications included: DROSPIRENONE; ETHINYL ESTRADIOL. Vaccination history included: BNT162B2 (DOSE 1; 04:00 PM; left arm), administration date: 09Apr2021, when the patient was 18 years old, for COVID-19 immunization; BNT162B2 (DOSE 2; Lot Number: EW0179; 05:30 PM; left arm), administration date: 11May2021, when the patient was 18 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 24Jan2022 09:45, outcome "recovering", described as "Intense dizziness"; BALANCE DISORDER (non-serious) with onset 24Jan2022 18:00, outcome "recovering", described as "Disequilibrium"; VERTIGO (non-serious) with onset 24Jan2022 18:00, outcome "recovering", described as "Felt like she was going to fall and vertigo"; ARTHRALGIA (non-serious) with onset 24Jan2022 18:00, outcome "recovering", described as "Both shoulders became sore"; HYPOAESTHESIA (non-serious) with onset 24Jan2022 18:00, outcome "recovering", described as "Arm of the vaccine site became numb"; PARAESTHESIA (non-serious) with onset 24Jan2022 18:00, outcome "recovering", described as "Arm of the vaccine site with pins and needles". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, balance disorder, vertigo, arthralgia, hypoaesthesia, paraesthesia.  Additional Information: The patient had no known allergies and with family history of blood clotting. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had intense dizziness for 30 minutes period after vaccine. At 18:00 (also reported as 9 hours later), more intense dizziness began again paired with disequilibrium where the patient felt like she was going to fall, and vertigo. Both shoulders became sore, and the patient's arm of the vaccine site became numb and with pins and needles. The events were considered non-serious by the patient. Since the vaccination, the patient has been tested for COVID-19 (PCR nasal swab) that was negative on 22Jan2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Disequilibrium; Felt like she was going to fall and vertigo; Both shoulders became sore; Arm of the vaccine site became numb; Arm of the vaccine site with pins and needles; Intense dizziness; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 19-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 24Jan2022 09:15 (Batch/Lot number: unknown) at the age of 19 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Birth control" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Diagnosed prior to vaccination. Concomitant medications included: DROSPIRENONE; ETHINYL ESTRADIOL. Vaccination history included: BNT162B2 (DOSE 1; 04:00 PM; left arm), administration date: 09Apr2021, when the patient was 18 years old, for COVID-19 immunization; BNT162B2 (DOSE 2; Lot Number: EW0179; 05:30 PM; left arm), administration date: 11May2021, when the patient was 18 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 24Jan2022 09:45, outcome "recovering", described as "Intense dizziness"; BALANCE DISORDER (non-serious) with onset 24Jan2022 18:00, outcome "recovering", described as "Disequilibrium"; VERTIGO (non-serious) with onset 24Jan2022 18:00, outcome "recovering", described as "Felt like she was going to fall and vertigo"; ARTHRALGIA (non-serious) with onset 24Jan2022 18:00, outcome "recovering", described as "Both shoulders became sore"; HYPOAESTHESIA (non-serious) with onset 24Jan2022 18:00, outcome "recovering", described as "Arm of the vaccine site became numb"; PARAESTHESIA (non-serious) with onset 24Jan2022 18:00, outcome "recovering", described as "Arm of the vaccine site with pins and needles". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, balance disorder, vertigo, arthralgia, hypoaesthesia, paraesthesia.  Additional Information: The patient had no known allergies and with family history of blood clotting. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had intense dizziness for 30 minutes period after vaccine. At 18:00 (also reported as 9 hours later), more intense dizziness began again paired with disequilibrium where the patient felt like she was going to fall, and vertigo. Both shoulders became sore, and the patient's arm of the vaccine site became numb and with pins and needles. The events were considered non-serious by the patient. Since the vaccination, the patient has been tested for COVID-19 (PCR nasal swab) that was negative on 22Jan2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Paraesthesia
Clinical narrative: He had a prickly feeling all around his trunk. Felt like shingles, but not at a single nerve bundle. It was all around his chest and back of both arms; Felt like someone was pulling on every one of his body hair fibers, very uncomfortable; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient.  A 58 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 19Jan2022 10:00 (Lot number: FJ8757) at the age of 58 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Treating High Cholesterol" (unspecified if ongoing); "repaired atrial flutter" (unspecified if ongoing). Concomitant medications included: SIMVASTATIN; MONTELUKAST; ASPIRIN 81. Vaccination history included: BNT162B2 (Dose Number: 2, lot number: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 07May2021, when the patient was 58 years old, for COVID-19 immunization; BNT162B2 (Dose Number: 1, lot number: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 03Mar2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 21Jan2022 16:00, outcome "not recovered", described as "He had a prickly feeling all around his trunk. Felt like shingles, but not at a single nerve bundle. It was all around his chest and back of both arms "; DISCOMFORT (non-serious) with onset 21Jan2022 16:00, outcome "not recovered", described as "Felt like someone was pulling on every one of his body hair fibers, very uncomfortable". Therapeutic measures were taken as a result of paraesthesia, discomfort, which included ibuprofen 800 mg.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: She is bleeding out of her vagina; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2022 10:30 (Lot number: FL0007) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: VAGINAL HAEMORRHAGE (medically significant) with onset 24Jan2022 07:00, outcome "unknown", described as "She is bleeding out of her vagina".  The event "she is bleeding out of her vagina" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaginal haemorrhage, vaginal disorder.  Clinical course: The patient is now having vaginal issues. She is bleeding out of her vagina. She has never had this issue before the vaccine. For treatment they are currently working with doctors to treat.  Additional information: the patient had no other vaccine in four weeks, no other medications in two weeks, no covid prior vaccination and no Known allergies.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 antibody test positive
Clinical narrative: Inappropriate schedule of vaccine administered; tested positive for covid; tested positive for covid; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date 07May2021 15:00 (Lot number: EW0172) at the age of 58 years as dose 2, single and administration date 03Mar2021 14:30 (Lot number: ER8737) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Treating High Cholesterol" (unspecified if ongoing), notes: other medical history: Treating High Cholesterol; "Repaired atrial flutter" (unspecified if ongoing), notes: other medical history: Repaired atrial flutter. Concomitant medication(s) included: SIMVASTATIN; MONTELUKAST; ASPIRIN 81. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jan2022 16:00, outcome "not recovered" and all described as "tested positive for covid"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate schedule of vaccine administered". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test positive: (20Jan2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No Known allergies and no covid prior vaccination was reported. Patient did not received any other vaccine in four weeks. Facility type vaccine was at Clinic. Patient Received the booster on Wednesday, on Thursday the next day tested positive for covid (validated with a PCR test at (Hospital name) don't believe it was the shot, patient wife tested positive on Wednesday afternoon. The reaction had was a prickly feeling all around his trunk. Feels like shingles, but not at a single nerve bundle. It was all around  chest and back of both arms. Feels like someone was pulling on everyone of body hair fibers. Very uncomfortable. Ibuprofen 800 mg helps. Treatment medication included Ibuprofen 800mg
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; 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 84 year-old female patient received bnt162b2 (COMIRNATY), administration date 02Dec2021 (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: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "urinary tract infection".  Additional information: The patient stated that on 02Dec2021 she received her first Pfizer Covid Vaccine and she has been trying to get her second one but just keeps getting the run around. She says at her first appointment she scheduled the second appointment but then she was diagnosed with a urinary tract infection so she had to cancel. The patient says she was able to reschedule that appointment but then her son-in-law came home and had Covid. She stated she lives with her daughter and son-in-law so she had to quarantine for 20 days and therefore had to cancel that appointment as well.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: diagnosed with COVID 19; diagnosed with COVID 19; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: Caller mentioned being immunocompromised. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID 19". Therapeutic measures were taken as a result of suspected covid-19. Clinical course: Patient called to ask a question her doctor could not answer. Patient was triple vaccinated but was recently diagnosed with COVID 19 and was prescribed with Paxlovid because patient was a high-risk patient. Patient mentioned being immunocompromised and wanted to get a fourth dose of a COVID vaccine. Patient queried whether Paxlovid will interfere with the fourth dose of vaccine. Patient finished the treatment course yesterday (day before reporting) and that was aware that between receiving treatment with monoclonal antibodies and receiving a dose of the COVID 19 vaccine there was a waiting period of 90 days, so patient wanted further information. No further information of the vaccine was given.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis; 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 right, administration date 27Feb2021 (Lot number: EP7534) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRAVASTATIN; LANSOPRAZOLE; IRBESARTAN. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number: EN6202), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 01Apr2021, outcome "not recovered", described as "rheumatoid arthritis". The event "rheumatoid arthritis" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of rheumatoid arthritis which included prednisone and Humira. Course of events: After the second shot, the patient started to get swelling in right foot, then left knee, then right shoulder, got worse and effected hands, wrist, feet. The pain traveled around body. Since then, he was seeing a Rheumatologist and he started on Humira. Now he has rheumatoid arthritis. No other vaccine in four weeks. There was no covid prior to vaccination, and no covid was tested after vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date 28Aug2021 (Lot number: fc3182) 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), administration date: Aug2021, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 03Sep2021, outcome "unknown", described as "tinnitus".  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy starting approximately 1 week after COVID booster
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Bicep swelled up and hives on the face.  Hives resolved and swelling has decreased.  Physician prescribed steroid dose pack pharmacy is awaiting receipt of prescription as of 2/12/22.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eyelid margin crusting, Ophthalmic herpes zoster
Clinical narrative: On 05/18/2021 - I went to urgent care because my right eye was painful and crusty. They prescribed erythromycin eye ointment to put in the eye. It got better and then t got worse again. I saw an optometrist, 06/05/2021- she diagnosed me with shingles in my right eye. She prescribed Valacyclovir hcl  1 gram tablet. After that it came back 3 more times, it kept flaring up. In September I had 2 of the Shingrex vaccines. 08/23/2021 was my 1st Shingrex. I got the 2nd one on 12/17/2021.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Delusion, Dizziness, Night sweats
Clinical narrative: Extreme stomach pain; extreme back pain; high fever 101+; night sweats; delusions and dizziness.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme stomach pain; extreme back pain; high fever 101+; night sweats; delusions and dizziness.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex reactivation, Herpes simplex test, Oral herpes, Pain
Clinical narrative: Herpes simplex virus reactivation- herpes simplex outbreak covering entire mouth making it impossible to eat or drink without pain for nearly a week, thus far
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Head discomfort, Injection site pain, Tinnitus
Clinical narrative: Injection site pain day(s) after shot, increase left ear hissing and mild ear pressure weeks after shot. Increase ringing in left ear month(s) after shot with continue mild ear/head pressure. Blood pressure normal. Scheduled doctor visit for April 12th (earliest time I can get in)
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: caught covid; caught covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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 patient had no other vaccine in four weeks and had no Covid prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 24Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 24Jan2022, outcome "recovering" and all described as "caught covid". The patient was tested for Covid post vaccination: SARS-COV-2 test: (24Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Nausea, Pyrexia
Clinical narrative: Nausea, slight fever, dizziness, numbness in left arm
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Chills, Inflammation, Nodule
Clinical narrative: A 37-year-old male patient receives a booster dose of Moderna on 01/14/2022. The patient reports that on the third day after its administration, he presented inflammation of the nodules in the area of ??the left armpit. He reports presenting secondary symptoms such as fever, chills, weakness and pain in the left armpit area due to the presence of the nodule. He reports that the measurement of the nodule was the size of his fist. The patient is considered afebrile, with no redness in the area and no pain to the touch.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: A 37-year-old male patient receives a booster dose of Moderna on 01/14/2022. The patient reports that on the third day after its administration, he presented inflammation of the nodules in the area of ??the left armpit. He reports presenting secondary symptoms such as fever, chills, weakness and pain in the left armpit area due to the presence of the nodule. He reports that the measurement of the nodule was the size of his fist. The patient is considered afebrile, with no redness in the area and no pain to the touch.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Oedema peripheral, Pain in extremity, Swelling, Throat tightness
Clinical narrative: Significant swelling, pain, edema of entire arm.  Pain with range of motion of her right upper extremity. Throat tightness.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Full blood count, Human chorionic gonadotropin, Leukocytosis, Metabolic function test
Clinical narrative: nausea, vomiting, syncope
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope, Vomiting, White blood cell count increased
Clinical narrative: nausea, vomiting, syncope
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cardio-respiratory arrest, Death, Dyspnoea, Fatigue
Clinical narrative: My husband felt generally tired and like he had a cold after the first moderna vaccine.  The second vaccine lot #020B21A on 3/31/2021, made him feel worse--more tired and joints hurting--more like flu.  He was slightly short of breath until a few days before his death, it got worse.  On the day before his death, he said he felt somewhat better, but I insisted we were going to call Dr. the next day on Monday.  He agreed.  Early Monday morning,  he went into severe respiratory distress.  I called 911.  He coded in the ambulance, and the code was continued at a local Hospital.  I was present.  He passed away in the ED on April 19, 2021.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Respiratory distress
Clinical narrative: My husband felt generally tired and like he had a cold after the first moderna vaccine.  The second vaccine lot #020B21A on 3/31/2021, made him feel worse--more tired and joints hurting--more like flu.  He was slightly short of breath until a few days before his death, it got worse.  On the day before his death, he said he felt somewhat better, but I insisted we were going to call Dr. the next day on Monday.  He agreed.  Early Monday morning,  he went into severe respiratory distress.  I called 911.  He coded in the ambulance, and the code was continued at a local Hospital.  I was present.  He passed away in the ED on April 19, 2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Immediate post-injection reaction, Lip swelling, Nasal congestion, Oropharyngeal pain
Clinical narrative: Immediately following vaccination,  my throat became itchy and sore, became itchy all over the body, face and lips swelled,  face became flush, lips were tingling,  nose became stuffy.  I took two benadryl and symptoms eventually ceased.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pruritus, Swelling face, Throat irritation
Clinical narrative: Immediately following vaccination,  my throat became itchy and sore, became itchy all over the body, face and lips swelled,  face became flush, lips were tingling,  nose became stuffy.  I took two benadryl and symptoms eventually ceased.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Nausea
Clinical narrative: Feeling extremely cold, shivering, fever of 99.3, feeling nauseas time 11:30 p.m. Fever of 99.9 at 12:15 a.m.. One tablet Tylenol, 500 mg at 12:20 a.m. Temperature at 1:45a.m. 98.4
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; Fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 03Jan2022 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "tested positive for COVID-19"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever". The patient underwent the following laboratory tests and procedures: pyrexia: (Jan2022) 101.4; sars-cov-2 test: (Jan2022) positive. Clinical information: Reporter son received first dose of Pfizer COVID-19 vaccine on 03Jan2022 and 9 days after the first dose he had only fever of 101.4 and 7 days after he had fever he tested positive for COVID-19, and his second dose is due on 24Jan2022 can he get his second dose or he has to wait, if he has to wait , how long does he have to wait before he gets his second dose. by the way he does not have fever or any other symptoms for the las 9 days.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Mobility decreased
Clinical narrative: Rigors, temp of 104.7, chills, teeth chattering, weakness, unable to get out of bed
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: Raynauds in both hands.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Dyspnoea, Muscular weakness, Pain in extremity
Clinical narrative: Pain and weakness in the arm that the vaccine was given in. Shortness of breath and chest discomfort.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Pain and weakness in the arm that the vaccine was given in. Shortness of breath and chest discomfort.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypersensitivity, Hypoaesthesia oral, Throat tightness
Clinical narrative: allergic reaction; lips started to get numb; throat feels like closing up; hard to swallow; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  AA female patient received bnt162b2 (BNT162B2), administration date 21Jan2022 (Lot number: FJ5683, Expiration Date: 31Jan2022) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENADRYL taken for premedication, start date: 21Jan2022. Vaccination history included: Covid-19 vaccine (Primary Immunization completed but manufacturer unknown), for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (medically significant) with onset 21Jan2022, outcome "unknown", described as "allergic reaction"; HYPOAESTHESIA ORAL (medically significant) with onset 21Jan2022, outcome "unknown", described as "lips started to get numb"; THROAT TIGHTNESS (medically significant) with onset 21Jan2022, outcome "unknown", described as "throat feels like closing up"; DYSPHAGIA (medically significant) with onset 21Jan2022, outcome "unknown", described as "hard to swallow". The events "allergic reaction", "lips started to get numb", "throat feels like closing up" and "hard to swallow" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of throat tightness. Clinical course was as follows: The patient reported after getting her booster shot on 21Jan2022, she ended up having allergic reaction to it and she spent 2 and half hours in the urgent care. Patient stated that her lips started to get numb and her throat feels like closing up and it's hard to swallow. Patient also stated that prior to getting the booster shot, they gave her Benadryl, it wasn't liquid, it was a pill. 30 minutes prior to getting the shot, but it didn't help and gave her a breathing treatment. She experienced the adverse reaction within 2 minutes or so. Patient also stated that other people are telling her that their tongues are getting numb, and per patient she wants to report it.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, COVID-19, Cough, Drug ineffective, Headache
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; congestion; headache; cough; Patient has asthma; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer-biontech (Dose Number: 2, Prev dose product: COVID 19,, Prev dose brand: Pfizer-BioNTech,, Prev dose brand unknown: False,, Prev dose lot unknown: True, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 29 years old, for COVID-19 immunization; Pfizer-biontech (Dose Number: 1, Prev dose product: COVID 19,, Prev dose brand: Pfizer-BioNTech,, Prev dose brand unknown: False,, Prev dose lot unknown: True, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jan2022, outcome "recovering" and all described as "Tested positive for COVID-19"; NASAL CONGESTION (non-serious) with onset 25Jan2022, outcome "recovering", described as "congestion"; HEADACHE (non-serious) with onset 25Jan2022, outcome "recovering", described as "headache"; COUGH (non-serious) with onset 25Jan2022, outcome "recovered" (25Jan2022), described as "cough"; ASTHMA (non-serious) with onset 25Jan2022, outcome "recovering", described as "Patient has asthma". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (25Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19, nasal congestion, headache. Therapeutic measures were taken as a result of cough, asthma. Clinical course: Tested positive for COVID-19 on 25Jan2022 using a home rapid test, following receipt of the primary series in Mar2021 and a booster in Oct2021. Patient reports congestion, headache and cough. Patient has asthma and required rescue inhaler medication, that resolved cough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; congestion; headache; cough; Patient has asthma; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer-biontech (Dose Number: 2, Prev dose product: COVID 19,, Prev dose brand: Pfizer-BioNTech,, Prev dose brand unknown: False,, Prev dose lot unknown: True, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 29 years old, for COVID-19 immunization; Pfizer-biontech (Dose Number: 1, Prev dose product: COVID 19,, Prev dose brand: Pfizer-BioNTech,, Prev dose brand unknown: False,, Prev dose lot unknown: True, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jan2022, outcome "recovering" and all described as "Tested positive for COVID-19"; NASAL CONGESTION (non-serious) with onset 25Jan2022, outcome "recovering", described as "congestion"; HEADACHE (non-serious) with onset 25Jan2022, outcome "recovering", described as "headache"; COUGH (non-serious) with onset 25Jan2022, outcome "recovered" (25Jan2022), described as "cough"; ASTHMA (non-serious) with onset 25Jan2022, outcome "recovering", described as "Patient has asthma". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (25Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19, nasal congestion, headache. Therapeutic measures were taken as a result of cough, asthma. Clinical course: Tested positive for COVID-19 on 25Jan2022 using a home rapid test, following receipt of the primary series in Mar2021 and a booster in Oct2021. Patient reports congestion, headache and cough. Patient has asthma and required rescue inhaler medication, that resolved cough.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Mass, SARS-CoV-1 test
Clinical narrative: His arm has got some bumps on it on the side where they gave him the shot/he felt some bumps on his arm, on one arm; 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 44 year-old male patient received bnt162b2 (BNT162B2) (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: MASS (non-serious), outcome "unknown", described as "His arm has got some bumps on it on the side where they gave him the shot/he felt some bumps on his arm, on one arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that he will probably take the 2nd shot the 04Feb but has not taken the 2nd shot yet. The patient just noticed some bumps on his arm and wanted to know if it was a normal side effect.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for covid in the beginning of Jan; I tested positive for covid in the beginning of Jan; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I have 9 stents" (unspecified if ongoing), notes: I have 9 stents no insurance and no primary care provider. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "I tested positive for covid in the beginning of Jan". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.