chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Gait disturbance, Pain, Swelling
Clinical narrative: extreme pain; swelling; redness in knee joints; Great difficulty walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Oct2021 12:00 (Lot number: pfizer3592) at the age of 70 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "10 year- old-knee replacements" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9266, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 26Feb2021, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9269, Vaccine Administration Time: 12:45 PM), administration date: 07Feb2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 03Oct2021 12:45, outcome "recovered", described as "extreme pain"; SWELLING (non-serious) with onset 03Oct2021 12:45, outcome "recovered", described as "swelling"; ERYTHEMA (non-serious) with onset 03Oct2021 12:45, outcome "recovered", described as "redness in knee joints"; GAIT DISTURBANCE (non-serious) with onset 03Oct2021 12:45, outcome "recovered", described as "Great difficulty walking". Therapeutic measures were not taken as a result of pain, swelling, erythema, gait disturbance.  Additional Information: Other vaccines within 4 weeks prior to COVID vaccine and post 2 weeks of vaccination, COVID prior and post vaccination, were reported to be none. There were no known allergies reported.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood
Clinical narrative: I got really high 20 minutes after my shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bipolar disorder" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "attention issues" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "hand tremors" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing); "Known allergies: black stitches" (unspecified if ongoing); "Known allergies: plastic medical tape" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; WELLBUTRIN; PROPRANOLOL; KLONOPIN. The following information was reported: EUPHORIC MOOD (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "I got really high 20 minutes after my shot". Therapeutic measures were not taken as a result of euphoric mood.  Additional information: First does lasting about 30 minutes, No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Lot number: EW0168) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TRI LINYAH taken for contraception. Vaccination history included: Bnt162b2 (Product: COVID 19 Dose 1, Pfizer,Lot number: EW0162, left arm.), for COVID-19 Immunization, reaction(s): "Dizziness"; Bnt162b2 (Dose 1 COVID 19 Pfizer,Lot number: EW0162,left arm.), for COVID-19 Immunization, reaction(s): "Abdomen pain in the upper right quadrant"; Bnt162b2 (Dose 1 COVID 19 Pfizer, Lot number: EW0162, left arm), for COVID-19 Immunization, reaction(s): "Nausea". The following information was reported: DIZZINESS (non-serious) with onset 19Apr2021, outcome "not recovered", described as "Dizziness". The event "dizziness" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of dizziness.  Additional information: 3 days after the second dose, the dizziness started again. As of now (10May) it has gone on for two days (since 09May). The dizziness occurs on and off, and the patient frequently feel like she was going to fall over in the chair sitting in. The patient did not  received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not  diagnosed with COVID-19. Since the vaccination,  the patient did not  tested for COVID-19. No known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Swelling
Clinical narrative: slight swelling; discomfort in armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 16:00 (Lot number: 30155BA) at the age of 34 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: Bnt162b2 (dose 1, single, lot number EL8982, Location of injection: Arm Left, Vaccine Administration Time: 15:00), administration date: 30Jan2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, single, Lot Number : EN6201, Location of injection: Arm Left, Vaccine Administration Time: 15:00), administration date: 20Feb2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 23Oct2021 17:00, outcome "recovering", described as "slight swelling"; DISCOMFORT (non-serious) with onset 23Oct2021 17:00, outcome "recovering", described as "discomfort in armpit". Therapeutic measures were not taken as a result of swelling, discomfort.  Additional Information: Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Myalgia, Neuralgia
Clinical narrative: nerve pain; muscle pain; Bruise; 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 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Oct2021 (Lot number: FF2589) at the age of 47 years as dose 1,single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DIAZEPAM taken for sleep disorder. The following information was reported: NEURALGIA (non-serious) with onset 05Oct2021, outcome "recovering", described as "nerve pain"; MYALGIA (non-serious) with onset 05Oct2021, outcome "not recovered", described as "muscle pain"; CONTUSION (non-serious) with onset 05Oct2021, outcome "not recovered", described as "Bruise". Therapeutic measures were taken as a result of neuralgia, myalgia, contusion.  Additional information- It was reported that patient had received  the shot three weeks and a day ago she had been having like feels like nerve pain in my arm in my leg and now in her  leg ,her  left leg it feels like muscles 'straight', never had any of these and also reported It's a chronic pain, it feels like nerve pain it started in my right arm and it passed it on her right leg and then to her, it started in her last upper thigh, it feels like some muscle it doesn't feel like nerve pain, it feels like a muscle or muscle pain."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Rash
Clinical narrative: Not unexpectedly, I felt a little sick overnight and all day the next day; I have a rash all across my torso, front and back, similar to the rash I got after my Shingrix (shingles) shot in June; I have a rash all across my torso, front and back, similar to the rash I got after my Shingrix (shingles) shot in June; My throat and armpit are a little sore, too; My throat and armpit are a little sore, too; temp. 100 degrees; achy; tired; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Lot number: FE3590) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: INFLUENZA, start date: 30Sep2021, stop date: 30Sep2021; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (dose 2, single, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 17Mar2021, for Covid-19 immunization; Bnt162b2 (dose 1, single, Batch/Lot No: EN6202, Location of injection: Arm Left), administration date: 26Feb2021, for covid-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Not unexpectedly, I felt a little sick overnight and all day the next day"; PYREXIA (non-serious) with onset 27Oct2021, outcome "not recovered", described as "temp. 100 degrees"; PAIN (non-serious) with onset 27Oct2021, outcome "not recovered", described as "achy"; FATIGUE (non-serious) with onset 27Oct2021, outcome "not recovered", described as "tired"; RASH (non-serious), HERPES ZOSTER (non-serious) all with onset 28Oct2021, outcome "not recovered" and all described as "I have a rash all across my torso, front and back, similar to the rash I got after my Shingrix (shingles) shot in June"; OROPHARYNGEAL PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 28Oct2021, outcome "not recovered" and all described as "My throat and armpit are a little sore, too". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of illness, pyrexia, pain, fatigue, rash, herpes zoster, oropharyngeal pain, axillary pain.  Additional information: Not unexpectedly, I felt a little sick overnight and all day the next day: temp. 100 degrees, achy, tired. I have a rash all across my torso, front and back, similar to the rash I got after my Shingrix (shingles) shot in Jun. My throat and armpit are a little sore, too. Reporter stated that I did NOT get a rash after Pfizer on 1 (Feb) or on 2 (Mar). I only previously got it after shingles shot on 1 (Jun). I did NOT get a rash after my flu shot, either (30Sep- just 4 weeks ago). Now, after Pfizer 3, it has reappeared. No if covid prior vaccination. No if covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Rash erythematous, Rash macular, SARS-CoV-2 test
Clinical narrative: After 2nd dose: red spot rash over stomach, arms and legs; After 2nd dose: red spot rash over stomach, arms and legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: RASH ERYTHEMATOUS (non-serious), RASH MACULAR (non-serious) all with onset Mar2021, outcome "recovered with sequelae" and all described as "After 2nd dose: red spot rash over stomach, arms and legs". The event "after 2nd dose: red spot rash over stomach, arms and legs" and "after 2nd dose: red spot rash over stomach, arms and legs" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash erythematous, rash macular.  Additional information: Patient received third dose in Oct2021, Lo no: fh8020 in left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. There were no known allergies. Events faded after dermatoligist drugs. Treatment included Oral and topical steroids.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Oct2021 (Lot number: FH8020) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP - 20mg lisinopril. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, lot unknown reason=Unable to locate or read the details), administration date: Feb2021, when the patient was 72 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, lot unknown reason=Unable to locate or read the details, After 2nd dose: red spot rash over stomach, arms and legs.), administration date: Feb2021, when the patient was 72 years old, for Covid-19 immunization, reaction(s): "Red spot rash over stomach, arms and legs". The following information was reported: RASH (non-serious) with onset Oct2021, outcome "recovered with sequelae" (Oct2021), described as "Rash on legs". The event "rash on legs" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19 via Nasal Swab in May2021 and result was negative.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: body aches; fever; diarrhea; Headache; chills; dry heaving first night; This is a spontaneous report received from contactable reporter (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 26Oct2021 18:15 (Lot number: Fh8028) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "bradycardia" (unspecified if ongoing). Concomitant medication(s) included: MIDODRINE. Past drug history included: Penicillin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 1, lot number=Er2613, administration time=12:00 PM, vaccine location=Left arm), administration date: 18Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, lot number=Em9809, administration time=13:00 PM, vaccine location=Left arm), administration date: 08Apr2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 26Oct2021 22:00, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 26Oct2021 22:00, outcome "recovering", described as "chills"; RETCHING (non-serious) with onset 26Oct2021 22:00, outcome "recovering", described as "dry heaving first night"; PAIN (non-serious) with onset 27Oct2021, outcome "recovering", described as "body aches"; PYREXIA (non-serious) with onset 27Oct2021, outcome "recovering", described as "fever"; DIARRHOEA (non-serious) with onset 27Oct2021, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of headache, chills, retching, pain, pyrexia, diarrhoea.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19?: No. Since the vaccination, has the patient been tested for COVID-19?: No    Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: body aches; fever; diarrhea; Headache; chills; dry heaving first night; This is a spontaneous report received from contactable reporter (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 26Oct2021 18:15 (Lot number: Fh8028) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "bradycardia" (unspecified if ongoing). Concomitant medication(s) included: MIDODRINE. Past drug history included: Penicillin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 1, lot number=Er2613, administration time=12:00 PM, vaccine location=Left arm), administration date: 18Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, lot number=Em9809, administration time=13:00 PM, vaccine location=Left arm), administration date: 08Apr2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 26Oct2021 22:00, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 26Oct2021 22:00, outcome "recovering", described as "chills"; RETCHING (non-serious) with onset 26Oct2021 22:00, outcome "recovering", described as "dry heaving first night"; PAIN (non-serious) with onset 27Oct2021, outcome "recovering", described as "body aches"; PYREXIA (non-serious) with onset 27Oct2021, outcome "recovering", described as "fever"; DIARRHOEA (non-serious) with onset 27Oct2021, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of headache, chills, retching, pain, pyrexia, diarrhoea.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19?: No. Since the vaccination, has the patient been tested for COVID-19?: No    Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 2 months ago the arm they put the vaccine in started aching when, patient sleep on it and it doesn't hurt to touch it; 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 male patient received bnt162b2 (BNT162B2), administered in arm, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), administration date: Feb2021, for COVID-19 immunisation, reaction(s): "no reaction at all". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "2 months ago the arm they put the vaccine in started aching when, patient sleep on it and it doesn't hurt to touch it".  Additional information: Patient stated that received the COVID vaccine about 9 months ago and then 2 months ago his arm started hurting and his doctor does not know what is causing that. Patient said he does not believe it was related to the vaccine and did not think it was an adverse reaction. It typically happened after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hyperaesthesia, Movement disorder, Peripheral swelling, Sensitive skin
Clinical narrative: After first shot arm got swollen and 4 inches long redness; After first shot arm got swollen and 4 inches long redness; Uncomfortable to move and sensitive skin to the touch; Uncomfortable to move and sensitive skin to the touch; Uncomfortable to move and sensitive skin to the touch; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Mar2021 13:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "After first shot arm got swollen and 4 inches long redness"; MOVEMENT DISORDER (non-serious), SENSITIVE SKIN (non-serious), HYPERAESTHESIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Uncomfortable to move and sensitive skin to the touch". Therapeutic measures were taken as a result of peripheral swelling, erythema, movement disorder, sensitive skin, hyperaesthesia.  Additional information: No other vaccine received in four weeks. After first shot arm got swollen and 4 inches long redness which went away within 10 days. Uncomfortable to move and sensitive skin to the touch. The patient received treatment with Alleve 400mg. No covid prior vaccination and not tested for covid post vaccination. No known allergies. The patient did not provide information to HCP regarding the reported adverse event(s) with the use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Limb discomfort, Movement disorder, Musculoskeletal discomfort, Pain
Clinical narrative: After first shot arm got swollen and 4 inches long redness; After first shot arm got swollen and 4 inches long redness; Uncomfortable to move and sensitive skin to the touch; Uncomfortable to move and sensitive skin to the touch; Uncomfortable to move and sensitive skin to the touch; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Mar2021 13:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "After first shot arm got swollen and 4 inches long redness"; MOVEMENT DISORDER (non-serious), SENSITIVE SKIN (non-serious), HYPERAESTHESIA (non-serious) all with onset 2021, outcome "not recovered" and all described as "Uncomfortable to move and sensitive skin to the touch". Therapeutic measures were taken as a result of peripheral swelling, erythema, movement disorder, sensitive skin, hyperaesthesia.  Additional information: No other vaccine received in four weeks. After first shot arm got swollen and 4 inches long redness which went away within 10 days. Uncomfortable to move and sensitive skin to the touch. The patient received treatment with Alleve 400mg. No covid prior vaccination and not tested for covid post vaccination. No known allergies. The patient did not provide information to HCP regarding the reported adverse event(s) with the use of the product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Blood test, Investigation, Parosmia, Physical examination
Clinical narrative: tinnitus/Tinnitus Left Ear / ringing in my left ear; smelling something like, I keep smelling something burning, everything smell burnt; 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 (BNT162B2), administration date 14May2021 (Lot number: EW0176, Expiration Date: Aug2021) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (ongoing); "she had tinnitus off and on before but it was in her right ear", start date: 2009 (unspecified if ongoing), notes: Caller states she had tinnitus off and on before but it was in her right ear from something in 2009. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose: Lot: ER8727 Expiration: Jul2021), administration date: 23Apr2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 16May2021, outcome "recovered" (Aug2021), described as "tinnitus/Tinnitus Left Ear / ringing in my left ear"; PAROSMIA (non-serious) with onset 2021, outcome "unknown", described as "smelling something like, I keep smelling something burning, everything smell burnt". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus. No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus/Tinnitus Left Ear / ringing in my left ear; smelling something like, I keep smelling something burning, everything smell burnt; 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 (BNT162B2), administration date 14May2021 (Lot number: EW0176, Expiration Date: Aug2021) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (ongoing); "she had tinnitus off and on before but it was in her right ear", start date: 2009 (unspecified if ongoing), notes: Caller states she had tinnitus off and on before but it was in her right ear from something in 2009. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose: Lot: ER8727 Expiration: Jul2021), administration date: 23Apr2021, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 16May2021, outcome "recovered" (Aug2021), described as "tinnitus/Tinnitus Left Ear / ringing in my left ear"; PAROSMIA (non-serious) with onset 2021, outcome "unknown", described as "smelling something like, I keep smelling something burning, everything smell burnt". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Mar2021 (Lot number: EM9810) as dose 1, single and administered in arm left, administration date 18Apr2021 (Lot number: EW0169) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information- It was reported that patient administered drug at pharmacy store . Patient administered flu shot the week before in her Right Arm prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hypersomnia
Clinical narrative: chills for 48 hours; Injection site pain; tiredness; headache; dizziness; muscle aches; pain; needed to sleep for 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Lot number: EW0175) as dose 2, single and administered in arm left, administration date 31Mar2021 (Lot number: EP7533) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN; PEPCID.  The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills for 48 hours"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle aches"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain"; HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "needed to sleep for 24 hours".  Additional information: Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Vaccination site pain
Clinical narrative: chills for 48 hours; Injection site pain; tiredness; headache; dizziness; muscle aches; pain; needed to sleep for 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Lot number: EW0175) as dose 2, single and administered in arm left, administration date 31Mar2021 (Lot number: EP7533) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN; PEPCID.  The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills for 48 hours"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle aches"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain"; HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "needed to sleep for 24 hours".  Additional information: Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: Hives/rashes, between 2-4 inches in diameter, all over body fro m shoulder, legs, back, stomach.  Very itchy.; Hives/rashes, between 2-4 inches in diameter, all over body fro m shoulder, legs, back, stomach.  Very itchy.; Hives/rashes, between 2-4 inches in diameter, all over body fro m shoulder, legs, back, stomach.  Very itchy.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 14:00 (Lot number: FK5618) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL.  The following information was reported: PRURITUS (non-serious), URTICARIA (non-serious), RASH (non-serious) all with onset 22Nov2021 15:30, outcome "unknown" and all described as "Hives/rashes, between 2-4 inches in diameter, all over body from shoulder, legs, back, stomach. Very itchy.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; felt "really tired"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 7 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset Nov2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "felt "really tired".  Additional information: The patient received pediatric formula vaccine on 18Nov2021. He had chills and felt "really tired" over the weekend. School nurse has quarantined him and pending negative Covid tests. Reporter wants to know what was the actual protocol for quarantine?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product administration error, Product preparation error
Clinical narrative: The 8 year old received 0.2 ml undiluted orange cap; The 8 year old received 0.2 ml undiluted orange cap; The 8 year old received 0.2 ml undiluted orange cap; arms are very sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 8 year-old male patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 20Nov2021 (Lot number: FK5127) at the age of 8 years as dose 1, 0.2 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 20Nov2021, outcome "unknown" and all described as "The 8 year old received 0.2 ml undiluted orange cap"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "arms are very sore". Therapeutic measures were not taken as a result of overdose, pain in extremity.  Additional information: This is the second case out of 2 cases. Nurse stated, "her two boys received their first COVID Vaccine this weekend and after it was administration to them she was notified a little while later that they were given the vaccine without any diluent added. So, it was administered, so my 8 year received 0.2 ml of the undiluted vaccine and my 12 year old received 0.3 ml of undiluted vaccine, which both are out of a pediatric formulated vial. So I just wanted to speak with someone about, I know there has been some other instances of this happening so far they seems like they are doing okay but I wanted to talk to someone about any other information. The patient didn't experience any other side effects except soreness in both arms.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Aug2021 13:15 (Lot number: FC3181) at the age of 17 years as dose 1, single and administered in arm left, administration date 06Sep2021 14:30 (Lot number: FD8448) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "if Covid-19 prior vaccination: Yes" (unspecified if ongoing), notes: if Covid-19 prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 14Aug2021 14:00, outcome "unknown", described as "elevated heart rate"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "Since receiving Covid-19 vaccine started to have an elevated heart rate. After first dose it was in high 90 then after second dose it was in 100th". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, condition aggravated. Additional information- It was reported that patient had no medical history. No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: received their first dose of Comirnaty on 13NOV2021 and got the 2nd dose 6 days ago, 19NOV2021 with them as well; Fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) from medical information team.  A 6 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: KF5127) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 13Nov2021, when the patient was 6 years old, for COVID-19 immunization.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "received their first dose of Comirnaty on 13NOV2021 and got the 2nd dose 6 days ago, 19NOV2021 with them as well"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "Fatigue".  Additional information: Reporter stated they have 2 patients, a 5-year-old female patient and a 7-year old male patient who received their first dose of Comirnaty on 13Nov2021 and got the 2nd dose 6 days ago, 19Nov2021 with them as well. Reporter asked if the patients are considered fully vaccinated or do they need to administer a booster dose for them. Two patients received the first dose of Pfizer COVID vaccine on 13Nov2021 and was given the second dose on 19Nov2021; got the second dose from school by accident 6 days after first dose. When probed for the side effects: Reporter stated the female patient had fever and for the male he had fatigue. That's what the parent told me they don't give me too much information.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101638690 same reporter/product/event, different patients.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from 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 10Apr2021 (Lot number: EW0162) at the age of 53 years as dose 1, single and administered in arm left, administration date 01May2021 (Lot number: EW0172) as dose 2, single for covid-19 immunisation; influenza vaccine (FLU), administration date 22Oct2021 (Batch/Lot number: unknown). Relevant medical history included: "chronic headache" (unspecified if ongoing), notes: chronic headache, Has had the last 20-30 years; "migraine" (unspecified if ongoing), notes: Has had the last 20-30 years. The patient's concomitant medications were not reported. Vaccination history included: Shingles shot (AE(s) following prior vaccinations: , Felt bad after getting the shingles shot. It was after the second shot. Felt like had 24 hour flu with it. , Does not have any details to provide a lot/exp date. , This was three years ago.), for felt bad; Shingles shot, for Felt like had 24 hour flu with it.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Apr2021, outcome "recovered" (02May2021), described as "sore arm".  Additional information: Patient reported that she was fine with the first 2 shots, she had a sore arm those two times. She thought that the arm soreness began later on the day she had the vaccine and it lasted maybe 24 hours.  Follow-up (29Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: dorsum of both hands edema2+ with erythema; Dorsum of both hands edema2 with erythema and left food had; edema and erythema painful; This is a spontaneous report received from a contactable reporter(s) (Other HCP). Other Case identifier(s): US-PFIZER INC-202101642289 (Pfizer).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 13Nov2021. The following information was reported: OEDEMA PERIPHERAL (non-serious) with onset 21Nov2021, outcome "unknown", described as "dorsum of both hands edema2+ with erythema"; ERYTHEMA (non-serious) with onset 21Nov2021, outcome "unknown", described as "Dorsum of both hands edema2 with erythema and left food had"; PAIN (non-serious) with onset 21Nov2021, outcome "unknown", described as "edema and erythema painful". The events "dorsum of both hands edema2+ with erythema", "dorsum of both hands edema2 with erythema and left food had" and "edema and erythema painful" were evaluated at the physician office visit. Therapeutic measures were taken as a result of oedema peripheral, erythema, pain.  Additional information: It was unknown that patient receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient received oral Benadryl for the treatment of the event. Patient did not have covid prior vaccination, have not tested covid post vaccination and was not have any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Second dose: had a fall 02Aug2021 and fell on right hand side and had to get an operation; 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 female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 (Lot number: ER8731) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "penicillin allergy" (unspecified if ongoing), notes: Reaction: Hives. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, lot: EP6955, NDC: Unknown , Expiration: Unknown , Route of administration: left arm, Time: First dose: AM), administration date: 20Mar2021, when the patient was 65 years old, for Covid-19 immunization.  The following information was reported: FALL (non-serious) with onset 02Aug2021, outcome "unknown", described as "Second dose: had a fall 02Aug2021 and fell on right hand side and had to get an operation".  Additional information: It was reported Second dose: Patient had a fall 02Aug2021 and fell on right hand side and had to get an operation: The caller states she received the vaccines in the left arm because the caller had a fall on 02Aug2021 and fell on right hand side and had to get an operation on right shoulder. The caller clarifies the fall occurred on 02Aug2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 37 year-old male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Lot number: EW0172) as dose 1, single and administration date 03May2021 (Lot number: EW0183) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "Tinnitus-ringing in ears". Additional information: Reporter reported that 37 year old son has expressed to me the same symptoms, tinnitus. He had continued to experience the same side effects to date as well. He had 2 shots. His lot numbers for the two shots and dates Were lot EW0172 03May2021 Lot EW0183 01Apr2021. No follow-up attempts are possible. No further information is expected.