chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: body broke out in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 17:00 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 05Apr2021, when the patient was 39 years old, for Covid-19 immunization, reaction(s): "No adverse effect"; Bnt162b2 (Dose 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 05Mar2021, when the patient was 39 years old, for Covid-19 immunization, reaction(s): "No adverse effect". The following information was reported: URTICARIA (non-serious) with onset 15Dec2021 06:00, outcome "recovering", described as "body broke out in hives". Therapeutic measures were not taken as a result of urticaria.  Additional Information: It was stated that, when she woke it was fine but after an hour body broke out in hives. They completely covered legs from the knee up, and they were on arms as well. The patient was not tested to Covid post vaccination.  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: Rash, SARS-CoV-2 antibody test
Clinical narrative: Full body rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 12:00 (Lot number: FK5127) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VYVANSE; GUANFACINE; DEXTROAMPHETAMINE HYDROCHLORIDE. The following information was reported: RASH (non-serious) with onset Nov2021, outcome "not recovered", described as "Full body rash". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash.  Follow-Up (29Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia, Palpitations
Clinical narrative: Heart burn; heart palpitations; chest pains; 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 male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Aug2021 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPEPSIA (non-serious) with onset 2021, outcome "unknown", described as "Heart burn"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "heart palpitations"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "chest pains". Therapeutic measures were not taken as a result of dyspepsia, palpitations, chest pain. Additional information: Patient receive  did not any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Neuralgia, Pain, Varicella
Clinical narrative: got the nerve ending pain; I didn't get shingles; I got all the pain of shingles/it is just a little sore; imbibing the chickenpox virus in my body; I have croaky voice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jun2021 (Lot number: EW0178) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "shingles", start date: 2020 (unspecified if ongoing), notes: I have had really bad case of shingles (later clarified) in the Nov and Dec last year. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Lot number: EW0178 , that's what on both of them.), administration date: 01Jun2021, when the patient was 77 years old, for COVID-19 Immunization. The following information was reported: NEURALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "got the nerve ending pain"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "I didn't get shingles; I got all the pain of shingles/it is just a little sore"; VARICELLA (non-serious) with onset 2021, outcome "recovered" (2021), described as "imbibing the chickenpox virus in my body"; DYSPHONIA (non-serious) with onset 2021, outcome "recovered", described as "I have croaky voice". The events "got the nerve ending pain", "i didn't get shingles; i got all the pain of shingles/it is just a little sore", "imbibing the chickenpox virus in my body" and "i have croaky voice" were evaluated at the physician office visit. Therapeutic measures were taken as a result of neuralgia, pain.  Additional information: Patient stated, this is happened to after got second injection. Patient had not shingles but patient got the nerve ending pain. Patient got all the pain of shingles for 2 and half weeks. Time of vaccination: May be between 4:30 and 5:00 clock. Start date of edverse events, it was probably thinking little may be 2, 3 4 days because patient had it for 2 and half weeks and I ended up going to patient doctor's. Patient still not experiencing, it lasted 2 and half weeks and it was gone. Patient went to the doctor, patient looked out it whatever patient husband and patient got whatever those patches are for pain and stuff like that we put on top of it so that I sleep at night.  Follow-up (22Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Flushing, Headache, Neck pain
Clinical narrative: Sever upper back and neck pain at 5pm; Sever upper back and neck pain at 5pm; Shivering uncontrollably; Face very flushed; Woke up with headache.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 18:30 (Lot number: FJ8762) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: ZITHROMAX.  The following information was reported: HEADACHE (non-serious) with onset 15Dec2021 08:00, outcome "not recovered", described as "Woke up with headache."; CHILLS (non-serious) with onset 15Dec2021 16:00, outcome "not recovered", described as "Shivering uncontrollably"; FLUSHING (non-serious) with onset 15Dec2021 16:00, outcome "not recovered", described as "Face very flushed"; BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset 15Dec2021 17:00, outcome "not recovered" and all described as "Sever upper back and neck pain at 5pm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, back pain, neck pain. Therapeutic measures were not taken as a result of chills, flushing.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported no. No Prolonged Hospitalization. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as yes. Since the vaccination, has the patient been tested for COVID-19 was reported as yes.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Sever upper back and neck pain at 5pm; Sever upper back and neck pain at 5pm; Shivering uncontrollably; Face very flushed; Woke up with headache.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Dec2021 18:30 (Lot number: FJ8762) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: ZITHROMAX.  The following information was reported: HEADACHE (non-serious) with onset 15Dec2021 08:00, outcome "not recovered", described as "Woke up with headache."; CHILLS (non-serious) with onset 15Dec2021 16:00, outcome "not recovered", described as "Shivering uncontrollably"; FLUSHING (non-serious) with onset 15Dec2021 16:00, outcome "not recovered", described as "Face very flushed"; BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset 15Dec2021 17:00, outcome "not recovered" and all described as "Sever upper back and neck pain at 5pm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, back pain, neck pain. Therapeutic measures were not taken as a result of chills, flushing.  Additional Information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported no. No Prolonged Hospitalization. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as yes. Since the vaccination, has the patient been tested for COVID-19 was reported as yes.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: experience daily crazy itchness; hives (full body, except face); allergy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 08:30 (Lot number: EW0175) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild with shrimp" (unspecified if ongoing), notes: Known allergies: Mild with shrimp an seafood.; "Seafood" (unspecified if ongoing), notes: Known allergies: Mild with shrimp an seafood.; "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 14Apr2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 30May2021, outcome "not recovered", described as "experience daily crazy itchness"; URTICARIA (non-serious) with onset 30May2021, outcome "not recovered", described as "hives (full body, except face)"; HYPERSENSITIVITY (non-serious) with onset 30May2021, outcome "not recovered", described as "allergy".  Adverse event: Since the 2nd dose consumer have been experience daily crazy itchness follow by hives (full body, except face). After self-test different antihistamines, the only one that temporarily stop the allergy was the Cetirize. Consumer just would like to know if was safe for her to get the booster because she don't wanna get worse than what she have been experienced. The patient had not been tested for covid post vaccination. Covid prior vaccination. The patient had not been tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea
Clinical narrative: Chest Pain; Dizzy; Hard time breathing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Aug2021 19:00 (Lot number: FC3182, Expiration Date: 31Oct2021) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 19Sep2021 20:00, outcome "not recovered", described as "Chest Pain"; DIZZINESS (non-serious) with onset 19Sep2021 20:00, outcome "not recovered", described as "Dizzy"; DYSPNOEA (non-serious) with onset 19Sep2021 20:00, outcome "not recovered", described as "Hard time breathing". The events "chest pain", "dizzy" and "hard time breathing" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of chest pain, dizziness, dyspnoea. Additional information: The patient did not receive any other vaccine within four weeks and patient did not receive any other vaccine within two weeks. The patient has not been tested for covid prior to vaccination. The patient was not covid prior to vaccination. No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Headache, Pain
Clinical narrative: red welt at injection site; red welt at injection site; headache; fever; SOB; aches, pains; chills; arm sore; lungs burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Dec2021 14:00 (Lot number: 3302680) at the age of 51 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 Number: 2, Batch/Lot No: en9581, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE REACTION (non-serious), URTICARIA (non-serious) all with onset 15Dec2021 01:00, outcome "recovering" and all described as "red welt at injection site"; HEADACHE (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "headache"; PYREXIA (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "fever"; DYSPNOEA (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "SOB"; PAIN (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "aches, pains"; CHILLS (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "arm sore"; PLEURITIC PAIN (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "lungs burning". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vaccination site reaction, urticaria, headache, pyrexia, dyspnoea, pain, chills, pain in extremity, pleuritic pain.  Additional Information:if other vaccine in fourweeks: No.other medications in twoweeks: NO.Ae resulted in: None of the above.if covid prior vaccination: No.if covid tested post vaccination: No.other medical history: n/a.known allergies: No.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pleuritic pain, Pyrexia, Urticaria, Vaccination site reaction
Clinical narrative: red welt at injection site; red welt at injection site; headache; fever; SOB; aches, pains; chills; arm sore; lungs burning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Dec2021 14:00 (Lot number: 3302680) at the age of 51 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 Number: 2, Batch/Lot No: en9581, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE REACTION (non-serious), URTICARIA (non-serious) all with onset 15Dec2021 01:00, outcome "recovering" and all described as "red welt at injection site"; HEADACHE (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "headache"; PYREXIA (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "fever"; DYSPNOEA (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "SOB"; PAIN (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "aches, pains"; CHILLS (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "arm sore"; PLEURITIC PAIN (non-serious) with onset 15Dec2021 01:00, outcome "recovering", described as "lungs burning". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vaccination site reaction, urticaria, headache, pyrexia, dyspnoea, pain, chills, pain in extremity, pleuritic pain.  Additional Information:if other vaccine in fourweeks: No.other medications in twoweeks: NO.Ae resulted in: None of the above.if covid prior vaccination: No.if covid tested post vaccination: No.other medical history: n/a.known allergies: No.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over body; itchiness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Dec2021 10:00 (Lot number: FK5127) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "was diagnosed with influenza about 3 weeks prior" (unspecified if ongoing). Concomitant medication(s) included: ROBITUSSIN [GUAIFENESIN]; DAYQUIL. The following information was reported: URTICARIA (non-serious) with onset 12Dec2021 12:00, outcome "not recovered", described as "Hives all over body"; PRURITUS (non-serious) with onset 12Dec2021 12:00, outcome "not recovered", described as "itchiness". The events "hives all over body" and "itchiness" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria, pruritus.  Additional information:  The patient did not receive any other vaccine within 4 weeks. The patient was received adverse event treatment prednisone then Benadryl and allegra. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rashes on the back and some on neck and nose; itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 14:45 (Lot number: F10007) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "digestive problems" (unspecified if ongoing). Concomitant medication(s) included: PAPAYA DIGESTIVE ENZYME COMPLEX. The following information was reported: RASH (non-serious) with onset 27Nov2021 18:30, outcome "recovering", described as "rashes on the back and some on neck and nose"; PRURITUS (non-serious) with onset 27Nov2021 18:30, outcome "recovering", described as "itchy". Therapeutic measures were not taken as a result of rash, pruritus. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema
Clinical narrative: red circle and bruising on my arm; red circle and bruising on my arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing); "Drug allergies: NKDA" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), CONTUSION (non-serious), outcome "unknown" and all described as "red circle and bruising on my arm".  Additional information: Clinical course: It was reported that patient had a reaction to Pfizer covid shot. She got a red circle and bruising on her arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: chills/freezing cold; pain in left arm pit; Left arm pit is slightly swollen; feverish; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202101814636 (Pfizer).  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Dec2021 14:00 (Lot number: FL3197) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Yes - allergic to certain tree nuts: allergy to legumes" (unspecified if ongoing), notes: Yes - allergic to certain tree nuts. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Jun2021, when the patient was 16 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26May2021, when the patient was 16 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 16Dec2021 22:00, outcome "recovered" (17Dec2021 11:00), described as "Headache"; PYREXIA (non-serious) with onset 17Dec2021 02:30, outcome "recovered" (17Dec2021 11:00), described as "feverish"; CHILLS (non-serious) with onset 17Dec2021 09:30, outcome "recovered" (17Dec2021 11:00), described as "chills/freezing cold"; AXILLARY PAIN (non-serious) with onset 17Dec2021 02:30, outcome "not recovered", described as "pain in left arm pit"; LYMPHADENOPATHY (non-serious) with onset 17Dec2021 02:30, outcome "not recovered", described as "Left arm pit is slightly swollen". Therapeutic measures were not taken as a result of headache, pyrexia, chills, axillary pain, lymphadenopathy.  Clinical course: Headache starting at 10 pm on 16Dec2021; then feverish; at 2:30 am on 17Dec2021 chills/freezing cold, headache; at 9:30am on 17Dec2021 chills, feverish, headache; At 11am on 17Dec2021 felt fine and no more symptoms. Adverse event start date: 16Dec2021 at 10:00 PM. If covid prior vaccination: No. If covid tested post vaccination: No. Additional symptom of pain in left arm pit which started 2:30am on 17Dec2021 and has not resolved. Left arm pit is slightly swollen. This symptom was not previously reported. Adverse event start date: 17Dec2021, Adverse event start time: 02:30 PM.  Additional information: The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Known allergies: Allergy to some tree nuts  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report received from a noncontactable other HCP (parent). A 7-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced pyrexia (fever), pain in extremity (arm pain), pain (body ache), with outcome of not recovered; and headache, with outcome of unknown. Therapeutic measures were taken as a result of pyrexia, pain in extremity, pain and headache. No follow-up attempts possible. No further information expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Giant sized golf ball hives swollen and enlarged; red and itchy on my throat and neck area in one spot; red and itchy on my throat and neck area in one spot; Giant sized golf ball hives swollen and enlarged; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 15:00 (Batch/Lot number: unknown) at the age of 7 years as dose1, single for covid-19 immunisation. Relevant medical history included: "ASTHMA" (unspecified if ongoing); "seasonal allergie" (unspecified if ongoing); "dog allergy" (unspecified if ongoing); "bug bites" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing); "Chronic otitis media" (unspecified if ongoing); "mild asthama" (unspecified if ongoing), notes: Family history: mild asthma. Family history included: "speech delay" (unspecified if ongoing). Concomitant medication(s) included: GUANFACINE HCL taken for attention deficit hyperactivity disorder (ongoing); ALBUTEROL HFA taken for asthma (ongoing); VENTOLIN HFA taken for asthma (ongoing). The following information was reported: URTICARIA (non-serious), SWELLING (non-serious) all with onset 16Dec2021 15:30, outcome "not recovered" and all described as "Giant sized golf ball hives swollen and enlarged"; ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 16Dec2021 15:30, outcome "not recovered" and all described as "red and itchy on my throat and neck area in one spot". Therapeutic measures were taken as a result of urticaria, erythema, pruritus, swelling.  Additional information: Adverse event -Giant sized golf ball hives swollen and enlarged and red and itchy on my throat and neck area in one spot 30 minutes after I got the shot hasn't gone away even took Benadryl and used the tropical cream. Patient had covid  prior vaccination. Patient was not covid tested post vaccination. It was unknown whether patient had known allergies. Patient did not had any other vaccinations within four weeks prior to the first administration date of the suspect vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Capillary disorder, Capillary fragility, Gingival bleeding, SARS-CoV-2 antibody test
Clinical narrative: Broken blood capillaries; Broken blood capillaries; bleeding gum; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Apr2021 13:30 (Lot number: EW0158) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "rls" (unspecified if ongoing); "migraines" (unspecified if ongoing); "mitral valve insufficiency" (unspecified if ongoing); "Appendectomy", start date: 16Sep2001 (unspecified if ongoing), notes: Surgery-16Sep2001; "Carpal tunnel release", start date: 1997 (unspecified if ongoing), notes: Surgery-Jun2003; "Deviated septum" (unspecified if ongoing), notes: Surgery-Jun2005. Concomitant medication(s) included: SERTRALINE HYDROCHLORIDE taken for anxiety, start date: 2000 (ongoing); TOPIRAMATE taken for migraine, start date: 2013 (ongoing); L-GLUTAMINE [GLUTAMIC ACID]; CURCUMIN. Past drug history included: Vicodin, reaction(s): "known allergies: vicodin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM, Route of administration: Intramuscular), administration date: 27Mar2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: CAPILLARY FRAGILITY (non-serious), CAPILLARY DISORDER (non-serious) all with onset 27Apr2021 07:00, outcome "recovered" and all described as "Broken blood capillaries"; GINGIVAL BLEEDING (non-serious) with onset 27Apr2021 07:00, outcome "recovered", described as "bleeding gum". The event "bleeding gum" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of capillary fragility, capillary disorder. Therapeutic measures were taken as a result of gingival bleeding.  Additional information: The patient had not other vaccine in 4 weeks. Event broken blood capillaries on right side of neck and bleeding gum on upper right side of mouth. Patient had not covid prior vaccination and had not covid tested post vaccination. The patient had not received prior vaccinations within 4 weeks. Adverse event term was 4 months for gum bleeding. Patient visited to physician office (dentist) for adverse event. The patient had received treatment with peroxil mouthwash. Patient stated, after second dose of pfizer shot, developed broken blood vessels on the right side of neck along with upper right side gums bleeding. This started 7-10 days after the shot. The broken blood vessels healed, disappeared within a week but the gum bleeding lasted about 4 months.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nervousness, Pyrexia, Swelling
Clinical narrative: Left armpit blew up; Fever; Swollen glands in my armpit; little nervous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Lot number: EN6207) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for pain; ADDERALL; OMEPRAZOLE; DULOXETINE; OXAL; TURMERIC [CURCUMA LONGA RHIZOME]. Vaccination history included: Bnt162b2 (1st dose of covid vaccine, lot number:EN6203), administration date: 26Feb2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Left armpit blew up"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Swollen glands in my armpit"; NERVOUSNESS (non-serious) with onset 2021, outcome "unknown", described as "little nervous".  Additional information: Additional information: seriousness and onset dates of the events was unspecified. Patient was received other medications and start and stop dates of concomitants was unspecified. As the patient is the reporter states that she had reaction to the Pfizer treatment, after the second shot on her left armpit blew up so, she was little nervous about getting the booster in Pfizer and she did not know if, could recommend Moderna or Johnson and Johnson, but Johnson & Johnson just came out and said that there is this causing blood clots (general statement)." Age at the time of adverse event, Consumer stated, "her age was 67, and do not understand what else you said, At time it was 66, she guess and do not know that do not keep tracking and all think withheld (Further not clarified appropriately, hence not captured in tab)", patient took treatment for the chronic pain (History) so I take Advil and pain patches. There were no prior vaccinations, Consumer stated, she had the injection at withheld drive through location.  withheld at withheld, this is where it was" Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information department and provided with the number as withheld and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday. consumer was informed that Pfizer might contact the consumer in case further information is required.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OCREVUS. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, SARS-CoV-2 test
Clinical narrative: loss of smell after 2nd shot. consistent issues since that second series; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 10:45 (Lot number: EN6198) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HYPOTHYROID" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing); "Allergies: Some Cephalosporins" (unspecified if ongoing). Concomitant medication(s) included: WILD YAMS; MACA [LEPIDIUM MEYENII]; SOYA LECITHIN. Past drug history included: Amoxicillan, reaction(s): "Allergies: Amoxicillin"; Doxycycline, reaction(s): "Allergies: Doxycycline". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN9581, Location of injection: Arm Left, Vaccine Administration Time: 04:30 PM), administration date: 29Jan2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: ANOSMIA (non-serious) with onset 25Feb2021, outcome "not recovered", described as "loss of smell after 2nd shot. consistent issues since that second series". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anosmia.  Additional information: loss of smell after 2nd shot. consistent issues since that second series. never recovered prior enhanced smell since then. Patient received Nasal Spray as treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.   Follow-Up: Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: fever; Headache; Throat hurting; She is having sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 15Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Dec2021, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset Dec2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "Throat hurting"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "not recovered", described as "She is having sore arm". Therapeutic measures were taken as a result of pyrexia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Blood pressure abnormal, Blood pressure measurement
Clinical narrative: I am sick; Feeling weak, tired and drowsy; I am having terrible headaches; Feeling weak, tired and drowsy; Feeling weak, tired and drowsy; dizzy; nervous; "has blood pressure" everyday; had shoulder, back, neck, and knee pain; had shoulder, back, neck, and knee pain; had shoulder, back, neck, and knee pain; had shoulder, back, neck, and knee pain; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A 45 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH8030) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Osteoarthritis" (unspecified if ongoing), notes: Verbatim: Osteoarthritis; "Spinal stenosis" (unspecified if ongoing), notes: Verbatim: Spinal stenosis; "Migraine headache" (unspecified if ongoing), notes: Verbatim: Migraine headache; "Hypersensitivity" (unspecified if ongoing), notes: Verbatim: Allergy. The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I am sick"; ASTHENIA (non-serious), FATIGUE (non-serious), outcome "not recovered" and all described as "Feeling weak, tired and drowsy"; HEADACHE (non-serious), outcome "unknown", described as "I am having terrible headaches"; SOMNOLENCE (non-serious), outcome "unknown", described as "Feeling weak, tired and drowsy"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; NERVOUSNESS (non-serious), outcome "unknown", described as "nervous"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as ""has blood pressure" everyday"; ARTHRALGIA (non-serious), BACK PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "had shoulder, back, neck, and knee pain"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, arthralgia, back pain, neck pain, arthralgia, myalgia.  Additional Information: No prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Laboratory test, Malaise
Clinical narrative: I am sick; Feeling weak, tired and drowsy; I am having terrible headaches; Feeling weak, tired and drowsy; Feeling weak, tired and drowsy; dizzy; nervous; "has blood pressure" everyday; had shoulder, back, neck, and knee pain; had shoulder, back, neck, and knee pain; had shoulder, back, neck, and knee pain; had shoulder, back, neck, and knee pain; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A 45 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH8030) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Osteoarthritis" (unspecified if ongoing), notes: Verbatim: Osteoarthritis; "Spinal stenosis" (unspecified if ongoing), notes: Verbatim: Spinal stenosis; "Migraine headache" (unspecified if ongoing), notes: Verbatim: Migraine headache; "Hypersensitivity" (unspecified if ongoing), notes: Verbatim: Allergy. The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I am sick"; ASTHENIA (non-serious), FATIGUE (non-serious), outcome "not recovered" and all described as "Feeling weak, tired and drowsy"; HEADACHE (non-serious), outcome "unknown", described as "I am having terrible headaches"; SOMNOLENCE (non-serious), outcome "unknown", described as "Feeling weak, tired and drowsy"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; NERVOUSNESS (non-serious), outcome "unknown", described as "nervous"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as ""has blood pressure" everyday"; ARTHRALGIA (non-serious), BACK PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "had shoulder, back, neck, and knee pain"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, arthralgia, back pain, neck pain, arthralgia, myalgia.  Additional Information: No prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Nervousness, Somnolence
Clinical narrative: I am sick; Feeling weak, tired and drowsy; I am having terrible headaches; Feeling weak, tired and drowsy; Feeling weak, tired and drowsy; dizzy; nervous; "has blood pressure" everyday; had shoulder, back, neck, and knee pain; had shoulder, back, neck, and knee pain; had shoulder, back, neck, and knee pain; had shoulder, back, neck, and knee pain; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A 45 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH8030) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Osteoarthritis" (unspecified if ongoing), notes: Verbatim: Osteoarthritis; "Spinal stenosis" (unspecified if ongoing), notes: Verbatim: Spinal stenosis; "Migraine headache" (unspecified if ongoing), notes: Verbatim: Migraine headache; "Hypersensitivity" (unspecified if ongoing), notes: Verbatim: Allergy. The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I am sick"; ASTHENIA (non-serious), FATIGUE (non-serious), outcome "not recovered" and all described as "Feeling weak, tired and drowsy"; HEADACHE (non-serious), outcome "unknown", described as "I am having terrible headaches"; SOMNOLENCE (non-serious), outcome "unknown", described as "Feeling weak, tired and drowsy"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; NERVOUSNESS (non-serious), outcome "unknown", described as "nervous"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as ""has blood pressure" everyday"; ARTHRALGIA (non-serious), BACK PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "had shoulder, back, neck, and knee pain"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, arthralgia, back pain, neck pain, arthralgia, myalgia.  Additional Information: No prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body temperature, Cough, Headache, Pyrexia
Clinical narrative: cough; Running a fever; Got a fever; Really bad headache; Headache lasted for couple of hours; She took the shower and she got really light headache; She is vomiting; Today she is throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient received bnt162b2 (BNT162B2), administration date 18Dec2021 13:20 (Lot number: FL0007, Expiration Date: 12Jan2022) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT.  The following information was reported: COUGH (non-serious), outcome "not recovered", described as "cough"; PYREXIA (non-serious), outcome "not recovered", described as "Running a fever; Got a fever"; VOMITING (non-serious) with onset 19Dec2021, outcome "not recovered", described as "She was vomiting; Today she was throwing up"; HEADACHE (non-serious), outcome "not recovered", described as "Really bad headache; Headache lasted for couple of hours; She took the shower and she got really light headache". Relevant laboratory tests and procedures were available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Reporter gave to patient, 200mg Advil last night for fever and it helped for fever.  Additional information included: Reporter stated, the patient was approximately 5 foot tall, and 90 pounds (reporter was not sure hence not captured in tab). Date of vaccination: Reporter stated, Dose 1 received on Saturday, 18Dec2021 at 1:20 pm on her left. The patient had no any vaccination 4 weeks prior to COVID 19 Vaccine. Reporter stated, she had asthma, so she was taking her asthma medications, she took Flovent and reporter don't had the box that had her information. Reporter stated, the fever she started, first she got really bad headache a really bad headache, and an hour after she had 'cough' and the headache lasted for couple of hours and then she got a fever and then today she was throwing up. Still experienced.  Follow-up attempts are completed. No further information is expected.