chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Axillary pain, Dizziness, Fatigue, Headache
Clinical narrative: Severe headache; very severe nausea; dizziness; rash on arms; tingling arms, upper back, & neck; pain in armpits & stomach; pain in armpits & stomach; extreme fatigue; 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 patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 (Lot number: Fe3590) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillin allergies" (unspecified if ongoing); "Suphanomides allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "chronic lyme disease" (unspecified if ongoing); "HBp" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: PRISTIQ; VYVANSE; LOSARTAN; CARVEDILOL; SYNTHROID. Past drug history included: Codein, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: GNG200, Location of injection: Arm Left), administration date: 23Feb2021, when the patient was 71 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 03Nov2021, outcome "recovered" (Nov2021), described as "Severe headache"; NAUSEA (non-serious) with onset 03Nov2021, outcome "recovered" (Nov2021), described as "very severe nausea"; DIZZINESS (non-serious) with onset 03Nov2021, outcome "recovered" (Nov2021), described as "dizziness"; RASH (non-serious) with onset 03Nov2021, outcome "recovered" (Nov2021), described as "rash on arms"; PARAESTHESIA (non-serious) with onset 03Nov2021, outcome "recovered" (Nov2021), described as "tingling arms, upper back, & neck"; AXILLARY PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 03Nov2021, outcome "recovered" (08Nov2021) and all described as "pain in armpits & stomach"; FATIGUE (non-serious) with onset 03Nov2021, outcome "recovered" (Nov2021), described as "extreme fatigue". Therapeutic measures were not taken as a result of headache, nausea, dizziness, rash, paraesthesia, axillary pain, abdominal pain upper, fatigue.  Additional information: It was unknown if prior to vaccination, the was patient diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Rash
Clinical narrative: Severe headache; very severe nausea; dizziness; rash on arms; tingling arms, upper back, & neck; pain in armpits & stomach; pain in armpits & stomach; extreme fatigue; 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 patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 (Lot number: Fe3590) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Penicillin allergies" (unspecified if ongoing); "Suphanomides allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "chronic lyme disease" (unspecified if ongoing); "HBp" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: PRISTIQ; VYVANSE; LOSARTAN; CARVEDILOL; SYNTHROID. Past drug history included: Codein, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: GNG200, Location of injection: Arm Left), administration date: 23Feb2021, when the patient was 71 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 03Nov2021, outcome "recovered" (Nov2021), described as "Severe headache"; NAUSEA (non-serious) with onset 03Nov2021, outcome "recovered" (Nov2021), described as "very severe nausea"; DIZZINESS (non-serious) with onset 03Nov2021, outcome "recovered" (Nov2021), described as "dizziness"; RASH (non-serious) with onset 03Nov2021, outcome "recovered" (Nov2021), described as "rash on arms"; PARAESTHESIA (non-serious) with onset 03Nov2021, outcome "recovered" (Nov2021), described as "tingling arms, upper back, & neck"; AXILLARY PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious) all with onset 03Nov2021, outcome "recovered" (08Nov2021) and all described as "pain in armpits & stomach"; FATIGUE (non-serious) with onset 03Nov2021, outcome "recovered" (Nov2021), described as "extreme fatigue". Therapeutic measures were not taken as a result of headache, nausea, dizziness, rash, paraesthesia, axillary pain, abdominal pain upper, fatigue.  Additional information: It was unknown if prior to vaccination, the was patient diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Myalgia, X-ray
Clinical narrative: Strong muscle pain/strong muscle pain that moved around the body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 82 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 25Jan2021 (Lot number: EL9261, Expiration Date: May2021) at the age of 82 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: MYALGIA (non-serious) with onset 27Jan2021, outcome "not recovered", described as "Strong muscle pain/strong muscle pain that moved around the body". The event "strong muscle pain/strong muscle pain that moved around the body" 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 myalgia. Additional information: prior to Vaccination the patient did not receive any other vaccination within four weeks prior to vaccination. No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Pyrexia
Clinical narrative: fever; felt lousy; chills; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 11Nov2021 (Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: HPV VACCINE taken for immunisation, administration date 26Oct2021. The following information was reported: FEELING ABNORMAL (non-serious) with onset 12Nov2021 19:00, outcome "not recovered", described as "felt lousy"; CHILLS (non-serious) with onset 12Nov2021 19:00, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 13Nov2021, outcome "not recovered", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pyrexia.  Additional information: Shot received on Thursday, withheld  on Friday, had chills on Friday night. Saturday morning had fever and chills with a temperature of 100.8 one hour after receiving Ibuprofen. Prior to vaccination, was the patient diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Next day after second dose, soreness and stiffness in arm; Next day after second dose, soreness and stiffness in arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 09:00 (Lot number: FF2587) at the age of 14 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, Batch/Lot No: FC3182, Location of injection: Arm Right, 1 week after first dose, grand maul seizure and hospitalization occurred), administration date: 17Sep2021, when the patient was 14 years old, for COVID-19 immunization, reaction(s): "grand maul seizure". The following information was reported: PAIN IN EXTREMITY (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "Next day after second dose, soreness and stiffness in arm". No follow-up attempts are possible. No further information is expected.  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 not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling in left foot; Numbness in foot; Tingling in left arm/tingling on left side; Numbness in left foot/Numbness in whole body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in left arm/tingling on left side), PARAESTHESIA (Tingling in left foot), HYPOAESTHESIA (Numbness in left foot/Numbness in whole body) and HYPOAESTHESIA (Numbness in foot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa medications). Concomitant products included MULTIVITAMINS [VITAMINS NOS] and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Aug-2021, the patient experienced PARAESTHESIA (Tingling in left arm/tingling on left side) and HYPOAESTHESIA (Numbness in left foot/Numbness in whole body). On 26-Aug-2021, the patient experienced PARAESTHESIA (Tingling in left foot) and HYPOAESTHESIA (Numbness in foot). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 25-Aug-2021 for Numbness and Tingling, at an unspecified dose and frequency. On 25-Aug-2021, PARAESTHESIA (Tingling in left arm/tingling on left side) and HYPOAESTHESIA (Numbness in left foot/Numbness in whole body) had resolved. At the time of the report, PARAESTHESIA (Tingling in left foot) and HYPOAESTHESIA (Numbness in foot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that, within 15 minutes of receiving the vaccine, patient started experiencing numbness in her left foot and tingling in her left arm. It went away while the patient was being observed, so she left the vaccination facility and went home. Several hours later, after about 3 hours of receiving the vaccine, patient was laying in bed and started experiencing numbness in her whole left side of the body. It went on for several hours. Patient took Tylenol and eventually the numbness and tingling went away. However, the next evening, patient was still experiencing numbness and tingling in her left foot. It lasted only for a few days before subsiding completely.   The patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   This case was linked to MOD-2022-507620 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Skin abrasion, Skin reaction, Swelling
Clinical narrative: Bumps swell up and are indented in the middle; Bumps swell; they are all over her face, neck, arms and chest and that they scar her skin.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN ABRASION (non-serious), outcome "unknown", described as "Bumps swell up and are indented in the middle"; SWELLING (non-serious), outcome "unknown", described as "Bumps swell"; SKIN REACTION (non-serious), outcome "unknown", described as "they are all over her face, neck, arms and chest and that they scar her skin.".  Information about lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 24Sep2021 17:45 (Lot number: FF8839) as dose 3 (booster),single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Gout" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); AMLODIPINE;HYDROCHLOROTHIAZIDE;LOSARTAN taken for hypertension (ongoing); VICTOZA taken for diabetes mellitus (ongoing); ALLOPURINOL taken for gout (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, Anatomical site of injection: L Deltoid, Batch/Lot number : EL3249), administration date: 15Jan2021, for Covid-19 immunization; Bnt162b2 (DOSE 2, Anatomical site of injection: L Deltoid, Batch/Lot number : EL9269), administration date: 05Feb2021, for Covid-19 immunization. The following information was reported: Rash(non-serious), outcome "unknown", described as "rash".  Additional Information:Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? Yes,If yes above, do you consider the Pfizer product had a causal effect to the adverse event? Yes.Conservation with another person who referenced rash very similar after 2nd shot so reached out to Pfizer All above dates are reconstructed no documentation time on occurrence.  Follow-up (16Dec2021): Follow-up attempts completed. No further information expected.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms
Clinical narrative: muscle cramps; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 25Oct2021 (Batch/Lot number: unknown) as dose 3(booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 01), for COVID-19 immunization; Bnt162b2 (DOSE 02), for COVID-19 immunization; Flu vaccine (Caller mentioned she had trouble with the flu shot as well.). The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "muscle cramps"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain". Therapeutic measures were taken as a result of muscle spasms, arthralgia.  Additional Information: Caller had received her booster dose of Comirnaty vaccine on 25Oct2021, and she has been experiencing joint pain and muscle cramps. She has doubled the dose of her potassium and Magnesium intake and wants to know what's the percentage of the reported side effects she is experiencing and how long these side effects will last? Caller mentioned she had trouble with the flu shot as well. Caller mentioned that she has talked to Safety department before hand and has reported her symptoms. Dept: E-transmitting potential duplicate AE, No further information such as age was obtained. Caller wanted to know what is Pfizer recommendation regarding taking additional supplement and vitamins for joint paint and muscle ache.   Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: injection site soreness; Fatigue; general body myalgia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization. The following information was reported: INJECTION SITE PAIN (non-serious), outcome "recovered", described as "injection site soreness"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue"; MYALGIA (non-serious), outcome "recovered", described as "general body myalgia". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus, Weight
Clinical narrative: trouble hearing; ear ringing, There is always something buzzing in her ear.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101418501 (Pfizer), US-PFIZER INC-202101418503 (Pfizer).  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 14:00 (Lot number: EW0196, Expiration Date: 30Sep2021) at the age of 51 years as dose 1, single and administration date 13Oct2021 14:00 (Lot number: FF8841) as dose 2, single for covid-19 immunisation. Relevant medical history included: "shingles", start date: 2007 (unspecified if ongoing), notes: In 2007 she got shingles from a flu vaccine. Concomitant medication(s) included: FLU VACCINE VII, administration date 11Oct2021. Vaccination history included: Flu vaccine (she get the flu vaccine every year), for Immunization. The following information was reported: TINNITUS (non-serious) with onset 23Sep2021, outcome "not recovered", described as "ear ringing, There is always something buzzing in her ear."; HYPOACUSIS (non-serious), outcome "not recovered", described as "trouble hearing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, hypoacusis.  Additional information: reporter, reporting on the covid vaccine and who states she is calling to report her experience after getting the shot. The caller states her ear has been ring since the day after getting first shot and has gotten more prominent after second, it is unbearable. There is always something buzzing in her ear, she has no peace. This has been going for has been three weeks and she is really concerned.  Reporter then reports that she thought it would stop but now, 3 to 4 weeks later it is still going on. First dose- 22sep2021, given about 2pm in the left arm, lot-ew0196. Second dose-13oct2021 given about 2pm in the left arm, lot-ff8841.  She does not take any medication. No treatment. Time the vaccination was given about 2pm. Vaccine was not administered at a facility. History of all previous immunization with the pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. No additional vaccines administered on same date of the pfizer suspect. No emergency room physician office. Prior vaccinations (within 4 weeks) 2 days before the second dose she got the flu shot, caller states the product was flulazal quad by gsk biomedics. She has no ndc, lot, or expiry. In 2007 she got shingles from a flu vaccine, she get the flu vaccine every year but this is the only time she had something happen. She has no product name, ndc, lot, or expiry for that product. Patients medical history and relevant tests (including any illness at time of vaccination) reported as none.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acne, Inappropriate schedule of product administration, Overdose, Urine odour abnormal, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 43-year-old male patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD8448 and FA6780), at the age of 43, in right arm, Aug 6, 2021, at 12:00 pm, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient had a vaccination overdose, inappropriate schedule of product administration (dose 1 and dose 2 administered on Aug 6, 2021), onset Aug 6, 2021, with outcome of unknown; vaccination site pain (after 2nd dose, immediate pain at injection site), acne and abnormal urine odor (urine smelled like a can of tuna), onset Aug 7, 2021, at 08:00, with outcome of recovered (2021). No therapeutic measures taken. Additional information: The patient did not have COVID-19 prior to vaccination, nor tested for COVID-19 post vaccination. Reportedly, patient did not receive any other vaccine in four weeks. The patient had no other medications in two weeks. After second dose, immediate pain at injection site but disappeared after 1 day. The acne has returned on day 2, not as severe as the 1st time. Urine smelling like a can of tuna has also returned. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Inflammation, Investigation, Neck pain
Clinical narrative: I had pain in my neck and going to both shoulders, like an upper body inflammation across my chest and neck that caused pain with activity; I had pain in my neck and going to both shoulders, like an upper body inflammation across my chest and neck that caused pain with activity; I had pain in my neck and going to both shoulders, like an upper body inflammation across my chest and neck that caused pain with activity; I had pain in my neck and going to both shoulders, like an upper body inflammation across my chest and neck that caused pain with activity; 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 54 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Mar2021 (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 (Caller states he had "no reaction" with his 1st dose of the Pfizer BTC Vaccine( 12 and over formula, purple cap)), for Covid-19 Immunization, reaction(s): "No reaction". The following information was reported: INFLAMMATION (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), CHEST PAIN (non-serious) all with onset 04Apr2021, outcome "recovered" (2021) and all described as "I had pain in my neck and going to both shoulders, like an upper body inflammation across my chest and neck that caused pain with activity". Relevant laboratory tests and procedures are available in the appropriate section.  Additional info: Patient was seen by his doctor and states he was also bitten by several ticks (lone star ticks) and he was tested for Lyme disease and the results were negative. Patient stated, my upper body was only affected not my lower body.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (17Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected..
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Nausea
Clinical narrative: Fever; chills; nausea; muscle aches; headache; injection site pain; This is a spontaneous report received from 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 right, administration date 16Dec2021 15:15 (Lot number: FK5618) at the age of 9 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing), notes: Note: ADHD.; "Lactose intolerance" (unspecified if ongoing), notes: Note: Lactose intolerance; "chemical sunscreen" (unspecified if ongoing), notes: Note: Chemical Sunscreen. Concomitant medication(s) included: APO-METHYLPHENIDATE ER; LACTAID; CETRIZINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Nov2021, when the patient was 9 years old, for Covid-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 17Dec2021, outcome "not recovered", described as "chills"; NAUSEA (non-serious) with onset 17Dec2021, outcome "not recovered", described as "nausea"; MYALGIA (non-serious) with onset 17Dec2021, outcome "not recovered", described as "muscle aches"; HEADACHE (non-serious) with onset 17Dec2021, outcome "not recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 17Dec2021, outcome "not recovered", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, nausea, myalgia, headache, vaccination site pain.  Additional information: Vaccine was administered at doctor office/Urgent care. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The AE did not result in emergency room or physician office. The patient received treatment with Tylenol.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Fever; chills; nausea; muscle aches; headache; injection site pain; This is a spontaneous report received from 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 right, administration date 16Dec2021 15:15 (Lot number: FK5618) at the age of 9 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing), notes: Note: ADHD.; "Lactose intolerance" (unspecified if ongoing), notes: Note: Lactose intolerance; "chemical sunscreen" (unspecified if ongoing), notes: Note: Chemical Sunscreen. Concomitant medication(s) included: APO-METHYLPHENIDATE ER; LACTAID; CETRIZINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11Nov2021, when the patient was 9 years old, for Covid-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset 17Dec2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 17Dec2021, outcome "not recovered", described as "chills"; NAUSEA (non-serious) with onset 17Dec2021, outcome "not recovered", described as "nausea"; MYALGIA (non-serious) with onset 17Dec2021, outcome "not recovered", described as "muscle aches"; HEADACHE (non-serious) with onset 17Dec2021, outcome "not recovered", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 17Dec2021, outcome "not recovered", described as "injection site pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, nausea, myalgia, headache, vaccination site pain.  Additional information: Vaccine was administered at doctor office/Urgent care. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The AE did not result in emergency room or physician office. The patient received treatment with Tylenol.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood culture, Blood test, Chest X-ray, Computerised tomogram, Culture urine
Clinical narrative: fatigue; no appetite; sinus infection; sick; lost 15lbs; swollen inflamed sinuses/sinus inflammation; increased white blood cells; chronic sinus pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 (Lot number: FC3182) as dose 2, single and intramuscular, administered in arm right, administration date 02Aug2021 (Lot number: FA74E5) 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: SINUSITIS (non-serious) with onset 01Sep2021, outcome "recovering", described as "swollen inflamed sinuses/sinus inflammation"; WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 01Sep2021, outcome "recovering", described as "increased white blood cells"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 01Sep2021, outcome "recovering", described as "chronic sinus pressure"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection"; ILLNESS (non-serious), outcome "unknown", described as "sick"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 15lbs". The events "swollen inflamed sinuses/sinus inflammation" and "chronic sinus pressure" were evaluated at the physician office visit and emergency room visit. The event "increased white blood cells" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinusitis, white blood cell count increased, paranasal sinus discomfort.  Additional information: Her son had an adverse reaction to your Covid vaccine. No prior vaccinations within 4 weeks. Patient's Medical History included pertinent details was Wisdom teeth on Aug2020. Still ongoing sinus inflammation. Starting 01Sep2021 (withheld) had increased white blood cells chronic sinus pressure. We met to our (withheld) who RX [to take] steroids and antibodies. (withheld) continued to have fatigued, no appetite and "Sinus infections" for months. In Dec were back at the ER where the Dr. said it was sinus issues. We had gone to an ENT who did a CT and showed us all of the inflammation. (withheld) was on steroids for 30days antibiotics 1 week off. He was sick a good, from the time of the second vaccine he cost 15lbs, did 4 rounds of steroid and antibiotics with no permanent relief. We started with zyrtec, flonase, pepcid and Allegra to help with the chronic inflammations.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Illness, Investigation, Paranasal sinus discomfort
Clinical narrative: fatigue; no appetite; sinus infection; sick; lost 15lbs; swollen inflamed sinuses/sinus inflammation; increased white blood cells; chronic sinus pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 (Lot number: FC3182) as dose 2, single and intramuscular, administered in arm right, administration date 02Aug2021 (Lot number: FA74E5) 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: SINUSITIS (non-serious) with onset 01Sep2021, outcome "recovering", described as "swollen inflamed sinuses/sinus inflammation"; WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 01Sep2021, outcome "recovering", described as "increased white blood cells"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 01Sep2021, outcome "recovering", described as "chronic sinus pressure"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection"; ILLNESS (non-serious), outcome "unknown", described as "sick"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 15lbs". The events "swollen inflamed sinuses/sinus inflammation" and "chronic sinus pressure" were evaluated at the physician office visit and emergency room visit. The event "increased white blood cells" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinusitis, white blood cell count increased, paranasal sinus discomfort.  Additional information: Her son had an adverse reaction to your Covid vaccine. No prior vaccinations within 4 weeks. Patient's Medical History included pertinent details was Wisdom teeth on Aug2020. Still ongoing sinus inflammation. Starting 01Sep2021 (withheld) had increased white blood cells chronic sinus pressure. We met to our (withheld) who RX [to take] steroids and antibodies. (withheld) continued to have fatigued, no appetite and "Sinus infections" for months. In Dec were back at the ER where the Dr. said it was sinus issues. We had gone to an ENT who did a CT and showed us all of the inflammation. (withheld) was on steroids for 30days antibiotics 1 week off. He was sick a good, from the time of the second vaccine he cost 15lbs, did 4 rounds of steroid and antibiotics with no permanent relief. We started with zyrtec, flonase, pepcid and Allegra to help with the chronic inflammations.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Sinusitis, Weight, Weight decreased, White blood cell count
Clinical narrative: fatigue; no appetite; sinus infection; sick; lost 15lbs; swollen inflamed sinuses/sinus inflammation; increased white blood cells; chronic sinus pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 (Lot number: FC3182) as dose 2, single and intramuscular, administered in arm right, administration date 02Aug2021 (Lot number: FA74E5) 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: SINUSITIS (non-serious) with onset 01Sep2021, outcome "recovering", described as "swollen inflamed sinuses/sinus inflammation"; WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 01Sep2021, outcome "recovering", described as "increased white blood cells"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 01Sep2021, outcome "recovering", described as "chronic sinus pressure"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection"; ILLNESS (non-serious), outcome "unknown", described as "sick"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 15lbs". The events "swollen inflamed sinuses/sinus inflammation" and "chronic sinus pressure" were evaluated at the physician office visit and emergency room visit. The event "increased white blood cells" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinusitis, white blood cell count increased, paranasal sinus discomfort.  Additional information: Her son had an adverse reaction to your Covid vaccine. No prior vaccinations within 4 weeks. Patient's Medical History included pertinent details was Wisdom teeth on Aug2020. Still ongoing sinus inflammation. Starting 01Sep2021 (withheld) had increased white blood cells chronic sinus pressure. We met to our (withheld) who RX [to take] steroids and antibodies. (withheld) continued to have fatigued, no appetite and "Sinus infections" for months. In Dec were back at the ER where the Dr. said it was sinus issues. We had gone to an ENT who did a CT and showed us all of the inflammation. (withheld) was on steroids for 30days antibiotics 1 week off. He was sick a good, from the time of the second vaccine he cost 15lbs, did 4 rounds of steroid and antibiotics with no permanent relief. We started with zyrtec, flonase, pepcid and Allegra to help with the chronic inflammations.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: fatigue; no appetite; sinus infection; sick; lost 15lbs; swollen inflamed sinuses/sinus inflammation; increased white blood cells; chronic sinus pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Aug2021 (Lot number: FC3182) as dose 2, single and intramuscular, administered in arm right, administration date 02Aug2021 (Lot number: FA74E5) 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: SINUSITIS (non-serious) with onset 01Sep2021, outcome "recovering", described as "swollen inflamed sinuses/sinus inflammation"; WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 01Sep2021, outcome "recovering", described as "increased white blood cells"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 01Sep2021, outcome "recovering", described as "chronic sinus pressure"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection"; ILLNESS (non-serious), outcome "unknown", described as "sick"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 15lbs". The events "swollen inflamed sinuses/sinus inflammation" and "chronic sinus pressure" were evaluated at the physician office visit and emergency room visit. The event "increased white blood cells" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinusitis, white blood cell count increased, paranasal sinus discomfort.  Additional information: Her son had an adverse reaction to your Covid vaccine. No prior vaccinations within 4 weeks. Patient's Medical History included pertinent details was Wisdom teeth on Aug2020. Still ongoing sinus inflammation. Starting 01Sep2021 (withheld) had increased white blood cells chronic sinus pressure. We met to our (withheld) who RX [to take] steroids and antibodies. (withheld) continued to have fatigued, no appetite and "Sinus infections" for months. In Dec were back at the ER where the Dr. said it was sinus issues. We had gone to an ENT who did a CT and showed us all of the inflammation. (withheld) was on steroids for 30days antibiotics 1 week off. He was sick a good, from the time of the second vaccine he cost 15lbs, did 4 rounds of steroid and antibiotics with no permanent relief. We started with zyrtec, flonase, pepcid and Allegra to help with the chronic inflammations.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nodule
Clinical narrative: my body is encapsulating the vaccine and its not releasing; its like a bubble its still there its on my body its not breaking down; when I drive with my left arm then I feel little achiness in there; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 (Lot number: IC3182) at the age of 60 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: FEELING ABNORMAL (non-serious) with onset 08Sep2021, outcome "not recovered", described as "its like a bubble its still there its on my body its not breaking down"; PAIN IN EXTREMITY (non-serious) with onset 08Sep2021, outcome "not recovered", described as "when I drive with my left arm then I feel little achiness in there"; PAIN (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Pain"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "my body is encapsulating the vaccine and its not releasing". The events "its like a bubble its still there its on my body its not breaking down", "when i drive with my left arm then i feel little achiness in there" and "pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of feeling abnormal, pain in extremity, pain.  Follow-up attempts completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Circumstance or information capable of leading to medication error, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: my body is encapsulating the vaccine and its not releasing; its like a bubble its still there its on my body its not breaking down; when I drive with my left arm then I feel little achiness in there; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 (Lot number: IC3182) at the age of 60 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: FEELING ABNORMAL (non-serious) with onset 08Sep2021, outcome "not recovered", described as "its like a bubble its still there its on my body its not breaking down"; PAIN IN EXTREMITY (non-serious) with onset 08Sep2021, outcome "not recovered", described as "when I drive with my left arm then I feel little achiness in there"; PAIN (non-serious) with onset 08Sep2021, outcome "not recovered", described as "Pain"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "my body is encapsulating the vaccine and its not releasing". The events "its like a bubble its still there its on my body its not breaking down", "when i drive with my left arm then i feel little achiness in there" and "pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of feeling abnormal, pain in extremity, pain.  Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Immunisation, Influenza like illness, Pain in extremity
Clinical narrative: Tested covid-19 positive; Tested covid-19 positive; headache; cough; flu body feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested covid-19 positive"; HEADACHE (non-serious), outcome "unknown", described as "headache"; COUGH (non-serious), outcome "unknown", described as "cough"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu body feeling". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Tested covid-19 positive two months after booster shot (3rd shot).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Headache, Influenza like illness
Clinical narrative: Tested covid-19 positive; Tested covid-19 positive; headache; cough; flu body feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested covid-19 positive"; HEADACHE (non-serious), outcome "unknown", described as "headache"; COUGH (non-serious), outcome "unknown", described as "cough"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu body feeling". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Tested covid-19 positive two months after booster shot (3rd shot).  The lot number for bnt162b2 was not provided and will be requested during follow up.