chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Ultrasound Doppler, Weight
Clinical narrative: When I first had it I didn't want to eat at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (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: DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "When I first had it I didn't want to eat at all". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter stated that patient first had it she didn't want to eat at all now , why she lost too much weight so she tried to eat and gain back the weight but 20 pounds is a lot she had only 5 ft 3 and a half; she has seen someone who had this only had one shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Pain, Pyrexia
Clinical narrative: feverish; ached all over; GI Issues; 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 (BNT162B2), administration date 12Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Nov2021, outcome "recovered" (2021), described as "feverish"; PAIN (non-serious) with onset 13Nov2021, outcome "not recovered", described as "ached all over"; GASTROINTESTINAL PAIN (non-serious) with onset 13Nov2021, outcome "not recovered", described as "GI Issues".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: developed localized lip swelling; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 7 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIP SWELLING (non-serious), outcome "recovering", described as "developed localized lip swelling". Therapeutic measures were taken as a result of lip swelling.  Additional information: The reporter was a pediatrician calling with a question regarding the Comirnaty vaccine. Reporter was stated that a 7 year old patient of his got the vaccine and then developed localized lip swelling 3 hours later and had no other symptoms. This lasted for a few hours. The patient's mother gave them Claritin and it got better. The caller is asking what he should tell the mother for the second dose. Should they pre medicate before giving it or should they skip it? Caller initially agreed to complete report then, requested telephone number and asked to be transferred. No further details were provided and full details unable to be obtained.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: experienced body aches; chills; medium to high grade fever; the injection site had significant redness and swelling that was painful; the injection site had significant redness and swelling that was painful; the injection site had significant redness and swelling that was painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: 330268D) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 17Oct2021. Vaccination history included: Bnt162b2 (Dose 2, lot number=EW0175, vaccine location=Left arm), administration date: 25Apr2021, when the patient was 34 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, lot number=ER8733, vaccine location=Left arm), administration date: 04Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 13Nov2021 20:30, outcome "recovering", described as "experienced body aches"; CHILLS (non-serious) with onset 13Nov2021 20:30, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 13Nov2021 20:30, outcome "recovering", described as "medium to high grade fever"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 13Nov2021 20:30, outcome "recovering" and all described as "the injection site had significant redness and swelling that was painful". The events "experienced body aches", "chills", "medium to high grade fever", "the injection site had significant redness and swelling that was painful", "the injection site had significant redness and swelling that was painful" and "the injection site had significant redness and swelling that was painful" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain, chills, pyrexia, vaccination site erythema, vaccination site swelling, vaccination site pain.  Additional information: The patient did not receive any other medications in two weeks. The patient did not have Covid prior vaccination. The patient did not get Covid tested post vaccination. Known allergies were none. Other medical history was none. From late night of 13Nov2021, experienced body aches, chills, and medium to high grade fever. The symptoms persisted through most of 15Nov2021. Additionally, the injection site had significant redness and swelling that was painful.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: experienced body aches; chills; medium to high grade fever; the injection site had significant redness and swelling that was painful; the injection site had significant redness and swelling that was painful; the injection site had significant redness and swelling that was painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: 330268D) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 17Oct2021. Vaccination history included: Bnt162b2 (Dose 2, lot number=EW0175, vaccine location=Left arm), administration date: 25Apr2021, when the patient was 34 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, lot number=ER8733, vaccine location=Left arm), administration date: 04Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 13Nov2021 20:30, outcome "recovering", described as "experienced body aches"; CHILLS (non-serious) with onset 13Nov2021 20:30, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 13Nov2021 20:30, outcome "recovering", described as "medium to high grade fever"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 13Nov2021 20:30, outcome "recovering" and all described as "the injection site had significant redness and swelling that was painful". The events "experienced body aches", "chills", "medium to high grade fever", "the injection site had significant redness and swelling that was painful", "the injection site had significant redness and swelling that was painful" and "the injection site had significant redness and swelling that was painful" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain, chills, pyrexia, vaccination site erythema, vaccination site swelling, vaccination site pain.  Additional information: The patient did not receive any other medications in two weeks. The patient did not have Covid prior vaccination. The patient did not get Covid tested post vaccination. Known allergies were none. Other medical history was none. From late night of 13Nov2021, experienced body aches, chills, and medium to high grade fever. The symptoms persisted through most of 15Nov2021. Additionally, the injection site had significant redness and swelling that was painful.   No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Pain assessment
Clinical narrative: The patient reported a sharp pain in the center of his chest; Described as a porcupine feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Nov2021 11:30 (Lot number: FK5127) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA, administration date 25Sep2021. The following information was reported: CHEST PAIN (non-serious) with onset 13Nov2021, outcome "recovered" (2021), described as "The patient reported a sharp pain in the center of his chest"; FEELING ABNORMAL (non-serious) with onset 13Nov2021, outcome "recovered" (2021), described as "Described as a porcupine feeling". The events "the patient reported a sharp pain in the center of his chest" and "described as a porcupine feeling" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient complained of a sharp pain near the center of his chest maybe 8 hours after getting the 1st dose of the COVID-19 (Comirnaty)-children's dose. The patient described it as having a porcupine in his chest. There were no accompanying clinical signs. They had called doctors office to determine whether they should take him to Urgent Care for evaluation. The patient described his pain level as a 5, maybe 4 1/2. Based on that and absence of other clinical signs, they were told to evaluate/monitor, the patient woke up without any complaints. The next evening the patient mentioned having the same feeling as the previous night after receiving the shot. After that, the patient did not report any additional pain or responses effects. There was no specific relevant test performed for thromboembolic events with thrombocytopenia.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: HBP diagnosed in Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Feb2021 (Lot number: EL9265) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies; several food products" (unspecified if ongoing), notes: Known allergies; several food products; "Known allergies;apples" (unspecified if ongoing), notes: Known allergies;apples; "Known allergies;strawberries" (unspecified if ongoing), notes: Known allergies;strawberries; "Known allergy: other products notedin allergy tests in past" (unspecified if ongoing), notes: Known allergy: other products noted, in allergy tests in past. Concomitant medication(s) included: AMLODIPINE; CLARITIN [LORATADINE]; FLONASE [FLUTICASONE PROPIONATE]; JUNEL FE. Vaccination history included: Bnt162b2 (Dose Number: 1 Batch/Lot No: EL3246 Location of injection: Arm Left), administration date: 13Jan2021, for Covid-19 immunization. The following information was reported: HYPERTENSION (non-serious) with onset Jun2021, outcome "unknown", described as "HBP diagnosed in Jun2021". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was not pregnant during the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any treatment for the adverse events.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: really bad nose bleeds after the booster; 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 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 Immunization; Bnt162b2 (DOSE: 2), for COVID-19 Immunization. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "really bad nose bleeds after the booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: her twin sister also had the same experience, her psoriasis had flared up, too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (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: Covid-19 vaccine (Dose:1, manufacture unknown.), for COVID-19 immunization. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "her twin sister also had the same experience, her psoriasis had flared up, too". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pruritus, Eye swelling
Clinical narrative: My eyes are swollen, itchy, and dried out.; My eyes are swollen, itchy, and dried out.; My eyes are swollen, itchy, and dried out.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 14:00 (Lot number: EW0164) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 25Oct2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: EYE SWELLING (non-serious), EYE PRURITUS (non-serious), DRY EYE (non-serious) all with onset 16Nov2021 05:30, outcome "recovering" and all described as "My eyes are swollen, itchy, and dried out.". Therapeutic measures were not taken as a result of eye swelling, eye pruritus, dry eye. No follow-up attempts are possible. No further information is expected.  Follow-up (24Nov2021): Follow-up attempts are completed. 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: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menarche
Clinical narrative: It was actually her first period; with a heavier flow for 6 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 14:00 (Lot number: FH8020) 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: MELATONIN. The following information was reported: MENARCHE (non-serious) with onset 28Oct2021 09:00, outcome "unknown", described as "It was actually her first period"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 28Oct2021 09:00, outcome "unknown", described as "with a heavier flow for 6 days". Therapeutic measures were not taken as a result of menarche, heavy menstrual bleeding.  Additional information: It was her first period with a heavier flow for 6 days in a bright red blood colour, nothing light or red-brown blood colour. No other vaccine was taken in four weeks. Other medications in two weeks included gummy vitamins and gummy melatonin. The patient was not covid tested post vaccination. The patient did not have any known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling
Clinical narrative: swelling and numbness in right arm; swelling and numbness in right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 08:30 (Lot number: EW0150) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hemachromatosis" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing); "Known allergies: corn and corn products and coconut" (unspecified if ongoing); "Known allergies: pork" (unspecified if ongoing), notes: Known allergies: corn and corn products, tomatoes, pork, coconut; "Known allergies: tomatoes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), HYPOAESTHESIA (non-serious), outcome "recovered" and all described as "swelling and numbness in right arm".  Additional information: Other vaccine in four weeks: No. Other medications in two weeks: multivitamin. Covid prior vaccination: No. Covid tested post vaccination: No. Adverse event: Following first dose, swelling and numbness in right arm subsided within 12 hours.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during pregnancy, Pain in extremity, Presyncope
Clinical narrative: Sore arm; almost fainted; headache about 18 hours after shot; Currently Pregnant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 15Nov2021 14:30 (Lot number: FH 3527) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 26Aug2021. The patient was 11 weeks pregnant at the time of exposure to BNT162B2; 9 weeks pregnant to influenza vaccine. The patient was 11 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 02Jun2022. Concomitant medication(s) included: FLU taken for immunisation, administration date 03Nov2021; MAGNESIUM; VITAMIN D [VITAMIN D NOS]; VITAMIN B6. Vaccination history included: Bnt162b2 (Dose 1, Lot number: ER 8730, Administration time: 07:30PM, Vaccine location: Left arm), administration date: 26Mar2021, when the patient was 30 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, Lot number: 8734 ER, Administration time: 07:30PM, Vaccine location: Left arm), administration date: 16Apr2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 16Nov2021 08:30, outcome "recovering", described as "headache about 18 hours after shot"; PAIN IN EXTREMITY (non-serious) with onset 16Nov2021 14:45, outcome "recovering", described as "Sore arm"; PRESYNCOPE (non-serious) with onset 16Nov2021 14:45, outcome "recovering", described as "almost fainted"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 15Nov2021 14:30, outcome "unknown", described as "Currently Pregnant". Therapeutic measures were not taken as a result of headache, pain in extremity, presyncope. Additional information: The patient is currently pregnant and taking prenatal vitamin. Allergies were unknown. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 post vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: burning chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 01Nov2021 (Batch/Lot number: unknown) at the age of 45 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: CHEST PAIN (non-serious), outcome "unknown", described as "burning chest". Additional information: Reason for no lot number: of COVID vaccine: Caller unwilling to complete the report.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Low grade fever; Congestion; Sore Throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 13Nov2021 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 15Nov2021, outcome "unknown", described as "Low grade fever"; NASAL CONGESTION (non-serious) with onset 15Nov2021, outcome "unknown", described as "Congestion"; OROPHARYNGEAL PAIN (non-serious) with onset 15Nov2021, outcome "unknown", described as "Sore Throat". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pyrexia, nasal congestion, oropharyngeal pain. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Pyrexia
Clinical narrative: I am shaking uncontrollably like I am cold; I am shaking uncontrollably like I am cold; I have a temperature of 100; 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 (BNT162B2), administration date 16Nov2021 (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. The following information was reported: CHILLS (non-serious), FEELING COLD (non-serious) all with onset 16Nov2021, outcome "unknown" and all described as "I am shaking uncontrollably like I am cold"; PYREXIA (non-serious) with onset 16Nov2021, outcome "unknown", described as "I have a temperature of 100". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (18Nov2021)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.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac discomfort, Pain
Clinical narrative: Had a little bit side effect; A little bit like my heart, I have the butterfly, a butterfly feeling; You are giving me more pain than, from my head to toe; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot no: FF8839), for COVID-19 immunization, reaction(s): "Symptoms that I had from both are different". The following information was reported: CARDIAC DISCOMFORT (non-serious), outcome "unknown", described as "Had a little bit side effect; A little bit like my heart, I have the butterfly, a butterfly feeling"; PAIN (non-serious), outcome "unknown", described as "You are giving me more pain than, from my head to toe".  Additional information: Patient stated, "First one was, PF12 or 1ZER and then it says FF8839, there was a more letters to it. It says a LOT# but it says two numbers in one. The first time the patient got it, there was two numbers and then the second one, there was two numbers." Patient stated, "I had to let you know that I did the Covid vaccine, the second one and just after the second one, I had a little bit side effect. So, I talked to the doctor today and she wants me to report the side effect. So, where do I report this information related to side effect. When again probed for the concern, Patient stated, "So, I took the Pfizer vaccine both one and two and now, I had a little side effect and the doctor want me to report it but she did not told me where to report it. So, where do I report this side effect information. Reporter type could not be probed as consumer hung up the call abruptly, hence reporter type captured as consumer or non-healthcare professional by default.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Rash
Clinical narrative: rash; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 07Nov2021 10:00 (Lot number: FK5127, Expiration Date: Jan2022) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 26Oct2021. The following information was reported: RASH (non-serious) with onset 08Nov2021, outcome "recovered" (11Nov2021), described as "rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: For causality she suspected the Pfizer Pediatric Covid19 vaccine is related to the reported event. The patient was not taking any medications. 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) was n/a. No additional vaccines administered on same date of the Pfizer suspect. Adverse event did not require a visit to Emergency Room/Physician Office. Prior Vaccinations (within 4 weeks) included a flu shot in her thigh and was not sure if it was the right or left thigh and was not 100 percent sure but thought it was in the left. AE(s) following prior vaccinations, Family Medical History Relevant to AE(s) were reported as none. Relevant Tests included ANA test done that was elevated and they could not figure out why and she had no specific results for that test.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Racing and pounding heart; Feeling out of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 14:30 (Lot number: FK5618) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT D [COLECALCIFEROL]; MOTRIN [IBUPROFEN]. Past drug history included: Flu vaccine, reaction(s): "Had allergy", notes: Had allergy to flu vaccine previously. The following information was reported: PALPITATIONS (non-serious) with onset 17Nov2021 19:45, outcome "unknown", described as "Racing and pounding heart"; DYSPNOEA (non-serious) with onset 17Nov2021 19:45, outcome "unknown", described as "Feeling out of breath". It was unknown if therapeutic measures were taken as a result of palpitations, dyspnoea. No follow-up attempts are possible. No further information is expected.  Follow-up (22Dec2021): Follow-up attempts completed. No further information 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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Headache; right shoulder pain; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Nov2021 13:15 (Lot number: FF2589) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 15Mar2021, when the patient was 56 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 02:45 PM, Route of Administration: Intramuscular), administration date: 22Feb2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 16Nov2021 20:00, outcome "recovering", described as "Headache"; ARTHRALGIA (non-serious) with onset 16Nov2021 20:00, outcome "recovering", described as "right shoulder pain". Therapeutic measures were taken as a result of headache, arthralgia.  Additional information: Facility type vaccine was Workplace clinic. 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. No Known allergies. No medical history. AE resulted in none of the above. The patient received Tylenol as treatment for the event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Adrenal disorder, Thyroid disorder
Clinical narrative: issue with her thyroid/adrenal gland afterwards; issue with her thyroid/adrenal gland afterwards; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THYROID DISORDER (non-serious), ADRENAL DISORDER (non-serious), outcome "unknown" and all described as "issue with her thyroid/adrenal gland afterwards". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (22Nov2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of the event start date.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Malaise; right ancillary lymph node swelling and pain/Armpit swelling and pain; right ancillary lymph node swelling and pain/Armpit swelling and pain; headache (stingy like a migraine); fatigue; Armpit swelling and pain is unique to third shot.; Armpit swelling and pain is unique to third shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Nov2021 09:30 (Lot number: FH8030) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2021 (unspecified if ongoing), notes: Had covid in Jan 2021. Concomitant medication(s) included: INFLUENZA VACCINE, administration date 11Oct2021. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EW0172, Location of injection: Right : Arm, Vaccine Administration Time: 12:00 PM), administration date: 28Apr2021, when the patient was 48 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: EP8834, Location of injection: Right Arm, Vaccine Administration Time: 10:30 AM), administration date: 06Apr2021, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "Had same kind of headache with first". The following information was reported: MALAISE (non-serious) with onset 16Nov2021 18:00, outcome "not recovered", described as "Malaise"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 16Nov2021 18:00, outcome "not recovered" and all described as "right ancillary lymph node swelling and pain/Armpit swelling and pain"; HEADACHE (non-serious) with onset 16Nov2021 18:00, outcome "recovered" (18Nov2021), described as "headache (stingy like a migraine)"; FATIGUE (non-serious) with onset 16Nov2021 18:00, outcome "not recovered", described as "fatigue"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 16Nov2021 18:00, outcome "not recovered" and all described as "Armpit swelling and pain is unique to third shot.". Therapeutic measures were not taken as a result of malaise, lymphadenopathy, lymph node pain, headache, fatigue, swelling, axillary pain.  Additional information: patient was not tested for covid post vaccination. had no known allergies. Vaccination facility: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Swelling
Clinical narrative: Malaise; right ancillary lymph node swelling and pain/Armpit swelling and pain; right ancillary lymph node swelling and pain/Armpit swelling and pain; headache (stingy like a migraine); fatigue; Armpit swelling and pain is unique to third shot.; Armpit swelling and pain is unique to third shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Nov2021 09:30 (Lot number: FH8030) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2021 (unspecified if ongoing), notes: Had covid in Jan 2021. Concomitant medication(s) included: INFLUENZA VACCINE, administration date 11Oct2021. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EW0172, Location of injection: Right : Arm, Vaccine Administration Time: 12:00 PM), administration date: 28Apr2021, when the patient was 48 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: EP8834, Location of injection: Right Arm, Vaccine Administration Time: 10:30 AM), administration date: 06Apr2021, when the patient was 48 years old, for COVID-19 Immunization, reaction(s): "Had same kind of headache with first". The following information was reported: MALAISE (non-serious) with onset 16Nov2021 18:00, outcome "not recovered", described as "Malaise"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 16Nov2021 18:00, outcome "not recovered" and all described as "right ancillary lymph node swelling and pain/Armpit swelling and pain"; HEADACHE (non-serious) with onset 16Nov2021 18:00, outcome "recovered" (18Nov2021), described as "headache (stingy like a migraine)"; FATIGUE (non-serious) with onset 16Nov2021 18:00, outcome "not recovered", described as "fatigue"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 16Nov2021 18:00, outcome "not recovered" and all described as "Armpit swelling and pain is unique to third shot.". Therapeutic measures were not taken as a result of malaise, lymphadenopathy, lymph node pain, headache, fatigue, swelling, axillary pain.  Additional information: patient was not tested for covid post vaccination. had no known allergies. Vaccination facility: Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nasopharyngitis, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Vomiting; diarrhea for 2 days; Fever; cold symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 11:00 (Lot number: Fk5127) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CLARITIN [LORATADINE]; MMR, administration date 29Oct2021; DTAP, administration date 29Oct2021; POLIO, administration date 29Oct2021; VARICELLA VACC., administration date 29Oct2021. The following information was reported: VOMITING (non-serious) with onset 13Nov2021 20:00, outcome "recovered" (Nov2021), described as "Vomiting"; DIARRHOEA (non-serious) with onset 13Nov2021 20:00, outcome "recovered" (Nov2021), described as "diarrhea for 2 days"; PYREXIA (non-serious) with onset 13Nov2021 20:00, outcome "recovered" (Nov2021), described as "Fever"; NASOPHARYNGITIS (non-serious) with onset 13Nov2021 20:00, outcome "recovered" (Nov2021), described as "cold symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, diarrhoea, pyrexia, nasopharyngitis.  Additional information: vaccination facility: Public Health Clinic/Veterans Administration facility. It as unknown if patient had Known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: High fever reaching up to 103.2°F; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9 year-old male patient received bnt162b2 (COMIRNATY) (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: PYREXIA (non-serious), outcome "recovered", described as "High fever reaching up to 103.2°F". Relevant laboratory tests and procedures are available in the appropriate section. 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she had mild soreness at the injection site; 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 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "she had mild soreness at the injection site".  Additional Informtion: Caller asked if multiple Pfizer Coivd-19 vaccines out there? Caller stated when she looks on the internet she saw there was the Pfizer BioNTech Covid-19 vaccine and the Comirnaty Covid-19 vaccine so she was curious if they are all the same? She received the first two Pfizer doses she only had mild soreness at the injection site. potential duplicate AE. Call was warm transferred to agent withheld NTID withheld Reportum# withheld. Patient was a 64-year-old female. Caller disconnected the call during warm transfer to agent. Caller questioned that she would like to know if the Pfizer booster dose she received was the same as the first two Pfizer doses to explain the different reaction she was having to the booster dose?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Polymerase chain reaction, Rash
Clinical narrative: 8-12 inch patches of rashes on multiple spots on my body. Started 4 months after the 2 second vaccine in May2021. Continues to this day. Tried Benadryl, Fexofenadine, clobetasol, Lidek, Medrol, Famoti; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Jan2021 (Lot number: EL3246) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NUVARING; FLUTICASONE; SPIRONOLACTONE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK9231, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 23Dec2020, for COVID-19 immunisation. The following information was reported: RASH (non-serious) with onset 15May2021 18:00, outcome "not recovered", described as "8-12 inch patches of rashes on multiple spots on my body. Started 4 months after the 2 second vaccine in May2021. Continues to this day. Tried Benadryl, Fexofenadine, clobetasol, Lidek, Medrol, Famoti". The event "8-12 inch patches of rashes on multiple spots on my body. started 4 months after the 2 second vaccine in may2021. continues to this day. tried benadryl, fexofenadine, clobetasol, lidek, medrol, famoti" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash and patiuent was treated with Benadryl, Fexofenadine, clobetasol, Lidek, Medrol and Famoti.  Additional information: On : 05Apr2021, patient underwent PCR (nasal swab) test which was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received multivitamins within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash/hives on neck for 2 days, beginning the evening of the injection; hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 16:00 (Lot number: fk5618) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "idiopathic urticaria" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: RASH (non-serious) with onset 17Nov2021 19:00, outcome "recovered" (2021), described as "Rash/hives on neck for 2 days, beginning the evening of the injection"; URTICARIA (non-serious) with onset 17Nov2021 19:00, outcome "recovered" (2021), described as "hives". The events "rash/hives on neck for 2 days, beginning the evening of the injection" and "hives" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of rash. Therapeutic measures were taken as a result of urticaria.  Additional information:  The patient only had localised hives responded to Benadryl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Lip swelling, Paraesthesia oral
Clinical narrative: Numbness; tingling and swelling of my lips; tingling and swelling of my lips; Sensation that the skin around my eyes and cheek bones was being stretched/weird feeling/ everything was going in slow motion; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left (Lot number: 3303080) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Hemochromatosis" (unspecified if ongoing); "Allergies: chicken" (unspecified if ongoing); "Allergies: Egg" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Flu shot, reaction(s): "Allergy: Flu shot". The following information was reported: HYPOAESTHESIA (non-serious) with onset 19Nov2021 10:00, outcome "not recovered", described as "Numbness"; PARAESTHESIA ORAL (non-serious), LIP SWELLING (non-serious) all with onset 19Nov2021 10:00, outcome "not recovered" and all described as "tingling and swelling of my lips"; FEELING ABNORMAL (non-serious) with onset 19Nov2021 10:00, outcome "not recovered", described as "Sensation that the skin around my eyes and cheek bones was being stretched/weird feeling/ everything was going in slow motion". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia oral, lip swelling, feeling abnormal. No follow-up attempts are possible. No further information is expected.