chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oral herpes, Pain, Pharyngeal swelling, Stomatitis
Clinical narrative: Throat swelling; tongue swelling; raw inside of mouth cheeks; fever blister above lip; soreness; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 17:45 (Lot number: Pf2590) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Coconut allergy" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE HYDROCHLORIDE. Past drug history included: Compazine, reaction(s): "known allergies: compazine"; Dilaudid, reaction(s): "known allergies: dilaudid". The following information was reported: PHARYNGEAL SWELLING (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "Throat swelling"; SWOLLEN TONGUE (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "tongue swelling"; STOMATITIS (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "raw inside of mouth cheeks"; ORAL HERPES (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "fever blister above lip"; PAIN (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "soreness"; FATIGUE (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "tiredness". The events "throat swelling", "tongue swelling", "raw inside of mouth cheeks", "fever blister above lip", "soreness" and "tiredness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pharyngeal swelling, swollen tongue, stomatitis, oral herpes, pain, fatigue.  Additional information included: The patient did not receive any other vaccine in four weeks. The patient had no covid prior vaccine. The patient had no covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Throat swelling; tongue swelling; raw inside of mouth cheeks; fever blister above lip; soreness; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 17:45 (Lot number: Pf2590) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Coconut allergy" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE HYDROCHLORIDE. Past drug history included: Compazine, reaction(s): "known allergies: compazine"; Dilaudid, reaction(s): "known allergies: dilaudid". The following information was reported: PHARYNGEAL SWELLING (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "Throat swelling"; SWOLLEN TONGUE (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "tongue swelling"; STOMATITIS (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "raw inside of mouth cheeks"; ORAL HERPES (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "fever blister above lip"; PAIN (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "soreness"; FATIGUE (non-serious) with onset 09Nov2021 01:00, outcome "recovering", described as "tiredness". The events "throat swelling", "tongue swelling", "raw inside of mouth cheeks", "fever blister above lip", "soreness" and "tiredness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pharyngeal swelling, swollen tongue, stomatitis, oral herpes, pain, fatigue.  Additional information included: The patient did not receive any other vaccine in four weeks. The patient had no covid prior vaccine. The patient had no covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Pain
Clinical narrative: nausea; lack of energy; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Apr2021 (Lot number: EW0161) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PTSD" (ongoing), notes: On medications to manage PTSD, Onset date: 10 + years; "Anxiety" (ongoing), notes: Onset date: 10 + years. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Time: 09:50, Anatomical site of Injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8732), administration date: 04Apr2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "recovered", described as "nausea"; ASTHENIA (non-serious), outcome "recovered", described as "lack of energy"; PAIN (non-serious), outcome "recovered", described as "body aches".  Additional information: Vaccination facility type: Pharmacy or Drug Store. No vaccine administration at military facility. No Prior vaccinations within 4 weeks. No Relevant test done.   No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Small, raised, itchy bumps on wrists, arms, chest, belly, neck, and back/ I would describe the rash as mild; Small, raised, itchy bumps on wrists, arms, chest, belly, neck, and back/ I would describe the rash as mild; Small, raised, itchy bumps on wrists, arms, chest, belly, neck, and back/ I would describe the rash as mild; Small, raised, itchy bumps on wrists, arms, chest, belly, neck, and back/ I would describe the rash as mild; Small, raised, itchy bumps on wrists, arms, chest, belly, neck, and back/ I would describe the rash as mild; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10 year-old male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 18:45 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eczema as a child" (unspecified if ongoing); "failure to thrive" (unspecified if ongoing). Concomitant medication(s) included: CYPROHEPTADINE. The following information was reported: RASH (non-serious), RASH (non-serious), RASH (non-serious), RASH PRURITIC (non-serious), RASH PAPULAR (non-serious) all with onset 10Nov2021, outcome "recovering" and all described as "Small, raised, itchy bumps on wrists, arms, chest, belly, neck, and back/ I would describe the rash as mild". Therapeutic measures were not taken as a result of rash, rash, rash, rash pruritic, rash papular. Additional information: The vaccine was administered in the shoulder. The patient did not receive any other vaccine within 4 weeks. The adverse events occurred the day after the vaccination. 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.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Starting Vaginally bleeding 2 days after first Vaccine and havent stopped to date.  It started out light and its now very heavy.; This is a spontaneous report received from 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 11Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single and administered in arm left, administration date 05Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 13Oct2021, outcome "not recovered", described as "Starting Vaginally bleeding 2 days after first Vaccine and havent stopped to date.  It started out light and its now very heavy.". Therapeutic measures were not taken as a result of vaginal haemorrhage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (16Dec2021): 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm was sore; slight fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Jan2021 (Lot number: EK9231, Expiration Date: 30Apr2021) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogren's syndrome" (ongoing); "Nodules on lung" (ongoing), notes: had these nodules for about 3 years and they haven't grown any; "compromised immune system" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "arm was sore"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "slight fever".  Additional information: The patient later received second and booster dose of bnt162b2 (BNT162B2), administered in arm left (dose 2) and arm right (booster), administration date 02Feb2021(dose 2) at the age of 72 years and 05Nov2021 (booster) at the age of 73 years (Lot number: EL8982 (dose2 ), 330268D (booster), Expiration Date: 31May2021 (dose 2)) at the age of 72 years as dose 2, single and dose 3 (booster), single respectively for covid-19 immunisation and after second dose, she was tired and sleepy for a couple of days, and had soreness in her inner arm and with the third dose (booster), she experienced fever, vomiting, diarrhoea, had the tiredness feeling, and her joints ache. She confirmed she was still experiencing the tiredness, nausea, and decrease in appetite. Additional vaccines administered on same date of the pfizer suspect was none. Prior vaccinations (within 4 weeks) were none.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dysstasia, Fatigue, Headache
Clinical narrative: dizziness; chest heaviness; could not stand well; itchy on the back of her neck; arm soreness; HA; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Nov2021 14:00 (Lot number: FF2589) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 18Feb2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "no adverse effect"; Bnt162b2 (Dose 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 28Jan2021, when the patient was 60 years old, for COVID-19 Immunization, reaction(s): "no adverse effect". The following information was reported: DIZZINESS (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "dizziness"; CHEST DISCOMFORT (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "chest heaviness"; DYSSTASIA (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "could not stand well"; PRURITUS (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "itchy on the back of her neck"; PAIN IN EXTREMITY (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "arm soreness"; HEADACHE (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "HA"; FATIGUE (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "fatigue". Therapeutic measures were not taken as a result of dizziness, chest discomfort, dysstasia, pruritus, pain in extremity, headache, fatigue.  Additional information: The patient reported no symptoms after the first two vaccines, but reports today at 15:00 that she had onset of arm soreness 12 hours later and then dizziness and then HA and itchy on the back of her neck and chest heaviness and "could not stand well" fatigue and that resolved about 24 hours after it started. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: dizziness; chest heaviness; could not stand well; itchy on the back of her neck; arm soreness; HA; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Nov2021 14:00 (Lot number: FF2589) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 18Feb2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "no adverse effect"; Bnt162b2 (Dose 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 28Jan2021, when the patient was 60 years old, for COVID-19 Immunization, reaction(s): "no adverse effect". The following information was reported: DIZZINESS (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "dizziness"; CHEST DISCOMFORT (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "chest heaviness"; DYSSTASIA (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "could not stand well"; PRURITUS (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "itchy on the back of her neck"; PAIN IN EXTREMITY (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "arm soreness"; HEADACHE (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "HA"; FATIGUE (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "fatigue". Therapeutic measures were not taken as a result of dizziness, chest discomfort, dysstasia, pruritus, pain in extremity, headache, fatigue.  Additional information: The patient reported no symptoms after the first two vaccines, but reports today at 15:00 that she had onset of arm soreness 12 hours later and then dizziness and then HA and itchy on the back of her neck and chest heaviness and "could not stand well" fatigue and that resolved about 24 hours after it started. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (005570). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed inflammation (chronic inflammation throughout entire body after receiving both of the vaccines), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Maternal exposure during pregnancy
Clinical narrative: dizzy and light headed; she is in her third trimester of pregnancy 32-33 weeks; tired; headache; 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 (pregnant) received BNT162B2 (COMIRNATY), administration date 10Nov2021 (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: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 10Nov2021, outcome "unknown", described as "tired"; HEADACHE (non-serious) with onset 10Nov2021, outcome "unknown", described as "headache"; DIZZINESS (non-serious) with onset 12Nov2021, outcome "unknown", described as "dizzy and light headed"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 10Nov2021, outcome "unknown", described as "she is in her third trimester of pregnancy 32-33 weeks".  Additional information: Clinical course: After receiving the Pfizer COVID-19 vaccine booster dose 10Nov2021, patient stated she was very tired, headache on Wednesday after the dose and this morning dizzy and light headed and just tired. Patient also stated she was in her third trimester of pregnancy 32-33 weeks.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Pain
Clinical narrative: Covid booster: chest pain; Covid booster: shoulder pain; Stated that he has pain when lying back and it is better when he leans forward; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (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 1, SINGLE), administration date: Jan2021, for COVID-19 immunization, reaction(s): "No adverse event"; Bnt162b2 (DOSE 2, SINGLE), administration date: Jan2021, for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "Covid booster: chest pain"; ARTHRALGIA (non-serious), outcome "unknown", described as "Covid booster: shoulder pain"; PAIN (non-serious), outcome "unknown", described as "Stated that he has pain when lying back and it is better when he leans forward".  Additional information: Patient stated that yesterday he had stabbing chest pain and proceeding the chest that he had shoulder pain. Patient stated that he remembered seeing on the consent form about pericarditis and myocarditis. Patient stated that he was in medical school and knows about those sorts. Stated that it was intermittent in nature. Patient stated that this seems consistent with that. Patient stated that he looked on website about it and read a article about pericarditis for the second shot and it was like about 20 days which was what made him concerned. Patient stated that he had chest pain like he never had before.   Follow-up attempts completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Heart rate, Heart rate increased, Off label use
Clinical narrative: as it was taken out side the window (19-42 days); Exposure during pregnancy; Fast heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Oct2021 09:00 (Lot number: FE3592) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "headaches", start date: 01Jan2020 (ongoing). Concomitant medication(s) included: KEPRA taken for headache, start date: 25May2021 (ongoing); PROPANOLOL BOEHRINGER taken for headache, start date: 25May2021 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Date: 02Sep2021, Time: 08:15 am, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: FE3592), administration date: 02Sep2021, for Covid-19 immunization, reaction(s): "First heart rate"; Bnt162b2 (Dose: 1), administration date: 02Sep2021, for COVID-19 Immunization, reaction(s): "Dizziness". The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "as it was taken out side the window (19-42 days)"; EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Exposure during pregnancy"; HEART RATE INCREASED (non-serious) with onset 2021, outcome "not recovered", described as "Fast heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior Vaccination (within 4 weeks) was none. Patient medical history included Illness/AE: Headches, onset date: 01Jan2020, stop date: Ongoing, pertinent: on treatment for chronic headches/migraines without. Still having effects of high/fast heart rate even on standing/staying still activity. Over 120bpm sometimes. It varies all the time. Doctor wrote or visits as adverse effects. Currently pregnant.  Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: had difficulty breathing afterwards; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 72 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "had difficulty breathing afterwards".  Additional information: To Whom It May Concern: As you may be aware, the FDA Guidelines (Docket No. withheld), require that: Reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant. Additionally, per CFR withheld, Post-marketing Reporting of Adverse Drug Experiences, updated 01Apr2016, the requirements of paragraphs of this section, concerning the submission of post-marketing 15-day Alert reports, also apply to any person other than the applicant whose name appears on the label of an approved drug product as a manufacturer, packer, or distributor (non-applicant). To avoid unnecessary duplication in the submission to FDA of reports required by paragraphs of this section, obligations of a non-applicant may be met by submission of all reports of serious adverse drug experiences to the applicant. If a non-applicant elects to submit adverse drug experience reports to the applicant rather than to FDA, the non-applicant must submit, by any appropriate means, each report to the applicant within 5 calendar days of initial receipt of the information by the non-applicant, and the applicant must then comply with the requirements of this section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Severe chills; Fever; Fatigue; Body ache; This is a spontaneous report from a contactable consumer. This 41-year-old female consumer (patient) reported for herself.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Allergy: Bactrim". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Severe chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body ache".  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Device Date: 12Nov2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Erythema, Eye pruritus, Nasal oedema, SARS-CoV-2 test
Clinical narrative: Swelling; redness; itching around both eyes; Face and nose mildly swollen; Face and nose mildly swollen; Intermittent coughing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 13Nov2021 10:30 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergy to nuts" (unspecified if ongoing), notes: Peanuts. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 13Nov2021 13:00, outcome "recovering", described as "Swelling"; ERYTHEMA (non-serious) with onset 13Nov2021 13:00, outcome "recovering", described as "redness"; EYE PRURITUS (non-serious) with onset 13Nov2021 13:00, outcome "recovering", described as "itching around both eyes"; SWELLING FACE (non-serious), NASAL OEDEMA (non-serious) all with onset 13Nov2021 13:00, outcome "recovering" and all described as "Face and nose mildly swollen"; COUGH (non-serious) with onset 13Nov2021 13:00, outcome "recovering", described as "Intermittent coughing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling, erythema, eye pruritus, swelling face, nasal oedema, cough.  Additional Information: Patient receive any other vaccines within 4 weeks prior to the COVID vaccine was no. Treatment received for the adverse event was medication and steroids.  Prior to vaccination, was the patient diagnosed with COVID-19 was yes. Since the vaccination, patient has not been tested for COVID-19 was no. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (16Dec2021): 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: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: Swelling; redness; itching around both eyes; Face and nose mildly swollen; Face and nose mildly swollen; Intermittent coughing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 13Nov2021 10:30 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergy to nuts" (unspecified if ongoing), notes: Peanuts. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 13Nov2021 13:00, outcome "recovering", described as "Swelling"; ERYTHEMA (non-serious) with onset 13Nov2021 13:00, outcome "recovering", described as "redness"; EYE PRURITUS (non-serious) with onset 13Nov2021 13:00, outcome "recovering", described as "itching around both eyes"; SWELLING FACE (non-serious), NASAL OEDEMA (non-serious) all with onset 13Nov2021 13:00, outcome "recovering" and all described as "Face and nose mildly swollen"; COUGH (non-serious) with onset 13Nov2021 13:00, outcome "recovering", described as "Intermittent coughing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling, erythema, eye pruritus, swelling face, nasal oedema, cough.  Additional Information: Patient receive any other vaccines within 4 weeks prior to the COVID vaccine was no. Treatment received for the adverse event was medication and steroids.  Prior to vaccination, was the patient diagnosed with COVID-19 was yes. Since the vaccination, patient has not been tested for COVID-19 was no. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (16Dec2021): 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; Fever; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 61 years as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (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. On an unspecified date patient experienced fatigue, fever, headache. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (16Dec2021): 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Parosmia, Symptom recurrence
Clinical narrative: headache; constant smell of gasoline; nauseous; constant smell of gasoline; 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 22Apr2021 (Lot number: ER8736) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number=8732, Vaccine location=Left arm), administration date: 01Apr2021, when the patient was 42 years old, for COVID-19 immunization, reaction(s): "One day after I got my first vaccine, I started to have a constant smell of gasoline.". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headache"; PAROSMIA (non-serious), SYMPTOM RECURRENCE (non-serious) all with onset 2021, outcome "not recovered" and all described as "constant smell of gasoline"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "nauseous". Therapeutic measures were not taken as a result of parosmia, symptom recurrence.  Additional information: Patient had no known allergies. Case was not serious. Patient received no other medications in two weeks. No other vaccine in four weeks. Reporter stated that One day after she got her first vaccine, she started to have a constant smell of gasoline. It lasted for a few days and they went away. Adverse event start date was on 02Apr2021. After her second vaccine, the same thing occurred. Since then she had the smell return every few weeks and last for a couple of days. She would like to know how to stop this smell as it made her feel nauseous and gave her a headache and kept coming back. No covid prior vaccination and not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Neck pain
Clinical narrative: first dose hit her the same way the first dose did in neck and shoulders/felt the stiffness and pain in left side of neck and arm and shoulder blade first; first dose hit her the same way the first dose did in neck and shoulders/felt the stiffness and pain in left side of neck and arm and shoulder blade first; first dose hit her the same way the first dose did in neck and shoulders/felt the stiffness and pain in left side of neck and arm and shoulder blade first; This is a spontaneous report received from 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 right, administration date 17Mar2021 (Lot number: ER2613) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing). There were no concomitant medications. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset Mar2021, outcome "recovered" (2021) and all described as "first dose hit her the same way the first dose did in neck and shoulders/felt the stiffness and pain in left side of neck and arm and shoulder blade first".  Additional information included: It was stated that the first dose hit the patient the same way the first dose did in neck and shoulders which lasted 10 days with the first shot, did not have the dried tissues and cramps at that time.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (parent). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FK5127), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient (reporter's daughter) developed urticaria (hives on her stomach and legs) and had hypersensitivity (allergic reaction to the vaccine), with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left arm numbness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 31Dec2020 07:30 (Lot number: EK9231) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Depression" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing); "dermatology condition" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZOLOFT; ACYLOVIR. The following information was reported: HYPOAESTHESIA (non-serious) with onset 05Jan2021, outcome "not recovered", described as "Left arm numbness". Therapeutic measures were not taken as a result of hypoaesthesia.  Additional Information: Left arm numbness, it comes and goes but persistent since first vaccinated. Patient had almost daily numbness of left arm, tingling-goes away and returns (ongoing). Patient did not receive other vaccine in four weeks of vaccination. Patient received other medications in two weeks of vaccinations were synthroid, zoloft and acyclovir. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, since the vaccination. Patient received dose 2 (Batch/ Lot number: EL8982) in left deltoid on 21Jan2021 at 08:00. Patient received dose 3 (Batch/ Lot number: FC3183) in left deltoid on 30Aug2021 at 19:45, due to weakened immune system (occasional use of high dose steroids). No specific relevant test for thromboembolic events with thrombocytopenia.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal
Clinical narrative: She is saying that her chest hurts, ants moving from all over chest; She is saying that her chest hurts, ants moving from all over chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), CHEST PAIN (non-serious), outcome "unknown" and all described as "She is saying that her chest hurts, ants moving from all over chest".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: eyes are swelling shut up; face is swollen; 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 Nov2021 (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: SWELLING OF EYELID (non-serious) with onset Nov2021, outcome "unknown", described as "eyes are swelling shut up"; SWELLING FACE (non-serious) with onset Nov2021, outcome "unknown", described as "face is swollen".  Additional information:It was reported that i got the first dose of the COVID vaccine this week and my eyes are swelling shut up and my face is swollen and I had been reading on the paper works that I got from the pharmacy that might be an allergic reaction. I don't know what to do about it but I wanted it to be noted I am not sure if there is some sort of procedure I should do now."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate, Heart rate increased, Pain
Clinical narrative: Fever; Fatigue; Body ache; Very rapid heartbeat (approx. 120-130 bpm when resting); Severe chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim". Vaccination history included: Bnt162b2 (dose number=1,, vaccine location: Left arm), administration date: 21Mar2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "Severe chills", "Fever", "Fatigue", "Body ache". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Severe chills"; PYREXIA (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Fever"; FATIGUE (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Fatigue"; PAIN (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Body ache"; HEART RATE INCREASED (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Very rapid heartbeat (approx. 120-130 bpm when resting)". The events "severe chills", "fever", "fatigue", "body ache" and "very rapid heartbeat (approx. 120-130 bpm when resting)" were evaluated at the physician office visit. 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Fatigue; Body ache; Very rapid heartbeat (approx. 120-130 bpm when resting); Severe chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim". Vaccination history included: Bnt162b2 (dose number=1,, vaccine location: Left arm), administration date: 21Mar2021, when the patient was 41 years old, for COVID-19 immunization, reaction(s): "Severe chills", "Fever", "Fatigue", "Body ache". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Severe chills"; PYREXIA (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Fever"; FATIGUE (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Fatigue"; PAIN (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Body ache"; HEART RATE INCREASED (non-serious) with onset 11Apr2021, outcome "recovered" (2021), described as "Very rapid heartbeat (approx. 120-130 bpm when resting)". The events "severe chills", "fever", "fatigue", "body ache" and "very rapid heartbeat (approx. 120-130 bpm when resting)" were evaluated at the physician office visit. 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.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: I was forced to get the Vaccine for my job but what I am looking that I keep feeling some weird palpitation is going on in my heart; 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, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "I was forced to get the Vaccine for my job but what I am looking that I keep feeling some weird palpitation is going on in my heart".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Overdose
Clinical narrative: Shortness of breath; Had a overdose of the Pfizer first dose of the Covid-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 19 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (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: DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "Shortness of breath"; OVERDOSE (non-serious) with onset 2021, outcome "unknown", described as "Had a overdose of the Pfizer first dose of the Covid-19 Vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: just a little bit of injection site soreness; 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 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 "just a little bit of injection site soreness".  Additional information: Patient had two vaccine shots for COVID and then patient had the booster shot on 12Nov2021. Patient had normal reaction to the vaccine. It just a little bit of Injection site soreness and that has happened again. Patient was unwilling to provide more information further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.