chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Erythema, Inflammation, Tenderness
Clinical narrative: Inflammation; Tenderness; erythema; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): GL-101221-2432.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; hyaluronic acid, lidocaine (RESTYLANE L), from May2021 (Batch/Lot number: unknown) to May2021; hyaluronic acid, lidocaine (JUVEDERM ULTRA PLUS), from May2021 (Batch/Lot number: unknown) to May2021. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "Inflammation"; TENDERNESS (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "Tenderness"; ERYTHEMA (non-serious) with onset Oct2021, outcome "recovered" (2021), described as "erythema". The action taken for hyaluronic acid, lidocaine and hyaluronic acid, lidocaine was unknown. Therapeutic measures were taken as a result of inflammation, tenderness, erythema.  Additional information: Patient was injected Restylane Kysse in the lip in the chin in May2021. In Oct2021 the patient presented with late onset inflammation in both the lips and the chin. Patient treated with Hylenex and Kenalog. Patient significantly improved after several treatments with Kenalog. Patient had COVID vaccine approximately 8 months prior to reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Grandson is very sick; Grandson is very sick from this vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male 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: ILLNESS (non-serious), outcome "unknown", described as "Grandson is very sick; Grandson is very sick from this vaccine.".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: I have been sick for about 2 weeks with the the side effect; I still don''t feel quite like myself; 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 3 (booster), 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, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I have been sick for about 2 weeks with the the side effect"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I still don''t feel quite like myself". The events "i have been sick for about 2 weeks with the the side effect" and "i still don''t feel quite like myself" were evaluated at the physician office visit.  Additional Information: The patient had vaccine (clarified as Pfizer COVID vaccine) on October 6. The answer that the patient got from his/her doctor was that his/her just have to come in and be monitored.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age, Pyrexia, Vaccination site pain
Clinical narrative: children received a higher dose for the second vaccine of COVID; The pts were administered with LOT# FK9729.; Fever; pain in the point of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 10 year-old female patient received BNT162b2 (BNT162B2), administered in arm left, administration date 11Feb2022 (Lot number: FK9729) at the age of 10 years as dose 2 (tris), 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 1, SINGLE), for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious) with onset 11Feb2022, outcome "unknown", described as "pt received a higher dose for the second vaccine of COVID"; PYREXIA (non-serious) with onset Feb2022, outcome "unknown", described as "Fever"; VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "pain in the point of injection"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 11Feb2022, outcome "unknown", described as "The pts were administered with LOT# FK9729.". Therapeutic measures were taken as a result of pyrexia, vaccination site pain.  Additional Information: It was reported as "One of my friends reported to me that his children received a higher dose for the second vaccine of COVID and that they are experiencing fever and pain in the point of injection. The second dose, the dosage that was wrong. Pts, 8 and 10, the dose administered was a higher dose." This is the case for 10 year old child.  They are both taking only children's Tylenol (Clarified taken as Treatment) at this time (Intent: Treatment), Tylenol for children. They are taking it for discomfort. They are not on any kind of therapy or medication (Further not clarified if taking any medications, hence not captured). The patient did not have any prior vaccination within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age, Pyrexia, Vaccination site pain
Clinical narrative: patient received a higher dose for the second vaccine of COVID; dose administered was a higher dose.; The patient's were administered with LOT# FK9729; Fever; pain in the point of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 8 year-old male patient received BNT162b2 (BNT162B2), administered in arm left, administration date 11Feb2022 (Lot number: FK9729) at the age of 8 years as dose 2 (tris), 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 1, SINGLE), for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious) with onset 11Feb2022, outcome "unknown", described as "children received a higher dose for the second vaccine of COVID; dose administered was a higher dose."; PYREXIA (non-serious) with onset Feb2022, outcome "unknown", described as "Fever"; VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "pain in the point of injection"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 11Feb2022, outcome "unknown", described as "The patients were administered with LOT# FK9729". Therapeutic measures were taken as a result of pyrexia, vaccination site pain.  Additional Information: It was reported as "One of my friends reported to me that his patient received a higher dose for the second vaccine of COVID and that they are experiencing fever and pain in the point of injection. The second dose, the dosage that was wrong. Patients, 8 and 10, the dose administered was a higher dose." This is the case for 8 year old child.  They are both taking only children's Tylenol (Clarified taken as Treatment) at this time (Intent: Treatment), Tylenol for patients. They are taking it for discomfort. They are not on any kind of therapy or medication. The patient did not have any prior vaccination within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Mycobacterium tuberculosis complex test, Ultrasound testes
Clinical narrative: After my first vaccine my menstrual lasted 10 days; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 15:00 (Lot number: FC3184) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing); "Cesarean section", start date: 20Feb2003 (unspecified if ongoing), notes: Illness/AE: Cesarean section, Onset date: 27Sep2005, Onset date: 28Feb2007, Onset date: 15Nov2014. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID], start date: 2019 (ongoing); B 12, start date: 2021 (ongoing). The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 23Dec2021, outcome "unknown", described as "After my first vaccine my menstrual lasted 10 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heavy menstrual bleeding.  Additional Information: The patient concomitant medication also include Women multivitamin start from 2019, Route: P.O (Per Oral), ongoing. The patient family medication history relevant to AE(s) includeds: Mom: blood pressure, High cholesterol. Dad: heart disease. The patient did not have other vaccine in four weeks. The patient has covid prior to vaccination. The patient was not tested post vaccination. The patient does not have known allergies. The patient consider the Pfizer product had a causal effect to the adverse event.     No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: just not thinking clearly; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (COMIRNATY), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid mrna vaccine (Dose 1), for Covid-19 immunization, reaction(s): "2 hours of weakness"; Moderna covid mrna vaccine (Dose 2), for Covid-19 immunization, reaction(s): "2 hours of weakness". The following information was reported: THINKING ABNORMAL (non-serious) with onset Oct2021, outcome "recovered", described as "just not thinking clearly". Additional information  61 year old male who had received initial two shots of Moderna Covid mRNA vaccine opted to receive Pfizer/BioNTech booster. His reason was that he had experienced 2 hours of weakness after receiving the Moderna vaccine although he then stated it was associated with having increased energy levels. In view of this opted to receive COMIRNATY booster some time in October 2021 time frame. This was associated with few hours of just not thinking clearly. This resolved with no interventions on own and no additional sequelae.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: PNC20
Symptoms: Injection site pain, Pain
Clinical narrative: Have observe some pain at the injection site at the moment of the vaccine administration/burning like pain; The pain was described as a burning like pain; This is a spontaneous report received from contactable Pharmacist from information team and a sales representative.  A 65 year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as single dose for immunization. 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 "Have observe some pain at the injection site at the moment of the vaccine administration/burning like pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "The pain was described as a burning like pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 68 year-old patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Lot number: EL9267) at the age of 68 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Anatomical site: Deltoid, Lot: EL8982, unit: 0.3ml), administration date: 29Jan2021, when the patient was 68 years old, for COVID-19 Immunization. The following information was reported: SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (non-serious), outcome "unknown", described as "SIRVA". Therapeutic measures were not taken as a result of shoulder injury related to vaccine administration.  Additional information: Anatomical Site of injection: deltoid. Vaccination facility type was Doctors office/ urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any treatment for the event. Specific Relevant Test for Thromboembolic Events with Thrombocytopenia and other relevant tests were unknown. Vaccine dose 3 was due on or after 23Jul2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Eructation, Laboratory test
Clinical narrative: Burning in digestive tract; Belching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0172) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoking", start date: 2021 (ongoing), notes: stopped smoking and then, Chantix was recalled and she started smoking again in 2021. The patient's concomitant medications were not reported. Past drug history included: Chantix, start date: 2021, stop date: 2021, for Smoking cessation, notes: Expiry Date: May2023, Dosage permanently discontinued. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot Number: ER8733, Anatomical Location: left arm), administration date: 08Apr2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Burning in digestive tract"; ERUCTATION (non-serious) with onset 2021, outcome "not recovered", described as "Belching". The events "burning in digestive tract" and "belching" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  The patient was not on any other vaccine 4 weeks prior to Pfizer vaccination. The patient had no AE(s) prior to Pfizer vaccination. The patient reported that she started smoking again after Chantix recall, she cannot remember the exact date, but started smoking again in 2021. She stated she was down to 2 cigarettes a day and alternating with 1 cigarette. She was up to 5 cigarettes a day now, depending on the day. She has had many tests for her digestive symptoms, unspecified and the doctors cannot make a diagnosis. This week she was having a digestive motility test. These events did not resulted in emergency room visit. She clarified these events occurred after stopping Chantix, and after she had the second Pfizer Covid vaccine, adult. Events Burning in digestive tract and Belching occurred at the end of May2022 or beginning of Jun2022. Belching still persisted.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Duodenogastric reflux, Dyspepsia, Eating disorder, Endoscopy abnormal
Clinical narrative: Burning in digestive tract; Belching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0172) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoking", start date: 2021 (ongoing), notes: stopped smoking and then, Chantix was recalled and she started smoking again in 2021. The patient's concomitant medications were not reported. Past drug history included: Chantix, start date: 2021, stop date: 2021, for Smoking cessation, notes: Expiry Date: May2023, Dosage permanently discontinued. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot Number: ER8733, Anatomical Location: left arm), administration date: 08Apr2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Burning in digestive tract"; ERUCTATION (non-serious) with onset 2021, outcome "not recovered", described as "Belching". The events "burning in digestive tract" and "belching" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  The patient was not on any other vaccine 4 weeks prior to Pfizer vaccination. The patient had no AE(s) prior to Pfizer vaccination. The patient reported that she started smoking again after Chantix recall, she cannot remember the exact date, but started smoking again in 2021. She stated she was down to 2 cigarettes a day and alternating with 1 cigarette. She was up to 5 cigarettes a day now, depending on the day. She has had many tests for her digestive symptoms, unspecified and the doctors cannot make a diagnosis. This week she was having a digestive motility test. These events did not resulted in emergency room visit. She clarified these events occurred after stopping Chantix, and after she had the second Pfizer Covid vaccine, adult. Events Burning in digestive tract and Belching occurred at the end of May2022 or beginning of Jun2022. Belching still persisted.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eructation, Hernia, Inflammation, Pain
Clinical narrative: Burning in digestive tract; Belching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0172) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoking", start date: 2021 (ongoing), notes: stopped smoking and then, Chantix was recalled and she started smoking again in 2021. The patient's concomitant medications were not reported. Past drug history included: Chantix, start date: 2021, stop date: 2021, for Smoking cessation, notes: Expiry Date: May2023, Dosage permanently discontinued. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot Number: ER8733, Anatomical Location: left arm), administration date: 08Apr2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Burning in digestive tract"; ERUCTATION (non-serious) with onset 2021, outcome "not recovered", described as "Belching". The events "burning in digestive tract" and "belching" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  The patient was not on any other vaccine 4 weeks prior to Pfizer vaccination. The patient had no AE(s) prior to Pfizer vaccination. The patient reported that she started smoking again after Chantix recall, she cannot remember the exact date, but started smoking again in 2021. She stated she was down to 2 cigarettes a day and alternating with 1 cigarette. She was up to 5 cigarettes a day now, depending on the day. She has had many tests for her digestive symptoms, unspecified and the doctors cannot make a diagnosis. This week she was having a digestive motility test. These events did not resulted in emergency room visit. She clarified these events occurred after stopping Chantix, and after she had the second Pfizer Covid vaccine, adult. Events Burning in digestive tract and Belching occurred at the end of May2022 or beginning of Jun2022. Belching still persisted.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Renal disorder, Spinal disorder
Clinical narrative: She does have cardiac, kidney and spinal issues; She does have cardiac, kidney and spinal issues; She does have cardiac, kidney and spinal issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 6 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and 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: CARDIAC DISORDER (non-serious), RENAL DISORDER (non-serious), SPINAL DISORDER (non-serious), outcome "unknown" and all described as "She does have cardiac, kidney and spinal issues". Additional information: The patient was asking if there was going to be a booster soon for 5-11 year old.Their 06-year-old had taken both doses. The patient does had cardiac, kidney and spinal issues. They live in withheld and vaccine rates are low. Nobody wears masks at the patient school or anywhere there. They do wear mask. They need a booster to keep her safe Or a third dose. It was approaching 4 months since her 1st dose. I am concerned. Please authorize a third Shot or Booster. Thank You The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight increased
Clinical narrative: Gained 50 lbs in the past 8 months after last shot; 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 male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), for COVID-19 Immunization.  The following information was reported: WEIGHT INCREASED (non-serious), outcome "not recovered", described as "Gained 50 lbs in the past 8 months after last shot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of weight increased.  Additional information: No other vaccine were received in four weeks. No other medications received in two weeks. It was reported that patient gained 50 lbs in the past 8 months after last shot and have not changed routine at work or at home. Diet has been the same before and after. No covid prior vaccination and not tested for covid post vaccination. No Known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: PNC20
Symptoms: Drug hypersensitivity
Clinical narrative: Good ad but I am allergic to it (Prevnar 20); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (174934). The reporter is the patient.  A 76-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Good ad but I am allergic to it (Prevnar 20)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity, Paralysis, SARS-CoV-2 test
Clinical narrative: feels paralyzed; Both upper arms esp. left hurt constantly deep to bone; hard to raise left arm up; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162B2 (COMIRNATY), administered in arm left, administration date 08Oct2021 14:30 (Lot number: 30155BA) at the age of 66 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Drug allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: FF8839, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 17Sep2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: PARALYSIS (medically significant) with onset 09Oct2021 08:00, outcome "not recovered", described as "feels paralyzed"; PAIN IN EXTREMITY (non-serious) with onset 09Oct2021 08:00, outcome "not recovered", described as "Both upper arms esp. left hurt constantly deep to bone"; INJECTED LIMB MOBILITY DECREASED (non-serious) with onset 09Oct2021 08:00, outcome "not recovered", described as "hard to raise left arm up". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of paralysis, pain in extremity, injected limb mobility decreased.; Sender's Comments: Based on the limited information provided, a possible contribution of the suspect product administration to the reported events cannot be excluded, due to a  temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PNC20
Symptoms: Allergy to vaccine
Clinical narrative: Allergy reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (174934). The reporter is the patient.  A 79-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergy reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Allergy to vaccine
Clinical narrative: allergic to the vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a sponsored program (174934). The reporter is the patient.  A 73-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic to the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: PNC20
Symptoms: Vaccination site pain
Clinical narrative: when the patient got the shot, it hurt a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (174934). The reporter is the patient.  A 53 year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) at the age of 53 years as a single dose for 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 "when the patient got the shot, it hurt a little bit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache
Clinical narrative: severe headache; "ice-pick", sharp stabbing headaches that come out of no where; "ice-pick", sharp stabbing headaches that come out of no where; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2020 (Lot number: EK5730) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing); "tension", start date: 2015 (unspecified if ongoing), notes: There was not other history of headache other than short lived course tension headaches during 2015; "headache", start date: 2015 (unspecified if ongoing), notes: There was not other history of headache other than short lived course tension headaches during 2015. Concomitant medication(s) included: OMEPRAZOLE; ATOMOXETINE. The following information was reported: HEADACHE (non-serious) with onset 19Dec2020, outcome "recovered with sequelae", described as "severe headache"; HEADACHE (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 19Dec2020, outcome "recovered with sequelae" and all described as ""ice-pick", sharp stabbing headaches that come out of no where". The events "severe headache", ""ice-pick", sharp stabbing headaches that come out of no where" and ""ice-pick", sharp stabbing headaches that come out of no where" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache, headache, condition aggravated.  Additional information: It was reported that, patient had severe headache for 3 days after initial vaccination that NSAIDS could not relieve and for 1 day after second vaccination. The more concerning side effect though was ice-pick, sharp stabbing headaches that come out of nowhere and last for seconds to several hours for the past year. They typically happen multiple times a week (3-5x). These have not resolved as of (4Mar2022) and often NSAIDs were little to no help. There was not other history of headaches other than a short lived course of tension headaches during 2015. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies.  Follow-up attempts completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Migraine, Pain, Pruritus
Clinical narrative: severe migraine; severe hives and itching; body aches; swollen tonsils; lymph nodes swelled to point couldnt turn head; severe hives and itching; fatigue; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2022 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: MIGRAINE (medically significant) with onset 20Feb2022, outcome "not recovered", described as "severe migraine"; URTICARIA (medically significant), PRURITUS (non-serious) all with onset 20Feb2022, outcome "not recovered" and all described as "severe hives and itching"; PYREXIA (non-serious) with onset 20Feb2022, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 20Feb2022, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 20Feb2022, outcome "not recovered", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 20Feb2022, outcome "not recovered", described as "lymph nodes swelled to point couldnt turn head"; TONSILLAR HYPERTROPHY (non-serious) with onset 20Feb2022, outcome "not recovered", described as "swollen tonsils". The events "severe migraine", "severe hives and itching", "fever", "body aches", "fatigue", "lymph nodes swelled to point couldnt turn head", "severe hives and itching" and "swollen tonsils" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Feb2022) negative. Therapeutic measures were taken as a result of migraine, urticaria, pyrexia, pain, fatigue, lymphadenopathy, pruritus, tonsillar hypertrophy.  Additional information: Known allergies: No. Other medical history: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tonsillar hypertrophy, Urticaria
Clinical narrative: severe migraine; severe hives and itching; body aches; swollen tonsils; lymph nodes swelled to point couldnt turn head; severe hives and itching; fatigue; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2022 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: MIGRAINE (medically significant) with onset 20Feb2022, outcome "not recovered", described as "severe migraine"; URTICARIA (medically significant), PRURITUS (non-serious) all with onset 20Feb2022, outcome "not recovered" and all described as "severe hives and itching"; PYREXIA (non-serious) with onset 20Feb2022, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 20Feb2022, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 20Feb2022, outcome "not recovered", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 20Feb2022, outcome "not recovered", described as "lymph nodes swelled to point couldnt turn head"; TONSILLAR HYPERTROPHY (non-serious) with onset 20Feb2022, outcome "not recovered", described as "swollen tonsils". The events "severe migraine", "severe hives and itching", "fever", "body aches", "fatigue", "lymph nodes swelled to point couldnt turn head", "severe hives and itching" and "swollen tonsils" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Feb2022) negative. Therapeutic measures were taken as a result of migraine, urticaria, pyrexia, pain, fatigue, lymphadenopathy, pruritus, tonsillar hypertrophy.  Additional information: Known allergies: No. Other medical history: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: 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 29-year-old male 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracting Covid-19". Clinical course: Reporter queried that how long should he wait to receive the booster dose of the Pfizer Covid vaccine, after contracting Covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: PNC13
Symptoms: Drug ineffective, Pneumococcal infection
Clinical narrative: a child still get IPD (Invasive pneumococcal disease) not covered by PREVNAR 13; a child still get IPD (Invasive pneumococcal disease) not covered by PREVNAR 13; This is a spontaneous report received from a contactable reporter(s) (Physician) for a sponsored program (175895).  A child patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMOCOCCAL INFECTION (medically significant), outcome "unknown" and all described as "a child still get IPD (Invasive pneumococcal disease) not covered by PREVNAR 13".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The association between the event lack of effect (pneumococcal infection) with PREVENAR 13 use can not be completely excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Developed severe constant ringing in right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02May2021 11:00 (Lot number: EW0176) at the age of 32 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: ER8731, Location of injection: Arm Right, Vaccine Administration Time: 14:30), administration date: 11Apr2021, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 19May2021, outcome "not recovered", described as "Developed severe constant ringing in right ear". The event "developed severe constant ringing in right ear" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus. Clinical Course: Covid test type post vaccination: Nasal Swab, Covid test name post vaccination: SARS-Cov-2 RNA RT-PCR, Covid test date: 09Jul2021, Covid test result: Negative, covid test type post vaccination: Nasal Swab, covid test name post vaccination: Randox COVID-19 qPCR, covid test date: 05Aug2021, covid test result: Negative, covid test type post vaccination: Nasal Swab, covid test name post vaccination: COVID-19 Molecular Lab Test PCR/NAAT, covid test date: 23Nov2021, covid test result: Negative, covid test type post vaccination: Nasal Swab, covid test name post vaccination=SARS-Cov-2 RT-PCR, covid test date=19Dec2021, covid test result; Negative, covid test type post vaccination=Nasal Swab, Covid test name post vaccination=2019-nCOV qPCR Assay, Covid test date: 07Feb2022, Covid test result: Negative  No other vaccine in four weeks and no medications in two weeks. No COVID confirmed prior vaccination. No Known allergies No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: anaphylaxis; having difficulty to breath; 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 26 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2022 (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), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset Feb2022, outcome "unknown", described as "anaphylaxis"; DYSPNOEA (non-serious) with onset Feb2022, outcome "unknown", described as "having difficulty to breath". The events "anaphylaxis" and "having difficulty to breath" were evaluated at the physician office visit.  Additional information: Caller states that about one month ago his son (26 years-old male) got the booster dose of the Pfizer-BioNTech COVID-19 Vaccine after completing the primary series. Almost instantly, after getting the booster, patient had to be taken to the hospital because he started having difficulty to breath. He got diagnosed with anaphylaxis. An ambulance had to take him to the hospital". He had no option but to get the vaccine or he would have lost his job. He'd lose his house if he loses his job.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose3 (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), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization.  The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown", described as "myocarditis".  Clinical Course: The reporter stated that My son was one of the unlucky few who developed myocarditis shortly after receiving the booster vaccine. As this was a direct result of the booster vaccine and is a rare but well documented vaccine injury.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As per available information, the casual association between the event myocarditis and suspected drug cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Illness, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: multiple pulmonary embolisms; short of breath; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date 22Nov2021 (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. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (death, medically significant) with onset 12Jan2022, outcome "fatal", described as "multiple pulmonary embolisms"; DYSPNOEA (non-serious) with onset 11Jan2022, outcome "unknown", described as "short of breath"; ILLNESS (non-serious) with onset 11Jan2022, outcome "unknown", described as "sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. The patient date of death was 12Jan2022. The reported cause of death was pulmonary embolism. Clinical course: Patient was a police officer as Per Covid mandates, he had to be vaccinated to keep his job. On 11Jan2022 he was feeling short of breath and thought he might of had Covid, so he called in sick for his shift at work and went and took a PCR test (which later came back negative). On 12Jan2022 he collapsed at home and was taken to the hospital by ambulance where after 2 hours of evaluation, he coded and died.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: multiple pulmonary embolisms