chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abortion spontaneous, Blood test, Haemorrhage, Human chorionic gonadotropin positive, Pregnancy test urine positive
Clinical narrative: Was blood work tested for pregnancy on Tuesday October 4. Lower than expect htc but still within acceptable. Started bleeding and loss of pregnancy October 7.  I, the patient also had several urine tests positive over the week prior. They were not increasing in darkness on test line. Personally felt something was up with pregnancy before I had my blood work done.
Age: 11.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: So far there are no adverse effects, but I mistakenly administered the Pfizer Bivalent Booster to this 11 year old patient today, I simply overlooked her DOB of birth on the form and did not realize she was not old enough.  Father of patient was notified this evening around 10:00 p.m. after the discovery of the error was made once we returned to the pharmacy after the flu shot/covid shot event and started scanning the consent forms into the computer system. Our computer system would not allow us to select Pfizer Bivalent Booster 12+  because the patient was not 12 years old.  Told father I would call tomorrow to check on daughter.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: So far there are no adverse effects, however, I mistakenly administered the Pfizer Bivalent 12+ dose to this 9 year old patient today at an offsite flu/covid clinic at her school.  We realized an error had been made when we returned to the store to scan the consent forms and the computer system would not allow us to add the Pfizer Bivalent Booster 12+ because the patient is not at least 12 years old.  Father of the patient was contacted this evening around 10:00 p.m.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Gait disturbance, Nausea, Vertigo
Clinical narrative: Dizziness, vertigo with room spinning, difficulty walking without assitance. Nausea and severe vomiting. Nausea and tired for 2 days
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Dizziness, vertigo with room spinning, difficulty walking without assitance. Nausea and severe vomiting. Nausea and tired for 2 days
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Watch alerted me of fast heart beat. Heart rate of 120-124 this evening. Sometimes drops to 110-115. I can feel my heart beating.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: >24 hrs after administration parent reported a rash to right thigh.  Photo provided appears to be circular, approx 1/2 dollar size with raised edges and red in color. No weeping noted.  Patent reports no SOB or pain to site.  Administering staff reports using 25G 1" needle with a 90degree angle.   Pt status monitored daily by Nurse Manager, no further progression of rash noted.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, General physical condition abnormal, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Per pt., approx 20 min after injection, developed sudden headache with pain 8/10, neck pain, and redness/itchiness/swelling at injection site. Arrived at school nurse office at 12:30. Reported that her fingers were swelling. Fingers were not visibly swollen, and her rings were freely movable around fingers.  BP 130/80, HR 90, 98% RA. Ice pack applied. Pt reported her daily meds (see above) and that she had not taken her daily anti-anxiety medication. Pt requested 2 cups water. Pt agreed to administration of 25mg Diphenhydramine po. Stated that it seemed to be helping. Denied "feeling like I am having anaphlaxis, I know how that feels." Reported arm/headache feeling better. continued: At 12:45, Pt ambulated  from Elementary School Nurse office to highschool nurse office for further observation. School nurse was familiar with pts baseline, and noted she looked different. PHN noted that patient was now diaphoretic and arm swelling seemed more pronounced. Pt agreed to have EMTs called, after being encouraged by 3 nurses. At 1pm, BP 152/90, HR 90, O2 sat went from 95% RA to 87% RA while awaiting ambulance. Pt remained talkative and sitting upright throughout. Denied shortness of breath or difficulty breathing.  Erythema marked with pen and did spread beyond pen border while awaiting transport. Pt transported to ER via Ambulance around 1:20pm.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Limb discomfort, Neck pain, Peripheral swelling
Clinical narrative: Per pt., approx 20 min after injection, developed sudden headache with pain 8/10, neck pain, and redness/itchiness/swelling at injection site. Arrived at school nurse office at 12:30. Reported that her fingers were swelling. Fingers were not visibly swollen, and her rings were freely movable around fingers.  BP 130/80, HR 90, 98% RA. Ice pack applied. Pt reported her daily meds (see above) and that she had not taken her daily anti-anxiety medication. Pt requested 2 cups water. Pt agreed to administration of 25mg Diphenhydramine po. Stated that it seemed to be helping. Denied "feeling like I am having anaphlaxis, I know how that feels." Reported arm/headache feeling better. continued: At 12:45, Pt ambulated  from Elementary School Nurse office to highschool nurse office for further observation. School nurse was familiar with pts baseline, and noted she looked different. PHN noted that patient was now diaphoretic and arm swelling seemed more pronounced. Pt agreed to have EMTs called, after being encouraged by 3 nurses. At 1pm, BP 152/90, HR 90, O2 sat went from 95% RA to 87% RA while awaiting ambulance. Pt remained talkative and sitting upright throughout. Denied shortness of breath or difficulty breathing.  Erythema marked with pen and did spread beyond pen border while awaiting transport. Pt transported to ER via Ambulance around 1:20pm.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Human chorionic gonadotropin, Pregnancy test positive
Clinical narrative: Minor denied sexual activity prior vaccination. MMR and Varicella were administered. A pregnancy test was performed and came back positive. Minor stated 9/12/22 was her LMP.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Hives all over body and swollen tongue
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore on bottom lip
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: patient was given a double dose of Moderna bivalent
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 025 instead of 05
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient was given 0.25 instead of 0.5
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: PT WAS GIVEN MODERNA MOVOVALET BOOSTER INSTEAD OF BIVALENT BOOSTER. NO ADVERSE EVENTS KNOWN ABOUT.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 0 Adverse events. 0 Treatment needed. 0 Symptoms
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Acute myocardial infarction, Arthralgia, Axillary pain, Cardiac monitoring, Catheterisation cardiac
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Severe, Additional Details: heart attack on 9/21/22, md diagnosed inflammatory syndrome afterwards; patient notified pharmacy on 10/04/2022, no other details
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Chest pain, Electrocardiogram, Inflammation, Intensive care, Laboratory test
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Severe, Additional Details: heart attack on 9/21/22, md diagnosed inflammatory syndrome afterwards; patient notified pharmacy on 10/04/2022, no other details
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Musculoskeletal stiffness, Myocarditis, Pain in extremity, Troponin increased
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Severe, Additional Details: heart attack on 9/21/22, md diagnosed inflammatory syndrome afterwards; patient notified pharmacy on 10/04/2022, no other details
Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Cardiac disorder, Multisystem inflammatory syndrome, Myocardial infarction
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: MIS (Multisystem Inflammatory Syndrome)(diagnosed by MD)-Severe, Additional Details: heart attack on 9/21/22, md diagnosed inflammatory syndrome afterwards; patient notified pharmacy on 10/04/2022, no other details
Age: 6.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events reported; A pediatrician reported that a 6 year old patient was given a dose of PNEUMOVAX 23 three years after receiving the inital dose instead of the recommended six years after the initial dose.; This spontaneous report was received from a physician concerning a 6-year-old patient of unknown date. The patient medical history, drug reactions or allergies, concurrent conditions, and concomitant therapies were not provided.     On an unspecified date in 2019, subject was vaccinated with the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (dose, route of administration, strength, vaccination scheme, anatomical site of vaccination, lot number, and expiration date were not reported) as prophylaxis. On 27-SEP-2022, the patient was vaccinated with the second dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) syringe piston (FMF) (dose, route of administration, strength, vaccination scheme, and anatomical site of vaccination were not reported, lot numbers U025499, which had been verified to be valid, expiration date reported and validated as 07-AUG-2023), as prevention for pneumococcal infection. This vaccination happened 3 years after receiving the initial dose instead of the recommended six years after the initial dose (Product use issue). No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE reported.; VARIVAX reconstituted with normal saline instead of the supplied sterile diluent was administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of an unknown age or gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 29-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 ml, lot #U016061, expiration date reported as 01-SEP-2023 however it was verify as : 20-MAY-2023, administered as prophylaxis (strength, and route of administration were not provided) reconstituted with normal saline instead of the supplied sterile diluent (vaccine incorrect diluent used). No additional adverse event was reported.
Age: 1.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling, Wrong product administered
Clinical narrative: injection site was red; injection site was red and swollen; on 30-AUG-2022, a 12 month old child who was supposed to receive a VARIVAX vaccine, was accidentally given a; HCP states that this vaccine was given subcutaneously instead of IM.; This spontaneous report has been received from a physician referring to a 12-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.      On 30-AUG-2022, the patient was supposed to receive a varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported), but accidentally was vaccinated with diphtheria toxoid (+) hepatitis b virus vaccine HBsAg (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) at a dose of 0.5 milliliters (mL), administered subcutaneously (lot number C5808AA had been verified to be a valid number; expiration date reported as 24-JAN-2024 and upon internal validation established as 14-JAN-2024) (vaccination scheme, frequency,  and anatomical site of injection were not reported) (wrong product administered and incorrect route of product administration).   On 31-AUG-2022, the mother of the child called the physician's office stating that the patient's injection site was red (vaccination site erythema) and swollen (vaccination site swelling). The outcome for both events was reported as recovered.  The causality relationship between diphtheria toxoid (+) hepatitis b virus vaccine HBsAg (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) and the events vaccination site erythema and vaccination site swelling was considered by the reporter as related; whereas, the causality assessment between the adverse events and varicella virus vaccine live (oka/merck) (VARIVAX) was considered to be not related.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Product Quality Group provided investigational results received. Conclusion: The complaint for "PFIZER BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Manufacturing facility concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 68 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 23Feb2021 as dose 2, single (Lot number: EL9266), in right arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 301308A), in right arm and on 05May2022 as dose 4 (booster), single (Lot number: FP4554), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Sep2022, outcome "recovered" (01Oct2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Sep2022) Positive; (01Oct2022) Negative; (04Oct2022) Positive. Therapeutic measure, Paxlovid,  was taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the available information in the case, the causal association between the events Vaccination failure, COVID-19 and the suspect drugs cannot be excluded.
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Ageusia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Wrong vaccine administered; headache; loss of taste; body chills; fever; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Known allergies: shrimp" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Allergy: cephalosporins, reaction(s): "Drug Allergy". Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown.), for Covid-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown.), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 29Sep2022, outcome "recovered with sequelae", described as "body chills"; FATIGUE (non-serious) with onset 29Sep2022, outcome "recovered with sequelae"; PYREXIA (non-serious) with onset 29Sep2022, outcome "recovered with sequelae", described as "fever"; HEADACHE (non-serious) with onset 29Sep2022, outcome "recovered with sequelae"; AGEUSIA (non-serious) with onset 29Sep2022, outcome "recovered with sequelae", described as "loss of taste"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Wrong vaccine administered". Therapeutic measures were taken as a result of headache, ageusia, chills, pyrexia, fatigue.  Additional information: Concomitant medication include prenatal vitamins. Patient did not have covid prior vaccination and not tested covid post vaccination. Patient received ibuprofen for the treatment of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine administered; headache; loss of taste; body chills; fever; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Known allergies: shrimp" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Allergy: cephalosporins, reaction(s): "Drug Allergy". Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown.), for Covid-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown.), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 29Sep2022, outcome "recovered with sequelae", described as "body chills"; FATIGUE (non-serious) with onset 29Sep2022, outcome "recovered with sequelae"; PYREXIA (non-serious) with onset 29Sep2022, outcome "recovered with sequelae", described as "fever"; HEADACHE (non-serious) with onset 29Sep2022, outcome "recovered with sequelae"; AGEUSIA (non-serious) with onset 29Sep2022, outcome "recovered with sequelae", described as "loss of taste"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Wrong vaccine administered". Therapeutic measures were taken as a result of headache, ageusia, chills, pyrexia, fatigue.  Additional information: Concomitant medication include prenatal vitamins. Patient did not have covid prior vaccination and not tested covid post vaccination. Patient received ibuprofen for the treatment of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Chest pain, Dyspnoea, Gait disturbance, Headache
Clinical narrative: shortness of breath; I was weak; not feeling too good; Heart Beating Too Fast/having a fast beating heart; could hardly make it up stairs because he had an issue walking; Chest pain; 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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 65 years 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), administration date: 11Mar2021, for COVID-19 immunization; BNT162b2 (dose 2, single), administration date: 01Apr2021, for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 23Sep2022, outcome "not recovered"; HEADACHE (non-serious) with onset 23Sep2022, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 23Sep2022, outcome "not recovered", described as "Heart Beating Too Fast/having a fast beating heart"; GAIT DISTURBANCE (non-serious) with onset 23Sep2022, outcome "not recovered", described as "could hardly make it up stairs because he had an issue walking"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; ASTHENIA (non-serious), outcome "unknown", described as "I was weak"; MALAISE (non-serious), outcome "unknown", described as "not feeling too good". The events "heart beating too fast/having a fast beating heart", "could hardly make it up stairs because he had an issue walking", "chest pain", "headache", "shortness of breath", "i was weak" and "not feeling too good" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: On 22Sep2022, the day after patient received the newest COVID-19 booster, the patient hardly made it up the stairs, he had an issue with walking, his heart was beating too fast, he had chest pain and a headache and that he wanted information on how long these side effects may last. The patient ended up going to the ER. When he got to the ER, patient was told that his heart was beating too fast. It started with the vaccine. He asked how long this will last. The patient was still not feeling too good. By having issues with walking and going upstairs, the patient mean that he was weak and he had shortness of breath. The patient was vaccinated before with the Pfizer vaccine and he never had an issue the following day. After taking this vaccine, the patient can't do much things and he was able to do a lot of things. He was concerned that's why he called.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Heart rate, Heart rate increased, Malaise
Clinical narrative: shortness of breath; I was weak; not feeling too good; Heart Beating Too Fast/having a fast beating heart; could hardly make it up stairs because he had an issue walking; Chest pain; 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 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 3 (booster), single (Lot number: GJ5342) at the age of 65 years 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), administration date: 11Mar2021, for COVID-19 immunization; BNT162b2 (dose 2, single), administration date: 01Apr2021, for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 23Sep2022, outcome "not recovered"; HEADACHE (non-serious) with onset 23Sep2022, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 23Sep2022, outcome "not recovered", described as "Heart Beating Too Fast/having a fast beating heart"; GAIT DISTURBANCE (non-serious) with onset 23Sep2022, outcome "not recovered", described as "could hardly make it up stairs because he had an issue walking"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; ASTHENIA (non-serious), outcome "unknown", described as "I was weak"; MALAISE (non-serious), outcome "unknown", described as "not feeling too good". The events "heart beating too fast/having a fast beating heart", "could hardly make it up stairs because he had an issue walking", "chest pain", "headache", "shortness of breath", "i was weak" and "not feeling too good" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: On 22Sep2022, the day after patient received the newest COVID-19 booster, the patient hardly made it up the stairs, he had an issue with walking, his heart was beating too fast, he had chest pain and a headache and that he wanted information on how long these side effects may last. The patient ended up going to the ER. When he got to the ER, patient was told that his heart was beating too fast. It started with the vaccine. He asked how long this will last. The patient was still not feeling too good. By having issues with walking and going upstairs, the patient mean that he was weak and he had shortness of breath. The patient was vaccinated before with the Pfizer vaccine and he never had an issue the following day. After taking this vaccine, the patient can't do much things and he was able to do a lot of things. He was concerned that's why he called.
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: She had a little pain in the arm when she received one of the 4 shots she has had of the Pfizer-BioNTech.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She had a little pain in the arm when she received one of the 4 shots she has had of the Pfizer-BioNTech.".  Additional information: It was reported that patient wanted to know if it would be possible to experience some adverse events days after receiving the Bivalent formulation. She mentioned that she has already received 4 shots of the Pfizer-BioNTech Covid 19 Vaccine. But she was concerned that the new Bivalent formulation might contain Doxycycline. She wants to know if this antibiotic is part of the ingredients of the bivalent formulation. She had a little pain in the arm when she received one of the 4 shots she had of the Pfizer-BioNTech.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: EFFEXOR; REXULTI; LISINOPRIL (other medication in 2weeks). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 26Sep2022 to 30Sep2022.  Clinical course: It was reported as they were double vaccinated and boosted with all Pfizer products.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: After taking a five day course of paxlovid, my husband and I both tested positive again after 3 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Normal pressure hydrocephalus
Clinical narrative: Interchange of vaccine products; had brain surgery and its for NPH Hydrocephalus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 81-year-old male patient received BNT162b2 (BNT162B2, NDC number and Expiry Date of Covid Vaccine was not Provided. Reason for no lot number: of Covid Vaccine: Caller unwilling to complete the report), as dose number unknown, single (Batch/Lot number: unknown) and as dose number uknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Other Products, Other Conditions and Investigations was Not Provided. Results in death, Life threatening, Disabling/Incapacitating, Congenital anomaly/birth defect: No Information. Caused/prolonged hospitalization: True. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant), outcome "unknown"; NORMAL PRESSURE HYDROCEPHALUS (hospitalization, medically significant), outcome "unknown", described as "had brain surgery and its for NPH Hydrocephalus". Reporter is the Patient. Caller states that he was calling about Covid 19 Vaccine Ba.5, clarifying he was calling about the Covid 19 Bivalent vaccines. He's had brain surgery and its for NPH Hydrocephalus, in which they put a cordage or hole in the back of the skull, and put in a shunt to the stomach, that was regulated with a valve, a magnetic valve, they did this at hospital in [place name withheld]. He did his drainer first at home the first time he got 42cc's, second time he got 30cc's, and they found that he can go 20 yards, at a speed increase of 5-7 seconds, before he was 17-20 seconds. Caller was concerned and wants to know if the Bivalent Covid Vaccine would not interfere with this operation, he was off blood thinners, but he wanted to know if the vaccine would effect this. Caller confirms that he has not been administered the Bivalent Covid Vaccine, but he has had 3 previous covid vaccines, in which 2 were from Pfizer and 1 was moderna. He did not want to do a safety report, he was not calling to report, he wanted to ask his questions. Safety report declined. He was 81 years old. Therapeutic measures were taken as a result of normal pressure hydrocephalus.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Off label use; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 28Jul2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "ankylosing spondylitis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: REMICADE; AMLODIPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; OFF LABEL USE (medically significant), outcome "unknown"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (03Oct2022) Positive, notes: retested positive for Covid 4 days after completing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19, off label use, immunisation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Hyperhidrosis, Myalgia, Pyrexia, Sleep disorder
Clinical narrative: Joint pain; fever; sweats; muscle pain bad enough to wake me from sleep; muscle pain bad enough to wake me from sleep; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 08:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Latex" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 01; UNKNOWN MANUFACTURER, Lot number: unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 02; UNKNOWN MANUFACTURER, Lot number: unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 03; UNKNOWN MANUFACTURER, Lot number: unknown), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 04Oct2022 at 22:00, outcome "recovering", described as "Joint pain"; PYREXIA (non-serious) with onset 04Oct2022 at 22:00, outcome "recovering", described as "fever"; MYALGIA (non-serious), SLEEP DISORDER (non-serious) all with onset 04Oct2022 at 22:00, outcome "recovering" and all described as "muscle pain bad enough to wake me from sleep"; HYPERHIDROSIS (non-serious) with onset 04Oct2022 at 22:00, outcome "recovering", described as "sweats". Therapeutic measures were not taken as a result of arthralgia, pyrexia, hyperhidrosis, myalgia, sleep disorder. Additional information: The patient did not have covid tested post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Light-headed/I woke up very light headed/Dizzy; arm got sore; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ5342) for covid-19 immunisation; rivaroxaban (XARELTO), (Batch/Lot number: unknown) for anticoagulant therapy. The patient's relevant medical history included: "blood thinners" (unspecified if ongoing), notes: I am on blood thinners. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Light-headed/I woke up very light headed/Dizzy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm got sore". The action taken for rivaroxaban was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Decreased appetite, Disorientation, Mobility decreased, Pain in extremity
Clinical narrative: Severe pain in legs and arms; Disoriented; No appetite; Couldn't move, couldn't lie in bed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 6 (booster), single (Lot number: 95665) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (ongoing), notes: Coronary artery disease, 7 stents; "Polymyalgia" (ongoing), notes: Polymyalgia, From: 2 years ago. There were no concomitant medications. Vaccination history included: BNT162b2 (Vaccine Name: Pfizer Covid vaccine; #1, Lot Number/Expiry Date: EM9809; unknown, Anatomical Location: not provided, No. of Previous Doses: 0, Date: 25Feb2021), administration date: 25Feb2021, when the patient was 75-year-old, for Covid-19 Immunization; Bnt162b2 (Vaccine Name: Pfizer Covid vaccine; #2, Lot Number/Expiry Date: EN6203/unknown, Anatomical Location: not provided, No. of Previous Doses: 1, Date: 26Feb2021, as provided by Caller), for Covid-19 Immunization; Bnt162b2 (Vaccine Name: Pfizer Covid vaccine; #3, Lot Number/Expiry Date: FC3184/unknown , Anatomical Location: not provided, No. of Previous Doses: 2, Date: unknown, Caller can't read date on vaccine card), for Covid-19 Immunization; Bnt162b2 (Vaccine Name: Pfizer Covid vaccine; #4, Lot Number/Expiry Date: unknown to Caller, Anatomical Location: not provided, No. of Previous Doses: 3, Date: unknown to Caller), for Covid-19 Immunization; Bnt162b2 (Vaccine Name: Pfizer Covid vaccine; #5, Lot Number/Expiry Date: unknown to Caller, Anatomical Location: not provided, No. of Previous Doses: 4, Date: provides date as: Apr2022), administration date: Apr2022, when the patient was 76 years old, for Covid-19 Immunization.  The following information was reported: MOBILITY DECREASED (non-serious) with onset 25Sep2022, outcome "recovering", described as "Couldn't move, couldn't lie in bed"; DISORIENTATION (non-serious) with onset 25Sep2022, outcome "recovering", described as "Disoriented"; DECREASED APPETITE (non-serious) with onset 25Sep2022, outcome "recovering", described as "No appetite"; PAIN IN EXTREMITY (non-serious) with onset 25Sep2022, outcome "recovering", described as "Severe pain in legs and arms".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201212043 Same product, patient, different AEs, different dose;
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 29Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 17Nov2021 as dose 3 (booster), single (Lot number: FJ1620), in left arm and on 11May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Skin cancers" (unspecified if ongoing); "allergies: Nickel" (unspecified if ongoing). Concomitant medication(s) included: MYLAN ATORVASTATIN, stop date: 24Sep2022. The patient experienced Covid 19 on an unspecified date. The patient received PAXLOVID as Covid 19 treatment from 25Sep2022 to 29Sep2022. The patient underwent the following laboratory tests and procedures:COVID-19 Virus test: Positive. The outcome of the event was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Right hand brown spots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Oct2022 at 01:00 as dose 1, single (Lot number: FP7150) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies : Pollen" (unspecified if ongoing); "Known allergies : Trees" (unspecified if ongoing). There were no concomitant medications. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 04Oct2022, outcome "not recovered", described as "Right hand brown spots". Therapeutic measures were not taken as a result of skin discolouration.  Additional information: No other medications in two weeks. Known allergies included pollen and trees.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 12Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing); "Known allergies: penicillin and sulfa allergy" (unspecified if ongoing); "Known allergies: penicillin and sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Paxlovid Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.