chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Death, Illness, Interstitial lung disease
Clinical narrative: interstitial pneumonia; ill; death; Initial information received on 20-Jan-2023 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 91 years old female patient (172 cm and 112 kg) who was ill, developed interstitial pneumonia and died after receiving influenza quadrival A-B multidose vaccine preserved [Fluzone].  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s), concomitant disease, risk factor and family history were not provided.  On 03-Oct-2022, the patient received an unknown dose of suspect influenza quadrival A-B multidose vaccine preserved, suspension for injection (strength, lot number and expiry date - not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient was ill (illness), developed interstitial pneumonia (interstitial lung disease) and died (unknown latency) following the administration of influenza quadrival A-B multidose vaccine preserved.  Reportedly, Patient was in good health until vaccine. Confirmed by Hospital this reaction was due to the flu vaccine.  Final diagnosis was (fatal) Not Applicable death.  It was unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (ill and interstitial pneumonia).  At time of reporting, the outcome was Unknown for the event ill, interstitial pneumonia and was Fatal for the event death.  No autopsy was done. The cause of death was reported as Death NOS.  Seriousness criteria: Medically significant and hospitalization on 09-Oct-2023 for the event interstitial pneumonia and  fatal for the event death.; Sender's Comments: Sanofi company comment dated 26-Jan-2023: This case involves a 91 years old female patient (172 cm and 112 kg) who was ill, developed interstitial pneumonia and died unspecified time after receiving influenza quadrival A-B multidose vaccine preserved [Fluzone]. Latency is unknown. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. No autopsy was done. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Not provided
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Autonomic Dysfunction; Orthostatic Intolerence; Presyncope; Fatigue; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 24-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination postural orthostatic tachycardia syndrome (POTS), headache, dizziness, presyncope, fatigue, orthostatic intolerance and autonomic nervus system imbalance.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007498:
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Presyncope
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Autonomic Dysfunction; Orthostatic Intolerence; Presyncope; Fatigue; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 24-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination postural orthostatic tachycardia syndrome (POTS), headache, dizziness, presyncope, fatigue, orthostatic intolerance and autonomic nervus system imbalance.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007498:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Headache; Autonomic Dysfunction; Orthostatic Intolerence; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 28-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome, orthostatic intolerance, autonomic nervous system imbalance, headache, dizziness and fatigue.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007594:
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Headache; Autonomic Dysfunction; Orthostatic Intolerence; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 28-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome, orthostatic intolerance, autonomic nervous system imbalance, headache, dizziness and fatigue.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007594:
Age: 40.0
Sex: M
Vaccine: HPV4
Symptoms: Feeling abnormal, Guillain-Barre syndrome, Postural orthostatic tachycardia syndrome
Clinical narrative: The patient now suffer from Guillain barrer syndrome; The patient now suffer from  POTS; The patient now suffer from  brain fog; The patient already had HPV was vaccinated with Gardasil; This spontaneous report was received from a 42-year-old male patient reporting on himself. The patient's  drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On unknown date, the patient already had Human papillomavirus infection. On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (dose, lot #, expiration date and route were not reported) (product use issue).         On an unknown date, the patient experienced guillain-barre syndrome, brain fog (mental disorder), and postural orthostatic tachycardia syndrome (POTS).     At the time of the report, action taken regarding therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), The outcome of the events and the relationship between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) were not reported.  Upon internal review, guillain-barre syndrome was determined to be medically significant.; Sender Comments.
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No symptomatic AE. No additional AE.; Nurse reporting an AE for PNEUMOVAX 23 that was administered to a 6 month old patient.; This spontaneous report was received from a Registered Nurse regarding a 6-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-JAN-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot #U027357, expiration date: 25-MAR-2023, (strength, anatomical location, and route of administration were not provided) administered as prophylaxis (Product administered to patient of inappropriate age). No symptomatic adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired VAQTA was administered to one patient. Product expired 1/14/2023 and was administered today 1/24/2023.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information of the patient's medical history, concurrent condition and concomitant therapy was not reported.  On 24-JAN-2023 (also reported as today), the patient was administrated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection 1 ml (lot #U021561, expiration date: 14-JAN-2023, strength, anatomical location and route of administration were not provided) for prophylaxis (expired product administered). The product was stored according to prescribing information through the date of administration. No additional adverse event (AE) details were available. No additional AE was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in Oct2021, 2nd on Oct2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In October 2021,received 1st dose).   In October 2022, the patient received the 2nd dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 18-Jan-2023. Reporter's Comments: This case was reported by patient via interactive digital media. The patient's doctor's office never sent him/her a reminder for his/her 2nd dose. When the patient went for his/her annual visit in October 2022 they gave him/her another dose.  The patient asked was he/she covered. Additional Supportive Information: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. Follow-up would not possible as no contact details were available.
Age: 51.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Menveo administered instead of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 51-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA793A, expiry date 31st January 2024) for prophylaxis.   Concurrent medical conditions included back pain, depression, vitamin d deficiency and blood cholesterol increased. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 17th January 2023, the patient received the 1st dose of Menveo. On 17th January 2023, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt date: 17-Jan-2023. Reporter's Comments: The reporter was a Medical assistant. Reporter stated that the patient came in for second dose of Shingrix vaccine and was inadvertently administered a dose of Menveo instead. The patient had not had any prior doses of Menveo. The patient was not immunocompromised.  At the time of reporting, the second Shingrix dose has not been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: Patient received Menveo instead of 2nd dose of Shingrix which led to wrong vaccine administered.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthropathy
Clinical narrative: all sort of joint problems; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ARTHROPATHY (all sort of joint problems) in a 5-decade-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHROPATHY (all sort of joint problems). At the time of the report, ARTHROPATHY (all sort of joint problems) outcome was unknown.            Concomitant medications were not reported.  Patient in 40s. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Doses were administered after 30 day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30 day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30 day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30 day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30 day beyond use date.).    No concomitant medications were reported. Vaccine was stored in refrigerator up to published expiration date without any indication of storage considerations outlined in standard information. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Blood triglycerides, Blood triglycerides increased, Catheterisation cardiac
Clinical narrative: Heart attack; Cholesterol and triglycerides were a little elevated; Cholesterol and triglycerides were a little elevated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4820691 (Genentech).  A 64-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Jan2020 (not ongoing), notes: I got COVID Jan2020.; "Multiple sclerosis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: MOMETASONE; TRAMADOL; TOPIRAMATE; METFORMIN; LOSARTAN; ROPINIROLE; SINGULAIR; SPIRONOLACTONE; EZETIMIBA; ALBUTEROL [SALBUTAMOL]; FUROSEMIDE; ASPIRIN [ACETYLSALICYLIC ACID]; BUPROPION; PANTOPRAZOLE; ROSUVASTATIN; RYBELSUS; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; SYMBICORT. Past drug history included: Levaquin, reaction(s): "Allergy to Levaquin", notes: Allergy to Levaquin; Macrobid for Allergy to Macrobid. Vaccination history included: Bnt162b2 (DOSE 1, My first vaccine was Pfizer), for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; BLOOD CHOLESTEROL INCREASED (non-serious), BLOOD TRIGLYCERIDES INCREASED (non-serious), outcome "unknown" and all described as "Cholesterol and triglycerides were a little elevated". The patient underwent the following laboratory tests and procedures: Blood cholesterol: little elevated; Blood triglycerides: little elevated; Catheterisation cardiac: Unknown results; Echocardiogram: Unknown results. Therapeutic measures were taken as a result of myocardial infarction.  Clinical course: On unknown date, patient started therapy with Pfizer COVID-19 Vaccine for unknown indication. On unknown date, it was reported that patient experienced COVID Jan2020. She took antibiotic and medicine to get it down and antiviral to keep it down and finally did get over it. She  took the vaccine and booster in- May2021. First vaccine was Pfizer and 3 weeks later took Pfizer 2nd vaccine. 3 days after taking the Pfizer vaccine, had a heart attack. The HCP told that if we had COVID should not have taken the second shot. She had a echocardiogram and heart cath and needed up needing 2 stents. My doctor told me my heart was in good condition but cholesterol and triglycerides were a little elevated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Myocardial infarction
Clinical narrative: Heart attack; Cholesterol and triglycerides were a little elevated; Cholesterol and triglycerides were a little elevated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4820691 (Genentech).  A 64-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Jan2020 (not ongoing), notes: I got COVID Jan2020.; "Multiple sclerosis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: MOMETASONE; TRAMADOL; TOPIRAMATE; METFORMIN; LOSARTAN; ROPINIROLE; SINGULAIR; SPIRONOLACTONE; EZETIMIBA; ALBUTEROL [SALBUTAMOL]; FUROSEMIDE; ASPIRIN [ACETYLSALICYLIC ACID]; BUPROPION; PANTOPRAZOLE; ROSUVASTATIN; RYBELSUS; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; SYMBICORT. Past drug history included: Levaquin, reaction(s): "Allergy to Levaquin", notes: Allergy to Levaquin; Macrobid for Allergy to Macrobid. Vaccination history included: Bnt162b2 (DOSE 1, My first vaccine was Pfizer), for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; BLOOD CHOLESTEROL INCREASED (non-serious), BLOOD TRIGLYCERIDES INCREASED (non-serious), outcome "unknown" and all described as "Cholesterol and triglycerides were a little elevated". The patient underwent the following laboratory tests and procedures: Blood cholesterol: little elevated; Blood triglycerides: little elevated; Catheterisation cardiac: Unknown results; Echocardiogram: Unknown results. Therapeutic measures were taken as a result of myocardial infarction.  Clinical course: On unknown date, patient started therapy with Pfizer COVID-19 Vaccine for unknown indication. On unknown date, it was reported that patient experienced COVID Jan2020. She took antibiotic and medicine to get it down and antiviral to keep it down and finally did get over it. She  took the vaccine and booster in- May2021. First vaccine was Pfizer and 3 weeks later took Pfizer 2nd vaccine. 3 days after taking the Pfizer vaccine, had a heart attack. The HCP told that if we had COVID should not have taken the second shot. She had a echocardiogram and heart cath and needed up needing 2 stents. My doctor told me my heart was in good condition but cholesterol and triglycerides were a little elevated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Inappropriate schedule of product administration, Influenza
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 31Jul2021 as dose 2, single (Lot number: EN8727, Expiration Date: 31Jul2021) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Diagnosed about 15 years ago. It is under control with medication.; "asthma" (unspecified if ongoing), notes: She has had bouts of asthma usually once a year. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose Pfizer Covid-19 vaccine: 06Mar2021 , NDC: 59267-100-2 , Lot: EN6199 , Exp: 30Jun2021), administration date: 06Mar2021, when the patient was 64-year-old, for COVID-19 Immunization. The following information was reported: INFLUENZA (non-serious) with onset 2021, outcome "recovered", described as "She had flu symptoms"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Jul2021, outcome "unknown", described as "2nd dose Pfizer Covid-19 vaccine: 31Jul2021". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had flu symptoms that lasted 12-24 hours and then she was fine. She would never had lost her doctor if she would have never got the vaccine and was in the study. She had to go back to the study the next day because she had severe flu symptoms. She said that they ran blood tests and a chest x-ray and everything came back normal. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was None. No family medical history relevant to AE.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had 4 doses and I recently got Covid; had 4 doses and I recently got Covid; 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 4 (booster), single (Batch/Lot number: unknown) 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 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 "had 4 doses and I recently got Covid".  Clinical course: It was reported that patient had 4 doses and I recently got Covid but it wasn't a very bad case. It was mostly sinus and in my chest. I was fatigued for about a week but I feel it could have been much worse if I wasn't vaccinated. Again thank you for all the hard work in making the vaccine.  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
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Body temperature, Cough, Drug ineffective, Pain
Clinical narrative: fever; body aches; runny nose; cough; abdominal pain; COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine (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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "body aches"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; COUGH (non-serious), outcome "unknown"; ABDOMINAL PAIN (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: Unknown results.  Clinical Course: Contracted COVID 2 months after receiving the updated bivalent booster. COVID was moderate fever, body aches, runny nose, cough, abdominal pain. Bad symptoms lasted 4 days. Lingering abdominal pain and runny nose for 1 more week.  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.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rhinorrhoea, Suspected COVID-19
Clinical narrative: fever; body aches; runny nose; cough; abdominal pain; COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine (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. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID"; PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "body aches"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; COUGH (non-serious), outcome "unknown"; ABDOMINAL PAIN (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: Unknown results.  Clinical Course: Contracted COVID 2 months after receiving the updated bivalent booster. COVID was moderate fever, body aches, runny nose, cough, abdominal pain. Bad symptoms lasted 4 days. Lingering abdominal pain and runny nose for 1 more week.  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: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Leg weakness, exacerbation; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 2023BI01180152.  A 70-year-old female patient received BNT162b2 (BNT162B2 NOS), 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: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "Leg weakness, exacerbation".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: she developed a tremor in her left hand; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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; Bnt162b2 (DOSE 3 (BOOSTER)), for Covid-19 Immunization. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "she developed a tremor in her left hand".  Additional information: A registered Nurse and also a recipient of Pfizer Covid 19 vaccine shot and booster who had been watching the news for the past week and seeing people complaining about twitching from the vaccine. She is a nurse who works for a small company who does drug discovery science, so she understands the background and is a complete supporter of the vaccine. She doesn't know if it's relevant but she got two boosters and the regular two shots since then she developed a tremor in her left hand for example she cannot eat a soup without falling off the spoon, her right arm is completely fine. She doesn't know if there's a real concern about tremor with the vaccine, but because she works in drug discovery she feels like it's important to have somebody who's reputable to talk about this. She thinks people are sensationalizing it in the media. She wanted to check if there are any studies or revealing a tremor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300015625 Same reporter and product, different patients;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Echocardiogram, Pericardial effusion
Clinical narrative: Pericardical effusion; 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 received BNT162b2 (BNT162B2), on 29Mar2021 as dose 2, single (Lot number: ER8733) at the age of 64 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypertension", start date: 1999 (ongoing); "Depression", start date: 2007 (ongoing); "Prediabetes", start date: 2019 (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (First dose, Lot. EN6205, administered intramuscularly), administration date: 04Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: PERICARDIAL EFFUSION (hospitalization, medically significant, life threatening) with onset Apr2021, outcome "recovered", described as "Pericardical effusion". It was specified that the adverse event started sometime in Apr2021, days after the second dose. She went to emergency on 24Jan2022 when it got very bad and unbearable. The patient was diagnosed with pericardical effusion and had heart surgery. The patient was hospitalized for pericardial effusion (start date: 24Jan2022, hospitalization duration: 5 day(s)). The event "pericardical effusion" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (24Jan2022) Pericardical effusion; Echocardiogram: (unspecified date) Unknown results. Therapeutic measures were taken as a result of pericardial effusion. Then, the patient received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Lot number: FF8641) at the age of 64 years intramuscular for covid-19 immunisation.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201185032 same patient/drug, different event/dose number;
Sex: U
Vaccine: COVID19
Symptoms: Connective tissue disorder, Neuromyotonia
Clinical narrative: possibly getting a connective tissue disorder; Isaac syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: CONNECTIVE TISSUE DISORDER (non-serious), outcome "unknown", described as "possibly getting a connective tissue disorder"; NEUROMYOTONIA (non-serious), outcome "unknown", described as "Isaac syndrome".  Additional information: It was reported have issue with the COVID vaccine to possibly getting a connective tissue disorder as well as being diagnosed with Isaac syndrome. Need to speak to someone. Have doc records to confirm would like someone to contact me.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Loss of consciousness
Clinical narrative: unresponsive 3 times; major heart issues; 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 patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer unknown), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "unresponsive 3 times"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "major heart issues". Additional information: The patient stated, "I have questions about complications I had hours after the Pfizer booster shot- who do I need to contact. I had major heart issues leaving me unresponsive 3 times. I would like a contact or someone to reach out to me."  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.
Age: 18.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered Pfizer bivalent dose for second dose within primary series, instead of Pfizer monovalent dose.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram retina, Cataract nuclear, Dermatochalasis, Intraocular pressure test, Macula thickness measurement
Clinical narrative: Diagnosed by Dr at their office. Diagnosis - Hemi-retinal arterial occlusion of the left eye.  She has lost blood flow and vision in the bottom of her left eye. She first noticed this about 3 weeks to 1 month prior to the appointment on 23 Dec, 2022.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Macular degeneration, Macular thickening, Optic atrophy, Optical coherence tomography, Pupil dilation procedure
Clinical narrative: Diagnosed by Dr at their office. Diagnosis - Hemi-retinal arterial occlusion of the left eye.  She has lost blood flow and vision in the bottom of her left eye. She first noticed this about 3 weeks to 1 month prior to the appointment on 23 Dec, 2022.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Retinal artery embolism, Retinal depigmentation, Retinal vascular disorder, Slit-lamp tests abnormal, Vision blurred
Clinical narrative: Diagnosed by Dr at their office. Diagnosis - Hemi-retinal arterial occlusion of the left eye.  She has lost blood flow and vision in the bottom of her left eye. She first noticed this about 3 weeks to 1 month prior to the appointment on 23 Dec, 2022.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous adhesions
Clinical narrative: Diagnosed by Dr at their office. Diagnosis - Hemi-retinal arterial occlusion of the left eye.  She has lost blood flow and vision in the bottom of her left eye. She first noticed this about 3 weeks to 1 month prior to the appointment on 23 Dec, 2022.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received bivalent Pfizer dose for second dose in primary series, instead of receiving monovalent Pfizer dose
Age: 23.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Injection site pain, Product storage error
Clinical narrative: Patient dis not have any reaction to vaccine. She wa administered an expired vaccine punctured the day before and was left in the fridge.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia, Rash pruritic
Clinical narrative: soreness at injection site; headaches; Low fever; tired; bumps on my neck, arms and hands, extremely itchy, don't know if i'm allergic; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2022, the patient received the 1st dose of Shingrix. In January 2023, unknown after receiving Shingrix, the patient experienced injection site pain, headache, fever, tiredness and itchy rash. On an unknown date, the outcome of the injection site pain, headache, fever, tiredness and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, fever, tiredness and itchy rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comments: The patient self-reported this case. The patient said he/she had been having headaches, a low fever, tired, soreness at injection site and had bumps on his/her neck, arms and hands that were extremely itchy. The patient did not know if he/she was allergic or if itching was a normal side effect.
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 month patient received Kinrix; Patient received kinrix instead of Infanrix; Received a fourth date of hep B (Engerix B Pediatric); This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Kinrix, Kinrix Pre-Filled Syringe Device and the 4th dose of Engerix B pediatric. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Engerix B pediatric, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: The reporter was a nurse. The reporter stated that the patient needed a dose of DTaP and they accidentaly gave Kinrix to the patient instead of Infanrix, which was how they received an extra dose of IPV.  This was the only dose of Kinrix the patient had ever received. The reporter reported that the patient also received fourth dose of Engerix b pediatric. The reporter reported that the patient was already reported this to the system. The reporter did not consent to follow up. Additional supportive information:The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that, they were intending to administered Infanrix and inadvertently administered Kinrix instead of Infanrix , which led to wrong vaccine administered. The patient received extra dose of Engerix B pediatric in error, which led to extra dose administered.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 18Jul2022, and the administration date was 14Sep2022).    No concomitant medications were reported.  Patient date of birth was reported as 03/10/201.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vaccines were stored in the fridge on 30-Jun-2021, there were different administration dates, starting on 02-Aug-2021 until 20-Sep-2021 being the last one. Patients did not report any side effects.    This case was linked to MODERNATX, INC.-MOD-2023-699002 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-699002:Master case
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; it was the bivalent vaccine and it was administered to a patient as a first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (it was the bivalent vaccine and it was administered to a patient as a first dose) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (it was the bivalent vaccine and it was administered to a patient as a first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (it was the bivalent vaccine and it was administered to a patient as a first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (it was the bivalent vaccine and it was administered to a patient as a first dose).    No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was reported.