chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Has patient ever had COVID + test or diagnosis? Jan2022, no hospitalizations; Has patient ever had COVID + test or diagnosis? Jan2022, no hospitalizations; This is a spontaneous report received from contactable reporter(s) (Pharmacist). Other Case identifier(s): MOD22-027171 (Moderna).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Has patient ever had COVID + test or diagnosis? Jan2022, no hospitalizations". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive, notes: no hospitalizations.  Clinical course: Pharmacist inquiring on incidence of fatigue after receiving the Moderna Bivalent vaccine. Patient's previous doses were all Pfizer doses. Pharmacist does not have lot information for both products. She received on Saturday 15Oct2022 and on Sunday, 16Oct2022, stated, " I felt like a polar bear just sleeping all day." Past Medical History: Patient did not have allergies (medications, food, and other products). Patient had COVID and test or diagnosis on January 2022, no hospitalizations. Patient did not have medical history relating to mentioned ae and both acute and chronic illnesses at the time of vaccination. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose #) was Flu shot simultaneously. Adverse event reported: " I felt like a polar bear just sleeping all day." AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experience a similar event in the past. AE Outcome) was recovered. Treatment was reported as none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Malaise, Myopathy
Clinical narrative: rare RYR1 myopathy; Being a congenital myopathy it is slowly progressive but it seems that the 3rd vaccine has accelerated this process to rapidly progressive; became very unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RYR1 myopathy" (ongoing), notes: congenital condition. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, I received all three Pfizer mRNA vaccines., I had no reactions or side effects with the first two), for COVID-19 immunization; Bnt162b2 (Dose 2, I received all three Pfizer mRNA vaccines., I had no reactions or side effects with the first two), for COVID-19 immunization. The following information was reported: MYOPATHY (medically significant), outcome "unknown", described as "rare RYR1 myopathy"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "Being a congenital myopathy it is slowly progressive but it seems that the 3rd vaccine has accelerated this process to rapidly progressive"; MALAISE (non-serious), outcome "unknown", described as "became very unwell".   Clinical course: The patient received all three Pfizer mRNA vaccines. The had no reactions or side effects with the first two but unfortunately became very unwell after the 3rd. After 9 months of deterioration the patient was finally diagnosed with a rare RYR1 myopathy. It is a congenital missense gene mutation which results in a substitution of an amino acid. This then has an effect on the protein that is produced from the chain of amino acids. Being a congenital myopathy it is slowly progressive but it seems that the 3rd vaccine has accelerated this process to rapidly progressive. As you are an expert on these vaccines patient wanted to hear your opinion. Is it possible that the vaccine could have provoked a reaction in patient's skeletal muscle condition and interfered with the misfolded protein caused by substituted amino acid: The gene mutation patient have was very rare and has only been recorded in 4 other people worldwide. Patient was sure it is impossible to cover such a rare eventuality in your clinical trials as little is know about these rare RYR1 missense variants. There are no FDA approved treatments for patient's condition or a cure but if patient had the chance to at least return to the way things were prior to the 3rd vaccine, patient would jump at that. Any information that may help me would be very gratefully received.  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: Feeling cold, Malaise
Clinical narrative: Not feeling well; Felt like he was freezing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): UNT-2022-024370 (Company).  An 87-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; treprostinil sodium (TYVASO), since 07Jan2022 (Lot number: 2102227, Expiration Date: 30Nov2023) at 12 ug 4x/day for pulmonary arterial hypertension. The patient's relevant medical history included: "Pulmonary arterial hypertension" (ongoing). Concomitant medication(s) included: ELIQUIS; DILTIAZEM HYDROCHLORIDE. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Not feeling well"; FEELING COLD (non-serious), outcome "unknown", described as "Felt like he was freezing". The action taken for treprostinil sodium was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Biopsy, Cutaneous lupus erythematosus, Eosinophil count, Investigation
Clinical narrative: Cutaneous lupus-erythematosus-like reaction arising after COVID-19 vaccination; This is a literature report for the following literature source(s):   A 33-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "no significant past medical history" (unspecified if ongoing), notes: None. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation.  The following information was reported: CUTANEOUS LUPUS ERYTHEMATOSUS (medically significant), outcome "recovered", described as "Cutaneous lupus-erythematosus-like reaction arising after COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Negative, notes: after treatment with fluocinonide 0.05% ointment; Biopsy: vacuolar interface alteration with superficial and, notes: mid-dermal perivascular and periadnexal lymphocytes; Eosinophil count: Not identified; acid-Schiff stain: no significant increase in thickness of the, notes: basement membrane; perivascular collections of lymphocytes., notes: Spaces between the collagen and dermal mucin are evident the spaces between collagen and dermal mucin are evident; vacuolar interface alteration and moderately brisk, notes: superficial perivascular and periadnexal lymphocytes; superficial to mid-dermal perivascular and, notes: periadnexal lymphocytes. There is very scant deep perieccrine inflammation; unremarkable; mildly increased dermal mucin, and the periodic, notes: acid-Schiff stain showed no significant increase in thickness of the basement membrane; Tumour marker test: clusters of positive cells within the infiltrate, notes: x 200. Therapeutic measures were taken as a result of cutaneous lupus erythematosus.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event Cutaneous lupus erythematosus and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Tumour marker test
Clinical narrative: Cutaneous lupus-erythematosus-like reaction arising after COVID-19 vaccination; This is a literature report for the following literature source(s):   A 33-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "no significant past medical history" (unspecified if ongoing), notes: None. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation.  The following information was reported: CUTANEOUS LUPUS ERYTHEMATOSUS (medically significant), outcome "recovered", described as "Cutaneous lupus-erythematosus-like reaction arising after COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Negative, notes: after treatment with fluocinonide 0.05% ointment; Biopsy: vacuolar interface alteration with superficial and, notes: mid-dermal perivascular and periadnexal lymphocytes; Eosinophil count: Not identified; acid-Schiff stain: no significant increase in thickness of the, notes: basement membrane; perivascular collections of lymphocytes., notes: Spaces between the collagen and dermal mucin are evident the spaces between collagen and dermal mucin are evident; vacuolar interface alteration and moderately brisk, notes: superficial perivascular and periadnexal lymphocytes; superficial to mid-dermal perivascular and, notes: periadnexal lymphocytes. There is very scant deep perieccrine inflammation; unremarkable; mildly increased dermal mucin, and the periodic, notes: acid-Schiff stain showed no significant increase in thickness of the basement membrane; Tumour marker test: clusters of positive cells within the infiltrate, notes: x 200. Therapeutic measures were taken as a result of cutaneous lupus erythematosus.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported event Cutaneous lupus erythematosus and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass
Clinical narrative: got a big lump; arm is very very red; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MASS (non-serious), outcome "unknown", described as "got a big lump"; ERYTHEMA (non-serious), outcome "unknown", described as "arm is very very red".  Additional Information: Description of Event Outcome: Caller said that she got the Pfizer shot on Sunday the 9th and her arm is very very red and she got a big lump and it seems not getting any better. She searched online and it says 2 or 3 days but it's the 5th day now.  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 test, Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: It was her fourth vaccine and the first three were moderna; feeling like she had covid over a month with the Pfizer vaccine; feeling like she had covid over a month with the Pfizer vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5, on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "It was her fourth vaccine and the first three were moderna"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "feeling like she had covid over a month with the Pfizer vaccine". The event "feeling like she had covid over a month with the pfizer vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: nothing. Clinical course: Reporter's mom (patient) had been feeling like she had covid over a month with the Pfizer vaccine. It was her fourth vaccine and the first three were Moderna. She didn't feel like this with the first three however, the last vaccine she put was on 23Sep2022. She had long term symptoms such as fatigue, feeling of fever, harsh headaches, body aches and pain in muscles. Reporter asked how this could be treated and how they could reverse the long term symptoms of it. They had gone with several specialist with blood test and nothing.  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
Symptoms: Lymphadenopathy
Clinical narrative: had swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "had swollen lymph nodes". 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: Drug ineffective, Suspected COVID-19
Clinical narrative: currently having symptoms of Covid-19; currently having symptoms of Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), in 2021 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 2022, outcome "unknown" and all described as "currently having symptoms of Covid-19".  Clinical course: The caller contacted us regarding the Covid-19 vaccine, he mentioned that he received the vaccines last year and is currently having symptoms of Covid-19. The caller only speaks another language and attempts to transfer to the consumer line, advising they will have to get a translator, and the caller hangs up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysphonia, Dyspnoea, Fatigue, Interchange of vaccine products
Clinical narrative: calcifications in lungs and is currently functioning with approximately 65% lung capacity; wheezing; shortness of breath; raspy voice; lack of stamina; 3 prior COVID vax via Moderna; 4th COVID vax was Pfizer BioNTech vax; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jun2022 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: Moderna covid-19 vaccine (Dose 1), for COVID-19 immunization; Moderna covid-19 vaccine (Dose 2), for COVID-19 immunization; Moderna covid-19 vaccine (Dose 3), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Jun2022, outcome "unknown", described as "3 prior COVID vax via Moderna; 4th COVID vax was Pfizer BioNTech vax"; PULMONARY CALCIFICATION (medically significant), outcome "unknown", described as "calcifications in lungs and is currently functioning with approximately 65% lung capacity"; WHEEZING (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; DYSPHONIA (non-serious), outcome "unknown", described as "raspy voice"; FATIGUE (non-serious), outcome "unknown", described as "lack of stamina". The events "calcifications in lungs and is currently functioning with approximately 65% lung capacity", "wheezing", "shortness of breath", "raspy voice" and "lack of stamina" required physician office visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: calcifications in lungs; Total lung capacity: 65 %.  Clinical course: Patient had 3 prior COVID vax via Moderna. 4th COVID vax in Jun2022 was Pfizer BioNTech vax. Within a few weeks post 4th dose, patient soon after started having wheezing, shortness of breath, raspy voice, lack of stamina. Patient has seen multiple doctors. CT scan shows what is believed to be calcifications in lungs and is currently functioning with approximately 65% lung capacity. No known case of active COVID around time of 4th vax or after. Patient is undergoing more evaluations in near future. She is open to discussing her situation.  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: Pulmonary calcification, Total lung capacity, Wheezing
Clinical narrative: calcifications in lungs and is currently functioning with approximately 65% lung capacity; wheezing; shortness of breath; raspy voice; lack of stamina; 3 prior COVID vax via Moderna; 4th COVID vax was Pfizer BioNTech vax; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jun2022 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: Moderna covid-19 vaccine (Dose 1), for COVID-19 immunization; Moderna covid-19 vaccine (Dose 2), for COVID-19 immunization; Moderna covid-19 vaccine (Dose 3), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Jun2022, outcome "unknown", described as "3 prior COVID vax via Moderna; 4th COVID vax was Pfizer BioNTech vax"; PULMONARY CALCIFICATION (medically significant), outcome "unknown", described as "calcifications in lungs and is currently functioning with approximately 65% lung capacity"; WHEEZING (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; DYSPHONIA (non-serious), outcome "unknown", described as "raspy voice"; FATIGUE (non-serious), outcome "unknown", described as "lack of stamina". The events "calcifications in lungs and is currently functioning with approximately 65% lung capacity", "wheezing", "shortness of breath", "raspy voice" and "lack of stamina" required physician office visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: calcifications in lungs; Total lung capacity: 65 %.  Clinical course: Patient had 3 prior COVID vax via Moderna. 4th COVID vax in Jun2022 was Pfizer BioNTech vax. Within a few weeks post 4th dose, patient soon after started having wheezing, shortness of breath, raspy voice, lack of stamina. Patient has seen multiple doctors. CT scan shows what is believed to be calcifications in lungs and is currently functioning with approximately 65% lung capacity. No known case of active COVID around time of 4th vax or after. Patient is undergoing more evaluations in near future. She is open to discussing her situation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19. Showed signs of aching, sweating, runny nose, headache and extreme tiredness; tested positive for COVID-19. Showed signs of aching, sweating, runny nose, headache and extreme tiredness; 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; 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 was not reported. Concomitant medication(s) included: SHINGRIX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID-19. Showed signs of aching, sweating, runny nose, headache and extreme tiredness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: After two Pfizer COVID-19 shots and two boosters, patient tested positive for COVID-19, showed signs of aching, sweating, runny nose, headache and extreme tiredness. Patient recently had Shingles vaccine as well. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 after two shots and two boosters; Tested positive for COVID-19 after two shots and two boosters; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  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; BNT162b2 (COMIRNATY), 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 "unknown" and all described as "Tested positive for COVID-19 after two shots and two boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID-19 after two shots and two boosters - all Pfizer. Clinical course: Patient showed signs of sweating, aching, drooling, cannot keep eyes open and very lethargic.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Lymph node pain, Lymphadenopathy
Clinical narrative: woke up with severe lower back pain; have swollen and tender lymph node in left armpit; have swollen and tender lymph node in left armpit; 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), on 21Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer"), for COVID-19 Immunization. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset Oct2022, latency 46 hrs after the suspect product(s) administration, outcome "unknown" and all described as "have swollen and tender lymph node in left armpit"; BACK PAIN (non-serious) with onset 22Oct2022, outcome "not recovered", described as "woke up with severe lower back pain". Therapeutic measures were taken as a result of back pain.  Additional information: Description of Event: 24 hours after bivalent booster in left shoulder, woke up with severe lower back pain, necessitating heavy NSAIDS and a lidocaine patch.46 hours after booster woke up with lower back pain again, and have swollen and tender lymph node in left armpit. Optional Information: Booster provided at Withheld site health services, obtained after 8 am on Friday 21Oct. Did not have any unexpected issues until yesterday morning. Event took place after use of product.  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: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: She was diagnosed with CIDP after her second dose of the COVID-19 shot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 2, 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 (DOSE 1 , Manufacturer Unknown), for COVID-19 Immunisation. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), outcome "unknown", described as "She was diagnosed with CIDP after her second dose of the COVID-19 shot". Clinical course: A woman came up to reporter at the (Name withheld) at the conference and reported she was diagnosed with CIDP after her second dose of the COVID-19 shot. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Pruititus, rash on abdomen, neck, face and legs.; Pruititus, rash on abdomen, neck, face and legs.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 19Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing), notes: Optional Information: Cholesterol, diabestes, blood pressure meds; "diabetes" (unspecified if ongoing), notes: Optional Information: Cholesterol, diabestes, blood pressure meds; "blood pressure" (unspecified if ongoing), notes: Optional Information: Cholesterol, diabestes, blood pressure meds. The patient took concomitant medications. The following information was reported: RASH PRURITIC (non-serious), RASH (non-serious) all with onset 20Oct2022, outcome "unknown" and all described as "Pruititus, rash on abdomen, neck, face and legs.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: the patient had an allergic reaction; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 17-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "the patient had an allergic reaction".  Additional information:: On 06Oct2022, it was reported that a patient started treatment on an unspecified date in Apr2021 with Pfizer BioNTech COVID-19 Vaccine for COVID-19 immunization. It was reported after the 1st dose, the patient had an allergic reaction, and after the 2nd dose, the reaction he experienced was close to anaphylaxis. No further follow-up is anticipated  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: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: shared with me that the second dose of the COVID-19 shot gave him CIDP; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received BNT162b2 (BNT162B2), as dose 2, 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 (Dose: 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), outcome "unknown", described as "shared with me that the second dose of the COVID-19 shot gave him CIDP". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Large intestine polyp
Clinical narrative: colon polyps; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  An adult male 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: LARGE INTESTINE POLYP (non-serious), outcome "unknown", described as "colon polyps".  Additional information: Age/Date of Birth: 60-64 Years  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: Drug ineffective, Suspected COVID-19
Clinical narrative: I got COVID; I got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) 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. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREVNAR 20 taken for immunisation as dose number unknown, single; AZITHROMYCIN. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got COVID". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event I got COVID cannot be excluded based on temporal association and available information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: (Withheld) sister caught COVID after vaccine; (Withheld) sister caught COVID after vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "(Withheld) sister caught COVID after vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: (Withheld) sister caught COVID after vaccine. Clinical course: Patient Age/Date of Birth: 10-17 years. Sister caught COVID after vaccine, so she came down with COVID, two weeks ago, um, one day of fever, tested positive, was fine afterwards. they tested him, and he was negative. At home test. Never had any symptoms, never got them the third booster. Reporter don't see the relevance in it right now, because, uh, number one, he never, um, contracted, even when the family got it. And, um, they had all their, they had their two.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: PT has hand pain after COVID vaccine/Both thumbs hurting; So this joint; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An elderly 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 "PT has hand pain after COVID vaccine/Both thumbs hurting"; ARTHRALGIA (non-serious), outcome "unknown", described as "So this joint".  Additional Information: It was reported that the patient had the age range of 65-69-years. It was reported that the patient had hand pain after COVID vaccine. Both thumbs hurting and the joint or.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: feeling off; Fatigue; Some body aches.; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). 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: Covid-19 vaccine (Primary immunization completed. Unknown manufacturer, Dose 2), for COVID-19 immunization; Covid-19 vaccine (DOSE 3), for COVID-19 immunization; Covid-19 vaccine (Primary immunization completed. Unknown manufacturer, Dose 1), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feeling off"; FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Some body aches.".  Additional information: It was reported that had side effects from COVID vaccine. The patient had the original two plus two boosters. Day or two, feeling off, fatigue, some body aches. States is, that normal. That's your immune system just ramping.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Musculoskeletal stiffness, Swelling
Clinical narrative: he developed increased swelling; he developed increased swelling; stiffness in the extremity; he had increased bruising; he had increased bruising; began experiencing mild bruising; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 52 years old male patient who experienced stiffness in the extremity, developed increased swelling, had mild bruising and increased bruising after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 05-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection (dose, strength, expiry date: unknown) lot UT7741MA via intramuscular route in the left deltoid for prophylactic vaccination.  He went diving on 10-Oct and began experiencing mild bruising (contusion) (latency: 5 days). 11-Oct he had increased bruising (contusion, condition aggravated) and stiffness in the extremity(musculoskeletal stiffness) (latency: 6 days). 12-Oct the symptoms improved then he developed increased swelling  (swelling, condition aggravated)  (latency: 7 days). 13-Oct the swelling persisted but improved throughout the day and he reports is nearly fulkly resolved of all symptoms.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on 13-Oct-2022 for all events.
Age: 43.0
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: medication error due to temperature excursion that exceeded the stability data and FLUZONE QUADRIVALENT multidose vial was administered to patient, with no reported adverse event; medication error due to temperature excursion that exceeded the stability data and FLUZONE QUADRIVALENT multidose vial was administered to patient, with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a 43-year-old (unknown gender) patient, reported a medication error due to temperature excursion that exceeded the stability data and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent Multidose] vial was administered to patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Sep-2022, the patient received suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (strength, formulation, dose , route: unknown) (lot number: UJ899AA and expiry date: 30-Jun-2023) in unknown administration site for Immunization and on the same day Fluzone Quadrivalent Multidose vial was administered to patient, with no reported adverse event (poor quality product administered)(latency same day) and medication error due to temperature excursion that exceeded the stability data, with no reported adverse event (product storage error) (unknown latency).  Action taken with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED was not applicable for both events.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; adminstered to patients with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 72 years old and unknown gender patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and  it was reported that this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and administered to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the patient developed a non-serious event that this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error)  On 22-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength, route: unknown) lot UJ899AA, expiration date: 30-Jun-2023 in unknown administration site as Immunization.  On 22-SEP-2022 the vaccine was administered to patient with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for all.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired ipol was given to a child with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional on 14-Oct-2022. number: 01322355.  This case involves a 7-year-old male patient to whom expired IPV (VERO) [IPOL] was given to a child with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) for Prophylactic vaccination; Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination; and Influenza Vaccine (Flu) for Prophylactic vaccination.  On 13-Oct-2022, the patient was administered expired dose of suspect IPOL at dose 0.5 ml once (lot: T1E872M, expiry date: 10-Oct-2022) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product
Clinical narrative: administered the fluzone QIV-PFS and while the needle was in the patient's skin the medication ran out onto the patients' arm with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 59 years old female patient who was administered the fluzone Qiv-Pfs and while the needle was in the patient's skin the medication ran out onto the patients' arm with no reported adverse event , it involved vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications and other vaccines were reported as none   On 12-Oct-2022, the patient received a  dose of 0.5 ml once (1x) of suspect INFLUENZA QUADRIVAL A-B VACCINE, with an unknown formulation and strength, (lot:  UT7716JA ; expiry date:  not reported)  via intramuscular route in the left deltoid for immunization.  It was reported that the caller stated that when she placed the needle on the end of the syringe, she heard a click sound prior to administration. The patient was administered the fluzone qiv-pfs and while the needle was in the patient's skin the medication ran out onto the patient's arm with no reported adverse event (accidental exposure to product) (onset date: 12-Oct-2022; latency : same day) . Large amount of vaccine was leaked  Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.