chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder, Depression
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 14:30 as dose 4 (booster), single (Lot number: GH0937) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment was Paxlovid which received from 28Oct2022 to 01Nov2022.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 1, single (Lot number: FK5127) and on 29Jan2022 as dose 2, single (Lot number: FL8094) at the age of 6 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: MIRALAX, Little Remedies Gas Relief. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Prior to vaccination (dose3), the patient was diagnosed with COVID-19".
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer exercise induced asthma infertility" (unspecified if ongoing), notes: other medical history: Breast cancer exercise induced asthma infertility; "known allergies: Sulpha" (unspecified if ongoing), notes: known allergies: Sulpha. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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.  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: 81.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Asthenia, Disturbance in attention, Migraine, Pain, Tremor
Clinical narrative: Horrendous migraine; 10 plus body hurt pain; hands went into extreme shaking; weak; mind unable to concentrate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 10:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "Osteo Arthritis" (unspecified if ongoing); "Dress Syndrome", start date: 26Jul2021 (unspecified if ongoing); "4-day coma", start date: 26Jul2021 (unspecified if ongoing); "loss of memory (just now getting some memory back)", start date: 26Jul2021 (unspecified if ongoing), notes: just now getting some memory back. The patient's concomitant medications were not reported. Past drug history included: Cymbalta, reaction(s): "known allergies: Cymbalta"; Pantoprazole, reaction(s): "known allergies: Pantoprazole"; Reclast, reaction(s): "known allergies: ReClast"; Voltaren, reaction(s): "known allergies: Voltaren"; Paxlovid, start date: 31Jan2021, stop date: 19Oct2022, for COVID-19 Vaccinations, notes: Brand: Pfizer. Vaccination history included: Covid-19 vaccine (Primary immunization completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset 2022, outcome "unknown", described as "mind unable to concentrate"; ASTHENIA (non-serious) with onset 2022, outcome "unknown", described as "weak"; TREMOR (non-serious) with onset 26Oct2022 at 19:00, outcome "recovered" (26Oct2022), described as "hands went into extreme shaking"; PAIN (non-serious) with onset 27Oct2022 at 12:01, outcome "recovered" (2022), described as "10 plus body hurt pain"; MIGRAINE (non-serious) with onset 27Oct2022 at 12:01, outcome "recovered" (2022), described as "Horrendous migraine". Therapeutic measures were not taken as a result of tremor. Therapeutic measures were taken as a result of migraine, pain.  Additional information: the patient's migraine and pain continued until it was treated with Fiorinal and Ultram but pain still lasted through the day. For six days, she was weak and her mind was unable to concentrate.  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: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coeliac disease" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient used Paxlovid from 18Oct2022 to 22Oct2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Exploding head syndrome, Nervous system disorder, Oral herpes, Seizure, Sleep disorder
Clinical narrative: a seizure in the temporal lobe of the brain; developed tinnitus; a large cold sore on her lower lip; a bright flash of light and large boom- seemed like an explosion inside her head/Episodic cranial sensory shock/Exploding head syndrome; neurological event; sleeping a her dream was interrupted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies eggs" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: GILENYA. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 43-year-old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), for COVID-19 immunization, reaction(s): "sleeping difficult", "tinnitus ringing in ears". The following information was reported: EXPLODING HEAD SYNDROME (non-serious) with onset 13Apr2022, outcome "recovered" (2022), described as "a bright flash of light and large boom- seemed like an explosion inside her head/Episodic cranial sensory shock/Exploding head syndrome"; ORAL HERPES (non-serious) with onset 13Apr2022, outcome "recovered" (May2022), described as "a large cold sore on her lower lip"; SEIZURE (medically significant) with onset 13Apr2022, outcome "recovered" (2022), described as "a seizure in the temporal lobe of the brain"; TINNITUS (non-serious) with onset 13Apr2022, outcome "recovered" (2022), described as "developed tinnitus"; NERVOUS SYSTEM DISORDER (non-serious) with onset 13Apr2022, outcome "recovered" (2022), described as "neurological event"; SLEEP DISORDER (non-serious) with onset 13Apr2022, outcome "recovered" (2022), described as "sleeping a her dream was interrupted". Therapeutic measures were not taken as a result of seizure, tinnitus, oral herpes, exploding head syndrome, nervous system disorder, sleep disorder. Clinical courses: The patient again developed tinnitus within a week. She also developed a large cold sore on her lower lip that would almost heal then reappear. Lasted about 6 weeks. During that time she also had another neurological event. While sleeping a her dream was interrupted with a bright flash of light and large boom- seemed like an explosion inside her head. She had learned since it was Episodic cranial sensory shock or also known as Exploding head syndrome, it can be related to tinnitus or a seizure in the temporal lobe of the brain. No other vaccine in four weeks. No COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: a seizure in the temporal lobe of the brain; developed tinnitus; a large cold sore on her lower lip; a bright flash of light and large boom- seemed like an explosion inside her head/Episodic cranial sensory shock/Exploding head syndrome; neurological event; sleeping a her dream was interrupted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies eggs" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: GILENYA. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 43-year-old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), for COVID-19 immunization, reaction(s): "sleeping difficult", "tinnitus ringing in ears". The following information was reported: EXPLODING HEAD SYNDROME (non-serious) with onset 13Apr2022, outcome "recovered" (2022), described as "a bright flash of light and large boom- seemed like an explosion inside her head/Episodic cranial sensory shock/Exploding head syndrome"; ORAL HERPES (non-serious) with onset 13Apr2022, outcome "recovered" (May2022), described as "a large cold sore on her lower lip"; SEIZURE (medically significant) with onset 13Apr2022, outcome "recovered" (2022), described as "a seizure in the temporal lobe of the brain"; TINNITUS (non-serious) with onset 13Apr2022, outcome "recovered" (2022), described as "developed tinnitus"; NERVOUS SYSTEM DISORDER (non-serious) with onset 13Apr2022, outcome "recovered" (2022), described as "neurological event"; SLEEP DISORDER (non-serious) with onset 13Apr2022, outcome "recovered" (2022), described as "sleeping a her dream was interrupted". Therapeutic measures were not taken as a result of seizure, tinnitus, oral herpes, exploding head syndrome, nervous system disorder, sleep disorder. Clinical courses: The patient again developed tinnitus within a week. She also developed a large cold sore on her lower lip that would almost heal then reappear. Lasted about 6 weeks. During that time she also had another neurological event. While sleeping a her dream was interrupted with a bright flash of light and large boom- seemed like an explosion inside her head. She had learned since it was Episodic cranial sensory shock or also known as Exploding head syndrome, it can be related to tinnitus or a seizure in the temporal lobe of the brain. No other vaccine in four weeks. No COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Wrong product administered
Clinical narrative: Treatment of COVID-19; received bivalent as dose number 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 14:00 as dose 1, single (Lot number: gj6665) at the age of 65 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 20Oct2022 at 14:00, outcome "unknown", described as "received bivalent as dose number 1"; COVID-19 (non-serious) with onset 24Oct2022, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Additional information: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. COVID-19 Treatment was Paxlovid which received from 24Oct2022 to 29Oct2022.  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: Cerebrovascular accident, Computerised tomogram, Illness, Malaise, Urinary tract infection
Clinical narrative: maybe you had a stroke; didn't feel good the other night; vertigo; urinary tract infection; I feel so much sicker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old 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: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "unknown", described as "maybe you had a stroke"; MALAISE (hospitalization), outcome "unknown", described as "didn't feel good the other night"; VERTIGO (hospitalization), outcome "unknown"; URINARY TRACT INFECTION (hospitalization), outcome "unknown"; ILLNESS (hospitalization), outcome "unknown", described as "I feel so much sicker". The events "maybe you had a stroke", "didn't feel good the other night", "vertigo", "urinary tract infection" and "i feel so much sicker" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: maybe you had a stroke. Pfizer-BioNTech COVID-19 Vaccine was reported to be a suspect product. Clinical course: Patient called in to find out if an order for their medications Diflucan, and Premarin vaginal cream had been shipped out to them. During the call patient stated that patient was in the hospital. Patient just didn't feel good the other night and went to the ER. They did a cat scan they said maybe patient had a stroke. Patient said that he/she didn't have a stroke. Patient have vertigo and have urinary tract infection (UTI). Patient stated that hopefully they send the patient home tomorrow. Patient later stated on the call, "Nobody know's about the Accupril? The quinapril's really not holding me. I have to take more quinapril' than I have to do Accupril. I still have to get my booster shot. A lot of people have been getting it and they've said they haven't been feeling well. It's not just Pfizer and Moderna it's all of them. The booster contains all 3 of the viruses so it's a hell of a lot stronger and a lot of people are saying why did I get this I feel so much sicker."  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: Vertigo
Clinical narrative: maybe you had a stroke; didn't feel good the other night; vertigo; urinary tract infection; I feel so much sicker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old 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: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "unknown", described as "maybe you had a stroke"; MALAISE (hospitalization), outcome "unknown", described as "didn't feel good the other night"; VERTIGO (hospitalization), outcome "unknown"; URINARY TRACT INFECTION (hospitalization), outcome "unknown"; ILLNESS (hospitalization), outcome "unknown", described as "I feel so much sicker". The events "maybe you had a stroke", "didn't feel good the other night", "vertigo", "urinary tract infection" and "i feel so much sicker" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: maybe you had a stroke. Pfizer-BioNTech COVID-19 Vaccine was reported to be a suspect product. Clinical course: Patient called in to find out if an order for their medications Diflucan, and Premarin vaginal cream had been shipped out to them. During the call patient stated that patient was in the hospital. Patient just didn't feel good the other night and went to the ER. They did a cat scan they said maybe patient had a stroke. Patient said that he/she didn't have a stroke. Patient have vertigo and have urinary tract infection (UTI). Patient stated that hopefully they send the patient home tomorrow. Patient later stated on the call, "Nobody know's about the Accupril? The quinapril's really not holding me. I have to take more quinapril' than I have to do Accupril. I still have to get my booster shot. A lot of people have been getting it and they've said they haven't been feeling well. It's not just Pfizer and Moderna it's all of them. The booster contains all 3 of the viruses so it's a hell of a lot stronger and a lot of people are saying why did I get this I feel so much sicker."  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: Asthenia, Ear disorder, Fatigue, Nervous system disorder, Tinnitus
Clinical narrative: tinnitus; fatigue; ear issue; virus severely attacks nervous system; weakness/overuse: senses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 28Dec2021 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jan2021, for COVID-19 immunization, reaction(s): "patient experienced load-grade dizziness after 1st vaccine". The following information was reported: EAR DISORDER (non-serious) with onset 28Dec2021, outcome "unknown", described as "ear issue"; FATIGUE (non-serious) with onset 28Dec2021, outcome "unknown"; TINNITUS (non-serious) with onset 28Dec2021, outcome "unknown"; NERVOUS SYSTEM DISORDER (non-serious) with onset 28Dec2021, outcome "unknown", described as "virus severely attacks nervous system"; ASTHENIA (non-serious) with onset 28Dec2021, outcome "unknown", described as "weakness/overuse: senses".  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: COVID-19, Drug ineffective
Clinical narrative: she got her last Pfizer Covid 19 booster dose on 14Oct, then got Covid; she got her last Pfizer Covid 19 booster dose on 14Oct, then got Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) 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), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "she got her last Pfizer Covid 19 booster dose on 14Oct, then got Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. She was prescribed Paxlovid, lot number GH5752.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 at 14:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: EE3590) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Hormone replacements" (unspecified if ongoing); "known allergies :Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID, start date: 01Jan2010, stop date: 03Nov2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Arthralgia, Headache, Influenza like illness
Clinical narrative: flu like symptoms; joint pain; headache; 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 01Nov2022 at 09:50 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 complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 02Nov2022, outcome "unknown", described as "flu like symptoms"; HEADACHE (non-serious) with onset 02Nov2022, outcome "unknown"; ARTHRALGIA (non-serious) with onset 02Nov2022, outcome "unknown", described as "joint pain".  Additional information: Started with flu like symptoms, joint pain and headache at approximately 1AM 02Nov2022. Symptoms continue through 6:30 AM. 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: U
Vaccine: COVID19
Symptoms: Hypothyroidism
Clinical narrative: low thyroid numbers; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: W25J2524) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes 2" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure but not bad. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, in Sep2022 as dose number unknown, single; METFORMIN; BISOPROLOL FUMARATE. Vaccination history included: moderna covid-19 vaccine (1st dose , lot number - 029L20A), administration date: 21Jan2021, for Covid-19 Immunization, reaction(s): "slight headache"; moderna covid-19 vaccine (2nd dose, lot number 013M20A), administration date: 18Feb2021, for Covid-19 Immunization; moderna covid-19 vaccine (Dose 3 (1st booster dose), lot number - 039D(?)21A), administration date: 23Oct2021, for Covid-19 Immunization; moderna covid-19 vaccine (Dose 4 (2nd booster dose), lot number 083J21A), administration date: 30Mar2022, for Covid-19 Immunization, reaction(s): "balance/equilibrium problem", "felt like falling over". The following information was reported: HYPOTHYROIDISM (medically significant), outcome "unknown", described as "low thyroid numbers". Clinical course: Caller stated that they had the 4 shots of the Moderna vaccines. After getting the 1st dose, they had a slight headache. When they took the 4th dose, they had a balance/equilibrium problem, they felt like they were going to fall over. They took the Pfizer for the bivalent booster and did not have any problems. They ask if they can take the Moderna booster in the future if this will be recommended on a yearly basis given the fact that they had some adverse events after the 1st and 4th doses. It was reported that patient has thyroid medication - Levothyroxine 25mg once a day (last Sep2022) - patient started with this medication as their last checkup showed low thyroid numbers. Flu vaccine was given in Sep2022 but not the same day as the Covid-19 vaccine. The patient has no known allergies and has never had COVID or tested for COVID.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Memory impairment
Clinical narrative: joints in arms, legs, back still ache; shortness of breath; tired later in day- somewhat exhausted; seem to be more forgetful of stuff including names; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu shot (Got my old people flu shot approximately 3-4 weeks ago.), administration date: 2022, for Immunisation; Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: unknown), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER),  SINGLE, Lot number: unknown), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 29Oct2022, outcome "not recovered", described as "joints in arms, legs, back still ache"; MEMORY IMPAIRMENT (non-serious) with onset 29Oct2022, outcome "unknown", described as "seem to be more forgetful of stuff including names"; DYSPNOEA (non-serious) with onset 29Oct2022, outcome "recovered" (2022), described as "shortness of breath"; FATIGUE (non-serious) with onset 29Oct2022, outcome "unknown", described as "tired later in day- somewhat exhausted". Therapeutic measures were taken as a result of arthralgia, dyspnoea.  Additional information: Shortness of breath had lessened, but stairs still affect patient the most. For the last two weeks patient had been using a backpack leaf blower for eight days for a minimum three hours at a time with seemingly no shortness of breath but really tired later in a day somewhat exhausted.  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: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hypoaesthesia, Nerve injury, Pain in extremity, Paralysis
Clinical narrative: almost paralyzed; stroke; nerve damage; numbness in left-hand fingers/arm numbness; pain all in his left arm; the needle going in the wrong way and hitting a nerve; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003908. 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: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 2021, outcome "unknown", described as "the needle going in the wrong way and hitting a nerve"; PARALYSIS (medically significant), outcome "unknown", described as "almost paralyzed"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; NERVE INJURY (non-serious), outcome "unknown", described as "nerve damage"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in left-hand fingers/arm numbness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain all in his left arm".  Clinical course:  It was reported the patient experienced a bad reaction. It was reported that patient was left him with nerve damage and described the needle going in the wrong way and hitting a nerve. The patient also experienced numbness in left-hand fingers, whole arm numbness and was almost paralyzed for 3 months. He had pain all in his left arm almost like he was having a stroke. The patient stated since last April, it took 3 months to get use back in his arm, that was the fear  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: Wrong technique in product usage process
Clinical narrative: almost paralyzed; stroke; nerve damage; numbness in left-hand fingers/arm numbness; pain all in his left arm; the needle going in the wrong way and hitting a nerve; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003908. 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: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 2021, outcome "unknown", described as "the needle going in the wrong way and hitting a nerve"; PARALYSIS (medically significant), outcome "unknown", described as "almost paralyzed"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; NERVE INJURY (non-serious), outcome "unknown", described as "nerve damage"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in left-hand fingers/arm numbness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain all in his left arm".  Clinical course:  It was reported the patient experienced a bad reaction. It was reported that patient was left him with nerve damage and described the needle going in the wrong way and hitting a nerve. The patient also experienced numbness in left-hand fingers, whole arm numbness and was almost paralyzed for 3 months. He had pain all in his left arm almost like he was having a stroke. The patient stated since last April, it took 3 months to get use back in his arm, that was the fear  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Chills, Lymphadenopathy, Pyrexia
Clinical narrative: chills; fever; lymph node swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (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 complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph node swelling".  Additional information: It was also reported that 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: M
Vaccine: COVID19
Symptoms: Therapeutic product effect decreased
Clinical narrative: vaccination efficacy has significantly decreased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 3-year-old 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: THERAPEUTIC PRODUCT EFFECT DECREASED (medically significant), outcome "unknown", described as "vaccination efficacy has significantly decreased". Clinical course: The patient's parent was disconcerted by the fact that their son, who has literally shed blood, sweat, and tears for the trial does not have access to the next step as the bivalent vaccine. It was further reported that this was especially deflating since the patient's vaccination efficacy has significantly decreased since the early spring receipt and was now waiting for early 2023 (as suggested by the site) to gain access.   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: Arthralgia, Autoimmune disorder, Back pain, Body temperature, Diarrhoea
Clinical narrative: her doctor thought it was an autoimmune reaction to Pfizer COVID-19 vaccine; swollen, red arm (diagnosed as cellulitis); injection site pain that was really bad; lymph nodes were swollen; 101 degree fever; nausea; diarrhea; joint pain; back pain that felt like a burning sensation and was constant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003909.  A female patient received BNT162b2, on 01Oct2021 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 complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "her doctor thought it was an autoimmune reaction to Pfizer COVID-19 vaccine"; VACCINATION SITE CELLULITIS (medically significant), outcome "unknown", described as "swollen, red arm (diagnosed as cellulitis)"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "injection site pain that was really bad"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes were swollen"; PYREXIA (non-serious), outcome "unknown", described as "101 degree fever"; NAUSEA (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; BACK PAIN (non-serious), outcome "unknown", described as "back pain that felt like a burning sensation and was constant". The patient underwent the following laboratory tests and procedures: Body temperature: 101, notes: degree.  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: Lymphadenopathy, Nausea, Pyrexia, Vaccination site cellulitis, Vaccination site pain
Clinical narrative: her doctor thought it was an autoimmune reaction to Pfizer COVID-19 vaccine; swollen, red arm (diagnosed as cellulitis); injection site pain that was really bad; lymph nodes were swollen; 101 degree fever; nausea; diarrhea; joint pain; back pain that felt like a burning sensation and was constant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003909.  A female patient received BNT162b2, on 01Oct2021 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 complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "her doctor thought it was an autoimmune reaction to Pfizer COVID-19 vaccine"; VACCINATION SITE CELLULITIS (medically significant), outcome "unknown", described as "swollen, red arm (diagnosed as cellulitis)"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "injection site pain that was really bad"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph nodes were swollen"; PYREXIA (non-serious), outcome "unknown", described as "101 degree fever"; NAUSEA (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; BACK PAIN (non-serious), outcome "unknown", described as "back pain that felt like a burning sensation and was constant". The patient underwent the following laboratory tests and procedures: Body temperature: 101, notes: degree.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: arm hurt a lot; had a fever with chills; had a fever with chills; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient 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 complete unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurt a lot"; PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "had a fever with chills".  Additional information: Patient stated arm hurt a lot and had a fever with chills after booster.  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: 2.0
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: A 2 year old died from a single Pfizer COVID shot after 6 hours the same day,and the CDC tried to hide it:; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A 2-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 2 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), 6 hrs after the suspect product(s) administration, outcome "fatal", described as "A 2 year old died from a single Pfizer COVID shot after 6 hours the same day,and the CDC tried to hide it:". The date and cause of death for the patient were unknown. It was unknown if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Pain, Swelling
Clinical narrative: painful axillary swelling; painful axillary swelling; 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), 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, SINGLE), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "painful axillary swelling". The event "painful axillary swelling" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Several doctor visits and many expensive tests, all to no avail.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: HIBV
Symptoms: Death, Haemophilus infection, Illness
Clinical narrative: was vaccinated for H.flu but acquired the illness systemically several months later and passed away; Initial information received on 28-Oct-2022 regarding an unsolicited valid serious case received from a other health professional.  This case involves Infant and unknown gender patient who after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB] acquired the illness systemically several months later and passed away.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (dose, strength, and lot number: unknown) via intramuscular route in unknown administration site for Haemophilus influenzae.  On an unknown date the patient developed a serious "was vaccinated for H.flu but acquired the illness systemically several months later and passed away" (Haemophilus infection) several months later and passed away (unknown latency) following the administration of HIB (PRP/T) VACCINE.  Final diagnosis was (fatal) for vaccinated for H.flu but acquired the illness systemically several months later and passed away. Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Fatal for the event. No autopsy was done. The cause of death was reported as Haemophilus influenza infection.  Seriousness criteria:  Medically significant for the event and was leading to death.; Sender's Comments: Sanofi Company Comment dated 02-Nov-2022: This case involves Infant and unknown gender patient who after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB] acquired the illness systemically several months later and passed away. The cause of death was reported as Haemophilus influenza. However, the patient's previous vaccine tolerance, concomitant medications and medical conditions, immunological status, allergy history, laboratory investigations and autopsy results  would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be excluded.; Reported Cause(s) of Death: Haemophilus influenzae