chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypersensitivity, Pain, Rash macular
Clinical narrative: allergic reaction; Raised painful , burny , sore blotches in several places after my 2nd vaccine.; Raised painful , burny , sore blotches in several places after my 2nd vaccine.; Raised painful , burny , sore blotches in several places after my 2nd vaccine.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Feb2022 11:30 (Lot number: 330258D) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sulfa drugs" (unspecified if ongoing); "Nickel" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 330258D, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 13Jan2022, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 09Feb2022 14:00, outcome "recovering", described as "allergic reaction"; PAIN (non-serious), BURNING SENSATION (non-serious), RASH MACULAR (non-serious) all with onset 09Feb2022 14:00, outcome "recovering" and all described as "Raised painful , burny , sore blotches in several places after my 2nd vaccine.". The events "allergic reaction", "raised painful , burny , sore blotches in several places after my 2nd vaccine.", "raised painful , burny , sore blotches in several places after my 2nd vaccine." and "raised painful , burny , sore blotches in several places after my 2nd vaccine." were evaluated at the emergency room visit. Therapeutic measures were taken as a result of hypersensitivity, pain, burning sensation, rash macular.  Additional information: Raised painful, burny, sore blotches in several places after my 2nd vaccine. Went to urgent care clinic and was prescribed meds for an allergic reaction, steroids and hydroxyzine. No other vaccine in four weeks. Patient received Other Medication in two weeks: Multivitamin/ birth control. Patient did not have covid prior vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure via breast milk, Hypersensitivity, Skin test
Clinical narrative: COVID-19/runny nose/congestion; developed allergic reaction to peanuts (and tree nuts, sesame); I am fully vaccinated and was nursing him; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 15 month-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "COVID-19/runny nose/congestion"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "developed allergic reaction to peanuts (and tree nuts, sesame)"; EXPOSURE VIA BREAST MILK (non-serious), outcome "unknown", described as "I am fully vaccinated and was nursing him". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Mother was fully vaccinated and was nursing him. Patient did not receive any Pfizer medication or vaccine. He has since developed allergic reaction to peanuts (and tree nuts, sesame) even though he did not have allergies with repeated prior exposure. Allergy was confirmed at allergist office with skin test performed 08Feb2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200239715 Mother case
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, Interchange of vaccine products, Off label use
Clinical narrative: OFFLABEL USE; Interchange of vaccine products BNT162B2 and J&J Janssen COVID Vaccine; COVID; COVID; 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 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 (Lot number: FH8027) at the age of 64 years as dose 2 (booster), single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN), administered in arm left, administration date 06Mar2021 (Lot number: 1805022, Expiration Date: 2021) as dose 1, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "OFFLABEL USE"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products BNT162B2 and J&J Janssen COVID Vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: blood test: liver inflammation.; sars-cov-2 test: covid virus, notes: He was later diagnosed with COVID virus.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: OFFLABEL USE; Interchange of vaccine products BNT162B2 and J&J Janssen COVID Vaccine; COVID; COVID; 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 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 (Lot number: FH8027) at the age of 64 years as dose 2 (booster), single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN), administered in arm left, administration date 06Mar2021 (Lot number: 1805022, Expiration Date: 2021) as dose 1, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "OFFLABEL USE"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products BNT162B2 and J&J Janssen COVID Vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: blood test: liver inflammation.; sars-cov-2 test: covid virus, notes: He was later diagnosed with COVID virus.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Esophageal reflux" (unspecified if ongoing); "Gastritis" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; VITAMIN B-12; PROGESTERONE; FLUAD QUAD. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "unknown" and all described as "COVID-19". Clinical course: The patient had no known drug Allergies. Patient has medication on hand, Missed 3 weeks of medication due to covid 08Jan2022. Withheld is aware and pt is now back on the medication. The patient medication were Vitamin D3, Vitamin B-12, Progesterone, Pfizer Covid-19 Vaccine, Fluad, Daily-Vite.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Irregularity of menstrual cycle; Increase in intensity of menstrual cycle; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP).   A 21 year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), intramuscular, administration date an unknown date in Dec2021 (Lot number: unknown) at the age of 20 Years as dose 2; single for COVID-19 immunisation. It was unknow if the patient had any relevant medical history. Concomitant medications included: EFFEXOR. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Irregularity of menstrual cycle"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset an unknown date in Dec2021, outcome "unknown", described as "Increase in intensity of menstrual cycle". It was unknown if the patient had taken any therapeutic measures as a result of the events.  Additional Information: It was unknown if the patient had any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, Investigation
Clinical narrative: severe attack; breathing difficult; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 06Jan2022 (Batch/Lot number: unknown) at the age of 39 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (hospitalization) with onset 10Jan2022, outcome "unknown", described as "severe attack"; DYSPNOEA (non-serious), outcome "unknown", described as "breathing difficult". The event "severe attack" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: unknown results; unknown results.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive on 09Jan2022; tested positive on 09Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (159558). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6203, Expiration Date: Jun2021) at the age of 31 years as dose 2, single and administered in arm left, administration date 11Feb2021 (Lot number: EL9265, Expiration Date: May2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "tested positive on 09Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive; (09Jan2022) positive.  Clinical course: She has natural immunity. She had COVID mid Jan and her work is mandating the booster vaccine in March, either the 29th or 30th. She is wanting to know if you should wait a certain amount of time between having natural immunity and getting the booster, and is it still indicated. She got the COVID vaccine last year. States the first 2 shots are approved, she is asking if the booster is being studied, is it approved for pregnant women.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200276294 mother/baby case
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Investigation, SARS-CoV-2 test
Clinical narrative: tested positive on 09Jan2022; tested positive on 09Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (159558). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6203, Expiration Date: Jun2021) at the age of 31 years as dose 2, single and administered in arm left, administration date 11Feb2021 (Lot number: EL9265, Expiration Date: May2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "tested positive on 09Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive; (09Jan2022) positive.  Clinical course: She has natural immunity. She had COVID mid Jan and her work is mandating the booster vaccine in March, either the 29th or 30th. She is wanting to know if you should wait a certain amount of time between having natural immunity and getting the booster, and is it still indicated. She got the COVID vaccine last year. States the first 2 shots are approved, she is asking if the booster is being studied, is it approved for pregnant women.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200276294 mother/baby case
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Transient ischaemic attack
Clinical narrative: after getting the 2nd dose, he had experienced TIA (Transient Ischaemic Attack) which he went to the ER and has been diagnosed with a DVT (Deep Vein Thrombosis).; after getting the 2nd dose, he had experienced TIA (Transient Ischaemic Attack) which he went to the ER and has been diagnosed with a DVT (Deep Vein Thrombosis).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (COMIRNATY), administration date 03Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 13Jul2021, for COVID-19 immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown" and all described as "after getting the 2nd dose, he had experienced TIA (Transient Ischaemic Attack) which he went to the ER and has been diagnosed with a DVT (Deep Vein Thrombosis).". The event "after getting the 2nd dose, he had experienced tia (transient ischaemic attack) which he went to the er and has been diagnosed with a dvt (deep vein thrombosis)." and "after getting the 2nd dose, he had experienced tia (transient ischaemic attack) which he went to the er and has been diagnosed with a dvt (deep vein thrombosis)." was evaluated at the emergency room visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administration error, Scratch
Clinical narrative: When the nurse administered the vaccine to my 5yo niece, she jerked away, the needle bent and scratched my niece's arm and some vaccine did not enter her arm. The nurse was new to giving vaccines in the first place; Some vaccine did not enter her arm/ Told my sister in law that my niece prob got 90% of the vaccine if she had to guess; When the nurse administered the vaccine to my 5yo niece, she jerked away, the needle bent and scratched my niece's arm; This is a spontaneous report from a contactable reporter (Consumer or other non HCP).   A 5-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 11Feb2022 at 16:00 (Lot number: unknown) at the age of 5 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 11Feb2022 at 16:00, outcome "unknown", described as "When the nurse administered the vaccine to my 5yo niece, she jerked away, the needle bent and scratched my niece's arm and some vaccine did not enter her arm. The nurse was new to giving vaccines in the first place"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 11Feb2022 at 16:00, outcome "unknown", described as "Some vaccine did not enter her arm/ Told my sister in law that my niece prob got 90% of the vaccine if she had to guess"; SCRATCH (non-serious) with onset 11Feb2022 at 16:00, outcome "recovered" (an unknown date in Feb2022), described as "When the nurse administered the vaccine to my 5yo niece, she jerked away, the needle bent and scratched my niece's arm". The event "When the nurse administered the vaccine to my 5yo niece, she jerked away, the needle bent and scratched my niece's arm" was evaluated at the emergency room visit. Therapeutic measures were not taken as a result of scratch.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that when the reporters sister in law asked if the patient needed to get another dose, the nurse did not know the answer and did not administer another one or refer her to anyone for the answer. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Arm discomfort; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Mar2021 11:00 (Lot number: ER8727) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D [COLECALCIFEROL]. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim", notes: known allergies: Bactrim.  The following information was reported: LIMB DISCOMFORT (non-serious) with onset 28Mar2021, outcome "recovered" (2021), described as "Arm discomfort". Therapeutic measures were not taken as a result of limb discomfort.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medication the patient received within 2 weeks of vaccination which included multivitamin. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: After the booster arm still hurts in shot area after 3 months like I just received it; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 22Dec2021 at 16:00 (Lot number: FS8757) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0171, Route of administration: Unspecified, Anatomical location: Left arm, Time of administration: 16:00), administration date: 06Apr2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8737, Route of administration: Unspecified, Anatomical location: Left arm, Time of administration: 16:00), administration date: 27Apr2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Dec2021 at 16:00, outcome "not recovered", described as "After the booster arm still hurts in shot area after 3 months like I just received it". Therapeutic measures were not taken as a result of the event vaccination site pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program. A 68-year-old male patient received the 2nd dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0150, expiration date: Jul 31, 2021), at the age of 67, in right arm, on Apr 2, 2021, at 09:45, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6206, expiration date: Jun 30, 2021), at the age of 67, in left arm, on Mar 12, 2021, approximately scheduled for 09:45 am, for COVID-19 immunization; and had several reactions: pain in the upper part of the left arm/left arm strain. The patient had pain in extremity (second dose: right arm pain), with outcome of unknown. No therapeutic measures taken as a result of pain in extremity. Additional information: The patient had no prior vaccinations within 4 weeks. No follow-up attempts possible. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Headache, Nausea
Clinical narrative: breathing trouble; chills; nausea; fever of 103.5; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Mar2021 16:15 (Lot number: EN6205) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Onset date: Long ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Time: 4:15 pm, Site and route of injection:, Anatomical site of Location: Right Arm, Route of administration: Intramuscular, Lot/Batch No: EL9267, Exp 31May2021, AE Term: 5 days, Onset date: 14Feb2021, AE Outcome: Recovered, Treatment: No, ), administration date: 13Feb2021, for Covid-19 immunization, reaction(s): "chills", "nausea", "horrible fatigue", "Ill for entire week", "trouble breathing". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "breathing trouble"; HEADACHE (non-serious) with onset 06Mar2021, outcome "unknown", described as "headache"; CHILLS (non-serious) with onset 07Mar2021, outcome "unknown", described as "chills"; NAUSEA (non-serious) with onset 07Mar2021, outcome "unknown", described as "nausea"; PYREXIA (non-serious) with onset 07Mar2021, outcome "unknown", described as "fever of 103.5". The events "breathing trouble", "headache", "chills", "nausea" and "fever of 103.5" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspnoea.  Additional Information: After 2 dose patient once again had breathing troubles used my inhaler and was checked by a doctor on location. Approximately 1 hour after shot patient had a headache. On 07Mar2021, patient started chills, Nausea and had a fever of 103.5. patient said work on 08Mar2021 and 09Mar2021. patient did contact her PCPs office each time either I or my husband talk to employee working their answering service.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: breathing trouble; chills; nausea; fever of 103.5; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Mar2021 16:15 (Lot number: EN6205) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Onset date: Long ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Time: 4:15 pm, Site and route of injection:, Anatomical site of Location: Right Arm, Route of administration: Intramuscular, Lot/Batch No: EL9267, Exp 31May2021, AE Term: 5 days, Onset date: 14Feb2021, AE Outcome: Recovered, Treatment: No, ), administration date: 13Feb2021, for Covid-19 immunization, reaction(s): "chills", "nausea", "horrible fatigue", "Ill for entire week", "trouble breathing". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "breathing trouble"; HEADACHE (non-serious) with onset 06Mar2021, outcome "unknown", described as "headache"; CHILLS (non-serious) with onset 07Mar2021, outcome "unknown", described as "chills"; NAUSEA (non-serious) with onset 07Mar2021, outcome "unknown", described as "nausea"; PYREXIA (non-serious) with onset 07Mar2021, outcome "unknown", described as "fever of 103.5". The events "breathing trouble", "headache", "chills", "nausea" and "fever of 103.5" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspnoea.  Additional Information: After 2 dose patient once again had breathing troubles used my inhaler and was checked by a doctor on location. Approximately 1 hour after shot patient had a headache. On 07Mar2021, patient started chills, Nausea and had a fever of 103.5. patient said work on 08Mar2021 and 09Mar2021. patient did contact her PCPs office each time either I or my husband talk to employee working their answering service.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: The patient developed multiple sclerosis after receiving the vaccine. The patient has a family history, but had no symptoms prior to the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An adult female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: Unknown), for Covid-19 immunization. It was unknown if the patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: MULTIPLE SCLEROSIS (disability, medically significant, life threatening), outcome "not recovered", described as "The patient developed multiple sclerosis after receiving the vaccine. The patient has a family history, but had no symptoms prior to the vaccine". The event "the patient developed multiple sclerosis after receiving the vaccine. the patient has a family history, but had no symptoms prior to the vaccine." was evaluated at the emergency room visit. Therapeutic measures were taken as a result of multiple sclerosis. It was unknown if since the vaccination, the patient has been tested for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: mother got her so-called flu shot she got sick; Initial information received on 13-Feb-2022 regarding an unsolicited valid social media non-serious case was received from a consumer/non-healthcare professional.  This case involves an adult female patient of unspecified age, who got her so-called flu shot she got sick while being vaccinated with influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received influenza vaccine (produced by unknown manufacturer) (strength, formulation, dosage regimen, lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested.   On an unknown date, the patient got her so-called flu shot she got sick (illness) (unknown latency) following the administration of influenza vaccine. The reported stated that they all got sick.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 13-Feb-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who experienced flu while receiving vaccine Influenza Vaccine.  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 Influenza Vaccine (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the Flu; Initial information received on 10-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who got the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, route, frequency, lot number and expiry date was unknown) not  in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient developed a non-serious event "got the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported" I got mine and immediately got the Flu and wish I had never gotten it , it was definitely terrible."   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the Flu).  At time of reporting, the outcome was Unknown for the event got the flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the flu in the last 55 years, is the year I got /he flu shot; Initial information received on 12-Feb-2022 regarding an unsolicited valid non-serious case received from a patient via social media.  This case involves an adult patient of unknown gender who experienced I got the flu in the last 55 years, is the year I got /he flu shot while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown strength, formulation, dosage form, frequency, route, administration site, batch number and expiry date) for immunization.  On an unknown date, the patient developed a non-serious event I got the flu in the last 55 years, is the year i got /he flu shot (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (I got the flu in the last 55 years, is the year I got /he flu shot).  At time of reporting, the outcome was Unknown for the event I got the flu in the last 55 years, is the year I got /he flu shot.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Adverse drug reaction
Clinical narrative: Mininmal side effects with any of them; Initial information from received on 11-Feb-2022 regarding an unsolicited valid  non-serious case received from a patient.  This case involves Adult and unknown gender patient who experienced mininmal side effects with any of them while receiving vaccines COVID-19 VACCINE and INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Kidney disorder.    In October 2021, the patient received a dose of suspect INFLUENZA VACCINE and COVID-19 VACCINE produced by unknown manufacturer (Formulation, Strength, lot number and expiry date not reported) via unknown route in and unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious mininmal side effects with any of them (adverse drug reaction) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) and COVID-19 VACCINE (COVID-19 VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Mininmal side effects with any of them).  At time of reporting, the outcome was Unknown for the event mininmal side effects with any of them.
Sex: F
Vaccine: FLUX
Symptoms: Critical illness
Clinical narrative: mother got a few shot about 15 years ago and got deathly ill; Initial information received on 12-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves an elderly female patient who got a few shot about 15 years ago and got deathly ill while receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date about 15 years ago, the patient received a dose of suspect Influenza vaccine (dose, route, strength, frequency, form, batch number: unknown) for immunization.  On an unknown date, the patient got a few shot about 15 years ago and got deathly ill (critical illness) (unknown latency) following the administration of Influenza vaccine. The event has been assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (critical illness).  At time of reporting, the outcome was Unknown for the event (critical illness).; Sender's Comments: Sanofi Company Comment dated 18-Feb-2022: This case involves an elderly female patient who had experienced "my mother got a few shot about 15 years ago and got deathly ill" (critical illness) while being treated with Influenza vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of past, medical, family history and concomitant medication precludes comprehensive case assessment. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: died from Guillian Barre syndrome; Initial information received on 13-Feb-2022 regarding an unsolicited valid Social Media serious case received from consumer/non-hcp.  This case involves an unknown age male patient who died from guillian barre syndrome, after receiving vaccine Influenza Vaccine.  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  Influenza Vaccine produced by unknown manufacturer (unknown dose, formulation lot number, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient died from guillian barre syndrome (guillain-barre syndrome) (unknown latency) .This event was assessed as medically significant and was leading to death.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (died from Guillian Barre syndrome).  At time of reporting, the outcome was Fatal for the event died from guillian barre syndrome. It is unknown if an autopsy was done. The cause of death was reported as Guillain Barre syndrome.; Sender's Comments: Sanofi company comment dated 17-Feb-2022: This case involves a male patient of unknown age who died from Guillian Barre syndrome after vaccination with influenza Vaccine (Manufacturer unknown). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: died from Guillian Barre syndrome
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received from United States on 14-Feb-2022 regarding an unsolicited valid social media non-serious case received from a consumer.  This case involves Adult and unknown gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Oct ( year unspecified) , the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer with unknown strength, lot number and expiration date via unknown route in unknown administration site for immunization. There will be no information available on the batch number for this case.  On an unknown date in January (year unspecified) the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: flu; sick; Initial information received on 13-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (non health care professional).  This case involves patient with unknown demographics who experienced flu and sick while receiving vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer,dose,frequency,strength,lot number,expiry date via unknown route in unknown administration site for immunization.  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for this event.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (flu, sick).  At time of reporting, the outcome was Unknown for the events flu and sick.; Sender's Comments: Sanofi Company Comment dated on 21-Feb -2022: This case involves patient with unknown demographics who experienced flu while receiving vaccine INFLUENZA VACCINE. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect product cannot be excluded in occurrence of the event.   However, lack of information of past and concomitant medication/ vaccination, any family history and any relevant medical history of patient, any concurrent conditions, lab data precludes comprehensive case assessment. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu shot once and got the worse case of the flu; Initial information received on 14-Feb-2022 regarding an unsolicited valid  non-serious case received from a patient.  This case involves an unknown age and unknown gender patient who experienced got the flu shot once and got the worse case of the flu while receiving influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication ,vaccination(s) and family history were not provided.   On an unknown date, the patient received  Influenza Vaccine once (with an unknown formulation, route, strength, batch number ,administration site and expiry date) produced by unknown manufacturer for immunization.   On an unknown date the patient developed a non-serious event of  got the flu shot once and got the worse case of the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu shot once and got the worse case of the flu).  At time of reporting, the outcome was Unknown for the (got the flu shot once and got the worse case of the flu).
Sex: U
Vaccine: FLUX
Symptoms: Viral infection
Clinical narrative: got vaccine but had virus; Initial information received on 11-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from patient.  This case involves an adult patient of unknown demographics who had virus while receiving Influenza Vaccine.  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 Influenza Vaccine produced by unknown manufacturer (strength, route, administration site, batch number and expiry date: unknown) for prophylactic vaccination. Information on batch number was requested.  On an unknown date the patient reported got vaccine but had virus (viral infection) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable  It was not reported if the patient received a corrective treatment for the event viral infection nos (not otherwise specified).  Outcome: Unknown
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: died after getting the shot.; Initial information received on 16-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp (non health care professional).  This case involves a patient with unknown demographics who died after getting the shot. while receiving vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer, dose, lot number, route not reported in unknown administration site for immunization.  On an unknown date the patient died after getting the shot (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  Final diagnosis was (fatal) died after getting the shot..  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (died after getting the shot.).  At time of reporting, the outcome was Fatal for the event died after getting the shot..  It is unknown if an autopsy was done. The cause of death was reported as Death NOS (not otherwise specified).; Sender's Comments: Sanofi company comment dated 21-Feb-2022: This case involves a patient with unknown demographics who died after getting the shot. while receiving vaccine INFLUENZA VACCINE. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.; Reported Cause(s) of Death: died after getting the shot.