chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Angioedema, Immobile, Suicidal ideation, Urticaria
Clinical narrative: hives; multiple anaphylactic reactions; suicide tendencies; it rendered her immobile; angioedema; 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 30 year-old female patient received bnt162b2 (COMIRNATY), administration date 26May2021 (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: 01), administration date: 05May2021, for Covid-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 2021, outcome "unknown", described as "multiple anaphylactic reactions"; SUICIDAL IDEATION (medically significant) with onset 2021, outcome "unknown", described as "suicide tendencies"; IMMOBILE (medically significant) with onset 2021, outcome "recovered", described as "it rendered her immobile"; ANGIOEDEMA (medically significant) with onset 2021, outcome "recovered", described as "angioedema"; URTICARIA (non-serious) with onset 02Jun2021, outcome "not recovered", described as "hives". The events "multiple anaphylactic reactions", "suicide tendencies", "it rendered her immobile", "angioedema" and "hives" were evaluated at the physician office visit. Therapeutic measures were taken as a result of anaphylactic reaction, suicidal ideation, immobile, angioedema, urticaria. The reporter stated that it was her first time having that condition in her life. Between Jun2021 and Sep2021, she experienced multiple anaphylactic reactions, she also had angioedema to the point that it rendered her immobile though it has resolved now; however, hives is still persistent to her up until today, she have consulted with doctors already and was given medications such as, epipen, inhaler, Xolair, and some other antihistamines and mast cell stabilizers. The reporter stated that it had affected her life since then, to the point that she had to stop going to work, was not being able to put any clothing because of her condition, went to counseling for her suicide tendencies, she shied away from her community for the longest time and her financial status were also affected.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Heart rate, Oxygen saturation
Clinical narrative: chest pain; fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier 20211258418.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Lot number: FW0161) at the age of 18 years as dose 1, single and administration date 19May2021 (Lot number: ER8736) as dose 2, single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN), administered in deltoid left, administration date 24Dec2021 (Lot number: 1855191, Expiration Date: 11Apr2022) as dose 3 (booster), single for immunisation. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: NAPROSYN [NAPROXEN]. The following information was reported: CHEST PAIN (non-serious) with onset 24Dec2021, outcome "recovering", described as "chest pain"; PYREXIA (non-serious) with onset 24Dec2021, outcome "recovered", described as "fever"; CHILLS (non-serious) with onset 24Dec2021, outcome "recovered" (25Dec2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, pyrexia, chills.  Additional information: The patient previously received non-company bnt 162 vaccine (dose number in series was 1) (form of admin, route of admin not reported, batch number: ER8736) dose was not reported, administered on 19May2021 for prophylactic vaccination. On an unspecified date, the patient experienced chest pain following vaccination with non-company bnt 162 vaccine (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2. s (dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: 11Apr2022) dose was not reported, 1 total, administered on 24Dec2021 to Left Deltoid for prophylactic vaccination. Concomitant medications included naproxen. On 24Dec2021, within 6 hours from vaccination, the patient experienced fever, chest pain and chills following vaccination with covid-19 vaccine ad26.cov2. s (dose number in series was 2). The patient received treatment with Aleve. Patient's chest pain symptom was faded. Patient's health care professional (HCP) suspected that the vaccination causeed chest pain. Patient did not go to emergency room (ER).  For chest pain, chills and fever causality as per reporter and manufacturer was possible.   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chest pain; fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier 20211258418.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Lot number: FW0161) at the age of 18 years as dose 1, single and administration date 19May2021 (Lot number: ER8736) as dose 2, single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN), administered in deltoid left, administration date 24Dec2021 (Lot number: 1855191, Expiration Date: 11Apr2022) as dose 3 (booster), single for immunisation. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: NAPROSYN [NAPROXEN]. The following information was reported: CHEST PAIN (non-serious) with onset 24Dec2021, outcome "recovering", described as "chest pain"; PYREXIA (non-serious) with onset 24Dec2021, outcome "recovered", described as "fever"; CHILLS (non-serious) with onset 24Dec2021, outcome "recovered" (25Dec2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest pain, pyrexia, chills.  Additional information: The patient previously received non-company bnt 162 vaccine (dose number in series was 1) (form of admin, route of admin not reported, batch number: ER8736) dose was not reported, administered on 19May2021 for prophylactic vaccination. On an unspecified date, the patient experienced chest pain following vaccination with non-company bnt 162 vaccine (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2. s (dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: 11Apr2022) dose was not reported, 1 total, administered on 24Dec2021 to Left Deltoid for prophylactic vaccination. Concomitant medications included naproxen. On 24Dec2021, within 6 hours from vaccination, the patient experienced fever, chest pain and chills following vaccination with covid-19 vaccine ad26.cov2. s (dose number in series was 2). The patient received treatment with Aleve. Patient's chest pain symptom was faded. Patient's health care professional (HCP) suspected that the vaccination causeed chest pain. Patient did not go to emergency room (ER).  For chest pain, chills and fever causality as per reporter and manufacturer was possible.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: live in (Name) had symptoms and tested positive on 15Feb2022, he had not symptoms but tested Ag positive on 16Feb2022 prior to work; live in (Name) had symptoms and tested positive on 15Feb2022, he had not symptoms but tested Ag positive on 16Feb2022 prior to work; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 33 year-old male patient received bnt162b2 (BNT162B2), administration date 19Oct2021 (Lot number: FF2589) at the age of 32 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 (Previous dose details , Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number= EL3247, Prev dose lot unknown=False, Prev dose administration date= 23Feb2021, Prev dose dose number=2), administration date: 23Feb2021, when the patient was 32 years old, for Covid-19 Immunization; Bnt162b2 (Previous dose details , Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number= EL3247, Prev dose lot unknown=False, Prev dose administration date= 03Feb2021, Prev dose dose number=1), administration date: 03Feb2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 16Feb2022, outcome "unknown" and all described as "live in (Name) had symptoms and tested positive on 15Feb2022, he had not symptoms but tested Ag positive on 16Feb2022 prior to work". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Feb2022) positive, notes: Other. It was unknown if therapeutic measures were taken as a result of drug ineffective, asymptomatic covid-19. COVID -19 prior vaccination was unknown reported.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: Brain bleed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01), for Covid-19 immunization; Covid-19 vaccine (Dose: 02), for Covid-19 immunization. The following information was reported: CEREBRAL HAEMORRHAGE (death, medically significant), outcome "fatal", described as "Brain bleed". The patient date of death was unknown. The reported cause of death was cerebral haemorrhage. It was not reported if an autopsy was performed. Reporter stated that the event happened before 14 days.  This report was not related to a study or programme. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Brain bleed
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Cardiac arrest, Hypertension
Clinical narrative: uncontrollable high blood pressure; cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP; patient's husband).  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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, Lot number unknown), administration date: 2021, for COVID-19 immunization. The following information was reported: CARDIAC ARREST (death, medically significant) with onset Dec2021, outcome "fatal", described as "cardiac arrest"; HYPERTENSION (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "uncontrollable high blood pressure". The patient was hospitalized for hypertension (start date: 2021). The patient underwent the following laboratory tests and procedures: blood pressure measurement: high, notes: uncontrollable high blood pressure. The patient date of death was Dec2021. The reported cause of death was cardiac arrest. It was not reported if an autopsy was performed. The reporter specified that shortly after taking the 2nd dose of covid vaccine, his wife developed uncontrollable high blood pressure. The patient was 52 years old and in perfect health before the vaccine. His wife was admitted into hospital, where she worked helped people for 31 years. She was released both times once they dropped her blood pressures. One week before Christmas, his wife had another high blood pressure event, and went into cardiac arrest on our way to the hospital and died.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Reported Cause(s) of Death: went into cardiac arrest on our way to hospital, and died.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: uncontrollable high blood pressure; cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP; patient's husband).  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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, Lot number unknown), administration date: 2021, for COVID-19 immunization. The following information was reported: CARDIAC ARREST (death, medically significant) with onset Dec2021, outcome "fatal", described as "cardiac arrest"; HYPERTENSION (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "uncontrollable high blood pressure". The patient was hospitalized for hypertension (start date: 2021). The patient underwent the following laboratory tests and procedures: blood pressure measurement: high, notes: uncontrollable high blood pressure. The patient date of death was Dec2021. The reported cause of death was cardiac arrest. It was not reported if an autopsy was performed. The reporter specified that shortly after taking the 2nd dose of covid vaccine, his wife developed uncontrollable high blood pressure. The patient was 52 years old and in perfect health before the vaccine. His wife was admitted into hospital, where she worked helped people for 31 years. She was released both times once they dropped her blood pressures. One week before Christmas, his wife had another high blood pressure event, and went into cardiac arrest on our way to the hospital and died.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Reported Cause(s) of Death: went into cardiac arrest on our way to hospital, and died.
Sex: F
Vaccine: COVID19
Symptoms: Death, Loss of consciousness
Clinical narrative: The day the patient went in to get the shot she passed out in the floor and died; The day the patient went in to get the shot she passed out in the floor and died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient in her 20's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown" and all described as "The day the patient went in to get the shot she passed out in the floor and died". The patient date of death was unknown. The reported cause of death was "The day the patient went in to get the shot she passed out in the floor and died". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: The day the patient went in to get the shot she passed out in the floor and died
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: DEATH (death), outcome "fatal". The patient date of death was unknown. The reported cause of death was "Unknown cause of death". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I did have COVID after my 2 vaccines- it was Aug of 2021; I did have COVID after my 2 vaccines- it was Aug of 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2021 13:30 (Lot number: ER8727) at the age of 57 years as dose 2, single and administered in arm right, administration date 13Mar2021 14:30 (Lot number: EP7534) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney cancer", start date: Jun2016 (unspecified if ongoing), notes: Removal of right kidney; "Gallbladder", start date: May2014 (unspecified if ongoing), notes: Removed; "Tonsils removed", start date: Jun1994 (unspecified if ongoing), notes: Removed; "Miscarriage" (unspecified if ongoing), notes: 4 Children, 2 miscarriage over 20years. Concomitant medication(s) included: LEXAPRO taken for anxiety (ongoing); LISINOPRIL taken for hypertension (ongoing). The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 13Aug2021, outcome "unknown" and all described as "I did have COVID after my 2 vaccines- it was Aug of 2021". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) fine and normal, notes: Reg-Blood test when Getting check ups all fine and normal; sars-cov-2 test: (13Aug2021) positive, notes: After vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Delirium, Drug specific antibody absent, Insomnia, Investigation, Pyrexia
Clinical narrative: Drug specific antibody absent; Drug effect incomplete; Delirious; Vaccination related malaise; Fever; Difficulty sleeping; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4282514-00 (Abbvie).  A 34 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1156159) at citrate free for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Daily Dose: 1)first dose (1 in 1 Once), Route of Admin: 1)Intra-muscular, Lot number: Unknown), administration date: 02Feb2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: DELIRIUM (medically significant) with onset Mar2021, outcome "recovered" (Mar2021), described as "Delirious"; DRUG SPECIFIC ANTIBODY ABSENT (non-serious), outcome "unknown", described as "Drug specific antibody absent"; VACCINATION COMPLICATION (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Vaccination related malaise"; PYREXIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Fever"; INSOMNIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Difficulty sleeping"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious), outcome "unknown", described as "Drug effect incomplete". The patient underwent the following laboratory tests and procedures: investigation: no antibodies, notes: Unknown date DRUG TEST: no antibodies. The action taken for adalimumab was unknown.  Clinical Course: It was unknown if patient was enrolled in a covid-19 vaccine trial. Source o report is Study. Solicited report from the USA by a consumer of a 34 year old male with events of non-serious patient stated drug test revealed no antibodies, second Covid vaccine made patient delirius/high fever/could not sleep and very sick and patient thought humira drug had little affect with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced patient stated drug test revealed no antibodies and patient thought humira drug had little affect. In Mar2021, the patient experienced second Covid vaccine made patient delirius/high fever/could not sleep and very sick. In Mar2021, the second Covid vaccine made patient delirius/high fever/could not sleep and very sick resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 34.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Therapeutic product effect incomplete, Vaccination complication
Clinical narrative: Drug specific antibody absent; Drug effect incomplete; Delirious; Vaccination related malaise; Fever; Difficulty sleeping; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4282514-00 (Abbvie).  A 34 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1156159) at citrate free for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Daily Dose: 1)first dose (1 in 1 Once), Route of Admin: 1)Intra-muscular, Lot number: Unknown), administration date: 02Feb2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: DELIRIUM (medically significant) with onset Mar2021, outcome "recovered" (Mar2021), described as "Delirious"; DRUG SPECIFIC ANTIBODY ABSENT (non-serious), outcome "unknown", described as "Drug specific antibody absent"; VACCINATION COMPLICATION (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Vaccination related malaise"; PYREXIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Fever"; INSOMNIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Difficulty sleeping"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious), outcome "unknown", described as "Drug effect incomplete". The patient underwent the following laboratory tests and procedures: investigation: no antibodies, notes: Unknown date DRUG TEST: no antibodies. The action taken for adalimumab was unknown.  Clinical Course: It was unknown if patient was enrolled in a covid-19 vaccine trial. Source o report is Study. Solicited report from the USA by a consumer of a 34 year old male with events of non-serious patient stated drug test revealed no antibodies, second Covid vaccine made patient delirius/high fever/could not sleep and very sick and patient thought humira drug had little affect with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced patient stated drug test revealed no antibodies and patient thought humira drug had little affect. In Mar2021, the patient experienced second Covid vaccine made patient delirius/high fever/could not sleep and very sick. In Mar2021, the second Covid vaccine made patient delirius/high fever/could not sleep and very sick resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Penis disorder, SARS-CoV-2 test, Skin discolouration, Vitiligo
Clinical narrative: I observed a small white dot on my penis; I observed a small decolorized patch on my penis forehead; confirmed as Vitiligo; high level of depression; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200321990 A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Jun2021 15:00 (Lot number: EW0183) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, lot_number=EW0169,, administration date=21May2021,, administration time=01:30, location=Left arm), administration date: 21May2021, when the patient was 43 years old, for covid-19 immunization. The following information was reported: PENIS DISORDER (non-serious) with onset Jul2021, outcome "not recovered", described as "I observed a small white dot on my penis"; SKIN DISCOLOURATION (non-serious) with onset Jul2021, outcome "not recovered", described as "I observed a small decolorized patch on my penis forehead"; VITILIGO (non-serious) with onset Jul2021, outcome "not recovered", described as "confirmed as Vitiligo"; DEPRESSION (non-serious) with onset Jul2021, outcome "not recovered", described as "high level of depression". The events "i observed a small white dot on my penis", "i observed a small decolorized patch on my penis forehead", "confirmed as vitiligo" and "high level of depression" 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 penis disorder, skin discolouration, vitiligo, depression.  Additional information: The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. AE treatment: Applying ointments as prescribed by dermatologist
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Illness, Influenza like illness
Clinical narrative: ill; pain in my chest; flu like illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unkown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu, for Immunization, reaction(s): "allergic to the flu shot". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "ill"; CHEST PAIN (non-serious), outcome "unknown", described as "pain in my chest"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like illness".  Additional information: It was stated by patient: "I got the Pfizer covid vaccine and became severely ill for three days. I had a strong pain in my chest and then I have continued getting a strange flu like illness about every couple weeks. I never had these symptoms before. I am allergic to the flu shot and I'm wondering if that has anything to do with my sickness."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle rigidity, Muscle swelling, Pain in extremity
Clinical narrative: left upper arm pain; there was mild swelling with hardness of the muscle at and below the injection site; there was mild swelling with hardness of the muscle at and below the injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Oct2021 (Lot number: 30155BA) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroid" (ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for hypothyroidism (ongoing). Vaccination history included: Bnt162b2 (DOSE: 1, Anatomical site of injection: Left upper arm, Route of administration: Intramuscular, Lot: EN6206), administration date: 05Mar2021, when the patient was 56 years old, for Covid-19 immunization, reaction(s): "continous Lt upper arm pain", "hard swelling beow injection site", "Continous upper arms muscle pain when raise arms overhead since day after both shots", "Left thyroid gland slightly swollen about 3 days after first vaccination and continues after second shot"; Bnt162b2 (DOSE: 2, Anatomical site of injection: Left upper arm, Route of administration: Intramuscular, Lot: EP6955), administration date: 26Mar2021, when the patient was 56 years old, for Covid-19 immunization, reaction(s): "continous Lt upper arm pain", "continous upper arms muscle pain when raise arms overhead since day after both shots", "Left thyroid gland slightly swollen about 3 days after first vaccination and continues after second shot". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "left upper arm pain"; MUSCLE SWELLING (non-serious), outcome "unknown", MUSCLE RIGIDITY (non-serious), outcome "recovering" and all described as "there was mild swelling with hardness of the muscle at and below the injection site".  Additional information: Vaccination Facility Type was Drug Store. Vaccine administered at was not done at Facility. The patient took no Prior vaccinations (within 4 weeks). The patient stated that there was mild swelling with hardness of the muscle at and below the injection site (lateral deltoid/ triceps area). It was not hard anymore, as of 14Feb2022, but continued to feel hard muscularly after lying on it for 5-10 minutes (used to be immediately hard/painful immediately) until about 01Jan2022. Relevant tests were none.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: No cough after 2nd injection, stop 10Mar2021. Dr. had no answer why my cough stop, Good thing.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Mar2021 13:00 (Lot number: EN6199) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cough", stop date: 10Mar2021, notes: Onset Date: 2 years; "Headache", start date: 12Feb2021, stop date: 06Mar2021, notes: no more headache. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Time: 11am, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/lot number: EN6201), administration date: 12Feb2021, for Covid-19 immunization, reaction(s): "Headache". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 06Mar2021, outcome "recovered" (10Mar2021), described as "No cough after 2nd injection, stop 10Mar2021. Dr. had no answer why my cough stop, Good thing.".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Myocardial infarction, Palpitations
Clinical narrative: Felt like having a heart attack; feels tightness in chest; heart palpitation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, Manufacturer Unknown), for COVID-19 Immunization. There were no other vaccine in four weeks. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "recovered with sequelae", described as "Felt like having a heart attack"; CHEST DISCOMFORT (non-serious), outcome "not recovered", described as "feels tightness in chest"; PALPITATIONS (non-serious), outcome "recovered with sequelae", described as "heart palpitation". Therapeutic measures were not taken as a result of myocardial infarction, chest discomfort, palpitations. Patient experienced heart palpitation on an unknown date. Patient also felt like having a heart attack. Patient still feels tightness in chest after 2 months of vaccination date. There was no COVID prior vaccination. It was unknown if patient was tested for COVID post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm Hurt; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm Hurt". Additional information: The patient stated that she had the second shot that day, she felt fine and her arm did not hurt like it did after the first one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Pyrexia
Clinical narrative: got sick like I had Covid again; fever of 103; This case is linked to case 2022SA055930(CLUSTER).  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 got sick like I had covid again and fever of 103, after receiving vaccine INFLUENZA VACCINE.   The patient's past medical history included had Covid and was in hospital for over a month.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date (6 months after Covid), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, dose, formulation: unknown) with lot number not reported via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  On an unknown date, the patient got sick like patient had covid again (malaise) and fever of 103 (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that I had Covid and was in hospital for over a month...almost died. I was never sick before Covid. 6mos. later got my first shot, got sick like I had Covid again...fevers of 103. Will not get anymore shots.  Relevant laboratory test results included: Body temperature - On an unknown date: [103]   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (got sick like I had Covid again, fever of 103).  At time of reporting, the outcome was Unknown for the event got sick like i had covid again and was Unknown for the event fever of 103.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Sickness; Initial information was received on 21-Feb-2022 regarding an unsolicited valid Social media non-serious case received from a consumer.  This case involves an unknown age male patient who reported sickness 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 an unknown manufacturer (formulation, strength, batch number, expiration date: unknown) via unknown route in an unknown administration site for immunization. Information on batch number has been requested.  On an unknown date, the patient reported sickness (illness) (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 (illness).  At time of reporting, the outcome was Unknown for the event (illness).
Sex: U
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: i know many who got the covid after all their shots; Initial information received on 16-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient who reported i know many who got the covid after all their shots 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 (form, strength, route, administration site, lot number, expiry date: unknown) for immunization.  On an unknown date the patient reported a non-serious event that i know many who got the covid after all their shots (covid-19) (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 (i know many who got the covid after all their shots).  Outcome was Unknown.
Age: 67.0
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 21-Feb-2022 regarding an unsolicited valid  social media non-serious case received from a consumer/non-hcp.  This case involves a 67 years old male who experienced 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 vaccine influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunisation. Information on batch number was requested.  On an unknown date the patient developed a non-serious sick (illness) (unknown latency) following the administration of vaccine influenza vaccine. Patient got one 5 years ago, never been so sick. No more.  Action taken: not applicable.  Outcome: Unknown
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu every year; Initial information received on 21-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/ non-health care professional via Digital Media.  This case involves an adult female patient who experienced got the flu every year while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested.  On an unknown date, the patient developed a non-serious event got the flu every year (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported that the man is 78years old, he have never had a flu shot, but his  wife got flu shot every year, and guess what, she got the Dam flu every year.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza).  At time of reporting, the outcome was Unknown for the event influenza.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: even as a kid they made me sick; Initial information received on 15-Feb-2022 regarding an unsolicited non-serious valid case from Social Media page received from a patient.  This case involves a adult patient of unknown demographics who reported even as a kid they made me sick while receiving Influenza Vaccine.  Past medical history: even as a kid they made me sick (Sickness).  Prior Use: Yes/ Not tolerated.   The patient's concomitant conditions, 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 (form, strength, route, dose, administration site, batch number, expiry date: unknown) for immunization. Batch number was requested.   On an unknown date the patient reported as a kid they made me sick (illness) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable.  Corrective treatment: not reported   Outcome was Unknown
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza, Malaise
Clinical narrative: every time I took the flu shot I was sicker than if I got the flu; Initial information received on 23-Feb-2022 regarding an unsolicited valid non-serious case from Social Media public post received from a patient.  This case involves Adult patient of unknown demographics who reported every time I took the flu shot I was sicker than if I got the flu 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 (form, Strength, route, dose, administration site, batch number, expiry date: unknown) for immunization.  On an unknown date the patient reported every time I took the flu shot I was sicker than if I got the flu (illness) (unknown latency) following the administration of  Influenza Vaccine.  Action taken was not applicable.  Corrective treatment: not reported   Outcome was Unknown.
Sex: U
Vaccine: FLUX
Symptoms: H1N1 influenza
Clinical narrative: h1n1 influenza; Initial information received on 23-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/ non-health care professional.  This case involves an adult patient of unknown gender and age who experienced H1N1 influenza 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 patients received a dose of suspect influenza vaccine produced by unknown manufacturer (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested.  On an unknown date, the patient developed a non-serious event H1N1 influenza (unknown latency) following the administration of influenza vaccine.  It was reported that the patient got the flu shot each year, got the h1n1, then the h1n1a, then the h1n1b. None of them were fun and was out of work for one week each. Worked forv school system, retiered- no flu. He/she did get it this year my doctor advised me. Also grew up military and had every vaccine imaginable. If someone doesn't want the vaccine, their business. Just because you took a vaccine doesn't mean you can't get it or spread it so safety for others doesn't mean you can't give it.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (H1N1 influenza).  At time of reporting, the outcome was Unknown for the event H1N1 influenza.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: Staff member complained of fast-sharp pain after the vaccine. Dizziness and everything seems very slow
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: The day after my shot around noon my underarms were in pain, my throat began to hurt and I had a really bad headache. My fever lasted for 2 days around 100 along with a stuffy head & sore muscles. I took ibuprofen only and things started to clear up about two weeks later and I am back to normal.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: The day after my shot around noon my underarms were in pain, my throat began to hurt and I had a really bad headache. My fever lasted for 2 days around 100 along with a stuffy head & sore muscles. I took ibuprofen only and things started to clear up about two weeks later and I am back to normal.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Injection site pain Swelling around injection site Rash/hives on arms Headache  Fever
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Injection site pain Swelling around injection site Rash/hives on arms Headache  Fever
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine beyond the published expiration date. Per Moderna Manufacterer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Memory impairment, Visual impairment
Clinical narrative: I received the vaccine and I was okay until about January and I got Covid-19 and then I started to having issues with my memory, and having shortness of memory. Also, my eyesight has changed.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Tinnitus, Vomiting
Clinical narrative: 10:20 AM Emesis liquid mucous. Resp intacr. No food intake today. Initially ringing in ears. 15 mins post vaccine. 10:25 am 136/90-HR 98- R 18- O2 Sat 93% Cont nausea 10:30 am  Cont nausea 10:35 am Nausea easing 10:40 am 122/83- HR 96 - R 16- O2 Sat 94% Pt feels ok to leave and plans to eat. Boyfriend said she may be pregnant. Pt called back to clinic later and said dgt sick and vomting.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Hypersensitivity, Lip pruritus, Swelling of eyelid
Clinical narrative: Patient had an allergic reaction to vaccine approximately 20-30 minutes from administration. Pt c/o itchy tongue, throat, lips and had visible swelling to eyelids. Denied difficulty breathing.  Administered 50 mg/ml of Dipenhydramine IM and followed up with patient at 12:20 pm, she denied trouble breathing, stated she was no longer itching and only felt her tongue slightly heavy. C/o fatigue from the dipenhydramine.