chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Pain, Pyrexia, Syncope
Clinical narrative: Syncopal episodes X 4; Fever; chills; pain/aches; Condition Aggravated; This is a spontaneous report from a non-contactable consumer. A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284) intramuscularly in left arm on 22Jan2021 at single dose for COVID-19 immunization. Medical history included traumatic brain injury from 2019 and ongoing, syncope from 2019 and ongoing (both reported as current Illness: traumatic brain injury? 2019 syncope? 2019). Concomitant medication included midodrine. The patient experienced fever, chills, pain/aches, on 22Jan2021 pm, condition aggravated on 22Jan2021, syncopal episodes X 4 on 23Jan2021 - transferred to ed - admitted. Events categories per reporter was permanent disability, hospitalized (3 days in hospital), emergency room visited. No office visited. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Off label use, Paraesthesia
Clinical narrative: My left and right arms have began to tingle; left and right arms go slightly numb 3-4 times per day for about an hour in length.; first dose on 29Jan2021 at 01:15 PM and second dose on 6Feb2021 at 03:00 PM; first dose on 29Jan2021 at 01:15 PM and second dose on 6Feb2021 at 03:00 PM; This is a spontaneous report from a contactable other healthcare professional (patient). A 21-year-old female patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration in the left arm, on 06Feb2021 at 15:00, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included unspecified birth control and venlafaxine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) on 29Jan2021 at 13:15, in the left arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient reported that on an unspecified date, her left and right arms began to tingle and went slightly numb 3-4 times per day for about an hour in length. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events "My left and right arms have began to tingle" and "left and right arms go slightly numb 3-4 times per day for about an hour in length" was not recovered. The patient has not been tested for COVID-19 since vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. The patient experienced rash on Jan2021. It was unknown if treatment was received for the adverse event. Clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Intense itching throughout my entire body; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269; Expiration date was not reported) on 05Feb2021 (16:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included asthma, high cholesterol and high blood pressure. The patient's concomitant medications were not reported. The patient previously took prochlorperazine maleate (COMPAZINE), and had drug allergy. The patient was not pregnant at the time of vaccination. On 05Feb2021 (18:00), two hours after the vaccination, the patient had intense itching throughout the entire body. There were no hives or rash, just the unbearable itching. The patient had received diphenhydramine (BENADRYL) as treatment for the event. The outcome of the event, intense itching throughout the entire body, was recovered in Feb2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Flushing
Clinical narrative: Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contactable nurse(patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 02Feb2021 11:45 AM at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient received the first  dose of BNT162B2 on 15Jan2021 for covid-19 immunization and experienced syncope. The patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) methylfolate and Ma. The patient experienced syncope after injection in Feb2021. A few episodes in 18 hrs, the patient experienced headache, body aches, intermittent fevers with flushing/chills, nausea night of 2nd injection and next day in Feb2021. The patient experienced severe fatigue, joint pain, felt very ill, akin to the flu in Feb2021.No treatment received for the adverse events. The patient underwent lab test included body temperature: intermittent fevers in Feb2021.The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to the event syncope is possible based on available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Malaise, Nausea, Pain
Clinical narrative: Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contactable nurse(patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 02Feb2021 11:45 AM at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient received the first  dose of BNT162B2 on 15Jan2021 for covid-19 immunization and experienced syncope. The patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) methylfolate and Ma. The patient experienced syncope after injection in Feb2021. A few episodes in 18 hrs, the patient experienced headache, body aches, intermittent fevers with flushing/chills, nausea night of 2nd injection and next day in Feb2021. The patient experienced severe fatigue, joint pain, felt very ill, akin to the flu in Feb2021.No treatment received for the adverse events. The patient underwent lab test included body temperature: intermittent fevers in Feb2021.The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to the event syncope is possible based on available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contactable nurse(patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 02Feb2021 11:45 AM at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient received the first  dose of BNT162B2 on 15Jan2021 for covid-19 immunization and experienced syncope. The patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) methylfolate and Ma. The patient experienced syncope after injection in Feb2021. A few episodes in 18 hrs, the patient experienced headache, body aches, intermittent fevers with flushing/chills, nausea night of 2nd injection and next day in Feb2021. The patient experienced severe fatigue, joint pain, felt very ill, akin to the flu in Feb2021.No treatment received for the adverse events. The patient underwent lab test included body temperature: intermittent fevers in Feb2021.The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to the event syncope is possible based on available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a Pfizer-sponsored program Pfizer RXPathways received by a contactable consumer(patient). A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced anaphylactic reaction to the first dose of the vaccine on an unspecified date and went to the hospital with outcome of unknown.    Information on the Lot/Batch Number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lip swelling, Rash, Swollen tongue
Clinical narrative: swollen tongue; swollen tongue and lips; worsened; rash; This is a spontaneous report from a contactable consumer (patient) via pharmacist. This adult female patient (age late 50) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. 15 mins after the 1st dose Pfizer Covid vaccine, the patient had runny ones swollen tongue and lips. Benedryl was administered, symptoms improved then worsened. Transport was called to hospital epi administered. RX steroids at the time of reporting was day 9 post vacc administration, the patient was still on steroids and continued rash. The patient described blood dripping from arm post stick. The patient wonder if administration was not IM.  Event took place after use of product. Outcome of the events was unknown.   Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Has been hospitalized with COVID for 10 days now; Has been hospitalized with COVID for 10 days now; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient had no underlying condition. The patient's concomitant medications were not reported. The patient's wife reported that the patient has been hospitalized with COVID for 10 days now since an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Oxygen saturation decreased, Pain in extremity, Pneumonia
Clinical narrative: Acute arm pain; chills; fever 40°C; loss of oxygen and conscience/diagnosed with pneumonia; loss of oxygen and conscience; This is a spontaneous report from a contactable consumer (patient). An 87-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: el9263) via an unspecified route of administration on 06Feb2021 14:15 at single dose in left arm for COVID-19 immunisation. Medical history included severe COPD (chronic obstructive pulmonary disease), atrial fibrillation, reflux gastritis, and was allergic to Penicillin. On 07Feb2021, the patient experienced acute arm pain, 2 days later chills, and 5 days later fever 40°C, loss of oxygen and conscience, 911 call diagnosed with pneumonia. Later they gave another diagnosis, the next day, no fever and no pain in the arm. The patient received antibiotics and steroids as treatment. Events resulted in visit to physician's office or another health professional, emergency room, hospitalization, potential mortal disease (immediate risk of death due to event). Events outcome was recovered on Feb2021. The patient hospitalized due to events for 4 days. The patient underwent lab tests and procedures which included body temperature 40°C on 07Feb2021, COVID test via nasal swab on 11Feb2021 with result of Negative.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Acute arm pain; chills; fever 40°C; loss of oxygen and conscience/diagnosed with pneumonia; loss of oxygen and conscience; This is a spontaneous report from a contactable consumer (patient). An 87-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: el9263) via an unspecified route of administration on 06Feb2021 14:15 at single dose in left arm for COVID-19 immunisation. Medical history included severe COPD (chronic obstructive pulmonary disease), atrial fibrillation, reflux gastritis, and was allergic to Penicillin. On 07Feb2021, the patient experienced acute arm pain, 2 days later chills, and 5 days later fever 40°C, loss of oxygen and conscience, 911 call diagnosed with pneumonia. Later they gave another diagnosis, the next day, no fever and no pain in the arm. The patient received antibiotics and steroids as treatment. Events resulted in visit to physician's office or another health professional, emergency room, hospitalization, potential mortal disease (immediate risk of death due to event). Events outcome was recovered on Feb2021. The patient hospitalized due to events for 4 days. The patient underwent lab tests and procedures which included body temperature 40°C on 07Feb2021, COVID test via nasal swab on 11Feb2021 with result of Negative.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Loss of consciousness, Syncope
Clinical narrative: I passed out, I was unconscious on the floor, my eyes were open and looked very strange he said, I was making gurgling sound.; I was unconscious on the floor/Tried to wake me up but it didn't work; Lethargic; This is a spontaneous report from a contactable consumer (patient).  A 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration at left arm on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient reported that: " I passed out the next morning for about 8 minutes my husband said, I was unconscious on the floor, my eyes were open and looked very strange he said, I was making gurgling sound. He threw water on me and he tried to wake me up but it didn't work. I came out of it I was very lethargic the whole day but the next day I was feeling a little bit better". No therapeutic measures were taken as a result of events. The patient outcome of lethargic was recovering; the outcome of the other events was recovered.  The information on the batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK, UNK
Symptoms: Blood glucose, Blood glucose decreased, Confusional state, Diabetes mellitus, Somnolence
Clinical narrative: I am diabetic and my blood sugar dropped in the middle of the night; I am diabetic and my blood sugar dropped in the middle of the night; Sleeping a lot; Confusion; This is a spontaneous report from a contactable consumer, the patient.  A 48-years-old female patient received  bnt162b2 (BNT162B2, Lot Number Unknown)  via an unspecified route of administration on an unspecified date (at 48 years of age) as a SINGLE DOSE for Covid-19 Vaccination , insulin (INSULIN) 'regular Insulin for sliding scale' Lot Number Unknown 'number under the bar code C:1011:1030310691833329. via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , insulin detemir (LEVEMIR) Lot Number 310018652576, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , insulin aspart (NOVOLOG) Lot Number 374934031098, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , semaglutide (OZEMPIC) weekly, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose, weekly for diabetes mellitus.  Medical history included hypertension. Concomitant medication included lisinopril (LISINOPRIL).  The patient reported  I am diabetic and my blood sugar dropped in the middle of the night, so my husband had to get up and give me something (Unspecified Medication) and then I am sleeping a lot and I do have some confusion on an unspecified date. The patient underwent lab tests that included blood glucose: dropped on an unspecified date. Treatment was given for diabetic and blood sugar dropping.  Consumer also stated, No, it is not that severe The clinical outcome of the events diabetic, blood sugar dropped in the middle of the night, Sleeping a lot and Confusion was Unknown. The action taken in response to the event(s)  for insulin was unknown, for insulin detemir was unknown, for insulin aspart was unknown, for semaglutide was unknown.  The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral
Clinical narrative: Left eyelid and area between my eyes was completely numb; Numbness in lip area; Numbness in chin/Moved to tip of nose; This is a spontaneous report from a contactable consumer (patient).  This  54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number Em9809), via an unspecified route of administration at single dose in the left arm on 04Feb2021 11:30  for covid-19 immunisation.  Medical history included pituitary tumour. The patient had not been tested for COVID-19 prior and post the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included famotidine, paracetamol (TYLENOL), cabergoline, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). On 04Feb2021 12:15, the patient experienced numbness in chin, then lip area. Moved to tip of nose and then several hours later, left eyelid and area between my eyes was completely numb. No treatment required. The outcome of the events was recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Facial paralysis, Herpes simplex, SARS-CoV-2 test
Clinical narrative: Bell's palsy - reactivate herpes simplex scars right eye; Bell's palsy - reactivate herpes simplex scars right eye; Bell's palsy - reactivate herpes simplex scars right eye; positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1284; Expiration date: 30Apr2021), via an unspecified route of administration in the right arm, on 23Jan2021 (at the age of 72-years-old) at a single dose for COVID-19 immunization. Medical history included high blood pressure (HBP) and COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included unspecified medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunization and influenza vaccine (FLU) on 05Jan2021 for immunization. The patient experienced positive COVID-19 test on 27Jan2021 and Bell's palsy - reactivate herpes simplex scars right eye on 01Feb2021. The patient underwent lab tests and procedures which included COVID-19 nasal swab: positive on 27Jan2021. Therapeutic measures were taken as a result of Bell's palsy - reactivate herpes simplex scars right eye, which included ganciclovir (ZIRGAN). The clinical outcome of positive COVID-19 test was unknown and of Bell's palsy - reactivate herpes simplex scars right eye was not recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Scar
Clinical narrative: Bell's palsy - reactivate herpes simplex scars right eye; Bell's palsy - reactivate herpes simplex scars right eye; Bell's palsy - reactivate herpes simplex scars right eye; positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1284; Expiration date: 30Apr2021), via an unspecified route of administration in the right arm, on 23Jan2021 (at the age of 72-years-old) at a single dose for COVID-19 immunization. Medical history included high blood pressure (HBP) and COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included unspecified medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunization and influenza vaccine (FLU) on 05Jan2021 for immunization. The patient experienced positive COVID-19 test on 27Jan2021 and Bell's palsy - reactivate herpes simplex scars right eye on 01Feb2021. The patient underwent lab tests and procedures which included COVID-19 nasal swab: positive on 27Jan2021. Therapeutic measures were taken as a result of Bell's palsy - reactivate herpes simplex scars right eye, which included ganciclovir (ZIRGAN). The clinical outcome of positive COVID-19 test was unknown and of Bell's palsy - reactivate herpes simplex scars right eye was not recovered.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: got the flu; Got very sick; Initial information was received on 09-Feb-2021 regarding an unsolicited valid non-serious case from a consumer.  This case involves patient (unknown demography) who had the flu (influenza) and got very sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, 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 (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had the flu (influenza) and got very sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for both the events.
Sex: U
Vaccine: FLUX
Symptoms: Feeling hot, Injection site paraesthesia, Mobility decreased, Pain in extremity, Rash erythematous
Clinical narrative: patient had tingling at the injection site; arm hurt to lift it; red patch on the lower arm; felt warm to the touch; Initial information received on 10-Feb-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional.  This case involves patient (unknown demographics) who had tingling at the injection site (injection site paraesthesia), arm hurt while lifting (pain in extremity), red patch on the lower arm (rash erythematous) and felt warm to the touch (feeling hot), after receiving INFLUENZA VACCINE.  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 [lot number and expiry date not reported] via unknown route in the upper arm near the shoulder for prophylactic vaccination  On an unknown date, the patient developed a non-serious tingling at the injection site (injection site paraesthesia), next day of vaccination arm hurt while lifting (pain in extremity), red patch on the lower arm (rash erythematous) and felt warm to the touch (feeling hot) (Unknown latency), following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The patient got recovered from all the events on an unknown date as it reported that the patient was feeling much better and did not take any of the medicines as directed.
Sex: F
Vaccine: FLUX
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: covid; feeling ill; Initial information was received on 10-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-health care professional.  This case involves a female patient (age unspecified) who experienced Corona virus disease (COVID-19), after she received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a non-serious ill feeling (malaise), (unknown latency) following the administration of INFLUENZA VACCINE and 1 week later patient tested positive for COVID (COVID-19).   It was unknown if the patient experienced any additional symptoms/events.  Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date: Positive  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported for reported events.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: very allergic; Initial information was received on 10-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer or Non-health care professional.  This case involves an adult patient (unknown age and unknown gender) who experienced very allergic, (hypersensitivity) while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious very allergic (hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine was not provided.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: patient had allergic reation; Initial information received on 10-Feb-2021 regarding an unsolicited valid non-serious case from non-healthcare professional.  This case involves patient (unknown demographics) who had allergic reaction (hypersensitivity), after receiving vaccine INFLUENZA VACCINE.  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 [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity) (Unknown latency), following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the  outcome is unknown for hypersensitivity.
Sex: M
Vaccine: FLUX
Symptoms: Death
Clinical narrative: patient died from a flu shot; Initial information was received on 12-Feb-2021 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media.  This case is linked to case 2021SA056035. (same reporter)  This case involves a male patient (reporter's father in-law) (age unspecified) who died (death), after he received INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient died from a flu shot (death) (unknown latency) following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events before death.  It was unknown if there were laboratory data/results available.   It was not reported if the patient received any corrective treatment before death.  It was unknown if an autopsy was done. The cause of death was reported as, the patient died from a flu shot.  At the time of reporting it was reported that, product name was not provided and it was reported via public post on the Sanofi flu shot campaign hence reporter assumed that the consumer was referring to the Sanofi flu vaccine.  There will be no information available on the batch number for this case.; Sender's Comments: This was a poorly documented social media case received from involved a male patient (age unspecified) who died (death) after administration of INFLUENZA VACCINE. The time to onset is unknown. Further information regarding medical history, concomitant disease or risk factor, concurrent condition during vaccination, previous vaccination and tolerance, laboratory tests ruling out other alternate etiologies and autopsy results is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient died from a flu shot
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error
Clinical narrative: expired Pentacel by mistake; Initial information was received on 03-Feb-2021 regarding an unsolicited valid non-serious case from an other health professional (Agency Inquiry Number: 00459652).  It was reported that DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was expired and administered to a patient by mistake on an unknown date for prophylactic vaccination (Expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 4.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Medication error, Wrong product administered
Clinical narrative: a four year-old child was administered Menactra, rather than the intended MMR vaccine/no AE;Initial information regarding an unsolicited valid non-serious case was received from another health professional via medical information (Reference number- 00472867) and transmitted on 12-Feb-2021.   This case involves a 4 year old female who received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] once, [injection, lot number: U6828AB, expiry date: 29-Jan-2022] via intramuscular route at right thigh on 28-Feb-2021 for prophylactic vaccination, rather than the intended MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] [lot number, expiry date and other dosing details not applicable] (wrong product administered).   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL), INFLUENZA VACCINE and HEPATITIS A VACCINE.  It was a case of actual medication error due to wrong vaccine administered.   No adverse effect had been reported after vaccination.   At the time of reporting it was reported that, the suspect was used first time.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Ear pain, Injection site erythema, Injection site warmth, Pain, Toothache
Clinical narrative: teeth pain, ear pain, body aches, red and warm at injection site.         Tylenol
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: red swollen hot area on arm started approximately 2 days after vaccine.  It is spreading up and down the arm and has spread around all sides.  From shoulder to wrist.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Pain
Clinical narrative: 12 hours after first dose of vaccine I had side effects of chills and fatigue 15 hours after second dose of vaccine I experienced chills, aches/pains, and could not sleep at all.  The only relief was hot baths.     With both vaccines I experienced dizziness and fatigue that is lingering well after both doses of vaccine were given.  Dizziness comes and goes but is consistently happening daily.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Dizziness, Haematocrit decreased, Haemoglobin decreased, Headache
Clinical narrative: dizziness, HA, loss of consciousness, convulsive syncope
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Human chorionic gonadotropin negative, Loss of consciousness, Metabolic function test normal, Nitrite urine present, Platelet count increased
Clinical narrative: dizziness, HA, loss of consciousness, convulsive syncope
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Urine leukocyte esterase positive, White blood cell count normal
Clinical narrative: dizziness, HA, loss of consciousness, convulsive syncope
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Felt dizzy and lightheaded immediately after vaccination.  As of 2/18/21 - 10:35 am client feels better with no symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Within ten minutes of having the first vaccine, I developed a strong metallic taste in my mouth. This subsided within approximately 2 hours.  Seven days after having the first vaccine, I developed ?Covid arm? at the injection site. The area is red, swollen, and very itchy.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Glossodynia
Clinical narrative: Chest tightness developed on day 3, intensity varies but is present constantly and has increased this morning (02/22/2021). Unusual sensation on tongue. These are the same symptoms I had when experiencing an allergic reaction to Repatha in Oct/Nov 2020. Those symptoms subsided after a month.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: After receiving her vaccine client stated that she feel a tingling sensation in the mid upper back area.  Vital signs obtained by EMS.  Bp 121/78, HR 82, O2 sat 97%, Blood sugar 120. Client states she feels better and discharged home by EMS.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Injection site pain, Neuropathy peripheral, Pain, Pain in extremity
Clinical narrative: neuropathy; a burning sensation to the left lateral part of her thigh and the inner part of her left thigh.; nerve pain or neuropathy; dull pain to the back of her right thigh which radiated to her right foot.; general soreness to her left arm in the area of the injection; This spontaneous report as received from a 37 years old female patient who was also a physician referring to herself. Information about pertinent medical history and concomitant medication was unknown. The patient had no known drug allergy (NKDA). The patient was not pregnant.  On 26-JAN-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, anatomical location, lot# and expiration date were not reported) intramuscularly for vaccination.       On the same day, after the administration the patient only felt some general soreness to her left arm in the area of the injection. On 05-FEB-2021, the patient began to experience dull pain to the back of her right thigh which radiated to her right foot. The patient felt this sensation more when sitting or driving but not as much while walking. On 10-FEB-2021, the patient was having a burning sensation to the left lateral part of her thigh and the inner part of her left thigh. The patient felt as if it was nerve pain or neuropathy. The patient had called her physician but had been unable to speak directly to the physician as of the time of reporting. No treatment was given for these events. The patient would seek further treatment if her condition worsens. The outcome of these events was not resolved.  The causality between these events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, neuropathy was determined to be medically significant.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 6-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 07-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 seconds. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059: US-009507513-2102USA004059:
Age: 1.92
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 23-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 08-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 seconds. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
Age: 1.25
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 12-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 seconds. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059: