chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Immunisation, Myalgia
Clinical narrative: Booster; Mild injection site pain (started date of booster dose); headache; muscle/joint aches; muscle/joint aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 10:30 (Lot number: FH8027) at the age of 52 years as dose 3(booster)single for covid-19 immunisation. Relevant medical history included: "Oysters" (unspecified if ongoing). Concomitant medication(s) included: SHINGRIX, administration date 02Dec2021. Vaccination history included: Pfizer (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM, Route of Administration: Intramuscular), administration date: 01Apr2021, when the patient was 51 years old, for Covid-19 immunization; Pfizer (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 11Mar2021, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 17:00, outcome "recovering", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2021 17:00, outcome "recovering", described as "Mild injection site pain (started date of booster dose)"; HEADACHE (non-serious) with onset 20Dec2021 17:00, outcome "recovering", described as "headache"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 20Dec2021 17:00, outcome "recovering" and all described as "muscle/joint aches"; CHILLS (non-serious) with onset 20Dec2021 17:00, outcome "recovering", described as "chills". Therapeutic measures were not taken as a result of immunisation.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Booster; Mild injection site pain (started date of booster dose); headache; muscle/joint aches; muscle/joint aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 10:30 (Lot number: FH8027) at the age of 52 years as dose 3(booster)single for covid-19 immunisation. Relevant medical history included: "Oysters" (unspecified if ongoing). Concomitant medication(s) included: SHINGRIX, administration date 02Dec2021. Vaccination history included: Pfizer (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM, Route of Administration: Intramuscular), administration date: 01Apr2021, when the patient was 51 years old, for Covid-19 immunization; Pfizer (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 11Mar2021, when the patient was 51 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 17:00, outcome "recovering", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 20Dec2021 17:00, outcome "recovering", described as "Mild injection site pain (started date of booster dose)"; HEADACHE (non-serious) with onset 20Dec2021 17:00, outcome "recovering", described as "headache"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 20Dec2021 17:00, outcome "recovering" and all described as "muscle/joint aches"; CHILLS (non-serious) with onset 20Dec2021 17:00, outcome "recovering", described as "chills". Therapeutic measures were not taken as a result of immunisation.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pyrexia
Clinical narrative: booster; fever; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 16 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FF8841) 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 (Batch/lot number: EP6955, Dose number: 2), for Covid-19 immunization; Bnt162b2 (Batch/lot number: EP6955, Dose number: 1), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PYREXIA (non-serious), outcome "recovered", described as "fever".  Additional information: The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Feeling abnormal, Immunisation, Tongue discomfort
Clinical narrative: Booster; Dry mouth; my tongue is stuck to the roof of my mouth; I feel like it did something to me/ I am really afraid/ terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Lot number: FJ8757) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL. Vaccination history included: Flu vaccine, administration date: 05Oct2021; Bnt162b2 (Dose 1, Lot number: ER8730, anatomical location: Left arm), administration date: Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, Lot number: EW0153.", anatomical location: Left arm), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "Dry mouth". The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Booster"; DRY MOUTH (non-serious) with onset Dec2021, outcome "not recovered", described as "Dry mouth"; TONGUE DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "my tongue is stuck to the roof of my mouth"; FEELING ABNORMAL (non-serious) with onset Dec2021, outcome "unknown", described as "I feel like it did something to me/ I am really afraid/ terrible". The events "dry mouth", "my tongue is stuck to the roof of my mouth" and "i feel like it did something to me/ i am really afraid/ terrible" were evaluated at the physician office visit.   Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Malaise
Clinical narrative: Dose =3; Felt unwell.; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 40 year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, administration date 2021 (Batch/Lot number: unknown) at the age of 40 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: Moderna (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Dose =3"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Felt unwell.". It was unknown if therapeutic measures were taken as a result of malaise. Additional information: The facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as Unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Injection site erythema, Pain, Swelling, Vaccination site pain
Clinical narrative: it seems a little red; swelled; booster; got a little sore; hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (Pfizer COVID 19 Vaccine- Solution for injection), administered in arm right, administration date 22Dec2021 (Lot number: 33025BD) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, LOT# of first shot: EW0158), administration date: 02Apr2021, when the patient was 53 years old, for COVID-19 Immunization; Bnt162b2 (2nd dose, LOT# of second shot: EW0164), administration date: 03May2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 22Dec2021, outcome "not recovered", described as "got a little sore"; PAIN (non-serious) with onset 22Dec2021, outcome "not recovered", described as "hurting"; INJECTION SITE ERYTHEMA (non-serious) with onset 23Dec2021, outcome "not recovered", described as "it seems a little red"; SWELLING (non-serious) with onset 23Dec2021, outcome "not recovered", described as "swelled". Therapeutic measures were not taken as a result of vaccination site pain, pain, injection site erythema, swelling.  Additional information: she got a little sore (Further clarification unknown hence event captured as per verbatim) after came back to apartment and it was been hurting and today (date not specified) it seems a little red and it was swelled and that was still hurting." No follow-up attempts are possible. Information about batch number cannot be obtained.Vaccination facility: Consumer stated, "The first two was done at the withheld. Done by Regulatory authority." Prior to the vaccination, the patient was not diagnosed with COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: pain in his hand; pain in the injection site/he is still having pain in his arm where he got the vaccine; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), 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) with onset Dec2021, outcome "unknown", described as "pain in his hand"; VACCINATION SITE PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "pain in the injection site/he is still having pain in his arm where he got the vaccine"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "body ache".  Additional Information: Response: Read from the attached document CONS -How long side effects last (v7.0), "Side effects reported with the vaccine include:" and "Persons Aged Between 5 and 11 Years: Local reactions duration was between 1 and 2 days and systemic reactions lasted around 1 day. All cases of lymphadenopathy (swollen lymph nodes) resolved within 2 weeks".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: had a breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  An 8-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFECTION (non-serious), outcome "recovered", described as "had a breakthrough infection".  Additional information: The patient had a breakthrough infection 2 weeks after completing full vaccination for COVID-19 her symptoms were mild and short lived.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram, Blood test, Ear infection, Otorrhoea, Pyrexia
Clinical narrative: she look it up as tinnitus, I had a buzzing noise in my head; I had a fever; she maybe had an infection inside her ear since the right ear sometimes has drainage; she maybe had an infection inside her ear since the right ear sometimes has drainage; 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 67 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "she look it up as tinnitus, I had a buzzing noise in my head"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "I had a fever"; EAR INFECTION (non-serious), OTORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "she maybe had an infection inside her ear since the right ear sometimes has drainage". The event "she look it up as tinnitus, i had a buzzing noise in my head" was 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 tinnitus, ear infection, otorrhoea.  Additional Information: The patient stated that she developed a buzzing noise in her head. She thought it could be fever, or the medicine effect on her body. There was a light buzzing in her head for a while. She refers that at first, in Mar2021, it was very light and she would ignore it. Then she google it, found out it was tinnitus and it was permanent and wanted to take care of it. She bought over the counter ear remedy and more medications. She went to the doctor and had an audiogram. The doctor confirmed it was permanent and prescribed steroid ear drops. She thought she maybe had an infection inside her ear since the right ear sometimes has drainage. She was checking her blood pressure and using ear drops in case there was an infection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: she look it up as tinnitus, I had a buzzing noise in my head; I had a fever; she maybe had an infection inside her ear since the right ear sometimes has drainage; she maybe had an infection inside her ear since the right ear sometimes has drainage; 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 67 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "she look it up as tinnitus, I had a buzzing noise in my head"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "I had a fever"; EAR INFECTION (non-serious), OTORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "she maybe had an infection inside her ear since the right ear sometimes has drainage". The event "she look it up as tinnitus, i had a buzzing noise in my head" was 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 tinnitus, ear infection, otorrhoea.  Additional Information: The patient stated that she developed a buzzing noise in her head. She thought it could be fever, or the medicine effect on her body. There was a light buzzing in her head for a while. She refers that at first, in Mar2021, it was very light and she would ignore it. Then she google it, found out it was tinnitus and it was permanent and wanted to take care of it. She bought over the counter ear remedy and more medications. She went to the doctor and had an audiogram. The doctor confirmed it was permanent and prescribed steroid ear drops. She thought she maybe had an infection inside her ear since the right ear sometimes has drainage. She was checking her blood pressure and using ear drops in case there was an infection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram, Dehydration, Ear discomfort, Fatigue, Feeling abnormal
Clinical narrative: she look it up as tinnitus, I had a buzzing noise in my head; I had a fever; she maybe had an infection inside her ear since the right ear sometimes has drainage; she maybe had an infection inside her ear since the right ear sometimes has drainage; 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 67 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "she look it up as tinnitus, I had a buzzing noise in my head"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "I had a fever"; EAR INFECTION (non-serious), OTORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "she maybe had an infection inside her ear since the right ear sometimes has drainage". The event "she look it up as tinnitus, i had a buzzing noise in my head" was 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 tinnitus, ear infection, otorrhoea.  Additional Information: The patient stated that she developed a buzzing noise in her head. She thought it could be fever, or the medicine effect on her body. There was a light buzzing in her head for a while. She refers that at first, in Mar2021, it was very light and she would ignore it. Then she google it, found out it was tinnitus and it was permanent and wanted to take care of it. She bought over the counter ear remedy and more medications. She went to the doctor and had an audiogram. The doctor confirmed it was permanent and prescribed steroid ear drops. She thought she maybe had an infection inside her ear since the right ear sometimes has drainage. She was checking her blood pressure and using ear drops in case there was an infection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Illness, Pain, Pain in extremity, Pyrexia, Syncope
Clinical narrative: she look it up as tinnitus, I had a buzzing noise in my head; I had a fever; she maybe had an infection inside her ear since the right ear sometimes has drainage; she maybe had an infection inside her ear since the right ear sometimes has drainage; 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 67 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "she look it up as tinnitus, I had a buzzing noise in my head"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "I had a fever"; EAR INFECTION (non-serious), OTORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "she maybe had an infection inside her ear since the right ear sometimes has drainage". The event "she look it up as tinnitus, i had a buzzing noise in my head" was 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 tinnitus, ear infection, otorrhoea.  Additional Information: The patient stated that she developed a buzzing noise in her head. She thought it could be fever, or the medicine effect on her body. There was a light buzzing in her head for a while. She refers that at first, in Mar2021, it was very light and she would ignore it. Then she google it, found out it was tinnitus and it was permanent and wanted to take care of it. She bought over the counter ear remedy and more medications. She went to the doctor and had an audiogram. The doctor confirmed it was permanent and prescribed steroid ear drops. She thought she maybe had an infection inside her ear since the right ear sometimes has drainage. She was checking her blood pressure and using ear drops in case there was an infection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram, Blood pressure measurement, Blood test, Condition aggravated, Immunisation
Clinical narrative: she look it up as tinnitus, I had a buzzing noise in my head; I had a fever; she maybe had an infection inside her ear since the right ear sometimes has drainage; she maybe had an infection inside her ear since the right ear sometimes has drainage; 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 67 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "she look it up as tinnitus, I had a buzzing noise in my head"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "I had a fever"; EAR INFECTION (non-serious), OTORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "she maybe had an infection inside her ear since the right ear sometimes has drainage". The event "she look it up as tinnitus, i had a buzzing noise in my head" was 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 tinnitus, ear infection, otorrhoea.  Additional Information: The patient stated that she developed a buzzing noise in her head. She thought it could be fever, or the medicine effect on her body. There was a light buzzing in her head for a while. She refers that at first, in Mar2021, it was very light and she would ignore it. Then she google it, found out it was tinnitus and it was permanent and wanted to take care of it. She bought over the counter ear remedy and more medications. She went to the doctor and had an audiogram. The doctor confirmed it was permanent and prescribed steroid ear drops. She thought she maybe had an infection inside her ear since the right ear sometimes has drainage. She was checking her blood pressure and using ear drops in case there was an infection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia, Tinnitus
Clinical narrative: she look it up as tinnitus, I had a buzzing noise in my head; I had a fever; she maybe had an infection inside her ear since the right ear sometimes has drainage; she maybe had an infection inside her ear since the right ear sometimes has drainage; 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 67 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "she look it up as tinnitus, I had a buzzing noise in my head"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "I had a fever"; EAR INFECTION (non-serious), OTORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "she maybe had an infection inside her ear since the right ear sometimes has drainage". The event "she look it up as tinnitus, i had a buzzing noise in my head" was 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 tinnitus, ear infection, otorrhoea.  Additional Information: The patient stated that she developed a buzzing noise in her head. She thought it could be fever, or the medicine effect on her body. There was a light buzzing in her head for a while. She refers that at first, in Mar2021, it was very light and she would ignore it. Then she google it, found out it was tinnitus and it was permanent and wanted to take care of it. She bought over the counter ear remedy and more medications. She went to the doctor and had an audiogram. The doctor confirmed it was permanent and prescribed steroid ear drops. She thought she maybe had an infection inside her ear since the right ear sometimes has drainage. She was checking her blood pressure and using ear drops in case there was an infection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Headache, Pyrexia, Tinnitus
Clinical narrative: she look it up as tinnitus, I had a buzzing noise in my head; I had a fever; she maybe had an infection inside her ear since the right ear sometimes has drainage; she maybe had an infection inside her ear since the right ear sometimes has drainage; 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 67 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Mar2021, outcome "not recovered", described as "she look it up as tinnitus, I had a buzzing noise in my head"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "I had a fever"; EAR INFECTION (non-serious), OTORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "she maybe had an infection inside her ear since the right ear sometimes has drainage". The event "she look it up as tinnitus, i had a buzzing noise in my head" was 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 tinnitus, ear infection, otorrhoea.  Additional Information: The patient stated that she developed a buzzing noise in her head. She thought it could be fever, or the medicine effect on her body. There was a light buzzing in her head for a while. She refers that at first, in Mar2021, it was very light and she would ignore it. Then she google it, found out it was tinnitus and it was permanent and wanted to take care of it. She bought over the counter ear remedy and more medications. She went to the doctor and had an audiogram. The doctor confirmed it was permanent and prescribed steroid ear drops. She thought she maybe had an infection inside her ear since the right ear sometimes has drainage. She was checking her blood pressure and using ear drops in case there was an infection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm; general achiness; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on [16Mar2021], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Jan2021 22:30 (Lot number: EL1283, Expiration Date: 19Jan2021) 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) with onset 2021 (onset time reported as 05:00 PM), outcome "unknown", described as "sore arm"; PAIN (non-serious) with onset 2021 (onset time reported as 05:00 PM), outcome "unknown", described as "general achiness".  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea
Clinical narrative: needs to throw up but has not vomited; she has not been feeling well; very tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Lot number: EL9266) at the age of 80 years 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: NAUSEA (non-serious) with onset 09Mar2021, outcome "recovering", described as "needs to throw up but has not vomited"; MALAISE (non-serious) with onset 09Mar2021, outcome "recovering", described as "she has not been feeling well"; FATIGUE (non-serious) with onset 09Mar2021, outcome "recovering", described as "very tired".  Additional information: It was reported 3 weeks ago she had the first shot. Patient was scheduled to get the second dose of the covid vaccine on 11Mar2021 (reported as tomorrow) but she had not been feeling well since 09Mar2021 (reported as yesterday): she felt very tired and needs to throw up but had not vomited. She woke up this morning and she was very tired and felt like she was wanting to throw up but she did not throw up, everything was better at the time of the report (reported as now). She had this feeling on 09Mar2021 (reported as yesterday) too but it was not as bad 09Mar2021 (reported as yesterday) it was the same symptoms but it was not as bad. She wanted to throw up part of the day on 09Mar2021 (reported as yesterday). She confirmed the tiredness and feeling like she wanted to throw up started 09Mar2021, right at the time of the report (reported as now) it was ongoing but it had improved. She said she did not have those signals right at the time of the report (reported as now) since she had been talking on the phone but she did still feel that it was ongoing. It was further reported that Her height had gone down some but she thought last time it was 5'4". She said she saw Vacuna control EL COVID 19. She asked was there a lot of more questions, she was not feeling that well and she had been standing that too long. She saw that was on the last line, the third. She asked does she still get the shot, the second one. She wanted to know what Pfizer recommends in this situation, does she have to go or can she skip tomorrow's vaccination. She asked if she could just talked with someone who is giving shots to see if she should have the second one.   No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain in the right shoulder, which gravitated to the elbow, forearm and hand, the opposite side of the vaccine site; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 87 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Feb2021 (Lot number: EN6201) at the age of 87 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "known allergies: food - uncooked fish roe" (unspecified if ongoing), notes: known allergies: food - uncooked fish roe. Concomitant medication(s) included: AMIODARONE; BYSTOLIC; EDARBI. The following information was reported: PAIN (non-serious) with onset 07Mar2021, outcome "recovering", described as "pain in the right shoulder, which gravitated to the elbow, forearm and hand, the opposite side of the vaccine site". Therapeutic measures were taken as a result of pain.  Additional information: The patient did not receive any other vaccine in four weeks. Covid prior vaccination and covid tested post vaccination was reported as no. Happened during the third week after the first Pfizer shot was administered on 10Feb. It started as a pain in the right shoulder, which gravitated to the elbow, forearm and hand, the opposite side of the vaccine site. The pain got worse after the second vaccine shot on 10Mar. Covid vaccine details: [{Product= COVID 19, Brand= Pfizer, Lot number=EN6206, Lot unknown= False, Administration date= 10Mar2021, Administration time= 10:30 AM, Vaccine location= Left arm}]. Ae treatment: tylenol and ibuprofen.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Rhinorrhoea
Clinical narrative: severe runny nose; chills; light headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 19Feb2021 (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: RHINORRHOEA (non-serious) with onset 03Mar2021, outcome "unknown", described as "severe runny nose"; CHILLS (non-serious) with onset 03Mar2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset 03Mar2021, outcome "unknown", described as "light headache". Therapeutic measures were taken as a result of rhinorrhoea, chills, headache.  Additional information: Patient received Pfizer Covid-19 vaccine first dose on 19Feb2021, 2 weeks after 1st dose on 03Mar2021 patient experienced chills, light headache and severe runny nose for 2 days. She took amoxicillin and antihistamine. Patient was advised to take the Covid-19 test and wait for the result until 12Mar2021 (reported as tomorrow) which on that day was her return day to take the 2nd dose. Patient wanted to know if she need to take the 2nd dose or need to wait for the result first prior to taking the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache". Additional info- Patient had a query she can take Tylenol or not.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Neck pain, Odynophagia
Clinical narrative: pain on left side of her neck; I can't swallow; when I swallow it hurts. I hurts like the top, but on the left side where you swallow; 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 female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (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: NECK PAIN (non-serious) with onset 16Mar2021, outcome "unknown", described as "pain on left side of her neck"; DYSPHAGIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "I can't swallow"; ODYNOPHAGIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "when I swallow it hurts. I hurts like the top, but on the left side where you swallow".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: paresthesia in my right leg and it moved to both legs, arms, and hands; 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 male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (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: PARAESTHESIA (non-serious) with onset 26Feb2021, outcome "unknown", described as "paresthesia in my right leg and it moved to both legs, arms, and hands".  Additional Information: The patient experienced paresthesia in his right leg and it moved to both legs, arms, and hands, within 10 min after vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: has some pain; dizziness; pain in her arm/ still occasionally feels her arm ache but it is not as painful; feels fatigued; Tired /tiredness/felt a lot more tired; she is coming down with a cold; Pain in Left Arm at Injection site; 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. Other Case identifier(s): US-PFIZER INC-2021301734 (Pfizer).  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 (Lot number: EN6204, Expiration Date: 30Jun2021) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Type 2 Insulin Dependent, About 27 years ago; "Hypothyroid" (ongoing), notes: Over 20 years ago. Concomitant medication(s) included: INSULIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "unknown", described as "pain in her arm/ still occasionally feels her arm ache but it is not as painful"; VACCINATION SITE PAIN (non-serious) with onset 10Mar2021, outcome "recovering", described as "Pain in Left Arm at Injection site"; PAIN (non-serious), outcome "unknown", described as "has some pain"; FATIGUE (non-serious) with onset 12Mar2021, outcome "unknown", described as "feels fatigued"; FATIGUE (non-serious) with onset 12Mar2021, outcome "unknown", described as "Tired /tiredness/felt a lot more tired"; NASOPHARYNGITIS (non-serious) with onset 12Mar2021, outcome "unknown", described as "she is coming down with a cold"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness".  Additional Information: Patient states that she is a diabetic and took her first dose on 10Mar2021. States the first side effect was pain in her arm and states she knows that was normal. She states that two days later she felt tired and fatigue. Clarified that she still occasionally feels her arm ache but it was not as painful but she still feels where got the shot and still has some pain six days later. Clarifies that she felt a lot more tired yesterday but she doesn't know if it was the time change but she still feels tired and fatigued but she did not go to bed late.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: has some pain; dizziness; pain in her arm/ still occasionally feels her arm ache but it is not as painful; feels fatigued; Tired /tiredness/felt a lot more tired; she is coming down with a cold; Pain in Left Arm at Injection site; 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. Other Case identifier(s): US-PFIZER INC-2021301734 (Pfizer).  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 (Lot number: EN6204, Expiration Date: 30Jun2021) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Type 2 Insulin Dependent, About 27 years ago; "Hypothyroid" (ongoing), notes: Over 20 years ago. Concomitant medication(s) included: INSULIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "unknown", described as "pain in her arm/ still occasionally feels her arm ache but it is not as painful"; VACCINATION SITE PAIN (non-serious) with onset 10Mar2021, outcome "recovering", described as "Pain in Left Arm at Injection site"; PAIN (non-serious), outcome "unknown", described as "has some pain"; FATIGUE (non-serious) with onset 12Mar2021, outcome "unknown", described as "feels fatigued"; FATIGUE (non-serious) with onset 12Mar2021, outcome "unknown", described as "Tired /tiredness/felt a lot more tired"; NASOPHARYNGITIS (non-serious) with onset 12Mar2021, outcome "unknown", described as "she is coming down with a cold"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness".  Additional Information: Patient states that she is a diabetic and took her first dose on 10Mar2021. States the first side effect was pain in her arm and states she knows that was normal. She states that two days later she felt tired and fatigue. Clarified that she still occasionally feels her arm ache but it was not as painful but she still feels where got the shot and still has some pain six days later. Clarifies that she felt a lot more tired yesterday but she doesn't know if it was the time change but she still feels tired and fatigued but she did not go to bed late.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: A consistent, dull, strained ache in my left arm at the vaccine site affects some movement in that arm.; A consistent, dull, strained ache in my left arm at the vaccine site affects some movement in that arm.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2021 12:45 (Lot number: EL3248) at the age of 49 years as dose number 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (Brand=Pfizer, Lot number= EJ1686, Lot unknown= False, Administration date=30Dec2020, Vaccine location=Left arm, Dose number=1), administration date: 30Dec2020, when the patient was 49 years old, for covid-19 immunisation. The following information was reported: MOBILITY DECREASED (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Feb2021, outcome "not recovered" and all described as "A consistent, dull, strained ache in my left arm at the vaccine site affects some movement in that arm.". Therapeutic measures were not taken as a result of mobility decreased, vaccination site pain.  Additional information: Facility type vaccine was the workplace clinic. Patient did not have covid prior to vaccination. Post vaccination patient did not have Covid. Patient did not have any known allergies.   No follow-up attempts are needed. No further information is expected.