chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chest discomfort, Chills, Extrasystoles
Clinical narrative: High fever (>101 F) for 24 hours; pain near site of injection at armpit; pain near site of injection at armpit; headache for first 24 hours; chills; Some skipped heartbeats were experienced; mild chest tightness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26Oct2021 12:00 (Lot number: FF2589) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL2347, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 02Mar2021, when the patient was 29 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "High fever (>101 F) for 24 hours"; VACCINATION SITE PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "pain near site of injection at armpit"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache for first 24 hours"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills"; EXTRASYSTOLES (non-serious) with onset 2021, outcome "not recovered", described as "Some skipped heartbeats were experienced"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "mild chest tightness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vaccination site pain, axillary pain, headache, chills, extrasystoles, chest discomfort.  Additional information: The patient had received no other vaccines within 4 weeks prior to COVID vaccine. The patient had not diagnosed with COVID prior vaccination and the patient had not tested to COVID post vaccination. Patient had high fever (>101 F) for 24 hours, pain near site of injection at armpit, headache for first 24 hours and chills. Continued into second day with mild fever (~100 F), no headache, continued pain in right arm and armpit. Some skipped heartbeats were experienced and mild chest tightness.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: High fever (>101 F) for 24 hours; pain near site of injection at armpit; pain near site of injection at armpit; headache for first 24 hours; chills; Some skipped heartbeats were experienced; mild chest tightness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26Oct2021 12:00 (Lot number: FF2589) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL2347, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 02Mar2021, when the patient was 29 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "not recovered", described as "High fever (>101 F) for 24 hours"; VACCINATION SITE PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "pain near site of injection at armpit"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache for first 24 hours"; CHILLS (non-serious) with onset 2021, outcome "not recovered", described as "chills"; EXTRASYSTOLES (non-serious) with onset 2021, outcome "not recovered", described as "Some skipped heartbeats were experienced"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "mild chest tightness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vaccination site pain, axillary pain, headache, chills, extrasystoles, chest discomfort.  Additional information: The patient had received no other vaccines within 4 weeks prior to COVID vaccine. The patient had not diagnosed with COVID prior vaccination and the patient had not tested to COVID post vaccination. Patient had high fever (>101 F) for 24 hours, pain near site of injection at armpit, headache for first 24 hours and chills. Continued into second day with mild fever (~100 F), no headache, continued pain in right arm and armpit. Some skipped heartbeats were experienced and mild chest tightness.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Pyrexia
Clinical narrative: Fever; chills; sore muscles; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 10:00 (Lot number: FF8841) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL 3247, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), administration date: 17Feb2021, when the patient was 35 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 3247, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), administration date: 27Jan2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 27Oct2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 27Oct2021, outcome "recovering", described as "chills"; MYALGIA (non-serious) with onset 27Oct2021, outcome "recovering", described as "sore muscles"; ASTHENIA (non-serious) with onset 27Oct2021, outcome "recovering", described as "weakness". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, asthenia.  Additional information: No covid prior vaccination nor covid tested post vaccination.  No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Insomnia, Myalgia
Clinical narrative: Headache; ache joints and muscles; ache joints and muscles; chills; sleep from 10-11 then tossed and turned and by 3am the adverse effects kicked in and have lasted all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 10:15 (Lot number: FF8841) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure. Concomitant medication(s) included: FLU, administration date 23Sep2021; LOSARTAN + HIDROCLOROTIAZIDA. Past drug history included: Demerol, reaction(s): "Allergy: demerol", notes: Known allergies: demerol. Vaccination history included: Bnt162b2 (dose number=1, dose lot number=EL3247,), administration date: 28Jan2021, when the patient was 49 years old, for COVID-19 Immunization; Bnt162b2 (dose number=2, dose lot number=EL3247,), administration date: 18Feb2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 28Oct2021 03:00, outcome "not recovered", described as "Headache"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 28Oct2021 03:00, outcome "not recovered" and all described as "ache joints and muscles"; CHILLS (non-serious) with onset 28Oct2021 03:00, outcome "not recovered", described as "chills"; INSOMNIA (non-serious) with onset 28Oct2021 03:00, outcome "not recovered", described as "sleep from 10-11 then tossed and turned and by 3am the adverse effects kicked in and have lasted all day". Therapeutic measures were not taken as a result of headache, chills, insomnia. Therapeutic measures were taken as a result of arthralgia, myalgia.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Yes. Other vaccine 4weeks product=Flu. Other vaccine 4weeks vaccine date=23Sep2021. Other medications in two weeks: Losartan/HCTZ 100/25. Adverse event: Headache, ache joints and muscles, chills. sleep from 10-11 then tossed and turned and by 3am the adverse effects kicked in and have lasted all day. I did take Advil for the aches. If treatment ae: no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Vaccine Facility information available.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no: 1), for COVID-19 immunization; Bnt162b2 (Dose no: 2), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "Chills".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: feeling tired; has some fever/has a slight fever of 37.8 C; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Lot number: FH8028, Expiration Date: 28Feb2022) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for Covid-19 immunization; Bnt162b2 (Dose number: 2), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feeling tired"; PYREXIA (non-serious), outcome "unknown", described as "has some fever/has a slight fever of 37.8 C"; HEADACHE (non-serious), outcome "unknown", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The caller is calling about the Pfizer covid 19 vaccine. The caller and her husband took the booster shot of the Pfizer covid 19 vaccine. When they came home, the expiration date on the caller's husband's said 28Feb2022. The vaccination cards have a sticker on it with the product information on it, it is not handwritten. Both the caller and her husband's lot was FH8028. The patient is feeling tired and has some fever. The patient has a headache, is tired and has a slight fever of 37.8 C. The patient has been staying in bed. The patient has a headache and is very tired.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: muscle aches; chills; 102.1 degree fever; Moderate headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from a sales representative. The reporter is the patient.  A 43-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 (Lot number: FF2593) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cosmetic skin" (unspecified if ongoing); "Hair loss" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LORATADIN taken for hypersensitivity, start date: Feb2021 (ongoing); FINASTERIDE taken for alopecia, start date: Jan2018 (ongoing); TRETINOIN taken for skin disorder, start date: Sep2021 (ongoing). Vaccination history included: Bnt162b2 (1st dose, Anatomical site of injection: L Arm, Route- Intramuscular, Lot/Batch number: EL3247), administration date: 23Mar2021, when the patient was 43 years old, for Covid-19 immunization; Bnt162b2 (2nd dose, Anatomical site of injection: Left Arm, Route- Intramuscular, Lot/Batch number: EL3247), administration date: 12Apr2021, when the patient was 42 years old, for Covid-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 27Oct2021, outcome "recovered" (28Oct2021), described as "muscle aches"; CHILLS (non-serious) with onset 27Oct2021, outcome "recovered" (28Oct2021), described as "chills"; PYREXIA (non-serious) with onset 27Oct2021, outcome "recovered" (28Oct2021), described as "102.1 degree fever"; HEADACHE (non-serious) with onset 27Oct2021, outcome "recovered" (28Oct2021), described as "Moderate headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, chills, pyrexia, headache.  Additional Information: It was reported that started experiencing symptoms about 10 hours after booster dose. Treated with Motrin every 8 hrs until resolved the next day.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: developed red spots at the site of her COVID-19 vaccine injection; developed red spots at the site of her Cosentyx (secukinumab) injection; red spots were painful; red spots were painful; red spots were itchy; red spots were itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; secukinumab (COSENTYX) (Batch/Lot number: unknown). Relevant medical history included: "Ankylosing spondylitis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 09Oct2021, outcome "unknown", described as "developed red spots at the site of her COVID-19 vaccine injection"; INJECTION SITE ERYTHEMA (non-serious) with onset 09Oct2021, outcome "unknown", described as "developed red spots at the site of her Cosentyx (secukinumab) injection"; VACCINATION SITE PAIN (non-serious), INJECTION SITE PAIN (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "red spots were painful"; VACCINATION SITE PRURITUS (non-serious), INJECTION SITE PRURITUS (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "red spots were itchy". The action taken for secukinumab was unknown.  Additional information: The causal relationship between the events injection site warmth, injection site erythema, injection site pruritus, injection site induration, injection site pain, and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Injection site reaction which the patient describes as redness, hardness, a little bit itchy but not too bad, and warm to touch / red spots lasted about 4 days and were painful and itchy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: developed red spots at the site of her COVID-19 vaccine injection; developed red spots at the site of her Cosentyx (secukinumab) injection; red spots were painful; red spots were painful; red spots were itchy; red spots were itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; secukinumab (COSENTYX) (Batch/Lot number: unknown). Relevant medical history included: "Ankylosing spondylitis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 09Oct2021, outcome "unknown", described as "developed red spots at the site of her COVID-19 vaccine injection"; INJECTION SITE ERYTHEMA (non-serious) with onset 09Oct2021, outcome "unknown", described as "developed red spots at the site of her Cosentyx (secukinumab) injection"; VACCINATION SITE PAIN (non-serious), INJECTION SITE PAIN (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "red spots were painful"; VACCINATION SITE PRURITUS (non-serious), INJECTION SITE PRURITUS (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "red spots were itchy". The action taken for secukinumab was unknown.  Additional information: The causal relationship between the events injection site warmth, injection site erythema, injection site pruritus, injection site induration, injection site pain, and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Injection site reaction which the patient describes as redness, hardness, a little bit itchy but not too bad, and warm to touch / red spots lasted about 4 days and were painful and itchy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2), intramuscular, administration date 22Oct2021 (Lot number: FF2589) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: el3247), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 23Oct2021, outcome "recovered" (Oct2021), described as "Fever"; NAUSEA (non-serious) with onset 23Oct2021, outcome "recovered" (Oct2021), described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility where the most recent COVID-19 vaccine was administered: workplace clinic. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. List of any other medications the patient received within 2 weeks of vaccination was unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Results of tests and procedures for investigation of the patient test on 29Oct2021. PCR Result: Pending, Lab Notes: Nasal Swab. The Pfizer Drug safety unit recently received the attached report submitted. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Left hip started hurting after 2nd dose and it worsened after the 3rd dose. The pain was mild and not enough to stop from daily tasks but noticeable esp. at night when lie down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Lot number: ER8731) as dose 2, single and administered in arm left, administration date 14Oct2021 (Lot number: FF2590) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 61 years old, for Covid-19 Immunization.  The following information was reported: ARTHRALGIA (non-serious) with onset Jun2021, outcome "unknown", described as "Left hip started hurting after 2nd dose and it worsened after the 3rd dose. The pain was mild and not enough to stop from daily tasks but noticeable esp. at night when lie down". Therapeutic measures were not taken as a result of arthralgia.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Other. Patient had no known allergies and had not received other vaccines in four weeks. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. Event was assessed as non-serious and not resulted in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. Patient do stretches and yoga and it seemed to help a little after 2nd dose. It worsened after 3rd dose and the stretching did not alleviate. Patient don't know if it was vaccine related, was in general good health and this hip pain seemed to show up suddenly. patient regularly exercise and do yoga and pilates.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: About ~18h after the third COVID19 vaccine injection, I had a low fever accompanied by headache, and sore muscles all over my body.; About ~18h after the third COVID19 vaccine injection, I had a low fever accompanied by headache, and sore muscles all over my body.; About ~18h after the third COVID19 vaccine injection, I had a low fever accompanied by headache, and sore muscles all over my body.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 17:00 (Lot number: 3203080) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: None. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 27Jan2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 17Feb2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), HEADACHE (non-serious), MYALGIA (non-serious) all with onset 30Oct2021, outcome "recovering" and all described as "About 18h after the third COVID19 vaccine injection, I had a low fever accompanied by headache, and sore muscles all over my body." The patient underwent the following laboratory tests and procedures: body temperature: (30Oct2021) low. Therapeutic measures were not taken as a result of pyrexia, headache, myalgia.  Additional Information: About 18 hours after the third COVID19 vaccine injection, Patient had a low fever accompanied by headache, and sore muscles all over body. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, Patient has been tested for COVID-19 and result is negative. known allergies and other medical history did not reported.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: developed a red spot an inch below the injection; developed a red spot an inch below the injection and it felt bruised.; itches; The day after that a lump started to form where the red area is. Each day the lump gets a little bigger; still hurting like a bruise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 12:45 (Lot number: EW0191) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 22Mar2021, when the patient was 59 years old, for Covid-19 Immunization; Bnt162b2 (Second Dose, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 12Apr2021, when the patient was 59 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 28Oct2021 09:00, outcome "not recovered", described as "developed a red spot an inch below the injection"; VACCINATION SITE BRUISING (non-serious) with onset 28Oct2021 09:00, outcome "not recovered", described as "developed a red spot an inch below the injection and it felt bruised. "; VACCINATION SITE PRURITUS (non-serious) with onset 28Oct2021 09:00, outcome "not recovered", described as "itches"; VACCINATION SITE MASS (non-serious) with onset 28Oct2021 09:00, outcome "not recovered", described as "The day after that a lump started to form where the red area is. Each day the lump gets a little bigger"; VACCINATION SITE PAIN (non-serious) with onset 28Oct2021 09:00, outcome "not recovered", described as "still hurting like a bruise". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site bruising, vaccination site pruritus, vaccination site mass, vaccination site pain.  Additional Information: Patient did not  receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was none. Reported Event: The day after I received the booster vaccine I developed a red spot an inch below the injection and it felt bruised. The day after that a lump started to form where the red area is. Each day the lump gets a little bigger; now in addition to it still hurting like a bruise it also itches.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nausea, Night sweats
Clinical narrative: night sweats; Fever>101°- 1 day; fatigue; headache; N; V; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 05Oct2021 13:30 (Lot number: 301258A) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE (ongoing); GLUCOSAMINE (ongoing); TURMERIC [CURCUMA LONGA] (ongoing); B-12 (ongoing). Vaccination history included: Bnt162b2 (First dose, Date: 19Jan2021, Time : 09:00 AM, Site of Injection: Upper Arm, Route of Injection: Intramuscular, Batch/ Lot number: EL3248), administration date: 19Jan2021, for COVID-19 immunization; Bnt162b2 (Second dose, Date: 09Feb2021, Time : 08:30 AM, Site of Injection: Upper Arm, Route of Injection: Intramuscular, Batch/ Lot number: EL9262), administration date: 09Feb2021, for COVID-19 immunization, reaction(s): "N", "V", "Fever >102 degree", "headache", "Fatigue", "sinus congestion"; Flu shot (high dose), administration date: 17Sep2021.  The following information was reported: NIGHT SWEATS (non-serious) with onset 07Oct2021, outcome "unknown", described as "night sweats"; PYREXIA (non-serious) with onset 07Oct2021, outcome "unknown", described as "Fever>101°- 1 day"; FATIGUE (non-serious) with onset 05Oct2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 05Oct2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 05Oct2021, outcome "unknown", described as "N"; VOMITING (non-serious) with onset 05Oct2021, outcome "unknown", described as "V". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of night sweats, pyrexia, fatigue, headache, nausea, vomiting.  Additional Information: No COVID-19 testing has been conducted. No Specific relevant test for Thromboembolic event with Thrombocytopenia.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: night sweats; Fever>101°- 1 day; fatigue; headache; N; V; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 05Oct2021 13:30 (Lot number: 301258A) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE (ongoing); GLUCOSAMINE (ongoing); TURMERIC [CURCUMA LONGA] (ongoing); B-12 (ongoing). Vaccination history included: Bnt162b2 (First dose, Date: 19Jan2021, Time : 09:00 AM, Site of Injection: Upper Arm, Route of Injection: Intramuscular, Batch/ Lot number: EL3248), administration date: 19Jan2021, for COVID-19 immunization; Bnt162b2 (Second dose, Date: 09Feb2021, Time : 08:30 AM, Site of Injection: Upper Arm, Route of Injection: Intramuscular, Batch/ Lot number: EL9262), administration date: 09Feb2021, for COVID-19 immunization, reaction(s): "N", "V", "Fever >102 degree", "headache", "Fatigue", "sinus congestion"; Flu shot (high dose), administration date: 17Sep2021.  The following information was reported: NIGHT SWEATS (non-serious) with onset 07Oct2021, outcome "unknown", described as "night sweats"; PYREXIA (non-serious) with onset 07Oct2021, outcome "unknown", described as "Fever>101°- 1 day"; FATIGUE (non-serious) with onset 05Oct2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 05Oct2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 05Oct2021, outcome "unknown", described as "N"; VOMITING (non-serious) with onset 05Oct2021, outcome "unknown", described as "V". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of night sweats, pyrexia, fatigue, headache, nausea, vomiting.  Additional Information: No COVID-19 testing has been conducted. No Specific relevant test for Thromboembolic event with Thrombocytopenia.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Headache; Body pains; Body chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Oct2021 (Lot number: EW0217) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 28Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6198, Location of injection: Arm Left), administration date: Mar2021, when the patient was 28 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left), administration date: Feb2021, when the patient was 28 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 28Oct2021 22:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 28Oct2021 22:00, outcome "recovering", described as "Headache"; PAIN (non-serious) with onset 28Oct2021 22:00, outcome "recovering", described as "Body pains"; CHILLS (non-serious) with onset 28Oct2021 22:00, outcome "recovering", described as "Body chills". Therapeutic measures were taken as a result of pyrexia, headache, pain, chills. Additional information: No other vaccine in four weeks. AE treatment included Ibuprofen. No covid prior vaccination. No covid tested post vaccination. No known allergies and no other medical history.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Headache, Illness, Movement disorder, Pain
Clinical narrative: new thing is a burning smell that has continued; headache; fever; severe body aches; couldn't open eyes; couldn't move; Very sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): MOD21-157214 (Moderna).  A 59-year-old female patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 20Mar2021, when the patient was 59 years old, for COVID-19 Vaccination. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "headache"; PYREXIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "fever"; PAIN (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "severe body aches"; EYE DISORDER (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "couldn't open eyes"; MOVEMENT DISORDER (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "couldn't move"; ILLNESS (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "Very sick"; PAROSMIA (non-serious), outcome "unknown", described as "new thing is a burning smell that has continued".  Additional information: Patient reporting her experiences after receiving the Moderna Covid-19 Booster dose (lot # 076C21A) on 220ct2021. She received Pfizer for both doses of her primary series of the Covid-19 vaccine. Starting 12 hours after her moderna booster dose she became very sick with headache, fever, severe body aches, couldn't open her eyes, or couldn't move. These symptoms lasted about 48 hours. This was all Just like the last time she received a dose of Pfizer on 10Apr2021 but more severe. The new thing Is a burning smell that has continued. She wants to know why that happened & is it normal. Consent granted for follow-up by the Safety Team with her and the vaccination facility. She does not have her doctor's & information currently. Email is the preferred method of contact. Abstract No abstract has been assigned to this case. The patient wants to know why that happened & is it normal. Patient reporting her experiences after receiving the Modema Covid-19 Booster dose. Life Threatening: No, Disabling/lncapacitating: No, Intervention/Medically Important: No, Congenital Anomaly/Birth Defect: No, Death: No, Hospitalization Required: No, Hospitalization Prolonged: No, Other: No, Product Complaint: There is no product complaint associated with this case.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Pyrexia
Clinical narrative: new thing is a burning smell that has continued; headache; fever; severe body aches; couldn't open eyes; couldn't move; Very sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): MOD21-157214 (Moderna).  A 59-year-old female patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 20Mar2021, when the patient was 59 years old, for COVID-19 Vaccination. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "headache"; PYREXIA (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "fever"; PAIN (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "severe body aches"; EYE DISORDER (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "couldn't open eyes"; MOVEMENT DISORDER (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "couldn't move"; ILLNESS (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "Very sick"; PAROSMIA (non-serious), outcome "unknown", described as "new thing is a burning smell that has continued".  Additional information: Patient reporting her experiences after receiving the Moderna Covid-19 Booster dose (lot # 076C21A) on 220ct2021. She received Pfizer for both doses of her primary series of the Covid-19 vaccine. Starting 12 hours after her moderna booster dose she became very sick with headache, fever, severe body aches, couldn't open her eyes, or couldn't move. These symptoms lasted about 48 hours. This was all Just like the last time she received a dose of Pfizer on 10Apr2021 but more severe. The new thing Is a burning smell that has continued. She wants to know why that happened & is it normal. Consent granted for follow-up by the Safety Team with her and the vaccination facility. She does not have her doctor's & information currently. Email is the preferred method of contact. Abstract No abstract has been assigned to this case. The patient wants to know why that happened & is it normal. Patient reporting her experiences after receiving the Modema Covid-19 Booster dose. Life Threatening: No, Disabling/lncapacitating: No, Intervention/Medically Important: No, Congenital Anomaly/Birth Defect: No, Death: No, Hospitalization Required: No, Hospitalization Prolonged: No, Other: No, Product Complaint: There is no product complaint associated with this case.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore shoulder; This is a spontaneous report from a contactable other-HCP. This 74-year-old male other HCP (patient) reported for himself.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 18Feb2021 (Lot number: EL9262) at the age of 74 years as dose 2, single and administered in arm, administration date 27Jan2021 (Lot number: EL9262) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu (Flu shot), administration date: 15Dec2020, when the patient was 74 years old. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore shoulder".  Additional information: Patient had no problem with the first two doses and all. But had sore shoulder and did see all kind a little bit (Not clarified) for the 4,5,6 hours but the another day It was fine.  Follow-Up (03Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: burning; neck,right hand,left ear itching; she got a rash on her neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 11:00 (Lot number: FE3592) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BURNING SENSATION (non-serious) with onset 21Oct2021, outcome "unknown", described as "burning"; PRURITUS (non-serious) with onset 21Oct2021, outcome "unknown", described as "neck,right hand,left ear itching"; RASH (non-serious) with onset 21Oct2021, outcome "recovered" (2021), described as "she got a rash on her neck". Additional information: she is going to go into urgent care since she is right there. Day 13 after 1st COVID shot I had a rash appear on my neck and went away after a few days.   No follow-up attempts are possible. No further information is expected
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Swelling
Clinical narrative: Swelling under his armpit; He said that he feels a little pressure and discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 (Lot number: EW0196, Expiration Date: Dec2021) at the age of 26 years as dose 3 (booster dose), single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Solution for injection, Anatomical Location: Left arm, Lot no: EL3247, Expiration: Unknown), administration date: 10Mar2021, when the patient was 26 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, Solution for injection, Anatomical Location: Left arm, Lot no: EL3247, Expiration: May2021), administration date: 31Mar2021, when the patient was 26 years old, for COVID-19 Immunization.  The following information was reported: SWELLING (non-serious) with onset 29Oct2021, outcome "recovering", described as "Swelling under his armpit"; DISCOMFORT (non-serious) with onset Oct2021, outcome "unknown", described as "He said that he feels a little pressure and discomfort".  Additional information: He received the booster shot from the Pfizer headquarters on 27Oct2021. Caller reported that he has some swelling under his armpit that he noticed this morning. Caller declined HCP information. He said that he felt a little pressure and discomfort, but would not say pain in any way. He thought it is going away anyways. Caller said that he felt discomfort when he raised his arm and he felt a little bump. Other Products was Yes. There was No Vaccine Administered at  Facility. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE(s) did not require a visit to Emergency Room and Physician Office. There were no Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). There was no AE(s) following prior vaccinations. There was no Family Medical History Relevant to AE(s). There was no Relevant Tests.  No follow-up attempts are possible. No further information is expected.