chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Immunisation, Therapeutic response unexpected
Clinical narrative: her arthritis symptoms disappeared; received booster dose of the pfizer covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient. A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Sep2021 (Lot number: EL3247) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: I am immune compromised because of my cancer treatment nine years ago; "arthritis" (unspecified if ongoing); "AFib" (unspecified if ongoing); "Mantle cell lymphoma" (unspecified if ongoing), notes: I am in remission 9 years now. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; ZOLOFT. Vaccination history included: Bnt162b2 (Dose: 1, Lot no: EL3247), administration date: 04Feb2021, when the patient was 77 years old, for COVID-19 immunisation; Bnt162b2 (Dose: 2), administration date: 09Mar2021, when the patient was 77 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Sep2021, outcome "unknown", described as "received booster dose of the pfizer covid-19 vaccine"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 15Sep2021, outcome "unknown", described as "her arthritis symptoms disappeared". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: The patient had arthritis and after getting the booster dose of the pfizer covid-19 vaccine her arthritis symptoms disappeared. She got it in Sep and have no pain. Her doctor told her that she should contact Pfizer as this would be helpful for people. They are hoping pfizer found the cure of arthritis. The patient was on thyroid medication and on a fluid pill (not clarified). Regarding the treatment, she reported that no treatment was taken, she do go water exercises three times a week but she have been doing that for years. So, nothing different than what she did before. She said she don't know why this worked quite well but if it works well she would have another booster shot down the road. She don't know if it has anything to do but she just wanted to know that. She don't know what make it different of or anything but like she said her doctor felt she should notify pfizer and as they might come up with arthritis cure all of them.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Immunisation, Pain, Pyrexia
Clinical narrative: third dose (Booster dose); Experiencing sore; Extreme fatigue; Had fever of 101 and had to take a day off; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administered in arm (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Manufacture: unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "third dose (Booster dose)"; PAIN (non-serious), outcome "unknown", described as "Experiencing sore"; FATIGUE (non-serious), outcome "unknown", described as "Extreme fatigue"; PYREXIA (non-serious), outcome "unknown", described as "Had fever of 101 and had to take a day off". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: Booster; Sore arm at the injection site location; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 07Dec2021 (Lot number: EW0196) at the age of 43 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: EL3247), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Sore arm at the injection site location". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Seriousness criteria was life threatening, results in death, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect: No. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Migraine with aura, Thyroid hormones test
Clinical narrative: booster; had a horrible Aura migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 08Dec2021 (Lot number: FH8027) at the age of 28 years as dose 3 (booster), single , single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: "I have Asthma. I am taking albuterol as emergency inhaler, (unclear voice) and Singulair."; "Migraine" (unspecified if ongoing), notes: I usually get them once every couple years. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma; SINGULAIR taken for asthma. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "booster"; MIGRAINE WITH AURA (non-serious) with onset 08Dec2021, outcome "unknown", described as "had a horrible Aura migraine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine with aura.  Additional info- Patient did not receive any vaccination within 4 weeks prior to vaccination. It was reported that patient need to know if I need to go a doctor for some sort of like cardiovascular issue (Further not clarified) or it's a normal side effect to get a migraine afterwards .Therapeutic measure were taken as AE and treatment was taken with 200 milligrams pills of Ibuprofen but no it usually doesn't, it helps a little bit but not enough.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Immunisation
Clinical narrative: Approximately 1 week later I developed Shingles which I have never had before; dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).   A 61 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Nov2021 14:00 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included High Blood pressure (unspecified if ongoing); Sleep Apnea (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Obscured by other product labelling, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 31Mar2021, when the patient was 60 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 01Mar2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 23Nov2021 14:00, outcome unknown; HERPES ZOSTER (non-serious) with onset 02Dec2021 16:00, outcome recovering. The event approximately 1 week later developed shingles which never had before, was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of herpes zoster. The lot number for bnt162b2 was not provided and will be requested during follow up.  COVID-19 vaccine was administered in the facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.  Since the vaccination, patient has not been tested for COVID-19. No known allergies were reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Poor quality product administered, Product temperature excursion issue
Clinical narrative: booster; patient received dose with a stability excursion; patient received dose with a stability excursion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Dec2021 10:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 10:00, outcome "unknown", described as "booster"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 08Dec2021 10:00, outcome "unknown" and all described as "patient received dose with a stability excursion".  Additional information: The caller reported that last night (07Dec2021) at 7 PM the vaccine was reconstituted and one dose is left at the temperature over night. The doses subsequent were taken out of the box, 4 doses were taken out of the box at 10:00 AM and administered as booster dose to patient. It was further reported that the COVID vaccine vial was reconstituted, she asks, you can get 5 doses from one vial right? She believes that you can. They took one dose out of the vial when it was reconstituted yesterday at 7:00 PM, so they used one dose, and then their policy after that is to damage the rest of it and don't use the rest of the vial. They close at 9:00 so the 6 hour time frame that it can be used would be after hours. The vial that was reconstituted was not damaged out and it was kept on the counter. They have two immunizers there and one thought that the other had reconstituted the vial that morning and the other thought the same. Caller knows that in the past she has been given some data on excursion stability from a regulatory authority and she didn't know if a regulatory authority had any stability data beyond the 6 hours or if she would have to go to a medical institute. She says that she thought that she was being transferred to see about the stability information. Other Products, Patient History and Investigation Assessment were not Provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101752818 Same reporter/drug/AE, different patient;US-PFIZER INC-202101752817 Same reporter/drug/AE, different patient;US-PFIZER INC-202101752816 Same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Energy increased, Immunisation, Therapeutic response unexpected
Clinical narrative: booster; Increased energy; increase effective extreme concentration; decreased anxiety/increased productivity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: SULFA" (unspecified if ongoing), notes: Known allergies: SULFA. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), for COVID-19 Immunization, reaction(s): "Increased energy", "had very positive side effects from each vaccine / increase effective extreme concentration, decreased anxiety, increased productivity"; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), for COVID-19 Immunization, reaction(s): "Increased energy", "had very positive side effects from each vaccine / increase effective extreme concentration, decreased anxiety, increased productivity". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; ENERGY INCREASED (non-serious) with onset 2021, outcome "recovered" (2021), described as "Increased energy"; DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "recovered" (2021), described as "increase effective extreme concentration"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "recovered" (2021), described as "decreased anxiety/increased productivity". Therapeutic measures were not taken as a result of energy increased, disturbance in attention, therapeutic response unexpected.  Additional Information: The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination was not tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Neck pain, Pain in extremity
Clinical narrative: Shakes; chills; fever; headache; neck pain; arm pain; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 11:15 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included FLU, administration date 2021. Vaccination history included Bnt162b2 (Dose Number: 1), administration date: 03May2021, when the patient was 36 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), administration date: 24May2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported IMMUNISATION (non-serious) with onset 06Dec2021 11:15, outcome unknown; TREMOR (non-serious) with onset 06Dec2021 20:30, outcome recovering; CHILLS (non-serious) with onset 06Dec2021 20:30, outcome recovering; PYREXIA (non-serious) with onset 06Dec2021 20:30, outcome recovering; HEADACHE (non-serious) with onset 06Dec2021 20:30, outcome recovering; NECK PAIN (non-serious) with onset 06Dec2021 20:30, outcome recovering; PAIN IN EXTREMITY (non-serious) with onset 06Dec2021 20:30, outcome recovering. Therapeutic measures were not taken as a result of tremor, chills, pyrexia, headache, neck pain, and pain in extremity. List of any other medications the patient received within 2 weeks of vaccination was reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device date was reported as 08Dec2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Shakes; chills; fever; headache; neck pain; arm pain; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 11:15 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included FLU, administration date 2021. Vaccination history included Bnt162b2 (Dose Number: 1), administration date: 03May2021, when the patient was 36 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), administration date: 24May2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported IMMUNISATION (non-serious) with onset 06Dec2021 11:15, outcome unknown; TREMOR (non-serious) with onset 06Dec2021 20:30, outcome recovering; CHILLS (non-serious) with onset 06Dec2021 20:30, outcome recovering; PYREXIA (non-serious) with onset 06Dec2021 20:30, outcome recovering; HEADACHE (non-serious) with onset 06Dec2021 20:30, outcome recovering; NECK PAIN (non-serious) with onset 06Dec2021 20:30, outcome recovering; PAIN IN EXTREMITY (non-serious) with onset 06Dec2021 20:30, outcome recovering. Therapeutic measures were not taken as a result of tremor, chills, pyrexia, headache, neck pain, and pain in extremity. List of any other medications the patient received within 2 weeks of vaccination was reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device date was reported as 08Dec2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 11:30 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date Sep2021. Past drug history included: Yes, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. can't get to the info, Location of injection: Arm Right, Vaccine Administration Time: 08:00 PM), administration date: 31Jan2021, when the patient was 73 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. can't get to the info, Location of injection: Arm Right, Vaccine Administration Time: 04:45 AM), administration date: 23Feb2021, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Oct2021 11:30, outcome "unknown", described as "Booster"; MYALGIA (non-serious) with onset 14Oct2021, outcome "recovered" (Oct2021), described as "Extensive muscle pain"; DIZZINESS (non-serious) with onset 14Oct2021, outcome "recovered" (Oct2021), described as "One day was very dizzy for about 4 hours". Therapeutic measures were taken as a result of myalgia. Therapeutic measures were not taken as a result of dizziness.  Additional information: Extensive muscle pain. Had to take Tylenol for 5 weeks.  One day was very dizzy for about 4 hours patient was not Prior to vaccination, was the patient diagnosed with COVID-19, Since the vaccination, patient was not patient been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Immunisation, Limb discomfort
Clinical narrative: Legs not working. Unable to stand or walk; Legs not working; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 12:45 (Batch/Lot number: unknown) at the age of 78 years as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: Diabetes mellitus (unspecified if ongoing). Concomitant medication(s) included: TRULICITY. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 23Feb2021, when the patient was 78 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 78 years old, for Covid-19 Immunization, reaction(s): Legs not working, Unable to stand or walk. The following information was reported: immunization, gait disturbance and limb discomfort with onset 08Dec2021, outcome recovered (Dec2021). The events legs not working. unable to stand or walk and legs not working were evaluated at the emergency room visit. Therapeutic measures were taken as a result of gait disturbance, limb discomfort. Additional information: Seriousness criteria was life threatening, results in death, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect: No. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Fluids for dehydration after dose 2 were given as treatment. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Immunisation, Neck pain, Pain assessment, Pain in extremity
Clinical narrative: He took the booster dose; Pain is in the joint of his shoulder and arm/pain in those areas were bad again; Pain is in the joint of his shoulder and arm/pain in those areas were bad again; pain in lower part of his neck; 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 75 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "spine surgery" (not ongoing), notes: Caller reported he had spine surgery.; "had surgery on his neck", start date: 03Feb2021, stop date: 03Feb2021, notes: Caller states he had surgery on his neck before getting the vaccines. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: Mar2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "Pain is in the joint of his shoulder and arm", "Pain in his neck", "Pain is in the joint of his shoulder and arm"; Bnt162b2 (Second dose), administration date: 2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "Pain is in the joint of his shoulder and arm", "Pain in his neck", "Pain is in the joint of his shoulder and arm". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "He took the booster dose"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "recovering" and all described as "Pain is in the joint of his shoulder and arm/pain in those areas were bad again"; NECK PAIN (non-serious) with onset 2021, outcome "recovering", described as "pain in lower part of his neck". The events "pain is in the joint of his shoulder and arm/pain in those areas were bad again", "pain is in the joint of his shoulder and arm/pain in those areas were bad again" and "pain in lower part of his neck" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported the pain was in the joint of his shoulder and arm and has been going on for 8 months. He took the booster dose and it got worse again but now it was better again but it never goes away and he sees a therapist. He told the therapist at the beginning of therapy his pain was a 10. And his last appointment was today and his pain is now 1-2. Patient wanted to know if other people have reported pain in the shoulder after the vaccines. Wanted to know how long does it last and was it going to go away. He asked could it be nerve issue. Caller states after the booster, the pain in those areas were bad again, but now it is 75% better. Caller states he has spoken to his doctor and he was scheduled for an MRI.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Menstrual disorder
Clinical narrative: got my period 2 days after shot which is one week early; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 06Dec2021 17:15 (Lot number: fj1620) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, previous dose brand=Pfizer, previous dose lot number=pfizerer6198, previous dose number=2), administration date: 24Feb2021, when the patient was 34 years old, for COVID-19 Immunization, reaction(s): "got my period 2 days after shot which is one week early. I have tracked my period for the last year and i have consistently gotten it every 28 days, except this month and the months of Mar and Apr"; Bnt162b2 (previous dose product=COVID 19, previous dose brand=PFIZER,, previous dose lot number=pfizerer8730, previous dose number=1), administration date: 03Mar2021, when the patient was 34 years old, for COVID-19 Immunization, reaction(s): "got my period 2 days after shot which is one week early. I have tracked my period for the last year and I have consistently gotten it every 28 days, except this month and the months of Mar and Apr". The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 17:15, outcome "unknown", described as "Booster"; MENSTRUAL DISORDER (non-serious) with onset 08Dec2021 18:00, outcome "unknown", described as "got my period 2 days after shot which is one week early". Therapeutic measures were not taken as a result of menstrual disorder.  Additional Information: The patient had no other vaccine in four weeks. Other medications in two weeks: birth control pill. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post the vaccination. adverse event: The patient had tracked her period for the last year and had consistently gotten it every 28 days, except this month and the months of March and April (which was around the time of my first and second shot)  Follow-Up (14Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Immunisation
Clinical narrative: I was shocked that the same day my left eye started twitching and now it has not stopped 2 days later.; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 15:45 (Lot number: FH8027) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MICROGESTIN. Vaccination history included: Bnt162b2 (dose number: 1, Lot number: EN6199, administration Time:03:00 PM, vaccine location: Left arm), administration date: 08Mar2021, when the patient was 19 years old, for COVID-19 immunization, reaction(s): "my left eye started twitching all day"; Bnt162b2 (dose number: 2, Lot number: ER2613, administration Time:02:00 PM, vaccine location: Left arm), administration date: 29Mar2021, when the patient was 19 years old, for COVID-19 immunization, reaction(s): "my left eye started twitching all day"; Flu shot (Anatomical Location: left arm), administration date: 01Nov2021. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 15:45, outcome "unknown", described as "Booster"; BLEPHAROSPASM (non-serious) with onset 06Dec2021 16:45, outcome "not recovered", described as "I was shocked that the same day my left eye started twitching and now it has not stopped 2 days later.". Therapeutic measures were not taken as a result of blepharospasm.  Additional Information: The patient had no known allergies. The patient stated "the day I got my first dose my left eye started twitching all day every day until one week after my second dose, 4 weeks later". Hospitalization prolonged reported as No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device date was reported 08Dec2021. The case was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: I contracted Covid about three weeks after my Pfizer booster injection; booster injection; I was previously vaccinated with the Moderna vaccine; I was previously vaccinated with the Moderna vaccine.; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 18:00 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "arthritic knees/hips" (unspecified if ongoing); "arthritic knees/hips" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ADVAIR; BENICAR; IBUPROFEN. Vaccination history included: Moderna covid-19 vaccine (First Dose), for Covid-19 immunization; Moderna covid-19 vaccine (Second Dose), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "booster injection"; OFF LABEL USE (non-serious) with onset 15Nov2021, outcome "unknown", described as "I was previously vaccinated with the Moderna vaccine"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Nov2021, outcome "unknown", described as "I was previously vaccinated with the Moderna vaccine."; COVID-19 (non-serious) with onset 28Nov2021, outcome "recovered", described as "I contracted Covid about three weeks after my Pfizer booster injection". The event "i contracted covid about three weeks after my Pfizer booster injection" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19.   Additional information: Not an adverse reaction in terms of allergies, but I contracted Covid about three weeks after my Pfizer booster injection. I was previously vaccinated with the Moderna vaccine. The patient did not receive any other vaccine in four weeks of covid-19 vaccine. The patient was not diagnosed with covid prior vaccination. The patient was tested for covid-19 post vaccination by nasal swab on 01Dec2021 and resulted positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthropathy, Chills, Fatigue, Head discomfort
Clinical narrative: feel like every joint is twisting; Fatigue; Chills; cramps in my stomach; I cannot repeat, it just hurt my head even more; my head is so heavy; I cannot repeat, it just hurt my head even more; my head is so heavy; I can't speak right, just not feeling well; I had the booster yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Dec2021 (Lot number: FH8027) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "I had the booster yesterday"; ARTHROPATHY (non-serious), outcome "unknown", described as "feel like every joint is twisting"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; CHILLS (non-serious), outcome "unknown", described as "Chills"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "cramps in my stomach"; HEADACHE (non-serious), HEAD DISCOMFORT (non-serious), outcome "unknown" and all described as "I cannot repeat, it just hurt my head even more; my head is so heavy"; MALAISE (non-serious), outcome "unknown", described as "I can't speak right, just not feeling well".  Additional Information: Consumer stated, "Look if I have to report this I am calling to through 'rc' I will feel tomorrow better and call you back. I'm having like post the vaccine (voice not clear) like not feeling well and I cannot repeat, it just hurt my head even more. I had the booster yesterday before noon I should say. I feel a little bit fatigue and 'feel better' in the evening but it was tolerable. But during the night time I started feel chills, shivers and cramps in my stomach and I feel like every joint is twisting and my head is so heavy. I don't think I do have a fever. But I can't even get up from the bed. Paraphrased the concern, Consumer stated, I had them over night, I didn't had them right away. I want to know is there anything that I can do to feel better. Is there any ideal for, I don't know for care of me, 'to gather' anything I can take just to feel better. Right now I'm not feeling well. I'm almost falling, I can't get up."  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Immunisation, Malaise
Clinical narrative: feel like every joint is twisting; Fatigue; Chills; cramps in my stomach; I cannot repeat, it just hurt my head even more; my head is so heavy; I cannot repeat, it just hurt my head even more; my head is so heavy; I can't speak right, just not feeling well; I had the booster yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Dec2021 (Lot number: FH8027) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021, outcome "unknown", described as "I had the booster yesterday"; ARTHROPATHY (non-serious), outcome "unknown", described as "feel like every joint is twisting"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; CHILLS (non-serious), outcome "unknown", described as "Chills"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "cramps in my stomach"; HEADACHE (non-serious), HEAD DISCOMFORT (non-serious), outcome "unknown" and all described as "I cannot repeat, it just hurt my head even more; my head is so heavy"; MALAISE (non-serious), outcome "unknown", described as "I can't speak right, just not feeling well".  Additional Information: Consumer stated, "Look if I have to report this I am calling to through 'rc' I will feel tomorrow better and call you back. I'm having like post the vaccine (voice not clear) like not feeling well and I cannot repeat, it just hurt my head even more. I had the booster yesterday before noon I should say. I feel a little bit fatigue and 'feel better' in the evening but it was tolerable. But during the night time I started feel chills, shivers and cramps in my stomach and I feel like every joint is twisting and my head is so heavy. I don't think I do have a fever. But I can't even get up from the bed. Paraphrased the concern, Consumer stated, I had them over night, I didn't had them right away. I want to know is there anything that I can do to feel better. Is there any ideal for, I don't know for care of me, 'to gather' anything I can take just to feel better. Right now I'm not feeling well. I'm almost falling, I can't get up."  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Immunisation
Clinical narrative: I checked my blood pressure it was 135/97, and 135/85 in the morning; Head ache at the same time in the evening; dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 13:15 (Lot number: FJ1620) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Yes" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Yes, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 08Apr2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 06May2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Dec2021 13:15, outcome "unknown", described as "dose 3"; HEADACHE (non-serious) with onset 06Dec2021, outcome "unknown", described as "Head ache at the same time in the evening"; BLOOD PRESSURE INCREASED (non-serious) with onset 06Dec2021 15:00, outcome "unknown", described as "I checked my blood pressure it was 135/97, and 135/85 in the morning". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of headache, blood pressure increased.  Additional Information:Seriousness was no,Seriousness criteria-Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating,Congenital anomaly/birth defect was no,Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Other medications were received by the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19.Since the vaccination, patient had not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction
Clinical narrative: This is a spontaneous report received from contactable reporter. The reporter is the patient. A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Dec2020 (Lot number: EK5730) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported.  The following information was reported: COVID-19 (non-serious) with onset Dec2020, outcome unknown. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient did not receive other vaccine in four weeks. Patient had other medications in two weeks which included Aleve. The patient had no covid prior vaccination.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Pain in extremity, Pyrexia
Clinical narrative: booster; chills; fatigue; arm pain; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional information: Event took place 24-36 hours after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Illness, Immunisation, Influenza like illness, Off label use, Product use issue
Clinical narrative: Off-Label Use; received the Comirnaty booster; Product use for unapproved combination; was very sick with flu like symptoms for 2 days; was very sick with flu like symptoms for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine ("DOSE X; MANUFACTUERER UNKNOWN" (where X=1, 2, or number unknown)), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Off-Label Use"; IMMUNISATION (non-serious), outcome "unknown", described as "received the Comirnaty booster"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Product use for unapproved combination"; ILLNESS (non-serious), INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown" and all described as "was very sick with flu like symptoms for 2 days". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Burning sensation, Immunisation, Lip swelling, Malaise
Clinical narrative: Swelling of face and lips; Swelling of face and lips; face felt like it was on fire; rash developed within minutes after swelling subsided; I was in bed since I didn't feel well; I was in bed since I didn't feel well; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 14:00 (Lot number: 330268D) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "reynauds" (unspecified if ongoing), notes: other medical history: reynauds; "High blood pressure" (unspecified if ongoing), notes: other medical history: High blood pressure; "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex., I also have an allergy to latex with the same type of symptoms; "known allergies: tetracycline" (unspecified if ongoing), notes: known allergies: tetracycline; "known allergies: iodine" (unspecified if ongoing), notes: known allergies: iodine. Concomitant medication(s) included: METOPROLOL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 14Feb2021, when the patient was 71 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3249, Location of injection: Arm Left), administration date: 24Jan2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 14:00, outcome "unknown", described as "Dose Number: 3"; LIP SWELLING (non-serious), SWELLING FACE (non-serious) all with onset 09Dec2021 16:00, outcome "recovering" and all described as "Swelling of face and lips"; BURNING SENSATION (non-serious) with onset 09Dec2021 16:00, outcome "recovering", described as "face felt like it was on fire"; RASH (non-serious) with onset 09Dec2021 16:00, outcome "recovering", described as "rash developed within minutes after swelling subsided"; MALAISE (non-serious) with onset 09Dec2021 16:00, outcome "recovering", described as "I was in bed since I didn't feel well"; BEDRIDDEN (non-serious) with onset 09Dec2021 16:00, outcome "recovering", described as "I was in bed since I didn't feel well". Therapeutic measures were not taken as a result of lip swelling, swelling face, burning sensation, rash, malaise, bedridden. Additional information: Rash may have been concurrent with swelling. About 24 hours after shot. Patient also have an allergy to latex with the same type of symptoms. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19 and Prior to vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.