chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Movement disorder, Musculoskeletal stiffness, Pain, Vaccination site pain
Clinical narrative: muscle pain (left arm); injection site swelling; fatigue; stiffness in arm of injection; hard to move around; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jul2021 12:00 (Lot number: EW0198) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Scoliosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "muscle pain (left arm)"; VACCINATION SITE SWELLING (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "injection site swelling"; FATIGUE (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "fatigue"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "stiffness in arm of injection"; MOVEMENT DISORDER (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "hard to move around"; PAIN (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "pain". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, fatigue, musculoskeletal stiffness, movement disorder, pain.  Additional information:  The patient did not receive any other vaccine within 4 weeks. The patient did not receive other medications in two weeks. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.    No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: muscle pain (left arm); injection site swelling; fatigue; stiffness in arm of injection; hard to move around; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jul2021 12:00 (Lot number: EW0198) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Scoliosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "muscle pain (left arm)"; VACCINATION SITE SWELLING (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "injection site swelling"; FATIGUE (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "fatigue"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "stiffness in arm of injection"; MOVEMENT DISORDER (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "hard to move around"; PAIN (non-serious) with onset 11Jul2021 15:00, outcome "recovered" (2021), described as "pain". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, fatigue, musculoskeletal stiffness, movement disorder, pain.  Additional information:  The patient did not receive any other vaccine within 4 weeks. The patient did not receive other medications in two weeks. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.    No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Had side effect and I just fall a sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 (Lot number: EW0175) at the age of 30 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing), notes: Verbatim: AFib. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Had side effect and I just fall a sick". Therapeutic measures were taken as a result of illness.  Additional information: When probed for the concern, patient stated I had been a side effect of Covid vaccine, on a first day I just fall a sick and I was trying to see, what are the protocol. When probed for any treatment for the event, patient stated I took Tylenol.   Follow-Up: Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills; body pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 04Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Aug2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "body pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Neck pain; Intermittent dull, throbbing headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Jul2021 13:00 (Lot number: EW0189) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulfa drugs; "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex; "Chronic fatigue" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: NECK PAIN (non-serious) with onset 20Jul2021 14:30, outcome "not recovered", described as "Neck pain"; HEADACHE (non-serious) with onset 20Jul2021 14:30, outcome "not recovered", described as "Intermittent dull, throbbing headache". The events "neck pain" and "intermittent dull, throbbing headache" were evaluated at the physician office visit. Therapeutic measures were taken as a result of neck pain, headache.  Additional information: Concomitant medications included ritual prenatal vitamin (MANUFACTURER UNKNOWN) and immunity medicine (MANUFACTURER UNKNOWN) both for unknown indications from unknown dates and unknown if ongoing.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 tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which included treatment with ibuprofen (MOTRIN) or paracetamol (TYLENOL) and there was no relief with these medications.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Overdose, Pain in extremity, Product preparation issue
Clinical narrative: Sore arm; Headache; Administered 0.5, instead of 0.3 of the Covid vaccine; Caller reports that she did do the whole 0.2 instead of the 1.8; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot Number: FD8448), via an Intramuscular route on 08Aug2021 11:00  at the age of 42 years as DOSE NUMBER UNKNOWN, 0.5ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had administered 0.5, instead of 0.3 of the covid vaccine on 08Aug2021, caller reported that she is a pharmacist who has been giving vaccinations. She gave some yesterday and gave the wrong dose. She wanted to know what to do. She is really felt upset and stated that, it was just 4 patients and she does not have any patient information to provide. It was reported that she is not at work today but will be tomorrow. She had been looking up all kinds of stuff about it. She is a floater and is working at With held. She had been working at an independent sore and only been giving Moderna, if it was Moderna, she would have probably had it memorized. She did a training back, a year ago. When she got to work, she hadn't been there in 2 days. She did not know that it was Pfizer. About 10 people were waiting and the alarm was going off. She had been trying to look up stuff to know all about it. It had been a while and it was different. She knows that it was supposed to be 5 to 6 doses and there was only 4 left. She had been over this and was worried this morning. The diluent was correct. She had used the 2ml vial and just threw out the vial. Caller reported that she did do the whole 0.2 instead of the 1.8, which is a mistake too but at least made it not as strong. Maybe this helped it out some. She clarified she used the 2ml vial for the diluent. On 08Aug2021 20:00 patient experienced pain in extremity (non-serious)  and headache (non-serious).Patient recovered from both events on 09Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (31Aug2021) This is a follow up-spontaneous report from a contactable Pharmacist. This Pharmacist reported in response to HCP letter via follow-up letter which included that: At risk classification was removed as new events are added. Patient initials and age at vaccination was captured as per follow up report. The dose route and time added. Narrative updated.  Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling good; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "not feeling good".  Additional Information: Caller had her first dose in March but she missed the second dose in April because she is not feeling good. Caller is asking if it is too late to get her second dose. Caller refused to provide her personal information. Provided the phone number and hours of PMI. Caller refused to be connected with agency. Caller said that she will just call the phone number and then she hangs up.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; queasy stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Aug2021 16:00 (Lot number: FC3180) at the age of 60 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, left arm, around 1600), administration date: 08Jul2021, when the patient was 60 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 07Aug2021, outcome "recovering", described as "Headache"; NAUSEA (non-serious) with onset 07Aug2021, outcome "recovering", described as "queasy stomach". The events "headache" and "queasy stomach" were evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.  Additional information: No emergency Room. The patient went to Physician Office chiropractor. None aside from first dose with in 4 weeks Prior Vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Instance of break thru menstruation - followed by an additional menstruation cycle; Instance of break thru menstruation - followed by an additional menstruation cycle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Jul2021 (Lot number: FA7484) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 01Aug2021 13:15, outcome "unknown" and all described as "Instance of break thru menstruation - followed by an additional menstruation cycle". It was unknown if therapeutic measures were taken as a result of menstrual disorder, menstrual disorder.  Additional information: The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Covid vaccine details: Administration date: Jul2021, Administration time: 12:45 PM. Facility type vaccine Pharmacy or Drug Store Known allergies: none. Other medical history: None  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation delayed
Clinical narrative: Have not had a menstrual cycle since getting covid vaccine.; Have not had a menstrual cycle since getting covid vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 16:30 (Lot number: EW0179) at the age of 15 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: MENSTRUAL DISORDER (non-serious), MENSTRUATION DELAYED (non-serious), outcome "not recovered" and all described as "Have not had a menstrual cycle since getting covid vaccine.". The event "have not had a menstrual cycle since getting covid vaccine." and "have not had a menstrual cycle since getting covid vaccine." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstrual disorder, menstruation delayed.  Additional information: The patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient was not diagnosed with COVID-19 prior and post vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at injection sight for 3 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jul2021 (Lot number: EW0217) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bicuspid aortic valve" (unspecified if ongoing); "Ascending aortic aneurysm" (unspecified if ongoing); "Mild AI" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing); "Known allergies: Iodinated diagnostic agents" (unspecified if ongoing); "Known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ATORVASTATIN. Past drug history included: Gentamicin, reaction(s): "Known allergies: Gentamicin"; Ciprofloxacin, reaction(s): "Known allergies: Ciprofloxacin". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Jul2021, outcome "recovered" (Jul2021), described as "Sore at injection sight for 3 days". Additional information: If other vaccine in four weeks: No. Other medications in two weeks: Metoprolol 25mg, Atorvastatin 10mg. If covid prior vaccination: No. If covid tested post vaccination: No   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 09:00 (Lot number: EN6206) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Graves' disease" (unspecified if ongoing), notes: other medical history: Graves' disease; "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure. Concomitant medication(s) included: LEVOTHYROXINE; ENALAPRIL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021 13:00, outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: left arm, hand and fingers went numb/unable to make my fingers work; Continued paresthesia whole left arm and hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Aug2021 17:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "iron deficiency" (unspecified if ongoing); "anemia" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; VIIBRYD; LAMICTAL; BUSPAR; NEURONTIN; FLEXERIL [CEFIXIME]. The following information was reported: HYPOAESTHESIA (non-serious) with onset 12Aug2021 02:00, outcome "recovered" (Aug2021), described as "left arm, hand and fingers went numb/unable to make my fingers work"; PARAESTHESIA (non-serious) with onset 12Aug2021 02:00, outcome "recovered" (Aug2021), described as "Continued paresthesia whole left arm and hand". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia.  Additional Information: Got shot left upper arm. 2 days after shot left arm, hand and fingers went numb, unable to make my fingers work. Continued paresthesia whole left arm and hand. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had been tested "negative" for COVID-19. Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? Yes. If yes above, do you consider the Pfizer product had a casual effect to the adverse event? Yes I believe the vaccine caused this event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Illness, Nausea
Clinical narrative: Very sick and feels to vomit; Very sick and feels to vomit; Shoulders and both arms are hurting; Headache; Dizzy; Shoulders and both arms are hurting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "Very sick and feels to vomit"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Shoulders and both arms are hurting"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy". Additional information: Reporter stated, His shoulders and both arms are hurting. He has headache, dizzy and feels like he got to vomit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sick and feels to vomit; Very sick and feels to vomit; Shoulders and both arms are hurting; Headache; Dizzy; Shoulders and both arms are hurting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "Very sick and feels to vomit"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Shoulders and both arms are hurting"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy". Additional information: Reporter stated, His shoulders and both arms are hurting. He has headache, dizzy and feels like he got to vomit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Limb discomfort, Pain in extremity
Clinical narrative: Left Arm pain. Felt like it was deep bone pain; Left Arm pain. Felt like it was deep bone pain; Restricted ability to use arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 09:15 (Lot number: FC3180) at the age of 57 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Morphine, reaction(s): "Known allergies". The following information was reported: PAIN IN EXTREMITY (non-serious), BONE PAIN (non-serious) all with onset 31Jul2021 11:00, outcome "not recovered" and all described as "Left Arm pain. Felt like it was deep bone pain"; LIMB DISCOMFORT (non-serious) with onset 31Jul2021 11:00, outcome "not recovered", described as "Restricted ability to use arm". Therapeutic measures were not taken as a result of pain in extremity, bone pain, limb discomfort.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Presciption Medicines within 2 weeks of vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Incredible arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-health care professional). The reporter is the patient.  A 42-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 10:30 (Lot number: Ew 0171) at the age of 42 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15May2021, outcome "not recovered", described as "Incredible arm pain". The event "incredible arm pain" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had incredible arm pain for four months. No sign of injury or damage from MRI or X-ray. The patient had no known allergies and no other medical history. He did not receive 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, he was not diagnosed with COVID-19. Since the vaccination, he had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Aug2021 10:30 (Lot number: FC3180) at the age of 28 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 (product=COVID-19, brand= Pfizer, lot number= EW0198, lot unknown= False, administration date= 24Jul2021, administration time= 10:00 AM, dose number= 1), administration date: 24Jul2021, when the patient was 28 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 14Aug2021 22:00, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 14Aug2021 22:00, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 14Aug2021 22:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of pain, chills, and headache. The patient did not have treatment for adverse event. Prior to Covid-19 the patient did not have vaccination. The patient did not tested for Covid-19 after post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large swollen lymph node in left side of neck/lymph node has gotten much larger in size; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 (Lot number: Fc3183) at the age of 25 years as dose 2, single and administered in arm left, administration date 22Jul2021 15:00 (Lot number: F47484) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Aug2021, outcome "not recovered", described as "Large swollen lymph node in left side of neck/lymph node has gotten much larger in size". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient reported that the lymph node had gotten much larger in size. Noticeable by just looking at it, no need to feel it. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the arm where the injection was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 12Aug2021 (Lot number: EW0165) as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "Soreness at the arm where the injection was".  Additional information: Reporter added, "My daughter has disability (Further clarification was unknown if daughter was financially disabled or physically, hence not captured as event), it's not the grandkids mother." Prior vaccination: Reporter stated, "No".  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: That feels real bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 (Lot number: FC3180) at the age of 53 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Diabetes; "Sarcoid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset Aug2021, outcome "unknown", described as "That feels real bad". Therapeutic measures were not taken as a result of feeling abnormal.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: My arm is hurting; Swollen hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0175) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm is hurting"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swollen hand". Therapeutic measures were taken as a result of pain in extremity, peripheral swelling. No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A little tenderness around injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: EN6200) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: he had the mild arthritis for years. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "A little tenderness around injection site". Therapeutic measures were taken as a result of vaccination site pain.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neck pain, Pain in extremity
Clinical narrative: I have pain in my neck, my left arm and now it's going down my left leg it's numb now; I have pain in my neck, my left arm and now it's going down my left leg it's numb now; I have pain in my neck, my left arm and now it's going down my left leg it's numb now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "I have pain in my neck, my left arm and now it's going down my left leg it's numb now".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Apathy, Chills, Headache, Throat irritation
Clinical narrative: low "motivation"; Chills; Headache; My throat was like irritation in throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0167) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: APATHY (non-serious) with onset 11Aug2021, outcome "unknown", described as "low "motivation""; CHILLS (non-serious) with onset 11Aug2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset 11Aug2021, outcome "unknown", described as "Headache"; THROAT IRRITATION (non-serious) with onset 11Aug2021, outcome "unknown", described as "My throat was like irritation in throat". Therapeutic measures were taken as a result of chills, headache, throat irritation.  Additional information: consumer stated, I am having some side effects from (Pfizer) Covid-19 Vaccine shot for 5 days it worsen and I came to the Doctor and Doctor told me to talk to you guys (Pfizer). It was reported by reporter "When probed for any treatment for the event, consumer stated, Today I took Tylenol 500 mg twice and some for my chills and then there was a spray they sprayed in my mouth, they gave couple of these, twice a day". Consumer stated, I was having a headache, chills, low motivation (not clarified) and in my throat was like irritation in throat. No Prior Vaccination within 4 weeks  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain
Clinical narrative: Little sore; He started to feel tired and have no energy; He started to feel tired and have no energy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "Little sore"; ASTHENIA (non-serious), FATIGUE (non-serious) all with onset Aug2021, outcome "unknown" and all described as "He started to feel tired and have no energy".  Additional information: The patient decided to get the first Pfizer shot of the vaccine last Friday which was on 06Aug2021. So, everything was fine, just a little sore like the flu vaccine but then that day, he started to feel tired and had no energy. The patient had experienced some side effects. So, he wanted to know how long did the side effects of the vaccine last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Mar 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), Feb 2021, for COVID-19 immunization. The patient experienced hot flush (4 weeks ever since getting hot flashes), onset 2021, with outcome of not recovered. Additional information: The patient reported that it's kind like go through just having a changed life. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: The lymph node above my left clavicle bone got enlarged/ swelling went down a few days later, but now 6 months later, you can still feel the enlarged lymph node.; The lymph node above my left clavicle bone got enlarged and hurt when touched a few days after getting the second dose of the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2021 18:00 (Lot number: EN6201) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "general anxiety disorder" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; DULOXETINE; PANTOPRAZOLE; VITAMIN D NOS. Past drug history included: Erythromycin, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (dose number=1, brand=Pfizer, lot number=EL9262, administration time=06:00 PM, vaccine location=Left arm), administration date: 26Jan2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 25Feb2021, outcome "not recovered", described as "The lymph node above my left clavicle bone got enlarged/ swelling went down a few days later, but now 6 months later, you can still feel the enlarged lymph node."; LYMPH NODE PAIN (non-serious) with onset 25Feb2021, outcome "not recovered", described as "The lymph node above my left clavicle bone got enlarged and hurt when touched a few days after getting the second dose of the vaccine". The events "the lymph node above my left clavicle bone got enlarged/ swelling went down a few days later, but now 6 months later, you can still feel the enlarged lymph node." and "the lymph node above my left clavicle bone got enlarged and hurt when touched a few days after getting the second dose of the vaccine" were 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 lymphadenopathy, lymph node pain.  Additional information: Patient had a mammogram in June to rule out anything and fortunately everything was normal. But it was still worrisome since it was suppose to go away, reported it to her doctor 2 months after the last dose of her vaccine as suggested if it was still there. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Presyncope
Clinical narrative: intense dizziness; lightheadedness; made her feel like she was going to pass out.; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Aug2021 (Lot number: FC3181) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS POSTURAL (non-serious) with onset 15Aug2021, outcome "unknown", described as "intense dizziness"; DIZZINESS (non-serious) with onset 15Aug2021, outcome "unknown", described as "lightheadedness"; PRESYNCOPE (non-serious) with onset 15Aug2021, outcome "unknown", described as "made her feel like she was going to pass out.".  Additional information : Patient described about 30-45 minutes after vaccine she bent down to pick something up then walked to her garage and had intense dizziness and lightheadedness that made her feel like she was going to pass out. Denies any previous heart issues, dizziness spells, or vaccination reactions.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site vesicles
Clinical narrative: Injection site is swollen and looks like a water blister.; Injection site is swollen and looks like a water blister.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Aug2021 (Lot number: FC3181) at the age of 40 years as dose 2, single and administered in arm left, administration date 24Jul2021 (Lot number: FA7484) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE VESICLES (non-serious), outcome "not recovered" and all described as "Injection site is swollen and looks like a water blister.". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site vesicles.  Additional information: AE does not result in emergency room/physician office. No COVID prior vaccination. Not tested for COVID post vaccination. There were no known allergies. No other vaccine in four weeks. No other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Irritability
Clinical narrative: annoying; she has lost some inches, she was five six but now is five foot three inches.; headaches; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date 28May2021 (Lot number: EWON1) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "blood sugar" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for heart alternation, start date: 2015; METFORMIN taken for blood glucose abnormal; HYDROCHLOROTHIAZID taken for hypertension; LEVOTHYROXINE SODIUM taken for thyroid disorder; BABY ASPIRIN. The following information was reported: HEADACHE (non-serious) with onset 30May2021, outcome "unknown", described as "headaches"; IRRITABILITY (non-serious), outcome "unknown", described as "annoying"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she has lost some inches, she was five six but now is five foot three inches.".  Additional information: She reports that since 30May2021 she has been experiencing headaches everyday, stating, "they're not very bad, but enough to be annoying" and "I don't usually have headaches, and I think that's what bothered me the most".She does report other medical issues and that she take different medications, but the Covid vaccine was the only change.She has not gotten the second dose of the Pfizer covid vaccine, but does take covid tests, weekly.She heard from her family members, "they said the second one is always worse than the first" and she stated "not everything is for everybody". She had got her first shot on 28May2021. She has a lot of medical problems that she takes medication for. That could be causing her to have headaches with the shot or something is going wrong. She didn't have any headaches the first two days after the shot. Then on 30May2021, she started having headaches. They are not really bad headaches, but enough to be annoying. She didn't normally have headaches. She has headache daily since having the shot. She is wondering if that was a side effect.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine
Clinical narrative: Lymphadenopathy (one swollen lymph node under my arm on the same arm as the injection); Migraine (with a history of migraines); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Jun2021 15:00 (Lot number: EW0182) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Severely allergy to pollen" (unspecified if ongoing), notes: Severely allergy to pollen (Pollen-food allergy syndrome, airway issues with some foods). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , lot number=EW0182, administration time=10:00 AM, vaccine location=Right arm, -No events reported), administration date: 12May2021, when the patient was 39 years old, for COVID-19 Immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 03Jun2021 09:00, outcome "recovered" (Jun2021), described as "Lymphadenopathy (one swollen lymph node under my arm on the same arm as the injection)"; MIGRAINE (non-serious) with onset 03Jun2021 09:00, outcome "recovered" (Jun2021), described as "Migraine (with a history of migraines)". Therapeutic measures were not taken as a result of lymphadenopathy, migraine.  Additional information: Patient did not have COVID prior to vaccination. Patient did not tested for COVID post vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not take other medications in two weeks.  No follow-up attempts are possible. No further information is expected.