chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeding disorder, Illness
Clinical narrative: got very sick; she couldn't eat; loose tarry stools; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 89 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometrial cancer" (unspecified if ongoing); "Stroke" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got very sick"; FEEDING DISORDER (non-serious), outcome "unknown", described as "she couldn't eat"; DIARRHOEA (non-serious), outcome "unknown", described as "loose tarry stools". The event "got very sick" was evaluated at the physician office visit. Additional information: The patient received the first vaccine on 10Mar2021 and she had all of the side effects the next day but then clarified that they accumulated from Friday to Saturday to Sunday. The patient got very sick. She had a zoom meeting with her primary care provider on Friday, 2 days/48 hours, after the vaccine and everything she was complaining about was common and they said to give it a couple of days. On Sunday, the patient couldn't eat and she had very loose tarry stools. The reporter called the oncology gynecologist nurse because her mother has chosen to have no more treatment (chemo) and she said to go ahead and have the nurses come; it has previously been decided that she would go on hospice if things turned differently. The patient was evaluated to go in the hospice program previously because in January, on her birthday, she had a stroke and came home and had visiting nurses and it was reported that it was coincidental that they were back into this now. The reporter stated no one was totally convinced that she was dying.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: "pretty sick for about 3 days"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 19Mar2021, outcome "recovering", described as ""pretty sick for about 3 days"". It was unknown if therapeutic measures were taken as a result of illness. Additional information: If other vaccine in four weeks: Unknown. Other medications in two weeks: Unknown. If COVID tested post vaccination: Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Myalgia, Pain in extremity, Protein C
Clinical narrative: had a reaction of poly-myalgias 5 days after receiving the vaccine; overall aches in the arms and legs; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 72-year-old male 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 was not reported. Concomitant medication(s) included: SIMVASTATIN. The following information was reported: MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "had a reaction of poly-myalgias 5 days after receiving the vaccine"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "overall aches in the arms and legs". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, pain in extremity.  Additional information: During the call the caller transferred the phone to the MD (call recording disclaimer provided) to provide additional details that the patient has a C-reactive protein of 31.3. He also takes simvastatin and the MD has discontinued that medication. His CK was normal but the patient continued to complaint of overall aches in the arms and legs. The patient received 80 mg of Depomedrol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: pain in the left side of head; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 01Mar2021 14:00 (Lot number: En6205) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ehlers-Danlos syndrome" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. The following information was reported: HEADACHE (non-serious) with onset 01Mar2021 14:00, outcome "unknown", described as "pain in the left side of head". Therapeutic measures were not taken as a result of headache. Additional information: 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. Patient has not been tested for COVID-19 since having the vaccine. The event did not result to doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Upper back and Right sided neck pain; Upper back and Right sided neck pain; upper back and right sided neck stiffness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Feb2021 13:30 (Lot number: EN6201) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM. The following information was reported: BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset 13Mar2021 09:00, outcome "not recovered" and all described as "Upper back and Right sided neck pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 13Mar2021 09:00, outcome "not recovered", described as "upper back and right sided neck stiffness". The events "upper back and right sided neck pain", "upper back and right sided neck pain" and "upper back and right sided neck stiffness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain, neck pain, musculoskeletal stiffness. Additional Information: The patient had no known allergies to medications, food, or other products.The patient has concomitant medication escitalopram 2.5mg per day. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021 at 09:00, two weeks after vaccination, the patient experienced upper back and right sided neck pain and stiffness. The patient was treated for back pain, neck pain and stiffness with chiropractic care on 22Mar2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021328139 same patient, vaccine, different dose and event
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Chills, Inappropriate schedule of product administration, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: blood pressure abnormal; Chills; bad body aches; stiffness; lymph node swelling; dose 1: 08Mar2021, dose 2: 22Mar2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Mar2021 13:00 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; XIGDUO. Vaccination history included: Bnt162b2 (dose 1, single via Intramuscular in left arm at, 13:00), administration date: 08Mar2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 22Mar2021 23:30, outcome "not recovered", described as "Chills"; PAIN (non-serious) with onset 22Mar2021 23:30, outcome "not recovered", described as "bad body aches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 22Mar2021 23:30, outcome "not recovered", described as "stiffness"; LYMPHADENOPATHY (non-serious) with onset 22Mar2021 23:30, outcome "not recovered", described as "lymph node swelling"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Mar2021 13:00, outcome "unknown", described as "dose 1: 08Mar2021, dose 2: 22Mar2021"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "blood pressure abnormal". Therapeutic measures were not taken as a result of chills, pain, musculoskeletal stiffness, lymphadenopathy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: blood pressure abnormal; Chills; bad body aches; stiffness; lymph node swelling; dose 1: 08Mar2021, dose 2: 22Mar2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Mar2021 13:00 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; XIGDUO. Vaccination history included: Bnt162b2 (dose 1, single via Intramuscular in left arm at, 13:00), administration date: 08Mar2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 22Mar2021 23:30, outcome "not recovered", described as "Chills"; PAIN (non-serious) with onset 22Mar2021 23:30, outcome "not recovered", described as "bad body aches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 22Mar2021 23:30, outcome "not recovered", described as "stiffness"; LYMPHADENOPATHY (non-serious) with onset 22Mar2021 23:30, outcome "not recovered", described as "lymph node swelling"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Mar2021 13:00, outcome "unknown", described as "dose 1: 08Mar2021, dose 2: 22Mar2021"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "blood pressure abnormal". Therapeutic measures were not taken as a result of chills, pain, musculoskeletal stiffness, lymphadenopathy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Feels sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (unknown if pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 17Mar2021 (Batch/Lot number: unknown) at the age of 41 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: ILLNESS (non-serious) with onset 18Mar2021, outcome "unknown", described as "Feels sick". It was unknown if therapeutic measures were taken as a result of illness.  Additional information: it was unknown if other vaccine in four weeks, if covid prior vaccination and if covid tested post vaccination. It was added that the patient Feels sick, out of work.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Paraesthesia oral
Clinical narrative: Gums swelling; Tingling in tongue; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 14Mar2021 12:30 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Allergies to sulfa" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1; 12:30 PM; left arm), administration date: 16Feb2021, when the patient was 69 years old, for COVID-19 immunization, reaction(s): "Swollen gums". The following information was reported: GINGIVAL SWELLING (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Gums swelling"; PARAESTHESIA ORAL (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Tingling in tongue". Therapeutic measures were not taken as a result of gingival swelling, paraesthesia oral.  Additional Information: The patient's concomitant medications included unspecified thyroid, blood pressure, and statin medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Muscle twitching
Clinical narrative: dose 1 start date : 27Feb2021 dose 2 start date : 03Mar2021; twitching on the left side of my face; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 03Mar2021 14:30 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "facial numbness" (ongoing), notes: Still have periodic facial numbness without facial drooping.; "Bell's palsy" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]; ANTIVERT [DIHYDROERGOCRISTINE;LOMIFYLLINE]. Vaccination history included: BNT162B2 (DOSE 1,SINGLE ; lot number: unknown; anatomical site :left arm; administration time: 14:30), administration date: 27Feb2021, when the patient was 66 years old, for COVID-19 immunisation, reaction(s): "numbness around my mouth", "Numbness facial". The following information was reported: MUSCLE TWITCHING (non-serious) with onset Mar2021, outcome "recovering", described as "twitching on the left side of my face"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Mar2021 14:30, outcome "unknown", described as "dose 1 start date : 27Feb2021 dose 2 start date : 03Mar2021". Therapeutic measures were not taken as a result of muscle twitching.  Additional information: The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Some fatigue; This is a spontaneous report received from a contactable consumer (patient's wife) from medical information team.  A male patient received BNT162B2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Some fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable consumer (patient's mother) from medical information team. The reporter is the parent.  A female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. 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 "Sore arm".  Additional Information: The patient also had both Pfizer COVID-19 vaccine shots. The patient experienced a sore arm after both shots. Like the patient's mother, the patient's sore arm started 11 hours after getting the shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Oropharyngeal pain
Clinical narrative: abdominal discomfort; diarrhea; sore throat; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 20Mar2021 (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: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "abdominal discomfort"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  No follow-up attempts are possible. Information on lot/ batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus/Sudden onset on ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 22Mar2021 09:00 (Batch/Lot number: unknown) at the age of 54 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 22Mar2021 10:00, outcome "unknown", described as "Tinnitus/Sudden onset on ringing in ears". Therapeutic measures were not taken as a result of tinnitus. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since having the vaccine. It was reported that the patient never had sudden onset of ringing in ears before.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Headache; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 18 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 22Mar2021 16:00 (Batch/Lot number: unknown) at the age of 18 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 23Mar2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset 23Mar2021, outcome "not recovered", described as "Sore throat". Therapeutic measures were taken as a result of headache, oropharyngeal pain. Additional information: Treatment included unspecified oral analgesic. The patient had no known allergies (NKA). Prior to vaccination, the patient has not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result to doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site rash
Clinical narrative: Swollen lymph nodes; Rash at injection site; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm right, administration date Mar2021 (Batch/Lot number: unknown) at the age of 41 years as dose 2, single, for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1; 03:30 PM; right arm), administration date: Feb2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Swollen lymph nodes"; VACCINATION SITE RASH (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Rash at injection site". Therapeutic measures were not taken as a result of lymphadenopathy, vaccination site rash.  Additional Information: The patient was administered with the vaccine in Mar2021 at 16:30. The events were experienced in Mar2021 at 19:00. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Illness, Joint range of motion decreased
Clinical narrative: dizzy; has had a headache and it is getting worse; she is so sick; she can not lift her head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (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: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; HEADACHE (non-serious), outcome "unknown", described as "has had a headache and it is getting worse"; ILLNESS (non-serious), outcome "unknown", described as "she is so sick"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "she can not lift her head". Additional information: The age of the patient was reported as 68 with unknown unit. Reporter wanted to know how long this will last and what to do to feel better.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Fatigue, Headache, Malaise
Clinical narrative: bad headache / the headache was in her forehead between the eyes; mild nausea; chills; bad taste; really tired; felt horrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 14Mar2021 (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: HEADACHE (non-serious) with onset 15Mar2021, outcome "unknown", described as "bad headache / the headache was in her forehead between the eyes"; NAUSEA (non-serious) with onset 15Mar2021, outcome "unknown", described as "mild nausea"; CHILLS (non-serious) with onset 15Mar2021, outcome "unknown", described as "chills"; DYSGEUSIA (non-serious) with onset 15Mar2021, outcome "recovered", described as "bad taste"; FATIGUE (non-serious) with onset 15Mar2021, outcome "unknown", described as "really tired"; MALAISE (non-serious) with onset 15Mar2021, outcome "recovered", described as "felt horrible".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: bad headache / the headache was in her forehead between the eyes; mild nausea; chills; bad taste; really tired; felt horrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 14Mar2021 (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: HEADACHE (non-serious) with onset 15Mar2021, outcome "unknown", described as "bad headache / the headache was in her forehead between the eyes"; NAUSEA (non-serious) with onset 15Mar2021, outcome "unknown", described as "mild nausea"; CHILLS (non-serious) with onset 15Mar2021, outcome "unknown", described as "chills"; DYSGEUSIA (non-serious) with onset 15Mar2021, outcome "recovered", described as "bad taste"; FATIGUE (non-serious) with onset 15Mar2021, outcome "unknown", described as "really tired"; MALAISE (non-serious) with onset 15Mar2021, outcome "recovered", described as "felt horrible".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood grouping, Influenza like illness
Clinical narrative: Flu like side effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 23Feb2021 11:45 (Lot number: EN6200) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing), notes: Thyroid; "Arthritis" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Diabetic" (unspecified if ongoing).  The patient reported her blood type is A-positive if this has any bearing. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included: INSULIN; LEVOTHYROXINE; LOSARTAN; METOPROLOL. 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. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like side effects". The patient underwent the following laboratory tests and procedures: blood grouping: a-positive. Additional information: flu-like side effects for full two days.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: anxiety; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 23 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Lot number: EN6207) at the age of 23 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: ANXIETY (non-serious) with onset 19Mar2021, outcome "recovered" (19Mar2021), described as "anxiety". Therapeutic measures were taken as a result of anxiety. Additional information: During her 15-minute waiting period after the injection on 19Mar2021, the patient began to experience anxiety. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Mood and Affect: Mood is anxious. Affect is flat. Treatment included: water, snacks and blanket Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Intervertebral disc protrusion
Clinical narrative: Slip disk; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERVERTEBRAL DISC PROTRUSION (non-serious), outcome "unknown", described as "Slip disk".  Additional Information: The patient got his first dose, and his second dose is in 30 days, but that he has a slip disk in his back, and he wanted to know if he can take Ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraines; This is a spontaneous report received from a contactable consumer.  An adult male patient received BNT162B2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset Mar2021, outcome "unknown", described as "Migraines". It was unknown if therapeutic measures were taken as a result of migraine.  Additional Information: The patient had two migraines within 1 week after first dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Spinal osteoarthritis
Clinical narrative: osteoarthritis in her back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "osteoarthritis" (ongoing), notes: she has osteoarthritis in her back and they want her to start a new medication called Prolia. The patient's concomitant medications were not reported. The following information was reported: SPINAL OSTEOARTHRITIS (non-serious), outcome "unknown", described as "osteoarthritis in her back". Therapeutic measures were taken as a result of spinal osteoarthritis.  Additional information: patient got her 1st dose on 12Mar2021 and she's supposed to get her 2nd on 04Apr2021, however she has osteoarthritis in her back and they want her to start a new medication called Prolia. She stated she was on a different medication, but it didn't work for her. She's supposed to get a Prolia injection on 23Mar2021 and wants to know if it would be alright or not. Clarified if she had osteoarthritis prior to the 1st dose, and she said she did. Clarified when the doctor discussed putting her on Prolia, she said she talked to them after the 1st dose and they decided to put her on it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Headache; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "Chills"; HEADACHE (non-serious), outcome "recovered", described as "Headache". It was unknown if therapeutic measures were taken as a result of chills, headache.  No follow-up attempts are possible. information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Hypoacusis
Clinical narrative: Hard of hearing; I can take medications (Unspecified Medications) that I take after I got Pfizer first shot of the vaccine (Clarified as COVID-19 Vaccine); This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP). Both female consumer (patient) and consumer (son) reported. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: HYPOACUSIS (non-serious), outcome "unknown", described as "Hard of hearing"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "I can take medications (Unspecified Medications) that I take after I got Pfizer first shot of the vaccine (Clarified as COVID-19 Vaccine) yesterday and I want to know if can take a certain medicine that I take?".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Tenderness
Clinical narrative: discomfort moving his arm or pushing on the muscle; muscle pain and soreness/moved from the main side of the muscle up to the back of the arm muscle too; Tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 03Mar2021 13:42 (Lot number: EN6202) at the age of 64 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: MYALGIA (non-serious) with onset 04Mar2021, outcome "recovered with sequelae" (Mar2021), described as "muscle pain and soreness/moved from the main side of the muscle up to the back of the arm muscle too"; LIMB DISCOMFORT (non-serious) with onset 19Mar2021, outcome "not recovered", described as "discomfort moving his arm or pushing on the muscle"; TENDERNESS (non-serious) with onset Mar2021, outcome "recovering", described as "Tenderness". Therapeutic measures were taken as a result of myalgia, limb discomfort, tenderness. Additional information: The patient did not receive any other vaccines within 4 weeks and on the day of the vaccination. The patient experienced muscle pain and soreness for a couple of days and was fine until 19Mar2021. The patient states it was the same pain and discomfort again like he previously had after receiving the shot. The patient took ibuprofen as a treatment but has not talked to his doctor. The patient was planning to get the second dose of the vaccine in the other arm (left arm) on 24Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Disorientation, Dizziness, Nausea
Clinical narrative: Nauseated; Dizzy; disoriented; cold sweats; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 59 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 18Mar2021 11:00 (Lot number: EN6204) at the age of 59 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 18Mar2021 11:03, outcome "recovered" (18Mar2021), described as "Nauseated"; DIZZINESS (non-serious) with onset 18Mar2021 11:03, outcome "recovered" (18Mar2021), described as "Dizzy"; DISORIENTATION (non-serious) with onset 18Mar2021 11:03, outcome "recovered" (18Mar2021), described as "disoriented"; COLD SWEAT (non-serious) with onset 18Mar2021 11:03, outcome "recovered" (18Mar2021), described as "cold sweats". Therapeutic measures were not taken as a result of nausea, dizziness, disorientation and cold sweat.  Additional information: Caller reported side effects from covid-19 vaccine. Stated that he took that vaccine on 18Mar and within minutes was nauseated, dizzy, disoriented and had cold sweats. Stated that it lasted like 5 minutes. Stated that he cannot imagine what else could have caused it. Stated that within 2-3 minutes it just slammed him. Stated that it was his first shot. He was concerned about taking second dose based on his experience. Stated that his sister had no issues on the first one and had side effects similar to what he had for the second one. Stated that his sister already did a report. Report reference number not provided. The patient had not received any other vaccine within 4 weeks. Patient had no adverse events prior to vaccination and had not been tested since the vaccination. The patient was not diagnosed with other illness, medical history and chronic health conditions.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Insomnia, Nausea
Clinical narrative: I can't sleep; I have a lot of headache, like constantly headache; Sweating; I am feeling nauseous; 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 female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 (Lot number: EN6208, Expiration Date: 06Jun2021) at the age of 58 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: HEADACHE (non-serious) with onset 18Mar2021, outcome "not recovered", described as "I have a lot of headache, like constantly headache"; HYPERHIDROSIS (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Sweating"; NAUSEA (non-serious) with onset 18Mar2021, outcome "not recovered", described as "I am feeling nauseous"; INSOMNIA (non-serious), outcome "unknown", described as "I can't sleep". Therapeutic measures were taken as a result of headache.  Additional information: Narrative case summary and further information: Selected Report Type Initial, Is the patient also the reporter Yes, Reporter type Consumer or other non-health professional. Primary / Prescribing Healthcare Professional Info, HCP postal address:. Is Covid Vaccine a Pfizer product Yes, Covid Vaccine manufacturer Unspecified, Dates for Covid Vaccine (Start Unspecified Stop Unspecified), NDC number of Covid Vaccine Unknown, UPC number of Covid Vaccine Unknown, Expiry Date of Covid Vaccine 06Jun2021. Other Products No, Patient History No, Investigation Assessment No. Additional Context: Consumer stated, "she called for report, she had her vaccine (Pfizer Covid Vaccine) on Thursday no on Tuesday, no on Wednesday and on yesterday she have a lot of headache, like constantly headache and last night it was like sweating and she was feeling nauseous, it's her first dose for the vaccine." Date of vaccine administration 17Mar2021. Adverse event start date 18Mar2021. Consumer further stated, "Is anything reported before like this for study, she can deal with it, it's nothing like the emergency. She think it's for the starting feeling like that." Reporter Type she is working for Hospitality. When probed for the mailing address of the pharmacy, consumer stated," (Pharmacy name), it's all she have, she don't know the zip code". Telephone#: Consumer stated, "she don't know that, she don't have." NDC# and UPC# Consumer stated, "she do see anywhere." Anatomical site of vaccine administration Right Arm. When probed for the indication, Consumer stated, "For the prevention of pandemic." When probed are you still experiencing the problem, Consumer stated, "Yes, and she don't know how it's going to be tomorrow." Outcome of event she don't she just tell you what she feel last night, she is calling because she can't sleep." Treatment Tylenol, Ibuprofen for headache. Dose 200 mg, Formulation Tablet.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: sore muscle; sore arm; This is a spontaneous report received from a 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 23Mar2021 (Lot number: EP6955) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Tussinex allergy" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; MIRENA. Past drug history included: Aspirin, reaction(s): "allergies". The following information was reported: MYALGIA (non-serious) with onset 23Mar2021, outcome "not recovered", described as "sore muscle"; PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "not recovered", described as "sore arm". Therapeutic measures were not taken as a result of myalgia, pain in extremity. Additional information: The most recent COVID-19 vaccine was administered in Workplace clinic. 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 has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Headache, Nausea
Clinical narrative: Headache; Eyes ached; Nausea; Faint feeling; This is a spontaneous report received from a non-contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ERV6208) via an unspecified route of administration on 17Mar2021 at 11:45 (at the age of 68-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included asthma. The patient was allergic to sulfa (sulfonamide allergy). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 17Mar2021 at 12:45, the patient experienced headache, eyes ached, nausea, faint feeling. It was reported that, the patient could not sit up because of headache, nausea and feeling faint. Therapeutic measures included unspecified anti-nausea and pain medications. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, eyes ached, nausea, faint feeling were resolved on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Amended Patient data, product data and Medical History data.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program Support (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (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 IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore in the arm".  Additional information: Is the reporter a healthcare professional (HCP): UNKNOWN, Occupation/Specialty: Unknown, Is the reporter's contact information available to you or a sub-contracted party: UNKNOWN, Is the reporter the prescribing HCP: UNKNOWN. Verbatim and Event Description: (name) originally called to ask whether the first vaccine dose is exactly the same as the 2nd vaccine dose. (Name) was scheduled to have his 1st vaccine supposedly on 23Mar2021. However, his niece helped him get an earlier schedule which is 02Mar2021, but on the different facility. (Name) had his 1st vaccine last 02Mar2021 and is scheduled to return for the 2nd dose on 23Mar2021. He is now wondering whether the 2nd dose of the vaccine is the same as the vaccine of the other facility where he was originally scheduled to get his first dose. Later in the conversation, he reported that he experienced a sore in the arm within 2 days after his first shot. Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.