chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Paraesthesia
Clinical narrative: Tingling ran down arm to fingers; Chills; Headache; This is a spontaneous report received from a non-contactable reporter (Consumer).  A 47-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE, Lot number: Unknown, Anatomical site: Left arm), for COVID-19 immunisation, reaction(s): "Tingling". The following information was reported: PARAESTHESIA (non-serious), outcome "recovered", described as "Tingling ran down arm to fingers"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; CHILLS (non-serious), outcome "recovered", described as "Chills". Therapeutic measures were taken as a result of headache. Additional Information: It was unknown if the patient received any other medications within 2 weeks of vaccination. It was unknown if the patient received 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 not tested for COVID-19. On an unknown date the patient experienced tingling ran down arm to fingers that lasted 2 seconds in injection arm, occurred after both vaccines. On an unknown date at 02:00, day after the vaccine, the patient awoke with severe headache that lasted 2 days. The patient experienced chills for days 3-5 post vaccine. The patient received ibuprofen and acetaminophen for the event headache. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021327146 same patient, different event, different dose of vaccine
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very sore arm; This is a spontaneous report received from a non-contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, 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), outcome "unknown", described as "very sore arm".  Additional information: The patient's age was reported as 72 (unit unspecified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, SARS-CoV-2 test
Clinical narrative: Headache in front of head; A metallic taste within 10 minutes of the injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 12:30 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies to Sulfa drug" (unspecified if ongoing). Family history included: "Genetic blood clotting" (unspecified if ongoing). Concomitant medication(s) included: XARELTO. The following information was reported: DYSGEUSIA (non-serious) with onset 23Mar2021 12:40, outcome "unknown", described as "A metallic taste within 10 minutes of the injection"; HEADACHE (non-serious) with onset 23Mar2021 12:45, outcome "unknown", described as "Headache in front of head". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia, 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. 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness of the arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 19Mar2021 (Batch/Lot number: unknown) at the age of 62 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: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "soreness of the arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021326529 Same reporter, suspect drug and event; different patient
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slight sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Slight sore arm". Additional information: The patient's age was reported as "80 something".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Occupational exposure to product
Clinical narrative: drawing up Pfizer covid vaccine and the medication got into her eyes; has irritation in her eyes; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (002191).  A 42 year-old female 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: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown", described as "drawing up Pfizer covid vaccine and the medication got into her eyes"; EYE IRRITATION (non-serious), outcome "unknown", described as "has irritation in her eyes". Therapeutic measures were taken as a result of occupational exposure to product. Additional information: Clinical course: The patient was drawing up Pfizer covid vaccine and the medication got into her eyes. She has rinsed it well but has irritation in her eyes. Caller wanted guidance on what they need to do.  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: Discomfort, Malaise
Clinical narrative: uncomfortable; feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 66 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: DISCOMFORT (non-serious), outcome "recovered", described as "uncomfortable"; MALAISE (non-serious), outcome "recovered", described as "feeling sick".  Additional Information: It was reported that events were over in 2 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: he got the first shot on 04Mar2021 and last week they called him and he received his second dose on Sunday, 21Mar2021.; He stated he had no reaction, only his arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 04Mar2021, for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "He stated he had no reaction, only his arm hurt"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Mar2021, outcome "unknown", described as "he got the first shot on 04Mar2021 and last week they called him and he received his second dose on Sunday, 21Mar2021.".  Additional information: Patient's age was reported as 73, with unknown units.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm that she got the injection in was sore/ like someone had punched her in her arm; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm, administration date 23Mar2021 12:15 (Batch/Lot number: unknown) at the age of 59 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing). Concomitant medications included: QUINAPRIL; POTASSIUM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Mar2021 13:00, outcome "recovering", described as "her arm that she got the injection in was sore/ like someone had punched her in her arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Additional medications that the patient received within two weeks of vaccination included vitamins. She had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination, and she has not been tested for COVID-19 since the vaccination. The patient took 2 NORLEX for pain in her arm at bedtime. On 24Mar2021 (one day later), her arm was not as sore as it was. Just a little sore but no medicine was needed for her arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Headache, Paraesthesia, Peripheral swelling
Clinical narrative: finger tips swollen and tingling; finger tips are swollen and tingling; head was hurting; cardiac event; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "finger tips swollen and tingling"; PARAESTHESIA (non-serious), outcome "unknown", described as "finger tips are swollen and tingling"; HEADACHE (non-serious), outcome "unknown", described as "head was hurting"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "cardiac event". The event "cardiac event" was evaluated at the emergency room visit.  Additional information: the patient was the reporter's mom. Caller reports that patient experienced a cardiac event and was in the emercgency room till 2 AM. Caller reports that his mom finger tips are swollen and tingling, and the left side of her head was hurting.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a little sore at site of needle injection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) at the age of 68 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: VACCINATION SITE PAIN (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "a little sore at site of needle injection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain
Clinical narrative: Stomach cramps; not strong contraction type pains, but dull, persistent pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FISH OIL; GLUCOSAMINE. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 19Mar2021 22:00, outcome "recovered" (26Mar2021 22:00), described as "Stomach cramps"; PAIN (non-serious) with onset 19Mar2021 22:00, outcome "recovered" (26Mar2021 22:00), described as "not strong contraction type pains, but dull, persistent pains". The events "stomach cramps" and "not strong contraction type pains, but dull, persistent pains" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of abdominal pain upper, pain.  Additional information: The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccine, the patient was not tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. The patient's concomitant medication also included DIGETIZYME. The vaccine was administered at 15:00. Clinical course: On 19Mar2021 at 22:00, the patient experienced stomach cramps, up to one week after the shot not strong contraction type pains, but dull, persistent pains, cannot do ab workouts and bowel movements were not affected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site with his arm being "a little bit sore"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) at the age of 69 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site with his arm being "a little bit sore"".  Additional information: It was reported that the event was experienced in the evening of the vaccination day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: arm hurts a little; has a little headache; pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (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), outcome "unknown", described as "arm hurts a little"; HEADACHE (non-serious), outcome "unknown", described as "has a little headache"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient explained she had the test done in preparation for her next travel and will get the results in 2-3 days. The patient asked what will happen if she received the vaccine while being having COVID-19. The patient explained her self-interrogation as to whether it would be side effects to the vaccine or symptoms to a COVD-19 infection. The patient was querying on how long the pain at the injection site and headache will last after getting the Pfizer-BioNTech COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus  mostly in my left ear.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 16Mar2021 07:30 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT; WELLBUTRIN. Past drug history included: Gentamicin, reaction(s): "known allergies: Gentamicin".  The following information was reported: TINNITUS (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Tinnitus  mostly in my left ear.". 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 was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. Adverse event 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: Pain in extremity
Clinical narrative: soreness of the arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65 year-old male 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness of the arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021324806 Same reporter, suspect drug and event; different patient.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: developed a little bit of headache; a little bit of body ache; 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 24Mar2021 (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 24Mar2021, outcome "unknown", described as "developed a little bit of headache"; PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "a little bit of body ache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood glucose, Blood glucose increased, Blood test, Fatigue
Clinical narrative: elevated blood glucose; Headache; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 06Mar2021 (Lot number: EJ1686) at the age of 78 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Arthritis" (ongoing), notes: in her shoulder, occupational related, possibly diagnosed about 20 years ago; "Type 1 diabetes" (ongoing), notes: diagnosed when she was 70 years old; "Blood pressure high" (ongoing); "thyroid imbalance" (ongoing); "seasonal allergies" (unspecified if ongoing); "pain" (unspecified if ongoing); "thinks she already had COVID", start date: Jan2020 (unspecified if ongoing); "lost her taste and smell", start date: Jan2020 (unspecified if ongoing); "lost her taste and smell", start date: Jan2020 (unspecified if ongoing). Concomitant medication(s) included: INSULIN taken for type 1 diabetes mellitus, start date: Apr2013 (ongoing); LOSARTAN taken for hypertension, start date: 2013 (ongoing); SYNTHROID taken for thyroid disorder, start date: 1987 (ongoing); VITAMIN D NOS (ongoing). Past drug history included: Anacin for pain; Claritin for seasonal allergies, notes: will be starting around the end of MAR2021 and beginning of APR2021; this is what she normally does. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset Mar2021, outcome "recovering", described as "elevated blood glucose"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient also takes a multivitamin for general health and takes the vitamin D supplement for bone density. Her headache seems to occur when she wakes up. She is due to take the next dose of BNT162B2 on 03Apr2021. The patient was scheduled to see her endocrinologist in about 2 to 3 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Headache, Liver function test, Renal function test
Clinical narrative: elevated blood glucose; Headache; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 06Mar2021 (Lot number: EJ1686) at the age of 78 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Arthritis" (ongoing), notes: in her shoulder, occupational related, possibly diagnosed about 20 years ago; "Type 1 diabetes" (ongoing), notes: diagnosed when she was 70 years old; "Blood pressure high" (ongoing); "thyroid imbalance" (ongoing); "seasonal allergies" (unspecified if ongoing); "pain" (unspecified if ongoing); "thinks she already had COVID", start date: Jan2020 (unspecified if ongoing); "lost her taste and smell", start date: Jan2020 (unspecified if ongoing); "lost her taste and smell", start date: Jan2020 (unspecified if ongoing). Concomitant medication(s) included: INSULIN taken for type 1 diabetes mellitus, start date: Apr2013 (ongoing); LOSARTAN taken for hypertension, start date: 2013 (ongoing); SYNTHROID taken for thyroid disorder, start date: 1987 (ongoing); VITAMIN D NOS (ongoing). Past drug history included: Anacin for pain; Claritin for seasonal allergies, notes: will be starting around the end of MAR2021 and beginning of APR2021; this is what she normally does. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset Mar2021, outcome "recovering", described as "elevated blood glucose"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient also takes a multivitamin for general health and takes the vitamin D supplement for bone density. Her headache seems to occur when she wakes up. She is due to take the next dose of BNT162B2 on 03Apr2021. The patient was scheduled to see her endocrinologist in about 2 to 3 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; felt a little run down; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "felt a little run down".  Additional information: The patient's age was reported as 71, no unit provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling ran down on arm to fingers that lasted 2 seconds (on left injected arm); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) (reported as patient's age: 47; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "recovered", described as "Tingling ran down on arm to fingers that lasted 2 seconds (on left injected arm)". Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: left arm pain; couldn't raise my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Feb2021, outcome "unknown", described as "left arm pain"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "couldn't raise my left arm". Therapeutic measures were taken as a result of pain in extremity. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Patient (Age: 68; Unit: Unknown) has tried, ice, paracetamol (TYLENOL), naproxen (ALEVE), laying on ice pack, and heating pad. She stated "The pain is going down my arm, and I don't know if I'm having a stroke or what. At first, I couldn't raise my left arm. I used the rubber band to try to strengthen it, still doing it. I'm a healthy person. I take only levothyroxine." Patient was asking for treatment advice for her arm pain.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: just a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Mar2021 16:30 (Lot number: EJ1685) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovering", described as "just a little tired". Therapeutic measures were not taken as a result of fatigue.  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Malaise, Nasopharyngitis
Clinical narrative: sick; cold; flu like symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 01Mar2021 (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 Mar2021, outcome "unknown", described as "sick"; NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "cold"; INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "flu like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: sick; cold; flu like symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 01Mar2021 (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 Mar2021, outcome "unknown", described as "sick"; NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "cold"; INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "flu like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (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: LYMPHADENOPATHY (non-serious) with onset 26Mar2021, outcome "unknown", described as "swollen lymph nodes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A female 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: HEADACHE (non-serious), outcome "recovered", described as "Headache".  Additional Information: After the patient's first Pfizer vaccine dose, she had a headache for one day and that was it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021346314 Same patient and product; different dose and event
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 33 year-old female 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymphadenopathy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Tremor
Clinical narrative: he started to experience tremors which caused him to fall on the floor; fall on the floor; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 71-year-old male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation. The following information was reported: TREMOR (non-serious) with onset 26Mar2021, outcome "unknown", described as "he started to experience tremors which caused him to fall on the floor"; FALL (non-serious) with onset 26Mar2021, outcome "unknown", described as "fall on the floor". Therapeutic measures were taken as a result of tremor, fall.  Additional information: At around 12:30 PM and today he started to experience tremors which caused him to fall on the floor. He also needed assistance in walking and getting up and caller stated that this is already the 2nd time it happened to him after taking the vaccine. Caller mentioned that she gave him Tylenol for the side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: severe pain on my arm; severe pain on my arm, arm pit on my left side where I got the vaccine and it's still badly hurting me; it's very difficult to go work with this pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "severe pain on my arm"; AXILLARY PAIN (non-serious), outcome "not recovered", described as "severe pain on my arm, arm pit on my left side where I got the vaccine and it's still badly hurting me"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "it's very difficult to go work with this pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: did not have ringing in her ears until after she got the vaccine and is having the ringing in her ears now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 18Mar2021 13:45 (Lot number: ER8727) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Rosuvastatin calcium for high cholesterol, reaction(s): "a little annoying cough", notes: 20mg tablets and she took that once a day orally at night but stopped taking it 3-4 days prior to vaccine because of cough; Crestor for Cholesterol, notes: does not remember when she was changed from the Crestor to the Rosuvastatin. Vaccination history included: Tetanus shot (given approximately 1.5 years ago), for immunisation. The following information was reported: TINNITUS (non-serious) with onset 21Mar2021, outcome "unknown", described as "did not have ringing in her ears until after she got the vaccine and is having the ringing in her ears now".  Additional Information: The vaccine was reported to be given in the left shoulder. The patient stated that thyroid cancer and breast cancer both run in her family and she had tested negative for both thyroid cancer and breast cancer. The patient reported that the ringing in the ear was gradual and was something she did not pay attention to because she normally did not have it. She mentioned that it happened when it was super quiet so she then noticed it was a little annoying and was getting a little louder. Events did not result to visit to emergency room and physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was scheduled to have the second dose of the Pfizer COVID Vaccine on 08Apr2021 at 1:45pm.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: Dental concern; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female 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: TOOTH DISORDER (non-serious), outcome "unknown", described as "Dental concern". Therapeutic measures were taken as a result of tooth disorder.  Additional Information: The patient was scheduled for her second dose this coming Friday (date unspecified). She was taking amoxicillin until Monday (date unspecified) due to some dental concern. She wanted to know if that was ok.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Illness
Clinical narrative: sick; Watery diarrhea; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "sick"; DIARRHOEA (non-serious), outcome "recovered", described as "Watery diarrhea".  Additional information: Caller reported that 2 weeks after her father received the Pfizer Covid-19 vaccine, her father got sick. Caller reported that her father had watery diarrhea and was a hot mess for almost a week. He was doing great then 2 weeks after the vaccine had this. However, it came and went that quickly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 12:20 (Lot number: EM9810) at the age of 68 years as dose 1, single for covid-19 immunisation; bcg vaccine (BCG VACCINE), administration date 01Mar2021 (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Mar2021, outcome "unknown", described as "sore arm".  Additional information: Patient reported she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 at 12:20PM in the left arm. She did not have any side effects except a sore arm. Event did not result to emergency room and physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus in left ear; This is a spontaneous report received from a non-contactable consumer.  A 65-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 07Mar2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing). Concomitant medication included: EXCEDRIN [CAFFEINE;PARACETAMOL]. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 10Mar2021, outcome "recovered" (17Mar2021), described as "tinnitus in left ear". The event "tinnitus in left ear" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: Additional medications received within two weeks of vaccination included lupus medications. She did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food and other products. The patient was not diagnosed with COVID-19 prior to vaccination, and she had not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Somnolence, Vaccination site pain
Clinical narrative: His muscles were hurting a little bit but not much; sleepy; there was pain where he took the COVID 19 vaccine in his left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (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: MYALGIA (non-serious) with onset 23Mar2021, outcome "recovering", described as "His muscles were hurting a little bit but not much"; SOMNOLENCE (non-serious) with onset 23Mar2021, outcome "unknown", described as "sleepy"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "there was pain where he took the COVID 19 vaccine in his left arm". Additional information: The patient was scheduled to receive the second dose on 02Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Muscle ache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 (Lot number: EN6207) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing). Concomitant medication(s) included: OZEMPIC taken for diabetes mellitus (ongoing); VARICELLA ZOSTER VACCINE. The following information was reported: MYALGIA (non-serious) with onset 18Mar2021, outcome "recovering", described as "Muscle ache"; CHILLS (non-serious) with onset 18Mar2021, outcome "recovering", described as "Chills". Therapeutic measures were taken as a result of myalgia, chills.  Additional information: The events reported to occurred on the night of 18Mar2021, 9 hours after the vaccination. The patient took Aspirin as treatment of the events.  No follow-up attempts are possible. No further information is expected.