chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose fluctuation, Blood glucose increased, Insulin resistance
Clinical narrative: My son has type 1 diabetes and had his first dose on Nov 3 and has had uncontrollably high blood sugars all day. Vaccine made his insulin resistant for 24 hours; My son has type 1 diabetes and had his first dose on Nov 3 and has had uncontrollably high blood sugars all day. Vaccine made his insulin resistant for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 8 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN taken for type 1 diabetes mellitus. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), INSULIN RESISTANCE (non-serious), outcome "recovered" (2021) and all described as "My son has type 1 diabetes and had his first dose on Nov 3 and has had uncontrollably high blood sugars all day. Vaccine made his insulin resistant for 24 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood glucose increased, insulin resistance.  Additional information: The patient had not COVID prior vaccination. The patient did not COVID tested post vaccination. No known allergies. The patient did not had other vaccine in four weeks. Other medications in two weeks was Insulin  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Dysmenorrhoea
Clinical narrative: cramps for ten days; severe spasms in my right eye lid, closing my eye, for five weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 12:30 (Lot number: FC3180) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid disease" (unspecified if ongoing); "IBS" (unspecified if ongoing); "I haven't had a period for ten years" (unspecified if ongoing); "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE; LOSARTAN; SPIRONOLACTONE. The following information was reported: DYSMENORRHOEA (non-serious) with onset 02Sep2021 05:00, outcome "unknown", described as "cramps for ten days"; BLEPHAROSPASM (non-serious) with onset 02Sep2021 05:00, outcome "unknown", described as "severe spasms in my right eye lid, closing my eye, for five weeks". The events "cramps for ten days" and "severe spasms in my right eye lid, closing my eye, for five weeks" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of dysmenorrhoea, blepharospasm.  Additional information: The patient had not had a period for ten years, had cramps for ten days and had her period for a week, had severe spasms in right eye lid, closing her eye, for five weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient did not have any known allergies. The patient later received second dose of BNT162B2 on 22Sep2021 13:30, at arm left, lot # 301358A as dose 2, single for COVID-19 immunization.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling in her arm; numbness and tingling in her arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 2021 (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 Immunization. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 2021, outcome "unknown" and all described as "numbness and tingling in her arm".  Additional Information: The case was reported as non serious. The pharmacist reported for a patient that, the patient received the 2nd dose of the Pfizer COVID vaccine and a few days later experienced numbness and tingling in her arm for a week now. She was worried about it that will it go away. Any information on that. The reporter stated "I am a healthcare provider and would like to discuss how to treat an adverse event that occurred in one of my patients".  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Head discomfort
Clinical narrative: Anxiety; not feeling well in my head; tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Oct2021 13:00 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single, administered in arm left (Batch/Lot number: unknown) as dose 2, single and (Lot number: 111) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Neuropathy" (unspecified if ongoing). Concomitant medication(s) included: MORPHINE; ATIVAN; GABAPENTIN. Past drug history included: Cipro for Known allergies : cipro.  The following information was reported: ANXIETY (non-serious) with onset 22Oct2021 15:00, outcome "not recovered", described as "Anxiety"; HEAD DISCOMFORT (non-serious) with onset 22Oct2021 15:00, outcome "not recovered", described as "not feeling well in my head"; FATIGUE (non-serious) with onset 22Oct2021 15:00, outcome "not recovered", described as "tiredness". The events "anxiety", "not feeling well in my head" and "tiredness" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of anxiety, head discomfort, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks. Patient did not receive any vaccine prior to COVID-19 vaccination and had not been tested since post vaccination. Facility where the most recent COVID-19 vaccine was administered reported as Pharmacy or Drug Store.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness, Pain in extremity
Clinical narrative: Sore arm; Extreme fatigue; Extreme muscle weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 03Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single), for COVID-19 immunization; Covid-19 vaccine (Dose 2, single), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Nov2021, outcome "not recovered", described as "Sore arm"; FATIGUE (non-serious) with onset 04Nov2021, outcome "not recovered", described as "Extreme fatigue"; MUSCULAR WEAKNESS (non-serious) with onset 04Nov2021, outcome "not recovered", described as "Extreme muscle weakness".  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: Lethargy, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: lymph node swelling and tenderness; lymph node swelling and tenderness; tenderness at the site of injection; moderate lethargy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single and administered in arm left, administration date 01May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Other medical history: Arthritis; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "recovering" and all described as "lymph node swelling and tenderness"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovering", described as "tenderness at the site of injection"; LETHARGY (non-serious) with onset 2021, outcome "recovering", described as "moderate lethargy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain, vaccination site pain, lethargy.  Additional information: first two doses resulted in lymph node swelling and tenderness plus tenderness at the site of injection and moderate lethargy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: "Strong headache", progressing to migraine overnight (over ~ 12-16 hours post vaccination); "Strong headache", progressing to migraine overnight (over ~ 12-16 hours post vaccination); This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 17:00 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Apr2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 04Nov2021 20:00, outcome "recovered" (Nov2021), MIGRAINE (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021) and all described as ""Strong headache", progressing to migraine overnight (over ~ 12-16 hours post vaccination)". Therapeutic measures were not taken as a result of headache, migraine.  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. 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.
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc protrusion
Clinical narrative: herniated disc; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. 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 "herniated disc".  Additional information: Reporter was scheduled to get spinal injection for her herniated disc in a week or two. She wants to know how much time was needed for her to schedule an appointment to get the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood oestrogen, Blood oestrogen decreased, Depression, Disturbance in attention
Clinical narrative: Low estrogen; can't concentrate/can't focus; has anxiety; can't sleep; Depressed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-160615 (Moderna), MOD21-160642 (Moderna).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD OESTROGEN DECREASED (non-serious), outcome "unknown", described as "Low estrogen"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "can't concentrate/can't focus"; ANXIETY (non-serious), outcome "unknown", described as "has anxiety"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; DEPRESSION (non-serious), outcome "unknown", described as "Depressed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Call received from patient who believed that she relieved the Moderna vaccine, stating that since  receiving her 2nd dose in April, she has low estrogen, cannot sleep, cannot focus, depressed, has anxiety and cannot concentrate. She was tested and test proves that she has low estrogen. She went  on to state that she is aware of 10 people who experienced the similar reactions. 5 of which are (Withheld) 5 and she is (Withheld) and did not mention the nationality of the other 5. Upon request of date of vaccination and LOT number/EXP Date for the Moderna vaccine, patient realized that she called the wrong number because she received both doses of the Pfizer vaccine. Age was not captured.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101533632
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Low estrogen; can't concentrate/can't focus; has anxiety; can't sleep; Depressed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-160615 (Moderna), MOD21-160642 (Moderna).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD OESTROGEN DECREASED (non-serious), outcome "unknown", described as "Low estrogen"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "can't concentrate/can't focus"; ANXIETY (non-serious), outcome "unknown", described as "has anxiety"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; DEPRESSION (non-serious), outcome "unknown", described as "Depressed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Call received from patient who believed that she relieved the Moderna vaccine, stating that since  receiving her 2nd dose in April, she has low estrogen, cannot sleep, cannot focus, depressed, has anxiety and cannot concentrate. She was tested and test proves that she has low estrogen. She went  on to state that she is aware of 10 people who experienced the similar reactions. 5 of which are (Withheld) 5 and she is (Withheld) and did not mention the nationality of the other 5. Upon request of date of vaccination and LOT number/EXP Date for the Moderna vaccine, patient realized that she called the wrong number because she received both doses of the Pfizer vaccine. Age was not captured.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101533632
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received three Pfizer BioNTech for kids the vaccines and all three boxes are expired; administered to 5 kids yesterday; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported  similar events for 5 patients. This is 2nd of 5 reports. This Pharmacist reported for a patient that:  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 06Nov2021 (Lot number: FK5127, Expiration Date: Aug2021) 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: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "received three Pfizer BioNTech for kids the vaccines and all three boxes are expired; administered to 5 kids yesterday".  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101534342 Same product and event, different patient
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: My problem is a numbness and loss strength in same in the hand that I receive the left shoulder, in the left shoulder; My problem is a numbness and loss strength in same in the hand that I receive the left shoulder, in the left shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An 85-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 (Batch/Lot number: unknown) at the age of 85 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "I am hard to hearing" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; no reaction or anything else), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE; no reaction or anything else), for Covid-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), MUSCULAR WEAKNESS (non-serious) all with onset Oct2021, outcome "unknown" and all described as "My problem is a numbness and loss strength in same in the hand that I receive the left shoulder, in the left shoulder". Therapeutic measures were not taken as a result of hypoaesthesia, muscular weakness.  Additional information: The patient received 3rd shot on 18Oct2021 (Confirmed as date of vaccination), say that again, she had no reaction or anything else on the first two shot. She stated that her problem was a numbness and loss strength in same in the hand that she received the left shoulder, in the left shoulder on the 18Oct2021 that was the 3rd shot and she have queries about others report on the same condition. Start date of adverse event was reported about 3 or 4 days ago. Patient's weight was 220 (unit not reported).  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: Alopecia, Hair colour changes
Clinical narrative: hair loss, getting big wads out of it/experiencing losing large amounts of hair while combing; her hair that used to be white is now turning green/her hair is turning from white to green; 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 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "she already had COVID" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B [VITAMIN B NOS] (ongoing); VITAMIN E [TOCOPHEROL] (ongoing); VITAMIN C [ASCORBIC ACID] (ongoing); FISH OIL. Vaccination history included: Bnt162b2 (DOSE: 1), administration date: 2021, when the patient was 66 years old, for COVID-19 immunization, reaction(s): "with her 1st dose and she says that the chest pain lasted a couple of days", "she didn't sleep all night because she had chest pains and all kinds of stuff", "thought that she was going to die because of all the things that she went through, it was a lot", "ran a high fever". The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "hair loss, getting big wads out of it/experiencing losing large amounts of hair while combing"; HAIR COLOUR CHANGES (non-serious) with onset 2021, outcome "unknown", described as "her hair that used to be white is now turning green/her hair is turning from white to green".  Additional information: Patient received her second dose of Comirnaty around May or Jun2021 but was not certain exactly when. She had changed shampoo three times. Ever since she took her shot she had been combing her hair once a week or twice a week and had been trying not to comb it too much but it depends on if she shampoos her hair or not. She had been working in the medical field since 1974, but she was a nurse tech. Her hair was thick and her hair should be down to her shoulders. If she wasn't taking the vitamins her hair would all be pulled out by now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Occupational exposure to product
Clinical narrative: eye is still burning; pharmacists that squirted some of the Pfizer BioNTech Covid 19 vaccine in his eye; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (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: EYE IRRITATION (non-serious), outcome "not recovered", described as "eye is still burning"; OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious), outcome "unknown", described as "pharmacists that squirted some of the Pfizer BioNTech Covid 19 vaccine in his eye". Therapeutic measures were taken as a result of eye irritation, occupational exposure to product.  Additional information:Clinical Pharmacy Specialist is calling on behalf of one of her pharmacists that squirted some of the Pfizer BioNTech Covid 19 vaccine in his eye.  The pharmacist reconstituted the vaccine and he used the negative pressure technique but the vial kind of exploded.  He did a water bath and she suggested he do another but the eye is still burning just a little bit.    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: Pain in extremity
Clinical narrative: First Dose: Sore Arm/Second Dose: Sore Arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 23Jan2021 (Lot number: EK9231) at the age of 75 years as dose 1, single and administration date 13Feb2021 (Lot number: EL9264) as dose 2, single for covid-19 immunisation. Relevant medical history included: "filling done at the dental office" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu shot, for Immunization, reaction(s): "her arm was swollen, warm and red", "her arm was swollen, warm and red", "her arm was swollen, warm and red". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Jan2021, outcome "recovered" (14Feb2021), described as "First Dose: Sore Arm/Second Dose: Sore Arm".  Additional information: Reporter states probably 20 years or more ago she had a reaction to a flu shot, a high dose flu shot. Reporter states her arm was swollen, warm and red. Reporter states the doctor gave her a shot to counteract it, probably antihistamine. After then, she had gotten a flu shot every year with no reaction. Lot, Expiration: Unknown. Reporter states she had a filling done at the dental office but that was before her shot, she doesn't know if that has anything to do with it or not.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: for my covid shot and I was in so much pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 82 year-old 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: PAIN (non-serious), outcome "unknown", described as "for my covid shot and I was in so much pain".  Additional information: Patient stated "I am out of medication I can be off of it for a couple of days but I had to be off of it for eight days for my covid shot and I was in so much pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Caller said he only got a "sore arm" in the first 2 shots of the Pfizer-BioNTech COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 84 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 19Feb2021 (Lot number: EN6198) at the age of 84 years as dose 1, 0.3 ml single and administered in arm right, administration date 12Mar2021 (Lot number: EN6206) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Caller said he only got a "sore arm" in the first 2 shots of the Pfizer-BioNTech COVID-19 Vaccine".  Additional information: With first 2 doses of the Pfizer COVID vaccine the patient only got a sore arm. He had the sore arm for about 2 to 3 days on both the first and second dose and he really couldn't say that he had any ill effect from it, it came and went and was just there for a few days and then he was fine. He did not think so, he was a pretty healthy guy for the most part. He did not take any prescription drugs or anything, he just was taking his regular vitamins.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Cataracts stage 4 / 2 years ago my cataracts were very mild; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old 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: CONDITION AGGRAVATED (non-serious) with onset Jan2021, outcome "not recovered", described as "Cataracts stage 4 / 2 years ago my cataracts were very mild". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: Follow-up (13Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Feel numbness to the arm/her left arm went numb for about 15 to 20 minutes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 26Mar2021 (Lot number: ER8730) at the age of 39 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: HYPOAESTHESIA (non-serious) with onset 26Mar2021, outcome "recovering", described as "Feel numbness to the arm/her left arm went numb for about 15 to 20 minutes". The event "feel numbness to the arm/her left arm went numb for about 15 to 20 minutes" was evaluated at the physician office visit.  Additional information: Time of the vaccination was reported as 13:00 or 14:00. After receiving the shot the left arm she began to feel numbness to the arm about 15 to 20 minutes. Immediately afterwards her left arm went numb for about 15 to 20 minutes. The caller's arm was extended out of the vehicle when they gave it to her. The nurse directed the caller to the observation area. Not even a minute after receiving the vaccine the caller's arm was going numb, completely numb. The caller waved down the staff and she went to the nursing station. The caller was kept in observation for 20-25 minutes and the caller couldn't feel anything in her left arm. Caller wanted to know is this a normal side effect. The caller didn't get the second shot because she was extremely scared. Caller would like to know if this a reported side effect of the Pfizer COVID vaccine and wants to know if she should proceed in receiving the second dose. This report is not related to study or program. No investigation assessment was reported. Vaccine was not administered at Military facility. No emergency room visited. The caller also said that she went to the doctor and he suggested for her to call Pfizer. The patient had no family history. The patient did not receive any other products. No previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The caller saw her Primary care provider a few weeks after this event to let them know that this event happened.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle swelling, Pain in extremity, Peripheral swelling
Clinical narrative: her hands started feeling like swollen; she only having muscle swelling; the pain of the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 09Nov2021 (Lot number: FF2587) at the age of 16 years as dose number unknown, singl for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "her hands started feeling like swollen"; MUSCLE SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "she only having muscle swelling"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "the pain of the arm". Therapeutic measures were taken as a result of peripheral swelling, muscle swelling, pain in extremity.  Additional details: primary reporter stated, I have a question, I went to the shot yesterday. I was asking for my daughter, everything was fine with me but I was little bit concerned about my daughter when she took her vaccine and she have like she just started telling me that her hands started feeling like swollen so I am kind of concerned about that. Primary Reporter stated that, patient did not received any other vaccine within 4-weeks prior to Covid-19 vaccine. Primary reporter stated, probed was not for the Prior medical history, primary reporter stated, she only having muscle swelling. The only thing she took it was Advil for the pain of the arm she was telling me. That's it."(not appropriately clarified hence not captured in tab). primary reporter stated, when probed for still experiencing the adverse event. it was still there, and the reason I know that it was swollen she putting her rings on that's were tight, the ring are tiny but they are loose."Treatment taken for the adverse event: Primary reporter stated, "Advil"  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Head discomfort
Clinical narrative: weird neurological sensation that felt like pressure and a cold sensation on her head; weird neurological sensation that felt like pressure and a cold sensation on her head; check the back of my head because it felt like it was wet. It's hard to describe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date Sep2021 (Lot number: 32030BD, Expiration Date: 30Nov2021) 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), for COVID-19 Immunization. The following information was reported: HEAD DISCOMFORT (non-serious), FEELING COLD (non-serious), outcome "unknown" and all described as "weird neurological sensation that felt like pressure and a cold sensation on her head"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "check the back of my head because it felt like it was wet. It's hard to describe".  Additional information: Patient said that she experienced a "weird neurological sensation that felt like pressure and a cold sensation on her head almost immediately after receiving my second dose. It lasted until day 3 and then it was intermittently happening. Sometimes I had to check the back of my head because it felt like it was wet. It's hard to describe."  Case was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Headache; Tiredness; Lightheadedness/Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 32-years-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 (Lot number: EW0153) at the age of 32 years as DOSE 2, SINGLE for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, lot number is EP695, location: left arm.), administration date: 26Mar2021, when the patient was 32 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "Tiredness"; DIZZINESS (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "Light-headedness/Dizziness". Therapeutic measures were not taken as a result of headache, fatigue, dizziness. Additional Information: It was reported that the tiredness for the second dose was the week of 16 Apr2021. Stated that the tiredness lasted for 3-5 days and she recovered completely. Stated that the light-headedness/dizziness lasted 3-5 days and she recovered completely. Stated that the second shot of Pfizer Covid 19 was on 16Apr2021. Stated that the lot number was EW0153. Stated that  the dosage was unknown that was given in her left arm. Stated that the first shot of Pfizer Covid 19 was on 26Mar2021. Stated that the lot number is EP695 and she cannot read the last digit after the number five. Stated that the dosage was unknown that was given in her left arm. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle tightness, Muscle twitching, Vaccination site pain
Clinical narrative: Muscle spasms; twitching in tricep of vaccination arm; Tightness in vaccination arm; burning sensation in vaccination arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 11:30 (Lot number: FF2590) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: covid prior vaccination. Concomitant medication(s) included: DULOXETINE. The following information was reported: MUSCLE SPASMS (non-serious) with onset 01Nov2021 17:00, outcome "not recovered", described as "Muscle spasms"; MUSCLE TWITCHING (non-serious) with onset 01Nov2021 17:00, outcome "not recovered", described as "twitching in tricep of vaccination arm"; MUSCLE TIGHTNESS (non-serious) with onset 01Nov2021 17:00, outcome "not recovered", described as "Tightness in vaccination arm"; VACCINATION SITE PAIN (non-serious) with onset 01Nov2021 17:00, outcome "not recovered", described as "burning sensation in vaccination arm". The events "muscle spasms", "twitching in tricep of vaccination arm", "tightness in vaccination arm" and "burning sensation in vaccination arm" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of muscle spasms, muscle twitching, muscle tightness, vaccination site pain. Additional information: Muscle spasms/twitching in tricep of vaccination arm from the day of vaccination still continuing a week and a half later. Tightness and burning sensation in vaccination arm beginning 2 days after and still occurring a week and a half after vaccination. Comparable to having blood pressure taken. No other vaccine in four weeks. Other medications in two weeks: duloxetine. Covid was not tested post vaccination. No known allergies. No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: began complaining of a sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CHILDREN'S MULTIVITAMIN. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 10Nov2021 14:30, outcome "recovering", described as "began complaining of a sore throat". Therapeutic measures were not taken as a result of oropharyngeal pain.  Additional information: The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any treatment for the adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 19:45 (Lot number: Fk5127) at the age of 8 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: VACCINATION SITE PAIN (non-serious) with onset 08Nov2021 20:00, outcome "recovering", described as "Sore at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient has not been tested for Covid-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Premature menarche
Clinical narrative: started menstruating, which is very unusual because had never started a menstrual cycle.; started menstruating, which is very unusual because had never started a menstrual cycle.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Nov2021 11:45 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADDERALL. The following information was reported: PREMATURE MENARCHE (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 10Nov2021 15:00, outcome "unknown" and all described as "started menstruating, which is very unusual because had never started a menstrual cycle.". Therapeutic measures were not taken as a result of premature menarche, menstrual disorder.  Additional information: The patient did not received any other vaccine in four weeks. The patient did not tested for COVID prior to vaccination and post vaccination. The patient did not reported any known allergies.   Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: SARS-CoV-2 test, Vision blurred
Clinical narrative: A day or two after getting my booster, I've noticed the same slight blurred vision.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 13:15 (Lot number: FE3590) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 05Nov2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. Concomitant medication(s) included: DIFFERIN; CLINDAMYCIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot Number: EL9266, at 10:30 AM, left arm), administration date: 17Feb2021, when the patient was 34 years old, for Covid-19 immunization, reaction(s): "dry eyes", "blurred vision", "headaches"; Bnt162b2 (Dose Number: 1, Lot Number: EL3247, at 10:00, Left arm), administration date: 27Jan2021, when the patient was 33 years old, for Covid-19 immunization, reaction(s): "blurred vision", "dry eyes", "headaches". The following information was reported: VISION BLURRED (non-serious) with onset Nov2021, outcome "unknown", described as "A day or two after getting my booster, I've noticed the same slight blurred vision.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated that during first two rounds, noticed blurred vision and thought it was due to contacts, dry eyes, etc. and went to eye doctor but he said nothing was wrong. It eventually went away but seemed to take several weeks of slightly blurred vision leading to headaches. A day or two after getting my booster, patient noticed the same slight blurred vision. Prior to vaccination the patient did not diagnosed with COVID-19 and tested for COVID post vaccination. Facility type Vaccine was workplace clinic. Other vaccines were administered in four weeks. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal, Insomnia
Clinical narrative: Glucose 2hr Post: 47; I haven''t  been sleeping since I received the Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 14:45 (Lot number: EN6205) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vitamin defficiency" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "weakened immune system" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3 taken for hypovitaminosis, start date: 22Jul2021 (ongoing); LISINOPRIL HCTZ taken for hypertension, start date: 28Oct2019 (ongoing); ATORVASTATIN taken for blood cholesterol increased, start date: 04May2020 (ongoing). Vaccination history included: Bnt162b2 (Time (24hr): 11:30 AM, Anatomical Site of injection: Left Arm, Batch/Lot number: EN6198), administration date: 11Mar2021, when the patient was 46 years old, for covid-19 immunisation. The following information was reported: INSOMNIA (non-serious) with onset 2021, outcome "not recovered", described as "I haven''t been sleeping since I received the Pfizer shot"; BLOOD GLUCOSE ABNORMAL (non-serious) with onset 11Apr2021, outcome "unknown", described as "Glucose 2hr Post: 47". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia.  Additional information: Patient had not been sleeping. She was not getting treated, she was told to take somethings from over the counter.  No follow-up attempts are possible. No further information is expected.