chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Burning sensation, Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: possible Rheumatoid Arthritis; cannot hardly walk on my legs; pain in her muscles and her bones; pain in her muscles and her bones; cannot pick up her left arm over her head without pain; burning in her skull, then felt it going through her knees, under her knee caps and traveling; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date Sep2021 (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: RHEUMATOID ARTHRITIS (medically significant) with onset Sep2021, outcome "not recovered", described as "possible Rheumatoid Arthritis"; GAIT DISTURBANCE (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot hardly walk on my legs"; BONE PAIN (non-serious), MYALGIA (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "pain in her muscles and her bones"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot pick up her left arm over her head without pain"; BURNING SENSATION (non-serious) with onset Sep2021, outcome "not recovered", described as "burning in her skull, then felt it going through her knees, under her knee caps and traveling". Clinical course details: Caller states that her pharmacist gave her Pfizer's number to call and report her adverse event following the vaccination of Pfizer COVID-19 Vaccine. Patient reported she received the product 5 months ago. Patient stated she think she had it in the month of Sep2021 when her sister-in-law died as she had it right after, that's around 5 months. Ever since she has taken the vaccine, patient cannot hardly walk on her legs. She stated pain in her muscles and her bones. She thinks that her symptoms were a reaction to the shot and went in two times and finally told the pharmacist that she waited all these months, and it was getting worse. She stated it did something to the muscles in her legs. She cannot pick up her left arm over her head without pain. She thinks that the vaccination may have triggered something. She questions possible Rheumatoid Arthritis.  The 1st time she received the product she notes that she had burning in her skull, then felt it going through her knees, under her kneecaps and traveling. She reported this to the pharmacist and was not sure it was supposed to happen or not and they advised it was as the shot goes through her body she said.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: possible Rheumatoid Arthritis; cannot hardly walk on my legs; pain in her muscles and her bones; pain in her muscles and her bones; cannot pick up her left arm over her head without pain; burning in her skull, then felt it going through her knees, under her knee caps and traveling; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date Sep2021 (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: RHEUMATOID ARTHRITIS (medically significant) with onset Sep2021, outcome "not recovered", described as "possible Rheumatoid Arthritis"; GAIT DISTURBANCE (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot hardly walk on my legs"; BONE PAIN (non-serious), MYALGIA (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "pain in her muscles and her bones"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot pick up her left arm over her head without pain"; BURNING SENSATION (non-serious) with onset Sep2021, outcome "not recovered", described as "burning in her skull, then felt it going through her knees, under her knee caps and traveling". Clinical course details: Caller states that her pharmacist gave her Pfizer's number to call and report her adverse event following the vaccination of Pfizer COVID-19 Vaccine. Patient reported she received the product 5 months ago. Patient stated she think she had it in the month of Sep2021 when her sister-in-law died as she had it right after, that's around 5 months. Ever since she has taken the vaccine, patient cannot hardly walk on her legs. She stated pain in her muscles and her bones. She thinks that her symptoms were a reaction to the shot and went in two times and finally told the pharmacist that she waited all these months, and it was getting worse. She stated it did something to the muscles in her legs. She cannot pick up her left arm over her head without pain. She thinks that the vaccination may have triggered something. She questions possible Rheumatoid Arthritis.  The 1st time she received the product she notes that she had burning in her skull, then felt it going through her knees, under her kneecaps and traveling. She reported this to the pharmacist and was not sure it was supposed to happen or not and they advised it was as the shot goes through her body she said.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Gait disturbance, Musculoskeletal pain, Myalgia
Clinical narrative: possible Rheumatoid Arthritis; cannot hardly walk on my legs; pain in her muscles and her bones; pain in her muscles and her bones; cannot pick up her left arm over her head without pain; burning in her skull, then felt it going through her knees, under her knee caps and traveling; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date Sep2021 (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: RHEUMATOID ARTHRITIS (medically significant) with onset Sep2021, outcome "not recovered", described as "possible Rheumatoid Arthritis"; GAIT DISTURBANCE (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot hardly walk on my legs"; BONE PAIN (non-serious), MYALGIA (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "pain in her muscles and her bones"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot pick up her left arm over her head without pain"; BURNING SENSATION (non-serious) with onset Sep2021, outcome "not recovered", described as "burning in her skull, then felt it going through her knees, under her knee caps and traveling". Clinical course details: Caller states that her pharmacist gave her Pfizer's number to call and report her adverse event following the vaccination of Pfizer COVID-19 Vaccine. Patient reported she received the product 5 months ago. Patient stated she think she had it in the month of Sep2021 when her sister-in-law died as she had it right after, that's around 5 months. Ever since she has taken the vaccine, patient cannot hardly walk on her legs. She stated pain in her muscles and her bones. She thinks that her symptoms were a reaction to the shot and went in two times and finally told the pharmacist that she waited all these months, and it was getting worse. She stated it did something to the muscles in her legs. She cannot pick up her left arm over her head without pain. She thinks that the vaccination may have triggered something. She questions possible Rheumatoid Arthritis.  The 1st time she received the product she notes that she had burning in her skull, then felt it going through her knees, under her kneecaps and traveling. She reported this to the pharmacist and was not sure it was supposed to happen or not and they advised it was as the shot goes through her body she said.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: possible Rheumatoid Arthritis; cannot hardly walk on my legs; pain in her muscles and her bones; pain in her muscles and her bones; cannot pick up her left arm over her head without pain; burning in her skull, then felt it going through her knees, under her knee caps and traveling; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date Sep2021 (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: RHEUMATOID ARTHRITIS (medically significant) with onset Sep2021, outcome "not recovered", described as "possible Rheumatoid Arthritis"; GAIT DISTURBANCE (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot hardly walk on my legs"; BONE PAIN (non-serious), MYALGIA (non-serious) all with onset Sep2021, outcome "not recovered" and all described as "pain in her muscles and her bones"; PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "not recovered", described as "cannot pick up her left arm over her head without pain"; BURNING SENSATION (non-serious) with onset Sep2021, outcome "not recovered", described as "burning in her skull, then felt it going through her knees, under her knee caps and traveling". Clinical course details: Caller states that her pharmacist gave her Pfizer's number to call and report her adverse event following the vaccination of Pfizer COVID-19 Vaccine. Patient reported she received the product 5 months ago. Patient stated she think she had it in the month of Sep2021 when her sister-in-law died as she had it right after, that's around 5 months. Ever since she has taken the vaccine, patient cannot hardly walk on her legs. She stated pain in her muscles and her bones. She thinks that her symptoms were a reaction to the shot and went in two times and finally told the pharmacist that she waited all these months, and it was getting worse. She stated it did something to the muscles in her legs. She cannot pick up her left arm over her head without pain. She thinks that the vaccination may have triggered something. She questions possible Rheumatoid Arthritis.  The 1st time she received the product she notes that she had burning in her skull, then felt it going through her knees, under her kneecaps and traveling. She reported this to the pharmacist and was not sure it was supposed to happen or not and they advised it was as the shot goes through her body she said.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 66-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 66 years as dose 2, 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, Batch/lot number: Unknown, Manufacturer: Unknown), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus".  Additional information: As per source, it was the shock of a loud whistle that almost caused Patient to veer off the road as he was driving home after getting his second COVID-19 vaccine. Patient thought it was a dog whistle going off right next to him. It was not a dog whistle; it was a piercing sound his brain conjured up for an unknown reason. Patient suspected it may have been a side effect of the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Is double vaccinated with a booster, and then got Covid where she was advised to get the medication Paxlovid; Is double vaccinated with a booster, and then got Covid where she was advised to get the medication Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the parent.  A 43 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at unk (once every 2 weeks) and second regimen (ongoing) (Batch/Lot number: unknown) at weekly (unk (every week)) for crohn's disease. Relevant medical history included: "Crohn's disease" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Humira for Crohn's disease. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Is double vaccinated with a booster, and then got Covid where she was advised to get the medication Paxlovid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive; positive. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of covid-19.  Clinical course: Reporter reported patients height would be 5 (feet) 7 (inches) and her weight would be about 170 pounds. Patient had a Crohn's disease patient was taking Humira once every 2 weeks. And then because of this severity of her Crohn's patient was taking it every week. So she have had the Pfizer, the usual 2 and the booster, but she was immunocompromised. So when she took the Paxlovid, it worked because she was COVID positive with symptoms, within 2 days of symptoms and felt a whole lot better. But then when she took her next dose of Humira, started getting symptoms again, took another test and it came back positive and the reporter wanted to know if patient could just take Paxlovid again. Reporter causality as No.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a causal relationship between reported events, drug ineffective, Covid-19 and suspect BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: he and his husband are presenting tinnitus and they believe it is an adverse reaction from the vaccine/ringing on his hear; 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 54 year-old male patient received bnt162b2 (BNT162B2), administration date 14Oct2021 (Lot number: FE3590) as dose 3 (booster), single, administration date 31Mar2021 (Lot number: EP6955) as dose 2, single and administration date 08Mar2021 (Lot number: EN6200) 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: TINNITUS (non-serious), outcome "unknown", described as "he and his husband are presenting tinnitus and they believe it is an adverse reaction from the vaccine/ringing on his hear".  Additional information: It was reported that, Caller was a consumer of Pfizer Covid-19 Vaccine, reached to report that he and his husband are presenting tinnitus and they believe it was an adverse reaction from the vaccine. Caller also reported that he read an article, mentioned that the author was Dr. The caller was a male, 54 years old, he reported never have had problems with hearing, but he was having a ringing on his hear during the day, it was not loud, and it starts when it's really silent with a dead silence.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Muscle spasms, SARS-CoV-2 test, Vision blurred
Clinical narrative: muscle cramps all over my body; my vision is blurry; my energy level is way down.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jul2021 13:00 (Lot number: fA7485) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0180, Location of injection: Arm Left), administration date: 11Jun2021, when the patient was 62 years old, for COVID-19 immunization.  The following information was reported: MUSCLE SPASMS (non-serious) with onset 23Jul2021 04:00, outcome "not recovered", described as "muscle cramps all over my body"; VISION BLURRED (non-serious) with onset 23Jul2021 04:00, outcome "not recovered", described as "my vision is blurry"; ASTHENIA (non-serious) with onset 23Jul2021 04:00, outcome "not recovered", described as "my energy level is way down.". The event "muscle cramps all over my body" was evaluated at the physician office visit. The events "my vision is blurry" and "my energy level is way down." were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, vision blurred, asthenia.  Additional Information: No known allergies. No other Vaccine in four weeks. No other medications in two weeks. If covid prior vaccination and If covid tested post vaccination: Yes. Covid test post vaccination: Covid test type post vaccination: nasal swab. covid test name post date: 19Jan2022; Covid test result: Negative.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; 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. The reporter is the parent.  A male 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pain in extremity, Vaccination site pain
Clinical narrative: Arm pain where I got the shot, we both have the symptoms; Arm pain where I got the shot, we both have the symptoms; I have diarrhea; Stomach pains; 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 64 year-old male patient received bnt162b2 (BNT162B2) (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:, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2:, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Arm pain where I got the shot, we both have the symptoms"; DIARRHOEA (non-serious), outcome "unknown", described as "I have diarrhea"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach pains".  Additional information: Reporter stated that he got booster shot and already had the first two doses. He had diarrhea, stomach pains, and arm pain where he got the shot. Reporter stated that he already had reported side effects in front of him from the paper they gave him  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Glomerulonephritis, Henoch-Schonlein purpura, Investigation
Clinical narrative: Development of IgA vasculitis with severe glomerulonephritis; Development of IgA vasculitis with severe glomerulonephritis; This is a literature report for the following literature source(s):   A 40 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: GLOMERULONEPHRITIS (medically significant), HENOCH-SCHONLEIN PURPURA (non-serious), outcome "unknown" and all described as "Development of IgA vasculitis with severe glomerulonephritis". The patient underwent the following laboratory tests and procedures: sCR (mg/dl) at development eGFR development to maximum: normal; hematuria: 2/hpf. Clinical course: The patient was on observation for initial dose of steroid treatment.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event glomerulonephritis cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: My left arm is pretty much useless since the 1st covid shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Apr2021 (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: LIMB DISCOMFORT (non-serious) with onset 24Apr2021, outcome "not recovered", described as "My left arm is pretty much useless since the 1st covid shot". The reporter left arm was pretty much useless since the 1st covid shot. The left Delta was all but wasted away in attribute. The reporter stated, the patient had vaccine dates for 24Apr and May 11th roughly patient thought.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Eye pain, Feeling abnormal, Suspected COVID-19, Tinnitus
Clinical narrative: I contracted the virus; I contracted the virus; terrible buzzing/ringing in my ears; aching in my eyes; a strange feeling in my head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) 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: Covid-19 vaccine (Dose 1, single; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I contracted the virus"; TINNITUS (non-serious), outcome "unknown", described as "terrible buzzing/ringing in my ears"; EYE PAIN (non-serious), outcome "unknown", described as "aching in my eyes"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "a strange feeling in my head".  Clinical Information: Patient had terrible buzzing/ringing in ears. Patient was not sure how long after second shot, but after second shot had been commenting about it for months to friends. Then patient contracted the virus and was looking up side effects of COVID because patient was experiencing aching in eyes and a strange feeling in head.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Illness, Pain in extremity, Vaccination site pain
Clinical narrative: arm pain where I got the shot, we both have the symptoms; arm pain where I got the shot, we both have the symptoms; diarrhea; vomiting; stomach pains; He states his wife is very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 64 year-old female patient received bnt162b2 (BNT162B2) (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, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE:2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "arm pain where I got the shot, we both have the symptoms"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pains"; ILLNESS (non-serious), outcome "unknown", described as "He states his wife is very sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: arm pain where I got the shot, we both have the symptoms; arm pain where I got the shot, we both have the symptoms; diarrhea; vomiting; stomach pains; He states his wife is very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 64 year-old female patient received bnt162b2 (BNT162B2) (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, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE:2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "arm pain where I got the shot, we both have the symptoms"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pains"; ILLNESS (non-serious), outcome "unknown", described as "He states his wife is very sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 26Oct2021 (Lot number: FD0810) at the age of 45 years as dose 3 (booster), single, administration date 18Mar2021 (Lot number: El3247) as dose 2, single and administration date 25Feb2021 (Lot number: El3247) 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 FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Mar2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Mar2022) positive.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not Feeling Well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415). The reporter is the patient.  An adult 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: MALAISE (non-serious), outcome "unknown", described as "Not Feeling Well".  Additional information: The first one did make me feel bad for a day or two but the second wasn't bad at all. Patient's Other medications, Past Medical History, Family History, Social History, Other relevant information were unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm when touched; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Apr2021 12:30 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Environmental allergies" (ongoing), notes: Environmental allergies; "Low Vitamin D" (ongoing); "High Blood pressure", start date: 09Jun2007 (ongoing); "Hypothyroidism", start date: 05Sep2008 (ongoing); "High Cholesterol", start date: 09Jun2007 (ongoing); "Anxiety", start date: 03Mar2010 (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); ATENOLOL taken for hypertension (ongoing); SERTRALINE taken for anxiety (ongoing); ALLER TEC taken for hypersensitivity (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin d decreased (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm when touched".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lacrimation increased, Rhinorrhoea
Clinical narrative: Fatigue; Runny nose; Watery eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03May2021 12:00 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure", start date: 09Jun2007 (ongoing), notes: High blood pressure; "Hypothyroidism", start date: 05Sep2008 (ongoing); "High Cholesterol", start date: 09Jun2007 (ongoing); "Anxiety", start date: 03Mar2010 (ongoing); "Low Vitamin D" (ongoing); "Environmental allergies" (ongoing), notes: Environmental allergies. Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); ATENOLOL taken for hypertension (ongoing); SERTRALINE taken for anxiety (ongoing); ALLER TEC taken for hypersensitivity (ongoing); VITAMIN D [COLECALCIFEROL] taken for vitamin d decreased (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 12:30 PM, Site and route of injection: Left upper arm, Intramuscular, Batch/Lot number: Not available provided at time of report completion, Sore arm when touched), administration date: 12Apr2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "Sore arm when touched". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; LACRIMATION INCREASED (non-serious), outcome "unknown", described as "Watery eyes".  Additional information- Prior vaccinations within 4 weeks reported and  specific relevant test for thromboembolic events with thrombocytopenia reported as none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: Dark stool following the administration of her first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 22 year-old female patient received bnt162b2 (COMIRNATY, 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: FAECES DISCOLOURED (non-serious), outcome "unknown", described as "Dark stool following the administration of her first dose". The lot number for the vaccine, Comirnaty, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; 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) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID-19".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Dizziness
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; 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) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID-19".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female 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 (Dose: 1), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "dizzy"; DEHYDRATION (non-serious), outcome "unknown", described as "dehydrated". Additional information: Reports she has had both vaccines with no side effects at all, but she had Regeneron and had a very bad reaction. They gave the Regeneron to her through an IV. States she saw stars in the sky and her throat was closing up, it was really bad. She wants to get the booster today. But wants to know if the booster dose has the same ingredients as the first two vaccines. Provides that she has the main two ingredients that were in the Regeneron. Reports those as: casirivimab and imdevimab. It's a concoction, but those are the two main ones. She had the first and second vaccines without any side effects. She did get a little dizzy after the second vaccine for a few minutes, but she was dehydrated. With Regeneron, she had a bad side effect, so she wants to make sure the ingredients in the third dose are the same as what is in the first and second doses. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Dizziness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female 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 (Dose: 1), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "dizzy"; DEHYDRATION (non-serious), outcome "unknown", described as "dehydrated". Additional information: Reports she has had both vaccines with no side effects at all, but she had Regeneron and had a very bad reaction. They gave the Regeneron to her through an IV. States she saw stars in the sky and her throat was closing up, it was really bad. She wants to get the booster today. But wants to know if the booster dose has the same ingredients as the first two vaccines. Provides that she has the main two ingredients that were in the Regeneron. Reports those as: casirivimab and imdevimab. It's a concoction, but those are the two main ones. She had the first and second vaccines without any side effects. She did get a little dizzy after the second vaccine for a few minutes, but she was dehydrated. With Regeneron, she had a bad side effect, so she wants to make sure the ingredients in the third dose are the same as what is in the first and second doses. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have not had an infection in either foot since I started taking these vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Apr2021 15:00 (Lot number: er8729) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "I have suffered from infections in between my small toes on both feet" (not ongoing), notes: infections in between toes on both feet for 15-20 years because of Athletes foot.; "Athletes foot" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". Vaccination history included: Bnt162b2 (Dose 1, administration time=15:00, anatomical location=Right arm, lot number=pn6199), administration date: 19Mar2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 08Apr2021, outcome "unknown", described as "I have not had an infection in either foot since I started taking these vaccines". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: No other vaccines in four weeks, no Covid prior to vaccination. The patient has not tested Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Ear, nose and throat examination
Clinical narrative: 8.5 months salty taste, later developed metallic taste for 2 months; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 12Apr2021 (Batch/Lot number: unknown) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "glucose intolerance" (unspecified if ongoing); "CAD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ace inhibitor, reaction(s): "allergies: ACE inhibitor"; Terazosin, reaction(s): "allergies: Terazosin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 21Mar2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: DYSGEUSIA (non-serious) with onset 19Apr2021, outcome "recovered", described as "8.5 months salty taste, later developed metallic taste for 2 months". The event "8.5 months salty taste, later developed metallic taste for 2 months" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia.  Additional information: No other vaccine in four weeks. No covid prior vaccination. Covid not tested post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash macular, Vaccination site warmth
Clinical narrative: now is experiencing "blotches" in the arm where he received the vaccine.; the blotches as not itching but being hot.; speak to someone about this event to make sure it is not an allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date Mar2022 (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: RASH MACULAR (non-serious), outcome "unknown", described as "now is experiencing "blotches" in the arm where he received the vaccine."; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "the blotches as not itching but being hot."; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "speak to someone about this event to make sure it is not an allergic reaction".  Additional information: caller behalf of her husband who received the Pfizer COVID-19 Vaccine last Friday and now is experiencing "blotches" in the arm where he received the vaccine. Caller wanted to know if this was normal. She also described the blotches as not itching but being hot. Patient wants to speak to someone about this event to make sure it is not an allergic reaction, or if her husband should go to the doctor.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Inappropriate schedule of product administration, Myalgia, Pain in extremity
Clinical narrative: feel a lot of pain in my limbs and my muscles; feel a lot of pain in my limbs and my muscles; bone pain; He got the duplicated first dose in Dec2021; 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 Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Pfizer-BioNTech), administration date: Jun2021, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Dec2021, outcome "unknown", described as "He got the duplicated first dose in Dec2021"; MYALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "feel a lot of pain in my limbs and my muscles"; BONE PAIN (non-serious), outcome "unknown", described as "bone pain".  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (22Mar2022): This is a spontaneous follow-up report from a contactable consumer. Updated Information Included reporter mailing address updated. Historical vaccine administration date updated.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A 58-year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired".  Additional information: Tired after getting second dose of Comirnaty and did get the Omicron variant after being vaccinated. The reporter considered that event was caused by suspect vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Iron deficiency
Clinical narrative: Iron deficiency; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 12Aug2021 16:15 (Lot number: EW0179) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anemia" (ongoing), notes: OTC Iron Supplement, Route: PO, Date: Oct2021, ; "Hypercholesterolemia", start date: 26Apr2021 (ongoing), notes: No meds needed at this time. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose1, Time:16:45 PM, Anatomical site of injection: deltoid left, Route of administration: Intramuscular, Batch number: EW0179), administration date: 19Jul2021, for COVID-19 immunization. The following information was reported: IRON DEFICIENCY (non-serious) with onset 17Sep2021, outcome "not recovered", described as "Iron deficiency". Therapeutic measures were taken as a result of iron deficiency.  Additional information: It was reported that, patient had not received any other vaccine within 4 weeks Prior to vaccinations. patient was also receiving OTC Iron Supplement.   No follow-up attempts are possible. No further information is expected.