chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Allergic reaction at injection site. Area is red and swollen for several days; Allergic reaction at injection site. Area is red and swollen for several days; Allergic reaction at injection site. Area is red and swollen for several days; Allergic reaction at injection site. Area is red and swollen for several days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 09:30 (Lot number: FF2590) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 12Oct2021. Vaccination history included: Bnt162b2 (Dose 2;, Lot number: ER8737,, Dose administration time: 11:30 AM, Vaccine location: Left arm), administration date: 20Apr2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose 1;, Lot number: EN6204,, Dose administration time: 11:30 AM, Vaccine location: Left arm, ), administration date: 30Mar2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE REACTION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), HYPERSENSITIVITY (non-serious) all with onset 01Nov2021, outcome "recovering" and all described as "Allergic reaction at injection site. Area is red and swollen for several days". Therapeutic measures were not taken as a result of vaccination site reaction, vaccination site erythema, vaccination site swelling, hypersensitivity.  Additional information: Allergic reaction at injection site. Area is red and swollen for several days. This occurred just on the 3rd shot. Adverse events start date: 01Nov2021. If patient recovered: Recovering. If treatment ae: No. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. Other mediation in two weeks: No. Known allergies: No. Other medical history: No.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Crystal urine, Dizziness, Gait disturbance, Magnetic resonance imaging head
Clinical narrative: dizziness; vomiting; vertigo; did not lodge up quick or bend down and she felt unsteady; 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 70 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 08Mar2021 (Lot number: EN6202) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Lot: EL9266, Route of administration: Intramuscular), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 Immunization; Flu shot (She gets the flu shot every year and she gets nothing except a sore arm and she went for the flu shot a month ago and had a sore arm), reaction(s): "Sore Arm". The following information was reported: VERTIGO (non-serious) with onset May2021, outcome "recovered" (20Oct2021), described as "vertigo"; GAIT DISTURBANCE (non-serious) with onset May2021, outcome "unknown", described as "did not lodge up quick or bend down and she felt unsteady"; DIZZINESS (non-serious) with onset 21Oct2021, outcome "unknown", described as "dizziness"; VOMITING (non-serious) with onset 21Oct2021, outcome "unknown", described as "vomiting". The events "vertigo", "did not lodge up quick or bend down and she felt unsteady", "dizziness" and "vomiting" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo, dizziness.  Additional information: The patient is calling about the Pfizer covid vaccine. She had a question and asks if vertigo is a side effect. Reports she never had vertigo before, and it happened approximately 6 weeks after getting the covid second shot and happened a couple of times since. She heard from people that read on internet that vertigo happens with the covid shot and she looked it up. When querying outcome, reports the vertigo happens out of nowhere, she could get up and it happened, first time she was getting out of a car, did not lodge up quick or bend down and she felt unsteady. The last time vertigo occurred was 20Oct2021. Reports it has happened 4 times since beginning of May2021 and she does not have exact dates to provide. Treatment: went to ENT doctor and the doctor did not find anything. She was sent for a brain MRI and did not find anything. Reports she was sick as a dog and this put her out of commission for 6 or 7 hours and saw her primary doctor. Her doctor did a series of blood tests and said it was fine and cannot come up with anything else. She asked her doctor if it was a possible side effect and her doctor told her that anything is possible and did not really answer her.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: dizziness; vomiting; vertigo; did not lodge up quick or bend down and she felt unsteady; 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 70 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 08Mar2021 (Lot number: EN6202) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Lot: EL9266, Route of administration: Intramuscular), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 Immunization; Flu shot (She gets the flu shot every year and she gets nothing except a sore arm and she went for the flu shot a month ago and had a sore arm), reaction(s): "Sore Arm". The following information was reported: VERTIGO (non-serious) with onset May2021, outcome "recovered" (20Oct2021), described as "vertigo"; GAIT DISTURBANCE (non-serious) with onset May2021, outcome "unknown", described as "did not lodge up quick or bend down and she felt unsteady"; DIZZINESS (non-serious) with onset 21Oct2021, outcome "unknown", described as "dizziness"; VOMITING (non-serious) with onset 21Oct2021, outcome "unknown", described as "vomiting". The events "vertigo", "did not lodge up quick or bend down and she felt unsteady", "dizziness" and "vomiting" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vertigo, dizziness.  Additional information: The patient is calling about the Pfizer covid vaccine. She had a question and asks if vertigo is a side effect. Reports she never had vertigo before, and it happened approximately 6 weeks after getting the covid second shot and happened a couple of times since. She heard from people that read on internet that vertigo happens with the covid shot and she looked it up. When querying outcome, reports the vertigo happens out of nowhere, she could get up and it happened, first time she was getting out of a car, did not lodge up quick or bend down and she felt unsteady. The last time vertigo occurred was 20Oct2021. Reports it has happened 4 times since beginning of May2021 and she does not have exact dates to provide. Treatment: went to ENT doctor and the doctor did not find anything. She was sent for a brain MRI and did not find anything. Reports she was sick as a dog and this put her out of commission for 6 or 7 hours and saw her primary doctor. Her doctor did a series of blood tests and said it was fine and cannot come up with anything else. She asked her doctor if it was a possible side effect and her doctor told her that anything is possible and did not really answer her.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Illness, Migraine
Clinical narrative: migraines; have a stomach bug; having a mild illness; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 11Oct2021 (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: MIGRAINE (non-serious) with onset Oct2021, outcome "unknown", described as "migraines"; ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "have a stomach bug"; ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "having a mild illness". Therapeutic measures were taken as a result of migraine.  Additional Information: Caller states she initiated treatment with Aimovig for migraines on 16Oct2021. Caller states she has already been on a daily steroid regimen for a while. The event stomach bug required frequent trips to the bathroom.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase increased
Clinical narrative: elevation of some labs, including ASTs.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 66 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ASPARTATE AMINOTRANSFERASE INCREASED (non-serious), outcome "unknown", described as "elevation of some labs, including ASTs.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller is a physician/HCP. Pfizer covid 19 vaccine/Comirnaty confirmed. Caller is asking for any information available on the effects of the vaccine and liver enzymes, including what labs were monitored or tested during the clinical trials of the vaccine or available toxicity information. Caller reported his patient had a moderate, symptomatic reaction following her booster dose administration of the vaccine. Caller "Ran her annual labs about five days after that" and observed elevation of some labs, including ASTs. Response provided caller with information from the Landmark trial protocol: LFTs are not required as a routine safety monitoring procedure for all participants in this study.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: soreness while lifting weights/a sore arm for a few days; significant tenderness in the vaccination arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 08Sep2021 (Lot number: EW0164) at the age of 57 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: PAIN (non-serious), outcome "unknown", described as "soreness while lifting weights/a sore arm for a few days"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "significant tenderness in the vaccination arm".  Additional Context: Caller states he has had a slightly unusual reaction to the Pfizer Covid vaccine, wants to know how to move forward. Caller got first shot on 08Sep2021, states he had a normal reaction afterwards, a sore arm for a few days, states since he considered himself low risk of exposure, he had planned to delayed his second shot, he states he was going to wait about 8 weeks to not have as strong of an immune response. States that around 20Oct2021, about 6 weeks after the first dose of the vaccine, he noticed a significant tenderness in the vaccination arm, clarifies he received the first dose in his left arm, states that more recently after 6.5-7 weeks and had significantly reduced range of motion in that shoulder. Caller is concerned about this delayed reaction.   Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus, Rash
Clinical narrative: Swollen lymph nodes in head and neck; Rash to scalp; itchiness to scalp; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 42 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: Covid-19 vaccine (Dose: 1, Batch/ Lot number: Not Available/ Provided at time of report completion., Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Batch/ Lot number: Not Available/ Provided at time of report completion., Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovering", described as "Swollen lymph nodes in head and neck"; RASH (non-serious), outcome "recovering", described as "Rash to scalp"; PRURITUS (non-serious), outcome "recovering", described as "itchiness to scalp". The events "swollen lymph nodes in head and neck", "rash to scalp" and "itchiness to scalp" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of lymphadenopathy, rash, pruritus.  Additional Information: Prior Vaccinations (within 4 weeks) was reported as unknown. Relevant tests was reported as none. Specific relevant test for thromboembolic events with thrombocytopenia was reported as none. She did mention that she made an appointment with her PCP and was told this was a reaction to her booster shot.  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: Arthritis, Musculoskeletal stiffness, Trigger finger
Clinical narrative: trigger fingers in both of my hands; stiffness both of my hands; arthiritis in my hands and finger; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 14Jun2021 (Batch/Lot number: unknown) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization. The following information was reported: TRIGGER FINGER (non-serious) with onset 2021, outcome "unknown", described as "trigger fingers in both of my hands"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "stiffness both of my hands"; ARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "arthiritis in my hands and finger".  Follow-up (04Nov2021):This is a follow-up spontaneous report from a non contactable consumer. This 75-year-old female consumer (patient) reported for herself that after the second shot which was a 14Jun a few weeks later she started getting a trigger fingers in both of her hands and arthritis in her hands and stiffness both of my hands  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: needle sticking pain on her body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-160751 (Moderna).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "needle sticking pain on her body". Additional information: The reporter 's friend was the patient. The reporter mentioned that the patient following administration with the Pfizer COVID19 vaccine experienced the same kind of thing as experienced by the reporter, a needle sticking pain on her body. There was no product complaint associated with this case 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: Asthenia, Cardiac disorder, Palpitations, Pyrexia
Clinical narrative: Heart problems; Palpitations / heart palpitations; Fever; Weakness; 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 66 year-old female patient received bnt162b2 (BNT162B2), administration date 25Oct2021 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "sleep apnea" (unspecified if ongoing), notes: Caller states she had sleep apnea, diabetes, and high blood pressure before her vaccines; "diabetes" (unspecified if ongoing), notes: Caller states she had sleep apnea, diabetes, and high blood pressure before her vaccines; "high blood pressure" (unspecified if ongoing), notes: Caller states she had sleep apnea, diabetes, and high blood pressure before her vaccines. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 01Oct2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Heart problems"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown", described as "Palpitations / heart palpitations"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weakness".  Additional information: Agent states that the Caller reports having heart problems, fever, weakness and heart palpitations with the second dose. Agent states the Caller wants to know the correct timeframe to get her third dose, her third dose is scheduled on 15Nov2021. Caller states her doctor told her to wait 6 months after the second dose, to get her third dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Rash macular, Urticaria
Clinical narrative: we all had this head toll/a rash; hives on the face that is itchy; hives on the face that is itchy; arm was sore; getting blotches on the face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (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 (non-serious), outcome "unknown", described as "we all had this head toll/a rash"; URTICARIA (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "hives on the face that is itchy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore"; RASH MACULAR (non-serious), outcome "unknown", described as "getting blotches on the face". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test, Tinnitus, Tremor
Clinical narrative: vertigo; headache; tinnitus loud; extreme fatigue; hand tremor; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 18Oct2021 15:45 (Lot number: ew0168) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Addison's disease" (unspecified if ongoing); "inflammatory disorder" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing), notes: Reaction: Rash; "Have had tinnitus for decades" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX; MYCOPHENOLATE; HYOSCYAMINE; BUPROPION. Vaccination history included: Bnt162b2 (Dose Number: 1, Brand: Pfizer ew 0177, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Event started: 21Sep2021), administration date: 20Sep2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "vertigo", "headache", "tinnitus loud", "extreme fatigue", "hand tremor", "slight disorientation", "memory problems".  The following information was reported: VERTIGO (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "vertigo"; HEADACHE (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "headache"; TINNITUS (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "tinnitus loud"; FATIGUE (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "extreme fatigue"; TREMOR (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "hand tremor". The events "vertigo", "headache", "tinnitus loud", "extreme fatigue" and "hand tremor" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, headache, tinnitus, fatigue, tremor.  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 has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; headache; tinnitus loud; extreme fatigue; hand tremor; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 18Oct2021 15:45 (Lot number: ew0168) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Addison's disease" (unspecified if ongoing); "inflammatory disorder" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing), notes: Reaction: Rash; "Have had tinnitus for decades" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX; MYCOPHENOLATE; HYOSCYAMINE; BUPROPION. Vaccination history included: Bnt162b2 (Dose Number: 1, Brand: Pfizer ew 0177, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Event started: 21Sep2021), administration date: 20Sep2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "vertigo", "headache", "tinnitus loud", "extreme fatigue", "hand tremor", "slight disorientation", "memory problems".  The following information was reported: VERTIGO (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "vertigo"; HEADACHE (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "headache"; TINNITUS (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "tinnitus loud"; FATIGUE (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "extreme fatigue"; TREMOR (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "hand tremor". The events "vertigo", "headache", "tinnitus loud", "extreme fatigue" and "hand tremor" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, headache, tinnitus, fatigue, tremor.  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 has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Pain, Paraesthesia, Pruritus
Clinical narrative: burning itching hands, and feet; burning itching hands, and feet; burning itching hands, and feet / Itching hands, palms, and webbing in fingers; Dizziness; blurrie vision; tingling in feet, hands, and legs; intense pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 12:00 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Syringomyelia" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: BURNING SENSATION (non-serious), BURNING SENSATION (non-serious) all with onset 03Nov2021, outcome "not recovered" and all described as "burning itching hands, and feet"; PRURITUS (non-serious) with onset 03Nov2021, outcome "not recovered", described as "burning itching hands, and feet / Itching hands, palms, and webbing in fingers"; DIZZINESS (non-serious) with onset 03Nov2021, outcome "not recovered", described as "Dizziness"; VISION BLURRED (non-serious) with onset 03Nov2021, outcome "not recovered", described as "blurrie vision"; PARAESTHESIA (non-serious) with onset 03Nov2021, outcome "not recovered", described as "tingling in feet, hands, and legs"; PAIN (non-serious) with onset 03Nov2021, outcome "not recovered", described as "intense pain". Therapeutic measures were not taken as a result of burning sensation, burning sensation, pruritus, dizziness, vision blurred, paraesthesia, pain.  Additional Information: The case was reported as non-serious. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. The patient reported that about known allergies that "Not that I know of". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The list of any other medications the patient received within 2 weeks of vaccination was reported as yes. It was reported that, 24 hours after vaccine burning itching hands, and feet. Really bad at night. Itching hands, palms, and webbing in fingers. Dizziness. Blurrie vision. Tingling in feet, hands, and legs. Comes and goes all day. Can be very intense pain/burning. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient received dose 2 (lot number: Ff2590) in right arm (date not reported). Device date was reported as 04Nov2021.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: burning itching hands, and feet; burning itching hands, and feet; burning itching hands, and feet / Itching hands, palms, and webbing in fingers; Dizziness; blurrie vision; tingling in feet, hands, and legs; intense pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 12:00 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Syringomyelia" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: BURNING SENSATION (non-serious), BURNING SENSATION (non-serious) all with onset 03Nov2021, outcome "not recovered" and all described as "burning itching hands, and feet"; PRURITUS (non-serious) with onset 03Nov2021, outcome "not recovered", described as "burning itching hands, and feet / Itching hands, palms, and webbing in fingers"; DIZZINESS (non-serious) with onset 03Nov2021, outcome "not recovered", described as "Dizziness"; VISION BLURRED (non-serious) with onset 03Nov2021, outcome "not recovered", described as "blurrie vision"; PARAESTHESIA (non-serious) with onset 03Nov2021, outcome "not recovered", described as "tingling in feet, hands, and legs"; PAIN (non-serious) with onset 03Nov2021, outcome "not recovered", described as "intense pain". Therapeutic measures were not taken as a result of burning sensation, burning sensation, pruritus, dizziness, vision blurred, paraesthesia, pain.  Additional Information: The case was reported as non-serious. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. The patient reported that about known allergies that "Not that I know of". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The list of any other medications the patient received within 2 weeks of vaccination was reported as yes. It was reported that, 24 hours after vaccine burning itching hands, and feet. Really bad at night. Itching hands, palms, and webbing in fingers. Dizziness. Blurrie vision. Tingling in feet, hands, and legs. Comes and goes all day. Can be very intense pain/burning. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient received dose 2 (lot number: Ff2590) in right arm (date not reported). Device date was reported as 04Nov2021.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Flare up of arthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (141010). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ XR. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization; Bnt162b2 (Dose 2, Single), for COVID-19 immunization. The following information was reported: ARTHRITIS (non-serious) with onset 01Oct2021 12:00, outcome "recovered" (2021), described as "Flare up of arthritis". Therapeutic measures were taken as a result of arthritis.  Additional information: Patient reported she had a flare after doing her COVID-19 booster vaccine about two weeks ago. Patient was treated this with prednisone and rest, and was doing better now. Patient also missed about a week of doses due to insurance issues about a month ago. Patient considered flare up of arthritis as non-serious. Patient stated that event flare up of arthritis is not related to the suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information the reported event flare up of arthritis assessed as unrelated to suspect drug BNT162B2.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cough, Pyrexia, Vaccination site pain
Clinical narrative: intense pain in the injection site; fever; Cough; upset stomach; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 14:45 (Lot number: Ew0172) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing), notes: Other medical history: Adhd.; "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder. Past drug history included: Amoxocillin, reaction(s): "known allergies; amoxicillin", notes: Known allergies: Amoxocillin. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "intense pain in the injection site"; PYREXIA (non-serious), outcome "recovering", described as "fever"; COUGH (non-serious), outcome "recovering", described as "Cough"; ABDOMINAL DISCOMFORT (non-serious), outcome "recovering", described as "upset stomach". Therapeutic measures were taken as a result of vaccination site pain, pyrexia, cough, abdominal discomfort.  Additional information: After receiving each dose Patient was sick for 3 days with a fever, cough, and upset stomach with intense pain in the injection site that traveled up to neck and down to left side. Patient couldn't move neck completely, but the side effects subsided after day three. Patient was advised to take antihistamine as a treatment of adverse events. No other vaccine in four weeks. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lip pain, Lip swelling
Clinical narrative: dermal fillers in my lips on 02Nov2021 i had extreme pain swelling, and significant bruising.; dermal fillers in my lips on 02Nov2021 i had extreme pain swelling, and significant bruising.; dermal fillers in my lips on 02Nov2021 i had extreme pain swelling, and significant bruising.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27May2021 14:45 (Lot number: Ew0172) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder. Past drug history included: Amoxocillan, reaction(s): "Known allergies: Amoxocilan", notes: Known allergies: Amoxocillin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0172, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 06May2021, when the patient was 30 years old, for Covid-19 immunization, reaction(s): "Injection site pain", "Fever", "upset stomach"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0172, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 06May2021, when the patient was 30 years old, for COVID-19 immunization, reaction(s): "Cough". The following information was reported: CONTUSION (non-serious), LIP PAIN (non-serious), LIP SWELLING (non-serious) all with onset 02Nov2021 23:30, outcome "recovering" and all described as "dermal fillers in my lips on 02Nov2021 i had extreme pain swelling, and significant bruising.". The event "dermal fillers in my lips on 02nov2021 i had extreme pain swelling, and significant bruising.", "dermal fillers in my lips on 02nov2021 i had extreme pain swelling, and significant bruising." and "dermal fillers in my lips on 02nov2021 i had extreme pain swelling, and significant bruising." was evaluated at the physician office visit. Therapeutic measures were taken as a result of contusion, lip pain, lip swelling.  Additional Information: Facility type vaccine: Pharmacy or Drug Store Facility country: No other vaccine in four weeks. After receiving each dose patient was sick for 3 days with a fever, cough, and upset stomach with intense pain in the injection site that traveled up her neck and down her left side. She couldn't move her neck completely but the side effects subsided after day three. 2. Patient received dermal fillers in her lips on 02Nov2021 she had extreme pain, swelling, and significant bruising. Taking an antihistamine helped to reduce the pain and swelling the following day. AE treatment: Advised to take antihistamine. Patient had Covid-19 prior vaccination. Patient was not tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Jan2021 15:00 (Lot number: EL3246) at the age of 24 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Jan2021, outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Vaccination Facility Type was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant drugs, Patient Medical History (including any illness at time of vaccination), Relevant Tests and Specific Relevant Test for thromboembolic events with thrombocytopenia were reported as none. The patient did not receive Advil, heat packs as treatment for the events. The patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL961, Expiry date: unknown), via an unspecified route of administration, administered in Left Arm on 22Jan2021 at 15:00 as dose 2, single and experienced Arm pain, chills, fever, body aches on 23Jan2021and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FE3590, Expiry date: unknown), via an unspecified route of administration, administered in Left Arm on 09Oct2021 (at the age of 25 years) as dose 3 (booster), single for covid-19 immunisation and experienced Sores, swollen armpit from 10Oct2021 to 24Oct2021. Dose one was followed by a sore arm which recovered to days post injection. Dose two caused covid-19 like symptoms, starting about 14 hours post injection. These symptoms resided after about 15 hours of rest. They included chills, fever, body aches, headache, and fatigue. One day post dose noticed swelling in my left underarm. The pain and swelling lasted two weeks.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: I'm losing my voice"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHONIA (non-serious), outcome "unknown", described as "I'm losing my voice"". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: had some back pain/ back pain before the booster; 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 patient.  A male patient received bnt162b2 (COMIRNATY) (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: BACK PAIN (non-serious), outcome "unknown", described as "had some back pain/ back pain before the booster". Therapeutic measures were not taken as a result of back pain.  Additional information: Patient also had another question that he had booster on Wednesday and before he had the vaccine, he had some back pain and did not want to take any ibuprofen or anything just to get max benefit. He was wondering once it had been 2 days, does it not matter if you take any anti-inflammatory.     Follow up (05Nov2021): This is a follow up spontaneous report from a Pfizer Sponsored Program.  The lot number for the vaccine, [COMIRNATY], was not provided and will be requested during follow up.  Follow-up (10Nov2021): 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: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Falling asleep in school tiredness; Falling asleep in school tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 14:00 (Lot number: FkS127) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history:Asthma. The patient's concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious), FATIGUE (non-serious) all with onset 05Nov2021 09:00, outcome "not recovered" and all described as "Falling asleep in school tiredness". Therapeutic measures were not taken as a result of somnolence, fatigue.  Additional information: patient had no allergies. Not tested covid post vaccination and prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Therapeutic response unexpected
Clinical narrative: all her pain was gone/the pain disappeared again; 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 74 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 21Oct2021 (Lot number: FF2590) at the age of 74 years as dose 3 (booster) single, administered in arm right, administration date 06Feb2021 (Lot number: EL9262) as dose 2, single and administered in arm right, administration date 16Jan2021 (Lot number: EL8982) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Verbatim: Diabetes; "Asthma" (ongoing), notes: Verbatim: asthma; "Overweight" (ongoing), notes: Verbatim: Overweight; "lipids were elevated for years" (unspecified if ongoing), notes: states the lipids were high prior to her receiving the Pfizer COVID Vaccine and the lipids were elevated for years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "recovering", described as "all her pain was gone/the pain disappeared again". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller said she had chronic pain even before the Pfizer COVID Vaccine and mentioned she already received both doses of the vaccine and her booster dose. States she received the 1st dose of the vaccine and the next morning all her pain was gone; states the pain came back gradually in Oct2021 and after she received the booster dose in Oct2021 the pain disappeared again; states she can walk more, her hands are usable and she can do more and whatever is in the vaccine is helping her with the pain and she can still feel the pain but it is not as severe. Caller states the pain came back in Sep2021 and Oct2021 gradually and she had the booster vaccine in Oct2021 and by then the pain was full back. States other than a blood test done she did not start any new medications and states she does not have cancer; states her lipids were high and they had been high for a long time so that was the reason she went to see if there was something going on and her nurse practitioner didn't want to miss anything and her lipids were high all the time; states the lipids were high prior to her receiving the Pfizer COVID Vaccine and the lipids were elevated for years and did not want to take a chance; states she went to Cancer # and they did a blood workup and there was not anything to be worried about and for her to come back in a year for more blood work; states she had the extensive blood work done and if there is anything that might help she will turn over the blood work results.  Follow-up attempts are completed. No further information is expected.