chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness in both legs escalating upwards to her waist and hands; Tingling in both legs escalating upwards to her waist and hands; driving crazy; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in both legs escalating upwards to her waist and hands), PARAESTHESIA (Tingling in both legs escalating upwards to her waist and hands) and FEELING ABNORMAL (driving crazy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy -Hives). Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication.    On 14-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Dec-2021, the patient experienced HYPOAESTHESIA (Numbness in both legs escalating upwards to her waist and hands) and PARAESTHESIA (Tingling in both legs escalating upwards to her waist and hands). In December 2021, the patient experienced FEELING ABNORMAL (driving crazy). At the time of the report, HYPOAESTHESIA (Numbness in both legs escalating upwards to her waist and hands), PARAESTHESIA (Tingling in both legs escalating upwards to her waist and hands) and FEELING ABNORMAL (driving crazy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2022, Blood test: normal (normal) Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The caller stated approximately 20 or 30 minutes after receiving the Moderna injection, patients started to experience events.  Patient reported she did not receive the second Moderna COVID-19 dose due to the numbness and tingling. Patient went to see her primary care physician. patient went to see a neurologist on 17-Feb-2022 and reported that the neurologist tested for nerve damage, and the results were normal. patient had a flu vaccine every year and never had any problems with the flu vaccine. patient mentioned the numbness and tingling was ongoing and constant each day. The symptoms worsened. No treatment medications reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Leukocytosis, White blood cell count
Clinical narrative: Elevated white cell count of 11800; This spontaneous case was reported by a physician and describes the occurrence of LEUKOCYTOSIS (Elevated white cell count of 11800) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced LEUKOCYTOSIS (Elevated white cell count of 11800). At the time of the report, LEUKOCYTOSIS (Elevated white cell count of 11800) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, White blood cell count: 11800 (High) 11800 count.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient height 7.1 foot. No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2022-488826 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Feb-2022: Follow-up received, contains updated patient demographics and patient route of administration of suspect vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received booster dose. No concomitant medications were reported. Date the vial was initially stored in the refrigerator on 02-Feb-2022 The vial did not undergone any temperature excursion. No treatment medications were reported.   This case was linked to MOD-2022-489211 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Receiving expired vaccine) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Receiving expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported. The vial was initially stored in the refrigerator on 02 Feb 2022 and it didn't undergo any temperature excursions.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Laboratory test, Malaise
Clinical narrative: Patient received expired vaccine. DH and Pfizer recommended revaccination. Upon calling patient to reschedule, the patient stated he was ill post vaccination and was seen by his doctor. The doctor ran tests. The patient states he is fine now. He stated he was unsure if the reaction was caused by the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 17 patients administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  Date the vial was initially stored in refrigerator was 28Sep2021. Date of administration of vaccine was on 28Sep2021 and 30Sep2022. The patient did not reported any adverse events.   This case was linked to MOD-2022-489458 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain lower, Back pain, Computerised tomogram, Condition aggravated
Clinical narrative: Since my second dose, I have ensured exponential lower back and leg pain, tingling, cramping, migraines, and in June developed a gastrointestinal problem that has not subsided, along with bloating, feeling full quickly, and lower abdominal pain. I had PCOS and endometriosis, but in August of 2021, CT scan detected a 3 inch cyst on my left ovary, and the cyst had a cyst on it. The left ovary was 15 times its normal size, so both were removed in September. After surgery, my leg and back pain have not subsided, and since my booster administered on 2/7/22, I have endured near crippling pain, have had to miss work and/or work from bed.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Hysterectomy, Impaired work ability, Magnetic resonance imaging, Migraine
Clinical narrative: Since my second dose, I have ensured exponential lower back and leg pain, tingling, cramping, migraines, and in June developed a gastrointestinal problem that has not subsided, along with bloating, feeling full quickly, and lower abdominal pain. I had PCOS and endometriosis, but in August of 2021, CT scan detected a 3 inch cyst on my left ovary, and the cyst had a cyst on it. The left ovary was 15 times its normal size, so both were removed in September. After surgery, my leg and back pain have not subsided, and since my booster administered on 2/7/22, I have endured near crippling pain, have had to miss work and/or work from bed.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Oophorectomy, Ovarian cyst, Ovarian enlargement, Pain
Clinical narrative: Since my second dose, I have ensured exponential lower back and leg pain, tingling, cramping, migraines, and in June developed a gastrointestinal problem that has not subsided, along with bloating, feeling full quickly, and lower abdominal pain. I had PCOS and endometriosis, but in August of 2021, CT scan detected a 3 inch cyst on my left ovary, and the cyst had a cyst on it. The left ovary was 15 times its normal size, so both were removed in September. After surgery, my leg and back pain have not subsided, and since my booster administered on 2/7/22, I have endured near crippling pain, have had to miss work and/or work from bed.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Since my second dose, I have ensured exponential lower back and leg pain, tingling, cramping, migraines, and in June developed a gastrointestinal problem that has not subsided, along with bloating, feeling full quickly, and lower abdominal pain. I had PCOS and endometriosis, but in August of 2021, CT scan detected a 3 inch cyst on my left ovary, and the cyst had a cyst on it. The left ovary was 15 times its normal size, so both were removed in September. After surgery, my leg and back pain have not subsided, and since my booster administered on 2/7/22, I have endured near crippling pain, have had to miss work and/or work from bed.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, Palpitations, Thyroxine free normal
Clinical narrative: started having heart palpitations around beginning of Feb. 2022.  Initially thought it was due to levothyroxine dose change but blood work reviewed by endocrinologist ruled out levothyroxine as the cause (this has happened in the past where I experienced heart palpitations due to increased dose to 75mcg from 50 mcg.  Current dose is 62.5 mcg).   Spoke with my primary doctor who made a referral to a cardiologist.  I have an appointment on 19MAR2022
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient presented to clinic for a Moderna booster and received  a full dose (.5ml) Moderna.  RN attempted to reach patient via phone but was unsuccessful.  A voice message was left notifying patient of administration error.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Azoospermia, Infertility, Laboratory test normal, Semen analysis
Clinical narrative: Infertility. First vaccine dose in January 2021, second dose 3 weeks later, booster October 2021. Diagnosed with azoospermia in October 2021. Zero sperm count.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient  presented to clinic for a Moderna booster and  received a (.5ml) full-dose Moderna vaccine . RN attempted to notify patient of error via phone without success.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 4th dose; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received 4th dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 031A21A, 001C21A and 011D21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Renal disease (Diagnosed with Kidney disease years before patient got his1st dose of moderna COVID-19 vaccine.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Patient received 4th dose). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received 4th dose) outcome was unknown.            Patient was in the list for Kidney transplant candidates On 14-Feb-2022, patient was advised by his doctor to get a 4th dose.Patient was told by the pharmacist that he got half dose Concomitant product information was not provided Treatment information was not provided
Age: 60.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Abdominal pain upper, Asthenia, Chills, Dyspnoea, Myalgia
Clinical narrative: right after the shots  about 15 minutes later i was dropping things on the floor and spilling things over. Then  At 9:00pm Feb.19, 2022 until 3:00am the next day within the time frame i was having a stomach ache, chills,muscle pains in my legs, nauseated and throwing up. hard to breathe sometimes i needed to raise the back of the bed to prop my head up for easy breathing. After throwing up many times i was able to fall asleep. now on Feb.20,2022 i feel much better just have a right side ache and runny nose now.
Age: 60.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Nausea, Pain, Rhinorrhoea, Vomiting
Clinical narrative: right after the shots  about 15 minutes later i was dropping things on the floor and spilling things over. Then  At 9:00pm Feb.19, 2022 until 3:00am the next day within the time frame i was having a stomach ache, chills,muscle pains in my legs, nauseated and throwing up. hard to breathe sometimes i needed to raise the back of the bed to prop my head up for easy breathing. After throwing up many times i was able to fall asleep. now on Feb.20,2022 i feel much better just have a right side ache and runny nose now.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac function test abnormal, Cardiomegaly, Extrasystoles, Heart rate irregular, Menstrual disorder
Clinical narrative: TWO ADVERSE REACTIONS: 1. My period is practically non-existent. I barely bleed! What happened to my ovaries??? Am  I still going to be able to have children in the future? My period has changed dramatically since getting vaccinated in May 2021 and 2nd dose in June 2021. I had a regular menstrual cycle in the past, a regular flow, and healthy and normal period. Now I hardly bleed and it greatly concerns me.  2. I don't have any heart disease in my family. I am now 38 and have an enlarged right part of my heart along with irregular heart beats - myocarditis.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Myocarditis
Clinical narrative: TWO ADVERSE REACTIONS: 1. My period is practically non-existent. I barely bleed! What happened to my ovaries??? Am  I still going to be able to have children in the future? My period has changed dramatically since getting vaccinated in May 2021 and 2nd dose in June 2021. I had a regular menstrual cycle in the past, a regular flow, and healthy and normal period. Now I hardly bleed and it greatly concerns me.  2. I don't have any heart disease in my family. I am now 38 and have an enlarged right part of my heart along with irregular heart beats - myocarditis.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Ear, nose and throat examination, Endoscopy, Hypoacusis, Tinnitus
Clinical narrative: Continuous TINNITUS that turned on beginning of September 2021 and has not subsided. 1st VACCINATION 05/22/2021 2nd VACCINATION 12/14/2021 Both ears but most prevalent in the right.  Also has caused a symmetric reduction of hearing in the higher frequency range . Never experienced TINNITUS throughout life span. Learned of the side affects only after receiving the second vaccination of the same vaccine J&J in 14,DEC of 2021. with disclosure info of medication . Slightly subsided months later ,only to increase once again upon vaccination "booster" of the same kind. ( dosage administered was equivalent in both shots )
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment and concomitant medications were not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Rhinorrhoea, Skin warm
Clinical narrative: my skin feels warm; I have a runny nose; I have joint pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (my skin feels warm), RHINORRHOEA (I have a runny nose), ARTHRALGIA (I have joint pain) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0165212A, 003B21A and 040A20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Augmentin), Acid reflux (esophageal) and Hernia (Patient had a hernia between her esophagus and top of her stomach.). Concomitant products included POTASSIUM CHLORIDE and PANTOPRAZOLE for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, the patient experienced SKIN WARM (my skin feels warm), RHINORRHOEA (I have a runny nose), ARTHRALGIA (I have joint pain) and NAUSEA (Nausea). At the time of the report, SKIN WARM (my skin feels warm), RHINORRHOEA (I have a runny nose), ARTHRALGIA (I have joint pain) and NAUSEA (Nausea) had not resolved.            No treatment details were provided   This case was linked to MOD-2022-489275 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 17 patients administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (17 patients administered expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  The vial was initially stored in the refrigerator on 14 Sep 2021.The vial did not undergo any temperature excursions. The patient did not report any other adverse events.  No treatment medication was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Some side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Some side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Some side effects). At the time of the report, VACCINATION COMPLICATION (Some side effects) outcome was unknown.            Concomitant products were not provided.  Treatment medications were not reported.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: Severe hot flashes 12 days after first shot/Hot flash on and off for 2 months, after first shot; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Severe hot flashes 12 days after first shot/Hot flash on and off for 2 months, after first shot) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043120A) for COVID-19 vaccination.     The patient's past medical history included Stroke and Hysterectomy.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HOT FLUSH (Severe hot flashes 12 days after first shot/Hot flash on and off for 2 months, after first shot). On 12-Apr-2021, HOT FLUSH (Severe hot flashes 12 days after first shot/Hot flash on and off for 2 months, after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported that On 18-Feb-2022, she no longer has the hot lashes. She was not able to take estrogen because of her medical history of stroke (Many years ago).Last year, her doctor had advised her not to take the second Moderna COVID-19, vaccine because if she had got the hot flashes. Her doctor told her that she needed to start the series again, since it had been a year post first shot. She also knows that the second shot had to be the same brand as the first shot, but since MD told her not to get Moderna second shot, she does not know what to do.  No concomitant medication was reported. No treatment medication was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizzy; Vertigo; This is a spontaneous report received from contactable reporter from medical information team.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 25Apr2021 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 25Apr2021, outcome "recovering", described as "Dizzy"; VERTIGO (non-serious) with onset 25Apr2021, outcome "recovering", described as "Vertigo".  Additional information: Per reporter, his wife received her first Pfizer Covid 19 Vaccine on 25April2021. When she raised her head up or down to focus on anything she became dizzy. It's going on 3 weeks now. He reported symptom had improved about 65-70%. The reporter was asking if the symptom had been reported. TRANSMITING, POSSIBLE  Response: Spoke from the attached document. Spoke under Clinical Trials Experience,  Literature Search, and Post- Authorization Safety Reports. the reporter was asking how long the vertigo might last? If it might cause permanent brain complications?. Response: Spoke from the attached document under clinical data. "Information on onset and duration was not provided". Per reporter his wife didn't have any health insurance. Reporter was asking if Pfizer had any type of program that will assist with any medical experience related to complications from the Pfizer Covid 19 Vaccine?. During documentation this agent realized that the FACT sheet with the information couldn't be emailed. Outbound call made on 13May2021 1:23 p.m. ET, disclaimer noted. Reporter made aware that the information couldn't be emailed. Reporter asked if he could call back to obtain the contact information "he was in a important meeting"?. Response: Spoke from the attached document PI. is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a  health emergency or a security threat. For more information about  regarding the Pfizer-BioNTech COVID-19 Vaccine used to prevent COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Vomiting
Clinical narrative: dizziness; headache; fatigue; threw-up; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 12May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset May2021, outcome "unknown", described as "dizziness"; HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset May2021, outcome "unknown", described as "fatigue"; VOMITING (non-serious) with onset May2021, outcome "unknown", described as "threw-up".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Vomited 3-4 times in the day; Nausea; 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) (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: NAUSEA (non-serious), outcome "recovered", described as "Nausea"; VOMITING (non-serious), outcome "unknown", described as "Vomited 3-4 times in the day".  Additional information: Caller explained that the patient got his second dose of the vaccine on Sunday and has been having nausea for 3 days. He was also vomited 3-4 times in the day  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: felt a little bit dizzy and light headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old female patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROBIOTICS; DIGESTIVE ENZYMES; CALCIUM; CALCIFEROL VIT D.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt a little bit dizzy and light headed".  Additional Information: Patient stated that she had experienced inflammatory issues before, such as having a severe allergic reaction to the flu vaccine and other vaccines. She has been taking probiotics, digestive enzymes, calcium, vitamin D to boost her immune system and anti-inflammatories as needed prior to the vaccination. She had since stopped taking them after the first dose of the Pfizer BioNtech COVID-19 vaccine. She also states that she and her husband, 57 years old, felt a little bit dizzy and lightheaded after taking the first dose of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: little bit dizzy and light headed after taking the first dose of the vaccine; 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 57 year-old male patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "little bit dizzy and light headed after taking the first dose of the 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: Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: She has a bad sore throat, congestion, and is super tired; She has a bad sore throat, congestion, and is super tired; She has a bad sore throat, congestion, and is super tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 09May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), NASAL CONGESTION (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "She has a bad sore throat, congestion, and is super tired".  Additional information: Reporter wanted to know if they were to get a covid test for patient to go to school, reporter was asking if there was a chance the vaccine could cause a positive result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: Has a spot under her breastbone on her ribcage that is "very" sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 10:30 (Lot number: EW0175) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for blood cholesterol; LORATADINE taken for hypersensitivity; CENTRUM SILVER +50 taken for supplementation therapy. Vaccination history included: Bnt162b2 (First dose , Lot :  ER8729, Expiration date: unknown), administration date: 16Apr2021, for COVID-19 immunisation. The following information was reported: MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 10May2021, outcome "not recovered", described as "Has a spot under her breastbone on her ribcage that is "very" sore".  Additional information: Event happened after the second dose of the vaccine. There is constant pain in that area, sometimes worse and sometimes not as bad. When the caller gets up in the morning, she doesn't feel it but when she's up moving around it starts hurting. AE didn't require a visit to emergency room or physician's office. No family medical history relevant to ae. Prior Vaccinations (within 4 weeks) was none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction, Electric shock sensation, Fatigue, Insomnia, Pain in extremity
Clinical narrative: tiredness and a sore arm; tiredness and a sore arm; felt electrified; could not sleep; there may be an interaction between Tenvir and he Pfizer covid-19 vaccine.; 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 1, single for covid-19 immunisation. Relevant medical history included: "Hepatitis B" (unspecified if ongoing), notes: history of hepatitis B and takes Tenvir daily as treatment. Concomitant medication(s) included: TENVIR taken for hepatitis b. The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "tiredness and a sore arm"; ELECTRIC SHOCK SENSATION (non-serious), outcome "unknown", described as "felt electrified"; INSOMNIA (non-serious), outcome "unknown", described as "could not sleep"; DRUG INTERACTION (non-serious), outcome "unknown", described as "there may be an interaction between Tenvir and he Pfizer covid-19 vaccine.".  Additional information:She stopped taking Tenvir for a couple of day and then felt normal again. However, when she resumed Tenvir, she again experienced the electrified feeling and not being able to sleep. She stopped Tenvir for the second time and reports only taking two tablets of Tenvir since getting the Pfizer covid-19 vaccine injection. The consumer suspected there may be an interaction between Tenvir and he Pfizer covid-19 vaccine. The consumer is scheduled to receive her second injection of the Pfizer covid-19 injection today since it has been 3 weeks since the first injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: couldn't sleep all night; 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 female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12May2021 19:00 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 12May2021, outcome "unknown", described as "couldn't sleep all night".  Additional information: It was reported that she has never stayed up all night and not been absolutely tired. She states she was not tired and has been trying to lay all morning and take a nap and can't sleep. This was ongoing, all night. She just felt she should be tired and was not. She was never stayed up all night and usually if she does stay up late, it takes the day to recoup. She wanted to know if anybody else was experiencing this. Patient had a family member just die Monday morning from Covid and many friends still battling Covid in the hospital. she does not take medication of any kind. No additional vaccines administered on same sate of the Pfizer Suspect. AE(s) was not require a visit to emergency room and physician office. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. No AE(s) following prior vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Skin burning sensation, Tremor
Clinical narrative: Burning head and face; headache; body aches; shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 16:30 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Melon, reaction(s): "Allergy:Melon", notes: Melon. The following information was reported: SKIN BURNING SENSATION (non-serious) with onset 31Mar2021 09:00, outcome "recovered" (2021), described as "Burning head and face"; HEADACHE (non-serious) with onset 31Mar2021 09:00, outcome "recovered" (2021), described as "headache"; PAIN (non-serious) with onset 31Mar2021 09:00, outcome "recovered" (2021), described as "body aches"; TREMOR (non-serious) with onset 31Mar2021 09:00, outcome "recovered" (2021), described as "shaking".  Additional information: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination patient was not tested for COVID-19. The patient was administered with dose 2 on 20Apr2021at 16:30 at left arm and experienced events weakness, fatigue, feverish, headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: my side effects with first one, tired, nauseous; my side effects with first one, tired, nauseous; 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 46 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "CHF" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METHADONE taken for dependence. Past drug history included: Methadone for Past addiction. The following information was reported: FATIGUE (non-serious), NAUSEA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "my side effects with first one, tired, nauseous".   Additional information: Patient reported that his side effects with first one were tired and nauseous; wasn't bad went away quick. Felt more like after the second vaccine, it was almost an antidote to the first one. Patient was really started feeling better after the second one, all energetic. Patient stated that he takes lots of medications(no further information).  No follow attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: immune compromised; 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) (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: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune compromised".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in right upper inner thigh; 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 77 year-old male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing), notes: gout in both feet. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Apr2021, outcome "unknown", described as "pain in right upper inner thigh".  Additional information: The patient mentioned after receiving the first shot of the Pfizer-BioNTech COVID-19 Vaccine, he felt pain on his right thigh. Then, after the second dose, caller reported to have experienced swelling on the right foot for 5 days already. The patient has gout in both feet but nothing like this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Vomiting
Clinical narrative: Throwing up; Sore throat; Stuffy nose; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06May2021 (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: OROPHARYNGEAL PAIN (non-serious) with onset 12May2021, outcome "unknown", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 12May2021, outcome "unknown", described as "Stuffy nose"; HEADACHE (non-serious) with onset 12May2021, outcome "unknown", described as "Headache"; VOMITING (non-serious) with onset 13May2021, outcome "unknown", described as "Throwing up".  Additional information: The patient stated that she got the second dose of the Pfizer Covid-19 vaccine on 06May2021. Yesterday she had a sore throat, stuffy nose and headache. Today it was worst, she was throwing up. Is it possible to have a reaction 1 week after receiving the Pfizer COVD-19 vaccine?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: He has developed dry mouth; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A male patient in his 30's received bnt162b2 (BNT162B2) (Lot number: EW 0186) as dose 2, single for covid-19 immunisation. Relevant medical history included: "shellfish" (unspecified if ongoing), notes: He has a shellfish allergy. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: DRY MOUTH (non-serious) with onset 13May2021, outcome "unknown", described as "He has developed dry mouth". Therapeutic measures were taken as a result of dry mouth.  Additional information: Reporter (Registered nurse) stated, "I just have a question. I am a RN (Registered Nurse) and I have been working at a vaccination site and one of the people that I gave the second vaccine (Unspecified vaccination) to today knows me personally so called me to ask they said that they had a dry mouth. And that person has a history of allergy to shellfish, he did wait, we did observe him for 30 minutes then he left the vaccination site at 2:30. He is not noticing anything else but he was concerned so he called me because he knows me, he said he also called a friend and her sister who is also an RN and she said her friend also had dry mouth (Split not made) and that it just went away but I tried to look into the website and see if that was the reported symptom and I couldn't find anything, so that's why I thought I would call and ask. When confirmed if the reporter have some question or want to report, reporter stated, "I really just wanted to ask what advice to give him, I mean at the time I told him, make sure he stays hydrated he'd already taken some Tylenol, he told me he cant take Benadryl because he gets kind of muscle spasms with it, so I just told him to call me back in a couple hours and let me know how he is doing but I wondered if I should have given him some other advice.     No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021547364 Same reporter/ drug/ event for different patients
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metal taste in his mouth after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-2021547682 (Pfizer).  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 05May2021 (Lot number: EW0171) at the age of 32 years 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: DYSGEUSIA (non-serious) with onset 05May2021, outcome "unknown", described as "Metal taste in his mouth after receiving the vaccine". Therapeutic measures were not taken as a result of dysgeusia.  Additional information: Caller states Someone caller know received the Pfizer COVID-19 Vaccine on 05May2021 and reported metallic taste. Caller wants to know if this has been reported with the vaccine. Response received as spoke from the attached document. Informed caller metal taste post vaccination has not been reported with the vaccine. However these may not be all the possible side effects of the Pfizer-BioNTech COVID-19. Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19. Vaccine was still being studied in clinical trials. Please speak to your HCP for more information. Treatment: reporter stated, No, he hasn't. Patient History, Other Products and Investigation Assessment was reported as no.  No follow-up attempts are possible. No further information is expected.