chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate, Heart rate irregular, Migraine, Myalgia
Clinical narrative: Shortness of breathe/S.O.B when lying down; feeling irregular heart rhythms; chest pain; chest pressure; migraine; feeling warm; arm pain; muscle pain; shivering/chills; fatigue; swollen at injection site; pain and swollen at injection site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 21-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7484, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 01Aug2021 at 12:00 pm (age at vaccination was 21 years) as dose 2, single for COVID-19 immunization. The patient's medical history included scoliosis. The patient did not have any known allergies. Concomitant medications or other medications the patient received in two weeks included melatonin and citrus aurantium, crataegus monogyna fruit, cymbopogon citratus, matricaria recutita flower, mentha spicata leaf, rosa x centifolia, rubus fruticosus leaf, tilia spp. flower (SLEEPYTIME HERB) (sleepytime tea) both taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0198, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 11Jul2021 (age at vaccination was 21 years) as dose 1, single for COVID-19 immunization. The 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Aug2021 at 14:45 pm, the patient experienced feeling warm, shivering/chills, migraine, chest pressure, chest pain, shortness of breathe/S.O.B when lying down, feeling irregular heart rhythms, fatigue, pain and swollen at injection site, muscle pain and arm pain. No treatment was received for the adverse events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain, Vaccination site swelling
Clinical narrative: Shortness of breathe/S.O.B when lying down; feeling irregular heart rhythms; chest pain; chest pressure; migraine; feeling warm; arm pain; muscle pain; shivering/chills; fatigue; swollen at injection site; pain and swollen at injection site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 21-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7484, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 01Aug2021 at 12:00 pm (age at vaccination was 21 years) as dose 2, single for COVID-19 immunization. The patient's medical history included scoliosis. The patient did not have any known allergies. Concomitant medications or other medications the patient received in two weeks included melatonin and citrus aurantium, crataegus monogyna fruit, cymbopogon citratus, matricaria recutita flower, mentha spicata leaf, rosa x centifolia, rubus fruticosus leaf, tilia spp. flower (SLEEPYTIME HERB) (sleepytime tea) both taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0198, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 11Jul2021 (age at vaccination was 21 years) as dose 1, single for COVID-19 immunization. The 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Aug2021 at 14:45 pm, the patient experienced feeling warm, shivering/chills, migraine, chest pressure, chest pain, shortness of breathe/S.O.B when lying down, feeling irregular heart rhythms, fatigue, pain and swollen at injection site, muscle pain and arm pain. No treatment was received for the adverse events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity, Pruritus, Rash macular, Urticaria
Clinical narrative: difficulty taking deep breaths; hives on her arm, legs & torso; skin itchiness; prickly red dots, broke out on her arms and legs; Left sore arm where she got injection; This is a spontaneous report from a contactable consumer. This 54-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FA7484 and expiry date: 30 Sep2021) via intramuscular route of administration on 01Aug2021 at 1200 hours on left arm (at 54-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included seasonal allergies, she cannot remember the date, maybe in her early 20's was ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the pfizer suspect, concomitant medications and relevant tests were reported as none. The patient did not require emergency room and physician office visit. On an unknown date in Aug2021 she just experienced left sore arm where she got the shot. She did not provide the start date and outcome. Within 2 days, on 04Aug2021, she started seeing prickly red dots. At first, she thought they were mosquito bites. She then broke out on her arms and legs. They were mainly there with a few scattered on her arm, legs and torso and they were hives. They were not going away. Her skin was itchy. On 06Aug2021 she also noticed that it seemed like she had difficulty taking deep breaths. She did not pay much mind to difficulty taking deep breaths. She noticed and said it was strange and was just keeping an eye on it. She thought to herself, why was this happening. She does have seasonal allergies. In line with this, caller would like to have recommendations about this as she feels reluctant to take the second dose of the vaccine considering the side effects she experienced during her first dose. The outcome of Left sore arm where she got injection was unknown. The outcome of other events was not recovered  Warm transferred caller to (withheld), Provided caller with phone of (withheld)  Follow-up attempts were completed. No further information was expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Spondylitis
Clinical narrative: Feel like I have arthritis in my neck, shoulders, low back, hips, hands, a week and a half out!; Feel like I have arthritis in my neck, shoulders, low back, hips, hands, a week and a half out!; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: FA7484), via an unspecified route of administration, administered in left arm on 30Jul2021 19:45 (at the age of 42-year-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Patient was not pregnant at the Time of Vaccination. Patient had not been tested for COVID-19 since the vaccination. Patient had no other vaccine in four weeks. Medical history included High cholesterol, high blood pressure, depression, Anxiety, hyperthyroidism and COVID-19 prior vaccination. Patient had no known allergies. Concomitant medication(s) in two weeks included vilazodone hydrochloride (VIIBRYD); rosuvastatin calcium (CRESTOR); losartan potassium (LOSARTIN); levothyroxine sodium (LEVOTHYROXIN), cholecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. On 05Aug2021 12:00, patient experienced arthritis in my neck, shoulders, low back, hips, hands, a week and a half out. Patient did not receive any treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Neck mass
Clinical narrative: developed a lump on her neck; I got super sick; This is a spontaneous report from a contactable consumer (patient herself). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8737, Expiration date: Unknown), via an unspecified route of administration on 15Apr2021 as dose 1, single and then received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0167, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced that she developed a lump on her neck and she got super sick on an unspecified date. It was reported that the patient received both doses of the Pfizer COVID-19 vaccine. She went to the doctor to get a sports physcal on Friday and showed them the bump she got. She told them about that lump on her neck when she got her first dose on 15Apr2021, she thought so and then after she got her first dose, she got super sick and then went to her doctor and told him. The doctor said it would go away after a month, but she got the shot back in April and now its August and she still had it. The doctor said it was normal and it would go away in a couple months. It had been a couple of months but it still had not gone away. It was reported that after the first dose, she experienced the side effects. The adverse events resulted in physician office visit. The outcome of the event lump on her neck was not recovered. The outcome of the event she got super sick was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash
Clinical narrative: Throat Swollen; Rash; This is a spontaneous report from a contactable consumer or other non-health care professional reported for patient.   A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0179, Expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 06Aug2021 (age at vaccination was unknown) at 10:00 as dose 1, single for COVID19 immunization. The patient medical history was not reported. Concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM); caffeine, magnesium salicylate (DIUREX WATER PILLS). On 08Aug2021, the patient experienced throat swollen, rash. No investigation assessment. Patient got the Pfizer Covid 19 Vaccine first dose on Friday and reports that she can breathe but has a swollen throat and rash. It did not happen immediately after the dose; it was 2 days later that patient had the Side effect. The consumer called to ask when the rash is going to go away. Caller confirmed information provided by the transferring agent. Caller at first provides 60 but then states wait she doesn't know her age and then confirms as 61. The patient has not seen the doctor in a long time. It initially started in the stomach area, then later at night after patient slept and woke up, consumer noticed they had the rash on the inside of both her arms, but it is not as bad as the stomach. The rash looks like little red dots. Patient only took Tylenol PM on the day of the first dose because her arm was hurting. Consumer took a water pill called Diurex that is over the counter. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Urticaria
Clinical narrative: hives got worse; hives got worse; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation; Solution for injection), dose 2 intramuscularly, administered in Arm Left on 11Jun2021 (Batch/Lot Number: EW0181) as DOSE 2, SINGLE (at the age of 17-year-old) for covid-19 immunisation. Medical history included migraine chronic from 08Aug2019 (Pertinent details: Occipital nerve block 11Feb2020), eczema from 01Apr2020, ongoing anxiety and ongoing (ADHD) attention deficit hyperactivity disorder. Concomitant medications (drugs taken within two weeks) included lisdexamfetamine mesilate (VYVANSE) taken for ADHD, desvenlafaxine taken for anxiety and botulinum toxin type a (BOTOX) taken for migraine all from an unspecified start date and ongoing. Historical vaccine included first dose of bnt162b2 on 21May2021 (Batch/lot number: EW0173, intramuscularly in left arm) (at the age of 17-year-old) for covid-19 immunisation and experienced bouts of hives/Chronic Hives. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. started having bouts of hives within 2 days after her first dose of the covid 19 vaccine and they not realize they were hives because she has had skin issues in the past. After she got her second dose the hives got worse which stated on 23May2021 and we eventually got her into the doctor who diagnosed them as chronic hives because they had been present for two months. The event caused Physician office visit. The patient started taking antihistamines (Singular and zertec) the hives cleared up. Therapeutic measures were taken as a result of hives got worse. The outcome of event reported as recovered on an unknown date on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Rhinorrhoea, SARS-CoV-2 test, Sneezing
Clinical narrative: Mucus; sneezing; cut body; tiredness; This is a spontaneous report from a non-contactable consumer (patient herself). A 24-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in Arm Left in 2021 (at the age of 24 years old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. 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 been tested for COVID-19. The patient was not pregnant at time of vaccination. On 06Aug2021 the patient experienced mucus, sneezing, cut body, tiredness. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 04Aug2021 Nasal Swab. The patient did not receive any treatment or no prolonged hospitalization for the events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: pain and tenderness in the left armpit; pain and tenderness in the left armpit; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 13-years-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: FA7485, Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in arm left on 08Aug2021 at 14:45 (age at vaccination 13-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: FA7484, Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in arm left on 18Jul2021 at 02:00 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergy (Known allergies: seasonal allergens) and autism from an unknown date and unknown if ongoing. Concomitant medications included that the patient received within 2 weeks of vaccination included clonidine, wellbutrin, abilify and sertraline taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Aug2021 at 10:00 AM, the patient experienced pain and tenderness in the left armpit. Treatment received for the adverse events reported as unknown. The outcome of events was unknown. The events were reported as non serious.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pain, Sensitive skin, Skin disorder
Clinical narrative: feeling short winded; skin sensitivity/Overall sensitivity on skin, to cold, hot, wind, clothing, water; pain; dizziness; Skin is just hot; Been in bed all morning; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team.  A 51-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484, Expiration date: not reported) via an unspecified route of administration, administered in the left arm at Pharmacy on 09Aug2021 at 11:00 (age at the time of vaccination was 51-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180, Expiration date: not reported), via an unspecified route of administration in the left arm on 19Jul2021 at (age at the time of vaccination was 51-year-old) as dose 1, single for COVID-19 immunization. On 09Aug2021, patient experienced feeling short winded, skin sensitivity/overall sensitivity on skin, to cold, hot, wind, clothing, water, pain, dizziness, skin is just hot and been in bed all morning. No additional vaccines administered on same date of the Pfizer Suspect and no prior vaccinations received (within 4 weeks). The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: feeling short winded; skin sensitivity/Overall sensitivity on skin, to cold, hot, wind, clothing, water; pain; dizziness; Skin is just hot; Been in bed all morning; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team.  A 51-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484, Expiration date: not reported) via an unspecified route of administration, administered in the left arm at Pharmacy on 09Aug2021 at 11:00 (age at the time of vaccination was 51-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180, Expiration date: not reported), via an unspecified route of administration in the left arm on 19Jul2021 at (age at the time of vaccination was 51-year-old) as dose 1, single for COVID-19 immunization. On 09Aug2021, patient experienced feeling short winded, skin sensitivity/overall sensitivity on skin, to cold, hot, wind, clothing, water, pain, dizziness, skin is just hot and been in bed all morning. No additional vaccines administered on same date of the Pfizer Suspect and no prior vaccinations received (within 4 weeks). The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Strabismus, Swelling face
Clinical narrative: a left sided exotropia of the eye witness on exam; left sided facial swelling; Patient experienced left sided chills; left sided headache; This is a spontaneous report from a contactable physician. This physician reported for a female patient.  A non-pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0198, Expiry date was not reported), via intramuscular route, administered in Arm Left on 12Jul2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced left sided chills, left sided headache, left sided facial swelling and a left sided exotropia of the eye witness on exam on an unspecified date 2021.  The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Began 1st day after 2nd injection with pain; Swelling at injection site; Heat at injection site; Redness at injection site; Itching began on day 2-3 with pain slowly subsiding; Itching began on day 2-3 with pain slowly subsiding; This is a spontaneous report from a contactable consumer (reported herself) A 58-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 07Aug2021 16:30 (Batch/Lot Number: EW0179) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included glaucoma, thyroid disorder. Concomitant medications included liothyronine sodium (CYTOMEL), atorvastatin calcium (LIPITOR) levothyroxine sodium (SYNTHROID). The patient previously took penicillin nos for hypersensitivity and historical vaccine included bnt162b2 lot number: EW0179, first dose for covid-19 immunisation with no reaction. The patient experienced pain at injection site on 08Aug2021 04:00 with outcome of not recovered, swelling at injection site on 08Aug2021 04:00 with outcome of not recovered, heat at injection site on 08Aug2021 04:00 with outcome of not recovered, redness at injection site on 08Aug2021 04:00 with outcome of not recovered, itching began on day 2-3 with pain slowly subsiding on 08Aug2021 04:00 with outcome of not recovered. No treatment was done.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Began 1st day after 2nd injection with pain; Swelling at injection site; Heat at injection site; Redness at injection site; Itching began on day 2-3 with pain slowly subsiding; Itching began on day 2-3 with pain slowly subsiding; This is a spontaneous report from a contactable consumer (reported herself) A 58-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 07Aug2021 16:30 (Batch/Lot Number: EW0179) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included glaucoma, thyroid disorder. Concomitant medications included liothyronine sodium (CYTOMEL), atorvastatin calcium (LIPITOR) levothyroxine sodium (SYNTHROID). The patient previously took penicillin nos for hypersensitivity and historical vaccine included bnt162b2 lot number: EW0179, first dose for covid-19 immunisation with no reaction. The patient experienced pain at injection site on 08Aug2021 04:00 with outcome of not recovered, swelling at injection site on 08Aug2021 04:00 with outcome of not recovered, heat at injection site on 08Aug2021 04:00 with outcome of not recovered, redness at injection site on 08Aug2021 04:00 with outcome of not recovered, itching began on day 2-3 with pain slowly subsiding on 08Aug2021 04:00 with outcome of not recovered. No treatment was done.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: Chickenpox-like blisters; rash on my arm and neck; This is a spontaneous report from a contactable consumer (reported for himself) A 52-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 31Jul2021 13:00 (Batch/Lot Number: FA7485) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing.     There were no concomitant medications. The patient experienced chickenpox-like blisters on 03Aug2021 with outcome of recovering ,and rash on my arm and neck on 03Aug2021 with outcome of recovering. Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dehydration, Dysmenorrhoea, Fatigue, Heavy menstrual bleeding
Clinical narrative: Severe menstrual cycles. Heavy flow, severe pain, fatigue, and nausia; Severe menstrual cycles. Heavy flow, severe pain, fatigue, and nausia; Severe menstrual cycles. Heavy flow, severe pain, fatigue, and nausia; Severe menstrual cycles. Heavy flow, severe pain, fatigue, and nausia; Severe menstrual cycles. Heavy flow, severe pain, fatigue, and nausia; Extreme dehydration everyday; Loss of appetite; This is a spontaneous report from a contactable consumer (patient).   A 27-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EL9266) on 14Apr2020 (age at vaccination 27 year old) and second dose on 28Apr2021 (Lot number EL9266), both via an unspecified route of administration at single dose for COVID-19 immunization. Medical history was unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 18May2021, patient experienced severe menstrual cycles, heavy flow, severe pain, fatigue, nausea, extreme dehydration every day, loss of appetite.  No treatment received. Outcome of events was not recovered.     Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Nausea
Clinical narrative: Severe menstrual cycles. Heavy flow, severe pain, fatigue, and nausia; Severe menstrual cycles. Heavy flow, severe pain, fatigue, and nausia; Severe menstrual cycles. Heavy flow, severe pain, fatigue, and nausia; Severe menstrual cycles. Heavy flow, severe pain, fatigue, and nausia; Severe menstrual cycles. Heavy flow, severe pain, fatigue, and nausia; Extreme dehydration everyday; Loss of appetite; This is a spontaneous report from a contactable consumer (patient).   A 27-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EL9266) on 14Apr2020 (age at vaccination 27 year old) and second dose on 28Apr2021 (Lot number EL9266), both via an unspecified route of administration at single dose for COVID-19 immunization. Medical history was unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 18May2021, patient experienced severe menstrual cycles, heavy flow, severe pain, fatigue, nausea, extreme dehydration every day, loss of appetite.  No treatment received. Outcome of events was not recovered.     Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Peripheral swelling
Clinical narrative: My right index finger been swollen; joints very painful; Mild headache; This is a spontaneous report from a non-contactable consumer . A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Jul2021 (Batch/Lot Number: EW0180) as single dose for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced her right index finger been swollen and the joints very painful and she has also experienced mild headache and she was scheduled to take second dose and she was very hesitating about taking the second dose because I have been experiencing these symptoms from I believe the first dose so, I am questioning whether or not I should be taking the second dose. The outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: He is not feeling well; Feverish; Tired; Headache; Muscle pain; This is a spontaneous report from a contactable consumer (patient's mother).  A 17-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EW0177) on 24Jul2021 and second dose (Lot number FC3181) on 14Aug2021, both via an unspecified route of administration at single dose for COVID-19 immunization. Medical history included Attention deficit hyperactivity disorder (ADHD). Concomitant medication included  lisdexamfetamine mesilate (VYNASE) 20 mg and escitalopram 10mg and vitamins. On 15Aug2021, patient experienced not feeling well, feverish, tired, headache, muscle pain. Outcome of event was feverish is not recovered, of other events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Nasal congestion, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Congestion; Weakness; Coughing; cold; This is a spontaneous report from a contactable consumer (patient).   A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot EN6207) on 17Mar2021 at 12:00 pm in arm and second dose (Lot ER8729) on 10Apr2021 at 11:00PM in left arm, both at age of vaccination 49 year old, via an unspecified route of administration at single dose for COVID-19 immunization. Medical history and concomitant medication were unknown. On 13Aug2021, patient experienced cold, congestion, weakness and coughing. No treatment received. Outcome of events congestion and cold was recovered, of event weakness and coughing was recovering. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 on 13Aug2021 ( COVID test nasal swab with unknown results).  Follow-up attempts are completed. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Generalized itching rash 4 days post vaccination, requiring benadryl aroud the click every 6 hours
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Cerebral artery occlusion, Cerebral infarction, Cerebrovascular accident, Computerised tomogram head abnormal
Clinical narrative: Patient suffered a stroke, a large-vessel occlusion, an M1  occlusion with large area infarct, he has sever left sided weakness, left facial droop, is unable to swallow well enough to eat or drink safely, he is unable to walk and has expressive aphasia and slurred speech.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dysarthria, Dysphagia, Facial paralysis, Gait inability, Hemiparesis
Clinical narrative: Patient suffered a stroke, a large-vessel occlusion, an M1  occlusion with large area infarct, he has sever left sided weakness, left facial droop, is unable to swallow well enough to eat or drink safely, he is unable to walk and has expressive aphasia and slurred speech.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypophagia
Clinical narrative: Patient suffered a stroke, a large-vessel occlusion, an M1  occlusion with large area infarct, he has sever left sided weakness, left facial droop, is unable to swallow well enough to eat or drink safely, he is unable to walk and has expressive aphasia and slurred speech.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Granuloma annulare
Clinical narrative: Granuloma annulare; This is a spontaneous report from a contactable consumer.  A 79 year old female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 in Arm Left on 29Jan2021 (Batch/Lot number was not reported) (at the age of 78 year old ) as single dose for covid-19 immunisation.  The patient's concomitant medications were not reported.  Two days later the bnt162b2 injection the patient experienced granuloma annulare. She stated she had in the past, she was not taking nothing at the point. She went to a dermatologist and the dermatologist did a biopsy on the subcutaneous rash that she ended up diagnosed with Granuloma annulare. She did not have a Laboratory Test anymore. She had already had a biopsy and was diagnosed with it. The consumer reported she has right now it is not going away. Nothing is happening, nothing is curing it. It may take 3 years for it to go away. The consumer got the second shot on bnt162b2 in 21Feb2021. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: slight body ache in legs; slight body ache in legs; Tightness of chest; severe muscle pain; shortness of breath; chills; fever; dizziness; tired; sleepy; My period was starting, but it stopped since after I took the vaccine and it never stopped before.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Pharmacy or Drug Store via an unspecified route, in left arm on 10Aug2021 18:00, at 44 years of age, (Batch/Lot Number: FA7485) as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm, on 20Jul2021 18:00 (Batch/Lot Number: EW0198). The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 after vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. In Aug2021 the patient suffered from tightness of chest, severe muscle pain, shortness of breath, chills, fever, dizziness, tired, sleepy. All these events lasted for 3 days. The patient did not go to hospital, but could not go to work. Moreover, her period was starting, but it stopped since after she took the vaccine (onset date unknown) and it had never stopped before. The patient further clarified that her period has been changed since she took the vaccine. She used to have her period once a month for 7 days since age 14, but now she gets her period every 2 weeks and it lasts 12-14 days. She also reported she was still getting slight body ache in legs, she never had before the vaccine. She regrets getting vaccinated. The patient didn't receive any treatment and all the reported events recovered with lasting effects, except for body ache and pain in legs, whose outcome was unknown at the time of the narrative.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: slight body ache in legs; slight body ache in legs; Tightness of chest; severe muscle pain; shortness of breath; chills; fever; dizziness; tired; sleepy; My period was starting, but it stopped since after I took the vaccine and it never stopped before.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Pharmacy or Drug Store via an unspecified route, in left arm on 10Aug2021 18:00, at 44 years of age, (Batch/Lot Number: FA7485) as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm, on 20Jul2021 18:00 (Batch/Lot Number: EW0198). The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 after vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. In Aug2021 the patient suffered from tightness of chest, severe muscle pain, shortness of breath, chills, fever, dizziness, tired, sleepy. All these events lasted for 3 days. The patient did not go to hospital, but could not go to work. Moreover, her period was starting, but it stopped since after she took the vaccine (onset date unknown) and it had never stopped before. The patient further clarified that her period has been changed since she took the vaccine. She used to have her period once a month for 7 days since age 14, but now she gets her period every 2 weeks and it lasts 12-14 days. She also reported she was still getting slight body ache in legs, she never had before the vaccine. She regrets getting vaccinated. The patient didn't receive any treatment and all the reported events recovered with lasting effects, except for body ache and pain in legs, whose outcome was unknown at the time of the narrative.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: slight body ache in legs; slight body ache in legs; Tightness of chest; severe muscle pain; shortness of breath; chills; fever; dizziness; tired; sleepy; My period was starting, but it stopped since after I took the vaccine and it never stopped before.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered at Pharmacy or Drug Store via an unspecified route, in left arm on 10Aug2021 18:00, at 44 years of age, (Batch/Lot Number: FA7485) as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route in left arm, on 20Jul2021 18:00 (Batch/Lot Number: EW0198). The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 after vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. In Aug2021 the patient suffered from tightness of chest, severe muscle pain, shortness of breath, chills, fever, dizziness, tired, sleepy. All these events lasted for 3 days. The patient did not go to hospital, but could not go to work. Moreover, her period was starting, but it stopped since after she took the vaccine (onset date unknown) and it had never stopped before. The patient further clarified that her period has been changed since she took the vaccine. She used to have her period once a month for 7 days since age 14, but now she gets her period every 2 weeks and it lasts 12-14 days. She also reported she was still getting slight body ache in legs, she never had before the vaccine. She regrets getting vaccinated. The patient didn't receive any treatment and all the reported events recovered with lasting effects, except for body ache and pain in legs, whose outcome was unknown at the time of the narrative.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report from a non contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration in Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Aug2021, the week after vaccination, the patient experienced chest pain and stated he didn't know if it was like myocarditis and didn't know what it was. The event outcome was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Osteoporosis
Clinical narrative: Osteoporosis; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced osteoporosis (non-serious) on an unspecified date with outcome of unknown. Patient mentioned an Osteoporosis treatment after the first and second doses of the vaccine. Patient queried if she needs a certain amount of time to get the booster shot before setting an appointment with her Rheumatologist for the osteoporosis treatment.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Rash
Clinical narrative: severe swelling in her eyes; severe rash all over her face; This is a spontaneous report from a contactable other health professional (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 06Jan2021 (at 22-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that on 06Jan2021 (reported as 2 hours after administration) she experienced severe swelling in her eyes, and a severe rash all over her face. Her mother called in right after it happened and when it was time to get her second shot, she was advised not to get her second shot. She held off, but now her work was requiring her to get the second shot and booster later. The outcome of the events was unknown.  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, Immunisation, Joint stiffness, Limb discomfort, Off label use
Clinical narrative: rash that was about 3 inches across and in a circle at the injection site; pain at the injection site in her left arm; extreme fatigue; in her left arm where she received the injection, when she bends her arm a certain way, like a 90 degree angle at the elbow, her arm locks there; left arm is immobile for a time; third dose was on 03Sep2021; third dose was on 03Sep2021; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose (BOOSTER) of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FD8448), via an unspecified route of administration, administrated in left arm on 03Sep2021, as DOSE 3, SINGLE (BOOSTER) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/ Lot Number: EM9809), via an unspecified route of administration, on 03Feb2021, as DOSE 1, SINGLE for COVID-19 immunization and experienced Sore arm; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, on 24Feb2021, as DOSE 2, SINGLE for COVID-19 immunization and experienced Sore arm. On an unspecified date, the patient experienced rash that was about 3 inches across and in a circle at the injection site, pain at the injection site in her left arm, extreme fatigue, in her left arm where she received the injection, when she bends her arm a certain way, like a 90-degree angle at the elbow, her arm locks there, left arm is immobile for a time. On 03Sep2021, the patient had received third dose. The outcome for all the events was not recovered.  The third Covid 19 vaccine lot number is in the formal field as the side effects associated with the third dose are the reason for her call. She declines to provide any additional information. No further information is provided or obtained.  Follow up (01Oct2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to Non-HCP letter sent via telephonic follow-up activity that included: Consumer mailing address was added.  Follow-Up (07Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: rash that was about 3 inches across and in a circle at the injection site; pain at the injection site in her left arm; extreme fatigue; in her left arm where she received the injection, when she bends her arm a certain way, like a 90 degree angle at the elbow, her arm locks there; left arm is immobile for a time; third dose was on 03Sep2021; third dose was on 03Sep2021; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose (BOOSTER) of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FD8448), via an unspecified route of administration, administrated in left arm on 03Sep2021, as DOSE 3, SINGLE (BOOSTER) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/ Lot Number: EM9809), via an unspecified route of administration, on 03Feb2021, as DOSE 1, SINGLE for COVID-19 immunization and experienced Sore arm; and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, on 24Feb2021, as DOSE 2, SINGLE for COVID-19 immunization and experienced Sore arm. On an unspecified date, the patient experienced rash that was about 3 inches across and in a circle at the injection site, pain at the injection site in her left arm, extreme fatigue, in her left arm where she received the injection, when she bends her arm a certain way, like a 90-degree angle at the elbow, her arm locks there, left arm is immobile for a time. On 03Sep2021, the patient had received third dose. The outcome for all the events was not recovered.  The third Covid 19 vaccine lot number is in the formal field as the side effects associated with the third dose are the reason for her call. She declines to provide any additional information. No further information is provided or obtained.  Follow up (01Oct2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to Non-HCP letter sent via telephonic follow-up activity that included: Consumer mailing address was added.  Follow-Up (07Oct2021): Follow-up attempts are completed. No further information is expected.