chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Oesophagogastroduodenoscopy, Oropharyngeal discomfort, Thrombocytopenia, Thrombosis, Varices oesophageal
Clinical narrative: Something is getting in the way in his throat .; stage 1 varices/some type of clot or thrombosis; Thrombocytopenia; Cirrhosis of the liver; stage 1 varices/some type of clot or thrombosis; Recently started having acid reflux and pain in his chest; Recently started having acid reflux and pain in his chest; This is a spontaneous report from a contactable consumer (patient brother). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 as single dose, dose 2 via an unspecified route of administration on an unspecified date in Mar2021 as single dose for Covid-19 immunization. Medical history included ongoing thrombocytopenia. The patient and his twin brother both have thrombocytopenia. The patients concomitant medications were not reported. On an unspecified date in Mar2021 the patient experienced thrombocytopenia, cirrhosis of the liver. On an unspecified date in 2021 recently started having acid reflux and pain in his chest, in Mar2021 patient had stage 1 varices/ some type of clot or thrombosis, in Jun2021, something was getting in the way in his throat. The patient underwent lab tests and procedures which included blood work: excellent on an unspecified date in 2021. It can't be cirrhosis because he has excellent blood work, electrocardiogram (ECG): abnormal on an unspecified date in Mar2021. They found stage I varices/ some type of clot or thrombosis and cirrhosis of the liver where he had had neither, previously, oesophagogastroduodenoscopy (EGD): had nothing like this when they did the last one in 2018, abnormal on an unspecified date in Mar2021. They found stage I varices/ some type of clot or thrombosis. The outcome of events was unknown.  Information about lot/batch number is requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clots in right leg that traveled to both lungs; Blood clots in right leg that traveled to both lungs; This is a spontaneous report from a contactable consumer (patient herself). A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: ER8727, Expiry date was not reported) via an unspecified route of administration in arm right on 29Mar2021 (at the age of 50-years-old) as dose number unknown, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: ER8735, Expiry date was not reported), via an unspecified route of administration in arm right on 29Mar2021 (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included asthma, allergies, seafood allergy and nuts allergy. Concomitant medications included predni (PREDNISOLONE ACETATE), azelastine hydrochloride (ASTELIN [AZELASTINE HYDROCHLORIDE]) unknown daily at night and salbutamol (ALBUTEROL HFA) when needed. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 05Jun2021 at 09:00, the reporter stated that the patient experienced blood clots in right leg that travelled to both lungs. Her unprovoked event on 05Jun2021 and hospitalized for five days. The patient started taking blood thinners for the rest of my life. The reporter classified the events as serious and stated the events result in emergency room/department or urgent care, hospitalization for 5 days. The patient underwent lab tests and procedures on 05Jun2021 which included sars-cov-2 test (nasal swab): negative. Therapeutic measures were taken as a result of events with blood thinners. The outcome of the events was resolved with sequelae.   Follow up needed, further information was requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Muscular weakness, Paralysis
Clinical narrative: was paralyzed from the waist down; muscle weakness in my legs; had 2nd dose of Pfizer Vaccine on 18Jun2021; This is a spontaneous report from a contactable consumer (Patient). An 85-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration, administered in left arm on 18Jun2021 at 10:00 AM (at the age of 85-years-old) as dose 2, single for COVID-19 immunization. The patient medical history included high blood pressure and known allergies. The patient did not have covid prior vaccination. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks of vaccination. Patient received other medications (unspecified) in two weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration, administered in left arm on 04Jun2021 at 10: 00 AM as dose 1, single for COVID-19 immunization. The gap between the two doses of vaccine was 14 days which was an inappropriate schedule of vaccine. On 18Jun2021 by 5:30 PM (same day of vaccination), patient was paralyzed from the waist down, and was in ICU for 2 days. The patient was given steroids as the treatment. The paralysis went away but left with muscle weakness in my legs. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability, or permanent damage. The patient was not tested for COVID-19 post vaccination. The outcome of event paralyzed was recovered with sequel, and muscle weakness in legs was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Nerve stimulation test, Neuropathy peripheral
Clinical narrative: Severe Peripheral Neuropathy; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 2 via an unspecified route of administration, administered in arm left on 17Apr2021 at 11:15 (at the age of 62-year-old) as dose 2, single for COVID-19 immunisation. Medical history included penecillin allergies and no other medical history reported. The patient's concomitant medications were not reported. The patient previously took bnt162b2 dose 1 (lot number and expiration date were not reported) administered in right arm on 27Mar2021 at 11:15 (at the age of 62-year-old) as dose 1, single for COVID-19 immunisation. 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 22Apr2021 at 12:00, the patient experienced severe peripheral neuropathy. The event resulted in emergency room/department or urgent care. Pain medication and gabapentin were received as treatment for the reported event. The patient underwent lab tests and procedures which included blood test and nerve stimulation test with unknown results on an unspecified date. The outcome of the event was resolving.   Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appendicitis, Computerised tomogram
Clinical narrative: Appendicitis; Stomach pain; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, in left arm on 06Feb2021 21:00 (at the age of 35-years-old) as dose 2, single for covid-19 immunization. Medical history included common cold. Patient had no known allergies. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ELQ142), via an unspecified route of administration, in left arm on 12Jan2021 11:00 as DOSE 1, SINGLE for covid-19 immunization. On 25Feb2021 16:00, the patient experienced appendicitis, stomach pain (04:00). Eventually went to the ER and it was confirmed via CT Scan that patient had an appendicitis. It was treated with antibiotics because surgery at the time was not safe. The doctor decided that her appendix needed to be removed. She never had any illness before that required any type of hosp. The most severe thing she get was a common cold, so this was unexpected. Facility where the most recent COVID-19 vaccine was administered was other. The patient was hospitalized for appendicitis, stomach pain for 5 days. The patient underwent lab tests and procedures which included CT Scan resulted that she had an appendicitis on 25Feb2021. Therapeutic measures were taken as a result of appendicitis, stomach pain. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received treatment with Antibiotics via IV and insertion of Line for events. The outcome of events were recovering.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in my arm that was bearable; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 24-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration, administered in Arm Left on 07Jun2021 10:30 (age at the time of vaccination 24-years-old), as a single dose for COVID-19 immunization. The patient medical history included asthma. The patient's concomitant medications were not reported. On 07Jun2021 12:30, the patient experienced pain in my arm that was bearable. Patient took Analgesic as therapeutic measures as a result of pain in my arm that was bearable. The outcome of the event was recovered on an unspecified date 2021.  Additional information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site is red, warm, swollen, and sore; injection site is red, warm, swollen, and sore; injection site is red, warm, swollen, and sore; injection site is red, warm, swollen, and sore; left arm was in severe pain; This is a spontaneous report from a contactable consumer or other non hcp. A 51 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jun2021 16:00 (Batch/Lot Number: EL00217) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune Hashimoto's  thyroiditis from an unknown date and unknown if ongoing for past 5.5 years , infectious mononucleosis from an unknown date and unknown if ongoing for past 5.5 years. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; creatine (CREATINE) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX (B50)) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported.  The patient previously took Depakote and imipramine and experienced drug hypersensitivity. From about 8 hours after the shot until about 44 hours later, the patient experienced left arm severe pain on 26Jun2021 with outcome of recovered. Also had injection site redness, warmth, swollen, and sore on 02Jul2021 04:00 with outcome of not recovered.   Follow-up (06Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Impaired work ability, Neck pain, Pain
Clinical narrative: Neck, left arm and chest pain; Neck, left arm and chest pain; Neck, left arm and chest pain; Unable to work; discomfort; Pain; This is a spontaneous report from a contactable consumer or other non-Health care professional (patient). A 19-year-old female (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 19May2021 13:00 (age at vaccination 18-years-old) as dose 2, single for covid-19 immunisation. The patient medical history reported as none and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 28Apr2021 13:00 as dose 1, single for covid-19 immunisation with no reaction on previous exposure to vaccine. Prior vaccination, the patient had no Covid. It was unknown if patient tested covid, post vaccination. On 24May2021 12:00, the patient experienced neck, left arm and chest pain. Patient was unable to work because of the pain and discomfort. The events resulted in doctor or other healthcare professional office/clinic visit. Events considered as serious with disability or permanent damage. The patient received treatment and doctors are still working this up for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Neck, left arm and chest pain; Neck, left arm and chest pain; Neck, left arm and chest pain; Unable to work; discomfort; Pain; This is a spontaneous report from a contactable consumer or other non-Health care professional (patient). A 19-year-old female (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 19May2021 13:00 (age at vaccination 18-years-old) as dose 2, single for covid-19 immunisation. The patient medical history reported as none and concomitant medications were not reported. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 28Apr2021 13:00 as dose 1, single for covid-19 immunisation with no reaction on previous exposure to vaccine. Prior vaccination, the patient had no Covid. It was unknown if patient tested covid, post vaccination. On 24May2021 12:00, the patient experienced neck, left arm and chest pain. Patient was unable to work because of the pain and discomfort. The events resulted in doctor or other healthcare professional office/clinic visit. Events considered as serious with disability or permanent damage. The patient received treatment and doctors are still working this up for the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Nasal congestion, Pyrexia
Clinical narrative: Severe headache; Fever; Flu symptoms; Congestion; This is a spontaneous report from a contactable consumer (patient). A 52-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW1077 and Expiration Date: unknown), via an unknown route of administration, administered in left arm on 24May2021 at 14:00 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation. Medical history included pcn (penicillin allergy) and covid-19 from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with covid-19. There was covid prior vaccination and it was unknown that Covid tested post vaccination. Concomitant medication included (medications the patient received within 2 weeks of vaccination) levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. On an unknown date in May2021 after the 1st shot, the patient experienced severe headache, fever, flu symptoms and congestion. The events resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for covid-19. Outcome of events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; varenicline tartrate (CHANTIX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history included cardiac disorder. The patient's concomitant medications were not reported. On an unknown date, the patient experienced myocarditis. The patient has a heart condition and need to quit. It's something that's going on around the heart. Patient stated that the heart is fine and everything's fine, have scar tissue and they were calling it myocarditis. The action taken in response to the event for varenicline tartrate was unknown. The outcome of the event was unknown.  Follow-up attempts are completed, information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Electric shock sensation, Feeling abnormal, Pain
Clinical narrative: Small and bigger blisters form; The small ones scab pretty quick; The bigger ones burn and hurt if touched; The bigger ones burn and hurt if touched; Areas where its scratched constantly turn red, then brown. it looks like a bruise then it turns black; Areas where it's scratched constantly turn red, then brown. it looks like a bruise then it turns black; feels like it's running through my blood; I have currents of shocks all over my body; Itchiness all over my body; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received bnt162b2 (formulation: solution for injection, Lot number: Batch/Lot Number: GP7533), dose 1 via an unspecified route of administration, administered in left arm (at the age of 43-years) on 16Mar2021 17:30 as dose 1, single for covid-19 immunisation. Medical history included back legs, hips, and chronic migraines from an unknown date and unknown if ongoing. The patient had no known allergies. The patient's concomitant medications were not reported. On 31Mar2021 at 13:00 patient experienced itchiness all over her body. Small and bigger blisters form. The small ones scab pretty quick. The bigger ones burn and hurt if touched. Areas where it's scratched constantly turn red, then brown it looks like a bruise then it turns black. It felt like a mosquito bite where she first feels the sting and then the itchiness. She had currents of shocks all over her body. And it also felt like it's running through her blood. Adverse events resulted in doctor or other healthcare professional office, clinic visit and Emergency room, department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Patient had received her dose 2, single bnt162b2 (Lot number: Batch/Lot Number: ER2613) on 06Apr2021 at 5:30 PM into the left arm. The patient underwent lab test which includes nasal swab (expedited RT-PCR COVID-19 test) on 21Jun2021, and it was negative. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of all the events with pills for itchiness and allergy and scabies treatment. The outcome of all the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Scab, Scratch, Skin discolouration
Clinical narrative: Small and bigger blisters form; The small ones scab pretty quick; The bigger ones burn and hurt if touched; The bigger ones burn and hurt if touched; Areas where its scratched constantly turn red, then brown. it looks like a bruise then it turns black; Areas where it's scratched constantly turn red, then brown. it looks like a bruise then it turns black; feels like it's running through my blood; I have currents of shocks all over my body; Itchiness all over my body; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received bnt162b2 (formulation: solution for injection, Lot number: Batch/Lot Number: GP7533), dose 1 via an unspecified route of administration, administered in left arm (at the age of 43-years) on 16Mar2021 17:30 as dose 1, single for covid-19 immunisation. Medical history included back legs, hips, and chronic migraines from an unknown date and unknown if ongoing. The patient had no known allergies. The patient's concomitant medications were not reported. On 31Mar2021 at 13:00 patient experienced itchiness all over her body. Small and bigger blisters form. The small ones scab pretty quick. The bigger ones burn and hurt if touched. Areas where it's scratched constantly turn red, then brown it looks like a bruise then it turns black. It felt like a mosquito bite where she first feels the sting and then the itchiness. She had currents of shocks all over her body. And it also felt like it's running through her blood. Adverse events resulted in doctor or other healthcare professional office, clinic visit and Emergency room, department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Patient had received her dose 2, single bnt162b2 (Lot number: Batch/Lot Number: ER2613) on 06Apr2021 at 5:30 PM into the left arm. The patient underwent lab test which includes nasal swab (expedited RT-PCR COVID-19 test) on 21Jun2021, and it was negative. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of all the events with pills for itchiness and allergy and scabies treatment. The outcome of all the events was not recovered.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Crying, Dysuria, Myalgia, Vomiting
Clinical narrative: severe aches and pains in muscles and joints; severe aches and pains in muscles and joints; it hurt to pee; in tears from the pain; throwing up; This is a spontaneous report from a contactable consumer (patient). A 15-year-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0168, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 25Jun2021 at 10:00 (at the age of 15-year-old) as a single dose for covid-19 immunisation at Center. The patient had no medical history and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included Colecalciferol (VITAMIN D), birth control and anti-depressant medications received within 2 weeks of vaccination. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 04Jun2021 at 10:00 (at the age of 15-year-old) as a single dose for covid-19 immunisation. The patient was fine at first from the day of vaccination, on 30Jun2021 at 07:00, (after 5 days of vaccination) she started having severe aches and pains in muscles and joints. No one could touch her. She thought it was the vaccine and then she mentioned that it hurt to pee. Patient was taken to urgent care to rule out UTI infections, which they did and then referred her to the E.R (emergency room) because no one could touch her. She was in tears from the pain, and she was also throwing up. Patient received pain medications through an IV (intravenous) and anti-nausea medication as a treatment. The events resulted in emergency room/department or urgent care. The reporter assessed the events as non serious. The outcome of the events was not recovered.  Follow up needed, further information has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Electrocardiogram change, Troponin increased
Clinical narrative: Severe chest pain; difficulty in breathing; EKG changes; elevated troponin level; This is a spontaneous report from a contactable consumer or other non hcp.   A 12-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration, administered in Arm Left at the age of 12-year-old on 30Jun2021 as single dose for covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. Patient had no relevant past drug history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 03Jul2021 05:30 the patient experienced severe chest pain, difficulty in breathing, ekg changes, elevated troponin level. The patient was hospitalized for the events. The patient underwent lab tests and procedures which included electrocardiogram: unknown, troponin increased: elevated. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the adverse event with Pain medication. The clinical outcome of events was recovering.  Information about batch/Lot number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Joint swelling
Clinical narrative: Barely able to walk; Pain in both knees; Both knees swollen; This is a spontaneous report from a contactable consumer or other non hcp. A 61-year-old adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0151)via an unspecified route of administration, administered in Left arm on 06May2021 at 08:30 (at the age of 61-year-old) as Dose 1,Single for COVID-19 immunization. The patient's medical history included high triglycerides, mild arthritis in back. The patient had no allergies. Since the vaccination, the patient has not been tested for COVID-19.Prior to vaccination, the patient  was not diagnosed with COVID-19. Concomitant medications included ascorbic acid, biotin, calcium pantothenate, calcium phosphate dibasic, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, potassium sulfate, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acid succinate, zinc sulfate (MULTI VITAMINS & MINERALS), vitamin D nos. On 13May2021,the patient experienced pain in both knees. Both knees swollen. Barely able to walk, gotten better but had to take ibuprofen for pain and am taking glucosamine sulfate. The patient was not tested positive post vaccination. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0165)via an unspecified route of administration, administered in Left arm on 27May2021 at 08:30 (at the age of 61-year-old) as Dose 2,Single for COVID-19 immunization. No treatment mentioned for all the events. The patient reported gotten better but has to take ibuprofen for pain and am taking glucosamine sulfate. The outcome of the events was not recovered/not resolved.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: This is a spontaneous report received from a contactable consumer (Patient). A 35-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 22Jun2021 at 15:30 (at the age of 35-year-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history reported as none. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with covid-19 and not received any other vaccine four weeks. Patient did not receive any medication two weeks of vaccination. The patient had known allergy to Amoxicillin. On 23Jun2021 at 08:00, the patient experienced dark spots in vision. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The outcome of the event was reported as not recovered. Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Muscle spasms, Palpitations
Clinical narrative: heart palpitations; Tiredness/extreme tiredness; left legs knee bellow knee pain; left leg muscle jumping; left hand numbness; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 64-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 16Jun2021 12:00 (at the age of 64-years-old) (Batch/Lot number: unknown and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunisation at pharmacy/drug store. The patient medical history and concomitant medications were not reported. The patient did not have any known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 29Jun2021 12:00, the patient experienced heart palpitations, tiredness/extreme tiredness, left legs knee bellow knee pain, left leg muscle jumping and left hand numbness. The patient did not receive treatment for the events. The clinical outcome of the events was reported as not recovered.  Information about Batch/Lot number was requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Having a difficult time breathing; This is a spontaneous report received from a contactable consumer or other non hcp. A 47-years-old female patient received second dose of bnt162b2 (PFIZER BIONTECH-COVID19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Jun2021 09:00 as single dose for COVID-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, known allergies: Macro Bid antibiotic. Concomitant medications included sertraline hydrochloride (ZOLOFT) and gabapentin taken for an unspecified indication, start and stop date were not reported. Prior and since the vaccination, patient was not tested and diagnosed with COVID19.The patient was not hospitalized after vaccination. The patient did not received any other vaccine within 4 weeks prior to COVID-19 Vaccine. The patient experienced having a difficult time breathing (dyspnoea) on 03Jul2021.The outcome of the event was not resolved.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Polymorphic light eruption
Clinical narrative: Polymorphic light eruption; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW01j8) via an unspecified route of administration right arm on 21Apr2021 at 11:00 (at the age of 37-years-old) single dose for COVID-19 immunization. The patient's medical history included muscle cramp. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0150) as single dose, administered in right arm on Mar2021 at 11.00 (at the age of 37-years-old). No reaction on previous exposure to drug. The patient's concomitant medication included ibuprofen (ADVIL 12 HOUR) taken for muscle spasms received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. On 01May2021, the patient experienced polymorphic light eruption. Its been diagnosed by patient dermatologist and patient had been managing it with prescription corticosteroids for about two months now. Patient never had this before. Patient did not required prolonged hospitalization. Patient received treatment. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash around neck / Have rash all body; Itchy all body; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in left arm on 29Jun2021 at 10:45 AM (vaccinated at the age of 12 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included atopic dermatitis from an unknown date and unknown if ongoing, allergic to apple and cedar tree, birth, Alder, Prennial Rye, sweet Varnal, Timochygrass. Concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. After taking the vaccine 11 am, on 29Jun2021 at 04:00 PM, patient got rash around neck around 4pm and all body except face around 12am -1am and took Benadryl to sleep. On next day, patient was still itchy all body and took Benadryl again to sleep. After the next day, patient went to ExerUrgent care and got steroids prescription creams. However, after 4 days now, patient still have not to get better and have rash all body. Therapeutic measures were taken as a result of the events with prescription steroids cream and Benadryl cream. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The report was non serious. Outcome of the events was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pancreatic enzymes increased
Clinical narrative: chest pain; elevated pancreatic enzymes; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single, and later received second dose of BNT162B2 (Lot number and Expiration date: Not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single; both for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced chest pain (non-cardiac) and elevated pancreatic enzymes and had to be hospitalized post receiving first dose and experienced the same symptoms after receiving second dose. It was reported patient had been hospitalized after each dose and events took place after receiving the vaccines. The outcome of events was unknown.  Information about Lot/Batch number requested.; Sender's Comments: Bases on the limited information in the report, , a causal association between the reported events of chest pain and pancreatic enzymes increased and suspect drug bnt162b2 cannot be excluded. The case will be reassessed upon follow up. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pustular
Clinical narrative: rash developed with a raised, red appearance and filled with fluid; Rash developed around neck, shoulders, butt, arms, chest, and legs; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EW0176) via an unspecified route of administration on 09May2021 at 11:30 (at the age of 40-years-old) in right arm as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history was reported as none and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (Lot number: EW0169) on 18Apr2021 at 10:30 in right arm as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccine in four weeks. Patient not had any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 28May2021 at 12:00, about 3 weeks after the second dose, patient had a rash developed with raised, red appearance and filled with fluid. Rash developed around neck, shoulders, butt, arms, chest, and legs. The event was assessed as serious (medically significant). It was reported patient consulted with four clinicians (two internal medicine and two dermatologists) and none of them could diagnose conclusively the cause of the rash, though all four commented that the reaction could be caused by the covid vaccine. The patient was treated with creams and medications (steroids) and they did not help to improve the symptoms or severity. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Device date was reported as 04Jul2021. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Inappropriate schedule of product administration
Clinical narrative: Dose1 14Jan2021 / Dose2 14Jan2021; Super heavy and painful menstrual cycles since taking the vaccine.; painful menstrual cycles since taking the vaccine; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non pregnant female patient received first dose of BNT162B2 (Batch/Lot number: EL8972, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on an unspecified date as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN5318, Expiration Date was not reported) via an unspecified route of administration, administered in left arm on an unspecified date as dose 2, single and for COVID-19 immunization at hospital. The patient medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT, 50mg, 1x per day), dulaglutide (TRULICITY, biweekly). List of any other medications the patient received within 2 weeks of vaccination included Zoloft 50mg, 1x per day. Trulicity biweekly. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 12:00AM the patient experienced super heavy and painful menstrual cycles since taking the vaccine. Patient was not hospitalized. No treatment was received for adverse event. Device Date: 04Jul2021. The outcome of the event Super heavy and painful menstrual cycles since taking the vaccine was not recovered and rest event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Heart rate increased
Clinical narrative: Chest pain; Racing heart; Elevated blood pressure; This is a spontaneous report from a Pfizer sponsored program. This consumer (Co-worker) reported for reported for a male patient unknown age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on unspecified date, at unknown dose single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter had a co-worker (patient) ended up getting the vaccine and had the events chest pain, racing heart and elevated blood pressure on an unspecified date. Outcome of the events was unknown.  Information on Lot/Batch information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: On an unspecified date caller received 2nd Pfizer Covid vaccine the end of March and started chemo in April, did not share when she was diagnosed with cancer; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date (as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On an unspecified date caller received 2nd Pfizer Covid vaccine the end of March and started chemo in April, did not share when she was diagnosed with cancer. She would like to know if she has immunity to the Coronavirus if she started chemo so soon after receiving the vaccine. The patient received treatment with chemo. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), both via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced "have had an adverse reaction to both the COVID vaccine and I also have got COVID even though I was vaccinated". So the patient was a break through case and wanted to speak with someone to give them the information and also to find out information they could only give the patient. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Dizziness
Clinical narrative: Feeling very heavy dizziness; wave in my head like dizziness in vision; light headed; Affects diabetes; my sugar is high; This is a spontaneous report from a contactable consumer (patient). A 59-year-old patient of an unspecified gender received bnt162b2 (manufacture: unspecified, formulation: solution for injection; Batch/Lot Number: FA6780; NDC number, UPC number and Expiry Date: unknown), dose 1 via an unspecified route of administration on 01Jul2021 as dose 1, single for covid-19 immunisation. Medical history included thyroid (when probed for any concomitant medication, consumer stated, "Thyroid medication") from an unknown date and unknown if ongoing and ongoing diabetes from an unknown date. The patient's concomitant medications were not reported. The patient got the first shot yesterday on 01Jul2021 and after that patient felt very heavy dizziness today and the sugar was high, high that affected diabetes and patient had lightheaded. They told to know at the Pharmacy, wave in the head like dizziness in vision. This shot affects diabetes like and said the sugar was high. Patient was all set, this was too much will call the doctor. The patient underwent lab test blood glucose which was increased on 01Jul2021. The outcome of the events was unknown. When asked for any treatment for the event, consumer stated, no the only I had done with, my insulin for my blood sugar. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I got the shot yesterday and I almost thought I was going to died; This is a spontaneous report received from a non-contactable consumer or other non hcp (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that I got the shot yesterday and I almost thought I was going to died. The clinical outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.