chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cholelithiasis, Computerised tomogram, Computerised tomogram thorax, Dyspnoea, Pancreatitis
Clinical narrative: CT showed that she had likely passed a gallstone and had pancreatitis; CT showed that she had likely passed a gallstone and had pancreatitis; seriously ill (serum calcium was 5.2), electrolytes all very low; seriously ill (serum calcium was 5.2), electrolytes all very low; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Right on 16Apr2021 10:00 (at the age of 37 years old) (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took her first dose of BNT162B2 administered to right arm on 26Mar2021 08:00 and experienced mild bout of pancreatitis. suspected gallstone and vomiting on 02Apr2021 07:30. Facility where the most recent COVID-19 vaccine was administered was at Pharmacy or Drug Store. Patient has no known allergies. The patient did not have COVID-19 prior to the vaccination. No prior medical history to the pancreatitis/gallstone events after the vaccine doses. Patient has not taken any other vaccine in four weeks nor other medications in two weeks. The patient was not pregnant at the time of vaccination. One week exactly after patient received the first dose of the vaccine reported as 02Apr2021 07:30, she had a mild bout of pancreatitis and suspected gallstone. Patient's vomiting lasted 7 hours. At the time, she thought it was a short-lived stomach bug, but when the same thing happened after the second dose of the vaccine, it was more severe and patient ended up in the hospital for a week. Patient never had gallbladder or pancreas issues prior to these two events. 3 weeks after her second dose reported as 09May2021 16:00, patient got severely ill, resisted going to the hospital a few days hoping it was another stomach bug. When she ended up in the ER, she was seriously ill (serum calcium was 5.2), electrolytes all very low, difficulty breathing despite a clear chest X-ray and CT scan of my lungs. Another CT showed that she had likely passed a gallstone and had pancreatitis. She spent about a week in the hospital while treatment was focused on stabilizing patient's electrolytes (Electrolytes by IV). She needed to have her gallbladder removed but was sent home to continue recovering as she couldn't undergo an operation while she was still having difficulty breathing. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient has not been tested for COVID, post vaccination. The outcome of the event was recovering at the time of report.   Information on the lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Orchitis
Clinical narrative: Diagnosis of Orchitis of right testicle; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EWO158), via an unspecified route of administration, administered in Arm Left, on 01Jun2021 08:15 (received at the age of 32-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The most recent COVID-19 vaccine was administered at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 post vaccination. Medical history included ankle sprain in 2020 (1 year ago) and skull fracture in 1991 (30 years ago). Concomitant medication included acetaminophen (ACETAMINOPHEN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EWO158), administered in Arm Left, on an 11May2021 08:15 (received at the age of 32-years-old) for COVID-19 immunisation and had no reaction. The patient previously took ibuprofen and experienced drug allergy. The patient experienced diagnosis of orchitis of right testicle on Jun2021. The adverse event resulted into a doctor or other healthcare professional office/clinic visit, emergency room visit, and hospitalization. Therapeutic measures were taken as a result of the adverse event. Treatment included ROCEPHIN, VIBRAMYCIN, ULTRAM. Outcome of the event was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: Large area of broken blood vessels in right eye; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 12May2021 09:45 (at age of 65 years old) as single dose for COVID-19 immunization. Medical history included Diabetes 2, high Blood Pressure, High cholesterol. Concomitant medications included: BP meds. 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 has not been tested for COVID-19. No known allergies. The patient experienced Large area of broken blood vessels in right eye on 13May2021 08:00 AM. AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received. The outcome of the event was recovered in 2021.  information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pain, Eye swelling, Hypersensitivity, Nausea
Clinical narrative: woke up with allergy all over the body; rash all over my body; minor pain; pain and swollen eyes; pain and swollen eyes; Swelling all over my face; my neck and my body is very red and Itchy; my neck and my body is very red and Itchy/body very red like sunburn; Nausea; This is a spontaneous report from a contactable consumers (one of them is the patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0168) via an unspecified route of administration into left arm on 10Jun2021 (at the age of 33-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jun2021 patient woke up with allergy all over the body, rash all over the body, minor pain, pain and swollen eyes, swelling all over the face, neck and body is very red; further reported as body was very red like sunburn and itchy and nausea. Patient went to the emergency room and was given a shot of steroid and a shot of Benadryl. Outcome of event "nausea" was unknown while the outcome of all other events was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Swelling face
Clinical narrative: woke up with allergy all over the body; rash all over my body; minor pain; pain and swollen eyes; pain and swollen eyes; Swelling all over my face; my neck and my body is very red and Itchy; my neck and my body is very red and Itchy/body very red like sunburn; Nausea; This is a spontaneous report from a contactable consumers (one of them is the patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0168) via an unspecified route of administration into left arm on 10Jun2021 (at the age of 33-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Jun2021 patient woke up with allergy all over the body, rash all over the body, minor pain, pain and swollen eyes, swelling all over the face, neck and body is very red; further reported as body was very red like sunburn and itchy and nausea. Patient went to the emergency room and was given a shot of steroid and a shot of Benadryl. Outcome of event "nausea" was unknown while the outcome of all other events was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 11Jun2021 16:30 (at age of 58 years old) as single dose for COVID-19 immunization. Medical history included mast cell activation syndrome, ehlers danlos syndrome, allergic to garlic, allergic to beef, known allergies: Narcotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included verapamil; pregabalin (LYRICA); famotidine; loratadine (CLARITINE); cromolyn sodium. The patient previously took omalizumab (XOLAIR), salbutamol (ALBUTEROL), Sorbitol, clindamycin, diclofenac diethylamine (VOLTAREN), sildenafil citrate (ZOLTAN), all had drug allergy. The patient had Anaphylaxis on 11Jun2021 03:30 PM. This case was Serious with Seriousness criteria-Life threatening. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event (epinephrin). The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Investigation, Malaise, Seizure
Clinical narrative: Feeling sick; Feeling dizzy; Seizure; vomiting; bad Headache; This is a spontaneous report from a contactable consumer. A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm right on 12Jun2021 (Lot Number: EN6198) as dose 2, single (at the age of 20 years old) for COVID-19 immunization. Medical history included asthma, attention deficit hyperactivity disorder (ADHD), Blood pressure high; all from an unknown date. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported and inhaler medication for asthma. No prior vaccinations (within 4 weeks). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT#EW0170), via intramuscular administered in right arm on 17May2021 (also reported as 07May2021) as dose 1, single for COVID-19 immunization and experienced no adverse effect. It was stated that it was just when he got the second dose of the COVID-19 Pfizer on 12Jun2021, it was supposed to be on 07Jun2021, but patient didnt go back in. Further stated that patient just started feeling sick just while ago (on unspecified date), but he started feeling dizzy on 13Jun2021. It was reported that patient got his second dose and on 13Jun2021, his vomiting could not stop and having bad headache, he could not stop vomiting. Consumer stated that he was trying to have like seizure or something on 13Jun2021. Reporter stated no treatment for the event. The patient had lab test at a hospital. They were checking out the Vitamin levels. The patient underwent lab tests and procedures which included checking out the vitamin levels: unknown results on 11May2021. The outcome of the events seizure, vomiting, bad headache was not recovered and outcome of feeling sick and feeling dizzy was unknown.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Feeling sick; Feeling dizzy; Seizure; vomiting; bad Headache; This is a spontaneous report from a contactable consumer. A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via intramuscular, administered in arm right on 12Jun2021 (Lot Number: EN6198) as dose 2, single (at the age of 20 years old) for COVID-19 immunization. Medical history included asthma, attention deficit hyperactivity disorder (ADHD), Blood pressure high; all from an unknown date. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported and inhaler medication for asthma. No prior vaccinations (within 4 weeks). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT#EW0170), via intramuscular administered in right arm on 17May2021 (also reported as 07May2021) as dose 1, single for COVID-19 immunization and experienced no adverse effect. It was stated that it was just when he got the second dose of the COVID-19 Pfizer on 12Jun2021, it was supposed to be on 07Jun2021, but patient didnt go back in. Further stated that patient just started feeling sick just while ago (on unspecified date), but he started feeling dizzy on 13Jun2021. It was reported that patient got his second dose and on 13Jun2021, his vomiting could not stop and having bad headache, he could not stop vomiting. Consumer stated that he was trying to have like seizure or something on 13Jun2021. Reporter stated no treatment for the event. The patient had lab test at a hospital. They were checking out the Vitamin levels. The patient underwent lab tests and procedures which included checking out the vitamin levels: unknown results on 11May2021. The outcome of the events seizure, vomiting, bad headache was not recovered and outcome of feeling sick and feeling dizzy was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood prolactin, Condition aggravated, Diabetes mellitus, Dizziness, Headache
Clinical narrative: I had little light seizures; I had little light seizures; Dizziness; My head was hurting; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 17May2021 (Lot Number: EW0170) (at age of 45-year-old) for covid-19 immunisation.  Medical history included type 2 diabetes mellitus, asthma, High blood pressure, High cholesterol, thyroid disorder, cardiac failure congestive, acid reflux, and seizure. There was no other vaccine in four weeks. Concomitant medications included lisinopril taken for hypertension, start and stop date were not reported; phenytoin (DILANTIN) taken for seizure, start and stop date were not reported; topiramate (TOPAMAX) taken for seizure, start and stop date were not reported; verapamil hydrochloride (CALAPTIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported.  On 17May2021, the patient stated, "Well, I have Type 2 Diabetes, plus I have some 'disc in heart' (Further clarification unknown)and I have Seizures and I have Asthma and High Blood Pressure. I have a lot of Heath Problems. And I felt Dizziness. My head was hurting. I had little light seizures." The patient underwent lab tests and procedures which included seizure levels : unknown results on 11May2021, diabetes mellitus: glucose low on 11May2021. No treatment was received for the events.  The outcome  of event 'little light seizures ' was unknown, of other events was recovering.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: I had little light seizures; I had little light seizures; Dizziness; My head was hurting; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 17May2021 (Lot Number: EW0170) (at age of 45-year-old) for covid-19 immunisation.  Medical history included type 2 diabetes mellitus, asthma, High blood pressure, High cholesterol, thyroid disorder, cardiac failure congestive, acid reflux, and seizure. There was no other vaccine in four weeks. Concomitant medications included lisinopril taken for hypertension, start and stop date were not reported; phenytoin (DILANTIN) taken for seizure, start and stop date were not reported; topiramate (TOPAMAX) taken for seizure, start and stop date were not reported; verapamil hydrochloride (CALAPTIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported.  On 17May2021, the patient stated, "Well, I have Type 2 Diabetes, plus I have some 'disc in heart' (Further clarification unknown)and I have Seizures and I have Asthma and High Blood Pressure. I have a lot of Heath Problems. And I felt Dizziness. My head was hurting. I had little light seizures." The patient underwent lab tests and procedures which included seizure levels : unknown results on 11May2021, diabetes mellitus: glucose low on 11May2021. No treatment was received for the events.  The outcome  of event 'little light seizures ' was unknown, of other events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Arm pain at injection site; Arm weakness; Immobility through shoulder continuous; This is a spontaneous report form a contactable consumer (patient). A 43-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration in left arm on 22May2021 (at the age of 43-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified birth control pills only medications received within 2 weeks of vaccination. Prior to 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 vaccine in four weeks of COVID vaccination. On 26May2021, the patient experienced arm pain at injection site 6 weeks after injection and arm weakness and immobility through shoulder continuous. The reporter reported seriousness criteria is Disabling/Incapacitating. As a corrective measure, the patient attended physician therapy. The adverse event was resulted in a visit to doctor or other healthcare professional office/clinic visit. The outcome of the events was resolving.  Amendment: This follow-up report is being submitted to amend previously reported information: this case upgrade to serious since reported seriousness criteria is Disabling/Incapacitating for all events.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cholelithiasis, Pancreatitis, Vomiting
Clinical narrative: I had a mild bout of Pancreatitis; Suspected gallstone; Vomiting; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old  non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration, administered in Arm Right on 26Mar2021 08:00 (Batch/Lot number was not reported) (at 37-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history was reported as none.  No known allergies.There was no COVID prior vaccination or no COVID  tested post vaccination. There was no other vaccine in four weeks.   The patient's concomitant medications were reported as no. The patient experienced a mild bout of pancreatitis, suspected gallstone, and vomiting on 02Apr2021 07:30. The events did not result in emergency room visit or physician office visit. No treatment received for this events. Event details reported as:  One week exactly after I received the vaccine, the patient had a mild bout of pancreatitis and suspected gallstone. Vomiting lasted 7 hours. At the time, the patient thought it was a short-lived stomach bug, but when the same thing happened after the second dose of the vaccine, it was more severe and the patient ended up in the hospital for a week. The patient never had gallbladder or pancreas issues prior to these two events. The outcome of the events was recovered with sequelae.  Information about lot/batch number has been requested.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, SARS-CoV-1 test
Clinical narrative: Anaphylactic reaction requiring medical attention.; This is a Spontaneous case report received from Pfizer Sponsored Program, from a contactable consumer (parent).   A 15-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 09Jun2021 at 19:30 as dose 2, single for covid-19 immunisation at pharmacy or drug store. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2, administered in left arm for COVID-19 immunization received on 19May2021 at 19:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination includes dentist twilight sedation. On 11Jun2021 at 12:00, the patient experienced anaphylactic reaction requiring medical attention (medically significant). Pregnazone shots, steroids shots were received as treatment for adverse event. The patient underwent lab tests and procedures which included sars-cov-1 test: negative on 13Jun2021. Therapeutic measures were taken as a result of anaphylactic reaction requiring medical attention. The adverse events resulted in Emergency room/department or urgent care. Device Date: 14Jun2021. The patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The outcome of the events was reported as not resolved.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: had hearing loss in one of the ear/hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got 2nd Covid vaccine (Pfizer Covid-19 Vaccine) and had every symptom that the patient saw online, after 3 days. The patient heard echo, the patient just want to say that had hearing loss in one of the ear after the 2nd vaccine and was not finding much on here, the patient had everything else but that's Friday (unspecified), the patient had the hearing loss in right ear. The patient never had this problem before. The outcome of event was unknown.  Information about batch/Lot number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: A week after my first vaccine I started developing hives all over of my body. I would get them about 2-3 times a week.; This is a spontaneous report from a contactable consumer or other non hcp.   A 27-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot Number: EL9266 expiry date was not reported) as dose 1 via an unspecified route of administration, administered at Arm Left on 13Feb2021 as a single dose (age at avccination was 27-years-old) for COVID-19 immunisation. Patient's medical history reported as none. The patient's concomitant medications were not reported. 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 have known allergies. The patient no other vaccine in four weeks. The patient had not received other medications in two weeks. The patient experienced a week after first vaccine she started developing hives all over of patient body and she would get them about 2-3 times a week. She went to an allergist and she cannot diagnose (urticaria) (disability). Therapeutic measures were taken because of a week after my first vaccine she started developing hives all over of my body. Patient received treatment of Allegra twice a day and Zyrtec. She would get them about 2-3 times a week. The outcome event was not recovered.   Information is needed. Further inform is requested.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia, SARS-CoV-2 test
Clinical narrative: Approximately two weeks after vaccination rapid development of Dementia, literally from Saturday evening to Sunday morning.; This is a spontaneous report from a contactable consumer (patient herself). A 96-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in right arm on 14Feb2021 13:15 as dose 1, single (at the age of 96-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Patient had been tested for COVID-19, since the vaccination using the nasal swab test with results as unknown on an unspecified date in 2021. Patient medical history included moderate dementia. Patient did had no known allergies. The concomitant medications were not reported. On 28Feb2021, approximately two weeks after vaccination patient developed rapidly Dementia, from Saturday (27Feb2021) evening to Sunday (28Feb2021) morning. The adverse events resulted in emergency room/department or urgent care, hospitalization (for a period of 2 days) and disability or permanent damage (as reported). The treatment received for the adverse events included supportive care. The outcome of the event was not recovered.   Information on Lot/Batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over my body every single day.; This is a spontaneous report from a contactable consumer or other non hcp. A 28-years-old female patient received second dose of bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13Mar2021 (Batch/Lot Number: EN9266), single for covid-19 immunization. The patient did not had any medical history. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID or any other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL6208) via an unspecified route of administration on 13Feb2021 as dose 1, single dose for covid-19 immunization and experienced hives all over her body a week after first dose of vaccine and she would get them about 2-3 times a week. In Mar2021, after receiving the second dose of vaccine the patient experienced hives all over her body every single day. The adverse event resulted in doctor or other healthcare professional office/clinic visit. She visited an allergist, but she cannot diagnose her. The patient knew that the event was from the vaccine. The patient was advised to take Allegra twice a day and Zyrtec as therapeutic measure for event. The outcome of the event was unknown.; Sender's Comments: As per the information provided in the narrative, the causal association between the suspect drug and the event cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea
Clinical narrative: Shortness of breath/breathing problems; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 27Feb2021 (at the age of 81-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included heart and blood pressure, depression and asthma. Concomitant medication included metoprolol taken for heart and blood pressure from Jan2021 and ongoing, escitalopram taken for depression, start and stop date were not reported and medication for asthma.(allergy drug for asthma). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9810), via an unspecified route of administration on 06Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. On 04Mar2021 the patient began to experience shortness of breath/breathing problems. On 06Mar2021 she was seen in the emergency department and evaluated for her shortness of breath. On an unknown date in Mar2021 she underwent computerised tomogram (CT) of her lungs which resulted normal (found nothing wrong). She received montelukast 10mg as treatment for the event. Stated that she began experiencing shortness of breath on 04Mar2021, she thought it was just normal so she did not do anything, states it continued and on Saturday morning, 06Mar2021 she went to the emergency room. On an unknown date in Mar2021 they did all the tests, CT of her lungs and everything and they found nothing wrong. She followed up with her family doctor who told her it was not an allergic reaction to the vaccine because if she was going to have one it would have been closer to when she got the vaccine. States she was then started on an antidepressant and an allergy drug for asthma. Clarifies she began escitalopram 5mg, and a medication for asthma, Montelukast, 10mg at night time for breathing to take at night, clarified this was all back in Mar2021. Caller stated she had been on medication since then, and it helped some. She wanted to know have other people had this problem from taking the vaccine, have they reported shortness of breath after the vaccine. She stated tomorrow she was going to the cardiologist. At the time of report, outcome of the event was not resolved.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: and have a question about a death being reported as possible link to COVID-19 vaccine; This is a spontaneous report from a contactable consumer. An unspecified age and gender patient received an unspecified dose of BNT162B2 via an unspecified route of administration on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unknown date, the patient experienced death and it was been reported as possible link to COVID-19 vaccine. The reporter stated that was reported a teen dead several days after gotten a vaccine. Since only Pfizer vaccine is available to teens and reporter wanted to know whether have a statement about this. The CDC was investigated any potential link. The outcome of event was fatal.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: and have a question about a death being reported as possible link to COVID-19 vaccine
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ACTHIB was inadvertently administered with no reported adverse event; Initial information was received on 22-Jun-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves six-month-old female patient who was inadvertently given expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ318ABA and expiry date: 18-Jun-2021] via an intramuscular route in the left vastus lateralis on 21-JUN-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Systemic: pt indicated that has numbness in fingers/hand/arm-Medium
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Disseminated varicella zoster virus infection, Myalgia, Pain in extremity, Rash vesicular
Clinical narrative: The patient is a 31 year old kidney transplant recipient who had been in his usual state of health and feeling well over the past months. On May 7, he received the first dose of COVID vaccine and experienced intense myalgias at that time. He recovered, but then around May 17 noted the onset of pain in the R thigh and lower R back and subsequently developed a vesicular rash in this area. He saw his primary care physician who prescribed gabapentin. However his pain worsened and the rash extended and he presented for admission. He was diagnosed with disseminated zoster, was hospitalized from 5/24/21 - 5/29/21 and was treated with IV acyclovir  followed by oral valacyclovir.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint injury, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood test, Hypotension, Loss of consciousness, Urticaria
Clinical narrative: 2 months later I had two insect bites and the second day I had a severe case of hives (I have never had hives before). This lead to anaphylactic shock resulting in low blood pressure and passing out. EMTs administered saline/epinephrine/steroid.  Currently Doing follow up for allergies.  Stopped taking lisinopril.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: I21.4 - NSTEMI (non-ST elevated myocardial infarction)
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Injection site erythema, Pyrexia, Syncope
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: I21.4 - Non-ST elevation (NSTEMI) myocardial infarction
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Lethargy
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Additional Details: Patient reports that the symptoms started the morning after she received the vaccine. She slept part of the day but felt very lightheaded and was throwing up a lot, so she called an ambulance and was treated with IV fluids in the ED. She reports a full recovery as of today, 6/28/2021.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Additional Details: Patient reports that the symptoms started the morning after she received the vaccine. She slept part of the day but felt very lightheaded and was throwing up a lot, so she called an ambulance and was treated with IV fluids in the ED. She reports a full recovery as of today, 6/28/2021.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Cold sweat, Diarrhoea, Fatigue
Clinical narrative: I woke up at 6am the morning after receiving the vaccination. I was awake for about 2 and a half hours when I began feeling exhausted, nauseated, had an intense headache and cold chills. I went back to bed at 8:30am. I covered myself with 2 quilts and my bathrobe due to chills. I had cold sweats, a fever, nausea, diarrhea, body pain, a migraine, lucid dreams, and hallucinations for the next 36 hours. At around 36 hours I still had a migraine, muscle and body pain, the other symptoms had waned. My last three symptoms lasted for about 4 days and slowly lessened over time.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Headache, Migraine, Myalgia, Nasopharyngitis
Clinical narrative: I woke up at 6am the morning after receiving the vaccination. I was awake for about 2 and a half hours when I began feeling exhausted, nauseated, had an intense headache and cold chills. I went back to bed at 8:30am. I covered myself with 2 quilts and my bathrobe due to chills. I had cold sweats, a fever, nausea, diarrhea, body pain, a migraine, lucid dreams, and hallucinations for the next 36 hours. At around 36 hours I still had a migraine, muscle and body pain, the other symptoms had waned. My last three symptoms lasted for about 4 days and slowly lessened over time.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: I woke up at 6am the morning after receiving the vaccination. I was awake for about 2 and a half hours when I began feeling exhausted, nauseated, had an intense headache and cold chills. I went back to bed at 8:30am. I covered myself with 2 quilts and my bathrobe due to chills. I had cold sweats, a fever, nausea, diarrhea, body pain, a migraine, lucid dreams, and hallucinations for the next 36 hours. At around 36 hours I still had a migraine, muscle and body pain, the other symptoms had waned. My last three symptoms lasted for about 4 days and slowly lessened over time.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Vomiting-Mild
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Asthenia, Cough, Hyponatraemia, Hypoosmolar state
Clinical narrative: N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia NASAL CONGESTION COUGH VOMITING WEAKNESS - GENERALIZED
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Vomiting
Clinical narrative: N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia NASAL CONGESTION COUGH VOMITING WEAKNESS - GENERALIZED
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: NSTEMI (non-ST elevated myocardial infarction)
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Fatigue, Lethargy
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: I21.4 - NSTEMI (non-ST elevated myocardial infarction)
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: NSTEMI (non-ST elevated myocardial infarction).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Flushing
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Pt fainted about 4 minutes after receiving the first covid vaccine, pt was warm, sweating.  He was light headed and dizzy for about 10 minutes, his girl friend came to pick him up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Pt fainted about 4 minutes after receiving the first covid vaccine, pt was warm, sweating.  He was light headed and dizzy for about 10 minutes, his girl friend came to pick him up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Peripheral swelling, Pruritus, Rash macular, Swelling face
Clinical narrative: Red blotches on both arms at bicep and minor blotches at groin (itchy) lasted approximately 1 day. This occurred twice in a period of 3 weeks. Severe swelling of the right hand lasted approximately 3 days. Severe swelling of left-side of face. Lasted approximately 3 days. Severe swelling of entire face including lips. Lasted approximately 3 days. The doctor prescribed a Medrol Dose Pak 3 times to correct the 3 events of swelling.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: NO EMS needed, pt felt on her head
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthenia, Chest discomfort, Confusional state, Dizziness
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Eye swelling, Fatigue, Flushing
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersensitivity, Hyperventilation, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Lethargy, Mouth swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling face, Syncope, Tachycardia, Throat tightness
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium