chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vomiting
Clinical narrative: 104F fever; Vomiting; Aches; Chills; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8737), via an unspecified route, administered in Left Arm on 14Apr2021 at 14:30 (at the age of 41-years) as single dose for COVID-19 immunization. The patient's medical history included allergy to cephalosporins and chronic hives of unknown origin. The patient had no other known allergies. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medication(s) included cetirizine and methylphenidate. The patient previously received first dose of BNT162B2 (Lot Number: ER8727), via an unspecified route of administration on 24Mar2021 at 19:15 (at the age of 14-years) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Apr2021 at 16:00, the patient experienced 104F fever, vomiting, aches, chills. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 104F fever. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Apr 2021.  No follow-up attempts are needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Fatigue
Clinical narrative: dry skin; fatigue; This is a Spontaneous report from a contactable consumer. A 51-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 24Mar2021 as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that during follow up of Ibrance, patient reported skipping 7 doses due to receiving Covid-19 vaccine, recommended by physician On unknown date in Apr2021 the patient experienced dry skin, fatigue. Patient was doing ok on medication, just dry skin. Dry skin was controlled with OTC creams. It was reported that medication will be set for delivery for Apr2021. The outcome of the event fatigue was unknown and dry skin was recovered on an unspecified date in 2021.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: blacked out; Arm soreness; body aches; dizziness; nausea; chills and sweats; chills and sweats; headache; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, administered in the left arm on 28Apr2021 at 10:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX) taken for an unspecified indication, start and stop date were not reported; levonorgestrel (MIRENA) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 on 06Apr2021 at 10:00 AM (Lot Number: unknown) via an unspecified route of administration in the left arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 28Apr2021 at 21:00, the patient experienced blacked out, arm soreness, body aches, dizziness, nausea, chills and sweats, and headache.  The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on an unknown date post vaccination.  The patient had not recovered from the events, blacked out, arm soreness, body aches, dizziness, nausea, chills and sweats, and headache.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: blacked out; Arm soreness; body aches; dizziness; nausea; chills and sweats; chills and sweats; headache; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, administered in the left arm on 28Apr2021 at 10:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX) taken for an unspecified indication, start and stop date were not reported; levonorgestrel (MIRENA) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 on 06Apr2021 at 10:00 AM (Lot Number: unknown) via an unspecified route of administration in the left arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 28Apr2021 at 21:00, the patient experienced blacked out, arm soreness, body aches, dizziness, nausea, chills and sweats, and headache.  The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on an unknown date post vaccination.  The patient had not recovered from the events, blacked out, arm soreness, body aches, dizziness, nausea, chills and sweats, and headache.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: terrible headache/head was like beating; This is a spontaneous report from a contactable consumer (patient reported for herself). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated had a COVID-19 Pfizer, Pfizer whatever called it, the Pfizer vaccine here and she didn't like the way she was feeling, she got a terrible headache since she had her head was like beating. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Oropharyngeal pain
Clinical narrative: Sore throat; flu-like symptoms; This is a spontaneous report from a contactable consumer. An adult female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Apr2021 (Lot Number: ER8729) as unknown, single dose for covid-19 immunization. Medical history included fish allergy and diagnosed with COVID-19. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Sore throat and flu-like symptoms on 15Apr2021. No treatment received. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Pain in extremity, Sluggishness
Clinical narrative: complained of chest pain after having the vaccine; very fatigued; very sluggish; Sore arm; This is a spontaneous report received from a contactable consumer (parent). A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (Lot Number: EW0177, at the age of 16-year-old) as single dose for covid-19 immunisation. Medical history included heart murmur. The patient's concomitant medications were not reported. Historical Vaccine included 2 vaccines in Mar2021 (Caller said that her son had 2 vaccines in Mar2021 on his annual doctor visit, she did not have the names of the vaccines and then had a booster for the vaccine 4 weeks later. The booster was 14 days prior to receiving the Covid vaccine), and meningococcal vaccine on 01May2021 (at the age of 16-year-old, Caller said that it was a meningococcal vaccine. She thought there were 2 different meningococcal vaccines). Caller was a consumer that was calling on behalf of her son that received his first dose of the Covid-19 Vaccine. She said that she saw on the news recently that Pfizer was looking into reports that teenagers were developing heart issues after receiving the vaccine. The caller said that her son was 16 years old and received his first dose on 15May2021. The caller said that her son had a really small heart murmur. When they got home later that day after he received the vaccine on 15May2021, he said that he had chest pain. She said that he did not have a fever, but was very fatigued and very sluggish for a couple of days. She said that this had been on her mind since she saw it on the news. She was concerned if he should get the second dose on 05Jun2021 with his pediatrician. The caller also said that because he turned 16 in Mar2021, he recently had 2 other vaccines and he had a booster. So he had 3 shots prior to having the Covid-19 Vaccine. The caller said that he received the Covid-19 Vaccine after 14 days of receiving the booster. The caller said that the fatigue and feeling sluggish lasted a couple of days, but stated that he was still tired a lot. The caller said that her son also reported that he had a sore arm. She said that he noticed it a couple of hours after his vaccination and lasted about 3 days. He had completely recovered from the sore arm. The outcome of the event chest pain was unknown, of event fatigue was not recovered, of event sluggish was recovering, of the event sore arm was recovered on 18May2021.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Glossodynia, Odynophagia, Oropharyngeal pain, Speech disorder, Streptococcus test
Clinical narrative: mild pain in tongue and throat/severe sore throat; mild pain in tongue and throat; Felt pain when swallowing; He could not talk normally cannot move tongue very much; He could not talk normally cannot move tongue very much; This is a spontaneous report received from Medical Information Team. A contactable physician (parent) reported that a 15-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22May2021 15:00 (Lot Number: EW0178, at the age of 15-year-old) as single dose for covid-19 immunisation. Medical history included seasonal allergies. Concomitant medications included loratadine (CLARITIN) taken for seasonal allergies; fluticasone propionate (FLONASE) taken for seasonal allergies. A pediatric gastroenterologist reported for his son. His son had the first dose of the Pfizer COVID-19 vaccine on 22May2021. On the next day on 23May2021, he experienced mild pain in the tongue and throat. He had no fever. The pain in the throat and tongue started on Sunday (23May2021), but it was mild and he was not concerned. His son had it on Monday (24May2021) and when he came home from school around 15:00 or 15:30, he was complaining of severe sore throat. His throat was hurting more. Severe from that time. He stayed home from school. Treated with Tylenol and Motrin. Didn't really work/helping. Pushing fluids. Felt pain when swallowing. He was not eating due to severity of the pain. Had severe pain when he tried to speak. He could not open his mouth well. Tried to keep his mouth closed. He could not talk normally cannot move tongue very much. They went to urgent care and had a strep test which came out negative on 25May2021. Reporter seriousness for pain in throat and tongue was disabling. The gastroenterologist wanted to know if his son's adverse reaction was an allergic reaction and if he should get the second dose of the vaccine. There was no prior vaccinations within 4 weeks. The outcome of the events was not recovered.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue movement disturbance
Clinical narrative: mild pain in tongue and throat/severe sore throat; mild pain in tongue and throat; Felt pain when swallowing; He could not talk normally cannot move tongue very much; He could not talk normally cannot move tongue very much; This is a spontaneous report received from Medical Information Team. A contactable physician (parent) reported that a 15-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22May2021 15:00 (Lot Number: EW0178, at the age of 15-year-old) as single dose for covid-19 immunisation. Medical history included seasonal allergies. Concomitant medications included loratadine (CLARITIN) taken for seasonal allergies; fluticasone propionate (FLONASE) taken for seasonal allergies. A pediatric gastroenterologist reported for his son. His son had the first dose of the Pfizer COVID-19 vaccine on 22May2021. On the next day on 23May2021, he experienced mild pain in the tongue and throat. He had no fever. The pain in the throat and tongue started on Sunday (23May2021), but it was mild and he was not concerned. His son had it on Monday (24May2021) and when he came home from school around 15:00 or 15:30, he was complaining of severe sore throat. His throat was hurting more. Severe from that time. He stayed home from school. Treated with Tylenol and Motrin. Didn't really work/helping. Pushing fluids. Felt pain when swallowing. He was not eating due to severity of the pain. Had severe pain when he tried to speak. He could not open his mouth well. Tried to keep his mouth closed. He could not talk normally cannot move tongue very much. They went to urgent care and had a strep test which came out negative on 25May2021. Reporter seriousness for pain in throat and tongue was disabling. The gastroenterologist wanted to know if his son's adverse reaction was an allergic reaction and if he should get the second dose of the vaccine. There was no prior vaccinations within 4 weeks. The outcome of the events was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body height, Hypoaesthesia, Paraesthesia, Weight
Clinical narrative: tingling and numbness below the knee/whole leg is numb and tingling; tingling and numbness below the knee/whole leg is numb and tingling; This is a spontaneous report from a contactable pharmacist (patient's mom).   A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25May2021 10:00 (Lot Number: EN0178) (at age of 34-year-old) as 1st dose, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks.The pharmacist  reported her daughter received the first dose of the Pfizer COVID-19 vaccine yesterday (25May2021) at 10:00. She noticed some tingling and numbness below the knee 6 hours after receiving the vaccine. The whole leg is numb and tingling. There's edema, swelling and bloating around the leg (and later the pharmacist  reported that the patient stated that her legs feel like they are loaded like they've got edema, but the patient's legs are not edematous and there is no pitting edema.). It's tight. It's not swollen but its feel numb. It's a feeling you get after dental work. The patient stated the numbness feels more like the numbing like if the dentist shoots up your teeth and gums. The pharmacist reported that the numbness and tingling in the patient's legs started yesterday, 25May2021, below the patient's knees and today (26May2021), the patient's whole leg is numb and tingling. The pharmacist reported that the patient can feel her legs, and that if the patient were to smack her leg, she would feel it. Seriousness criteria: Caller reported that the seriousness is between serious and disabling, but the numbness and tingling is not disabling yet.  Caller stated that she just doesn't know what to expect. The events did not result in emergency room visit or physician office visit. The outcome of event was not resolved.; Sender's Comments: Based on the temporal relation, the association between the paresthesia and hypoaesthesia cannot be completely ruled out with the available information.  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: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: tingling and numbness below the knee/whole leg is numb and tingling; tingling and numbness below the knee/whole leg is numb and tingling; This is a spontaneous report from a contactable pharmacist (patient's mom).   A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25May2021 10:00 (Lot Number: EN0178) (at age of 34-year-old) as 1st dose, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks.The pharmacist  reported her daughter received the first dose of the Pfizer COVID-19 vaccine yesterday (25May2021) at 10:00. She noticed some tingling and numbness below the knee 6 hours after receiving the vaccine. The whole leg is numb and tingling. There's edema, swelling and bloating around the leg (and later the pharmacist  reported that the patient stated that her legs feel like they are loaded like they've got edema, but the patient's legs are not edematous and there is no pitting edema.). It's tight. It's not swollen but its feel numb. It's a feeling you get after dental work. The patient stated the numbness feels more like the numbing like if the dentist shoots up your teeth and gums. The pharmacist reported that the numbness and tingling in the patient's legs started yesterday, 25May2021, below the patient's knees and today (26May2021), the patient's whole leg is numb and tingling. The pharmacist reported that the patient can feel her legs, and that if the patient were to smack her leg, she would feel it. Seriousness criteria: Caller reported that the seriousness is between serious and disabling, but the numbness and tingling is not disabling yet.  Caller stated that she just doesn't know what to expect. The events did not result in emergency room visit or physician office visit. The outcome of event was not resolved.; Sender's Comments: Based on the temporal relation, the association between the paresthesia and hypoaesthesia cannot be completely ruled out with the available information.  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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: seronegative rheumatoid arthritis seemed to flare after her vaccines; This is a spontaneous report from a contactable physician. A 77-year-old female patient received bnt162b2 (Pfizer), dose 1 via an unspecified route of administration on 01Mar2021 (Lot Number: EN6205), dose 2 via an unspecified route of administration on 22Mar2021 (Lot Number: EN6205) as single doses for COVID-19 immunisation. Medical history included ongoing seronegative rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced seronegative rheumatoid arthritis seemed to flare after her vaccines on an unspecified date with outcome of not recovered. The event was reported as non-serious. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymph node pain, Vaccination site pain
Clinical narrative: On the same arm around the area lower than the armpit towards the breast she felt pain.; On the same arm around the area lower than the armpit towards the breast she felt pain. The caller thinks it was just the lymph nodes; having pain in her left arm, which is the arm she had her COVID vaccine in, under her armpit towards her breast area; This is a spontaneous report from a contactable nurse (parent). An 18-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 24May2021 (at the age of 18-year-old) (Batch/Lot Number: EW0179) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient had no relevant medical history and no concomitant medications. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0165) on 03May2021 (at the age of 17-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The nurse was calling about her daughter who experienced some side effects after receiving the Pfizer COVID Vaccine on 24May2021. The daughter had the vaccine administered on the left arm. On the same arm around the area lower than the armpit towards the breast she felt pain. The nurse thinks it was just the lymph nodes and nothin to worry about but the daughter wanted to hear that from someone else and not form her. The nurse was asking if this what the daughter was experiencing was normal and was it the lymph nodes. The nurse further reported that her daughter was having pain in her left arm, which was the arm she had her COVID vaccine in, under her armpit towards her breast area and she was wondering if that was normal. The nurse stated that personally she thinks that it was from her daughter's lymph nodes but since the nurse was the patient's mom, she would rather hear this from someone else. The events started on 25May2021. The reporter considered the events as serious medically significant. The patient had not yet recovered from the events.; Sender's Comments: The events Breast pain, Lymph node pain and Vaccination site pain are assessed as possibly related to the suspect bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), based on strong temporal association.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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Retinal artery occlusion, SARS-CoV-2 test
Clinical narrative: Branch retinal artery occlusion (stroke); Branch retinal artery occlusion (stroke); This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0171 and expiration date not provided), via an unspecified route of administration, in left arm, on 25Apr2021 12:45 (at the age of 29-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history reported as "none". Patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient experienced branch retinal artery occlusion (stroke) on 05May2021 16:15. Events resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care, disability or permanent damage. The patient underwent lab tests and procedures, which included COVID-19 test (Nasal Swab) was negative on 10May2021, and negative on 18May2021. Therapeutic measures were taken as a result of events and included treatment with acetylsalicylic acid (ASPIRIN), atorvastatin calcium (LIPITOR) and ongoing tests/consultations. The outcome of the events was not recovered.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Muscle twitching, Syncope
Clinical narrative: extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting in fainting and twitching while unconscious; extreme headache resulting in fainting and twitching while unconscious; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 25May2021 at 11:00 as an unknown dose number, at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme headache resulting in fainting and twitching while unconscious on 25May2021 at 20:00. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Coeliac disease, Herpes zoster
Clinical narrative: Celiac disease; Mild case of shingles on the left side; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL46202), via an unspecified route of administration, administered in right arm on 03Mar2021 12:00 (at the age of 68 years old) as 2nd dose, single for COVID-19 immunization. Medical history included mild high blood pressure, and known allergies to sulfa and gluten, all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included lisinopril taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9267) in Feb2021 at 12:00 PM, administered in Left arm, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she had a mild case of shingles on the left side about 20Mar2021. Her doctor saw it and said it was definitely shingles. She has no other health problems except celiac disease on 20Mar2021. No treatment was received for the events. The outcome of the events was recovered with sequelae.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Chest discomfort, Discomfort, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 13May2021 13:00 at age of 24 years old as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart pain, pushing down on the chest, and being very heavy, feels really weak, short of breath, he can't get deep breaths in, uncomfortable, all on 16May2021.  The outcome of all events was not recovered.   Clinical course: Caller stated he got the vaccine 13May2021, the first dose. Caller states he had bad heart pain, that he was 24 years old and it was like it was not sharp but it was like it felt heavy all the time, like his chest was heavy like somebody was pressing on it (on Sunday he began to have heart pain that he describes as being worse in the morning, pushing down on the chest, and being very heavy). Stated he felt really weak. Caller stated these started on Sunday, 16May2021 last week and it was pretty uncomfortable. Caller stated he wanted to know what to do next, should he reported to his doctor or got it checked and was it normal. Caller stated he was also short of breath, he can't get deep breaths in and that started the same day 16May2021. Caller provided all his symptoms were persisting. States they all started in the afternoon. Caller stated it was the Pfizer Covid 19 vaccine. Stated the 1st dose was 13May2021 in his left arm at 1pm. Caller does not have dose, NDC, lot or expiry date to provide as he does not have his card. Events were not required to visit emergency room or physician's office. There had no evets occurred I following prior vaccinations.  There had no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient's Medical History and relevant test were none. Vaccine was not administered at Military Facility.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Computerised tomogram, Dehydration, Nephrolithiasis, Renal pain
Clinical narrative: Trying to stay hydrated; noticed a bit of pinkish red when he went to the bathroom; He woke up with a lot of pain / renal pain; kidney stone; This is a spontaneous report received from a contactable consumer (patient). This 28-year-old Male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EW0172, Expiry: 31Aug2021) via an unspecified route of administration, administered in left upper arm as single dose for COVID-19 immunisation on 24Apr2021.  The patient medical history included seasonal allergies (From Unspecified to Ongoing) around 10 or 11 years old and allergic with tree pollen mainly, cedar trees and animal fur (usually took Tylenol, Claritin and Zyrtec). The patient concomitant medications included 10mg oral cetirizine hydrochloride (ZYRTEC) for seasonal allergies so that he can breathe normally.  Patient was diagnosed with kidney stone on 24Apr2021, same day evening when he got the first Covid-19 vaccine. The patient was trying to stay hydrated, noticed a bit of pinkish red when he went to the bathroom, he thought it was just a side effect. Woke up with a lot of pain and after some testing, they told him he had a kidney stone. He was fighting a kidney stone and taking medication for span of time between first covid-19 vaccination and second vaccination. He doesn't think it is related. The doctor gave a couple medications just for monitoring things, the next day after 13May2021, he went for a CT and haven't felt anything since from the kidney stone.  Prior to vaccination, patient was not diagnosed with COVID-19.  Since the vaccination, the patient not been tested for COVID-19.  Treatment therapy included 0.4mg oral tamsulosin HCL taken for kidney stone from 03May2021 to 13May2021, hydrocodone and acetaminophen taken for renal pain from 03May2021 to 13May2021 (patient only took when he was in drastic pain (pain for kidney stone). Not as a daily medication). The outcome of event kidney stone was resolved on 13May2021. The outcome of other events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: large clotting discharge with period; period came earlier than usual and very heavy/clots are still present; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (lot number: Rw0186), via an unspecified route of administration in arm left on 13May2021 15:00 at single dose for COVID-19 immunisation. Medical history included no just bipolar. Concomitant medications included carbamazepine (TEGRETOL) for bipolar, and bupropion hydrochloride (WELLBUTRIN) for bipolar over 25 years daily with no unusual side effects. Patient previously received the first dose of BNT162B2 (lot: Ee0186) in arm left on 22Apr2021 15:00 for COVID-19 immunisation and experienced period came earlier than usual and very heavy. On 21May2021 13:00, the patient experienced large clotting discharge with period. This had never happened before and period had never been this heavy or early. Then it stopped but a few days later clots were still present. Looked it up and others had reported uterine lining shedding and heavy bleeding. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Pyrexia, SARS-CoV-2 test, Seizure
Clinical narrative: hallucinations; left sided temporal seizures; fevers; This is a spontaneous report received from a contactable other-HCP. A 66 years old male patient  received BNT162B2 (lot number unknown) at single dose for COVID-19 immunisation on unknow date. Relevant medical history included: Type I Diabetes, CKD III (Chronic kidney disease stage 3), Hypertension and Heart failure.   Relevant concomitant drug was unknown. Patient reported of fevers since 22May2021 two days after the vaccine. Two weeks later he reported to have hallucinations per son and also left sided temporal seizures, both since 22May2021. The patient was independent and living alone before this episode. Antiepileptic medication was received as treatment.  The patient was hospitalized due to the events. The outcome of event was resolving. The patient had Covid-19 NAAT (Nasal swab) test on 22May2021 with negative result. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on temporal association and profile of the product, the events were considered related to suspect product BNT162B2 (lot number unknown).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pyrexia, SARS-CoV-1 test
Clinical narrative: fever every night, of just over 100; body aches; massive joint pain; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old male patient received second of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 13Apr2021, at the age of 34-years-old, (Lot Number: EW0153) as 2ND DOSE, SINGLE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19.  Historical vaccine includes first dose of BNT162B2, on 23Mar2021 left arm (Lot number: EP7534). On 14Apr2021, the day after the second shot, the patient had fever every night, of just over 100, has body aches and massive joint pain for over 30days. The adverse event required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events was assessed as serious, disability.  Since the vaccination, the patient been tested for COVID-19, test: Nasal Swab on 20May2021 with negative result.  The outcome of the events was recovering. Treatment received for the adverse event includes prednisone.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: had an allergic, anaphylaxis, reaction to the pfizer vaccine; had an allergic, anaphylaxis, reaction to the pfizer vaccine; This is a spontaneous report from a non-contactable consumer (pateint).  A patient of unspecified age and gender received (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNK, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  It was reported 'I had an allergic, anaphylaxis, reaction to the pfizer vaccine. ' The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: ocular swelling; allergic reaction; This is a spontaneous report from a non-contactable pharmacist. A 16-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 16 years old on 26May2021 on left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced ocular swelling and allergic reaction in May2021. The events were resulted in Emergency room/department or urgent care. Treatment was received for the events. Since the vaccination, the had patient been tested for COVID-19 with unknown results in 2021. The outcome of the events were not resolved.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, the events are considered related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pain in extremity, Peripheral swelling, Thrombosis
Clinical narrative: She had 2 blood clots in her right leg, and she was now on Eliquis; she had right leg swelling; she had right leg pain; flu; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 06May2021 (Batch/Lot Number: Not Provided) as a single dose,  for covid-19 immunisation, with first dose given 15Apr2021. Medical history and concomitant medications were not reported.  The patient  said she had the flu 3 days after getting her second COVID-19 Vaccine, had right leg swelling, right leg pain, and had 2 blood clots in her right leg. The patient said she was now on apixaban (ELIQUIS), and financial assistance, due to being on unemployment. The outcome of the events was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myocarditis, Ventricular extrasystoles
Clinical narrative: she may have myocarditis; symptomatic ventricular ectopy; fatigue; headache; This is a spontaneous report received from a contactable consumer for a female patient (our young, female physician) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 1ST DOSE, SINGLE DOSE for covid-19 immunisation on unknown date. The patient's concomitant medications were not reported.  The patient who was with no major medical problems  developed symptomatic ventricular ectopy that she stated to begin 10 days after her second vaccine dose (Pfizer). She is currently under the care of a cardiologist who believed she might have myocarditis. She also experienced fatigue and headache with her second vaccine dose. She was started on ibuprofen and is feeling "a little better". She denied fever or other systemic manifestations. The outcome of the events was unknown.  Therapeutic measures were taken as a result of she may have myocarditis (myocarditis).  Information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Diarrhoea, Feeling abnormal, Gastrointestinal disorder
Clinical narrative: Bleeding rectally for three days; couldn't think; Headache; Intestinal issues; Felt almost like she had COVID; Diarrhea; Nauseated; Felt like she was smothering; Felt foggy in her head like she couldn't think; Weak; Eye felt not right, blurry; Confused; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Provided) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history and  concomitant medications were not reported. The patient experienced bleeding rectally for three days, headache, intestinal issues, felt almost like she had covid, diarrhea, nauseated, felt like she was smothering, felt foggy in her head like she couldn't think, weak, didn't feel right, just not herself, eye felt not right, blurry and confused on an unspecified date. The outcome of bleeding rectally, headache, intestinal issues, felt almost like she had covid, diarrhea, nauseated, felt like she was smothering, felt foggy in her head like she couldn't think, weak, didn't feel right, just not herself, eye felt not right, blurry and confused  was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Mental impairment, Nausea, Rectal haemorrhage
Clinical narrative: Bleeding rectally for three days; couldn't think; Headache; Intestinal issues; Felt almost like she had COVID; Diarrhea; Nauseated; Felt like she was smothering; Felt foggy in her head like she couldn't think; Weak; Eye felt not right, blurry; Confused; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Provided) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history and  concomitant medications were not reported. The patient experienced bleeding rectally for three days, headache, intestinal issues, felt almost like she had covid, diarrhea, nauseated, felt like she was smothering, felt foggy in her head like she couldn't think, weak, didn't feel right, just not herself, eye felt not right, blurry and confused on an unspecified date. The outcome of bleeding rectally, headache, intestinal issues, felt almost like she had covid, diarrhea, nauseated, felt like she was smothering, felt foggy in her head like she couldn't think, weak, didn't feel right, just not herself, eye felt not right, blurry and confused  was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Suffocation feeling, Vision blurred
Clinical narrative: Bleeding rectally for three days; couldn't think; Headache; Intestinal issues; Felt almost like she had COVID; Diarrhea; Nauseated; Felt like she was smothering; Felt foggy in her head like she couldn't think; Weak; Eye felt not right, blurry; Confused; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Provided) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history and  concomitant medications were not reported. The patient experienced bleeding rectally for three days, headache, intestinal issues, felt almost like she had covid, diarrhea, nauseated, felt like she was smothering, felt foggy in her head like she couldn't think, weak, didn't feel right, just not herself, eye felt not right, blurry and confused on an unspecified date. The outcome of bleeding rectally, headache, intestinal issues, felt almost like she had covid, diarrhea, nauseated, felt like she was smothering, felt foggy in her head like she couldn't think, weak, didn't feel right, just not herself, eye felt not right, blurry and confused  was unknown.  Information on the lot/batch number has been requested
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Vaccination site swelling
Clinical narrative: Hard swelling at injection site; pain started  that went from shoulder blade, down the left arm, to my fingers; pain started  that went from shoulder blade, down the left arm, to my fingers; pain started  that went from shoulder blade, down the left arm, to my fingers; All 5 fingers became numb; This is a spontaneous report received from a contactable consumer (patient) reporting for herself received via COVAES. A 70 year-old female (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number er8730 and expiration date 24Mar2021) (at 70 years old), via an unspecified route of administration, on 14Apr2021 at 15:00 as a single dose for COVID-19 vaccination (anatomical location: arm left), administered at Pharmacy or Drug Store. Medical history included: arthritis. Concomitant medications included: Diclophenac. On 28Mar2021, the patient experienced hard swelling at injection site. Within 3 days a pain started that went from shoulder blade, down the left arm, to my fingers. All 5 fingers became numb. Over the next 6 weeks the pain decreased and is now gone, but 2 of my ringers remain numb from the tip to the 1st knuckle. The outcome of the events was recovered/resolved with sequel. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.The reporter classified the event(s) as serious.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I am fully vaccinated; I have COVID; I am fully vaccinated; I have COVID; This is a spontaneous report received 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 MRNA VACCINE; solution for injection; Lot Numbers: Unknown) both via an unspecified route of administration on unspecified dates in Feb2021 (dose 1) and Mar2021 (dose 2), both as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she was fully vaccinated and had COVID, on an unspecified date. The patient called to report that she received the Pfizer vaccine and was fully vaccinated. The first shot was in February and the second one was in March, and now the patient had COVID. The patient wanted to know how long this would last before they got over it. The clinical outcome of the event I am fully vaccinated; I have COVID was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.