chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Nausea, Pain, Pain in extremity, Urine analysis
Clinical narrative: HANDS, ARMS AND FACE BECAME FUZZY; HANDS, ARMS AND FACE BECAME NUMB; LOST 2 POUNDS IN 4 HOURS; SEVERE SORENESS IN HIS LEFT ARM; SORENESS IN SHOULDERS AND DOWN BACK; NAUSEA; SEVERE STOMACH PAIN; SEVERE VOMITING; SORENESS ALL DAY; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no reaction to vaccines previously. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 07-JUL-2021 10:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021 around 23.00 after vaccination, the patient developed severe soreness on left arm, shoulders and down back; it was reported that the patient had soreness all the day. The patient had severe vomiting to which patient lost two pounds in four hours. On 08-JUL-2021, patient was taken to ER (emergency room) at 5:45 and he continued to have severe stomach pain (stomach was moving), nausea and vomiting. The patient's hands, arms and face became fuzzy and then numb. The patient was given multiple unspecified medications to ease symptoms, along with an unspecified IV (intravenous). The patient also had tests of blood, urine and a CAT (computerized tomography) scan and the results were not reported. The patient was treated with morphine and was discharged from ER (emergency room) around noon on 08-JUL-2021. The patient's stomach was still not all the way well at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach pain, and the outcome of severe vomiting, soreness all day, nausea, hands, arms and face became fuzzy, hands, arms and face became numb, severe soreness in his left arm, soreness in shoulders and down back and lost 2 pounds in 4 hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210723452- covid-19 vaccine ad26.cov2.s- severe stomach pain,  severe vomiting, soreness all day,  hands, arms and face became fuzzy, hands, arms and face became numb, lost 2 pounds in 4 hours . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210723452- covid-19 vaccine ad26.cov2.s- nausea,  severe soreness in his left arm, soreness in shoulders and down back. This event(s) is labeled per Agency and is therefore considered potentially related.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuritis, Pain
Clinical narrative: SHINGLES; FEELING TIRED; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and neuropathy, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced shingles. On 14-MAY-2021, the subject experienced feeling tired. Laboratory data (dates unspecified) included: HbA1C (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, and shingles. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Glycosylated haemoglobin, Herpes zoster
Clinical narrative: SHINGLES; FEELING TIRED; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and neuropathy, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced shingles. On 14-MAY-2021, the subject experienced feeling tired. Laboratory data (dates unspecified) included: HbA1C (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, and shingles. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: NUMBNESS IN LEFT ARM; TINGLING SENSATION TO LEFT ARM; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included occasional use of marijuana, non smoker, and occasional alcohol drinker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced numbness in left arm. On 22-JUN-2021, the subject experienced tingling sensation to left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in left arm, and tingling sensation to left arm. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: SOME VACCINES DRAWN UP IN THE COOLER AT 8:30 AM AND DELIVERED THE LAST DOSE AT 3 PM IN THE AFTERNOON (AFTER MORE THAN 6 HOURS OF TIME); FILLED SYRINGE STORED FOR MORE THAN 6 HOURS IN A COOLER GIVEN TO A PATIENT; This spontaneous report received from a health care professional concerned a 74 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 05-AUG-2021) dose was not reported, administered on 07-JUL-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021, the subject experienced some vaccines drawn up in the cooler at 8:30 am and delivered the last dose at 3 pm in the afternoon (after more than 6 hours of time). On 07-JUL-2021, the subject experienced filled syringe stored for more than 6 hours in a cooler given to a subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the some vaccines drawn up in the cooler at 8:30 am and delivered the last dose at 3 pm in the afternoon (after more than 6 hours of time) and filled syringe stored for more than 6 hours in a cooler given to a patient was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: SOME VACCINES DRAWN UP IN THE COOLER AT 8:30 AM AND DELIVERED THE LAST DOSE AT 3 PM IN THE AFTERNOON (AFTER MORE THAN 6 HOURS OF TIME); FILLED SYRINGE STORED FOR MORE THAN 6 HOURS IN A COOLER GIVEN TO A PATIENT; This spontaneous report received from a health care professional concerned a 74 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 05-AUG-2021) dose was not reported, administered on 07-JUL-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021, the subject experienced some vaccines drawn up in the cooler at 8:30 am and delivered the last dose at 3 pm in the afternoon (after more than 6 hours of time). On 07-JUL-2021, the subject experienced filled syringe stored for more than 6 hours in a cooler given to a subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the some vaccines drawn up in the cooler at 8:30 am and delivered the last dose at 3 pm in the afternoon (after more than 6 hours of time) and filled syringe stored for more than 6 hours in a cooler given to a patient was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Gait disturbance, Influenza like illness, Injection site pain
Clinical narrative: I started feeling flu-like symptoms around 14 hours after the second vaccine. Each symptom occurred at the same time at 03:37 AM on July 14, 2021. The symptoms included achiness, cold shivering, slightly elevated temperature (100.8 °F), and almost complete muscular tension in arms and legs. It made it difficult to walk. I took a mixture of Tylenol (acetaminophen) and Advil available in one tablet. I took 2x of these, drank plenty of fluids, and went to bed around 05:15 AM on Wednesday, July 14, 2021. I had a heating blanket along with a microwave bean bag to keep myself warm. I woke up at 1:45 PM with most side effects subsiding, besides vaccine injection site still remaining sore.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Pain
Clinical narrative: I started feeling flu-like symptoms around 14 hours after the second vaccine. Each symptom occurred at the same time at 03:37 AM on July 14, 2021. The symptoms included achiness, cold shivering, slightly elevated temperature (100.8 °F), and almost complete muscular tension in arms and legs. It made it difficult to walk. I took a mixture of Tylenol (acetaminophen) and Advil available in one tablet. I took 2x of these, drank plenty of fluids, and went to bed around 05:15 AM on Wednesday, July 14, 2021. I had a heating blanket along with a microwave bean bag to keep myself warm. I woke up at 1:45 PM with most side effects subsiding, besides vaccine injection site still remaining sore.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia, Paraesthesia
Clinical narrative: 11 hours after 2nd dose of Pfizer COVID 19 mRNA vaccine patient developed tingling and numbness to R side of face.  Persisted another three days which prompted mother to page pediatrician. Recommended to be seen in ED
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, C-reactive protein normal, Chest X-ray normal, Chest discomfort, Differential white blood cell count normal
Clinical narrative: Body flush, shortness of breathe, chest tightness, prolonged severe episodic anxiety and panic attacks without prior history
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Flushing, Full blood count normal, Human chorionic gonadotropin negative
Clinical narrative: Body flush, shortness of breathe, chest tightness, prolonged severe episodic anxiety and panic attacks without prior history
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Panic attack, Urine analysis normal
Clinical narrative: Body flush, shortness of breathe, chest tightness, prolonged severe episodic anxiety and panic attacks without prior history
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Electrocardiogram abnormal, Nausea, Sinus bradycardia
Clinical narrative: Patient c/o  mild chest tightness, dizziness  and nausea about 7 minutes after received Jansen cover-19 while siting in observation area around 11:43. He fainted right after. Patient was lowed from chair to yoga mat with assistance of paramedics. He was positioned in supine  with legs elevated. Patient regained consciousness once laying supine. He denies chest pain. His first set of vital signs: BP 140/87; P 51; Res 18; O2 saturation 98% at 11:45. Patient reviewed his past medical history including hypertension and palpitation. He states he des not take medication for hypertension and he takes atenolol 25mg PRN for palpitation. Last time he took it was week and half ago. EKG was performed by paramedics and it was sinus bradycardia. Patient states he felt back to normal. His VS at 11:50: BP 131/85; P 57; Res 18. Assisted Patient sitting up then standing up. Patient denies dizziness, chest pain or tightness. His standing BP was 142/82. Patient was observed for another 15 minutes then walked out of observation area.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient c/o  mild chest tightness, dizziness  and nausea about 7 minutes after received Jansen cover-19 while siting in observation area around 11:43. He fainted right after. Patient was lowed from chair to yoga mat with assistance of paramedics. He was positioned in supine  with legs elevated. Patient regained consciousness once laying supine. He denies chest pain. His first set of vital signs: BP 140/87; P 51; Res 18; O2 saturation 98% at 11:45. Patient reviewed his past medical history including hypertension and palpitation. He states he des not take medication for hypertension and he takes atenolol 25mg PRN for palpitation. Last time he took it was week and half ago. EKG was performed by paramedics and it was sinus bradycardia. Patient states he felt back to normal. His VS at 11:50: BP 131/85; P 57; Res 18. Assisted Patient sitting up then standing up. Patient denies dizziness, chest pain or tightness. His standing BP was 142/82. Patient was observed for another 15 minutes then walked out of observation area.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt initially received Pfizer EL9263 2/5/21 and today 7/16/21 was given Moderna 034C21A due to vaccine availability at the event and pt status. Pt insisted and verbally gave consent in getting Moderna vaccine today despite given the option to receive same vaccine as first dose in a different clinic and different date/times. VAERS report submitted.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain in injection site on right arm
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt initially received Pfizer EL9263 2/5/21 and today 7/16/21 was given Moderna 034C21A due to vaccine availability at the event and pt status. Pt insisted and verbally gave consent in getting Moderna vaccine today despite given the option to receive same vaccine as first dose in a different clinic and different date/times. VAERS report submitted.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: Fever, chills, body aches, cough, congestion, loss of appetite, fatigue
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Fever, chills, body aches, cough, congestion, loss of appetite, fatigue
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Paraesthesia, Taste disorder
Clinical narrative: Heart rate increase. Short of breath. Tingling in hands and arms. Light headed. Bad taste in mouth.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Hyperhidrosis, Myalgia
Clinical narrative: Fever, chills, muscle aches, chest congestion, sweats, cough with chest pain
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary congestion, Pyrexia
Clinical narrative: Fever, chills, muscle aches, chest congestion, sweats, cough with chest pain
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test normal, Central nervous system lesion, Dizziness, Dyspnoea
Clinical narrative: Felt faint, shortness of breath was kept extra 30 min.  In days after the shot I went from feeling like I was in a fog and expected fever. Into hypersensitivity to light and sounds which caused me not to be able to leave my home until June 2021.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperacusis, Magnetic resonance imaging head abnormal, Photophobia, Pyrexia
Clinical narrative: Felt faint, shortness of breath was kept extra 30 min.  In days after the shot I went from feeling like I was in a fog and expected fever. Into hypersensitivity to light and sounds which caused me not to be able to leave my home until June 2021.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain, Injection site urticaria
Clinical narrative: Dark purple nickel-sized bruise at injection site, pain wraps all the way around bicep, hives about 3 inches from injection site - this morning the size of a nickel, now the size of a half dollar bill.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Heavy menstrual bleeding, Hypoaesthesia, Irritable bowel syndrome
Clinical narrative: IBS symptoms started and continue to persist. Foot numbness and bruising as well. None of these things were ever an issue until after getting the vaccine. Also experienced heavy periods 1.5 weeks after both vaccines even though my birth control doesn?t have me having a period.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Sudden and brief severe headaches right side of head since vaccine - started approx 18 hours after vaccine administration and continues every 10-15 minutes.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Dysstasia, Gait disturbance, Hypoaesthesia
Clinical narrative: With in 4 hours of vaccination patient felt nauseated and vomited. Nausea lasted approximately 8 day. At about 8 to  10 days after vaccination began having joint and muscle pain in the lower half of body. Could not stand or walk without assistance, condition continued at same severity for about 7 days, then began to slowly improve. He saw doctor (His current pain specialist for several years) on 7/14/2021 and described his symptoms and condition, but no medication was prescribed for his condition. He currently states that he feels about 80% of himself prior to vaccination. Still has muscle numbness and muscle "burning" while standing and feel fatigued yet. He feels he is still slowly improving
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: With in 4 hours of vaccination patient felt nauseated and vomited. Nausea lasted approximately 8 day. At about 8 to  10 days after vaccination began having joint and muscle pain in the lower half of body. Could not stand or walk without assistance, condition continued at same severity for about 7 days, then began to slowly improve. He saw doctor (His current pain specialist for several years) on 7/14/2021 and described his symptoms and condition, but no medication was prescribed for his condition. He currently states that he feels about 80% of himself prior to vaccination. Still has muscle numbness and muscle "burning" while standing and feel fatigued yet. He feels he is still slowly improving
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dizziness, Nausea, Pyrexia
Clinical narrative: Severe rigors, nausea, lightheaded ness, loose stools, fever up to 102.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Herpes zoster
Clinical narrative: Two weeks after the shot I developed a bad case of Shingles on my face, interior mouth and up through the nerve running into my head.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Went home fron work with a sore neck/shoulder. Iced my neck. 1 hour later started feeling ho/cold flashes. Felt feverish. Started icing me head. Within 5 minute my heart starts racing and and start beathing heavy. I try to take big deep slow breaths. I cant. I call my friend.  10 minutes of talking and and it gets worse. He comes to picking me up 15 minutes later im fully hyperventilating enroute to hospital  5 minutea later my body is shaking and i have pins and needles on my extremities. 1 minute later i feel im about to passout and my brain is going to shut off. 2 minutes later i get to the hospital. Hyperventilating and hands cramped i cant get my health card out. My friend pulls it out for me. I sit waitinf to be attended for 10-15 minutes still hyperventilating and still heart racing. Eventually i get in for tests. About at the 2.5 hour mark is when my heart and breathing start getting a bit better. 3.5 hrs in is where i started feeling (though exhausted) normalish
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling of body temperature change, Hot flush, Hyperventilation
Clinical narrative: Went home fron work with a sore neck/shoulder. Iced my neck. 1 hour later started feeling ho/cold flashes. Felt feverish. Started icing me head. Within 5 minute my heart starts racing and and start beathing heavy. I try to take big deep slow breaths. I cant. I call my friend.  10 minutes of talking and and it gets worse. He comes to picking me up 15 minutes later im fully hyperventilating enroute to hospital  5 minutea later my body is shaking and i have pins and needles on my extremities. 1 minute later i feel im about to passout and my brain is going to shut off. 2 minutes later i get to the hospital. Hyperventilating and hands cramped i cant get my health card out. My friend pulls it out for me. I sit waitinf to be attended for 10-15 minutes still hyperventilating and still heart racing. Eventually i get in for tests. About at the 2.5 hour mark is when my heart and breathing start getting a bit better. 3.5 hrs in is where i started feeling (though exhausted) normalish
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Neck pain, Palpitations, Paraesthesia, Pyrexia
Clinical narrative: Went home fron work with a sore neck/shoulder. Iced my neck. 1 hour later started feeling ho/cold flashes. Felt feverish. Started icing me head. Within 5 minute my heart starts racing and and start beathing heavy. I try to take big deep slow breaths. I cant. I call my friend.  10 minutes of talking and and it gets worse. He comes to picking me up 15 minutes later im fully hyperventilating enroute to hospital  5 minutea later my body is shaking and i have pins and needles on my extremities. 1 minute later i feel im about to passout and my brain is going to shut off. 2 minutes later i get to the hospital. Hyperventilating and hands cramped i cant get my health card out. My friend pulls it out for me. I sit waitinf to be attended for 10-15 minutes still hyperventilating and still heart racing. Eventually i get in for tests. About at the 2.5 hour mark is when my heart and breathing start getting a bit better. 3.5 hrs in is where i started feeling (though exhausted) normalish
Sex: U
Vaccine: COVID19
Symptoms: Respiration abnormal, Tremor
Clinical narrative: Went home fron work with a sore neck/shoulder. Iced my neck. 1 hour later started feeling ho/cold flashes. Felt feverish. Started icing me head. Within 5 minute my heart starts racing and and start beathing heavy. I try to take big deep slow breaths. I cant. I call my friend.  10 minutes of talking and and it gets worse. He comes to picking me up 15 minutes later im fully hyperventilating enroute to hospital  5 minutea later my body is shaking and i have pins and needles on my extremities. 1 minute later i feel im about to passout and my brain is going to shut off. 2 minutes later i get to the hospital. Hyperventilating and hands cramped i cant get my health card out. My friend pulls it out for me. I sit waitinf to be attended for 10-15 minutes still hyperventilating and still heart racing. Eventually i get in for tests. About at the 2.5 hour mark is when my heart and breathing start getting a bit better. 3.5 hrs in is where i started feeling (though exhausted) normalish
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Aphthous ulcer, Chills, Dizziness, Ear pain
Clinical narrative: Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash. Fever didn't go away unitl 7/12 evening, chills were gone but all other symptoms stay. Since 7/8, also developed painful sore throat and canker sore on tongue. Dizziness is constant since day (7/7). On 7/14, had sudden increased dizziness, scalp twitching/headche, ring in left ear and sharp ear pain from right ear, right face hot to touch, almost fainted. Saw Internal doctor on 7/15, was diagnosed as Vestibular Neuronitis. Til today, I have constant dizziness, headache with scalp twitching, ear pain and right face hot to touch.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye irritation, Headache, Hot flush, Muscle twitching, Oropharyngeal pain
Clinical narrative: Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash. Fever didn't go away unitl 7/12 evening, chills were gone but all other symptoms stay. Since 7/8, also developed painful sore throat and canker sore on tongue. Dizziness is constant since day (7/7). On 7/14, had sudden increased dizziness, scalp twitching/headche, ring in left ear and sharp ear pain from right ear, right face hot to touch, almost fainted. Saw Internal doctor on 7/15, was diagnosed as Vestibular Neuronitis. Til today, I have constant dizziness, headache with scalp twitching, ear pain and right face hot to touch.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Skin warm, Tinnitus
Clinical narrative: Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash. Fever didn't go away unitl 7/12 evening, chills were gone but all other symptoms stay. Since 7/8, also developed painful sore throat and canker sore on tongue. Dizziness is constant since day (7/7). On 7/14, had sudden increased dizziness, scalp twitching/headche, ring in left ear and sharp ear pain from right ear, right face hot to touch, almost fainted. Saw Internal doctor on 7/15, was diagnosed as Vestibular Neuronitis. Til today, I have constant dizziness, headache with scalp twitching, ear pain and right face hot to touch.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vestibular neuronitis
Clinical narrative: Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash. Fever didn't go away unitl 7/12 evening, chills were gone but all other symptoms stay. Since 7/8, also developed painful sore throat and canker sore on tongue. Dizziness is constant since day (7/7). On 7/14, had sudden increased dizziness, scalp twitching/headche, ring in left ear and sharp ear pain from right ear, right face hot to touch, almost fainted. Saw Internal doctor on 7/15, was diagnosed as Vestibular Neuronitis. Til today, I have constant dizziness, headache with scalp twitching, ear pain and right face hot to touch.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Aphthous ulcer, Balance disorder, Chest pain, Chills
Clinical narrative: Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash. Fever didn't go away unitl 7/12 evening, chills were gone but all other symptoms stay. Since 7/8, also developed painful sore throat and canker sore on tongue. Dizziness is constant since day (7/7). On 7/14, had sudden increased dizziness, scalp twitching/headche, ring in left ear and sharp ear pain from right ear, right face hot to touch, almost fainted. Saw Internal doctor on 7/15, was diagnosed as Vestibular Neuronitis. Til today, I have constant dizziness, headache with scalp twitching, ear pain and right face hot to touch.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Ear pain, Electrocardiogram, Eye irritation
Clinical narrative: Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash. Fever didn't go away unitl 7/12 evening, chills were gone but all other symptoms stay. Since 7/8, also developed painful sore throat and canker sore on tongue. Dizziness is constant since day (7/7). On 7/14, had sudden increased dizziness, scalp twitching/headche, ring in left ear and sharp ear pain from right ear, right face hot to touch, almost fainted. Saw Internal doctor on 7/15, was diagnosed as Vestibular Neuronitis. Til today, I have constant dizziness, headache with scalp twitching, ear pain and right face hot to touch.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Haemoglobin, Headache, Heart rate increased, Hot flush
Clinical narrative: Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash. Fever didn't go away unitl 7/12 evening, chills were gone but all other symptoms stay. Since 7/8, also developed painful sore throat and canker sore on tongue. Dizziness is constant since day (7/7). On 7/14, had sudden increased dizziness, scalp twitching/headche, ring in left ear and sharp ear pain from right ear, right face hot to touch, almost fainted. Saw Internal doctor on 7/15, was diagnosed as Vestibular Neuronitis. Til today, I have constant dizziness, headache with scalp twitching, ear pain and right face hot to touch.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle twitching, Oral herpes, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash. Fever didn't go away unitl 7/12 evening, chills were gone but all other symptoms stay. Since 7/8, also developed painful sore throat and canker sore on tongue. Dizziness is constant since day (7/7). On 7/14, had sudden increased dizziness, scalp twitching/headche, ring in left ear and sharp ear pain from right ear, right face hot to touch, almost fainted. Saw Internal doctor on 7/15, was diagnosed as Vestibular Neuronitis. Til today, I have constant dizziness, headache with scalp twitching, ear pain and right face hot to touch.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Presyncope, Pyrexia, Tinnitus, Troponin T, Vestibular neuronitis
Clinical narrative: Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash. Fever didn't go away unitl 7/12 evening, chills were gone but all other symptoms stay. Since 7/8, also developed painful sore throat and canker sore on tongue. Dizziness is constant since day (7/7). On 7/14, had sudden increased dizziness, scalp twitching/headche, ring in left ear and sharp ear pain from right ear, right face hot to touch, almost fainted. Saw Internal doctor on 7/15, was diagnosed as Vestibular Neuronitis. Til today, I have constant dizziness, headache with scalp twitching, ear pain and right face hot to touch.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Felt dizzy 10-15 minutes right after the shot, but managed to drive home. High fever at night with chills, body ache, headache, abdominal pain, ear pain, arm pain, burning eyes and hot flash. Fever didn't go away unitl 7/12 evening, chills were gone but all other symptoms stay. Since 7/8, also developed painful sore throat and canker sore on tongue. Dizziness is constant since day (7/7). On 7/14, had sudden increased dizziness, scalp twitching/headche, ring in left ear and sharp ear pain from right ear, right face hot to touch, almost fainted. Saw Internal doctor on 7/15, was diagnosed as Vestibular Neuronitis. Til today, I have constant dizziness, headache with scalp twitching, ear pain and right face hot to touch.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient sent tested positive for COVID  on 07/15 when fully vaccinated. he did not have any symptoms
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Neck pain, Pyrexia
Clinical narrative: Fever; Joint pain, knee pain; Neck pain; This is a spontaneous report from a contactable physician, the patient. A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma, ventricular septal defect and patient was suspected COVID-19 in Jan2021. Concomitant medications included BUPROPIN (150mg), vit C (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN), vit D (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was diagnosed with COVID-19 in Jan2021. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 13:00 (after 24 hours of vaccination), the patient experienced fever of 38.9C, knee pain, joints pain and neck pain. The patient underwent body temperature and results was 38.9C. The patient received treatment for the adverse events with acetaminophen (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN) for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, joints pain (knee pain) and neck pain were resolved on an unknown date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Cerebrovascular accident, Headache, SARS-CoV-2 test negative
Clinical narrative: Loss of balance, headache, and stroke; Loss of balance, headache, and stroke; Loss of balance, headache, and stroke.; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration, administered in left arm on 20Apr2021 at 09:00 (at the age of 73-years-old) as dose 2, single for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: En6206), via an unspecified route, administered in left arm on 30Mar2021 at 09:00 (at the age of 73-years-old) for covid-19 immunisation. Patient has no known allergies. Patient received other unspecified medications within 2 weeks of vaccination (name of medications not specified). Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. On 02Jun2021, the patient experienced loss of balance, headache, and stroke. The events resulted in emergency room/department or urgent care. The patient was hospitalized for loss of balance, headache and stroke for 5 days. Treatment was received for events as medical care and medications. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient has been tested for covid-19, sars-cov-2 nasal swab test: negative on 30Jun2021. Outcome of events was recovering.   Follow-up attempts are needed. Further information is requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Malaise, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: not feeling well; fever; her arm hurt; injection site reactions described as redness and itching. Both injections were in different places.; injection site reactions described as redness and itching. Both injections were in different places.; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number PR-AMGEN-PRISL2021038613). This case was split from master case 2021287765. A 31-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03Jun2021 (at the age of 31-year-old), as a single dose, for COVID-19 immunization. The patient's medical history included ongoing rheumatoid arthritis and ongoing ankylosing spondylitis. Concomitant medication included etanercept (ENBREL, solution for injection in pre-filled pen, 50 mg), 50 mg weekly taken for rheumatoid arthritis and ankylosing spondylitis, start and stop date were not reported. The patient would resume Enbrel use on 10Jun2021. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were not provided), via an unspecified route of administration, on an unknown date, as a single dose, for COVID-19 immunization. On 04Jun2021, the patient not feeling well, fever and her arm hurt. On an unknown date in Jun2021, the patient developed injection site reactions described as redness and itching. The outcome of the events was recovered on an unknown date in Jun2021.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular
Clinical narrative: Menstruation early by 1 week, intense menstrual pain
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Patient had the recommended two vaccine injections properly temporal spacing. A month later he was found to have rather severe hypertension, which he never had before the vaccine. When I saw him (a few days ago) he was on at least one blood pressure drug, and his BP on arrival in office was 195/100.  None of his health care providers asked him about vaccination. I did, and was surprised to find the problem started just one month later. No symptoms other than marked hypertension. He states he had been quite healthy until this.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: arm numbness or tingling, similar to what was reported for Guillain-Barré syndrome. Always since vaccination
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a certified medical assistant (C.M.A.) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 10-JUN-2021, the patient was vaccinated with one of following incorrectly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (strength, dose and route were not reported) for prophylaxis: lot # T003384 has been verified to be a valid lot number, expiration date reported as 27-JAN-2022, but upon internal validation established as 28-JAN-2022; lot # T007231 has been verified to be a valid lot number, expiration date reported as 26-FEB-2022, but upon internal validation established as 27-FEB-2022; lot # S023656 has been verified to be a valid lot number, expiration date reported as 29-JUL-2021, but upon internal validation established as 30-JUL-2021; lot # S039313 has been verified to be a valid lot number, expiration date reported as 03-DEC-2021, but upon internal validation established as 04-DEC-2021 (incorrect product storage). The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Sex: U
Vaccine: MMR
Symptoms: Product temperature excursion issue
Clinical narrative: vaccine that underwent a temperature excursion was administered; No additional adverse effect reported; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # T007231, expiration date was reported as 26-FEB-2022 but upon internal validation established as 27-FEB-2022; lot # T003384, expiration date was reported as 27-JAN-2022 but upon internal validation established as 28-JAN-2022; lot # S023656, expiration date was reported as 29-JUL-2021 but upon internal validation established as 30-JUL-2021; lot # S039313, expiration date was reported as 03-DEC-2021 but upon internal validation established as 04-DEC-2021) underwent a temperature excursion.  On 11-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose and route of administration were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004367: US-009507513-2106USA004368: US-009507513-2106USA004370: US-009507513-2106USA004372: US-009507513-2106USA004384: US-009507513-2106USA004374: US-009507513-2106USA004375: US-009507513-2106USA004376: US-009507513-2106USA004377: US-009507513-2106USA004356: US-009507513-2106USA004365:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine that underwent a temperature excursion was administered; No additional adverse effects were reported; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022; lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion.  On 11-JUN-2021 and 20-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356: US-009507513-2106USA004368: US-009507513-2106USA004370: US-009507513-2106USA004372: US-009507513-2106USA004384: US-009507513-2106USA004374: US-009507513-2106USA004375: US-009507513-2106USA004376: US-009507513-2106USA004378: US-009507513-2106USA004379: US-009507513-2106USA004382: US-009507513-2106USA004366: US-009507513-2106USA004365: US-009507513-2106USA004377:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T024283, expiration date was reported as 14-JUL-2022 but upon internal validation established as 15-JUL-2022; lot # T032930, expiration date was reported as 27-SEP-2022 but upon internal validation established as 28-SEP-2022) underwent a temperature excursion.  On 11-JUN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 7.3 Fahrenheit (F) (between 6 to 14 F) for 10 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004367: US-009507513-2106USA004368: US-009507513-2106USA004370: US-009507513-2106USA004372: US-009507513-2106USA004384: US-009507513-2106USA004356: US-009507513-2106USA004375: US-009507513-2106USA004376: US-009507513-2106USA004377: US-009507513-2106USA004366: US-009507513-2106USA004365:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a certified medical assistant (C.M.A.) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 10-JUN-2021, the patient was vaccinated with one of following incorrectly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not reported) for prophylaxis: lot # T024283 has been verified to be a valid lot number, expiration date reported as 14-JUL-2022, but upon internal validation established as 15-JUL-2022; lot # T032930 has been verified to be a valid lot number, expiration date reported as 27-SEP-2022, but upon internal validation established as 28-SEP-2022 (incorrect product storage). The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356: