chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Blood test normal, Computerised tomogram normal, Generalised tonic-clonic seizure, Magnetic resonance imaging normal
Clinical narrative: GRAND MAL SEIZURE; This spontaneous report received from a consumer concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetic, and other pre-existing medical conditions included: no known allergies. The patient did not have history or family history of ever having a seizure before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-APR-2021, approximately three weeks after vaccination, the patient experienced his first grand mal seizure. Patient was rushed to the emergency room. Patient since had three more seizures for a total of 4. Patient had to go to the emergency an additional time on 10-JAN- 2022. Patient was being seen by a neurologist and a cardiologist in addition to his family doctor. They had ruled out blood clots, aneurysm and stroke, but still did not know origin of the grand mal seizures. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from grand mal seizure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220213197-COVID-19 VACCINE AD26.COV2.S-Grand mal seizure. 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).
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: GRAND MAL SEIZURE; This spontaneous report received from a consumer concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetic, and other pre-existing medical conditions included: no known allergies. The patient did not have history or family history of ever having a seizure before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-APR-2021, approximately three weeks after vaccination, the patient experienced his first grand mal seizure. Patient was rushed to the emergency room. Patient since had three more seizures for a total of 4. Patient had to go to the emergency an additional time on 10-JAN- 2022. Patient was being seen by a neurologist and a cardiologist in addition to his family doctor. They had ruled out blood clots, aneurysm and stroke, but still did not know origin of the grand mal seizures. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from grand mal seizure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220213197-COVID-19 VACCINE AD26.COV2.S-Grand mal seizure. 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).
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Differential white blood cell count, Full blood count, Immune thrombocytopenia, International normalised ratio
Clinical narrative: On 2/4/2022, presented to ER with parents for concerns of nosebleeds, bleeding gums, and petechial rash for one day. Patient reports his gums started bleeding earlier today; this also occurred two days ago but stopped on it's own and they attributed it to his braces so didn't think much of it. He started to have a nosebleed around 1500 today; he has since had four more nosebleeds. His mother also noticed some blood in his underwear today; patient states he has not seen any blood in the toilet or in his stool. Mom reports the patient does not have any significant medical problems. He's never had something like this happen before. No daily medications. UTD on vaccines per parent. Did recently receive his COVID booster on 1/21 per patient, and did feel ill for a few days after. No family history of bleeding disorders.  Patient was then admitted to the Pediatric Hematology-Oncology Service for further evaluation and management of Immune thrombocytopenia . 2/5/2022: Although platelets did not significantly increase after one dose of IVIG,  mucosal bleeding has stopped and petechiae are regressing, he has no new sites. He still endorses blood in his stools.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prothrombin level, Prothrombin time, Reticulocyte count, Serum ferritin, Urine analysis
Clinical narrative: On 2/4/2022, presented to ER with parents for concerns of nosebleeds, bleeding gums, and petechial rash for one day. Patient reports his gums started bleeding earlier today; this also occurred two days ago but stopped on it's own and they attributed it to his braces so didn't think much of it. He started to have a nosebleed around 1500 today; he has since had four more nosebleeds. His mother also noticed some blood in his underwear today; patient states he has not seen any blood in the toilet or in his stool. Mom reports the patient does not have any significant medical problems. He's never had something like this happen before. No daily medications. UTD on vaccines per parent. Did recently receive his COVID booster on 1/21 per patient, and did feel ill for a few days after. No family history of bleeding disorders.  Patient was then admitted to the Pediatric Hematology-Oncology Service for further evaluation and management of Immune thrombocytopenia . 2/5/2022: Although platelets did not significantly increase after one dose of IVIG,  mucosal bleeding has stopped and petechiae are regressing, he has no new sites. He still endorses blood in his stools.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time normal, Blood lactate dehydrogenase increased, C-reactive protein normal, Epistaxis, Gingival bleeding
Clinical narrative: On 2/4/2022, presented to ER with parents for concerns of nosebleeds, bleeding gums, and petechial rash for one day. Patient reports his gums started bleeding earlier today; this also occurred two days ago but stopped on it's own and they attributed it to his braces so didn't think much of it. He started to have a nosebleed around 1500 today; he has since had four more nosebleeds. His mother also noticed some blood in his underwear today; patient states he has not seen any blood in the toilet or in his stool. Mom reports the patient does not have any significant medical problems. He's never had something like this happen before. No daily medications. UTD on vaccines per parent. Did recently receive his COVID booster on 1/21 per patient, and did feel ill for a few days after. No family history of bleeding disorders.  Patient was then admitted to the Pediatric Hematology-Oncology Service for further evaluation and management of Immune thrombocytopenia . 2/5/2022: Although platelets did not significantly increase after one dose of IVIG,  mucosal bleeding has stopped and petechiae are regressing, he has no new sites. He still endorses blood in his stools.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematochezia, Haemorrhage, Immune thrombocytopenia, Immunoglobulin therapy, International normalised ratio normal
Clinical narrative: On 2/4/2022, presented to ER with parents for concerns of nosebleeds, bleeding gums, and petechial rash for one day. Patient reports his gums started bleeding earlier today; this also occurred two days ago but stopped on it's own and they attributed it to his braces so didn't think much of it. He started to have a nosebleed around 1500 today; he has since had four more nosebleeds. His mother also noticed some blood in his underwear today; patient states he has not seen any blood in the toilet or in his stool. Mom reports the patient does not have any significant medical problems. He's never had something like this happen before. No daily medications. UTD on vaccines per parent. Did recently receive his COVID booster on 1/21 per patient, and did feel ill for a few days after. No family history of bleeding disorders.  Patient was then admitted to the Pediatric Hematology-Oncology Service for further evaluation and management of Immune thrombocytopenia . 2/5/2022: Although platelets did not significantly increase after one dose of IVIG,  mucosal bleeding has stopped and petechiae are regressing, he has no new sites. He still endorses blood in his stools.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Mucosal haemorrhage, Petechiae, Platelet count decreased, Prothrombin time normal
Clinical narrative: On 2/4/2022, presented to ER with parents for concerns of nosebleeds, bleeding gums, and petechial rash for one day. Patient reports his gums started bleeding earlier today; this also occurred two days ago but stopped on it's own and they attributed it to his braces so didn't think much of it. He started to have a nosebleed around 1500 today; he has since had four more nosebleeds. His mother also noticed some blood in his underwear today; patient states he has not seen any blood in the toilet or in his stool. Mom reports the patient does not have any significant medical problems. He's never had something like this happen before. No daily medications. UTD on vaccines per parent. Did recently receive his COVID booster on 1/21 per patient, and did feel ill for a few days after. No family history of bleeding disorders.  Patient was then admitted to the Pediatric Hematology-Oncology Service for further evaluation and management of Immune thrombocytopenia . 2/5/2022: Although platelets did not significantly increase after one dose of IVIG,  mucosal bleeding has stopped and petechiae are regressing, he has no new sites. He still endorses blood in his stools.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cells urine positive, Serum ferritin normal, Urine analysis abnormal
Clinical narrative: On 2/4/2022, presented to ER with parents for concerns of nosebleeds, bleeding gums, and petechial rash for one day. Patient reports his gums started bleeding earlier today; this also occurred two days ago but stopped on it's own and they attributed it to his braces so didn't think much of it. He started to have a nosebleed around 1500 today; he has since had four more nosebleeds. His mother also noticed some blood in his underwear today; patient states he has not seen any blood in the toilet or in his stool. Mom reports the patient does not have any significant medical problems. He's never had something like this happen before. No daily medications. UTD on vaccines per parent. Did recently receive his COVID booster on 1/21 per patient, and did feel ill for a few days after. No family history of bleeding disorders.  Patient was then admitted to the Pediatric Hematology-Oncology Service for further evaluation and management of Immune thrombocytopenia . 2/5/2022: Although platelets did not significantly increase after one dose of IVIG,  mucosal bleeding has stopped and petechiae are regressing, he has no new sites. He still endorses blood in his stools.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest discomfort, Electrocardiogram, Eye pain, Feeling abnormal
Clinical narrative: The patient developed numbness and tingling in her L arm about 5 minutes after the injection was given.  The symptoms in her arm resolved the following day. However, the day after the injection, the patient developed chest pain.  She described it as a substernal tightness or pressure. This pain caused her to seek medical attention and she presented to the ED at Hospital.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Laboratory test, Pain in jaw, Paraesthesia
Clinical narrative: The patient developed numbness and tingling in her L arm about 5 minutes after the injection was given.  The symptoms in her arm resolved the following day. However, the day after the injection, the patient developed chest pain.  She described it as a substernal tightness or pressure. This pain caused her to seek medical attention and she presented to the ED at Hospital.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest discomfort, Chest pain, Electrocardiogram, Full blood count
Clinical narrative: The patient developed numbness and tingling in her L arm about 5 minutes after the injection was given.  The symptoms in her arm resolved the following day. However, the day after the injection, the patient developed chest pain.  She described it as a substernal tightness or pressure. This pain caused her to seek medical attention and she presented to the ED at Hospital.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Metabolic function test, Myocardial necrosis marker, Paraesthesia
Clinical narrative: The patient developed numbness and tingling in her L arm about 5 minutes after the injection was given.  The symptoms in her arm resolved the following day. However, the day after the injection, the patient developed chest pain.  She described it as a substernal tightness or pressure. This pain caused her to seek medical attention and she presented to the ED at Hospital.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: resident was given 0.3 ml of pfizer vaccine without being diluted with normal saline, resident received a concentrated dose of vaccine
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Anxiety, Arthralgia, Chest pain
Clinical narrative: Heart Racing, palpitations, nausea, vomiting, headache, pain that moved from one location to another, body tremors, muscle pain, muscle contractions, muscle spasms, dizziness, lightheaded, anxiety, numbness in tongue, brain fog, brain zaps, muscle weakness, fatigue, chest pain, ringing in ears, joint pain, twitching, internal vibrations, left upper quadrant pain , right abdominal pain, flushing, sensitivity to light, extreme dehydration, difficult swallowing.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Dysphagia, Electric shock sensation, Fatigue
Clinical narrative: Heart Racing, palpitations, nausea, vomiting, headache, pain that moved from one location to another, body tremors, muscle pain, muscle contractions, muscle spasms, dizziness, lightheaded, anxiety, numbness in tongue, brain fog, brain zaps, muscle weakness, fatigue, chest pain, ringing in ears, joint pain, twitching, internal vibrations, left upper quadrant pain , right abdominal pain, flushing, sensitivity to light, extreme dehydration, difficult swallowing.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Headache, Hypoaesthesia oral, Muscle contractions involuntary
Clinical narrative: Heart Racing, palpitations, nausea, vomiting, headache, pain that moved from one location to another, body tremors, muscle pain, muscle contractions, muscle spasms, dizziness, lightheaded, anxiety, numbness in tongue, brain fog, brain zaps, muscle weakness, fatigue, chest pain, ringing in ears, joint pain, twitching, internal vibrations, left upper quadrant pain , right abdominal pain, flushing, sensitivity to light, extreme dehydration, difficult swallowing.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching, Muscular weakness, Myalgia, Nausea
Clinical narrative: Heart Racing, palpitations, nausea, vomiting, headache, pain that moved from one location to another, body tremors, muscle pain, muscle contractions, muscle spasms, dizziness, lightheaded, anxiety, numbness in tongue, brain fog, brain zaps, muscle weakness, fatigue, chest pain, ringing in ears, joint pain, twitching, internal vibrations, left upper quadrant pain , right abdominal pain, flushing, sensitivity to light, extreme dehydration, difficult swallowing.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain, Palpitations, Photophobia, Tinnitus
Clinical narrative: Heart Racing, palpitations, nausea, vomiting, headache, pain that moved from one location to another, body tremors, muscle pain, muscle contractions, muscle spasms, dizziness, lightheaded, anxiety, numbness in tongue, brain fog, brain zaps, muscle weakness, fatigue, chest pain, ringing in ears, joint pain, twitching, internal vibrations, left upper quadrant pain , right abdominal pain, flushing, sensitivity to light, extreme dehydration, difficult swallowing.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Heart Racing, palpitations, nausea, vomiting, headache, pain that moved from one location to another, body tremors, muscle pain, muscle contractions, muscle spasms, dizziness, lightheaded, anxiety, numbness in tongue, brain fog, brain zaps, muscle weakness, fatigue, chest pain, ringing in ears, joint pain, twitching, internal vibrations, left upper quadrant pain , right abdominal pain, flushing, sensitivity to light, extreme dehydration, difficult swallowing.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus. Primary care; awaiting appointment for ENT.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle disruptions  - continuing to monitor , reported to doctor in October 2021
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test negative, Chills, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: After receiving the vaccine, during night had chills, fever and sore arm for 1 night. Reduced mostly next day. After that about 10 days later started feeling very itchy and soon got hives all over the body. Never had any food or allergy reactions before.  Started taking allegra for the last month and still did not completely go away.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: After receiving the vaccine, during night had chills, fever and sore arm for 1 night. Reduced mostly next day. After that about 10 days later started feeling very itchy and soon got hives all over the body. Never had any food or allergy reactions before.  Started taking allegra for the last month and still did not completely go away.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dysgeusia, Fatigue, Malaise
Clinical narrative: Minutes after receiving it I had a metallic taste in my mouth with wasn't that big a deal it went away. For the last seven or eight days now though I've been sick and couldn't even need a full meal for the first week after receiving it and I've had diarrhea and nausea, and fatigue with restlessness when attempting to sleep.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Restlessness
Clinical narrative: Minutes after receiving it I had a metallic taste in my mouth with wasn't that big a deal it went away. For the last seven or eight days now though I've been sick and couldn't even need a full meal for the first week after receiving it and I've had diarrhea and nausea, and fatigue with restlessness when attempting to sleep.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: After receiving my shot on Friday 2/4 later that evening I had pain and swelling in my underarm
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Neuralgia, Pain, X-ray dental
Clinical narrative: Severe Nerve pain right side upper and lower teeth. Sharp shocking pain when any liquids, even water, touch mid to back right side teeth. Nerve pain also noted when sustaining open mouth and breathing. Touch of breath on teeth causes pain.  Dentist evaluation 02/06/22. An experienced dentist reviewed x-rays of teeth and assessed mouth. He reported that he did not see any problems that would cause that pain.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Acupuncture, Anxiety, Back pain, Blood test, Burning sensation
Clinical narrative: Sore arm for first 3 days, then extreme and anxiety pain in cervical spine. Nausea, dizziness and burning sensation in all four limbs (especially in hands and feet). Four months later, I developed chronic back pain in thoracic spine and shoulder blades.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Laboratory test, Magnetic resonance imaging, Musculoskeletal pain, Naturopathy
Clinical narrative: Sore arm for first 3 days, then extreme and anxiety pain in cervical spine. Nausea, dizziness and burning sensation in all four limbs (especially in hands and feet). Four months later, I developed chronic back pain in thoracic spine and shoulder blades.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Spinal pain
Clinical narrative: Sore arm for first 3 days, then extreme and anxiety pain in cervical spine. Nausea, dizziness and burning sensation in all four limbs (especially in hands and feet). Four months later, I developed chronic back pain in thoracic spine and shoulder blades.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: product storage error; Patient were given dose of the Moderna COVID 19 after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient were given dose of the Moderna COVID 19 after 30-day Use By Date) and PRODUCT STORAGE ERROR (product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient were given dose of the Moderna COVID 19 after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). On 07-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Patient were given dose of the Moderna COVID 19 after 30-day Use By Date) had resolved. At the time of the report, PRODUCT STORAGE ERROR (product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anaemia, Computerised tomogram, Computerised tomogram abdomen normal, Computerised tomogram pelvis abnormal
Clinical narrative: Since getting the vaccine, my body can not regulate temperature. I get hot  (with sweating) out of no where then I?ll get cold and then hot all within the matter of minutes. I have lost a lot of weight without exercise. I profusely sweat in my sleep at night to the point I have to change clothes and sheets. This never happened before.  When I eat I immediately get stomach pain that stops me from eating for 5-10 min then at times I can continue eating and other times I can not
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax normal, Endoscopy normal, Feeling of body temperature change, Hyperhidrosis, Magnetic resonance imaging normal
Clinical narrative: Since getting the vaccine, my body can not regulate temperature. I get hot  (with sweating) out of no where then I?ll get cold and then hot all within the matter of minutes. I have lost a lot of weight without exercise. I profusely sweat in my sleep at night to the point I have to change clothes and sheets. This never happened before.  When I eat I immediately get stomach pain that stops me from eating for 5-10 min then at times I can continue eating and other times I can not
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pelvic cyst, Scan with contrast, Temperature regulation disorder, Ultrasound scan normal
Clinical narrative: Since getting the vaccine, my body can not regulate temperature. I get hot  (with sweating) out of no where then I?ll get cold and then hot all within the matter of minutes. I have lost a lot of weight without exercise. I profusely sweat in my sleep at night to the point I have to change clothes and sheets. This never happened before.  When I eat I immediately get stomach pain that stops me from eating for 5-10 min then at times I can continue eating and other times I can not
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Since getting the vaccine, my body can not regulate temperature. I get hot  (with sweating) out of no where then I?ll get cold and then hot all within the matter of minutes. I have lost a lot of weight without exercise. I profusely sweat in my sleep at night to the point I have to change clothes and sheets. This never happened before.  When I eat I immediately get stomach pain that stops me from eating for 5-10 min then at times I can continue eating and other times I can not
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Heart rate, Heart rate increased, Hypoaesthesia
Clinical narrative: Contant headache; pain chest; high heartbeat; facial numbness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 17:30 (Lot number: FC3184) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shirm lobster" (unspecified if ongoing), notes: known allergies Shirm lobster. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 11Sep2021, outcome "not recovered", described as "Contant headache"; CHEST PAIN (non-serious) with onset 11Sep2021, outcome "not recovered", described as "pain chest"; HEART RATE INCREASED (non-serious) with onset 11Sep2021, outcome "not recovered", described as "high heartbeat"; HYPOAESTHESIA (non-serious) with onset 11Sep2021, outcome "not recovered", described as "facial numbness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, chest pain, heart rate increased, hypoaesthesia.  Additional information: No other vaccine in four weeks. Multi vitamin was other medications in two weeks. No covid prior vaccination. Patient was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Gluten sensitivity
Clinical narrative: I developed a gluten allergy; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 30Apr2021 at 14:00 (Lot number: unknown) at the age of 30 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Allergic reaction to analgesics" (unspecified if ongoing), notes: Known allergies: NSAIDS. There were no concomitant medications. Past drug history included: Aspirin, reaction: "Drug allergy", notes: Known allergies: aspirin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical location: left arm, Administration time: 13:00), administration date: 09Apr2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: GLUTEN SENSITIVITY (non-serious) with onset 04Jun2021, outcome "not recovered", described as "I developed a gluten allergy". The event "I developed a gluten allergy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of gluten sensitivity.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Treatment taken as a result of gluten sensitivity included Daily Benadryl.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: DT
Symptoms: Autism spectrum disorder, Balance disorder, Communication disorder, Disturbance in attention, Dizziness
Clinical narrative: Very dizzy, felt like I was falling over for years. Could not concentrate. Autism qualities. Quiet. Could not articulate or communicate for years
Age: 34.0
Sex: F
Vaccine: DT
Symptoms: Dysarthria
Clinical narrative: Very dizzy, felt like I was falling over for years. Could not concentrate. Autism qualities. Quiet. Could not articulate or communicate for years
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Blood test, Feeling abnormal
Clinical narrative: Hair Loss/ I started losing hair. I have almost none left on the right side of my head.; I feel like I'm on the brink of insanity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Oct2021, outcome "unknown", described as "third shot at the end of October"; ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "Hair Loss/ I started losing hair. I have almost none left on the right side of my head."; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "I feel like I'm on the brink of insanity". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After third shot at the end of October patient started losing hair and had none left on the right side of head. Patient had hair before these injections and now it's literally going down the drain. Patient have been to the doctor and all blood work came back normal. The patient doesn't go out because the patient was so embarrassed about the appearance. So, in order to save my life I sacrificed my hair and in a sense my life. I'm beyond angry.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: VARCEL
Symptoms: Contraindicated product administered, Product communication issue, Varicella zoster virus infection
Clinical narrative: patient was inadvertently administered varicella vaccination while on sirolimus therapy, and she developed a zoster infection; patient was inadvertently administered varicella vaccination while on sirolimus therapy, and she developed a zoster infection; it was communication error between physicians; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a female patient of unknown age (reported as child or infant) with pulmonary vein stenosis (PVS). The patient was on sirolimus therapy administered as pneumocystis pneumonia (PCP) prophylaxis.  There was no information about the patient's allergies, drug reactions or medical history provided. On an unknown date, the patient was inadvertently administered varicella virus vaccine live (oka/merck) (manufacturer unknown) for prophylaxis  (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported). On an unknown date, she developed varicella zoster virus infection, grade 3 (also reported as mild). As treatment the patient received acyclovir. The outcome of varicella zoster virus infection was unknown. It was also reported that an communication error between the pediatrician and the cardiologist occurred and the patient should not had been given the varicella vaccine while on sirolimus therapy (product communication issue, contraindicated product administered). The authors considered varicella zoster virus infection to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown).     The authors considered the event of varicella zoster virus infection to be medically significant.   Literature report: Systemic Sirolimus Therapy for Infants and Children With Pulmonary Vein Stenosis; Systemic Sirolimus Therapy for Infants and Children With Pulmonary Vein Stenosis;  A copy of the published article is attached as further documentation of the patient's experience
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; VARlVAX was administered after the excursion; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant medications included sterile diluent (STERILE DILUENT).  On 18-JAN-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 (units not provided) (lot #U020244, expiration date: 28-JUN-2023) (strength, frequency and route of administration were not provided) for prophylaxis. No adverse events were reported. According to the reporter, the temperature excursion was 30 degrees Fahrenheit for a time frame of 30 minutes on an unspecified date product storage error), without any previous temperature excursion.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient had no known side effects; Vaccine reached (34.3F); This spontaneous report was received from an administrator and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-JAN-2022, the patient was administered a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(strength, lot #, and expiration date were not provided) for prophylaxis. Prior to administration, the vaccine experienced temperature excursion of 34.3 degrees Fahrenheit for 4 hours 23 minutes and 0 seconds (Product storage error). There were no previous excursions. Patient had no known side effects (No adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA006297: US-009507513-2201USA005595: US-009507513-2201USA005673: US-009507513-2201USA005751: US-009507513-2201USA005901: US-009507513-2201USA006295: US-009507513-2201USA006305: US-009507513-2201USA006322: US-009507513-2201USA006342: US-009507513-2201USA006419: US-009507513-2201USA006445: US-009507513-2201USA006297:
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Fatigue, Injection site swelling, Pyrexia
Clinical narrative: general discomfort; Indication: She has asthma, allergies, and often gets ear infections and sinus infections; fever of 10 IF; fatigue; injection site was swollen; This spontaneous report was received from a 20-year-old female reporting on herself. The patient's medical history was not reported. The patient's concurrent conditions included hypersensitivity, and asthma. Historical drugs included Neosporin, and Polysporin. Concomitant therapies were not reported.  On 21-JAN-2022, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product use in unapproved indication)  On the same date, the patient felt general discomfort on the night and it had gotten progressively worse. Then,  On an unknown date in January 2022 she had fever of 101 Fahrenheit for the last three days and had experienced a lot of fatigue. Also, after vaccination the area of injection site was swollen to the size of a quarter, now the area is swollen to the size of a grapefruit (Vaccination site swelling). The patient was planning to go see her doctor.   At the time of reporting, the patient had not recovered from general discomfort, fever, vaccination site swelling  and fatigue.   The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: one of their nurses accidently gave a 12 month old patient an MMR vaccine that expired by 6 days; no additional AE reported; This spontaneous report was received from a nurse via company employee and refers to a 12-month-old patient of unknown gender. No information regarding patient's medical history, concurrent conditions and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot#, expiration date, dose number, dose, route and site of administration were not provided) for prophylaxis. The vaccine was expired by 6 days (Expired product administered). No other adverse events were reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information on pertinent medical history, concomitant medications and drug reactions/allergies was not reported.   On 14-JAN-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U022321, expiration date 15-JUL-2023) 0.5 milliliter for prophylaxis (dose number, route of administration and location of administration were not reported).  The vaccine was exposed to a temperature of -14.1 C for 12 minutes. There were no previous temperature excursions. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; the vaccine was adminsitered after a temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information on pertinent medical history, concomitant medications and drug reactions/allergies was not reported.   On 24-JAN-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U020239, expiration date 28-JUN-2023) 0.5 milliliter for prophylaxis (dose number, route of administration and location of administration were not reported).  The vaccine was exposed to a temperature of -14.1 C for 12 minutes. There were no previous temperature excursions. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; the vaccine was administered after a temperature excursion.; Information has been received from a nurse referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.     On 21-JAN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (0.5 milliliter, lot # U022321, expiration date:15-JUL-2023, strength, frequency and route were unknown) for prophylaxis (incorrect product storage). No additional adverse event was reported.          The stored temperature was -14.1 degree Celsius. The time frame was 12 minutes. There was no previous temperature excursion.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered; This spontaneous report as received from a licenced practical nurse, via a company representative, and refers to a 6 year old patient of unspecified gender. No information was reported concerning the patient's medical history, concurrent conditions or concomitant medications.  On 26-JAN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot T025508 for prophylaxis (dose and route of administration were unknown). The vaccine expired on 23-JAN-2022. The reporter  was not sure how effective vaccine was. She requested any additional information or if the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was still effective.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE reported; product administered to patient after temperature excursions; This spontaneous report was received from a medical assistant referring to a 12 month old patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 27-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # U008180, expiration date on 12-MAR-2023, once, for prophylaxis (dose, and route were not reported). The vaccine was administered to the patient after temperature excursions as follows:7.4 F degrees for 0 hours 25 minutes 0 seconds, 6.4 F degrees for 0 hours 20 minutes 0 seconds and 5.9 F degrees for 0 hours 15 minutes 0 seconds. There were previous temperature excursions at 31.3 F degrees for 10 hours 28 minutes 0 seconds; between range 6 F degrees to 14 F degrees; no exact temperature was provided; for 1 hour 15 minutes 0 seconds; 11 F degrees for 4 hours 6 minutes 0 seconds.No additional adverse events were reported. No product quality complaint involved.  This is the report number five out of seven total.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Product was admnistered to patient after temperature excursions; This spontaneous report was received from a medical assistant and refers to a 2 year old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.     On 21-JAN-20221, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot number U008180 with expiration date 12-MAR-2023 (dosage [frequency reported as once], route of administration, and anatomical location were not reported) for prophylaxis, which experienced  temperature excursions: 7.4°F for 0 hours, 25 minutes and 0 seconds; 6.4°F for 0 hours, 20 minutes and 0 seconds; and 5.9°F for 0 hours, 15 minutes and 0 seconds. In addition, the vaccine had previous temperature excursions: at 31.3°F for 10 hours,28 minutes and 0 seconds; between range of 6°F to 14 °F (no exact temperature was provided) for 1 hour, 15 minutes and 0 seconds; and 11°F for 4 hours, 6 minutes and 0 seconds.  This is one of several reports received from the same reporter.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Haematemesis, Product administered to patient of inappropriate age
Clinical narrative: spit up blood after the first dose; patient age: 4 months old; This spontaneous report was received from a licensed practical nurse via a company representative and refers to a 4-month-old female patient. The patient's concurrent conditions included sever milk allergy and spitting up blood (Haematemesis). No information regarding the patient's medical history or concomitant medications was provided.  On an unknow date, the 4-month-old female patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (dose, lot #, expiration date were not reported) for prophylaxis (Inappropriate age at vaccine administration).  On an unspecified date, after the first dose, the patient spit up blood (Haematemesis). It was reported that the patient sought medical attention, however it was unknown if she had any treatment given or any laboratory test performed. The outcome of the event was unknown.  The causality assessment between the event and the suspect vaccine was not provided.  Upon internal review, the event of Haematemesis was considered to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: no additional adverse events reported; she did not screw the needle on the syringe good enogh and of the vaccine spraying out of the patient, only partial dose was delivered; This spontaneous report has been received from Licensed practical nurse concerning to 5-year-old unknown gender patient. The patient's current conditions, medical history and historical drug were not reported. No concomitant therapies were provided.  On 01-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, (lot #U016064 and expiration date since it makes match with the autopopulated expiration date 20-MAY-2023) (strength, route of administration, and indication were not provided).   It was reported that while was prepping a dose of virus vaccine live (oka/merck) (VARIVAX), the nurse did not screw the needle on the syringe good enough and when was administered the vaccine to the patient, only a partial dose (unknown amount) was delivered due to some of the vaccine spraying out of the hub where the needle attaches (underdose). No additional adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details; a patient received an expired dose of MMR-II; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.   On 01-FEB-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # S037500, expiration date 20-NOV-2021; dose and route were not reported) for prophylaxis (expired product administered). Other suspect therapy included sterile diluent (manufacturer unknown) (dose, route, indication, lot# and expiration date were not provided). No additional adverse event (AE) details.