chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Colitis ulcerative, Drug ineffective, Vaccination site pain
Clinical narrative: ulcerative colitis; lack of drug effect; joint pain; vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 18-Apr-2021.    This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of COLITIS ULCERATIVE (ulcerative colitis) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included No adverse event (No medical history provided.).   On 16-Nov-2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. In March 2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On an unknown date, the patient experienced COLITIS ULCERATIVE (ulcerative colitis) (seriousness criterion medically significant), DRUG INEFFECTIVE (lack of drug effect) and ARTHRALGIA (joint pain). In March 2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. At the time of the report, COLITIS ULCERATIVE (ulcerative colitis), DRUG INEFFECTIVE (lack of drug effect) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Disease progression, Gait disturbance, Spinal pain
Clinical narrative: Transverse myelitis aggravated; She feels her spine is broken in two; Can't walk without pain; This spontaneous case was reported by a consumer and describes the occurrence of DISEASE PROGRESSION (Transverse myelitis aggravated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Myelitis transverse.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DISEASE PROGRESSION (Transverse myelitis aggravated) (seriousness criterion medically significant), SPINAL PAIN (She feels her spine is broken in two) and GAIT DISTURBANCE (Can't walk without pain). At the time of the report, DISEASE PROGRESSION (Transverse myelitis aggravated), SPINAL PAIN (She feels her spine is broken in two) and GAIT DISTURBANCE (Can't walk without pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was unknown. Treatment information was not provided.  Company comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Petit mal epilepsy
Clinical narrative: grand mal seizures; absence seizures; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) and PETIT MAL EPILEPSY (absence seizures) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Seizures (Patient had a history of seizures but had not had any since a very long time.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) (seriousness criterion medically significant) and PETIT MAL EPILEPSY (absence seizures) (seriousness criterion medically significant). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) and PETIT MAL EPILEPSY (absence seizures) outcome was unknown. Not Provided          Concomitant medication use was not reported.  Treatment information was not reported.  The patient reported that he had a grand mal seizure approximately 8 hours after the first vaccine dose. Thereafter, the patient stated that he is now averaging 3 -4 seizures per week. The patient endorses that he has never had daytime seizures before.  The patient saw his neurologist who said there was no concern and advised that he continue to monitor.   The patient stated that he did receive his second dose of the vaccine, dates were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's hx of seizure is a confounding factor that may play a possible contributory role.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's hx of seizure is a confounding factor that may play a possible contributory role.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, X-ray
Clinical narrative: Pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included AMLODIPINE, LEVOTHYROXINE, IRBESARTAN and LANSOPRAZOLE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion hospitalization). At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, X-ray: pneumonia pneumonia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to hospital on an unspecified date and x-ray exam showed that he had pneumonia. The patient was prescribed with antibiotics and cough medicine. The patient was to check if doxycycline and promethazine medicine will effect on his second dose schedules on 21-APR-2012. The reporter did not provide an assessment for the event , pneumonia.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death after 1 dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (death after 1 dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            This spontaneous case was reported by a consumer and describes the occurrence of DEATH (death after 1 dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          The reporter stated that she was not sure of the vaccine name that the patient used.; Sender's Comments: This is a male patient of unknown age,  who received mRNA-1273 Vaccine and died on an unknown date after receiving first dose of vaccine. No medical hx or conmeds were provided. The fatal outcome may be related to the patient's pre-existing comorbidities Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: death after 1 dose of vaccine
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Body temperature, Cardiac disorder, Dizziness, Hypersensitivity
Clinical narrative: fever; palpitations; heart disease, unspecified; allergy; asthma; dizzy; wrong injection technique; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 17-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong injection technique). On an unknown date, the patient experienced PALPITATIONS (palpitations) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization), CARDIAC DISORDER (heart disease, unspecified), HYPERSENSITIVITY (allergy), ASTHMA (asthma) and DIZZINESS (dizzy). At the time of the report, PALPITATIONS (palpitations), PYREXIA (fever), CARDIAC DISORDER (heart disease, unspecified), HYPERSENSITIVITY (allergy), ASTHMA (asthma) and DIZZINESS (dizzy) outcome was unknown and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong injection technique) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 104 °F (High) 104 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient received Covid-19 vaccine the same day as she did her first Humira (adalimumab) injection. The patient reported that they told her at the hospital that the symptoms were due to the Covid-19 vaccine.  Treatment medication included Benadryl (diphenhydramine).  Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Wrong technique in product usage process
Clinical narrative: fever; palpitations; heart disease, unspecified; allergy; asthma; dizzy; wrong injection technique; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 17-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong injection technique). On an unknown date, the patient experienced PALPITATIONS (palpitations) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization), CARDIAC DISORDER (heart disease, unspecified), HYPERSENSITIVITY (allergy), ASTHMA (asthma) and DIZZINESS (dizzy). At the time of the report, PALPITATIONS (palpitations), PYREXIA (fever), CARDIAC DISORDER (heart disease, unspecified), HYPERSENSITIVITY (allergy), ASTHMA (asthma) and DIZZINESS (dizzy) outcome was unknown and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong injection technique) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 104 °F (High) 104 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient received Covid-19 vaccine the same day as she did her first Humira (adalimumab) injection. The patient reported that they told her at the hospital that the symptoms were due to the Covid-19 vaccine.  Treatment medication included Benadryl (diphenhydramine).  Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Herpes ophthalmic
Clinical narrative: Mild Herpetic Keratitis relapse; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HERPES OPHTHALMIC (Mild Herpetic Keratitis relapse) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Herpetic keratitis.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES OPHTHALMIC (Mild Herpetic Keratitis relapse) (seriousness criterion medically significant). At the time of the report, HERPES OPHTHALMIC (Mild Herpetic Keratitis relapse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative
Clinical narrative: Colitis ulcerative aggravated; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COLITIS ULCERATIVE (Colitis ulcerative aggravated) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Ulcerative colitis.    The patient's past medical history included No adverse event (No reported medical history).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced COLITIS ULCERATIVE (Colitis ulcerative aggravated) (seriousness criterion medically significant). At the time of the report, COLITIS ULCERATIVE (Colitis ulcerative aggravated) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case concerns a 62-year-old female with a serious unexpected event of ulcerative colitis flare. Event onset the same day as first dose mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 62-year-old female with a serious unexpected event of ulcerative colitis flare. Event onset the same day as first dose mRNA-1273. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis flare up; This spontaneous case was reported by an other health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin allergy manifested by rash). Concomitant products included PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) for Rheumatoid arthritis, ADALIMUMAB (HUMIRA AC) for Rheumatoid arthritis and Crohn's disease.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram head, Headache, Occipital neuralgia
Clinical narrative: Occipital Neuralgia after the first shot of Moderna. COVID vaccine.  Very sharp pain on the right side of my head. I take Gabapentin 6 times a day for pain. Nothing else helps.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: I developed very itchy bumps all over my body a few days after both the first and the second shot. The bumps were much worse after the second shot and continued to linger for over a month (bumps would fade and new ones would develop. Finally I took benedryl three nights in a row and that seemed to knock them back. I've done everything I can to rule out some sort of bug. The person with whom I share a bed has not been developing these bumps. They do not resemble bed bug bites. The closest resemblance is to mosquito bites, but there are no mosquitos in this area this time of year.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Motion sickness
Clinical narrative: recurrent dizziness, motion sickness,lasting for hours, no nausea or vomiting.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Feeling abnormal, Nausea, Palpitations, Panic reaction
Clinical narrative: immediate symptoms - bowel movements are very different and continue to this day. Like babies poop. Specific date of occurrence 3/24/2021 - 2 pm: was standing in my home office feeling just fine and then my heart started racing and I was immediately nauseous to the point I had to lay on the floor on my back and tell myself to breathe.  I felt like my heart was going to jump out of my chest, so I got up and grabbed my wrist blood pressure monitor and went and lay back on the floor telling myself to breathe. I took the first reading and it said 200/52/57  so I too it again 199 / 50 / 58.  I started to panic and remembered I had bought some cans of oxygen for my father and had one in the bathroom. I went and breathed on that for about 2 minutes. My reading then went back down to a more normal range. Since that time my head doesn't feel the same and it scared me enough to tell my husband and mom, yet they both told me not to stress about it. I have only experienced ongoing bowel movements and the weird head feeling since that time but did contact my Dr. for an appointment. I want be certain I didn't have a stroke or something peculiar.   I had noticed my heart rate increasing but wasn't sure if I was imagining it, so I restarted taking my blood pressure numbers on 3/22. My blood pressure that morning at 6 am was 113/59/72.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Pain, Pain in jaw
Clinical narrative: Jaw pain and numbness on left side under ear Body aches Chills
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood test, Hypoaesthesia, Limb discomfort
Clinical narrative: I immediately began to feel my arm asleep, it wastes the ring finger and the little fimger. then i was taking iboprofen ) sr, order to me, the was eors and he gave me diclofenacoy take it 5 day but i star havin ptoblems with my eyes and legs.  my my sensory nervous systerm is very devilite. I ca"t smell and I have no Taste  this week i did an MRI and x ray
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Sensory disturbance, Visual impairment, X-ray
Clinical narrative: I immediately began to feel my arm asleep, it wastes the ring finger and the little fimger. then i was taking iboprofen ) sr, order to me, the was eors and he gave me diclofenacoy take it 5 day but i star havin ptoblems with my eyes and legs.  my my sensory nervous systerm is very devilite. I ca"t smell and I have no Taste  this week i did an MRI and x ray
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Herpes zoster, Rash, Viral test
Clinical narrative: I had Shingles three years ago and was diagnosed with Shingles again on 04.22.21. It effects my left leg and thigh. Rash/blisters started on 04.18.21. It is possible the Covid Pfizer vaccine reactivated the virus.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash around the injection area
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: Diverticulitis; The initial case was missing the following minimum criteria: Adverse Effect. Upon receipt of follow-up information on 09Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on 07Apr2021, as SINGLE DOSE for covid-19 immunisation.  Medical history included shellfish allergy. The patient's concomitant medications were not reported.  The patient received tetanus vaccine on 30Dec2020 for immunization. The patient took the Pfizer covid vaccine shot on 07apr2021, but her doctors gave her augmentin because she has diverticulitis. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: tenderness on the injection site after the 1st dose; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: unknown) via an unspecified route of administration at a single dose on 21Jan2021, for COVID-19 immunization. Medical history included shingles and anxious to get first COVID vaccine dose due to having received second Shingles vaccine dose, one month ago. Concomitant medications were not reported. On an unspecified date in Oct2020, the patient also had first dose of Shingrix vaccine, and the second dose on 19Dec2020. The patient had question about if someone had received any vaccines in the last 14 days. On an unspecified date, after the first dose, the patient experienced tenderness on the injection site. She was scheduled to receive the second on 11Feb2021. The outcome of the event of tenderness on the injection site was unknown. Upon follow-up on 10Feb2021: The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 10Feb2021, this case now contains event information and was considered as valid.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Investigation, SARS-CoV-2 antibody test
Clinical narrative: felt cruddy for a few days afterward; This is a spontaneous report from a contactable physician. A female patient of an unspecified age (Age: 35; Unit: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown, Expiration Date: Unknown) via an unspecified route of administration on 09Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced got her blood tested for the igg and igm titers for the covid spike protein and her levels were undetectable, felt cruddy for a few days afterward on Jan2021. The patient underwent lab tests and procedures which included blood test: unknown results on 27Jan2021 blood tested for the IgG and IgM titers , investigation: unknown results on She even had the lab re run her test results, sars-cov-2 antibody test: undetectable on 27Jan2021 Covid Spike Protein and her levels were undetectable. The patient stated she felt cruddy for a few days afterward. On 27Jan2021 she got her blood tested for the IgG and IgM titers for the Covid Spike Protein and her levels were undetectable. She even had the lab re run her test results. She has asked several infectious disease doctors and they had no answer. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: First dose Sore arm; This is a spontaneous report received from a contactable consumer (reporting on himself). A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL1284 and Expiry date: Mar2021), via an unspecified route of administration in Arm Left on 05Jan2021 13:30 (at the age of 61-years-old) as single dose for COVID-19 immunization. Medical history included supraventricular tachycardia, herpes virus infection, lymphadenectomy and idiopathic mesenteric lymphadenopathy. Concomitant medication(s) included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]); cyclobenzaprine (CYCLOBENZAPRINE); metoprolol (METOPROLOL) and atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that patient experienced first dose sore arm. Patient took second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL1284 and Expiry date: Apr2021), via an unspecified route of administration in Arm Left on 26Jan2021 13:15 (at the age of 61-years-old) as single dose for COVID-19 immunization. Second dose 8 hours post headache, sore arm and entire upper torso pain, chills and fever 101-102F 12 hrs. I was lethargic the whole next day with severe headache. Normal 2nd day after. Since the vaccination, patient not tested for COVID-19. The outcome of the event was recovering.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Gait disturbance, Pain, Sleep disorder
Clinical narrative: I had aches all over 2 days after 2nd vaccination on 4/5/21.  Within a week, I had constant pain in my left knee and a little in my right.  I'm in constant pain which is not relieved with Tylenol, ice or heat compresses, epsom baths, light exercise, or stretching.  At night I have trouble sleeping because my knee is so painful.  Several times I've almost fallen.  My lower back is also bothering me because I can't walk normally and am putting even pressure on my knees, legs, and back.  Prior to the second shot, I was having this kind of ongoing pain.  It has severely limited my ability to get around and I often use a cane so I won't fall.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Rash
Clinical narrative: Patient woke up on the morning of 04/01/2021 with a sizable rash on the right side of his torso. Ha was not sure if it was a big/spider bite so left it alone. Then during the day within a 30 min span his arm flared up with a similar rash. No new food/allergies, nor time rolling in the forest.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lethargy
Clinical narrative: Lethargic, joint pain, and headache
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Chills, Condition aggravated, Fatigue, Influenza like illness
Clinical narrative: Cold and flu like symptoms for 2 days after initial vaccine and 1 day after second dose, including fever, chills, lethargy and overall tiredness. Have not had my period since administration of second vaccine
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nasopharyngitis, Pyrexia
Clinical narrative: Cold and flu like symptoms for 2 days after initial vaccine and 1 day after second dose, including fever, chills, lethargy and overall tiredness. Have not had my period since administration of second vaccine
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chills, Hyperhidrosis, Malaise
Clinical narrative: Felt well for 12 hours. Then: Pain in lungs, kidneys, joints, muscles; Chills (do not know if had fever; very high perspiration); Extreme pain and burning in all of sinuses, felt like the membranes were on fire; All pain was so extreme I truly wanted to kill myself; We were told to take paracetamol at the time of vaccination, but disregarded the advice; Started taking paracetamol after getting it next morning from our pharmacy; Was sick for three days, but the worst lasted for about 22 hours.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pulmonary pain, Renal pain, Sinus pain, Suicidal ideation
Clinical narrative: Felt well for 12 hours. Then: Pain in lungs, kidneys, joints, muscles; Chills (do not know if had fever; very high perspiration); Extreme pain and burning in all of sinuses, felt like the membranes were on fire; All pain was so extreme I truly wanted to kill myself; We were told to take paracetamol at the time of vaccination, but disregarded the advice; Started taking paracetamol after getting it next morning from our pharmacy; Was sick for three days, but the worst lasted for about 22 hours.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Immune thrombocytopenia, Platelet count
Clinical narrative: Idiopathic thrombocytopenic purpura (ITP); This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura (ITP)) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura (ITP)) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 06-Mar-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura (ITP)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Full blood count: 238 (Inconclusive) 238. On 06-Mar-2021, Platelet count: 3 x 1000 (Inconclusive) 3 x 1000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. She was first admitted to the ER on 06Mar2021. Indicator was that her platelet was 3x 1000.  She received a platelet infusion and her platelet count went up and then down.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: New information includes reporter email address, lot # of vaccine, treatment information.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Embolism
Clinical narrative: THROMBOEMBOLIC COMPLICATION; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included cardiovascular comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry Date: UNKNOWN) with unknown dose, 1 total, on unspecified date for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced thromboembolic complication, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thromboembolic complication was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This 56-year-old male patient, with unspecified cardiovascular co-morbidities, was reported in the news to have a "thromboembolic complication" and was hospitalized after an unspecified duration of receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  No ther details was reported.  Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per organization causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information will be requested once contact information is obtained
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling lymph nodes in armpit and clavicle; swelling and pain at injection site; swelling and pain at injection site; a little rash in right forearm; This is a spontaneous report received from a non-contactable consumer (patient). A 57-years-old female patient received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 57-years-old, via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:30 AM (Lot Number: EW0151) as single dose for covid-19 immunisation. Medical history included Diabetes, Hypertension, Neuropathy, Radiculopathy. No allergies to medications, food, or other products. Concomitant medications included metformin hydrochloride; losartan; atorvastatin (LIPITOR); clonidine (CATAPRESS); clonazepam (KLONOPIN). Patient received first dose of BNT162b2, at the age of 57-years-old, administered in Arm Left on 03Mar2021 10:15 AM (Lot Number: EN6207) for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling lymph nodes in armpit and clavicle on 07Apr2021 21:00 with outcome of recovering, swelling and pain at injection site on 07Apr2021 21:00 with outcome of recovering, a little rash in right forearm on 07Apr2021 21:00 with outcome of recovering. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumonia vaccine, date of vaccination: 2018, 2019; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (2101USA007302), referring to an approximately 68 years old female patient.  Information about medical history, concurrent conditions and concomitant therapies was not provided.   In 2018 and 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).     This case was split from a legal case regarding the same patient.; Sender's Comments:  US-009507513-2101USA007302:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient had no reported side effects; expired dose of MMR-II was administered to a 4 year old patient; This spontaneous report was received from an office manager and refers to a 4-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 12-APR-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S005249 with expiration date on 20-FEB-2021, 0.5 milliliter, therapy type rHA (route of administration was unknown) for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE; expired vaccine (VAQTA) has been administered to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-APR-2021, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot # T014590, expiration date 15-APR-2021 (route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse events reported; VAQTA was administered to a patient and the vaccine was expired; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.     On 19-APR-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # T014590, expiration date 15-APR-2021; strength, dose/frequency and route were not reported) for prophylaxis (expired product administered). The reporter would like to know if they need to administer another dose of the product. No other adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Rash; Fever; Headache; This is a spontaneous report from a contactable consumer, based on information received by Pfizer(manufacturer control number: US-AMGEN-USASP2021053276), license party for etanercept (ENBREL).  This non-serious spontaneous report (USASP2021053276) was reported on 06/APR/2021 by a consumer and involves a 78 years old female patient who had rash [PT: rash], fever [PT: pyrexia] and headache [PT: headache] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included arthropathic psoriasis, unspecified. The patient's concomitant medications included cyanocobalamin, lisinopril and Vitamin D (colecalciferol). The patient's co-suspect medication included covid-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient received a second shot of covid vaccine. Subsequently, the patient had rash, fever and headache. No treatment information was received. The outcome of the events rash, pyrexia and headache was reported as recovered/resolved. The events rash, pyrexia and headache was resolved on an unknown date. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events rash, pyrexia and headache. The causal relationship between the events rash, pyrexia, headache and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. No follow up attempts are possible. No further information is expected.  Pfizer is a marketing authorization holder of covid vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of covid vaccine has submitted the same report to the regulatory authorities.
Age: 77.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Restlessness, Sleep disorder
Clinical narrative: pain in the area of the shot / upper left arm / pain of various degrees ranging from an annoyance to a degree of pain that will...and has...awakened me at night; degree of pain that will...and has...awakened me at night.; This case was reported by a consumer and described the occurrence of injection site pain in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th July 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and wakefulness. On an unknown date, the outcome of the injection site pain and wakefulness were unknown.   It was unknown if the reporter considered the injection site pain and wakefulness to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself/ himself. The patient received Shingrix vaccine in left upper arm and experienced pain in the area of the shot. The patient reported that this was a pain of various degrees ranging from an annoyance to a degree of pain that awakened patient at night. The patient did not take anything for it and just let it work itself out. The patient stated that if there were reported side effects of Shingrix vaccine, then add his/her experience to it.
Sex: F
Vaccine: MEN
Symptoms: Anaphylactic shock, Angioedema
Clinical narrative: Develop recurring angioedema; She gets to carry an epipen just in case she goes into anaphylactic shock.; This case was reported by a consumer via interactive digital media and described the occurrence of angioedema in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced angioedema (serious criteria GSK medically significant) and anaphylactic shock (serious criteria GSK medically significant). The patient was treated with ambiguous medication nos (Epipen (Nos)). On an unknown date, the outcome of the angioedema was unknown and the outcome of the anaphylactic shock was not recovered/not resolved.   The reporter considered the angioedema and anaphylactic shock to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient received the vaccine and it caused her to develop recurring angioedema. The patient had to carry an Epipen for the rest of her life just in case she would go into anaphylactic shock.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: for a few days his body didn't feel too good; This case was reported by a consumer via licensee and described the occurrence of feeling unwell in a 68-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient did not have medical history. It was reported that the patient was healthy person, he was doing exercise and lot of things. The patient did not took any recent vaccines or any concomitant medication. The patient took flu shot after certain age and for few days his body did not feel good. The patient was taking flu shot for about 8 years and stated that it did not happen when he gets them, he must have gotten used to them. The reporter consented to follow up.