chrisvoncsefalvay/vaers-outcomes huggingface dataset:
myocarditis; Strange weird bilateral wrist pain severe; Pericarditis/inflammation around the heart; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for two patients (twins). This is the first of two reports.  A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170), via an unspecified route of administration, administered in the left arm, on 26Apr2021 10:00, as 2nd dose, single, for COVID-19 immunization, at a pharmacy/drug store. Medical history included ongoing rare metabolic disorder. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735) received at age 22 years, on 05Apr2021, for COVID-19 immunisation. On 26Apr2021, the patient received the second dose of BNT162B2. In the evening of the same day, 26Apr2021, the patient experienced tiredness/fatigue, and headache. In the morning of 27Apr2021, the patient was feeling really crappy and they though it was like the flu and it would pass. In the evening of 27Apr2021, the patient didn't sleep at all and was uncomfortable all night and pain. On the same day, 27Apr2021, the patient had severe chest pain, chest tightness, and lightheadedness. On 28Apr2021, the pain didn't go away, and the twins had elevated ST evaluation on the EKG (electrocardiograph). ST evaluation was done by the reporter's husband who is a retired firefighter emergency medical technician. The reporter decided to take the patient to hospital and said that the other twin had the same symptoms but kept saying his wasn't as bad as his brother's because he did not want to go to the hospital. The doctor advised the reporter to bring the other twin. The twins had the same echo cardiogram on 28Apr2021 (unknown results). On 28Apr2021, their troponin levels were elevated, and their cardiac enzymes continued to go up. On the same day, 28Apr2021, the patient had a strange weird bilateral wrist pain severe. It was reported that the twins were hospitalized on 28Apr2021 with myocarditis/pericarditis and inflammation around the heart. Treatment for myocarditis/pericarditis included ibuprofen and colchicine; and Toradol for breakthrough pain. The reporter stated that the twins are two identical males with the same DNA, had the vaccine at the same time, had the reactions at the same length of time, have the same lifestyle and live at the same house. The reporter said it would go a long way if they help her understand the complication. The patient recovered "strange weird bilateral wrist pain severe" on 29Apr2021. The outcome of the event myocarditis and pericarditis/inflammation around the heart was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021487544 same reporter, suspect drugs and events; different patients
Lingering achiness; Brain fog feelings with the second bivalent booster; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Lingering achiness) and FEELING ABNORMAL (Brain fog feelings with the second bivalent booster) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Lingering achiness) and FEELING ABNORMAL (Brain fog feelings with the second bivalent booster). At the time of the report, PAIN (Lingering achiness) and FEELING ABNORMAL (Brain fog feelings with the second bivalent booster) outcome was unknown.            Concomitant medication was not provided. Treatment medication information was not provided by the reporter.   This case was linked to MOD-2023-694104 (Patient Link).
sensation of a lump in throat; Increased heart rate; Ten minutes after receiving the vaccine she experienced a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of SENSATION OF FOREIGN BODY (sensation of a lump in throat), HEART RATE INCREASED (Increased heart rate) and HEADACHE (Ten minutes after receiving the vaccine she experienced a slight headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety disorder, Overweight and Difficulty breathing. Concomitant products included ALPRAZOLAM for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SENSATION OF FOREIGN BODY (sensation of a lump in throat), HEART RATE INCREASED (Increased heart rate) and HEADACHE (Ten minutes after receiving the vaccine she experienced a slight headache). At the time of the report, SENSATION OF FOREIGN BODY (sensation of a lump in throat), HEART RATE INCREASED (Increased heart rate) and HEADACHE (Ten minutes after receiving the vaccine she experienced a slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Swelling, redness (diameter of standard baseball) at site where ZOSTAVAX was given. Pt to follow up w/MD.
brain fog; intense headache; muscle aches; stomach pain; fatigue; 2nd dose on 06Jan2021; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular left arm on 06Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included milk allergy. Patient was not pregnant. There were no concomitant medications. The patient took the 1st dose of BNT162B2 on 23Dec2020 15:30 (left arm). The patient experienced 5 days ongoing brain fog, intense headache, muscle aches, stomach pain, and fatigue on 06Jan2021 21:00. Outcome of the events of brain fog, headache, muscles aches, stomach pain and fatigue was not recovered. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  Information on the lot/batch number has been requested.
No additional adverse effect reported; incorrect product storage; 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 patients concurrent conditions, concomitant therapies or medical history provided.    On 01-JUL-2020, the patient was vaccinated with dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, in the leg, lot #S021732 (verified to be valid), expiration date: 10-JAN-2021, albumin status has been verified as recombinant human albumin (rHA) for prophylaxis (strength, dose, frequency were not reported), which was reconstituted with properly stored sterile diluent, lot # R004036 (verified to be valid), expiration date: 08-OCT-2020. Administered dose of vaccine experienced the temperature excursion between -9 and 8 degrees Celsius (°C) (-8.77 °C) for 13 hours. Data logger was involved. There was previous excursion reported: between -9 and 8 degrees Celsius (-9.45 °C) for 6 hours and 30 minutes. No adverse event was reported.
Myopericarditis - chest pain started 3d after dose #2 of Pfizer COVID-19 vaccine
Patient reports onset of oral/throat itching about 10 minutes after dose, without any other symptoms.  She took oral diphenhydramine about 1 hour later, and itching resolved after about 20 minutes (total time about 70-80 minutes).  She did not seek any attention at the time, since she sometimes has similar symptoms when she eats in restaurants and is unsure of the ingredients, and attributed symptoms to anxiety.   At this time, we are unsure if she should receive her 2nd dose, or wait for a different vaccine.  Please reply if possible.
Pt awoke multiple times in the early morning sleeping period profusely sweating  and needing to change of clothes, sheets/blankets and undergarments  at times 1:00AM, 3:00AM, 5:00AM, fever, headache. Symptoms have improved with Panadol medicine dose. Pt states since 1st dose feeling of drunkenness' and imbalanced has persisted.
I am post menopausal and prior to my annual Obgyn visit, I felt like I may have either worn something that caused a little irritation or I was about to have a yeast infection.  A couple days later I had my annual pap screening.  My results came back that I had ASC-US and HPV.  I have been celibate for over 20 years and have had regular annual screenings and was never told I had HPV even when I was sexually active.  A few days after my exam I began spotting.  I was advised that there have been an increase in  post menopausal women experiencing spotting after taking the vaccine.
I had my vaccination on 03/05/2022. On 05/26/2022 I had a headache that turned into a bad migraine. It started to affect my eyesight. Eye strain. It kept getting worse and were prescribed glasses. I lost my vision in my left eye. and then I went to the emergency room on 06/05/2022 as the pain was so bad. I had an MRI and Spinal Tap on 06/05/2022. I was diagnosed with Optic Neuritis in left eye and lesions throughout my brain. I was diagnosed with Multiple Sclerosis. I have ongoing medical appointments and I see the Neurologist 04/20/2023.
changes in a menstrual cycle; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUAL DISORDER (changes in a menstrual cycle) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (changes in a menstrual cycle). At the time of the report, MENSTRUAL DISORDER (changes in a menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient was administered a dose of varivax which was reconstituted with expired sterile diluent; This spontaneous report was received from a study coordinator, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug allergies/reactions were not provided.  On 02-APR-2020, the patient was administered a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength, dose, schedule, route of administration, anatomical location were not provided; lot# R023504, expiry date reported and validated as 16-AUG-2020) for prophylaxis which was reconstituted with an expired sterile diluent (strength, dose, frequency, route of administration were not provided; lot# N028746, expiry date reported and validated as 17-MAR-2020) (expired product administered). There was no associated product quality complaint.
Flu like symptoms, followed by sunburn feeling on 11/9/2021, followed by severe back pain from spine on 11/18/2021, emergency room visits on 11/18/2021 and 11/19/2021. Was given pain medication and sent home. 11/20/2021 paralyzed from the chest down. aw PCP on 11/22/2021 who did nothing but refer me to a physiologist, neurologist and to get MRI's of my brain and spine. physiologist did not help and sent me home. Did not get MRI due to paralysis and pain. went to an alternative medical center where I was diagnosed with Guillin Barr syndrome on 12/13/2021. I started ultraviolet blood infusion therapy on 12/21/2021 I. I had an antibodies blood draw on 21/20/2021 to check for COVID antibodies, none were found. Since starting treatment I am managing my pain better, I can move to a standing position but cannot stand alone, I am still unable to walk but making progress. Tremors through my body are still present. Loss of vision and hearing, but has since returned since starting treatment. Vision is not where it was pre-vaccine but is improving. The list of symptoms from this "vaccine" is far too large to name everything in this small space.
Awoke next morning with hives on buttock; used Hydrocortisone cream, self prescribed. Following day, Friday, took Benadryl, on own, with relief, resolving by Saturday. On Sunday, hives were getting larger, still taking Benadryl. On Monday, developed hives on each hand. Denies other symptoms. Referred to MD to assess.
Information has been received from a medical assistant referring to a 3 month old male patient. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
paresthesia, lightheadedness.  Narrative:  At the conclusion of his vaccination wait period, he alerted post-vaccination monitoring nursing staff to c/o mild lightheadedness and left LE paresthesia. Both started just at the end of the 15 minute wait period. He denied pruritus, urticaria/hives, swelling/angioedema, flushing, confusion/disorientation, dizziness, weakness, LOC, SOB/stridor, tachycardia/palpitations, nausea/vomiting, or abdominal cramping. Did note h/o lumbar issues and having experienced neuropathy in the past over his right LE. O: T98.7F BP 135/82 RR 77 RR 10-11 Sp02 97% on RA Gen: non-toxic, not in distress, answering questions appropriately, pleasant, well groomed HEENT: atraumatic/normocephalic, PERRL, throat non-erythematous/no exudate, no swelling Neck: no swelling CV: regular rate and rhythm, normal Sl/S2, no murmurs Pulm: clear to auscultation bilaterally with no wheezes/rales/rhonci Ext: moves all 4 spontaneously, no edema Skin: no lesions or rashes, no urticaria Neuro: CN Ill-XII grossly intact, 5/5 strength UE and LE, sensation equal on b/l LE. Visualized ambulating >100 feet - gait normal/non-antalgic. Assisted stretching manuvers did not elicit/exacerbate/alleviate parestheisa Psych: appropriate, thoughts linear and non-tangential A/P: 66 yo Veteran at vaccination clinic for 1st dose of Moderna, who experienced post vaccination adverse effect. Lightheadedness resolved and left LE paresthesia w/vast improvement upon rest/stretching for another 15 minutes after sx onset. Reassurance provided.
Leg terrible sore, very painful, refuses to walk on it. No redness noted at site.
The patient is a 15 year old male in otherwise good health until he began to experience numbness, paresthesias, and weakness of the right foot on the morning of 7/13/21.  He had previously received the Pfizer COVID-19 vaccine; first dose on 6/15/21 and second dose on 7/6/21. His symptoms had a waxing and waning course but progressed over the course of 3 days to include right foot drop and burning pain, prompting his father to take him to the emergency room on 7/15/21; he was admitted to the hospital and started on IV immunoglobulin with rapid resolution of his symptoms, receiving 2 total doses.   See continuation page for more details. Lumbar puncture showed elevated CSF protein, and MRI findings suggested an acute inflammatory neuropathy.  Hospital course was only complicated by a mild positional headache and several episodes of non-bloody non-bilious emesis, attributed to IVIG treatment.  After a 3 day stay, patient was discharged on 7/18/21 to follow up at an outpatient neurology clinic for assessment and to undergo electromyography studies.  Of note, the patient's 50 year old father had experienced two episodes of progressive motor weakness and paresthesias of the extremities requiring hospitalization, including once in 2008 following a diarrheal illness, and again on 5/27/21 after receiving his first dose of the Moderna COVID-19 vaccine on 5/4/21. Both illnesses were ultimately diagnosed as autoimmune peripheral polyneuropathies and treated with IV immunoglobulin.  He was assessed in the emergency room on 5/11/21 presenting with paresthesias of the left extremities and bilateral foot weakness, and left with strict return precautions without treatment or diagnostic testing. On 5/12/21 and 5/15/21 he visited a different emergency room with similar symptoms and received a lumbar puncture that showed slightly elevated protein in the CSF without leukocytes; both times he was discharged without treatment.  He returned to the first hospital's emergency room on 5/16/21 with progression of lower extremity weakness accompanied by neuropathic pain, and was referred to outpatient neurology for further assessment.  On 5/27/21 he was admitted from the neurology clinic and successfully treated with 4 doses of IV immunoglobulin during a 4 day hospital stay; the fifth dose was not administered due to neutropenia.  He reports gradual improvement of his symptoms with IVIG treatment and physical therapy.
Itching began at injection site on 8th morning after vaccination, with clearly-defined red area on skin, approximately 3" in diameter, centered on injection site.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer) concerned a 55 year old female. Initial information was processed along with additional information received from  RA department on 08-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: pre diabetic, and mango allergy. The patient was not pregnant at the time of reporting. On 16-APR-2021 12:00, the patient received covid-19 vaccine ad26.cov2.s (first dose) (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered to left arm for prophylactic vaccination. The batch number was not reported and has been requested. On 15-OCT-2021 16:00, the patient received non-company suspect elasomeran (Moderna) (second dose) (dose number in series: 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered to left arm for prophylactic vaccination. On 15-APR-2022 12:00, the patient received non-company suspect elasomeran (Moderna) (third dose) (dose number in series: 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered to left arm for prophylactic vaccination. Concomitant medications included levothyroxine sodium (Synthroid). On 25-MAY-2022 07:00, the patient experienced relapse of covid-19 symptoms and positive covid-19 antigen test which indicated suspected covid-19 infection (dose number in series: 2) and suspected clinical vaccination failure (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000233847. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified. based on the evaluation/investigation performed.; Sender's Comments: V0.20220601952-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Not eating well. Crying on and off for 3 days. But she is better now.
Narrative:  Other Relevant Hx: Symptoms:  NauseaVomiting & SYMPTOMS STARTED ON 1/8 AFTER INJECTION AND LASTED APPROX 24 HOURS INCLUDING CHILLS, NAUSEA, AND VOMITING
Headache, Fever, SHIVERS AND SHAKES Narrative:  Other Relevant History:
Information has been received from a physician concerning a patient who on 22-JUL-2009 was vaccinated with the second dose of GARDASIL (lot# 661703/0651X). On 22-JUL-2009 the patient experienced dizziness and blurry vision after vaccination. It was reported that the patient did not experience any adverse effect on first dose. At the time of reporting the patient's outcome was unknown. This is one of several cases from the same reporter. Additional information has been requested.
painful arm and couple days later a rash appeared on my forearm and didn?t go away and grew bigger in time frame of 20 days until i received 2nd shot on 3/24/2022
Sore throat, difficulty swallowing.  Left arm pit pain for a few days.  Had swelling behind left knee with pain, but that has spontaneously resolved.  Axillary pain both sides but greater on left side.  Ibuprofen as needed.
Redness and swelling, warm to touch, starting night of immunization, worsening over 2 days.
First shot 2 years ago without getting the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the retail pharmacist. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
A nurse reported that a 22year old female received an injection of Pnu-Imune 23 vaccine on 07/08/01. Within 24 hours, the patient developed an injection site reaction characterized by an area of swelling measuring 5 to 6 inches in diameter  with pain and warmth. The patient developed fever of  101 degrees F, chills,  loss of appetite and achy joints. She was seen in the emergency clinic of the reporting office and was given 6 mg Calestone. On 07/10/01, the reporter indicated that the injection site symptoms are improving; however, achy joint persist. This is one of 2 patients from this facility who experienced an adverse event following receipt of Pnu-Imune 23lot 473-556.) Additional information received from the reporter on 07/30/01 provided the patient's idea of birth and medical history. ( See related HQ3184612JUL2001)