chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia, Fever, congestion, lymph node in left armpit Narrative:  Other Relevant History:
40 min after vaccine was given my face turned red and tight on left side. Then something happened next day. Face on left side felt weird like tight skin and a little numbness on left side that comes and goes on left side since and a little swelling on left side of face.
Lost vision (one eye); This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Lost vision (one eye)) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (Lost vision (one eye)) (seriousness criteria hospitalization and medically significant). At the time of the report, BLINDNESS (Lost vision (one eye)) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  The patient knewpeople who had experienced same issue after 3-6 months of taking second vaccination. Lost vision (one eye).  Patient was hospitalized for couple of weeks and no doctors could point out the causes. They said they could do nothing and gave patient steroid and asked them to go home.  Company Comment: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of Blindness. The event occurred on an unknown date after the second dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome of the event was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-419388, MOD-2021-423102, MOD-2021-423139 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious event of Blindness. The event occurred on an unknown date after the second dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome of the event was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
pt recv vax 1967 & 1967 & lab eval revealed that pt converted for everything but measles;subsequently pt was vaccinated a total of 4 times, had a titer test & no conversion was noted;
Pain at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunization.    Co-suspect products included non-company products TREPROSTINIL tablet for Pulmonary arterial hypertension and TREPROSTINIL DIOLAMINE (ORENITRAM) tablet for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included RIOCIGUAT (ADEMPAS) for an unknown indication.   On 14-Jul-2017, the patient started TREPROSTINIL (Oral) 3.5 milligram three times a day. 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 and TREPROSTINIL DIOLAMINE (ORENITRAM) (Oral) 2.5 milligram. On an unknown date, TREPROSTINIL DIOLAMINE (ORENITRAM) (Oral) dosage was changed to 1 milligram. On 21-Dec-2022, the patient experienced VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            Patient began therapy with Orenitram (treprostinil diethanolamine), on 14 Jul 2017 for primary pulmonary arterial hypertension. The patient was supplied with Orenitram 2.5 mg and 1 mg and the current dose was reported as 3.5 mg, oral, three times a day.  The reporter did not provide causality for the event of vaccination site pain with Orenitram. The reporter's causality for the event of vaccination site pain with COVID-19 vaccine was considered to be possibly related.  No treatment information was provided.
Subject received FLUZONE on 9/29/2008.  He began developing symptoms of transverse myelitis on 10/13 and even if these events could be completely unrelated I would prefer to file this report.  01/02/2009 PCP records received which include daily progress notes from hospital admission.  2/23/09 MR received for 2 admissions 10/14-12/23/2008 with D/C DX: Transverse Myelitis. Pt initially presented after onset of knee pain, numbness, paresthesias, weakness and difficulty ambulating. PE (+) for lack of crimasteric, patellar, and achilles reflex, inability to move lower extremities, loss of strength of LE, and (+) Babinski. Admitted for eval and tx.  Urology consult for urinary retention. pt to self cath. Tx: steroids and plasmapheresis. Developed spasticity and E. coli UTI during admission. Transferred to rehab on 12/3/08 with some improvement in sensation and movement.
seizures; Initial information received on 04-May-2021 regarding an unsolicited valid serious case received from a consumer.  This case involves a 8 month old female patient who experienced seizure, while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Past vaccination included PENTACEL (October and January) with no problems.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, concomitant medication and family history were not provided.  On an unknown date (March), the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) (Suspension for injection) (Frequency once) via an intramuscular route in the leg for prophylactic vaccination.  On an unknown date, the patient developed a serious seizure (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  It was also reported that Caller is requesting information on ingredients of PENTACEL, and also asks if the ingredients change from lot to lot because his daughter received two PENTACEL vaccines with no problems, but the third one she received resulted in adverse event. He wonders if the third one had any different ingredients.   It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.   Corrective treatment: anti-seizure medication.  At the time of reporting, the outcome of event was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case involves a 8 month old female patient who had seizure, after receiving PENTACEL. The time to onset is unknown. Past vaccination included PENTACEL. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
This spontaneous report was received from a nurse and health professional and refers to a 5 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe rash over chest, upper arms back & belly. Some of the bumps opened up causing extensive itching. None of the creams applied helped.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives"; PRURITUS (non-serious), outcome "unknown", described as "Itchy all over my skin". Additional information: After I got the first shot, patient had few hives for the next few weeks. Like 1 hive on the top of my arm, 1 hive on the top of my thigh and then 1 hive on my neck. So, It was relatively minimal but I was kind of itchy all over my skin. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt called today stating that the day after vaccine she developed a sensation like "falling asleep" from the waist down to feet with gradual loss of feeling since 5/12/18. She has an appointment at her PMD on 5/18/18.  I encouraged her to call PMD again and possibly go to emergency room.  She was thankful for the call.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 at 16:00 as dose 3 (booster), single (Lot number: EW0217) at the age of 54 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Sep2021 at 13:00 as dose 1, single (Lot number: 003B21A), in right arm, on 04Oct2021 at 13:00 as dose 2, single (Lot number: 041B21A), in right arm, on 21May2022 at 10:00 as dose 4 (booster), single (Lot number: 037A22B), in right arm and on 26Nov2022 at 15:30 as dose 5 (booster), single (Lot number: 024H22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021 at 16:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti-viral details: Product=COVID 19 Treatment, Brand=Pfizer, Treatment start date=03Jan2023, Treatment stop date=08Jan2023, Indication=Treatment of COVID-19. No known allergies reported. No other medication in 2 weeks.
soreness in the arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 2nd September 2021, several hours after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received Shingrix in left arm deltoid intramuscularly and couple of hours later had soreness in her arm where she received the vaccine. The reporter did not have lot/expiry date, however, she provided NDC number: 58160-0823-11. The reporter did not give consent to follow up and with the with HCP (health care professional).
Information has been received from a nurse practitioner and a certified nurse midwife, for the pregnancy registry for GARDASIL, concerning a 21 year old female with no medical history, no known drug allergies and with no history of previous pregnancies who on 15-FEB-2008 was vaccinated IM with the first 0.5 ml IM dose of GARDASIL (lot # 659962/1740U).  The patient received the second 0.5 ml IM dose on 15-Apr-2008 (lot# 659962/1740U).  There was no concomitant medication.  On 15-APR-2008 the patient had a positive pregnancy test result.  The patient's LMP was 03-Mar-2008 and an estimated delivery date is 08-Dec-2008.  No other symptoms were noted.  Patient sought medical attention via an office visit.  Follow up information has been received from a certified nurse midwife, for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female patient.  In May 2008, the patient was seen due to a miscarriage.  It is not known if the patient had received any prenatal care prior to the miscarriage.  Upon internal review, miscarriage was determined to be an other important medical event.  No further information is available.
She also mentions that every after she gets the pfizer covid vaccine she experiences Guillain-Barre symptoms.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "She also mentions that every after she gets the pfizer covid vaccine she experiences Guillain-Barre symptoms.".  Clinical Course: Reported as, She mentioned that every after she gets the pfizer covid vaccine she experiences Guillain-Barre symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
17JUN98 T99, malaise, aches, sweating, chills, n/v, diarrhea, abd pain, cramping, h/a, palpitations, tingling, insomnia, rt sided pain; to MD told not to complete vax series ;18JUN98 flu like sx;19JUN98 T101.4, n/v, severe h/a;
On day of vaccination; arm pain, malaise, fever (? temp), body aches - lasted 2 days. Then patient was well for 2 days - no residual symptoms. Then developed severe headache 4/20 - seen at our office - CT head normal - given TORADOL PO and told to f/u if needed. Seen in ER 4/22 for same headache, no fever, no N/V at that time. Seen again 4/25 for headache - not much change. Some fever to 101 , weak, tired, appetite fair. Still has headache.
Nausea, vomiting, increased fatigue within hours of vaccine for 1 day in PM.
102.1 fever, body aches, head aches, swollen lymph nodes, arm pain
Pt. had a headache and then became extremely sleepy at school where he had to take an hour nap.
Patient given PNEUMOVAX 1/8/2013. Came into clinic morning of 1/10/13 with warm to the touch rash on right upper arm. Dr looked at reaction and sent patient home.
Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dental disorder NOS.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever). At the time of the report, PYREXIA (Low grade fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment Medication were provided. The patient enquired that if he could take Antibiotic for his dental treatment.
Information has been received from a health professional concerning a 6 year old female who on 16-JUL-2001 was vaccinated SC in the left arm with a first dose of Varivax (lot # 638248/0496L). On 01-JAN-2007 the patient experienced a rash that was papular for 3 days, then a varicella rash all over the body. There are several hundred (50-249) that were continuing to break out at the time of the office visit on 04-JAN-2007. The patient had recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2007. Follow-up information was received from a health professional, who reported that the child had no medical conditions, pre-existing allergies, or illness at the time of vaccination on 16-JUL-2001. On 04-JAN-2007 the patient presented with numerous poxs, approximately 100-250 spots. Supportive treatment included oatmeal baths, diphenhydramine hydrochloride for itching, and acetaminophen for increased temperatures. Seven to ten days post onset, approximately 11-JAN-2007, the patient was recovered. No further treatment was necessary. No further information is expected.
Information has been received from a physician concerning a 9-week-old male who on 05-DEC-2006 was vaccinated PO with the first 2.0 ml dose of Rotateq vaccine (human-bovine) (lot#655082/0779F). Concomitant vaccinations administered on that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine and a dose of Hib conj vaccine (manufacturer unknown). The physician reported that on 06-DEC-2006, the patient developed a inguinal hernia. Unspecified medical attention was sought and the patient was subsequently hospitalized and underwent surgery. After surgery, the patient was considered to be recovered as he was noted to be fine. Additional information has been requested.
Information has been received from a physician who between 1996-1997 was vaccinated with her first, second and third doses of  VARIVAX (Oka/Merck). The physician stated that she was administered her third dose because her VZV titers were low. Her antibody titers were 0.85 IgG. The outcome was unknown. There was not product quality complaint. No further information was provided. Additional information has been requested.
vaccination to an 11 year old as their first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccination to an 11 year old as their first dose) in an 11-year-old patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccination to an 11 year old as their first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccination to an 11 year old as their first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   Reporter did not allow further contact
Heavy painful period... abnormal timing and extremely heavy. Cramps were so bad that I would be screaming in pain.
Both sides of his face look like he had slept real hard and then woke up, but it never went away.  Is how dad described it.  Mom said it looked like he was crying blood it was real red both sides of his face.  Spoke on the phone only patient has gone to school.  Was instructed to take them (he and sister) to see ther primary care provider.
Information has been received from a pharmacist concerning a 54 year old female with a history of pneumonia and with no drug reactions or allergies reported, who on an unspecified date was vaccinated IM with a dose of PNEUMOVAX 23 (expiration date 24-JAN-2012). There was no concomitant medication. On 04-JAN-2011 the patient's arm became swollen after receiving the vaccination. Patient received "supportive" treatment for the arm became swollen. The patient sought unspecified medical attention. At the time of report, the outcome of the patient was recovering. Additional information has been requested.
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L010146, expiry date: 24-MAR-2017, dose, route unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Patient was at a vaccination clinic where Moderna, Pfizer and J&J were provided.  Patient filled out a consent for a Moderna vaccine.  She went to the Pfizer vaccination station.  The vaccinator verified verbally that the patient was here for a Pfizer vaccine.  The patient said yes.  The vaccinator gave a Pfizer vaccine.  After the vaccination clinic, we were processing the paperwork and realized that the patient filled out a Moderna consent form (and not pfizer).  Dr., the medical doctor at clinic, was informed and contacted the patient.  The patient was understanding.  Both Mederna and Pfizer are mRNA vaccinations.  She was feeling fine.  She was provided a new vaccination card and made aware that her 2nd dose should be a Pfizer.  System was updated to reflect the vaccine given and an electronic consent was sent to the patient so we have a consent form for Pfizer on our records.
Stoke occurred, including symptoms of:  severe headache, shortness of breath, trouble speaking, plus leg pain
right shoulder hurt; This spontaneous case was reported by a non-health professional and describes the occurrence of ARTHRALGIA (right shoulder hurt) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, IRBESARTAN, AMLODIPINE BESILATE (AMLODIPINE BESYLATE), PRAVASTATIN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN N), INSULIN LISPRO (ADMELOG), TRAZODONE, GABAPENTIN, ESCITALOPRAM and HYDROXYZINE EMBONATE (HYDROXYZINE PAMOATE) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ARTHRALGIA (right shoulder hurt). At the time of the report, ARTHRALGIA (right shoulder hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.    This case was linked to MOD-2021-275416 (Patient Link).