chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Welting at the injection site; Itching at the injection site; A spontaneous report was received from a consumer concerning herself, who is a 82-years-aged female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching at the injection site, welting at the injection site  The patient's medical history was not provided. No concomitant medications were reported.  On 09 Feb 2021, prior to the onset of the events, the patient received their unspecified doses of mRNA-1273 (Lot number: 011620A) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, patient experienced the event itching about a week later after receiving vaccination. Patient reported that on 18 Feb 2021 she noticed welting at the injection site (all symptoms are ongoing).  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event Itching at the injection site, welting at the injection site was not resolved at the time of reporting
Acute cellular rejection; This literature-non-study case was reported in a literature article and describes the occurrence of TRANSPLANT REJECTION (Acute cellular rejection) in a 50-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   Acute cellular rejection in liver transplantation recipients following vaccination against coronavirus disease 2019: A case series. Liver Transpl.    The patient's past medical history included Liver transplantation.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSPLANT REJECTION (Acute cellular rejection) (seriousness criterion medically significant). At the time of the report, TRANSPLANT REJECTION (Acute cellular rejection) outcome was unknown. Related      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered TRANSPLANT REJECTION (Acute cellular rejection) to be related.    Company comment: This is a literature-non-study case concerning a 50-year-old male patient with medical history of liver transplant, who experienced the serious (medically significant) unexpected event transplant rejection, after receiving an unspecified dose of mRNA-1273.  Very limited information has been received: Clinical course, diagnostic tests and treatment details were not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant and treatment medications were reported.   This case was linked to MOD-2022-621440, MOD-2022-621478 (E2B Linked Report).; Sender's Comments: Company comment: This is a literature-non-study case concerning a 50-year-old male patient with medical history of liver transplant, who experienced the serious (medically significant) unexpected event transplant rejection, after receiving an unspecified dose of mRNA-1273.  Very limited information has been received: Clinical course, diagnostic tests and treatment details were not available. The benefit-risk relationship of mRNA-1273 is not affected by this report. MOD-2022-621478:Patient 3: 61 years female MOD-2022-621440:Patient 1: 71 years male
I am vaccinated (2X Pfizer) and boosted (1X Pfizer and 1X Moderna). I started having sore throat and fatigue on Sunday July 3rd, 2022. My husband had started experiencing sore throat and fatigue on 07/02/2022. He tested positive for COVID-19 by home test and PCR. My sore throat and fatigue continued on Monday July 4th, along with low grade (99.5) fever. I contacted my doctor who is treating me for COVID-19 with Paxlovid.
Asymetrical sensorineural hearing loss; Sudden hearing loss of the left ear; Tinnitus of the left ear; Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or around 09-FEB-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX), (lot #, administration route, anatomical location and expiration date were  unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the zoster vaccine live (ZOSTAVAX) vaccine, the patient was diagnosed with asymmetrical sensorineural hearing loss, tinnitus of the left ear and sudden hearing loss of the left ear. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, patient symptoms have resulted in physical limitations not present prior to using of the vaccine. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. Patient sustained severe and permanent personal injuries. Patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The aforementioned events were consider as serious due to disability. Upon internal review the deafness neurosensory and sudden hearing loss were considered as medically significant events.
Fever/Temperature running 99-100 during the day and running 101-102 for 6 nights now; Sore arm the first day; This is a spontaneous report received from a contactable nurse (who is also the patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 08Jan2021 11:00, at single dose, for covid-19 immunization, in the hospital. Medical history included asthma, Raynaud's phenomenon, eczema, environmental allergies, and COVID-19 (prior to vaccination). The patient is not pregnant. Concomitant medication included ergocalciferol (VIT D), calcium, ascorbic acid (VIT C), thiamine and zinc. The patient did not receive other vaccines in four weeks. The patient experienced sore arm the first day, on 09Jan2021. Fever started about 30 hours after injection, on 09Jan2021 at 17:00. Her temperature was running 99-100 during the day and running 101-102 for 6 nights now. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.
No signs or symptoms reported; Temperature excursion that ocurred on 2/3/2021 on Gardasil 9. Gardasil 9 was given; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 03-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5ml, lot# 1614898 and expiration date 15-NOV-2021, for prophylaxis (strength, dose, route and frequency were not reported). No signs or symptoms reported.  The temperature excursion was of 31.3 Fahrenheit degrees (°F) for 0 hours 15 minutes and 0 seconds, 33.4°F for 0 hours 15 minutes and 0 seconds. Time frame 30 minutes total. A previous temperature excursion was not reported. A digital data logger was not involved.  This is one of 3 reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1614898; expirationdate: 15-NOV-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; Sender's Comments:  US-009507513-2104USA001082: US-009507513-2104USA001254:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2014, the patient was inoculated at a pharmacy with ZOSTAVAX for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. The female patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. During 2016, she was treated (by an unspecified healthcare professional) at a medical center, for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a nurse refers to approximately a 67 year old patient. The patient concurrent condition included drug reactions/allergies to penicillin. On 13-DEC-2013 the patient was vaccinated with PNEUMOVAX23 lot # J004332, expiry date reported as August 2014, and 0.5 ml once, intramuscular. Concomitant medications included unspecified topical cream. Approximately on December 2013 the patient experienced redness from the elbow up into axillary, it was tender, had chills and low grade fever for 2 days. The patient sought medical attention and contacted the office. The nurse stated that the physician advised patient to use ice and take BENADRYL. The outcome of redness from the elbow up into axillary, it was tender and chills are unknown. The outcome of low grade fever for 2 days was reported as recovered/resolved. Additional information has been requested.
Fever, dizziness, headache, weakness, night sweats persisting for 4 weeks now and beginning to include chest tightness.
Initial and follow-up information has been received for a pregnancy registry for Gardasil.  A nurse reported concerning a 23 year old female with a penicillin allergy, sulfonamide allergy, drug hypersensitivity to REGLAN and allergy to flu vaccine with a history of 1 full term delivery (no birth defects and no complications), family history of maternal diabetes who on 02-FEB-2007 was vaccinated with Gardasil, 0.5 mL in her left arm (route unspecified) (LOT# 655617/1447F).  Concomitant therapy included NUVARING, MYLANTA, ZOFRAN, and prenatal vitamins.  As of 26-APR-2007, the patient was pregnant.  Her last menstrual period was 08-FEB-2007.  It was confirmed by an office pregnancy test and unspecified "prenatal labs with blood tests" (results not reported).  On 16-APR-2007, the patient had an ultrasound with results within normal limits (WNL) and reason for testing was "dating".  No problems were reported.  As of 26-APR-2007, the patient was pregnant and was taking prenatal vitamins.  The patient's estimated date of delivery was 11-NOV-2007.  Follow-up information was received from the registered nurse via a questionnaire and medical records.  All screening ultrasounds were normal.  On 07-NOV-2007, the patient delivered a full term normal female infant 6 pounds, 12 ounces, Apgar score 8 and 9.  There were no infections or illnesses during the pregnancy.  There was no complications during the pregnancy or labor/delivery.  It was indicated on the questionnaire that the baby had congenital anomalies.  A phone call was made to the registered nurse who reported that the baby did not have any congenital anomalies and that it was an error on the questionnaire.  The mother had group B streptococci (GBS) positive and was treated with vancomycin.  On 07-NOV-2007, at birth, the baby was given vitamin K IM.  On 09-NOV-2007, the baby had mild jaundice.  On 15-NOV-2007 newborn check up, the baby had mild gynecomastia and a touch of jaundice, sclera was yellow.  Breast feeding continued.  On 17-NOV-2007, evaluation revealed the baby had green discharge on the left conjunctiva.  Diagnosis as left nasolacrimal duct stenosis.  The baby was treated with OCUFLOX.  On 07-DEC-2007, the baby had a check up.  It was reported that the baby was fussy and gassy.  The baby had colic behavior, sudden screaming and acts as if in pain.  Dx was gastroesophageal reflux.  Treatment included: continue with ofloxacin, continue breast feeding, reflux precautions and ZANTAC 1 ml twice daily.  To return in 1 month for evaluation.  The outcome of abdominal colic, left nasolacrimal duct stenosis, GERD, gynaecomastia, jaundice, and screaming was not reported.  At an office visit on 15-MAR-2008 at 4 months of age, it was noted that the baby had complete agglutination of the labia minora which was "removed".  No additional information is expected.  Medical records available upon request.
21OCT pt recvd vax & 23OCT congestion started; 25OCT n&v severe required 2 liters of IV fluid in the ER; vomiting has resolved; severe h/a requiring medication w/codeine; 8NOV still extremely fatigued;
Tested positive for covid after receiving the first dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for covid after receiving the first dose of the vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for covid after receiving the first dose of the vaccine). The patient was treated with Monoclonal antibody treatment (MONOCLONAL ANTIBODIES) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid after receiving the first dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Patient had COVID positive test results after receiving the first dose of the Moderna Covid-19 Vaccine.     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 product use was not provided by the reporter.
Erythema, warmth and swelling immediately after injection, at injection site. The follow up states the vaccine date as 12/4/02 and the onset occurred almost immediately after vaccination.
Information has been received from a registered nurse concerning 9 patients who were vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX due to a human error. There were no adverse effects reported. Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information has been requested.
experiencing longer and more painful menstruation/Her friend is experiencing the same thing period; experiencing longer and more painful menstruation/Her friend is experiencing the same thing period; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown" and all described as "experiencing longer and more painful menstruation/Her friend is experiencing the same thing period".  Additional Context: Caller is just curious. His girlfriend got the Adult COVID vaccine . She got the two shot series. Since, her menstrual cycle has been altered. She said she had talked to her friends who got the vaccine and experienced the same thing. Her periods are longer and more painful. It was concerning to him because she was in child bearing age, and this was her menstrual cycle. He was just curious. He had not know if she wants to do a report. He will tell her to report it online or call in if she wants to report. He was a doctor, but he wasn't her doctor. She was 33 years old.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101882983 same reporter/drug/event, different patients
a pediatric dose of the Pfizer-BioNTech COVID-19 Vaccine. a 0.2ml undiluted vaccine was administered to one of their patients; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A child male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "a pediatric dose of the Pfizer-BioNTech COVID-19 Vaccine. a 0.2ml undiluted vaccine was administered to one of their patients".  Additional information: Caller was a pharmacist. She called regarding a paediatric dose of the Pfizer-BioNTech COVID-19 Vaccine. a 0.2ml undiluted vaccine was administered to one of their patients. She asked what she should tell the parents. Caller declined to be transferred to hospital as her colleague will be the one filling the report instead.: e-transmitting AE. Reason for no lot number of Covid-19 Vaccine was reporter stated, "No, I am not at the store, I am left." When probed for the concern, reporter stated, "I am actually off work, but I have a question that I want to call for my Pharmacy colleague that made an error today on dilution of a kid vaccine (administered). I didn't know that there was anything else that we needed to tell the mom other than just give any medication to help with the side effect like how else do we talk to the Mom and tell her. Reporter stated, "Actually his weight is of a smaller dose, but I don't have any specific details of his age. I think he is just a big 10 or 11 year old, but I just didn't know what we needed to tell the Mom other than watching for the side effect and what side effect I should talk her about." Reporter asked, "do you want me to call you back if there's any adverse reaction he had."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Could not lift her arm; blood pressure went up; headaches; right hand went numb and burns off and on; right hand went numb and burns off and on; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's girlfriend's daughter) that:  A 75-year-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine; solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient shared she received both doses of the vaccine. She said she has talked with a pharmacist who recommended calling Pfizer and that she has experienced her symptoms for five months. The patient stated that after the first vaccine she felt like she could not lift her arm. After the second shot, she felt like she had a problem with reaching, with lifting things. She said also that she felt "the muscles behind my things, same thing. It hurts. She was given Mobic, took that for six days then my blood pressure went up and I started getting headaches and then my right hand went numb and burns off and on. She has been to physical therapy, but is unsure if that is helping, and was told to see a rheumatologist and a neurologist. She hasn't "slept for nights", that she is a side sleeper and keeps turning from one side to the other. Patient was asking if her symptoms have been reported and wanted to know length of time of the symptoms and what she should do. Patient also shared her girlfriend's daughter is much younger, in her forties, but is having the same things. Her daughter told her to ride it out for six months and was also told that skinny people had a harder time after the vaccine. Patient said she had never heard of such a thing and asked if weight affected symptoms.  Response: Spoke from PI, referencing table 3.0 in section 6.1, LAB-1457-10.0 Revised: 25 June 2021, when sharing about those experiencing muscle pain. Informed caller that weights were not in the reporting data gathered in the PI.  Informed caller, when asking about if others had reported length of symptoms, that there is not information gathered that I can speak to regarding that information but that data is still being collected from callers such as herself and is being monitored by Pfizer and many other regulatory agencies.  Informed caller that Pfizer is unable to make treatment recommendations and she should continue following her HCP recommendations.  Lot/batch number is not available despite of follow-up attempts made. Follow up attempts have been completed and no fruther information is expected.
I developed a skin condition on my hands and feet; I had a punch biopsy done on 12/01/2022. The results of the tests determined it was either eczema dermatitis with lichenoid features or pityriasis rubra pilaris, but I was diagnosed with the latter after additional pathology testing. It's a very rare skin condition that sort of began after receiving my first booster but got worse after my bivalent. My dermatologist prescribed me topical solutions clobetasol 0.5% and tazarotene 0.1% to help treat the condition. As of now, we're seeing improvement. The itchiness and redness has been reduced tremendously.
INADVERTENTLY VACCINATED BEFORE AGE 12 YRS. INFO COULD NOT BE CLARIFIED. SUSPECTED WRONG DATA ENTRY.
Child received 4 imm at his 6 year well check. NKA. Child cried after imm. After 10 minutes child came back into office c/o chest pain. Child was wheezing, pulse ox 96 HR 88 no color changes. XOPENEX and BENADRYL given.
It was reported that an adult male patient received a Fluzone SV vaccination lot UO677AA administered in his right deltoid, date of vaccination not specified. Within minutes of receiving Fluzone, the patient expressed feeling tightness in his chest with itching sensation over his body. Within 45 minutes, he had numbers in hands and feet. Hives broke out over chest area than extremities. Treatment of 50mg Benadryl was given. Followed up with primary care physician who prescribed Benadryl 50 mg every 4 hours. Patient denied being allergic to eggs.
High pitched abnormal shrill cry on/off over 3 hours.  Per mother's report.
Patient received Moderna booster on 10/25/21 and lot 026C21A was found to be expired on 10/24/21 shortly after vaccination. No adverse reactions were noted. We have reached out to Moderna for guidance and vials in that lot have been put in quarantine.
On 9/29/09 patient's mother noticed his face was asymmetric, he had poor movement of the right side of his face. When he drank fluids they leaked out of the right side of his mouth. Patient's mother reported that he had been sick for two weeks with eye drainage and congestion. Patient seen in the ED on 9/29/2009, and diagnosed with Bell's Palsy
arm redness and swelling occurring ~9 days after dose administration. cleared ~ 2 days later
Felt light headed, nausea, hands and fingers tingling, vision- not able to focus, pupils pin-point. Lasted about 10 minutes. Symptoms started to subside after water.