chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. Developed hives after second dose that required biopsy and was seen by MD for allergy testing that resulted in finding of allergy to pfizer vaccine. Dermatology visit on 11/11/21 The patient is a 39-year-old who comes today with wife for evaluation of a rash. Per patient, this rash started approximately 4 months ago, few days after his second COVID-19 vaccine. Denies other new medications, herbs, supplements, can be somewhat itchy, somewhat faded. It is affecting neck, shoulders, wrists, and ankles. He has no history of hepatitis, liver problems, otherwise well. Has not tried any treatments on this before.  PAST MEDICAL HISTORY: Ulcerative colitis. Today, he is on Pentasa and mercaptopurine.  PHYSICAL EXAM: GENERAL: Well no apparent distress.  SKIN: Fitzpatrick skin type 4. Multiple, depigmented lesions 1 to 2 cm on neck, posterior shoulders, right wrist, ankles.  ASSESSMENT AND PLAN: Likely lichen planus pigmentosus.   4 mm punch biopsy with 2 x 4-0 nylon placed on left neck. Steri-Strips applied. Wound care reviewed. Start clobetasol ointment twice a day for 2 weeks, and will follow up with him when the biopsy results become available and then for suture removal.  11/19/21 Biopsy Results Called pt with bx results, left detailed voicemail.  Diagnostico: Liquen plano Pigmentoso.  Left call back number if he had nay other questions. Also suggested to write them down and send them through my health app or at his nurse visit to remove the sutures. For a better response .  Left Neck: Lichenoid Dermatitis, w/ concurrent post-inflammatory pigmentary alteration
headache after 2nd shot; Received 6 doses in one shot for the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after 2nd shot) and ACCIDENTAL OVERDOSE (Received 6 doses in one shot for the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced HEADACHE (headache after 2nd shot) and ACCIDENTAL OVERDOSE (Received 6 doses in one shot for the 2nd dose). On 20-Sep-2021, ACCIDENTAL OVERDOSE (Received 6 doses in one shot for the 2nd dose) had resolved. At the time of the report, HEADACHE (headache after 2nd shot) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
This case was reported by a consumer and described the occurrence of "positive hepatitis B titre" in a 35 year old female subject who was vaccinated with Engerix-B for prophylaxis. A physician or other health care professional has not verified this report.  The subject's relevant medical history included arthritis. Concurrent medications included Motrin and Dyazide. On 01 May 2006 the subject received 1st dose of Engerix-B (1 ml, unknown lot number). On 01 May 2006, the subject received "some other (unspecified) vaccinations which she reports may have been mixed in the same syringe as Engerix-B. She reports 5cc volume of injection, not just 1cc for hepatitis B shot." This was considered to be a medication error. It is recommended that Engerix B be given in a separate syringe when concomitant administrations of other vaccines are required. At the time of reporting, the subject had not yet received a second dose of hepatitis B vaccine. On 10 August 2006, 101 days following the 1st dose of Engerix-B, "she had a titre drawn that was hepatitis B surface antigen positive." As a result, the subject has been denied entry into nursing school. She reported that she was going to a gastroenterologist for viral load testing. At the time of reporting the outcome of the event was unresolved. Follow up received on 30 August 2006 indicated that prior to vaccination with Engerix-B she had previously tested negative for hepatitis B in 2005 and her husband had tested negative as well. Viral load testing was negative but she reported that "it seems that an assay was positive at some point."
Case number PHEH2015US003149, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to an 11 year old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly on 19 Jan 2015. It was reported that the vaccine was frozen with excursion of 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, 0.8 C for 36 minutes on 24 Jan 2015 and 0.6 C for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error (incorrect storage of drug).
left me paralyzed in my left arm; nerve damage; muscles not functioning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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: MONOPLEGIA (medically significant), outcome "unknown", described as "left me paralyzed in my left arm"; NERVE INJURY (medically significant), outcome "unknown", described as "nerve damage"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "muscles not functioning".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Client reports a few hrs after receiving vaccine. She began with severe muscle aches, spasms, n&V, fever and numbness of the hands approx x 12 hrs.
This spontaneous report as received from a nurse practitioner refers to 3 patients of unknown age and gender. The reporter stated that three doses of unsupported VARIVAX (Merck) (Lot# J008229, expiry date: 12-JUL-2015) subcutaneous, (dose, frequency and location unspecified) might have been administered to three patients. No adverse effects reported. At the time of report, the outcome of the event was unknown. Additional information has been requested.
pulse raised to 100; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse raised to 100), PYREXIA (fever) and FATIGUE (fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     Patient never had COVID-19 positive diagnosis or test and no allergy including medications, food and other products.  The patient's past medical history included Heart disease, unspecified (Started since 30 years ago and no recent change in status such as improvement or worsening.) and Open heart surgery. Previously administered products included for Product used for unknown indication: Flu shot (flu shot given 1 month ago). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Type 2 diabetes mellitus (Started since 4 years ago and no recent change in status such as improvement or worsening.) and Blood pressure high (Started since 30 years ago and no recent change in status such as improvement or worsening.). Concomitant products included METFORMIN and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes, HYDROCHLOROTHIAZIDE for Diuretic therapy.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced HEART RATE INCREASED (pulse raised to 100), PYREXIA (fever) and FATIGUE (fatigue). On 28-Oct-2021, PYREXIA (fever) and FATIGUE (fatigue) had resolved. On 29-Oct-2021, HEART RATE INCREASED (pulse raised to 100) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: pulse raised to 100 for 4 days (High) Pulse raised to 100 for 4 days.         It was reported that patient did not experienced a similar event in the past and this adverse event didn't cause patient to seek medical care including office visit, Urgent care, ER and hospitalized. Other concomitant medicine: Beta Blockers for an unknown indication. No treatment information were provided by the reporter.   This case was linked to MOD-2022-535597, MOD-2022-535621, MOD-2022-535625, MOD-2022-535597 (Patient Link).
Patient received Janssen Covid 19 vaccine on 04/09/2021, then came to pharmacy and received the complete series of Pfizer vaccine. Patient stated that he never received a covid-19 vaccine on 06/30/21 was verbally asked and answered a questionnaire and signed off never received a vaccine. Patient received a Pfizer vaccine (dose 1) on 06/30/21 and Pfizer vaccine (dose 2) on 07/21/21. Follwed up with patient on 07/22/21 at approx 5pm patient has no complaints and no side effects, advised patient to be watchful and seek medical treatment immediately if experience any sign of side effect. Patient was given VSAFE handout on 06/30/21
Vaccine at 1115a.  Hydrated after the vaccine a lot.  Was fine most of the day and evening, except for increasing soreness of arm at injection site. Woke up at 2a with headache, then sleepless most of the night.  Sore arm. Headache and general feeling of nausea thru mid afternoon, 2p.  Sensitive skin, occasional slight chills.  Headache turned very severe mid afternoon.  Fever of 101.  Took 2 Excedrin around 530p, used ice pack on head and neck.  Felt slightly better around 7p and was able to eat some food. Noticed swelling under my arms that evening, particularly left arm.  Headache mostly gone by 930p.  Slept 9 1/2 hours. Seem recovered, except for sore arm and continued lymph node swelling.
Slurred speech and ataxia while at work, brought to ER where his symptoms had essentially resolved. He had a CT head and CTA head and neck which were all negative. He was not a TPA candidate. His co-workers reported him having waxing and waning dizziness, headaches, slurred speech and some confusion. Patient was admitted with DX of TIA to the med-surg unit.
Temperature excursion, non-mixed vaccine was exposed to a temperature up to 55 degrees F for ~ 24 hours prior to receiving it.; Temperature excursion, non-mixed vaccine was exposed to a temperature up to 55 degrees F for ~ 24 hours prior to receiving it.; This is a spontaneous report from a contactable healthcare professional. A 59-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9810) via intramuscular route of administration in the left arm on 24Feb2021 at 07:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021 at 07:45, the patient experienced Temperature excursion, non-mixed vaccine was exposed to a temperature up to 55 degrees Fahrenheit for approximately 24 hours prior to receiving it and it was unsure for how long refrigerator temperature was out of range but it appeared it was approximately 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event temperature excursion, non-mixed vaccine was exposed to a temperature up to 55 degrees Fahrenheit for approximately 24 hours prior to receiving it, was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
104.2 Temperature (the high).  Treated with Tylenol for increased temperatures.  Temperature increased and decreased for 2 days.
This spontaneous report was received from a registered pharmacist refers to an approximately 70-year-old female patient with no drug reactions or allergies. On 13-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # 0242AE, expiration date 01-APR-2013) dose and route not reported. No concomitant medications were reported. Pharmacist reported that the patient experienced a painful red line going down from injection site down to her elbow after receiving ZOSTAVAX. It was red, little bit swollen and painful, and the red line appeared approximately on an unknown date in September 2012, within a couple of days of receiving ZOSTAVAX. Patient applied some cold packs to the area and pain was relieved. Patient came in on 03-OCT_2012 (reported as yesterday) and spoke to pharmacist. Patient still had about 2 inches of line going down from the injection site. The event pain resolved on an unknown date. The event red line did not resolve at the time of this report. The outcome of other reported events were unknown. The patient sought medical attention by speaking to the pharmacist. The is one of several reports from the same reporter. Additional information has been requested.
Sore arm muscle and pain when reaching high. Vaccine induced bursitis of both elbows with pain and swelling.   Using ibuprofen and ice packs along with compression sleeves until symptoms resolve. Have called to inform my MD.
pt recv vax & exp vaccine failure & devel chickenpox;A total of 7 patients from a daycare ctr were reported;
One week after 1 shot, I aquired a raging headache,  bad body aches, chills, fatique NO temp, No cough,  I'm on day 6 of feeling poorly with raging headache.
Had flu like symptoms which included body aches, sever chills/shaking, and fever for about 24 hours.  Took Tylenol over the counter around 3am and then another dose later that morning.  The severe chills went away after the first dose of Tylenol but fever came back.  Took another dose later of Ibuprofen and that was the last medication taken for the symptoms.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 30-MAY-2013, the patient was vaccinated with improperly stored VARIVAX dose 1, lot # 0610AE (dose, route, vaccination site, expiry date unknown). On 01-JUL-2013, the patient received improperly stored VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2014 (dose, route, vaccination site unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Erythematous, indurated area ~7x7 cm of right upper extremity, nontender, no abscess, afebrile. Recommended children's benadryl q 6 hours and if no improvement or worsening, Keflex x 7 days.
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 28-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Patient started having SOB in June 2021; in July found to have a large Pulmonary embolism; Was readmitting for SOB 2 more times and ultimately died 08/24/2021;
This spontaneous report was received from a nurse practitioner referring to her son who is 11 year old. The Patient's pertinent medical history, concurrent conditions, concomitant medications, were not reported. No previous drug reactions or allergies were reported. On an unknown date, the patient was vaccinated with adult dose of VAQTA (strength, dose, frequency, route, lot number and expiry date not reported) for prophylaxis. No adverse effects were reported. No product quality complaint involved.
I tested positive for Covid-19 on April 11, 2023, I experienced coughing, sneezing, chest congestion. fever, I was taking a cough suppressant and was also prescribed Paxlovid for my symptoms.
Pt presents to office with rash which began 2/7/22, rash is measles like in appearance.
Pt vaccinated with DTP/OPV/MMR/HBCV vomited in morning, fever in the evening of 102-104, rash the following morning and T 104.  17OCT90 rash & temp gone, eating & drinking good.
Information hs been received from a nurse practitioner concerning a 14 year old female student with no pertinent medical history and no known drug allergies who on 22-SEP-2008 at 16:00, was vaccinated with the first dose of GARDASIL (lot # 660616/0570X) into her right deltoid. There was no illness at time of vaccination. On 23-SEP-2008 AM the patient experienced bilateral lower extremity red raised rash. No lab diagnostic studies were performed. One week later, the patient recovered. The patient did not seek medical attention. Additional information is not expected.
The patient stated that the injection site turned purple and that she had a red swollen area that extended all the way around the front of her arm and below her elbow.
(1) Lymphadenopathy in the left breast (2) Neuropathy in both legs - I received this diagnosis from the Neurologist who evaluated me on 04/28/21.
Patient's mother phoned to report a reaction to an immunization her daughter received from our clinic. The patient did go to a physician who reportedly diagnosed the patient with "cellulitis" at the site of the immunization.  The mother describes the site as "red and swollen" and "a little bigger than a silver dollar."  The mother denies any drainage from the site.
Mild Fever, Rash/redness at site, bruising. Took some TYLENOL for the fever which helped. The redness/rash greatly reduced the next day when she came in and reported the event. She had never had a reaction to the flu shot before. Her other shot felt fine.
Dry cough; severe pain in throat/like a tickle; Cant sleep because of cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), OROPHARYNGEAL PAIN (severe pain in throat/like a tickle) and INSOMNIA (Cant sleep because of cough) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced COUGH (Dry cough), OROPHARYNGEAL PAIN (severe pain in throat/like a tickle) and INSOMNIA (Cant sleep because of cough). At the time of the report, COUGH (Dry cough), OROPHARYNGEAL PAIN (severe pain in throat/like a tickle) and INSOMNIA (Cant sleep because of cough) outcome was unknown.            Treatment information was not provided. Concomitant product use was not provided. Lab data was not provided.
Initial report was received on 03 September 2013 from a health care professional. An unknown infant (end of pregnancy date reported as 05 November 2012) had received during mother's pregnancy Tdap and Influenza vaccine (manufacturers, lot numbers, routes and dates of administration not reported) and an unspecified amount of time later was found to have IUGR (Intrauterine growth restriction). The mother had a history of asthma and concomitant medications included albuterol and pantoprazole. No further information was available at the time of the report. The infants outcome was not reported. This case linked mother case 2012-08665. Documents held by sender: none.
At 2 months of age, 8/27/97, HIB #1, Hep B #1, IVP #2, DTaP #1; 10/22/97 HIB #2, Hep B #2, IPV #2, DTaP #2. Reacted to immunization with fever then several hours later convulsions. Seizures not present prior. No improvement over several weeks. Took child to hospital and doctor gave 10/27/97 shots; I said no. She did them anyway. Child died a few months later.  8/12/03: Information received from corrections facility where the reporter is an inmate, indicates that he may not receive outside phone calls but letters are permitted. A letter of request for ER and inpatient record was faxed for the admission on 11/22/03. 8/14/03 This record was received and includes: the ER evaluation; the H&P and the Discharge Summary w/ an addendum that includes the findings from the transfer hospital where child was hospitalized for more extensive evaluation of abnormal head CT. The discharge diagnosis on 11/25/97 was Failure To Thrive. The addendum which was added after the child's transfer and evaluation at the higher level of care facility was a diagnosis of Krabbe Disease, an autosomal recessive genetic disorder leading to progressive demyelination of the nervous system. As a result of this evaluation, it was also determined that the mother's father was also the child's father and this man was later arrested and arraigned on sexual assault charges. There was no autopsy done on this patient per Office of Chief Medical Examiner.  8/13/03 Call to PMD for this child from birth to the time of his death, to request immunization and relevant OV records. Since it has been 5 yrs since the death of this patient, they have placed the records in storage. She has agreed to locate the records and send them to VAERS  9/3/03 Official Certificate of Death received which confirms the cause of death as Krabbe's Disease. A copy of the 5 pp. Discharge Summary from hospital  is received for the admission from 11/25/97-12/02/97. The discharge diagnosis is listed as progressive leukodystrophy, probable Krabbe Disease. It is not clear if or when the immunization records with lot#s will be received. That information will be added when available. Follow-up is otherwise complete.