chrisvoncsefalvay/vaers-outcomes huggingface dataset:
highest temperature reached was 8.7C and the total amount of time that the temperature was out of range for all 5 excursions was 40 minutes with no reported adverse event; Initial information received on 11-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient with unknown demographics who had highest temperature reached was 8.7c and the total amount of time that the temperature was out of range for all 5 excursions was 40 minutes with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE with unknown dosing lot UJ393AAA via unknown route in unknown administration site for immunization.  On 24-AUG-2021 the patient had highest temperature reached was 8.7c and the total amount of time that the temperature was out of range for all 5 excursions was 40 minutes with no reported adverse event (intercepted medication error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (highest temperature reached was 8.7C and the total amount of time that the temperature was out of range for all 5 excursions was 40 minutes with no reported adverse event).  At time of reporting, the outcome was Unknown for the event highest temperature reached was 8.7c and the total amount of time that the temperature was out of range for all 5 excursions was 40 minutes with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 11-APR-2016 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # L038018, expiration date: 13-SEP-2017) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effect reported. The RECOMBIVAX HB was exposed to 49.7 degree Fahrenheit for 1 hour and 45 minutes; there was no previous temperature excursion reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a 24 year old female pt with aspirin allergy and a history of migraines who on 08/14/2001 was vaccinated with the second dose of varicella vaccine. Concomitant therapy included iron. On 09/25/2001, a serum varicella zoster virus antibody test was performed which revealed negative results. After two doses of varicella vaccine, the reporting physician considered the results to indicate a failure to seroconvert. It was indicated that the pt had sought medical attention because she had no history of chicken pox and wanted to become pregnant. No further info was provided. Additional info has been requested.
C/o dark spot on (R) arm after immunizations 3 wks ago on 6/15/10.  States initially no fever, blister, redness or swelling.  States child c/o sl. itching problem #1 other dyschromia (R) bicep.
Bad body aches, particularly bottoms of feet; Bad body aches, particularly bottoms of feet; This is a spontaneous report from a contactable consumer. A female patient of unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient was pregnant at the time of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in 2021, the patient had very bad body aches, particularly the bottoms of feet for 2 days. The clinical outcome of the events bad body aches, particularly bottoms of feet were resolved on an unspecified date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The shot itself was very painful going in right arm radiating pain thru  my right arm which had not happened on my first 2 vaccine shots of Pfizer. Then I began having a lot of pain moving around my breastbone, sternum, heart and maybe lung area all through the night after getting the booster. The next day I continued having some pain in these same areas intermittently thru the day. I also began having a lot of lower back pain and also very bad and lingering headache and some dizziness. I am still having the headache 5 days later but the other pain has subsided for the most part.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, a healthcare provider administered the ZOSTAVAX (dose, route, and lot # not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. Late in 2014, the patient was treated by a physician for Shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the event was not unknown. Causality assessment was related.
6/26/08 - patient complained itching immediately after MMR given patient seen by MD. no findings compatible with reactions; 7/22/08 - patient returned to clinic with complained of muscle aches and pains since 7/2/08 - diagnosed with probable serum sickness
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot #, dose and route not reported) on 12-SEP-2008 and the second dose of GARDASIL (Lot #, dose and route not reported) on 24-SEP-2012. No adverse effect. It was not known if the patient sought for medical attention. Additional information has been requested.
immunocompromised patient given 0.25ml as 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (immunocompromised patient given 0.25ml as 3rd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (immunocompromised patient given 0.25ml as 3rd dose). At the time of the report, UNDERDOSE (immunocompromised patient given 0.25ml as 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was on high dose of immunocompromising medication before the vaccine.  The patient was then in the facility to get the booster dose as 4th dose. HCP was asking whether they should give an additional 0.25ml or give a full dose 0.5ml.  No treatment medications were reported.
I got shingles about one month after the second dose. I had severe pain around my spine and back on Friday (4/23/2021) and by the next morning developed red bumps on the left side of my nose that I at first mistook for acne. They produced a very tiny amount of white liquid secretion. The bumps turned darker and I got a red rash on the left side of my nose. The left side of my face as well as the lymph nodes around my collar area swelled up. By Tuesday morning, it spread to my left eye, so I went to the ER where they started me on two new antibiotics. After none of the antibiotics worked, I started an antiviral (acyclovir) and antiviral eye drops and started to improve. The rash and swelling reduced and no new blisters have formed. The doctor and I both thought it likely I had shingles.
Initial report received from a healthcare professional on 13 September 2012. A 32-year-old pregnant female patient, had received an intramuscular (IM) first dose of ADACEL vaccine on 13 September 2012 (lot number U4384AA, anatomical site of vaccination was not reported). The date of the patient Last Menstrual Period was 07 February 2012. Estimated Date of Delivery was reported as 14 November 2012. It was reported that the patient did not experienced any adverse event. The patient's obstetrical history, current medical history, and concomitant medication were not provided. The patient treatment for infertility was included In vitro fertilization (IVF). The outcome was reported as unknown. Follow-up information was received 03 September 2013 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded to serious. Relevant illness during pregnancy/ongoing included thrombocytopenia and anemia. Medications used during pregnancy consisted of MAXARON FORTE, "Tetanus", RHOGAM and "Flu" (manufacturers, lot numbers, routes, sites and dates of administration not reported). Maternal history consisted of one pregnancy with a normal outcome. On 24 October 2012, the patient deliver twins; outcomes reported as normal. The outcome for the events of thrombocytopenia and anemia were not reported. Documents held by sender: None.
Approximately 3 1/2 weeks after vaccine- increasing neck pain on right, enlarged lymph node right axilla, then pain in wrists, right > left, painful to do pushups or turn lids, red and swollen. LN resolved with zpack. Still some pain in wrists and swelling in fingers, pain in right side neck.
A HBP was transferred onto the line by a Merck account representative to report a temperature excursion. The caller stated doses of improperly stored VARIVAX were administered to patients.; no additional adverse events; This spontaneous report was received from a healthcare business professional (HBP) concerning an unknown age and gender patient. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On an unknown date, varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# W039294, expiry date: 11-DEC-2024) was stored at a temperature of 17.4 degree Fahrenheit (F) for 2 hours 0 minutes and 0 seconds. There was no previous temperature excursion. After temperature excursion, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (dose, route of administration, and anatomical location not provided) as prophylaxis (product storage error). There were no additional adverse events reported (no adverse event).  This is one of 9 reports received from the same reporter.
Narrative:  Patient received one COVID vaccine. PMH COPD (on 4L home NC, 2/2 alpha-1 anti-trypsin deficiency), Afib (not on AC d/t hx of hemoptysis), asthma, colon cancer, and OSA (not on CPAP) presenting as transfer from hospital for placement. Patient was recently admitted to hospital from 1/21-1/28/21 for COVID PNA , he was treated with remdesivir, dexamethasone and Unasyn. He required high flow O2 during that admission and was discharged back to nursing home on home 4L O2. 2/1/21 - patient was admitted again to hospital for shortness of breath, non- productive cough, and lethargy with CXR showing bilateral pleural effusions L>R. He was treated for aspiration PNA with Unasyn course, 2/1-2/5/21, with improvement in symptoms. Patient was evaluated by SLP at hospital for dysphagia and underwent video fluoroscopic swallow evaluation on 2/5 and was cleared for pureed diet with honey thick liquids. Hospital transfer note stated patient's family (nephew and nice) wanted him transferred here for placement in new LTC. Patient was sent to hospice where he died shortly after.
This spontaneous case reported by a consumer, describes the occurrence of back pain (low-back pain), fatigue and myalgia (muscle pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 036A21A) for COVID-19 immunization. No medical history reported. On Mar 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 9, 2021, patient experienced back pain (low-back pain), fatigue and myalgia (muscle pain). At the time of the report, back pain (low-back pain), fatigue and myalgia (muscle pain): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Just a little runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Just a little runny nose) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Just a little runny nose). At the time of the report, RHINORRHOEA (Just a little runny nose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-117032 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Events resolved and consumer declined further follow up
Nausea, discomfort, became very hot. Visuals that were almost hallucinogenic. Light colors were glowing like neon. Paterns were very vivid and intense. Blurred vision.  Dizziness. Lasted for about 10 minutes. Started 5 minutes after shot. Reported it to nurses after symptoms subsided. They gave me some water and I stuck around to be monitored. Everything was fine until the 4th day when I got a sinus infection which lasted for a week. Got a Covid test just in case on that Sunday. It was negative.
Shortly after administration, patient said it felt "really hot" in the vaccine room and began fanning herself with the paperwork in her hand. The pharmacist opened the door to get some air circulating. Gave the patient some water and an ice pack for the back of her neck. The patient said she felt much better after 5 minutes.
Fever, chills, fatigue. Began within 10 hours of receiving the vaccine. Symptoms lasted overnight. Next morning, no symptoms. Then 36 hours after the vaccine (by 6:00 pm next day), low grade fever and chills and fatigue again. Sore arm on day 2 only.
coughing; runny nose; foam around mouth; meta pnuemonia virus; coronavirus HUK 1 diagnosis; adenovirus diagnosis; dehydrated; rash on right thigh; screaming; stopped eating/ stopped drinking; fever; could not stay asleep/ began to feel sleepy, had trouble staying asleep, was waking up every hour; This case was reported by a consumer via call center representative and described the occurrence of metapneumovirus infection in a 14-month-old female patient who received HAV (Havrix 720) (batch number 3HR79, expiry date 16th September 2021) for prophylaxis.   On 14th January 2020, the patient received Havrix 720 (intramuscular). On 16th January 2020, 2 days after receiving Havrix 720, the patient experienced sleep disturbance. On 18th January 2020, the patient experienced screaming, appetite absent and fever. On 19th January 2020, the patient experienced metapneumovirus infection (serious criteria GSK medically significant), coronavirus infection, adenovirus infection, dehydration and rash. On 20th January 2020, the patient experienced cough, runny nose and foaming at mouth. On an unknown date, the outcome of the metapneumovirus infection, coronavirus infection, adenovirus infection, sleep disturbance, screaming, appetite absent, fever and dehydration were not recovered/not resolved and the outcome of the rash, cough, runny nose and foaming at mouth were recovering/resolving.   It was unknown if the reporter considered the metapneumovirus infection, coronavirus infection, adenovirus infection, sleep disturbance, screaming, appetite absent, fever, dehydration, rash, cough, runny nose and foaming at mouth to be related to Havrix 720.  Additional information was provided as follows: On 18th January 2020, 4 days after receiving Havrix 720, the patient began to feel sleepy, had trouble staying asleep, was waking up every hour, had a fever of 103 degrees C, stopped eating and drinking. On 19th January 2020, 5 days after receiving vaccine, the patient had a rash on her right thigh and was dehydrated. The patient went to the emergency department and was hydrated venously. In January 2020, the patient had an X-ray which was negative. The patient had nose swab and the swab results showed the patient had coronavirus HUK1, adenovirus, and metapneumonia virus. The next day after the hospital visit, 6 days after receiving vaccine, the patient experienced cough, runny nose and white foam-like liquid around her mouth. At the time of reporting, all symptoms had not resolved or improved and were becoming worse. The patient required emergency room visit. The reporter consented to follow up.
Chills/ Shaking   5 minutes mild fever  1 day visual distortion 2 days weakness 2 days
C/O feeling woozy. Evaluated by EMT. VSS. O2 Sat 99 %. Patient had water and snack to take home. She was alert, oriented, gait steady at time of "discharge". She declined transfer to the hospital.
Patient called and stated her shoulder and arm were both very sore from the time she got her vaccination and hurting unlike any other time she got a vaccine. Site of injection is red, hot and swollen, a lot of shoulder pain. Advised supportive care, TYLENOL for discomfort and ice/cold compress, patient to call md in the morning and we will call provider in the morning also (patient called us 8:30pm.
Swelling and expanding erythema at site on LUE irregular in shape slight warmth to touch 3.5 x 4.0 inches.
Sore shoulder that has lasted for 9 days.  Bothers her if she sleeps on it or lifts something.
My booster crushed me for a good 24 hours; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (My booster crushed me for a good 24 hours) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (My booster crushed me for a good 24 hours). At the time of the report, IMMUNISATION REACTION (My booster crushed me for a good 24 hours) had resolved.            No relevant concomitant medications were reported. No treatment medication reported.
Information has been received from a nurse concerning a female who on 30-OCT-2008 was vaccinated with PNEUMOVAX vaccine (lot #662599/1076X), 0.5ml, intramuscularly. Secondary suspect therapy included influenza virus vaccine (manufacturer unspecified) in the same arm on 30-OCT-2008. On 31-OCT-2008, 1 day after the vaccination, the patient experienced redness at the injection site, fever of 103f and chills. It was not known if this was the patient's first dose of PNEUMOVAX vaccine. The nurse was not aware if treatment was prescribed but stated the patient was recovering. The patient sought medical attention with a phone call to the office. This is one of 2 reports received from the same resource. Additional information has been requested.
Within 15-minutes of vaccination, the patient reported SOB and felt that they were having difficulty taking deep enough breaths. EMS evaluated patient on-site. Patient was hypertensive (182/89) with a FSBG of 85 mg/dL. 12-lead EKG  was unremarkable with sinus bradycardia without ectopy. ETCO2 values are within normal limits with square waveform. EMS transported patient to hospital. On arrival, patient noted her condition was probably due to anxiety and left without seeing a physician.
Dry eye syndrome; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (Dry eye syndrome) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.    Co-suspect product included non-company product MINERALS NOS, VITAMINS NOS (MULTIVITAMIN AND MINERAL SUPPLEMENT) for Osteoporosis.    Family history included Sjogren's syndrome since an unknown date. Concurrent medical conditions included Leukemia. Concomitant products included MACROGOL 3350 (MIRALAX) for Digestion impaired, MAGNESIUM GLYCINATE for Leukemia, ACYCLOVIR [ACICLOVIR] for Shingles, ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient started MINERALS NOS, VITAMINS NOS (MULTIVITAMIN AND MINERAL SUPPLEMENT) (unknown route) at an unspecified dose. In February 2021, the patient experienced DRY EYE (Dry eye syndrome). The patient was treated with DEXAMETHASONE, TOBRAMYCIN (TOBRAMYCIN + DEXAMETHASONE CELSUS) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DRY EYE (Dry eye syndrome) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Mother had a history of Lupus and Raynaud's syndrome. Patient is enrolled in Covid-19 clinical trial for SARS COVE 2 Anti-Body, blood drawn twice so far. Their recent Antibody test made only 1 spike protein antibody. They want to find out if their body will still make more antibodies.   This case was linked to MOD-2021-155690 (Patient Link).
Pain at site of injection, muscle soreness rest of day, restlessness, unable to sleep, headaches, pain in both legs, nausea, fever, diarrhea through day. On 8/17 felt better. Today hives appeared at site of injection, swollen, redness and hot to touch.