chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 100.5 F 6 hours after vaccine administered.  Tylenol given.  Fever of 103.1 F 15 hours after vacine administered.  Redness and swelling, and pain around injection site.  Tiredness, irritability, and loss of appetite.
Severe swelling, redness, heat and pain at the injection site which interfered with sleep. Swelling and redness migrated down the arm over the next week or so, with pain and heat diminishing each day. The day afterwards, achiness and malaise similar to the feeling with a bad cold.
I had PCR test and I tested at myself at home, but my tests came back negative. A week later, I went to the hospital and I tested positive for COVID-19. I had been sick for previous weeks and was worried about emboli. So, I had a breakthrough case of COVID-19.
The day after the 2nd shot I was fevered, chilled and achy joints. One week after the 2nd shot I had several sores on my body, mostly the left side..also shooting pain down left leg. A couple day later a rash appeared on my lower leg, which was diagnosed as shingles.  I have not had any stressful situations happening, thus making me question if the vaccine lowered my immune system thus triggering shingles.
Noticed bump to upper arm the night of receiving the vaccine. Pain to arm and shoulder with certain movements continues. Ice, ibuprofen, and return to clinic if worse.
At around 5 am, I woke up with severe trouble breathing and extreme sinus congestion. Also have some body aches and feel feverish. It has been going on for over an hour now and not going away.
Pt complained of a large wheal on right deltoid that developed on 10/27/00, 2 days, post vax. Wheal is now resolved.
Right Thigh 15 x 9 cm area of erythema, induration warmth, tenderness and cellulitis, received antibiotic.
4 year old was administered with Flublok Quadrivalent / No AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 4 years old male patient who received a  0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA1965, Expiration Date: 30-Jun-2020) on 01-Nov-2019  The patient's past medical history ,treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Patient tested positive for COVID 8/18/21. Patient admitted to hospital 8/21/21 with atrial fibrillation with rapid ventricular rate. Patient deceased 9/18/21
Swelling of injection site, warm to the touch. Patient afebrile, vesicular rash.
Given Covid Pfizer on the right arm no symptoms no signs given expired vaccine on patient 1-2 days late
I started having numbness and tingling in my hands, arms, legs, and feet about a week after the vaccine. The symptoms got progressively worse over the course of a month and I have weakness in my legs and right arm now. I developed small-fiber neuropathy, proven by a sweat test done at Medical Clinic. I am currently taking gabapentin, but it has little effect on my symptoms. The weakness, numbness, tingling, and pins and needles feeling has been getting worse the last few months and I have fallen a few times.
Information has been received from a physician and medical records concerning a 12 year old white male student with no drug allergies, who on 03/16/1995, was vaccinated in the lateral thigh with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot # 611177/1127A) and another does of measles virus vaccine live (+) mumps virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot # 631837/0930J) was administered on 09/09/1999, in the deltoid. Concomitant medication included tuberculin purified protein derivative (PPD Tine test). The patient was not ill at the time of vaccination. A laboratory test showed an increase in IgG antibody and mumps IgM antibody was less than 10. The medical records indicate that the patient was seen by an ENT specialist for the evaluation of her bilateral parotitis. She had a temperature of 102 initially dropped to 100 at the time of her visit to the specialist's office. It was noted that the patient had diffuse swelling of both parotid glands. On examination the external ear canal bilaterally were unremarkable, tympanic membranes were translucent, and there was no evidence of middle ear effusion, the nasal mucous membranes were minimally congested, the oral cavity was unremarkable and she had diffuse non tender swelling of both parotids. a specimen of the pharyngeal secretions and secretions from the parotid duct were sent to the laboratory for culture and sensitivity testing. The results showed normal bacterial flora. A serology was sent for mumps IgG and IgM. IgG antibody was elevated at 2.53%, with a level of greater than 1.1 being positive. Mumps virus IgM antibody was less than 10. The patient's mother reported to the physician that the patient's parotid glands had gone down to normal size and she no longer was febrile. The ENT specialist reported it is possible that the patient did have a mild case of mumps and has recovered as of 03/05/2005. Additional information has been requested.
This spontanoeus report as received from a registered nurse concerning a patient of unknown age who on an unknown date was vaccianted with a dose of MMR II. (lot # H012139. Exp 29-JUN-2014) that was exposed to 70 F for 600 hours (25 days) no stability to support this excursion (dose and route not provided). The patient was not experiencing any known symptoms. Additional information has been requested.
This spontaneous report was received from a license practical nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot number N035957 and expiration date of 10-OCT-2020) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On 06-SEP-2018, the reporter stated that there were 10 vials of GARDASIL 9 in a multi-vial carton and a flip cap was missing (Product quality issue) from one of the vials of GARDASIL 9, the same vial of GARDASIL 9 appeared excessively cloudy when compared to other vials in box, the color was white and was more viscous (Liquid product physical issue). It was also mentioned that the reporter usually see thru the liquid in a GARDASIL 9 vial, nevertheless it looked like thick sugar water with little particulates visible. The appearance of the liquid appears different when compared to the other vials that were in the same shipment of GARDASIL 9. No adverse effects were reported. The outcome of product quality issue and issue and liquid product physical issue was unknown. Additionally, the reporter did not provide causality assessment between the events and vaccination with GARDASIL 9.
Patient came in to health department on 10/10/12 complaining of a reaction to her immunizations she received on 10/1/12. Patient states that she received Tdap and Flu vaccine on 10/1/12. On 10/2/12 she started with diarrhea that lasted for one day. She also complained of pain in her right lung that started on 10/2/12 and lasted for a total of 5 days and a dry cough and hoarseness that started on 10/2/12 and appears to be ongoing but is improving. On 10/8/12 she admits to starting with headaches that are in the back of her head on the right side only. The headaches have improved but do seem to come back with the coughing spells. She has taken ROBITUSSIN DM cough medicine four times a day for the cough, ADVIL 2 tabs every 6 hours as needed for the headache and cough drops for the cough and hoarseness. She denies any reaction at the injection site. She also denies any rash, chills fever or nausea. She did admit to her temperature remaining 97.2 throughout all of this. She is scheduled to go to urgent care this afternoon, 10/10/12, to be evaluated for her symptoms.
Onset of peripheral edema, 11/6/08. Progression to bruising rash, diagnosed Henoch Schonlein Purpura on 11/7/2008. Urinalysis showed hematuria consistent with HSP.
IM given to R deltoid, urticaria started to L cheek and progressed to both cheeks, forehead and upper chest over 2 hrs.
Pt returned to clinic on 4/13/21 with report of allergic reaction to vaccine received on 3/15/21. Pt states approx 6-8 hours post vaccine she had sudden onset shortness of breath, chest pain, throat discomfort, skin rash, itchiness, facial and hand swelling. She sought medical attention Emergency Department where she was treated with PO steroids, Benadryl and anti-hypertensives. Symptoms resolved same day and she was subsequently discharged home. Pt followed up with PCP  who advised her not to receive the second dose
around 6pm ( 5 or so hours after vaccination) i felt itching under my right shoulderblade.  that worsened overnight and turned to red rash.  this slowly spead to the middle of my upper back and then to just under my right breast.  after a few days it spread to the middle of my chest.  today it is spreading to the top of my right breast.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX lot # N031002, expiration date 03-NOV-2019, subcutaneously for prophylaxis. Concomitant therapy included sterile diluent which was used to reconstitute VARIVAX and was properly stored. The doses of VARIVAX experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius (-2.7 degrees Celsius) for 3 hours 45 minutes. There was no previous temperature excursion. The temperature excursion was detected by a data logger. No adverse effects were reported. This is one of two reports received form the same reporter. Sender's Comments: US-009507513-1808USA003893.
Bad heartburn type symptoms. Not normal for me. Since 0900 1-6-2021 No treatment taken yet
p/recv vax almost immed the pt exp a total body tremor & difficulty breathing as well as sweating; pt admitted to ER & treated w/IV saline, benadryl, & motrin;
Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness. After 15 minute observation period pt informed nurse of slight dizziness and thinks its anxiety. She was evaluated by EMS and per EMS is okay to be discharged home. Vitals were WNL and pt was alert, oriented, and ambulatory at discharge.    Assessment : Time of assessment 1503. Alert and oriented.   Actions taken:  Vitals sign taken  Vitals WNL    Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 15 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.
Patient had 4 Pfizer Covid vaccine with health decline after each one. Had dementia, urinary track infection, stroke and then death. Patient had Pfizer Covid vaccine on 12/29/2020 and 1/19/2021 followed with declining cognitive status with MOCA score 16/20, followed with worsening of depressed mood on antidepressants with no improvement. Then she had UTI on 04/01/2021. She had Pfizer Covid vaccine on 9/28/21 and influenza Vaccine on 10/10/21, followed by worsening of cognitive decline. Patient can not perform serial 7s (counting backwards from 100), can only calculate to number 93. Brain MRI showed progressive atrophy and micro-vascular changes on 11/16/2021. Then on 12/23/21 nurse reports that pt took a turn for the worse and can not remember any names. Admitted to hospital from 4//11/22 to 4/13/22 for UTI, AKI, diarrhea. Emergency room visit on 4/19/22 for UTI. Then had 4th Pfizer Covid vacc on 4/21/22. Patient passed away on 4/30/22 from stroke.
1 cm nodule.  7 cm erythema + induration.  R deltoid.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 18-OCT-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 platelet forming units (PFU), lot # N016090 with expiration date on 23-AUG-2017 via intramuscular route. The dose of the vaccine was reconstituted with sterile diluent (MERCK), lot # N013282 with expiration date on 23-AUG-2019 (dose was not reported). The reporter also stated that both ZOSTAVAX and sterile diluent (MERCK) were properly stored. No adverse events were reported.
8hr p/vax child devel large (8inch edematous & red area  over site of inj DTAP);progressed over the next 2 days to blister in area of inj painful to move;
patient was shaking with seizure-like movements, never lost consciousness, felt light-headed and dizzy, gave a cold compress then patient became ill, 911 was  called, patient was evaluated and refused transport, this all happened over a 30 minute period
Tested positive for COVID 19 on 6/20/2022 in the late afternoon, home test. Had increased congestion and phlegm in my cough. Confirmed testing with a PCR at Pharmacy the next day. Pulmonologist, Dr started me on Paxlovid, could not tolerate side effects, stopped after 3 doses. Altered taste, severe , nausea and abdominal pain.  Felt like I had a cold , took Mucinex, Corricidin HBP, Allegra, Tylenol and Advil as needed.  Low grade fever first 2 days along with sinus congestion, cough and fatigue.  Seemed to be doing okay but then day 8 and 9, cough increased, developed chest congestion, and shortness of breath. By day 10 morning, cough worse, breathing tight, Shortness of breath, fatigue. Called PCP office, by noon, I took myself to Patient First,  Vitals and chest X-ray done. Dr ordered ProAir inhaler and  Prednisone 60 mg daily for 7 days.  Pulmonologist adjusted Prednisone to 40 mg daily and PCP ordered nebulizer treatments 4 hours to replace inhaler. Over the next week, I started improving. Fatigue remained for 2 more weeks. Day 14, I finally tested negative on a home test. I was positive still on Day 10. PCP follow up started me on a Z-pack due to lung sounds on July 7, 2022 . Today July29, I still have a slight cough but otherwise pretty normal self.
aching; Circumstance or information capable of leading to a medication error; Drug dose administration interval too long; This case was reported by a other health professional via call center representative and described the occurrence of pain in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Twinrix and the 3rd dose of Twinrix. On an unknown date, unknown after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced pain, circumstance or information capable of leading to medication error and drug dose administration interval too long. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the circumstance or information capable of leading to medication error and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain to be related to Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient's last dose cause a lot of aching for the patient. The reporter stated that a patient received their second dose of Twinrix accelerated schedule on time today, but the patient would most likely receive their third dose late due to being out of town, and if administered late might lead to circumstance or information capable of leading to medication error and lengthening of vaccination schedule. The reporter did not consent to follow-up. The reporter declined to provide more information.
Tingling in feet. Worse over time moved to hands. Muscles soreness, severe head ache. Symptoms still present 13 days later.
Shortness of breath, wheezing, throat tighness, body aches without fever beginning 3 days ago lasting 2 days resolved spontaneously overnight
pt recvd vax & w/in 1hr p/vax exp lt side numbness & felt hot on lt side of body;lt arm & lt side of face swelled;addl exp blister on lt sided of lip,blistering @ inj site;seen @ ER treated w/an unspecified meds;sx are getting better
Vomiting starting at 36 hours after vaccine administration, for around 6 hours off and on through the night. No fever, and otherwise healthy/happy.; vaccine Location=Left leg; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 2-year-old female patient received BNT162b2 (BNT162B2), on 24Jun2022 at 09:15 as dose 1, single (Lot number: FT9142) at the age of 2 years, in left leg for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 24Jun2022 at 09:15, outcome "unknown", described as "vaccine Location=Left leg"; VOMITING (non-serious) with onset 25Jun2022 at 22:00, outcome "recovered", described as "Vomiting starting at 36 hours after vaccine administration, for around 6 hours off and on through the night. No fever, and otherwise healthy/happy.". Therapeutic measures were not taken as a result of product administered at inappropriate site, vomiting.  Additional information:Facility type vaccine: Doctor's office/urgent care, The patient did not receive other vaccine in fourweeks or any other medication in two weeks. The patient reported vomiting starting at 36 hours after vaccine administration, for around 6 hours off and on through the night. No fever, and otherwise healthy/happy. The patient did not receive covid prior vaccination or covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
lay in bed trembling and shaking; This case was reported by a consumer via call center representative and described the occurrence of tremor in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tremor. On an unknown date, the outcome of the tremor was recovered/resolved.   It was unknown if the reporter considered the tremor to be related to Shingrix.  Additional details were provided as follows: The patient was either age 54 or 55 received both shots of Shingrix. The second shot her cousin lay in bed with trembling and shaking with the covers over. This case has been linked with case US2020AMR193653, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020191504:same reporter
Pulmonary embolism reaction to Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism reaction to Moderna vaccine) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism reaction to Moderna vaccine) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism reaction to Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided by the reporter.  No treatment information was provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Further information is expected.
This spontaneous report was received from a supervisor, referring to a currently 15 month old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 06-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1903USA000677; US-009507513-1903USA000680; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000683; US-009507513-1903USA000684; US-009507513-1903USA000685.
low grade fever, fatigue, headache, muscle aches, chills, pain at injection site these symptoms started around 9:00am 24 hours after injection of second dose.
Fatigue mentally and physically; Sensitive skin similar to when havethe flu but less pronounced.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 15:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the COVID-19 vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 15:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 09:00, the patient experienced fatigue mentally and physically and sensitive skin similar to when had the flu but less pronounced. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fatigue mentally and physically and sensitive skin similar to when have the flu but less pronounced were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
A three year old patient was given an adult dose of Hep A vaccine (HAVRIX) for dose number two. The order was for private Hep A as the patient was non VFC. This office does not purchase private pedi Hep A vaccine. The nurse administered the vaccine from the private inventory not realizing that the dose was incorrect.