chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1-26-2021 -Itchy rash, about 3x2 inches in size, seemed to disappear, then reappeared 1-31-2021 with increase in size  5x3 inches ; no pain  No treatment
Headache, Myalgia, Arthralgia, SkinRash, Left arm swelling, facial swelling, swollen glands Narrative:  Received prednisone to reduce facial  swelling and hives  Other Relevant History:
Information has been received from a physician concerning a 10 days old female patient who on 04-SEP-2010 was vaccinated with the first dose of PEDVAXHIB (manufacturer unknown) (Lot #, expire date and route not reported). On 16-NOV-2010, the patient was vaccinated with the second dose of PEDVAXHIB (manufacturer unknown) (Lot #, expire date and route not reported). Suspect vaccine included first dose of ROTARIX (Lot # A41FB088A, expire date and route not reported) administered on 04-SEP-2010 and second dose of ROTARIX (Lot # A41FB088A, expire date and route not reported) administered on 16-NOV-2010. Concomitant vaccines on 04-Sep-2010 (also reported as 07-Oct-2010) included PREVNAR. Physician reported that on 30-DEC-2010, patient was diagnosed with intussusception and was admitted to the hospital. The patient had surgery and the intussusception was reduced and the patient recovered. Physician added that had not seen the patient for a post-hospital follow up visit. This is one of two reports from the same source. Additional information has been requested.
Very strong fatigue; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (Pfizer/ BioNTech COVID-19 vaccine, lot number: EM9810), intramuscularly in deltoid right on 10Feb2021 15:00 at single dose for COVID-19 immunisation. Medical history included breast cancer from 1989 and ongoing, gastrooesophageal reflux disease (GERD) from 2010 and ongoing, osteoporosis from 1989 and ongoing, macular degeneration (MAC. degeneration), and allergies. Concomitant medications included anastrozole (ARIMIDEX) for breast cancer from 1998 and ongoing, famotidine for GERD from 2018 and ongoing, calcium carbonate/colecalciferol (VITAMIN D 2000) for osteoporosis from 2010 and ongoing, ascorbic acid/tocopheryl acetate/xantofyl/zeaxanthin/zinc (AREDS) for MAC. degeneration from 2015 and ongoing, and cetirizine hydrochloride (ZYRTEC ALLERGY) for allergies. Patient received the first dose of BNT162B2 (lot number: EL3247), intramuscularly in right deltoid on 20Jan2021 17:00 for COVID-19 immunisation and experienced severe headache, and fatigue. When patient received the first dose, some of the vaccine was flowing down her arm and she worried that she did not receive the whole dose and would like to check if she had antibodies. The patient experienced very strong fatigue on 11Feb2021. Treatment was not received for this event. Outcome of the event was resolved on 18Feb2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L025738, expiration date 14-AUG-2017 or lot # L029631, expiration date 14-AUG-2017 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 48 degrees Fahrenheit for 89 hours. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Patient came in for second dose of the COVID vaccine and was given the Pfizer vaccine instead of the Moderna vaccine. The consent form was not filled out completely, so our intern,  confirmed with patient and patient gave verbal confirmation that he was there for the pfizer vaccine. He did not have his vaccination card on him at that time. Error was not noticed until later on, after vaccination, when he gave us his card. When the error was found, we explained what happened to the patient and asked if he was feeling unusual. Patient gave confirmation that he was ok and would wait 30 minutes. After 30 minutes, intern checked with the patient that he was fine to leave. We instructed the patient to check if any unusual symptoms occur, head to emergency room right away and explain what happened. And patient confirmed.
Initial unsolicited report received from a registered nurse on 22 September 2016. This case involves a 40 years old female who was vaccinated with a dose of Fluzone Quadrivalent (batch number: UI158AB, expiry date, dose, route of administration was not reported) intramuscularly at left deltoid on 19 September 2016. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unspecified date, following the vaccination, patient experienced burning, redness, heat and swelling from the elbow to the shoulder on the left side. Lab data and corrective treatment were not reported. On an unspecified date, 5 days after the onset the patient recovered from events. List of documents held by sender: none.
Information has been received from a nurse concerning a 2 patients who were vaccinated IM with Gardasil. Subsequently the patients experienced a headache and sweating. This is one of several reports received from the same source. No further information is available.
Breakthrough COVID 19 infection after fully vaccinated; Breakthrough COVID 19 infection after fully vaccinated; This is a spontaneous report from a non-contactable consumer (patient) reported for self. A patient of an unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced breakthrough COVID 19 infection after fully vaccinated (drug ineffective). The event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are possible, information about Lot/Batch number cannot be obtained. No further information is expected.
Chills, body aches, nausea, vomiting, headache, sleeplessness began 14 hours after injection and lasted 24 hours.
BURNING PAIN UNDER UNDERARM; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine  (form of admin and route of admin were not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced burning pain under my underarm. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on 09-APR-2021, and burning pain under underarm on 11-APR-2021. This report was non-serious.
No adverse effect; The patietn was administered a dose of improperly stored VARIVAX; This spontaneous report has been received from a nurse, concerning to a patient of unknown age and gender.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies were not reported. Concomitant therapies included sterile diluent.  On 22-JUL-2019, the patient was vaccinated with a dose of improperly stored (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, and anatomical location were not reported)  (lot # S000133 and expiration date 02-JAN-2021) as prophylaxis.   In addition, temperature: total time in the range -9°C to 8°C (8.2C); time frame: 6 hours 12 minutes, with no previous temperature of excursion. The excursion call was made by a data logger.; Sender's Comments:  US-009507513-1907USA015149: US-009507513-1907USA014540:
As per the clinic that Patient mom took patient she went to clinic at 2pm complaining that the child would not sleep crying since 3:30am would not eat anything vomiting 4 times at home and once in the clinic pt had fever was sent to lincoln hospital and diagnosed with intussusception of the intestines
headace, dizziness, nauseated, ringing in ears, eye focus, "heavy" arms and legs
Beyond the 30 day use by date, 22Apr2022; Inadvertently administered to a patient an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered to a patient an expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Beyond the 30 day use by date, 22Apr2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered to a patient an expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Beyond the 30 day use by date, 22Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered to a patient an expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Beyond the 30 day use by date, 22Apr2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vaccine was administered to the patient around lunch time on 25-Apr-2022 probably at 12 noon. The vial was stored in refrigerator on 23-Mar-2022. The vial doesn't undergone any temperature excursion.  It was reported that it would be the second dose of vaccine.  No treatment medications was reported.
Information has been received from a physician concerning a 6 year old female relative who was vaccinated with one dose of Measles virus live. The reporting physician noted that he was not sure if the patient received MMR or measles virus vaccine live. Subsequently, the patient developed diabetes post-vaccination. The patient sought unspecified medical treatment. Additional information has been requested.
on day of vax had elevated temp 104,leg swollen Wed evening cont to have low grade fever;on Friday & Saturday t101-102 started being listless & lethargic & no appetite;advised to see PP
atypical inconsolable crying beginning 1 hr p/vax & lasting for 4 hrs;
5cm circular area of atropy @ inj site;delotid area warm & painful to the point it wakes person from sleep;going on since receipt of inj in 1993
Sudden fever 107.0 degrees Fahrenheit axillary, flushed, pale, lethargic, eyes rolled back, legs twitching for 30 seconds. Temperature rechecked after febrile seizure like episode with a result of 102.7 degrees Fahrenheit. Tylenol was given at time of vaccination (3 PM) and at 7 PM after fever. Tylenol and Ibuprofen was alternated for the next 24 hours. Last fever at 11 AM on 11/21/2015. These events occurred after scheduled vaccinations PVC13 and DTAP (previously received) and flu shot (new).
Took the COVID booster shot. Was sick with fever, joint pain/muscle aches, and extreme weakness for 2 weeks. Symptoms came and went every 3 days for up to a month. Three months after booster, developed high heart rate for a month straight. Chest pain, short of breath, and heart "skipping a beat". CRP Cardiac was high and still is high. Diagnosed with myocarditis.
This spontaneous report as received from an other health professional refers to a patient of unknown age. It was reported that a 1 month old patient was inadvertently administered a dose of VAQTA, 0.5 ml, intramuscular on an unspecified date, instead of the intended RECOMBIVAX. No adverse effects reported. Outcome of medication error was unknown. Causality was assessed as not related. Additional information has been requested.
I had difficulty walking because I was so weak and dizzy.; I had difficulty walking because I was so weak and dizzy.; I had difficulty walking because I was so weak and dizzy.; headache; nausea; until the 4th day I was so sick; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 14:30 (Lot number: FC3180) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL. The following information was reported: GAIT DISTURBANCE (non-serious), ASTHENIA (non-serious), DIZZINESS (non-serious) all with onset 25Aug2021 04:00, outcome "unknown" and all described as "I had difficulty walking because I was so weak and dizzy."; HEADACHE (non-serious) with onset 25Aug2021 04:00, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 25Aug2021 04:00, outcome "unknown", described as "nausea"; ILLNESS (non-serious) with onset 25Aug2021 04:00, outcome "unknown", described as "until the 4th day I was so sick". The events "i had difficulty walking because i was so weak and dizzy.", "i had difficulty walking because i was so weak and dizzy.", "i had difficulty walking because i was so weak and dizzy.", "headache", "nausea" and "until the 4th day i was so sick" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gait disturbance, asthenia, dizziness, headache, nausea, illness.  Additional information: The patient did not receive any vaccination, prior vaccine within Four weeks. The other medications in two weeks was Lisinopril. The patient was not tested for Covid-19 prior vaccination. The patient was tested for Covid-19, post vaccination. There were no Known allergies reported. The patient stated, it started with extreme weakness, dizziness, headache, and nausea the next morning. I had difficulty walking because I was so weak and dizzy. The headache would not go away even with 800mg of Motrin. Symptoms grew worse and worse until the 4th day I was so sick I thought I might have a stroke and die. It is now one week later and while I still have dizziness and a headache I can finally walk and eat. There is no way what happened to me is safe. I'm a healthy adult who is fully vaccinated with no problems ever with any other vaccine. Treatment was provided with Promethazine 25mg and Motrin 800mg.  Follow-up attempts are completed. No further information is expected.
We administered a COVID19 bivalent vaccine that was over the BUD. We pulled it from the fridge and first punctured it at 10:32am on 1/9/23. It should have been discarded on 1/9/23 at 10:32pm. We administered the vaccine at 1:50pm on 1/10/23. We have contacted Moderna on how to proceed.
excessive blood in urine lasting 4 hours  Urine test CT Scan cystoscopy  no findings, no conclusion
Information has been received from a registered nurse (RN) concerning a child who was vaccinated with a dose of MMR II. The RN reported that the patient subsequently developed a fever. Unspecified medical attention was sought. At the time of this report. The outcome was unknown. Additional information has been requested.
Within 25 minutes of injection, began having: Tingling in lips and tongue. Redness in lips. Itchiness in face; later felt in legs. Scratchy throat. Red splotchy areas on both arms. Symptoms continued for over 2 hours.  Took a Benadryl (25 mg) around 10:30 am. Most symptoms gradually went away, but continued to feel intermittent skin itchiness in limbs for the rest of the day. Felt bad all day.
Initial solicited report received on 05 October 2015 from a consumer in the study. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject was sick on an unspecified date post vaccination. It was reported that the subject was not sick anymore because of the vaccine. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Persistent mild headache, still having it almost 2 weeks post-vaccination (1 day following vaccination, also had fever and chills)
I received the 2nd Moderna Covid Vaccine on 9/14/21 and I had the normal symptoms of a low grade temperature starting approximately 24 hours later, then when i woke up Thursday morning (the 2nd day) i had raw open lesions inside my mouth, and the skin inside my mouth and on my lips are peeling off. One open lesion went away approximately 5 days (9/19/21) after receiving the vaccine but then i woke up this morning  (the 6th day-9/20/21) and there is another large open raw lesion inside my mouth. It feels like the inside of my mouth is on fire and eating away my skin. it is very painful.
No additional adverse effects; four pediatric patients received the adult formulation of VAQTA; This spontaneous report was received from the office manager and refers to an unspecified pediatric patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 26-NOV-2019, the patient was vaccinated with the adult formulation of hepatitis a vaccine, inactivated (VAQTA) 50U/1.0ml, 1 milliliter, once,  lot # S012250 expiration date on 07-JUL-2020 (route and anatomical location were not provided), for prophylaxis. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA011814: US-009507513-1912USA011815: US-009507513-1912USA003828:
hx of prolonged crying (mother stated all noc) high pitched-high fever mother did not take
Post menopausal uterine bleeding; Minor symptoms.  Had not had a period in several years.  Spotting day of vaccine, full period day after.  Mirena IUD removed in 2021.
No adverse effects reported; TE with VARIVAX, Improperly stored; This spontaneous report has been received from a medical assistant referring to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 21-SEP-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5 mL; lot# W018825 has been verified to be a valid lot number and expiration date was 14-JUN-2024; strength, and route of administration were not reported) for prophylaxis. The vaccine administered was improperly stored and experienced temperature excursion (TE) (product storage error). No adverse effects were reported (no adverse event).    This is one of twenty reports received from the same reporter.; Sender's Comments:  US-009507513-2310USA007229: US-009507513-2310USA004910: US-009507513-2310USA007057: US-009507513-2310USA007161: US-009507513-2310USA005031: US-009507513-2310USA007286: US-009507513-2310USA007121: US-009507513-2310USA007332: US-009507513-2310USA007059: US-009507513-2310USA006693: US-009507513-2310USA007217: US-009507513-2310USA007118: US-009507513-2310USA007066: US-009507513-2310USA005525: US-009507513-2310USA005744: US-009507513-2310USA005372: US-009507513-2310USA007218: US-009507513-2310USA008042: US-009507513-2310USA007123:
Red mark (circle) on arm at injection site (site sore and itchy lasted only day or 2) now fine but mark still there.
Patient developed a pruritic rash 2 days after Adacel administration which originated at the immunization site. Patient then developed chest pain and the rash worsened. One day later the patients' penis got red and swollen. Mom states that none of these symptoms were present prior to the shot.
had the flu xmas day; Initial information received on 26-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who had the flu xmas day after receiving influenza vaccine  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  In October 2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  In Dec-2022 the patient had the flu xmas day (influenza) (latency: 2 months approximately) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (had the flu xmas day).  At time of reporting, the outcome was Unknown for the event had the flu xmas day.
Information has been received from a registered nurse (R.N.) and a mother of a student concerning another child in elementary school who was vaccinated with a dose of Varivax. It was reported that the patient now has breakthrough chickenpox after an outbreak occurred in the elementary school. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that the index case was an unimmunized individual. Additional information is not expected.
Patient is a 71 year old male with a PMHx to include diabetes, coronary artery disease, hypertension, reflux, dyslipidemia presents from his apartment with dizziness, headache, diaphoresis, and fevers. Patient reports he saw his primary care physician early this morning for a routine examination and toward the end of the examination he received a flu shot. Patient reports as he was driving home from his appointment he began to feel ill. When he got home he continued to feel ill, however finished up some chores around the house. The couple of hours later he began to feel worse with development of some lightheadedness/dizziness and beginning to feel feverish. Patient was painting a deck at the time and had to stop because of how poorly he felt. Patient attempted to go inside and rest however her symptoms continued to worsen. He also reports developing a headache and some diaphoresis. Patient reports that his headache is severe. "Worst headache of his life", diffuse, dull/achy, nonradiating, no alleviating factors. Patient denies any new neck stiffness/pain. When his wife got home at approximately 1630 she did give him some naproxen. Patient then tended to rest however after a couple hours of rest he continued to feel poor with new redness to his face. His wife he didn't hurt that time which was 102.8 orally at home. After calling the nursing hotline, they were prompted to report him or his department for evaluation. The patient reports prior to examination and flu shot this morning he was feeling quite well. He denies any recent illnesses, cough, congestion, sore throat, chest pain, dyspnea, abdominal pain, nausea, vomiting, diarrhea, rashes. Patient denies any numbness, tingling, or any weakness. Patient has had flu shots in the past, has never had a reaction to his knowledge.