chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves Adult patient who experienced rash, while he/she received vaccines SHINGRIX and FLUBLOK QIV. 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 INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. The patient developed a non-serious rash following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and following the administration of SHINGRIX. (Other relevant tests included No lab test.) Final diagnosis was rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for rash.
APPROXIMATELY 15 MINUTES AFTER INJECTION, RECIPIENT BECAME EXTREMELY NAUSEA DIAPHORETIC DIZZY WITH CHEST PAIN. RECIPIENT WAS SENT TO ER AND SEEN BE PHYSICIAN.  EKG, BNP, CARDIAC ENZYMES, CBC, CMP, D DIMER ORDERED. RECIPIENT RECEIVED 1 LITER BOLUS OF NORMAL SALINE IV, AND ATIVAN 1 MG IV GIVEN. RECIPIENT WAS DISCHARGED HOME AND RETURNED TO WORK THE FOLLOWING DAY.
VERY FATIGUE; BURNING NEUROPATHY; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included environmental allergy. The patient was healthy previously. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on left arm on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-APR-2021 (two hours after vaccination), the patient's whole body went numb, especially the extremities and it was tingling and numb all over the body. On the same day, the patient experienced burning neuropathy. On 06-APR-2021, two days later, the numbness lessened and his feet were always in burning pain and it inhibited ability to walk and was very fatigued all the time. The patient's muscles in hand were weak and it was hurting to open a jar. Later, the patient was no longer experiencing severe weakness but unable to stand for long periods of time due to pain. He was unable to sit too long because the burning pain radiated to the feet. The patient also felt pain in the back of the legs once sitting. The patient had no breathing problems. It was reported that, the patient spoke to neurologist within two days of experiencing these symptoms and was told to watch it and stay in contact as it might take up to six months for symptoms to resolve.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very fatigue, and burning neuropathy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210728778-Covid-19 vaccine ad26.cov2.s- Burning neuropathy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Information has been received from a legal firm regarding a case in litigation concerning a male who on 10/16/96 was vaccinated with hep B vaccine recombinant (no batch reported, manuf unk). Other immunizations included the following vaccines Acel-Imune (lot 434814 given on 12/9/96) (lot 441-103 given on 4/29/97) (lot 453-846 given on 10/19/98), hep B vaccine recombinant (Engerix B) (lot 2137A2 given on 12/9/96) (lot 2149A2 given on 4/29/97), Tripedia (lot 7L81673 given on 2/26/98), haemophilus B conjugate vaccine (lot M200RC given on 2/26/98, manuf unk) and HibTITER (lot M040RL given on 10/19/98). It is alleged that the pt developed severe neurodevelopmental disorders with associated high mercury exposure levels, mercury poisoning by the cumulative dose of mercury in thimerosal, and now suffers, and in the future will continue to suffer from toxic neurological effects of mercury poisoning. It was reported that the pt was exposed to very high doses of mercury contained in thimerosal from vaccinations administered during the period from October 1996 through at least October 1998. Upon internal review, severe neurodevelopmental disorders, mercury poisoning, and toxic neurological effects of mercury poisoning were considered other important medical events (OMIC). No further info is available.
Patient became dizzy, hypotensive and pale after vaccine administration. She felt better soon after with cool air and water.
Severe chills and fever and sweating started at 7pm and continued until around 6am.   Severe pain in right calf muscle started at 3am on 6/3 and lasted for 24 hours.  At the direction of my dr, i was seen in the ER at hospital. The hospital checked for blood clot but ultra sound showed no clots.
Patient came to pharmacy on 10/29 and said the site of her flu shot was still inflamed and red. I called her on 10/31 to check up on her. Her husband said she was feeling better.
Within 30 minutes, pt had erythematous, maculopapilar rash to 75% of his body-face, chest, arms, legs, upper back. Pt. was given oral BENADRYL. Within 20 minutes, ras was greatly decreased. No other symptoms occurred.
Pediatric (0.5 ml)dose / to a 33 year old / patient / All doses / in / series was pediatric dose; Pediatric (0.5 ml)dose / to a 33 year old / patient; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number 4CL44, expiry date 24th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2020, the patient received the 1st dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 22nd December 2020, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were received as follows: The 33 year old patient had received 0.5ml pediatric dose of Engerix B in the 3 dose series, which led to underdose and adult use of a child product. This case was for the 1st dose of Engerix B pediatric. All doses given in the series was pediatric dose. The reporter enquired to draw a titer or revaccination. The reporter consented to follow up. For tolerance to 2nd dose refer case US2021AMR132393 and for 3rd dose, refer case US2021131430.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021131430:Same reporter. US-GLAXOSMITHKLINE-US2021AMR132393:Same reporter.
Patient completed Covid 19 vaccine series on 01/07/2021 and was diagnosed with Covid 19 on 4/5/2021
Case number PHEH2014US022576, is an initial spontaneous report received from a pharmacist on 10 Nov 2014. This case refers to a 42 years old male patient. past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN, (batch number: 14625P), at a dose of 0.5 ml intramuscularly on 09 Nov 2014, that had been at 34 F to 39.4 F. No adverse event was reported following this administration error (incorrect storage of drug).
2 days p/vax pt devel a low grade fever 99.7, myalgias (esp arms & legs also feet) described as aching & hot, diarrhea;denied nasal congestion or other resp sx;
Information has been received from a woman in a physician's office concerning a female who was vaccinated with the second dose of pneumococcal vaccine 23 polyvalent (Lot # 644106/0819M).  the woman reported that the patient had an injection site reaction as her upper inner arm became red, hot, raised and swollen.  A diagnosis of cellulitis was subsequently made.  The patient sought unspecified medical and was treated with cephalexin (KEFLEX).  At the time of this report the outcome was unknown.  The woman also reported that another patient also developed cellulitis after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES # 0302USA00944).  Additional information has been requested.
A non-serious spontaneous report of twenty-eight patients received expired FLUMIST was received from a health professional concerning a 15-year-old female. Neither relevant medical history nor concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 02-Mar-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Patient did not report adverse events. This report is being submitted because the patient received an expired dose. The dose the patient received was at room temperature beyond the 6hr expiration time.
Chills, slight fever, body aches, slight headache, fatigue.  All symptoms lasted about 10 hours except fatigue which lasted 24 hours.
Moderna 2/2/21, 2/26/21, 11/5/21, 6/16/22. Positive on 9/4/22
This child received DTaP, IPV, and MMR on 2/21/01. The mother reported arm swollen, hard, and red. The doctor put the child on antibiotics (pending for doctors note).
Patient fainted briefly. Her face was  flushed. time was 2:45 PM.
Moderna COVID-19 vaccine EUA Rash from shoulder to elbow 3 inches across, itchy and painful, fever, 100* 3 days, Fatigue 6 days beginning 3-2-2021 Rested, slept a lot.  applied ice pack to arm with rash, daily oral antihistamine.  I felt normal and all side affects had disappeared within 10 days.
eyelids became droopy, unstable on feet, weakness, and legs giving out.  10/29/2009 Medical records received for DOS 10/18.  ED visit. Eyes droopy and unstable on feet s/p vaccine. On PE ptosis eyelids bilat. Limitation of R horizontal gaze. Sensitivity to light. PERRL. Difficulty standing on heels. Strength 5/5 UE/LE. Reflexes Achilles 3+, patellar 2+.  CT, LP WNL. Possible post-immunization encephalitis with opthalmoplegia and ataxia.  Stable. Discharge to home. Follow-up 1-2 days.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with MMR II lot # L012479, expiration date 10-APR-2017 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as improperly stored MMR II was administered to unspecified patients. There was no adverse event. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Febrile seizure, status epilepticus.  08/15/2008 MR received for DOS 6/27-30/2008 with DX: Seizure. Pt presented in status epilepticus with respiratory failure.  Pt initially fussy following vax, improved with Tylenol. Later developed tonic-clonic movements and stiffness.  Unresponsive.  En route to hospital via EMS was having tonic-clonic seizure despite rectal Diastat. Hypoventilating on Phenobarb so intubated. Fever developed 4 hrs after admission. Extubated with return to baseline mental status.  PE (+) for mild asymmetry in tone with slightly increased tone in R upper and lower extremities and increased reflexes. Mild axial hypotonia which improved. Hyperpigmented macules on back, left trunk and left leg. Neuro exam to baseline prior to d/c.
Case number PHEH2014US016774 is an initial spontaneous report received from a consumer (patient's father) on 19 Aug 2014. This report refers to a male patient whose age was not reported. His medical history and concomitant medications were not reported. He was vaccinated with a dose of MENVEO (batch number: not reported) subcutaneously on an unknown date. The patient's father stated that he was not pissed off. No adverse event was reported following the maladministration.
Symptoms began on 3/9. She presented to urgent care  on 3/11 with petechial rash on both legs and arms, purpuric bruising on bottom lip, and mild nosebleeds x 2 days. Transferred on 3/11 to Hospital for lab work due to suspicion of idiopathic thrombocytopenic purpura, and found to have a platelet count <2. Treated with IVIG from 3/11 to 3/12. Platelets normalized by follow-up testing on 3/18, confirming the diagnosis of ITP.
pain over my right eye; chills; pain over her right eye, like a headache over her right eye; burning in her legs from her knees to her feet; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning in her legs from her knees to her feet), EYE PAIN (pain over my right eye), CHILLS (chills) and HEADACHE (pain over her right eye, like a headache over her right eye) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BURNING SENSATION (burning in her legs from her knees to her feet). On an unknown date, the patient experienced EYE PAIN (pain over my right eye), CHILLS (chills) and HEADACHE (pain over her right eye, like a headache over her right eye). The patient was treated with PARACETAMOL (TYLENOL) on 29-Apr-2021 for Headache, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning in her legs from her knees to her feet), EYE PAIN (pain over my right eye), CHILLS (chills) and HEADACHE (pain over her right eye, like a headache over her right eye) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was reported to take Excedrin on 29-APR-2021 and Tylenol for her headache.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-098575 (Patient Link).
This spontaneous report as received from health care worker refers to an unknown number of patients of unknown demographics. Patient's concurrent conditions and medical history were not reported. From October-2013 to December-2013, patients were vaccinated with VARIVAX (Merck) (dose, route, frequency and lot were not reported) that may have been improperly stored. No adverse effects were reported. Additional information is not expected.
pain in the arm of injection after the first dose; rash on the same arm of injection after the first 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 VACCINATION SITE PAIN (pain in the arm of injection after the first dose) and VACCINATION SITE RASH (rash on the same arm of injection after the first dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm of injection after the first dose) and VACCINATION SITE RASH (rash on the same arm of injection after the first dose). At the time of the report, VACCINATION SITE PAIN (pain in the arm of injection after the first dose) and VACCINATION SITE RASH (rash on the same arm of injection after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided   Reporter did not allow further contact
Patient received Moderna COVID Vaccine Lot 028A21A Exp 04/28/2021, no adverse event reported.
Pain in upper arm.  Redness and itching around injection site, that grew larger and larger over the course of a week, starting at silver dollar size around the injection site, and ending in a 9"x 6" rash that covered most of upper arm
pt recvd vax 2MAR95 broke out in hives Thurs PM which became much inc over 3MAR & 4MAR t983 R; 4MAR annular erythematous target lesion of face, erythematous annular lesion w/central clearing on trunk & extremities;
Flu Symptoms; Dull headache; Low 99 fever; Joint pain; Muscle pain; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the right arm on 07Aug2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included pravastatin (MANUFACTURER UNKNOWN), nicotinic acid (NIACIN) and fish oil (MANUFACTURER UNKNOWN); all were taken for unspecified indications from unknown dates and unknown if ongoing. On 08Aug2021 at 07:00, the patient experienced flu symptoms which included dull headache, low fever of 99 (unit unspecified), joint pain, muscle pain and tiredness. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with Advil 400 mg after 24 hours and night before bed. The clinical outcome of the events flu symptoms, dull headache, low 99 fever, joint pain, muscle pain and tiredness was resolved on an unknown date in Aug2021.
Information has been received from a health professional concerning a 72 year old white male with no past medical history who on Jan 04 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649694/0386P), intramuscularly, There was no illness at the time of vaccination. On Jan 05 2005, in the morning, the patient experienced pain, redness and swelling at the injection site. The patient was treated with rest, moist heat and Caphalexin (Keflex (x 7 days). Subsequently, the patient recovered after 72 to 96 hours. There were no relevant diagnostic teat or laboratory date performed. It ws noted that the patient and the patients sibling did not experience any adverse symptoms following prior vaccinations. It was noted that four other patients had similar reaction (WAES0502usa00745, WAES0503USA00536, WAES0503USA00538, WAES0503USA00540). No further information is available.
pt experienced dizziness for about 15 minutes after the vaccine. She reclined in a chair and drank a juice box and completely recovered. She reports this has happened before with vaccines.
This is a 59-year-old female who's  possible reaction to the Covid vaccine was as follows: She had gotten the vaccine at approximately 8:30 AM and had stayed at the vaccination area for about 15 minutes and felt okay.  She got up to walk outside and started feeling dizzy.  Her hands felt tingly.  She also felt a little short of breath.  She came back in and sat down and the symptoms did not seem to really improve.  She states they have been about the same over the last 20 minutes or so. She was then escorted to the ED of the facility for evaluation & treatment if needed. Per the ED doctor's notes: " The patient did feel much better after just being observed here and after getting Benadryl." She was released home. Employee health followed up with her at 4:30 PM the same day & at 9:45 am 1/6/21--she reported that she was doing well at both follow ups, a little tired but had not had any repeat of previous symptoms.
Right upper arm swollen, red and warm to touch. Swelling extends from shoulder to elbow.
HEADACHE; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 19-MAR-2021. This report was non-serious.
Local induration and erythema with discomfort. Seen on the 7th day and was resolving with 4cm X 3cm diameter area.
Fatigue, Headache, Congestion, Mild Cough - 4 days after 1st vaccination dose
Had covid 12/17/2021. Received antibody therapy 12/21/2021. Was treated in the ER 12/23/2022 and diagnosed with covid pneumonia. Treated with steroids and continued with breathing treatments.  Took 30 days for symptoms to improve.    From January 4-31, 2022 I had a menstrual period.  Have been having menstrual periods monthly since June 2021 lasting 14-21 days each month.  Was not previously having periods due to IUD.
A 15 month old female with no significant past medical history received her scheduled immunizations and subsequently developed swelling and redness at the injection site. She presented to the ED with a low grade fever and decreased appetite. She was diagnosed with a local reaction resulting from the immunizations, was given acetaminophen Tylenol, and was discharged in stable condition.
aches to hips and knees; some fatigue; stiffness and ache at back of neck
Information has been received from a nurse concerning a 17 year old female who on 05-JUN-2007 was vaccinated with a 0.5 mL of varicella virus vaccine live (Oka/Merck). It was reported that with in 36-48 hours after receiving the vaccination the patient experienced soreness and a larger than normal red area around the injection site. Unspecified medical attention was sought. No product quality complaint was involved. This is one of two reports from the same source. Additional information is expected.