chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My son age 5 was given the MMR/Varicella (Chickenpox) shots on the same day, February 19th 2009. One shot in each leg. On Tuesday February 24th, he went to bed feeling just fine at 7pm. At 11pm he woke up delirious with a fever of 104.6*. He complained of his neck and legs hurting. I took him into the Dr.s  the next morning where he was given a strep and flu test, both came back negative. Although we were told it was just a virus, ride it out with fluids and TYLENOL. (Please note we saw a PA and not our typical pediatrician). On February 28th, pt finally had his first day without a high fever. That was also the day he developed a rash all over his back, chest and groin. I had been on the phone with Nurses Hotline several times over the last week. No one else in our home has gotten sick. His little brother has been caught drinking after him and playing the same kids flute and he luckily has not come down with anything. Between the nurses and I, we have come to the assumption that he has had a bad reaction to the MMR/Varicella vaccinations. I was turned on to the CDC web-site by the call center nurse from the hotline. I am writing this solely out of concern and not out of any sort of disapproval or discontent with our pediatrician. We have always been very pleased with medical group, P.C. and Dr. That is, after all, why we continue to drive from city, state, back to city. I have long been at odds with the CDC's schedule of shots and the over giving of multiple vaccinations on the same day. As a parent I urge you to please, please consider rethinking the schedule for shots. I for one will never allow my children to have more than one vaccination on a single visit. I'm not against vaccines. I understand the importance of them. But it is truly an overload on these little bodies to have more than one given at any one time. Seriously, please, if you saw my poor little boy over the last week- this was horrible. Sincerely, a concerned parent.
Immediate warm rush to my head and body. Heart was beating out of my chest and difficultly breathing. Heart rate spiked to 150 (normal around 55). Hand, legs, and mouth started to go numb. Eventually settled down after about 1 hr. Have not felt normal since which has been 3 days.
Chills, muscle aches, chest tightness, headache, diarrhea, enlarged lymph node on my left side right under clavicle.   Chills, muscle aches, headache and fatigue began about 14 hrs after injection and continued for about 24 hrs. Headache  and fatigue continued on for 48hrs. Diarrhea probably started about 18 hrs after injection and was very mild throughout the next day. Enlarged lymph node didn't start until around 38 hrs later and although it has reduced significantly it is still a bit enlarged.
This case was reported by a healthcare professional and described the occurrence of an adult male subject (a dentist) not responding to therapy following vaccination with HEPATITIS B vaccine (manufacturer unspecified).  In the 1980's, the subject received a three dose series of HEPATITIS B vaccine (unknown).  A titer was taken on an unspecified date after the series and at that time, the subject showed negative HEPATITIS B antibody titers.  The subject received a second three dose series of HEPATITIS B vaccine in the 1990's.  The reporter did not think a titer was taken after completion of the 1990 series.  An antibody titer taken in JUNE 2008 was negative.  Twice the subject did not respond to therapy with HEPATITIS B vaccine.  At the time of reporting the outcome of the events was unspecified.
Severe headache, nausea and vomiting. Arm numbness, severe pain radiating down arm.
crying which started 1/2 hr p/vax; high pitched lasting 3 hrs, inconsolable; mom called Pediatrician p/1 hr of crying who recommended given APAP;
Presented for SOB. Admit for COVID PNA. Hx of DM, HTN. Tx w/abx, steroids, Vit C, Zinc, remdesivir, O2. By DC weaned from 15L NRB mask to 1L NC at rest. DC'd home w/home O2.
This spontaneous report was received from a pharmacist concerning a female patient of unknown age. Patient's medical history and drug allergies was not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # L002310, expiry date 08-JUL-2016. On the same day of office visit patient received other suspect therapies included TENIVAC, ACTHIB, OVERSTIM S ENERGIX and IPV (unspecified). No information on concomitant medications was provided. On an unknown date, the patient experienced tightness at the injection site as well as burning sensation after receiving PNEUMOVAX 23. On an unknown date, the patient also reported that she had an intolerable pain in the arm that she received PNEUMOVAX 23. After receiving PNEUMOVAX 23 patient had visited an unspecified emergency room on an unspecified date. It was unknown whether the patient was admitted to the hospital. It was unknown how adverse effects were treated. The outcome of the events was unknown. The relatedness of the event with the suspect therapy was not provided. No product quality complaint (PQC) was involved. Additional information has been requested.
c/o mil h/a & malaise following vax; states these sx occur following Td vax; on 10FEB92 devel hives w/pruritus; states hives started on scalp & spread to perineum, inguinal area, elbows, legs, neck, forehead & back;
LEFT LOWER ABDOMINAL PAIN DISCOMFORT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diverticulosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to the right arm for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced left lower abdominal pain discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left lower abdominal pain discomfort. This report was non-serious.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 77 years old female patient who received two doses of FLUZONE HIGH DOSE, which included one wrong FLUZONE HD dose instead of Pneumococcal Vaccine. The patient's past medical history was not provided. No concomitant medications received. On 16-Oct-2018, the patient received a 0.5 ml dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine, lot UJ022AB (expiry date: 18-Apr-2019) via unknown route in the right deltoid and on an unknown date, patient received another dose of FLUZONE HIGH DOSE instead of Pneumonia vaccine. It was a case of actual medication error due to extra dose administered and Wrong vaccine administered. No adverse event occurred. 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 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.
SYNCOPE - PATIENT LOST CONSCIOUSNESS AFTER ADMINISTERING THE SHOT.  PATIENT REGAINED CONSCIOUSNESS QUICKLY.  NO FALL OR INJURY INVOLVED.
Developed pinkish to erythematous macular rashes on the face, arms and scalp a few minutes after receiving first dose of Prevnar; did not have any respiratory symptoms; given a dose of Benadryl; mom says rashes resolved after 5 hours.
6/14/17 Tenderness and redness at left upper arm injection site. 6/15/17 Increased tenderness/pain, redness, swelling from site to below elbow. Treated with ibuprofen, pain medication.  6/16/17 Symptoms decreased in PM.
Information has been received from a physician concerning a 3 yr old female with no medical history or allergies who on 30Jan03 was vaccinated SC in the right leg with a 0.5ml dose of varicella virus vaccine live (lot 643820/0864M). The child had a rash at the time of vaccination. On 02MAy05 the pt developed a low grade fever and then on 02May05 developed chicken pox lesions on the trunk and legs.  She had about 50 lesions total. The doctor prescribed antihistamines for the itching. No other treatment was given. The pt is recovering. No product quality complaint was involved. Follow up information indicated that on 02May05 the child developed breakthrough varicella with <50 vesicles dried type on chest and <10 on the legs. Her temp was 99 max. Additional information has been requested.
Fever of 105 degrees. About 10 hours after shots given, mom noticed fever. Took to hosp.; TYLENOL and ibuprofen given. Sent home. Fever gone by next day.
Headache; Chills; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and chills. On an unknown date, the outcome of the headache and chills were unknown.   It was unknown if the reporter considered the headache and chills to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The patient received Shingrix shot and had a reaction of headache and chills. The patient enquired whether he or she expect this reaction again after receiving the second shot . The permission to follow up was denied.
Sudden onset profound Diplopia / double vision, followed by disorientation and dizziness, followed by pressure in head and ears with tinnitus.  Diplopia and dizziness / disorientation lasted less than 30 seconds, but other symptoms persisted
sleeping 12 to 13 hours a day; Coughing; bed ridden for 3 days; flu-like symptoms; chest pains / still has tenderness in chest that is exacerbated with deep breathing and coughing; chills; been having continued ongoing fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (Coughing), BEDRIDDEN (bed ridden for 3 days), SOMNOLENCE (sleeping 12 to 13 hours a day) and CHEST PAIN (chest pains / still has tenderness in chest that is exacerbated with deep breathing and coughing) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), BEDRIDDEN (bed ridden for 3 days), CHEST PAIN (chest pains / still has tenderness in chest that is exacerbated with deep breathing and coughing), CHILLS (chills), FATIGUE (been having continued ongoing fatigue) and PYREXIA (fever). On an unknown date, the patient experienced COUGH (Coughing) and SOMNOLENCE (sleeping 12 to 13 hours a day). The patient was treated with MORPHINE for Adverse event, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), COUGH (Coughing), BEDRIDDEN (bed ridden for 3 days), SOMNOLENCE (sleeping 12 to 13 hours a day), CHEST PAIN (chest pains / still has tenderness in chest that is exacerbated with deep breathing and coughing), CHILLS (chills), FATIGUE (been having continued ongoing fatigue) and PYREXIA (fever) outcome was unknown.            Concomitant medication was not provided.  Patient lab data includes-EKG and blood work and indicated that patient had not experienced a heart attack. Patient went to the emergency room on Monday 02-AUG-2021.   This case was linked to MOD-2021-278786 (Patient Link).
This spontaneous report as received from a physician refers to a patient of unknown age. On an unspecified date the patient was vaccinated with a first dose of RECOMBIVAX HB (lot # not reported). Then the patient was vaccinated with a second dose of RECOMBIVAX HB (lot # not reported) on an unspecified date, described as five days after the first vaccination. No adverse effect reported. It was unknown if the patient sought medical attention or not. Additional information has been requested.
Body aches; Legs hurting from calves on both sides; Chills; Arm where shot went hurt tremendously; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 (at the age of 54-years-old) as a single dose for covid-19 immunization. Lot number reported from patient card is either: EM9810 or CM9810. Time vaccination was given was between 2pm-3pm. The patient medical history was not reported. There were no concomitant medications. Prior vaccinations within 4 weeks had no adverse events. Prior vaccinations he had Flu shot two months ago. On 08Feb2021, the patient had body aches, legs hurting from calves in both sides. Arm where shot went hurt tremendously but was better today. He is still sore. Had chills where he was hot and then cold, but that is gone. He still has the body aches. Had his legs hurting before, but just on one. He got the COVID-19 Vaccine and it amplified it more. Both legs started hurting like a muscle aches but hasn't done any exercising besides walking. Was hot and cold on the 08Feb2021, and in the evening started feeling all of the aches. Especially when he lays down to get comfortable. He has to move around. Just had mild body aches now. He felt like going to doctor visit, yesterday felt like going but didn't visit, it was hurting, woke up with milder aches today. Next COVID-19 Vaccine in 01Mar2021. Outcome of the event was unknown. Follow-up attempts completed. No further information expected.
Patient was given vaccine that had been drawn in a syringe for longer than 6 hours. No somatic complaints from patient at this time.
No adverse event; RN calls to report MMR II Lot#u013035 exp 4/23/2023 administered to a patient. No further AE.  No PQC; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-AUG-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, one time, lot #u013035, expiration date: 23-APR-2023, administered as prophylaxis (strength, and route of administration were not provided). No adverse events were reported.
fever, chills, severe headache, body aches, lymph system pain, severe rash and pain - lower extremities, shortness of breath, chest discomfort fever and chills lasted 3 days, all other symptoms lasted at least 2 weeks and rash is still healing after 4 weeks
ARM BARELY SORE; BIT TIRED; This spontaneous report received from a patient concerned an 89 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced vaccination adverse reaction when treated with tetanus vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced arm barely sore, and bit tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm barely sore and bit tired was not reported. This report was non-serious.
Moderna COVID?19 Vaccine EUA: chills, joint pain, difficulty breathing fatigued
7-24-07 awoke with bandaid size welt, red warm, ice and advil. Seen by physician 7-25-07 Hytone Crm applied tid. Mom reports less redness. less swelling.
This spontaneous report has been received from a pharmacist, via company representative, referring to a group of unspecified patients (demographics were not reported). The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, PNEUMOVAX 23 and ZOSTAVAX (strength, doses, routes, lot #, expiration dates or anatomical locations, for both vaccines were not reported) were administered with sterile water diluent to unspecified patients for prophylaxis, at shorter intervals than recommended; they might have been administered simultaneously, or up to a week apart. No adverse effects were reported and no additional information was provided. Additional information has been requested.
Case symptoms began 8/26/2022. Case hospitalized 8/27 - still hospitalized as of 9/15/22.
Red rash with bumpy skin appeared within 2 hours on my back and the next day more appeared on my left arm.  A total of 5 spots appeared.
Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had rash.
Pt took 25mg of benadryl prior to coming to get the shot  reported dizziness 2 mins after injection, headache 5 mins after injection, face tingling 7 mins after shot, hot arm and injection site (was not warm to touch) 10 mins after injection, 21 mins after injection patient states slight swelling of tongue, dizziness subsided 20mins after injection, some "spark-like" floaters started 20 mins after injection and then subsided 26 mins after injection, 42 mins after injection patient states she still has a little heat in her arm and very slight swelling of tongue (which is normal for her after all her reaction to things). She states she is back to her normal after injections. Pt advised to keep her epi pen close and go to the ER immidatley if symptoms come back or worsen. She is also advised to follow up with her PCP to discuss getting the second dose. Pt verbalizes she understands.  BP: 124/68  5mins after injection 02: 99% 5mins after injection
Patient states she received the Moderna vaccine 2 shot series in early 2021 + Moderna booster sometime in October.  Spoke with patient directly and patient's significant, neither able to provide place nor exact dates.   Patient directly admitted to hospital from transplant clinic for low oxygen saturation (mid to low 80s) despite patient denial of any symptomology for Covid-19.   *The total of available information contained in this report.
PATIENT REPORTS HAVING MODERATE PRURITIS OF THE SKIN FOR 1 NIGHT OF 02/02/2021.  NO REACTIONS NOTED.
had swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "had swollen lymph nodes". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever (101.8 degrees)  for 24 hours Ongoing chronic headaches that happen spontaneously over several days.
Pt. received vaccine while under the age of 18. No known adverse effects have been observed.
Fainted; Did not feel well; Hit head; A little pain in arm; A spontaneous report was received from a 68-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the events, fainted, hit head, did not feel well, and a little pain in arm.    The patient's medical history was not provided. Relevant concomitant medications reported included ezetimibe, atorvastatin, and atenolol.   On 04 Jan 2021 at 9:00 am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient reported that she took the vaccine on 04 Jan 2021 and she did not feel anything after but a little pain in her arm.   On 05 Jan 2021 around 7:00 pm, the patient went to her fridge for a drink and told her husband she did not feel very well, and then fainted. The patient reported that she hit her head and has never fainted before. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, fainted, hit head, did not feel well, and a little pain in arm, were unknown.; Reporter's Comments: This case concerns a 68-year-old female patient  with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of Syncope, the non-serious listed event of Pain in extremity, and the non-serious unlisted events of Head injury and Malaise.  Based on the current available information and temporal association between the use of the product and the onset of the events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Transverse myelitis  numbness in lower extremities  paralysis in lower body from hips to feet from  July to present
got guillan barre from her flu shot; Initial information received on 17-Nov-2022 regarding an unsolicited valid Social Media serious case received from a consumer.  This case involves an unknown age female patient who got guillan barre from her flu shot after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, lot number, expiry date: unknown) via unknown route in unknown administration site for flu.  On an unknown date the patient had got guillan barre from her flu shot (guillain-barre syndrome) (unknown latency) following the administration of influenza vaccine.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (guillain-barre syndrome).  At time of reporting, the outcome was Unknown for the event guillain-barre syndrome.  Seriousness criteria: Guillain-barre syndrome was assessed as medically significant.
? June 20 ? struggling to breathe; morphine administered ? June 21 ? passed away