chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylaxis reaction; Initial information received on 21-Oct-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a 6 years old patient who experienced anaphylaxis reaction (anaphylactic reaction), while he/she received vaccines DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE, VARICELLA ZOSTER VACCINE [VARICELLA VACCINE] and KINRIX.  The patient's past medical history included Food allergy with allergies pork/porcine and beef and Food allergy with allergies to gelatin. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect VARICELLA ZOSTER VACCINE produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE produced by unknown manufacturer (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient received a dose of suspect KINRIX not produced by Sanofi Pasteur (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious anaphylaxis reaction (anaphylactic reaction) (Unknown latency) following the administration of VARICELLA ZOSTER VACCINE, DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE and KINRIX. This event was assessed as medically significant.  (Other relevant tests included no lab data.) Final diagnosis was anaphylaxis reaction.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for anaphylaxis reaction.  Information on the batch number was requested; Sender's Comments: This case involves a 6 years old patient who experienced anaphylaxis reaction (anaphylactic reaction), while he/she received vaccines DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE, VARICELLA VACCINE (LIVE) and KINRIX. Time to onset is unknown with the role of vaccine. However, further information including concomitant medications and lab tests excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be individually assessed.
This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with VARIVAX (merck) She is reporting that about 501 patients over the period of 08/27/2012 to 09/24/2012 have received VARIVAX doses that were exposed to unknown temperatures because the shipping duration took 5 days to the practice. No AE reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced incorrect storage of drug. No treatment information was reported. The outcome of incorrect storage of drug is unknown. Incorrect storage of drug is not related to VARIVAX (Merck). Additional information has been requested.
mom states 2 days p/vax on 14MAR95, took pt to MD because of fever of 103 which could not get to stay down w/APAP; no signs of infect were noted by MD;
This is a spontaneous report from a non-contactable consumer based on information received by Pfizer from Merck (manufacturer control number: 1-13570869034), for PREVNAR. A female patient of unspecified age and ethnicity received PREVNAR single dose via an unspecified route of administration on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient experienced keeps getting pneumonia on an unspecified date with outcome of unknown. No additional information was reported.
Informatoin has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, dose number, lot# and route were not reported), which was improperly stored. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Approx 10 days after shot, began to have blurriness in left eye. Treated as dry eye syndrome for 2 weeks, did not resolve and began to lose more vision. Diagnosed with Central Retinal Vein Occlusion  (CRVO) on 11/8. Treatment for CRVO has improved vision some but central vision is still gone from left eye/blurriness inhibits reading with left eye
Pt. was vaccinated 2-26-2003 she was not ill at the time. Thursday 2-27-2003 around lunch time she started having lunch and immediately felt nauseated and vomited. It was shocking to her how quickly she went from feeling well to feeling sick. She went home and laid down for awhile, around 7 pm that same evening she ate 2 slices of pizza she was again sick. No one in the family or that she was around has flu like or similiar symptoms. 2-28-2003 She stayed home from work "just felt crappy" her upper body joints hurt (shoulders, elbows, & wrist) lower body joints no symptoms. She had a headache. She called her hospital contact person to see if they thought it could be related to her vaccination. They told her to check her temp. it was 99.8 (usually she runs low)they suggested she come in to be seen by the hospital epidemiologist Dr.  She said that he thought medically it probably was a virus but that it would be a good idea to report it just in case. The Dr. adviced her to rest, take fluids check back in on monday. Today 2-28-2003 she still is tired, can't eat, is drinking fluids, her throat hurts but she thinks it is from throwing up, and her upper body joints still hurt.
Passed out. Seizure without shaking muscles contracted and fists clenched. Dizziness. Tingle in arms.
Patient reports a black spot, redness and pain lasting 1.5 yrs from where she believes her vaccination site occurred.
EARLY/MID MARCH HAD L EAR STUFFINESS/FULLNESS. THOUGHT I HAD WAX BUILDUP. WAS ABOUT READY TO GO TO MD TO HAVE EAR CHECKED AND ON 3/22/21 HAD SEVERE VERTIGO ATTACK. THOUGHT I WAS HAVING A HEART ATTACK. WENT TO ER & THEY DX POSITIONAL VERTIGO. VERTIGO ATTACKS CONTINUED EVERY 3-4 DAYS & THEN DAILY SO SAW ENT SPECIALIST & DX WITH MENIERE?S DISEASE.  ON DIURETIC AND LOW SODIUM DIET. MEDS FOR ATTACKS DIDN?T REALLY WORK. STARTED HAVING MORE BALANCE/DIZZY ISSUES IN MAY/JUNE. IN JULY SAW  ENT, HAD BALANCE TESTING. STATED SYMPTOMS CONSISTENT WITH MENIERE?S BUT ALSO DX WITH PPPD. SAW VESTIBULAR REHAB AND NOW DOING VISUAL OCULAR REFLEX  AND BALANCE EXERCISES. SEEING SOME IMPROVEMENT?.FINALLY.
Woke up on Tuesday morning, October 12, with a slight headache and aching left arm at site.  As the day progressed I became loopy and then I became feverish with chills.  I took 2 Tylenols, Arthritis formula.  That was all I had in my house to take.  By 9:00PM, I felt better.  I have never had a reaction to a vaccination before.
I went to the ER on March 1, 2021, I had chest pressure and shortness of breath. The doctors were unable to find anything wrong. I was admitted on 03/18/2021 for a cardiac work up and the Doctor's still didn't find anything. The following month I was still having episodes, but my Primary Doctor felt like it was anxiety. My doctor then started me on medication for Anxiety. June 08, 2021, I was diagnosed with Atrial Fibrillation. By the time I made it to the ER they were gone. Since then, I've had 3 Cardioversions and 1 Cardiac ablation. I'm Actively in Cardiac Care.
8/24/23: 8 pm - injection site soreness  11 pm - restlessness   8/25/23: 2:30 am - Muscle aches, shivers, headache, fatigue   6 am - muscle aches, fatigue, headache
Info has been received from an MA concerning an 8 year old female with an "unremarkable" history and no known allergies who on 12/18/97 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 3/30/05, the pt experienced serious breakthrough of varicella. Lesions were noted on her face, neck, scalp, trunk and back. On 3/31/05, the pt was seen in the office and according to her family "there were more lesions than yesterday". At the time of the report, the pt had not recovered. There was no product quality complaint involved. Additional info has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at a physician's office (and administered by a physician) as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by the same physician at the office for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a physician concerning an 8 year old female, with no medical history and no allergies, who on 26-JUN-2000 was vaccinated once with a 0.5 ml dose of Varivax (Lot# 635207/0075K). There was no concomitant medication. On 05-SEP-2006 the patient presented with breakthrough rash with more than 50 lesions. It was noted that the patient was still developing more. At the time of the report the patient had not recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The reporter expressed concern about the lot. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
pt recv vax 19JUL95 & 13NOV95 pt devel varicella lesions & was dx w/chicken pox;pt subsequently recovered
Narrative: Patient is 66 year old male with past medical medical history of COPD, Hyperlipidemia, Hypertension, GERD, NAFLD, prostate cancer (s/p radiation and androgen deprivation therapy in remission), chronic back pain on opiods, hypogonadism on testosterone (started day prior to hospitalization). Patient received first dose of Moderna COVID vaccination on 2/10/21. Additionally, he started taking tropism on 2/10 following urology recs for bladder spasms, and he received his first testosterone shot for hypogonadism on 2/11. Patient presented to ED on evening of 2/13 with chief complain of right sided abdominal pain, constipation, bright red blood in urine earlier that day. Patient was admitted (primary working diagnosis at the time was acute colitis, with CT imaging confirming inflammatory process in the colon akin to mild colitis) and started on antibiotics, fluids and had stood study conducted. On 2/14, patients lactate increased from 3.6 to 6.7, which prompted consult to general surgery. Patient transferred to medical stepdown. Surgery consult results "likely colitis with possible pseudo-obstruction. No surgical indication currently seen on CT scan. Will treat with bowel rest, IV antibiotics, IV fluids, avoid dehydration and optimize fluid status." "Recommended GI consult to consider colonic decompression" GI consult placed on 2/14 also - recommendation that endoscopic decompression was not needed at the time of consult as the colon was fluid filled rather than full of gas. continue IV fluids, antibiotics, monitoring on stepdown. Patient appeared to be improving (lactic acid down to 5.5) At 16:33 on 2/14/21, patient found down on the floor next to his bed with brown vomit around him. Code blue called and CPR was initiated immediately. After ~ 15 minutes ROSC was achieved, patient had been intubated and patient was transferred to MICU. Patient coded again (~2300). After family meeting, family opted for DNR status. Patient went into cardiac arrest again 0259 on 02/15/2021, and passed away. PEA/Asystole Arrest believed to be secondary to profound hypoxia in the setting of a massive aspiration event (autopsy not performed).
Patient was given vaccine on 1-9-21, today on 1-17-21 she noticed a bump on her arm where the vaccine was given.  It is tender and a little red.
A few hours after her arm was sore and painful. A few hrs later a red hard ring began to grown. In the morning a huge hard painful sport was all around the upper arm.
This spontaneous report as received from a pharmacist refers to two unspecified patients of unknown age and gender. No concurrent conditions and medical history were reported. In July 2015, the patients were vaccinated with doses of (Oka/Merck) VARIVAX lot # K006134, expiration date, route and dose were not provided). Concomitant medication were not provided. On an unknown date in 2015, the patients experienced injection site redness and itching. The patients did not seek for medical attention. Therefore, no treatment was given for the events. The outcome of injection site redness and itching was reported as recovered on an unspecified date in 2015. The reporter did not assess the relatedness of (Oka/Merck) VARIVAX to the events. This is one of several reports from the same source. Additional information has been requested.
Muscle pain in arm where injection took place occurs with certain arm movements. After 9 months it is not getting better.
keeps eating, constantly hungry; This is a spontaneous report from a contactable consumer or other non hcp.     A 67-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 19May2021 as 2nd dose, single for covid-19 immunisation.  Medical history included chronic obstructive pulmonary disease unknown if ongoing COPD. The patient's concomitant medications were not reported. It was reported that, Caller reported that she and her husband got their 2nd Pfizer covid vaccine, he felt tired and a sore arm. She had no side effects. Caller later adds that the only side effect she has is she keeps eating, constantly hungry. They both received their 1st dose on 28Apr2021, 2nd one was yesterday 19May2021. Caller would like to know is Pfizer giving placebos out. She is worried because she did not have any side effects to the covid vaccine. The patient experienced keeps eating, constantly hungry on an unspecified date with outcome of unknown.    Follow-up (20May2021): This is a Follow-up spontaneous report from contactable consumer. This female consumer (patient) reported information included.   Information about batch/lot number has been requested. .
Extreme itching, redness from shoulder to elbow on left arm.  Getting worse each day.
loss of taste; started coming down with symptoms of the virus; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) and VACCINATION COMPLICATION (started coming down with symptoms of the virus) 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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste) and VACCINATION COMPLICATION (started coming down with symptoms of the virus). At the time of the report, AGEUSIA (loss of taste) and VACCINATION COMPLICATION (started coming down with symptoms of the virus) outcome was unknown.            The treatment history was not reported. The concomitant medication was not reported.
I am experiencing dizziness and confusion at times.  It has been constant for over a month and is worse when I look up to the left or lay down.
Red face; Rash on face; Rash on neck; Rash  on arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red face), RASH (Rash on face), RASH (Rash on neck), RASH (Rash  on arm) and RASH (Rash) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included CORTISONE ACETATE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ERYTHEMA (Red face), RASH (Rash on face), RASH (Rash on neck), RASH (Rash  on arm) and RASH (Rash). At the time of the report, ERYTHEMA (Red face), RASH (Rash on face), RASH (Rash on neck), RASH (Rash  on arm) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.
The evening Following the Shingrix shot I started to feel ill. Body aches, hot and cold, dizzy. In the a.m. after arising I felt very weak. Used the bathroom and started to feel extremely ill. I was headed back to bed but passed out onto the Floor. When I awoke I felt extreme pain in my jaw and was bleeding. My husband took me to the emergency room of Hosp. where I had a CT Scan of my head and EKG. Was then transferred to Hosp - trauma unit. After subsequent CT scans of my head and x-rays it was determined I had broken my jaw in three places and needed surgery. After four days and a complete medical workup (echocardiogram, EKG, heart monitor, CT Scans of head and x-rays of jaw). I was scheduled for surgery. Nothing was found (other than the jaw issues) in the tests and I was found to be in good health. I went home and I'm still recovering after 6 weeks. Don't know how my jaw will eventually heal (still in the process) per my maxillofacial surgeon from hospital who I have been seeing for follow up.
Six days after 1 year vaccinations, he had a fever which we then gave Tylenol and on 8th day after vaccinations he collapsed and started seizing. he seized for 1.5 hours. Doctors could not stop the seizing and needed to intubate him. He almost died and was put in PICU. He was hospitalized for 2 weeks and when he came home my 1 year old child was like a newborn. He couldn't even roll over. To this day he is going for therapy and takes Tegretol 3 times a day. Otitis media. Electrolytes abnormal. The 60 day follow up states his speech is at about 17 months. His gross motor skills are getting better but he is at about 20 month. And his fine motor skills is at about 19-21 months. My side was affected on the left side we are still doing activities to strengthen his left side.
This spontaneous report was received from a pharmacist regarding a 58-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reaction or allergies were not reported. On 16-AUG-2018, the patient was administered the first dose of RECOMBIVAX HB for prophylaxis (lot #, expiration date, strength, frequency and route of administration were not reported). On 02-NOV-2018, the patient was vaccinated with the second dose of RECOMBIVAX HB for prophylaxis (lot #, expiration date, strength, frequency and route of administration were not reported). No adverse effects were reported.
had it several times, had the Shingles Vaccine/Suspected Vaccination Failure; I've had it several times; No words can really describe the horrific pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had it several times, had the Shingles Vaccine/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: I've had it several times) and pain (Verbatim: No words can really describe the horrific pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 01-Mar-2023. This serious case was reported by a consumer via interactive digital media.  The patent stated that no words that describe the horrific pain. The patient had shingles several times and had the vaccine. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
This spontaneous report was received from a physician concerning an approximately 18 year old female patient with no pertinent medical history and no drug reactions/allergies. On 20-FEB-2013 the patient was reinserted with 68 milligrams (mg) of NEXPLANON (lot number reported as 102176/173940, expiry date unspecified) for contraception after the removal of the NEXPLANON due to insertion failure on the same day. Other suspect therapy included GARDASIL (lot number, expiry date, dose and route unspecified) received on 20-FEB-2013. Concomitant therapies included Tdap and MENACTRA received on 20-FEB-2013. On 20-FEB-2013, the patient was spooked. The physician was sure that the patient would have had a bruise since the insertion site was bleeding more than other patients she had performed insertions on in the past. On 20-FEB-2013, after the patient went to home after getting NEXPLANON, the patient felt like faint and tired while standing up from sitting. No lab tests were performed. Therapy with NEXPLANON was continued. The outcome of all the events was reported as resolving. The relatedness for all the events was unknown for NEXPLANON and GARDASIL. This is one of the two reports of the same patient. Additional information is not expected.
chills Narrative:  When patient presented for covid vaccine dose #2, patient reported the day after covid vaccine dose #1 patient experienced extreme headaches, muscle aches and chills. Patient did not report taking any treatment medications.
Mom contacted office to request VAERS (Vaccine Adverse Event Reporting System). She advised child received KINRIX (SKB lot TZ434) to left thigh IM and MMRV (PROQUAD - MSD lot K025765) SQ to right thigh 4/22/2016. That evening he was okay and she didn't notice any issues on Saturday. Sunday 4/24/2016 church caretakers reported child had a large red raised area to right thigh. Child had no trauma, injury, exposure to new detergents, soaps, clothing, foods, toys, etc. Child seen by medical and told was allergic reaction to vaccines and prescribed oral Prednisone and ZYRTEC which was helping. Child had no fever or rash elsewhere on body.
STATES INABLITY OF NOT BEING ABLE TO MAINTAIN HIS BALANCE OR WALK STEADILY. DOES HAVE H/O L SIDED WEAKNESS POST CVA.  HYPOTENSION PER VITAL SIGNS. HEADACHES, LIGHTHEADEDNESS, AND LOW PULSE COMPLAINT PRIOR TO VACCINE. UNSURE SYMPTOMS ARE VACCINE RELATED VS CHRONIC ILLNESSES.
Vomiting, chest heaviness, red/hot/swollen face and fever of 102.  Resolved after 48 hours.  Did not seek medical attention