chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report A0370073A describes a 62 year old male who died following receipt of hep B vaccine recombinant. The medical history included hypertension. The vaccinee was scheduled to received a liver transplant; the condition that caused the pt to require a transplant was not provided. The vaccinee received his first and second injections of Engerix-B on unspecified dates. He had no adverse experiences following these injections. He received his third injection of EngerixB at 14:20 on 05/29/2002. He remained in the physician's office for observation for 15 mins post-immunization. He stopped breathing in his car as his wife drove him home, approximately 20 mins after leaving the physician's office. His wife drove directly to the local ER, where he was pronounced dead. The cause of death was unknown at the time of this report.
minor fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) (patient).  An adult female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "minor fatigue". Therapeutic measures were not taken as a result of fatigue.  Additional information: Age group: Adult (18-64 Years). If other vaccine in four weeks: Unknown. Other medications in two weeks: Unknown. Adverse event: This was a person cutting my hair who mentioned that after shot 1 she felt minor fatigue and that's it - but after shot 2 she felt like she had come down with the flu, complete with shivers, muscle pain, fatigue, and headache for a full 24 hours afterwards. This mention occurred 2 hours ago. If covid prior vaccination: Unknown. If covid tested post vaccination: Unknown. Known allergies: Unknown. Other medical history: Unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ADVERSE REACTION; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (ADVERSE REACTION) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (ADVERSE REACTION). At the time of the report, ADVERSE REACTION (ADVERSE REACTION) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Bright red blotches on both knees & just below the knees.  Seen at 2:15 pm. No other symptoms. Redness is fading now at 3:30 pm.
Extreme menstrual-type cramping but no period (period was due that weekend) after vaccination. Cycle stalled for 22 days and I continued to have some PMS symptoms (migraine). The vaccine caused some sort of immune response that stopped my period that month. I have not had a cycle interruption like that since my 20s. I do have PCOS, but PCOS cycle interruptions usually don't have normal PMS symptoms and then suddenly stop. I took two pregnancy tests during that time a week apart and both were negative.
1/26 102.6+ fever  2/8 left axillary lymphadenopathy  2/19 sever vestibular neuritis
High blood pressure (very unusual for me), hives, high fever, headache, delirium. After dose #1, my doctor prescribed prednisone for the 2nd shot to help offset some of the reaction. My normal blood pressure is 90-something/60-something, and has been for years. Since the vaccines, it's stayed at 100-something/70-something and it's months later. My temperature has also always been 96.7 F and now it's 97.7 F and I feel unwell every day. I have a history of cardiac issues, and I am concerned about inflammation in my cardiac muscle. I already have scarring from when I had myocarditis as a child.
Adrenal crisis treated with 30mg prednisone, 50mg hydrocortisone x2 6 hours apart, caffeine, Motrin, Zofran, chicken broth for electolytes> Signs included hypotension, nausea, headache, weakness, I am a retired doctor married to an Endocrinologist and living to take care of my 2yo grandson for my daughter who is a resident in PEDS , I and my family are very familiar with managing my illness, which infrequently presents with crisis and I very rarely must be hospitalized .
A report was received from a health care professional on 11/21/2003 concerning a 21 year old female vaccinee who experienced decreased consciousness and fever and was subsequently admitted to hospital with a possible West Nile Virus diagnosis on 11/05/2003 after receiving Fluvirin vaccine on 10/22/2003.  On 11/05/2003, two weeks following Fluvirin vaccination, the vaccinee experienced decreased consciousness and fever and was admitted to hospital with possible West Nile Virus diagnosis.  The vaccine experienced several seizures while in hospital that were resistant to standard doses of IV diazep and lorazepam.  The vaccinee remains hospitalized and her seizures are controlled using propofol drip.  At the time of the report the outcome was not reported.  There was insufficient information to determine the reporter's causality assessment.  Follow up pending. The discharge summary received on 1/15/04 states chills, malaise, tics and drop attacks. Medical records states viral infection, tachycardia, encephalopathy. msv
Pain, itching, hard and warm to touch, red (large area of redness) at injection site.
This spontaneous report as received from medical assistant refers to a patient of unknown age. No medical history and concurrent conditions were reported. On 20-MAY-2015, the patient was vaccinated inadvertently with M-M-R II (lot number: K011317 and expiry date 13-AUG-2016) 0.5 ml injection subcutaneously and VARIVAX (Merck) (lot number: L001335 and expiry date: 13-JAN-2017) (dose and route of administration was not reported) concomitantly that had been stored improperly. No concomitant medications were reported. No adverse effects reported. The outcome of improperly stored product was unknown. The reporter considered incorrect product storage to be not related to M-M-R II and VARIVAX (Merck). No product quality complaint (PQC) was filed. No further information provided. This is one of the several reports of the same reporter. Additional information has been requested.
Vaccine 8/24/16 930am; arm sore that night; 8/25/16 hard to raise arm and Fever 102 degree that night; took TYLENOL. Body aches, ears red, headache -tried Ibuprofen and sinus MUCINEX for HA - still has as of 8/29/16; Started itching and blotching on 8/28/16; soreness gone aches gone; Recommended TAGAMENT and BENADRYL for arm itching.
Onset of muscle contracture of left arm. Gradual increase of sx, starting 24 hrs after administration of vaccine. Pain (L) shoulder, elbow, hand. Limited use of (L) arm hand.
Lip Swelling; cough; fever; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (Lip Swelling), COUGH (cough), PYREXIA (fever) and CHILLS (chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 061L20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included USTEKINUMAB (STELARA) for Crohn's disease.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced COUGH (cough), PYREXIA (fever) and CHILLS (chills). On 31-Jan-2021, the patient experienced LIP SWELLING (Lip Swelling). At the time of the report, LIP SWELLING (Lip Swelling) had not resolved and COUGH (cough), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had her Stelara shot 1week after vaccination based on Guidance given by her GI doctor.13 days after the first dose patient had a Chocolate cupcake which she had it previously following which her Lip swelled up so much that it looked like she got punched real hard. Treatment Medicines include Benadryl and Epipen   This case was linked to MOD-2021-067744 (Patient Link).
shingles; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.   In or around 21-OCT-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose of preventing shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date (reported as "shortly after receiving the vaccine"), the pt suffered a bad case of shingles. It was reported that as a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and sustained severe, serious, progressive and permanent personal and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   By the time of reporting, the patient was considered to be not recovered from the event. Moreover, the event was considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the reported event was considered to be disabling.
Pt had HEP A #2 injection in RT deltoid.  Following 2 days had localized swelling & redness.  Symptoms lessened by 3rd day.
Got vx years ago. Have shingles since 02Feb/Suspected vaccination failure; Have shingles since 02Feb; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 2nd February 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had the vaccine years ago. The patient had shingles since 2nd February 2022.  The patient could not think of any pain worse than this. The patient thought the medical community should put more focus on the pain and try to come up with a cure.  This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not reported. Note: The year of event onset not reported conservatively considered as February 2022.
MILD FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.No concomitant medications were reported.  On an unspecified date, the subject experienced mild fever. The action taken with covid-19 vaccine was not applicable. The outcome of mild fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210539009 and 20210545499.
Information has been received from a certified medical assistant (CMA) referring to a patient of unknown age and gender. No information regarding patient's relevant medical history, current condition and concomitant medications was provided. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013206, expiration date 29-JAN-2017, dose and route were unknown). The vaccines were stored under 34.5 F (min) and 37.9 f (max) for 24 hours. There was no previous temperature excursion. It was called because of a "data logger". NO adverse effects were reported. This is one of the several reports received from the same reporter.  Additional information has been requested.
Information has been received from a nurse practitioner concerning a female who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient developed a rash. It was unknown whether medical attention was sought. There was no product quality complaint. No other information was available. Additional information has been requested.
pt recvd vax & devel inject site rxn at dtap site consisting of erythema & inflammation; tx w/ ice packs;
Tingling and numbness at injection site and spreads to other parts of the body at different times.  Chills and nervousness.  Difficulty sleeping.
Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated IM with 0.5 ml of PNEUMOVAX 23 (lot# 667913/1021Z). It was reported that the patient experienced extensive redness, pain and feeling of heat at injection site. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Follow-up information has been received from a licensed practical nurse concerning a patient who on 26-OCT-2010, was vaccinated subcutaneously (previously reported as IM) with a dose of PNEUMOVAX 23 (lot# 667913/1021Z). It was reported that the patient called to say she had been seen by ortho "for bump she has from [PNEUMOVAX 23]," and that she was told this is a reaction to the injection. The area was now peeling, "not so much pain, but lump is still present from injection." The patient was taking BENADRYL for three weeks and it was noted that this was continued. The patient was instructed to watch for blood pressure elevation, to check at a pharmacy at least once a week. At the time of reporting the outcome was unknown. All available medical records will be provided upon request. No further information is expected.
Facial muscle twitching, muscle twitching and spasms in forearms, fingers lasting for several days
I am having headache, it feels like migraine headache; Upset stomach; Vomiting; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81-year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE) (Batch/Lot number: unknown); hepatitis b vaccine (HEPATITIS B VACCINE) (Batch/Lot number: unknown); varicella zoster vaccine (VARICELLA ZOSTER VACCINE) (Batch/Lot number: unknown); influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown). Relevant medical history included: "Schizoaffective disorder" (not ongoing), notes: diagnosed by years ago but I no longer have this.; "Manic depressive illness" (not ongoing), notes: diagnosed by years ago but I no longer have this. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "I am having headache, it feels like migraine headache"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Upset stomach"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea". Therapeutic measures were not taken as a result of headache, abdominal discomfort, vomiting, diarrhoea.  Additional information: The reporter stated that, I am calling you is I am having side effects from the vaccine adverse COVID-19 shots that I have had. The vaccine, I had 3 of them and I am having headache, it feels like migraine headache, I am also having upset stomach, vomiting and diarrhea at this time". Concomitant medications: Consumer stated, "I am taking about 15 medications (Further clarifications unknown). And I also had the Hepatitis B vaccine which they gave me, I have had the Pneumococcal (Unspecified Pneumococcal vaccine), I have had the Flu Shot (Unspecified flu vaccine), I have had the Shingles shot (Unspecified Shingles shot) (Further clarifications unknown if the vaccine was administered within 4 weeks of COVID 19 Vaccine hence captured as suspect conservatively)." LOT#/ Batch# and date of the shots for the vaccines (Hepatitis B vaccine, Unspecified Pneumococcal vaccine, Unspecified flu vaccine, Unspecified shingles shot):   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Provider administered covid 19 Bivalent Booster 0.2mL (NDC 80777-0283-99) instead of Moderna Bivalent dose 0.25mL (NDC 80777-282-99) as first dose of primary series. No adverse reaction.
At the 2 week mark after taking the vaccine I developed severe backache ,a fever,fatigue and disorientation.
Intermittent runs of tachycardia accompanied with dyspnea and diaphoresis. Symptoms began approximately 6 hours after receiving vaccine and has persisted.
This spontaneous report was received from a healthcare worker, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored (temperature 6.5 Fahrenheit, for 6 months) doses of VARIVAX, lot # L037561, expiry date 29-SEP-2017 and lot # L020002, expiry date 02-JUN-2017, (dose, frequency and route of administration not reported). No adverse effects reported. Vaccines were back in range. Previous temperature excursion was reported as no. It was because of a data logger. No product quality complaint (PQC) was involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
About 30 minutes post injection patient reported pain with numbness in (L) shoulder and extending down to fingers. About 15 minutes after initial pain report (45 minutes post injection) slight swelling was noted in patient (L) arm as well. Initial evaluation concluded potential allergy related to cross contamination of latex in prefilled syringe due to contact with the syringe lid and possible nerve agitation associated with injection. Patient was given 400 mg of ibuprofen (her chosen pain reliever) and 25 mg of diphenhydramine. Patient's symptoms subsequently subsided a few hours later.
Developed a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Developed a cold) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NASOPHARYNGITIS (Developed a cold). At the time of the report, NASOPHARYNGITIS (Developed a cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received on 23-JUN-2021 contains no significant information. Updated reporter details.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.
Narrative: Hospital, acute resp failure, cough. Remdesivir, dex, azithromycin, ceftriaxone, oxygen, d/c to home. Covid +, moderna x 4
Approx. 33 hours after receiving the Fluzone vaccination, the pt. reports a large, solid, raised "welt" extending from injection site to elbow on L arm.  She says it itched like a hive. Later, round, smaller "welts" appeared on her left shoulder, back, left and right legs and on her buttocks.  These "welts" also itched. She used Aveeno to relieve the itching, which it did. She also took a dose of 50mg Benadryl, which seemed to help, also. She does not complain of any other symptoms.  The "welts" have cleared as of 11/3/05.
Admin ADACEL 3/16/10 and patient developed warm erythatus rash.
Fever; Chills; Headache; Nausea; Arm is sore at the injection site also; This case was reported by a other health professional via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th June 2020, the patient received the 2nd dose of Shingles vaccine. On 12th June 2020, 1 days after receiving Shingles vaccine, the patient experienced fever, chills, headache, nausea and injection site pain. On an unknown date, the outcome of the fever, chills, headache, nausea and injection site pain were unknown.   It was unknown if the reporter considered the fever, chills, headache, nausea and injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received shingles vaccine and experienced fever, chills, headache and nausea. Arm was sore at the injection site also. The reporter would not provide any name or contact information for themselves and then abandoned the chat did not had a chance to verify if it was GlaxoSmithKline Shingrix vaccine.
Right after gettthe firat shot i became really warm and flushed. They just told me to sit and wait to get better. I doubt they reported anything since they didn?t mention this website that i am finding until now. Then I got Mastitis, left breast got really swollen hard to touch and painful right the next day after receiving vaccine. Never had mastitis in all my years of breastfeeding even with my prior child. Also expressed milk coming out was in a  blue hue for several months. Usually color change  would only happen depending in food i take like veggies but did no eat any green veggies or anything similar in color. Told nurse who have me the 2nd shot and i didn?t have ins to gi see a doctor. Plus mastitis did not get worse since I was able to help it by expressing milk out but only happened to that breast for more than 2 weeks but milk lkept coming out that color for months. Told the people at pharmacy that it happened they didn?t note it or did anything else.