chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 12:31 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 12:31 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients).    Patient received vaccine in deltoid. No concomitant product reported by the reporter.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions experienced by the patient. It was unknown if patient had ever been diagnosed or tested positive for COVID-19.  No treatment medication reported by the reporter.
Information has been received from a nurse practitioner concerning her 7-year-old daughter who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed chicken pox after vaccination. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was issued. Follow-up information received indicates that the patient is a healthy, white 7-year-old female with no pre-existing allergies, birth defects, or medical conditions, who on 15-Feb-2001 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included a first dose of measles virus vaccine live (Wistar RA 27/3). There was no illness at the time of vaccination. In the morning of 23-May-2007, the patient developed chicken pox. It was unknown if laboratory of diagnostic tests were performed. On 30-May-2007 the patient recovered. Additional information is not expected.
Maculopapular rash which progressed to vesicles, pruritic, no fever.
I AM PREGNANT I AM 33 WEEKS PREGNANT. IT HAS BEEN A HEALTHY PREGNANCY AND I HAVE NEVER HAD TO GO TO THE EMERGENCY ROOM FOR ANY DISCOMFORT MY DUE DATE IS AUGUST 12,2021. YESTERDAY I WAS VACCINATED AGAINST COVID AND SO FAR I HAVE NOT HAD ANY ADVERSE REACTIONS TO THE VACCINE.
pt had generalized T-C sz which lasted 4 hrs p/receiving vax & lasted appro x40-45 mins according to mom; mom noted rt arm stiffness, unresponsiveness then generalized body twitching; t101.2; OM in ER dx febrile seizure;
This initial spontaneous report was received from a registered nurse regarding an multiple unspecified patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patients received a doses of improperly stored ROTATEQ lot #K022990, expiration date 26-JUN-2016 and lot # L001316, expiration date 10-NOV-2016 dose and route were not provided. It was exposed to temperature of 47.4F for 1 hour and 4 minutes. Previously it was exposed to temperature of 50.3F for 1 hour and 20 minutes as well as 48.9F for 2 hours. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Onset of rash 2/4/2012 starting on trunk and progressing to neck, face, arms, legs.
after his 12 month vaccines he became pretty cranky and had a hard time staying asleep but he wasn't like that before the vannines then on 03/02/2020 he had his first seizure experience and he almost died he was turning blue and his seizure just kept on he wouldn't come out of it called EMS they took him to Hospital he had 2 more seizures at the Hospital his vitals were dropping and had a breathing tube put in and then was transported to another hospital and stayed over night until his breathing and vitals were back to normal, my osn was fine before his vaccines and i feel it is not safe for him to continue to have vaccines it is obvious it was his vaccines and i did research and met other familie ti met other families that had the same thing happen and were told it was the vaccines and the child was exempt from getting anymore vaccines i had no idea atg first because i was told from the Neurologist oh we still don't know why kids get febrile seizues and that's a lie because after doing my own research the child vaccines can in fact cause seizures and many other issues. he had another episode at 14 months old and had to call EMS again , he has not had any vaccines since 2020 now he is fine he has had no more seizures and i want to keep it that way , i don't think it's safe to give babies so many vaccines at once and in such a short time .
24Aug95 pt recv 1 dose vax. 19Feb98 pt devel 10 lesions that were itchy. pt afebrile.
On  3-13-2021, right arm became increasingly itchy around injection site.  By 8pm, upper right arm was covered in a red, swollen, welt.  roughly 4-5 inches across and 0.5-2 inches tall.  The area was noticeably hot to touch, stiff, and still painfully itchy.  Elbow joint and wrist joint began aching.   3-14-2021 - no change in right arm - still covered in a swollen itchy rash, elbow and wrist joint still ached 3-15-2021 - elbow and wrist joint no longer ache, rash size has diminished in size by about half.  The rash that is present is still red, swollen, itchy, and hot to touch. Called Clinic.
Patient had an asthma attack 15 minutes after receiving the first dose of the vaccine. Patient developed hives and had red itchy arms. Upon follow up with her doctor, patient received breathing treatment and medication.
No additional AE; a patient who was administered PROQUAD that was reconstituted with STERILE SALINE instead of STERILE DILUENT.; a patient who was administered PROQUAD that was reconstituted with STERILE SALINE instead of STERILE DILUENT.; This spontaneous report has been received from a registered nurse referring to a 4-year-old female patient. Information regarding the patient's medical history, concurrent conditions, concomitant medications, drug allergies or reactions were not provided.   On 11-SEP-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, albumin status rHA, 0.5 milliliter subcutaneously (SC) in her right thigh, lot number: W036941 and expiration date was 19-MAY-2024 for prophylaxis at public health/hospital. Additionally, it was reported that the vaccine was reconstituted with sterile saline instead of sterile water diluent. However, it was reported that the operator was trained. The nurse advised patient's parents she would need re-vaccination after one month and she was rescheduled. No adverse reaction or illness reported by patient's family. No product quality complaint was involved. No temperature excursion occurred as a result of a reading from a Digital Data Logger. This event was reported to the physician and to health department previously.
Patient still feeling dull pain on his left arm where he received the immunization, pronounce pain when pressure is applied in the area
red lesion at the injection site, approx 2 in across, firm, tender, and warm to the touch. very painful and slightly itchy
About 10 min after patient received 2nd dose, swelling on face and eyes. patient described difficulty breathing/something in throat. administered 1 dose of epipen. within 1 minute reaction was getting better, patient was back to normal in 5-10 min. facility called ambulance, patient was taken to hospital for futher evaluation.
sweating; diarrhea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included chemotherapy (1 and half years before the date of reporting).   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Shingrix and Influenza vaccine, the patient experienced diarrhea, vomiting and sweating. The patient was treated with sodium chloride (Intravenous Normal Saline). On an unknown date, the outcome of the diarrhea, vomiting and sweating were unknown.   It was unknown if the reporter considered the diarrhea, vomiting and sweating to be related to Shingrix and Influenza vaccine.  Additional details were reported as follows: The patient was was due for their 2nd dose in the week of reporting. The patient had the flu shot at the same time and had a horrid reaction like diarrhea, vomiting and severe sweating. The patient had to go to the urgent care for an intravenous 1000 saline for hydration.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On an unspecified date during 2016, the patient was treated by a physician for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Woke up @ 3am and was given tylenol for fever 103F, at 8am cried & screamed inconsolably until afternoon, about 6 hours according to mom. Had low grade fever on 5/20/01 and on 5/21/01 no fever. No history of redness or swelling of extremities or rashes.
At time of visit for vaccine administration, client's mother reported client as a healthy adolescent with no acute or chronic illnesses. Mother denied any reaction to previous vaccines. Only reported allergy at the time of vaccination was to penicillin. Client appeared healthy at time of visit and in no emotional or physical distress. Within 1 1/2 hrs of vaccination, mother contacted clinic reporting client having a reaction to the vaccines. 30 minutes later client presented to clinic with bilateral periorbital swelling and redness, blisters noted to upper checks below bilateral periorbital sockets.  Client denied any headaches, or pain to face or eyes; client denied any pressure to eyes. Client remained calm and cooperative throughout process, showing no signs of emotional or physical distress (including respiratory distress).
Chest pain, SOB, nausea, abnormal EKG and elevated blood pressure within 48 hours of shot.  Pain decreased with nitro. Transported to ER by ambulance admitted for 3 days heart cath performed and within normal range and normal cardic enzymes within first 48 hours of chest pain. 12/22/06-records received and reviewed. Cardiac consultation Impression: angina symptoms Hypertension.  Seen in ER with C/O dizziness, sudden onset of chest pain. Echocardiogram: normal left ventricular systolic function with an estimated ejection fraction of 55 to 60% without any evidence of left ventricular hypertrophy, dilatation or regional wall motion abnormalities. Cardiac angiography: no coronary stenosis, no coronary anomaly, no bridging coronary arteries, normal left ventricular systolic function, normal left ventricular end diastolic pressure at 10mmHg.
Swollen face with small bumps, discoloration on the face, itchy, stings
Numbenss to feet & hands; hospital 15MAY92 thru 19MAY92;
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department three days after vaccination reporting five hours of left-sided weakness. Diagnosed with right pontine stroke, admitted to hospital, initiated anti-platelet and cholesterol-lowering medications, symptoms resolved, and patient discharged to home medically stable.
extreme fatigue; headache; nausea; joint & muscle pain; joint & muscle pain; chills; slight 1 degree temp; slight sore throat; tender glands; feeling very unwell; foggy brain.; tender site for 1 day; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6208), via an unspecified route of administration in the right arm on 11Mar2021 (at the age of 74-years-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medication reported as yes.  The patient previously received flu vaccine but never had a flu. The patient had allergies to medications, food, or other products. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EL9266), via an unspecified route of administration in the right arm on 18Feb2021 at 11:30 and experienced very tired and slept for about 10-12 hours each day. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the vaccination. The patient underwent body temperature test and result was reported as slight 1 degree temp. The patient experienced tender site for 1 day on 11Mar2021 and the patient experienced extreme fatigue, headache, nausea, joint and muscle pain, chills, slight fever, slight sore throat, tender glands, feeling very unwell, had very foggy brain on 15Mar2021 at 16:00 (Reported as Day 3). Therapeutic measures were not taken for the events. The clinical outcome of the events site tender, extreme fatigue, headache, nausea, joint and muscle pain, chills, slight fever, slight sore throat, tender glands, feeling very unwell, had very foggy brain was resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Seizure-Mild, Additional Details: EMT was called, they picked him up. I asked his wife how he was doing after he was in the ER vehicle and she said they told her his blood pressure was low and blood sugar was low. He is not a diabetic.
This spontaneous report as received from a consumer refers to herself, a 24 year old female patient with allergy to BACTRIM. No information regarding the patient's pertinent medical history. On an unknown date (reported as late February 2017), the patient was vaccinated with second dose of GARDASIL 9 (route, dosage, lot number and expiration date not reported), for HPV preventation. Concomitant therapies included LEXAPRO, hormonal contraceptives (unspecified), and XANAX. On an unknown date, the patient experienced "strong abdominal pain and cramps" that lasted for hours after receiving the second dose of GARDASIL 9. The patient stated she had no reaction after receiving her first dose of GARDASIL 9. The outcome of abdominal pain was reported as recovered/resolved. No contact information available. Additional information is not expected.
Relevant history: Had endometrial ablation in 2014, no menstruation, cramping, or anything similar up for >6 years. Got 2nd vax (Pfizer) dose on 3/22/21. Around 4/23-4/24 have some mild cramping, don't realize that it might be menstrual cramps at the time as this is the first time in 6+ years I have had any signs of menstruation. Every month since I have at least some moderate cramping, with about half of the months being incredibly severe and debilitating (vomiting, unable to move from pain). I now have to take narcotics some months to get through. Considering hysterectomy if it doesn't resolve within ~ 1 yr.   Made me very hesitant to get booster- if vaccines were less politicized and I could rely on herd health I would not have gotten one but as it were risking death with COVID is probably worse.
Fatigue; headache; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: en6202) as dose 2, single and administered in arm right, administration date 06Feb2021 09:00 (Lot number: ema9809) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogren's Syndrome" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Rheumatism" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Radiation enteritis" (unspecified if ongoing); "migraine" (unspecified if ongoing); "periodic chronic fatigue" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin"; Meloxicam, reaction(s): "Known allergies: Meloxicam"; Codiene, reaction(s): "Known allergies: Codiene". The following information was reported: FATIGUE (non-serious) with onset 27Aug2021 19:00, outcome "recovered" (2021), described as "Fatigue"; HEADACHE (non-serious) with onset 27Aug2021 19:00, outcome "recovered" (2021), described as "headache"; PAIN (non-serious) with onset 27Aug2021 19:00, outcome "recovered" (2021), described as "body aches". The events "fatigue", "headache" and "body aches" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, headache, pain.  Additional Information: Facility type vaccine was Doctor's office/urgent care. Patient did not receive other vaccine in four weeks or other medications within two weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 after vaccination. After first shot: Fatigue, headache, body aches x 3 days. Then one day normal, then 1 days of fatigue. Second shot: Fatigue, headache, body aches x 4 days. Then one day normal, then 2 days of fatigue.  No follow-up attempts are possible. No further information is expected.
Currently pregnant - 36 weeks, 4 days day of the vaccine. Due date is 3/11/2021 but will be induced on 3/4/2021 because I am 36, no other underlying health conditions. Allergic to Cipro and Sulfa medications. Currently taking prenatal and 50 mg of Zoloft. Waited the 15 mins and felt fine; driving home about 30-40 minus after vaccine, swallowing felt difficult and tongue began to swell slightly. I went to my primary care; they said my throat looked clear but tongue was slightly swollen. I was given Tylenol extra strength (2 pills) and 25 mg injection of Benadryl in the left arm.  Encouraged to still get the second dose and take Benadryl prior the vaccine as well as go to the primary office to be observed after the shot.
Fever of 103 that was from 2 am to 10 am.  Tylenol given and fever went away.
Two days after the second shot, April 2, 2021, my left armpit started to hurt and it was swollen the size of a  lemon and the swelling lasted for 4 days. April 9th - 11th, 2021, my armpit was still in pain and April 11th - 13th, 2021, I had a mild headache and I never get headaches. On May 19th, 2021,  I had a mammogram, and I can't remember the doctors name. I had to wait six week to get one and in the mammogram results it showed a lot of swelling in my lymph nodes under my left armpit and swelling in my breast. They said they think it's okay.  Up until this date, the left arm is still week and I have pain in my left armpit down to my truck to my waist.
Pt received 1st Flu vaccine in clinic. Parents left office and shortly after called to report Pt began crying and then went limp and fainted after arriving home from office visit.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-NOV-2018, the patient was vaccinated with a dose of VAQTA (lot # N023953, dose and route of administration were not provided) for prophylaxis which expired on 05-NOV-2018. No adverse effects were reported.