chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Blotchy area around injection site on her left shoulder and arm), MYALGIA (body aches), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE RASH (Blotchy area around injection site on her left shoulder and arm). On 13-Apr-2021, the patient experienced MYALGIA (body aches), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills). On 14-Apr-2021, the patient experienced RASH MACULAR (Blotchy area around injection site on her left shoulder and arm). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site rash, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Blotchy area around injection site on her left shoulder and arm), MYALGIA (body aches), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and VACCINATION SITE RASH (Blotchy area around injection site on her left shoulder and arm) outcome was unknown.
1 hour after shot, throat felt slightly off. 22 hours after shot began to experience headaches and head fog. Following day had extreme body aches (especially on sides), headaches, head fog, and fever.  Very lathargic. Throat felt normal again.  Following day most body aches were gone, but also received periodic headaches and still had some body aches and soreness. Began to feel itchy. Itchiness location wandered throughout day - began in groin, moved to legs, moved to chest, then to head. Following day still have itchiness but primarily on head and to some extent on feet. In the evening, upper lip also became very swollen. This is current status of side effects felt.
Localized fever at injection site of 103 degrees. Pain at injection site. Fever at injection site lasted 4 days beginning 3 days after injection.
WeOn August 11, 2019 I had the 2nd shot of the Shingix vaccination at the same location as I had the 1st shot - Pharmacy store. I can't absolutely say the adverse reaction is from the Shingrix vaccination but I suspect it might. Over the course of the next month I noticed swelling that was not normal but I wouldn't call it severe. My lip was swollen for 3 days which is unusual. My tongue swelled a little bit for a day or two and that is unusual. The back of my left hand swelled but I thought I might have hit it as I did yard work. In the corner of the same hand on the back between my thumb and forefinger it swelled and I thought it could be a bug bite. The severe reactions I experienced began sometime overnight Wednesday, September 18, 2019 into Thursday, September 19, 2019.  I woke up and my genitals had swollen a bit. We took note of it and, as it was the first day of a trip, went about our day. That night I stopped to use the restroom and it had become more severe to include my penis. I went to Emergency Room. I was never admitted and they treated me and had me check in with the Urologist at the end of my stay and all seemed well. However, that last day, Monday, September 23, 2019 I remember biting my lip but not very hard when I ate breakfast. Through the day my lip became more and more swollen and when I entered my plane my entire bottom lip was swollen over my top lip. The next day I began experiencing hives. I did go to my primary doctor on Tuesday, September 24, 2019 to check in with her about it. That Saturday, September 28, 2019 I experienced a swollen tongue and went to emergency room for treatment. Thru today, Monday, October 14, 2019, when not on steroids, I have experienced severe hives and swelling to include my entire face with my eyes swollen shut.
Left jaw is pretty sore. Not all the time. But it gets sore. I believe its effecting the temporalmandibular. No I've never had a broken jaw or injury to it in past. Also my wife had the same shot the same day the same arm.and has the same effects?  And I can taste a chem taste at times also.
A non-serious spontaneous report of a 71 year old got a dose of H1N1 LAIV was received from a registered pharmacist/healthcare professional concerning a 71-year-old male. On 17-Dec-2009 the patient received a dose of H1N1, Intranasal. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Information has been received from GSK with assigned other company number(MFC# US2017GSK086689) on 16-JUN-2017. This spontaneous report as received from a physician via company representative refers to an adolescent female patient of unknown age. On an unknown date the patient was vaccinated with varicella virus vaccine live (oka/merck)(manufacturer unknown) (lot#, dose and route were not reported) for prophylaxis. Other suspect therapies included mepolizumab(NUCALA)(indication, dose, route and frequency were not reported). The physician mentioned that the patient that after approximately her 3rd dose of mepolizumab(NUCALA) had an exposure to someone with chickenpox and got sick of chickenpox. Her other schoolmates did not get infected. She had a complete history of chickenpox vaccination (vaccination failure). Mepolizumab(NUCALA) was interrupted. The outcome of chickenpox and vaccination failure was unknown. It was unknown if the reporter considered chickenpox and vaccination failure to be related to varicella virus vaccine live (Oka/Merck)( manufacturer unknown) and mepolizumab(NUCALA). Additional information has been requested.
Patient was given a third dose of shingrix four days after his second and what should  have been his final dose. Spoke with patient yesterday and he has not had any adverse effects.
This spontaneous report was received from a 53 years old female patient, who was reporting on herself. The patient's concurrent conditions included leukemia, migraines and anxiety. The patient's concomitant medications were not reported. The patient was allergic to certain antibiotics (unspecified). On 31-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 injection (dose, route of administration, lot # and expiration date were not reported), for prevention of pneumococcal disease. On approximately 31-AUG-2017, reported as "since she was administered the PNEUMOVAX 23", she was not feeling well. She spoke with an unspecified healthcare provider at an unspecified cancer hospital where she was being treated for leukemia. The healthcare provider told the patient that what she was experiencing were common side effects of PNEUMOVAX 23. The patient declined to provide the specific reactions she was experiencing. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not assessed by the reporter (she did not want to say they were from PNEUMOVAX 23 if they were not).
Case number PHEH2016US032011, is an initial spontaneous report received from a consumer (patient's wife) on 05 Dec 2016. This report refers to a 38 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1620501, expiration date: Jun 2017) on 26 Nov 2016 at a dose of 0.5 ml, intramuscularly. On an unknown date (few days after the injection), the patient had a headache and muscle pain in back of his neck. The patient went to a physician who diagnosed him with dysphagia. On an unknown date, the patient felt like a lump in his throat. The outcome of the event dysphagia was reported as condition unchanged and the outcome of the other events was not reported. The seriousness and outcome of the events were not reported.
Feeling faint, shaky, vomited a small amount. 911 called. Patient recovered and requested to go home.
swelling to feet, body aches, chills, sinus congestion, facial/lip swelling, patient describes throat as feeling like it is closing, cough, SOB, fatigue , mucous in stool, chest pain.
Patient reports shortness of breath ad her heart racing. EMS performed EKG which was abnormal - ST elevation. Patient was transported to ER. Daughter of patient reports that patient was at the ER 2 days prior due to blood pressure.
Huge Bruise; Threw up; Migrane Headache; Numbness; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient asked about timing of second dose due to adverse event reported on first dose. She indicated she had a huge "bruise", threw up, migraine headache and numbness. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt received vaccinations on 6/26/01 and mother called office on 7/9/01, stating pt developed head to toe purpura rash on 7/8/01 and increased fever and neck swelled. Pt to local MD and was put on antibiotics. Rash to hands and soles of feet. Very concerned regarding child having "measles". Talked to Immunization supervisor. I talked to someone else at another facility and they advised pt to be checked for Rocky MT Spotted Fever. Mother took child to MD on 7/10/01 and he felt was a reaction to injections. Child was fever-free on 7/11/01 but still has rash. Child was sensitive to light.
This case was reported by a healthcare professional and described the occurrence of jaw pain in a 36-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 24 July 2012, the subject received 1st dose of ENGERIX B (details unknown, left arm). On 24 July 2012, 2 hours after vaccination with ENGERIX B, the subject experienced severe jaw pain, jaw tightness, neck discomfort, headache and general malaise. The healthcare professional reported that the subject came to their clinic about two hours after receiving an ENGERIX B vaccination, complaining of severe jaw pain, jaw tightness, neck discomfort, headache, and general malaise. She did not receive any other vaccinations at that time. At the time of reporting, the symptoms seem to be improving. The healthcare professional considered the events were probably related to vaccination with ENGERIX B.
shortness of breath; diarrhea; chills; fatigue; shaking; This is a spontaneous report from a Pfizer-sponsored program  received by a contactable consumer. A male patient (reporter's husband) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had taken the first dose of the Pfizer COVID-19 vaccine on 22Mar2021. The next day, 23Mar2021, the reporter had to take the patient to the hospital as recommended by his doctor. He had experienced shortness of breath, diarrhea, chills, fatigue, and he was shaking. He had been in the hospital for 3 days. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
This initial non-serious spontaneous case, was received on 18-Oct-2017, from a consumer, concerning 32-year-old adult female patient of 14 weeks pregnancy. The patient had no concomitant medications. On 18-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: Intramuscular, anatomical location, batch number, expiry date: not reported). It was reported that, patient was 14 weeks pregnant and received FLUCELVAX vaccine. The patient had no adverse event. The estimated date of delivery was reported as 17-Apr-2018.
Pt recvd 1st & 2nd dose of Engerix-B; 1st dose uneventful; Onset of events occured about 2 wks p/2nd vax; no treatment given; gallstones were ruled out;
Patient received a dose before the recommended age; A HCP called to report that she inadvertently administered a dose of PROQUAD to a 2 year old patient. The caller said the patient had received "MMR and Varicella vaccines at their 12 month doctor appointment." The caller did not provide brand names f; This spontaneous report was received from an other Health Professional and refers to a 2-year-old male patient.  The patient's medical history, concurrent conditions were not reported. The patient had received measles vaccine (+) mumps vaccine (+) rubella vaccine (MMR) and Varicella vaccines (unspecified) at their 12 month doctor appointment.   On an unspecified date, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, lot #, expiration date, route of administration were not reported). On 28-MAR-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (lot #W034209, expiration date: 24-APR-2024), administered intramuscularly (left deltoid) for prophylaxis (dose and strength were not reported) (Product administered to patient of inappropriate age) and sterile diluent was used to reconstitute the vaccine (lot#and expiration were not provided). The patient also was vaccinated with diphteria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (VERO) (+) tetanus vaccine toxoid (KINRIX) (lot number 69N2M intramuscular (right deltoid).
Received Full Dose First booster instead of half dose; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (Received Full Dose First booster instead of half dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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. In May 2022, the patient experienced ACCIDENTAL OVERDOSE (Received Full Dose First booster instead of half dose). At the time of the report, ACCIDENTAL OVERDOSE (Received Full Dose First booster instead of half dose) outcome was unknown.            Patient was not Immune compromised.         No concomitant medication were reported.   Patient  received 3 doses of Moderna COVID-19 vaccine. First full dose, 2nd full dose and Booster dose recently. Patient stated that on the vaccination card it stated that patient received a full dose.     No treatment information was provided by the reporter.
This child complained immediately of extreme burning in arm. Bleeding when needle was pulled out of skin but there was no blood when plunger pulled back prior to injecting vaccine. One hour at home, the child was complaining that her chest hurt and she started coughing. I advised the mother to give her Tylenol and apply ice to injection site. Never complained of shortness of breath to my knowledge, but the mother called back in about thirty minutes and reported severe arm pain, crying, crying, more chest pain along with coughing. Advised to call private physician or go immediately to the ER. Two hours later the child was seen at the ER and was given a cough medicine that contained Codeine and the mother reported the doctor said that the child had a cold starting. The mother also said that after the child got back home she had taken the cough medicine and relaxed that she felt better. The child went to school the day after the episode, the mother said that she still had a "sore arm", then. NOTE: the client before this child was extremely loud when given his immunizations and required most of the clinic staff.
Client complained of dizziness at 11:09. Will call for a ride home. Offered to call 911 (client refused) Suggested client go to ED. Client left to home in a LYFT; stated he has no other way home; instructed to go to the ED
This spontaneous report was received from licensed vocational nurse practitioner via company representative regarding 5 patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date in July 2016, the patients received unspecified doses of VARIVAX immunization series that were improperly stored (Lot # M006731, expiry date: 09-FEB-2018). Temperature time frame: 14.5 F, 6 hours and 24 minutes cumulatively. There was previous temperature excursion. The call was because of data logger. The nurse stated that the vaccinations occurred between 15-JUL-2016 to 22-JUL-2016. No adverse effects were reported. No product quality  complaint (PQC) was involved. Additional information has been requested.
Temp 100, chills, headache, body aches, mild pain at injection site starting 13 1/2 hrs post injection for 24hrs Tx: ice to site, Tylenol
Starting late on 8/25/2020, he started to feel fatigued. He started having some warmth and redness at the injection site. By the time his wife contacted me on 8/2/2020, he was also having intermittent fever of 100 degrees, feeling chills and had redness and swelling on the anterior part of his upper right arm. I referred him to his doctor for an immediate consult. The doctor thought he was having an allergic response. The provider told him to take Benadryl and ibuprofen. He was prescribed cephalexin, but was instructed not to take it unless he developes a fever of 104 decrees.
Patient experienced pain, redness, and swelling to left upper arm and area was warm to the touch after vaccine administration on 6/01/16. Area was red and swollen on back side of upper arm approximately 2 inches above elbow and coming around inner arm under axilla. Patient had taken BENADRYL, applied compresses and taken TYLENOL for pain. Onset of symptoms were reported to have occurred within a few hours after administration. No changes occurred over night to next morning (6/2/16). As day progressed to later in the evening, redness, pain, and swelling continued down arm making arm numb and tingly. Client preceded to ER for treatment as instructed by local health department if symptoms worsened. At ER patient was given bolus IV 0.9% 1000ml, BENADRYL 25 mg IVP, TORADOL 30 mg IVP, SOLU-MEDROL 40 mg IVP, and CLARITIN 10 mg Oral. Patient was sent home with prescriptions for PERCOCET 5-325 1 tablet by Oral route every 6 hours as needed and Prednisone 20 mg 2 tablets by Oral route once daily for 2 days. Patient to continue as needed for symptoms, BENADRYL, CLARITIN, and may use ibuprofen 800 mg every eight hours as needed for pain. Patient to follow-up with Primary Care Physician in 5-6 days. 6/6/16 Patient reports symptoms are resolved as of Sunday 6/5/16.
Pulmonary Embolism in both lower lobes of lungs. Life flighted to Hospital.
Patient reports getting Moderna vaccine, and RN that administers remember having extra doses of Moderna to give this patient on 3/27/21. However, when went to process thru 2nd vaccine dose, the consent form filled out by the RN has information about the Pfizer vaccine. Patient, RN, and pharmacist on duty all seem cofident that the patient received Moderna even though the consent form was labeled with Pfizer vaccine information.
COVID arm (left arm) Symptoms: Red, swollen, hot, mildly itchy 8.5 cm width  x 7 cm height Onset: less than 24 hours. Duration: approximately 1 week  Treatment:  Applied cold compresses and sparing amounts or either hydrocortisone or betamethasone
resident had cold, back sore and runny nose with blood clothes . she got better after three weeks .
FELT LIKE I HAD COVID AGIAN  . BODY PAIN   ,FEVER , GI UPSET . SHORT OF BREATH  ,FATIGUE  LASTED FOR 4 DAYS
Lethargy, Fever (100.4), Tiredness, Headache, pain at injection site (right arm), Flu like symptoms continuing past 40 hours after 2nd Covid 19 vaccine injection.
Nausea, vomiting, cramping, fever, chills, lethargy, headaches, and body aches
Exactly 32 hours after injection, both myself and a 61 year old friend who got the vaccine with me experienced the following: vomiting, incredible amounts of mucus coming from lungs, uncontrollable diarrhea, violent sweating and chills, extreme headache, bed-ridden for two days. Both the pharmacy and the health dept. refused to record our reactions, and the health dept. hung up when we tried to report this incident. The pharmacy would not call us back.
developed malar rash on face on 11-15-07; was prescribed levo-cetirizine by dermatologist which she took for 2 days; rash recurred on 11-19-07; she reported to CDC occ health clinic on 11-27-07; dispensed hydrocortisone cream which she never used; did not continue levo-cetirizine; no recurrence of rash since then;
Got COVID shot. Next morning woke up with a swollen collarbone lymph node. Felt ok in the morning. Not warm to the touch or sore. No physical allergic reaction like hives or redness, just a lot of fluid in the node.
Patient missed the time frame between the both doses of Moderna COVID-19 vaccine; Stomach flu; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed the time frame between the both doses of Moderna COVID-19 vaccine) and GASTROENTERITIS VIRAL (Stomach flu) 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 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed the time frame between the both doses of Moderna COVID-19 vaccine) and GASTROENTERITIS VIRAL (Stomach flu). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed the time frame between the both doses of Moderna COVID-19 vaccine) and GASTROENTERITIS VIRAL (Stomach flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: added patient demographics, updated first dose details, added adverse event, updated adverse event detail