chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low grade fever; Chills; Body aches; Joint pains; Headache; severely sick; This is a spontaneous report from a contactable consumer (patient). This 59-year-old female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484, Expiry Date, NDC Number: Unknown), via an unspecified route of administration, administered on left upper arm on 25Jul2021 at 15:30 (at the age of 59-year-old) as dose 1, single for covid-19 immunization. Medical history included Covid 19 which she had in the first part of October and had double pneumonia. She was sick a long time but got well. She was recommended to get the vaccine. The patient took Covid vaccine as per doctor recommendation since she had such a bad case of it, in dental field and a sister with chemo. No investigation assessment. The patient's concomitant medications were not reported. Patient stated that she got the Covid vaccine on 25Jul2021 (Sunday) and had been severely sick since then. She felt like she had Covid all over again. She wanted to know whether it was normal to have it this long or not. She wanted to know whether this was something she should be concerned with or not. She had a low grade fever, chills, body aches, joint pains, headache and severely sick on 26Jul2021. Stated that she took Advil for the chills, body aches. Stated that she had tried hot showers but it did not help. Stated that the Advil would break her fever and as soon as that went away it came back. Stated that all the events started at 12:01 am on Monday. She was about to overdose on Advil to make it tolerable to keep the fever down and for her body aches because they were so severe. She took four Advil every four hours. Stated that her fever came back and started climbing and the body aches were unbearable. Stated that it was just like when she had Covid last year. Stated that the first days were normal and she was not getting any better. Stated that her husband had the same shot the same day and he was fine. Stated that she did know if she could do the second one. Treatment received for all events. The outcome of all events were not recovered.   Follow-up attempts are completed. No further information is expected
02/18/22 presents to ED for "abdominal wall pain and swelling". PMHx of "multiple ventral hernias after complicated intraperitoneal onlay mesh placement with mesh infection"
Complained of numbness and tingling and swelling of lips 1.5 hours after flu shot. Started Benadryl ever 6 hours.  Lips still "puffy" next day, but feeling was back.
severe nausea, vomiting, inability to drink for 36+ hrs, diarrhea for several days, severe fatigue
pt lives in a nursing home; was dx with a positive COVID test on 1/29/22; placed in isolation; DNR; on O2 via NC; given Dexamethasone, ABX, Guaifenisen; pt found deceased in the nursing home
adm to hosp 31AUG95 w/3wk hx progressive non prod cough,SOB & fevers;devel abd pain,diarrhea;lost 30lbs;pt had multiple diagnostic studies,devel pleural effusion,viral pneumonia & measles pneumonia;
Fever for more than 24hrs at 101.6F ,chills, sweating, very severe headache, sensitivity to light and sound, widespread body aches and pains.
patient states that she did not prefer the Pfizer vaccine and had been advised that she should get Moderna due to having previous high blood pressures.  She, however, consented to  Prizer because it was the only one she could find available in the area.  This pharmacy does not have Moderna available.  Patient says that since she has  received the vaccine her blood pressure has become high.  Before the vaccine she reports that her blood pressure had become normal and her dr had removed her blood pressure medication.
Patient developed Intussusception on 8/21/20. She started having vomiting, lethargy and bloody stools on that day and parents took her to ER where the diagnosis was made.
Migraine headache on April 7th, right leg pain behind knee on April 8th, minor headaches during the week lying down from March 27th to March 12th.
1 of 2 pt from a long-term care facility, out of 50 vaccinees, to die (of unspecified causes & p/an unspecified interval) following receipt of flu vax;
Patient experienced shooting pain and tingling in her arm after being vaccinated. Patient believes she was given shot incorrectly into a nerve after consulting w/ a doctor.
heartrate went to 145 20 hours later and temp went to 100.9.  Arm has 2 red circles and it's over 48 hours later.  Arm red developed the same night as the vaccine
Three days after getting shingles vaccine, I noticed a vertical line of raised bumps (at 4" long) on my upper left buttocks. Not painful; a little itchy. On Aug 12 Dr. examined me, diagnosed it as shingles, and prescribed Acyclovir for 7 days. The rash cleared up during this time.
One day post vax the pt developed an injection site reaction characterized by itching, rash and a wheel. Pt refused medication for treatment and was slowly recovering. Follow up states the patient recovered.
Information has been received from a consumer, who had chickenpox as a child, according to her mother, who had cared for two children who had chickenpox, and who had a titer which showed no immunity to the disease, who, "about seven years ago", in approximately 1998, was vaccinated with a series of varicella virus vaccine live (Oka/Merck). It was reported that "recently", in 2005, the patient had another titer and it again showed no immunity. It was noted that the patient's doctor suggested to get the series again. Additional information has been requested.
his arm is sore and tight; his arm is sore and tight; specifically soreness where the shot was.; This is a spontaneous report from a contactable consumer reported for himself. This 26-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer covid 19 vaccine on 20Apr2021 and his arm was sore and tight, specifically soreness where the shot was. Event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The pt received the vaccine in the left deltoid on 4/16, on 4/18/ she noticed redness and itching at the site. The site measured 165 cm x 150 cm, was warm to the touch, red and hard. The pt was sent to "immediate care" for further evaluation.
Loss of consciousness; Dizziness; Hyperhidrosis; This case was received via FDA VAERS (Reference number: 1321990) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Coronary artery bypass graft (X4 vessels). Concurrent medical conditions included Coronary artery disease, Hypertension and Hyperkeratosis lenticularis perstans. Concomitant products included LISINOPRIL, METOPROLOL, ATORVASTATIN and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 16-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness) and HYPERHIDROSIS (Hyperhidrosis). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness) and HYPERHIDROSIS (Hyperhidrosis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 102/70 (Inconclusive) 102/70. On an unknown date, Heart rate: 54 (Inconclusive) 54. On an unknown date, Oxygen saturation: 95 percent (Inconclusive) 95 percent room air.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that he left site in no acute distress, awake alert oriented to person, place time and situation.  No treatment information was given.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This non-serious initial spontaneous case, was received from a Pharmacist on 02-Oct-2017, concerning a 78-year-old female patient. The patient's medical history included: allergic to CIPRO. On 02-Oct-2017, the patient was administered with FLUAD (TIV) (dose: less than 0.5 ml, route of administration: Intramuscular, anatomical location: right deltoid, batch number: 179203, expiry date: Jun-2018) (explicitly coded to incomplete dose administered). It was reported that the vaccine squirted out from the orange part while trying to retract the needle like a faulty tip (explicitly coded to needle issue) but no adverse event was experienced by the patient. PTC (Product Technical complaint) report was received where the complaint refers to a syringe, which leaked during administration and resulted in a partial dose being administered. PTC Reference Number: 1024960 was initiated for leaking syringe during administration for FLUAD batch number: 179203. The defect was discovered during the use of the vaccine. Partial dose was administered. It was reported that the complaint sample was already was disposed. The orange button where pressed to retract the needle was the location of the leak and the needle appeared tightly attached. It was reported that, there were no signs of damage on the syringe. The reporter assessed the report as non-serious. PTC report was received on 02-Oct-2017 and updated the information. Non-significant follow-up received on 18-Oct-2017: Batch number was added in the screen. The narrative was amended accordingly.
Pt w/ hx of allergy to PCN (Rash).  PMH significant for Depression and Asthma. 7mins post vaccination pt c/o lightheadedness Vitals: 90/47, HR 82.  Pt states she has a hx of low BP. She did not have breakfast before coming for vaccination.  Pt monitored for a total of 30mins, given crackers & H2O.  Symptoms self resolved.
CHILLS, HEADACHE ON DAY OF ADMINISTRATION, HIVES DEVELOPED ON BELLY, NECK AND ARMS 2 DAYS LATER AND CONTINUE STILL
7X 8 cm area of redness approximately 2 inches below site of injection.  Area is also swollen and has some fluid collection at the lower portion of the redness.  Client reports itching in the am, but has decreased.  Voices discomfort to touch similar to what a bruise feels like. Discomfort level is 2/ 10 when touched.
severe systemic reaction; pale and blue hands; pale hands; cold hands; shacking hands; Severe chills; This case was reported by a physician via call center representative and described the occurrence of nonspecific reaction in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 30th June 2020, the patient received the 1st dose of Bexsero. On 30th June 2020, 2 hrs 30 min after receiving Bexsero, the patient experienced nonspecific reaction, skin discoloration, pale skin, cold hands, tremor of hands and chills. On an unknown date, the outcome of the nonspecific reaction, skin discoloration, pale skin, cold hands, tremor of hands and chills were unknown.   It was unknown if the reporter considered the nonspecific reaction, skin discoloration, pale skin, cold hands, tremor of hands and chills to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero and after 2 and a half hours patient started with severe chills, shacking, both her hands were cold, pale and blue and reported a severe systemic reaction.  No hives, no swelling no anaphylactic reaction involved. Not complete DOB was reported.  No further details were provided.
lt arm below deltoid & above elbow area of erythema & tenderness devel p/vax given;
102 degrees - 1:00 am -  minus 7 degrees after received shot. Soreness at the site. No redness, or swelling H/A response. Rash/Line elbow.
Headache, Fever, Sore arm, and sore throat fever 101 Narrative:
The day following vaccination, experienced lethargy; Somnolence; Headache; Myalgia; Joint pain; Left axillary tenderness/lymphadenopathy; Left axillary tenderness/lymphadenopathy; Fever (highest 102.1),; Cough; This is a spontaneous report from a non-contactable physician, the patient. A 43-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 25Sep2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, HTN (hypertension) and Graves disease from an unknown date, unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received amlodipine (MANUFACTURER UNKNOWN) on unknown date, for unspecified indication and experienced drug allergy. On 26Sep2021, the day following vaccination, the patient experienced lethargy, somnolence, headache, myalgia, joint pain, left axillary tenderness, lymphadenopathy, fever (highest 102.1), cough. All symptoms resolved within the following day except for L axillary lymphadenopathy which remained unresolved. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. On the same day, the patient underwent body temperature and the result was 102.1 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events lethargy, somnolence, headache, myalgia, joint pain, left axillary tenderness, fever (highest 102.1), cough were resolved on an unknown date in 27Sep2021, whereas the event left axillary lymphadenopathy was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, at single dose on 13Mar2021 (Lot number: unknown) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported, on 18Mar2021, the patient tested positive for COVID. She completed the 10 days of quarantine. She returned for her COVID test on 29Mar2021, it was positive. She was told that she could keep testing positive for 2-3 weeks even without any symptoms. She was concerned that she will have to restart the whole COVID vaccine series after having tested positive for COVID. The patient would like to know if she can get the 2nd dose of the COVID vaccine after having tested positive for COVID although she no longer had symptoms. Event outcome was unknown.  Information on the lot/batch number has been requested
Rectal temp 106-fever lasted 3days rnge 102ax; no growth CSF or BC; CXR rt bronchial pneumonia & bronchitis; Given Rocephin 175mg IM in ER;
received dose reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 30th September 2023) for prophylaxis.   On 23rd August 2022, the patient received Menveo. On 23rd August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: The medical assistant reported that the patient received a dose of Menveo incorrectly reconstituted with sterile water. No symptoms were reported. The patient were twins. The reporter consented to follow up by email. Additional supportive information: The patient received a dose of Menveo incorrectly reconstituted with sterile water, which led to wrong solution used in drug reconstitution. This case was linked with case US2022123184 reported by same reporter.; Sender's Comments:  US-GSK-US2022123184:Same reporter
Patient received second dose of shingrix vaccine on 9/13/19.  Patient came to pharmacy on 9/30/19 to report that her arm was still sore.  Stated that there was some redness initially but that had gone away but some pain was still there.  Patient was instructed to contact their physician to discuss the reaction
Very High Blood Presser---Concerned about a Heart Attach--Teeth Aching--Back Pain--Chest Pain--Feeling like a heavy object was on her chest or stomach--Pain from back moved to her sides.
pt recv vax 20MAR97 10AM & for 6hr p/vax pt went home & cried & was inconsolable per mom & grandma;came back to clinic p/6hr t100.7R, highly agitated;rt thigh is erythematous & tender to touch-lt thigh is nl;tx Ibuprofen & DPH;
On the day I received my second vaccination, I went home and started to not feel well. About 4PM, I had fatigue, body pain. I thought that if I ate something, I wouldn't feel so bad. It didn't work. At 8PM, I took ibuprofen. The following day, I didn't feel well. A week later, I went to the ER at about 3 AM. I had serious heart palpitations and panic attack. I took a few aspirins, which helped. They wanted to admit me to the hospital to see if I had a heart condition, but I didn't want that. The following day, I signed myself out and went to my doctor. I had gone to my cardiologist, and I was told I was fine.
Patient reported throat feeling scratchy, eyes red itchy, hives on neck, and itchiness all over body  within 5 minutes of receiving vaccine..  Patient reported feeling the same after first 2 vaccines but did not report it because it resolved quickly.  After 15 minutes,  patient reported symptoms to EMT because they were not resolving.  EMT notified RN.  RN assessed patient and administered 25mg of Benadryl. Within 5-10 minutes, symptoms began to subside.
6-22-11 Below vaccines administered. 6-23-11 (R) lower arm (between shoulder & elbow) started to turn red & swell, sensitive to touch. Mild HA started - relieved with EXCEDRIN & chills. 6-24-11 Presented to health department w/above complaint (R) arm red, swollen, warm to touch 3 1/2 x 2 1/2" induration.
Pt recvd 2nd dose of measles vax on 23APR91 & on 29APR91 pt had an asthma attack which did not respond to Albuterol; 2MAY91 devel a fever;
Itching; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 31Mar2021 at 14:00 (age at vaccination was 44-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included allergy to nuts. The patient's concomitant medications included a cholesterol medicine (as reported) from Feb2021. On 31Mar2021 (reported as at night), the patient experienced itching. It was reported that the patient took diphenhydramine (BENADRYL, 25 mg), so she was better and was not itching anymore. She also state that she took ibuprofen 800 mg and was not experiencing anything anymore. The patient said that she saw itching was listed as a possible side effect and would like to know if she was good with taking the second shot. The outcome of the event was recovered on an unspecified date of 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a female subject of unspecified age who was vaccinated with H1N1 (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of H1N1 (unknown route, site of injection and batch number). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine at an unspecified trimester. At an unspecified time after vaccination with H1N1 and prior to 20 weeks gestation, the subject experienced spontaneous abortion. This case was assessed as medically serious by GSK. This case is linked to 27 other cases (related by publication). Summary of the article: The potential serious consequences of maternal influenza infection in pregnancy have long been recognized; pregnant women are at increased risk for influenza-associated morbidity and mortality. As reviewed recently, there are limited data on the safety of influenza vaccine in pregnancy; however, to date, there has been no indication that seasonal influenza vaccines containing inactivated virus pose a risk to the mother or the foetus. This has led to the current recommendation that all pregnant women be vaccinated with the seasonal influenza vaccine regardless of trimester. Despite these recommendations, vaccination rates remain less than optimal. Surveys have demonstrated that mothers' concerns about safety contribute to poor compliance with vaccine recommendations. This situation was escalated during the 2009-10 H1N1 pandemic season, when lack of safety data about the pandemic H1N1 (pH1N1) monovalent vaccine was coupled with intensive public health messaging that emphasized the need for all pregnant women to be vaccinated. Additional safety information on pH1N1-containing vaccines when used in pregnancy was therefore needed. The purpose of this study was to evaluate the foetal risk and relative safety of the pH1N1 influenza vaccine. To assess risks and relative safety of the pH1N1-containing vaccines, the author conducted a prospective cohort study of pH1N1-vaccine-exposed and unexposed comparison women who were recruited during pregnancy and followed to outcome between October 2009 and August 2012. There were 1032 subjects available for analysis; 841 women were exposed to a pH1N1-containing vaccine in pregnancy, and 191 women were unexposed to any influenza vaccine in pregnancy. Nine of 328 (2.7%) first-trimester-exposed pregnancies resulted in an infant with a major birth defect compared to 6/188 (3.2%) in the unexposed. The hazard ratio (HR) for spontaneous abortion was not elevated. Adjusted HRs for preterm delivery were elevated for exposure anytime in pregnancy, specifically with exposure in the 1st or 2nd trimester. However, the mean decrease in gestational age in the exposed pregnancies was approximately three days. In conclusions, no meaningful evidence of increased relative risk or HR for major birth defects, spontaneous abortion, or small for gestational age infants was demonstrated.
Patient received booster dose on 2/1/22.  Caregiver called in to hospital call center reporting side effects - swelling and tenderness in  arm pit of the vaccinated arm. Had rapid heart beat and fevers 2/2/22. Pt was avised to be reevaluated by urgent care 2/3/22.  During Urgent care visit, pt does report feeling nervous due to axillary swelling.