chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received from a pharmacist on 29-Aug-2018, concerning a 45-year-old, adult, female patient. The patient had no medical history. The patient did not receive any concomitant medications. On 25-Aug-2018, the patient received FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported]. On the same day after vaccination, the patient felt it circulating around other muscles in her arm. The pharmacist who gave her injection, said it was the right dose and in the right place. On the same day, the patient had recovered from the event. The reporter assessed this case as non-serious. Update received on 20-Sep-2018: Non-significant case correction received with IRD: 29-Aug-2018: The first sentence of the case comment was modified from 'A 45-year-old, female patient felt abnormal on the same day after receiving the suspect vaccine FLUCELVAX QIVc' to 'A 45-year-old, female patient felt abnormal as the vaccine is circulating around the muscles in her arm on the same day after receiving the suspect vaccine FLUCELVAX QIVc'. Non-significant follow-up report received from pharmacist on 10-Oct-2018: The reporter confirmed the start date of the suspect product as 25-Aug-2018. No new information received.
Normal soreness in the arm; This is a spontaneous case, initially received from other non-health professional on 18-Dec-2018, concerning a male patient of unspecified age.  The patient had soreness in arm upon receiving intramuscular injection in the past (unspecified dates) but he found it normal.  On 14-Dec-2018, the patient received Fluad TIV [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, anatomical location: intramuscular, route of administration: deltoid, batch number, expiry date: not reported] for influenza prophylaxis.  On 15-Dec-2018, 1 day after vaccination, the patient experienced normal arm soreness. At the time of the report, the patient felt almost resolved (also reported as almost nothing).  The outcome of the event was recovering.  The reporter assessed this case as non-serious.; Reporter's Comments: A male patient of an unspecified age experienced arm soreness, on the next day of administration of Fluad (TIV). The company assessed the event arm soreness as related due to the plausible temporal relationship between the suspect vaccine and the reported event.
This spontaneous prospective pregnancy report, was received from a nurse practitioner, and refers to a female patient of unknown age. Information about the patient's medical history, concurrent conditions and drug reactions/allergies was not provided. On an unknown date, the patient became pregnant, however, the last menstrual period (LMP) and estimated delivery date (EDD) were not known. Moreover, on an unknown date, the patient was vaccinated with a dose of M-M-R II for prophylaxis. Concomitant therapies included sterile diluent. No adverse effects were reported. At the time of reporting, the pregnancy outcome was pending.
Right arm is swollen, red, and very itchy at injection site. Also have some redness with small bump on left arm.
This report describes a 48 y.o. female who experienced swelling of the throat after receiving Hep B vaccine recombinant (Engerix-B) for prophylaxis. Medical history, concurrent conditions, and concurrent medications were not specified. On 8/29/02, the vaccinee received her 1st injection of Engerix-B (lot ENG5346A2). A "few days" later, the subject experienced watery eyes, itching of the ears, swelling of the throat, and congestion. Initial treatment included diphenhydramine (Benadryl), however her physician later prescribed fexofenadine hydrochloride (Allegra) for her symptoms. Events resolved after approximately 3 weeks.
p/recvd vax pt's mom brought pt back to clinic w/in 1/2 hr, flushed w/hives developing all over body, ears & eyes edematous, no resp distress;
This spontaneous report was received from a physician via a field representative refers to an 8 weeks old male patient with milk protein intolerance diagnosed at one month (approximately on 15-MAR-2014). On 14-APR-2014, the patient was vaccinated with a dose of ROTATEQ 2 mg 1 standard package tube of 2, lot # J011334, expire date 13-MAY-2015, 2 ml, oral, as indicated. Other suspect therapies included PENTACEL and PREVNAR. There was no concomitant medication. On 14-APR-2014 about 5 hours after administration the patient exhibited discomfort, fussiness, and crying for about an hour after receiving ROTATEQ. The mother of the patient noted that the problem appeared to be "gastro related". It was also noted that the patient had blood in stools intermittently. It was reported that there was no blood in patient's stools prior to vaccination on 14-APR-2014. The patient visited office on 16-APR-2014, and no blood was found in stool. However, the patient's mother reported blood in stools in the evening of 16-APR-2014. The physician described this as hematochezia. Lab diagnostic studies were performed on 16-APR-2014. The patient sought medical attention by calling and visiting primary physician. At the time of this report the problem was still ongoing and had not been resolved. The outcome of the events was not recovered. The relationship between events and ROTATEQ was not reported. Additional information has been requested.
swelling in my hands and feet; swelling in my hands and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 (Lot number: EL9261) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 21Oct2021; TIROSINT taken for thyroid disorder; TESTOSTERONE/ESTROGEN. Past drug history included: Prednisone, reaction(s): "Known allergies: prednisone". The following information was reported: PERIPHERAL SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "swelling in my hands and feet". Therapeutic measures were not taken as a result of peripheral swelling, peripheral swelling.  Additional information: The patient started having swelling in her hands and feet after the first 2 covid vaccinations. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
p/recv varicella pt began  fever of 104, then spots appeared on l knee then to thigh & 3 spots on stomach
Day after vaccine woke with small nodule in arm at injection site; Slight itching/tingling; Slight itching/tingling; very photosensitive to the point nearly passed out; This is a spontaneous report received from a contactable consumer (patient). A 64-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0150) via an unspecified route of administration in left arm on 12May2021 at 10:45 (at the age of 64-year-old) as single for covid-19 immunisation at hospital. The patient medical history included asthma, IBS (irritable bowel syndrome), fibromyalgia, possibly MS (multiple sclerosis) and recent attempted repair of atrial septal defect on 22Jan2021. The patient known allergies: iodine, demerol, phenobarbital, sodium pentathol, dilaudid and vancomycin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA) 60mg daily and acetylsalicylic acid (ASPIRINE) 81mg daily (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to covid vaccine. It was reported that after vaccination there was no reaction at first. On 13May2021 at 07:15, day after vaccine patient woke with small nodule in arm at injection site; seemed to burst and release something into arm on rubbing. Slight itching/tingling, no noticeable rash, for about an hour. 3 hours later when went outside was very photosensitive to the point nearly passed out. This occurred for 3 days if patient went out in sunlight. Nurse from hospital said not what they were told was customary or something to look for or note. The patient did not receive any treatment for the events. The outcome of events was reported as resolved on an unspecified date in Jun2021.   Information on lot/batch number was available. Additional information has been requested.
Patient received vaccines in our office on 11/18/20 and had no immediate reaction. On 11/19/20 patient went for a walk and came home and was fine, but then was found passed out on floor for a few seconds. She woke and was unable to move any of her extremities. Patient was taken to the ER where she was tested for many things and given IV fluids. All testing was WNL. Over time, movement came back and patient was discharged home and is recovering at home.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Medical history and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with an expired dose of ROTATEQ (lot # L004466, expiry date:02-AUG-2016). No adverse effects were reported. Additional information has been requested.
Vaccine given at 1:25 PM. No issues with redness, swelling, or pain at site of injection at the time of the injection. Patient denied any redness or swelling at the site after injection, only stated, "The severe pain started at 8 pm at the site of the injection in my left deltoid muscle and radiates down to my wrist. When I palpate down my arm, the muscles "feel sore"." Denied numbness, redness, swelling or tingling in fingers or arm. Patient stated, "I have been taking TYLENOL, but it is only helping a little. When I move my arm the pain level is an 8, but when I keep my arm still the pain level is only a 2."
patient status started to decline within a few hours of receiving her covid vaccine she was weak, developed increased shortness of breath and went to the emergency room were she was diagnosed with STEMI and within 2 days expired.
Next day-chest pain, shortness of breath, paleness, dizziness, nausea, vomiting, fever. ER ran labs and CXR and physician said everything looked fine and released her.
fever; Body aches; Not feeling well; She had been feeling ok all week, has not felt bad, just felt a little rundown; Sore left arm where injection site was; This is a spontaneous report from a contactable consumer (daughter). A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9269; Expiration Date: 03May2021), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 at 10:30 (at the age of 20-year-old) as 1st dose, single for COVID-19 immunization. The Patient's Medical History was not reported. Family medical history of the patient was not reported. Concomitant medications were reported as none. The Patient has received prior vaccinations (within 4 weeks), prior to the COVID vaccine reported as none. Additionally, vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as None. Consumer stated that her daughter received the first dose of the pfizer covid 19 vaccine while at school on 07Feb2021. The patient woke up around at 08:00, 15Feb2021 with fever, body aches and not feeling well. She had been feeling ok all week, had not felt bad, just felt a little rundown since around 08Feb2021; but she was a college student so that was not shocking. She had sore left arm where injection site was with onset around 08Feb2021. Consumer wanted to know if those were common to get side effects from the Pfizer COVID-19 Vaccine this long after vaccine or could she (patient) had COVID-19, should they had her tested for COVID-19. Consumer stated, they kind of anticipated side effects immediately following the vaccine; but unsure about side effects that was long after she was administered the Pfizer COVID-19 Vaccine. On 15Feb2021 at 08:00, the patient experienced fever, body aches, not feeling well; on 08Feb2021, felt a little rundown and sore left arm where injection site was. The patient did not require any visit in emergency room or physician office for events. The reporter classified the patient was not hospitalized. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 15Feb2021 and Saliva tested for COVID-19: negative on Feb2021, Negative for COVID-19 at school every other day. The outcome of the event 'Sore left arm where injection site was' resolved on unspecified date of Feb2021, event 'Felt a little rundown' was with unknown outcome and all other events was not recovered.  Follow-up (15Feb2021): This is a follow-up spontaneous report from a contactable consumer. event information and patient information was added.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Patient came and complaint that the Saturday after getting the vaccine she ended up in the hospital. She had a lot of check ups done but everything came back negative. She thought that the Pfizer vaccine gave her Covid but the hospital said she was negative for COVID.She tells me that she has a chronic condition Bronchiostasis and also, thinks that the vaccine could of exacerbated it. Outcome she told that she was going to go to her medical doctor.
SYNCOPE, HEADACHE, VOMITING, CHILLS,  NUMBNESS IN FACE AND HANDS, AND COULD NOT WALK
PT fully vaccinated for COVID-19 and tested positive via COVID-19 nasal swab 12May
The day after, I woke up with a sore arm. It was red and swollen. I was real fatigued. I had a slight small headache. I had some sinus pressure. I had diarrhea. A couple days later, I felt better. I was getting a headache every night. A week later, I had a 3-day migraine starting at the base of my skull. It was pounding. No matter what I took it didn't help. My heart rate was elevated. I was super tired. I still had diarrhea. I was very uncomfortable. I went to urgent care. The COVID test came back negative and they told me it was just a virus. The next day, my headache finally went away. I still get headaches from time to time, but it's not terrible. I am currently battling an upset stomach. I think it is from the pain medications. I have a doctor visit next week.
got Kinrix @ 1:55p. at 4:00pm noticed redness and swelling at the kinrix  injection site. Mom used benadryl ointment. Came 8/13/2021 to us tp report reaction. Provider perscribed Benadryl Allergy Children's Liquid.
Pt received covid 19 vaccine. Few minutes later, pt was feeling dizzy and syncope. EMS responded to evaluate, however PT's condition was unchanged. Fire/Rescue was called in to assist. Fire/Rescue evaluated PT on scene at 17:25 hours. Pt declined transport.
This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received SHINGRIX (batch number 5NY3B, expiry date unknown) for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than 4 months after receiving SHINGRIX, the patient experienced pain, fatigue, myalgia and fever. On an unknown date, the outcome of the pain, fatigue, myalgia and fever were unknown. The reporter considered the pain, fatigue, myalgia and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient experienced pain, fatigue, myalgia and fever. The reporter considered the symptoms were related. For tolerance to 2nd dose refer linked case US2018GSK171806, for the same patient.
Nursing note on 10/7 @ 0800 states Pt's pneumonia vaccine site on the Left arm appears to be red, slightly swollen, and hot to touch. Pt does not complain of any pain at the site, and refused an ice pack. No further orders.
This spontaneous prospective pregnancy report as received from a certified medical assistant refers to a 16 years old female patient with none pertinent medical history and none drug reactions/allergies. On 05-NOV-2013 the patient was vaccinated with the first dose of GARDASIL lot # J008423, expiry date 21-JAN-2016, 0.5 ml, intramuscularly. The patient was pregnant with last menstrual period of 31-MAR-2013 and estimated due date of 05-JAN-2014. Initial exposure to GARDASIL was at 31 weeks. There were no lab diagnostics studies performed. The pregnancy outcome was outcome pending. The patient's outcome was unknown, also reported as not recovered. No additional doses of GARDASIL were administered. Additional information has been requested.
1st dose on 07Nov2019 and is late for 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Patient was given a flu shot & subsequently lost consciousness briefly & fell & struck his head. He promptly regained consciousness but was transported by ambulance to the ER for evaluation. He was treated & released. The patient has recovered fully & is doing well.
Within 24 hours, I had a splitting headache and body pains ( especially neck and feet)/weakness. I broke out into a full body rash. After 24 hours, headache relieved and left an Arora. I am now 7 weeks out and am still having dizziness and occasional headaches as rashes that come and go. Recently, I?ve experienced weakness in my legs, inside trembling and heart racing episodes. I have NOT had one day since the 2 Nd vaccine without dizziness. I?ve also had cold symptoms and ear issues.  In two day, I?ll be at my 8 week mark since second dose. I?m living on the sofa, miserable and basically, housebound.
Woke up with a slight headache and nausea. At around 1p.m. both symptoms had become more severe.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female 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.     It was unknown if patient ever tested positive for COVID-19.     On 26-Sep-2022 at 2:10 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 26-Sep-2022 at 2:10 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022) 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 (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to August 2022).    Concomitant medication information was not provided.  It was reported that the bivalent vaccine stored in the refrigerator underwent several temperature excursions going back to Aug-2022.  The patient received first, second and third doses of Moderna COVID-19 vaccine via intramuscular route and site of administration was reported as deltoid muscle.  The patient received the fourth dose of Moderna COVID-19 bivalent vaccine on deltoid muscle and no adverse reactions were reported.  No treatment information was provided.
Headache, Arthralgia, NauseaVomiting, LOSS OF APPETITE, SLIGHT DISORIENTATION Narrative:
At first, I experienced fever, chills, body aches, headache.  Then experienced tingling in feet and hands, and now also in left cheek.
Patient described arm pain and numbness during injection. Resolved after 20 min with ice pack. 2/20/20 follow up - Patient reports feeling ok.
pt complained of headache, body ache,sore throat, cough. Pt given deconamine,tessalon,and tylenol. Seen by Physician 2/7/07.Pt states immunizations record was falsefied to cover double flu vaccination. documentation show Hep B was given. Pt states he did not receive Hep B. He states he was given a yellow sticky note and sent to Technician for shot. On the note he says it stated Thyphoid and Flu. He stated when he tried to tell the tech that he had receive the flu already he was told that he was gonna have to get what was on the sticky. The pt wasn't given record of vaccination, due to the fact the nurse felt AFCITA verification would slow the process. Vaccine documentation was input at the end of the day.
Fever of 103.1 on 7/18/10 with continued fever of 99s to low 100s throughout the week; headache throughout the week; episodes of nausea and emesis; decreased appetite; abnormal lab values, especially WBC, AST, ALT; client continues to follow up with doctor and will have labs repeated again on 7/29/10
could not sleep , tossing and turning all night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep , tossing and turning all night) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INSOMNIA (could not sleep , tossing and turning all night). At the time of the report, INSOMNIA (could not sleep , tossing and turning all night) outcome was unknown.            Treatment for the event was not provided. No concomitant medications were reported
Neurological problems.  Fasciculations, weak muscles, paresthesia, and peripheral neuropathy.
Fever of 102.7, chills, body aches, fatigue, headache, nausea
48 hours after round 1 of the moderna vaccine, Patient developed severe diarrhea and vomiting.  The diarrhea and vomiting led to acute dehydration which substantially lowered blood pressure.  Patient was then brought to ER and hospitalized for 2 days related to the severe dehydration. Patient has not had similar symptoms in previous 2 years to this incident.