chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subsequent to receiving vax, the pt developed hives. The reporter is trying to rule out all vaccines without preservative. The reporter is not certain if the the hives were related to therapy with haemophilus b conjugate vaccine + hepatitis b vaccine recombinant (yeast). The pt sought unspecified medical attention. No further information is available.
Patient felt fine after shot, then started feeling weak, hot, lightheaded, then lost consciousness.  Tapped patient, yelled his name, called 911, monitored breathing and blood pressure, provided him water, banana, oragne juice when he woke and waited for Ems.  He left with ems but was feeling much better.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F dose 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data cas support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVX (merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Presented to ER on 7/14/06 with c/o nausea and diarrhea. States that she had received smallpox vaccination the previous day. Started not feeling well one hour after vaccination. Afebrile. Diagnosed as vaccine reaction per ER report. CBC and BMP were done, those results are not available at this time. Was given Imodium, Tylenol 500mg 2 tabs, Phenergan, and Tordol at time of visit. Discharged with orders to push fluids, Compazine 10mg po q 6-8 hours prn nausea, Tylenol 500mg 2 pills every four hours as needed and follow up the next day.
A report was received from a health professional concerning a 37 year old pt, who is a nurse and who experienced an allergic reaction after receiving a Fluvirin vaccine on 16Oct02. The pt has a medical history of latex allergy, no other allergies are known, is not allergic to eggs. On 16Oct02 the pt experienced an allergic reaction after receiving Fluvirin vaccine in the left arm. Within 10 minutes the pt developed general edema, redness from the elbow to shoulder and itching that spread to the torso. The pt was diaphoretic without shortness of breath, RR 20, HR 90, BP 142/68 mmHg. The pt medicated herself with 25mg of diphenhydramine and was seen in the ER, where 60mg of prednisone was administered. The symptoms gradually dissipated that day. The pt had received flu vaccine in previous  years and received about 3 months ago a diphtheria/tetanus vaccination. At the time of reporting the pt had recovered. The reporter has assessed the relationship of study medication to the event as probable. (OMIC)
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 13-MAR-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Hot flashes, irregular periods (10 cycles in two months- each lasted 3-4 days).. painful cramping.. heavier than normal flow.  Previous cycle was 2 days per 30.. Fatigue, Irritability, weight gain
Swelling in cheek.  Patient states swelling was at the site of nerve in cheek.  Nerve felt hard.  Was not painful, just slightly tender if touched.  Patient read online to take Benadryl.  Swelling subsided in a couple of days.
With 2 month vaccines pt in 2-3 days of crying, we elected not to give 4 month DTP and must give a DT. Pt still has 3 days of irritability crying and episode of unstable jerky. Doin well currently but due for 6 month shot C.
IZ given in office at 2:30pm on 06/11/02. Doctor called 06/19/02 and stated child had "seizure" activity, arms and legs jerking in a rhythmic motion. This activity occurred at 5-6 pm on 06/11/02 and lasted < 1 minute. No other 'seizure" activity noted by parents.
I had a rash on my scalp that spread down my back, arms, and legs. It was also on the back of my hands. It lasted for about three months. I saw a dermatologist twice and was given steroid cream and prescription shampoo. Neither worked and I had to take two rounds of steroid pills. It still took about 4 or 6 weeks to clear up after the treatment. It seems to be coming back   The rash was very itchy.
Pt state she had one dose of Men-   B,Bex 10/05/20 and next day noted worsening skin rash on her torso and    arms worse near the site of injection, no feverhives, HA,or SOB    reported but rash spreading and very uncorfortable because of    itchiness.    SKIN/BREAST:   multiples mildly elevated erythematous patchy, very itchy    lesion both arms and torso, more intense Left lateral upper    arm near the site of the immunization.
day after injection site was VERY sore (no reaction from  first two shots; this was the booster shot); that lasted for several days, along with unusual pain in muscle/bone area in right hand (shot was in right arm).; then starting sometime a couple days ago, started having problems with double vision/blurred vision, never had this problem before...
Patient had a smallpox vaccine and one week later developed pruritic rash neck and forearm and around smallpox vaccine.
Onset rash 11/6 or 11/7/12, spreading. Consistent with varicella.
This case was reported by a healthcare professional to a sales representative and described the occurrence of arm heavy in a subject of unspecified gender and noted not to be pediatric who was vaccinated with TWINRIX, GlaxoSmithKline.  The healthcare professional reported to the sales representative that, "patients" experienced adverse events following receipt of vaccination with TWINRIX, however, a specific number of subjects was not reported.  On 21 November 2007, the healthcare professional indicated that "within the past month" the subject received unspecified dose of TWINRIX (1 ml, unknown, unknown arm).  The date of administration of TWINRIX was not provided.  In 2007, less than one month after vaccination with TWINRIX, the subject experienced heaviness in the arm, injection site burning, and injection site pain.  The healthcare professional indicated a product complaint reporting that the office was concerned there was a quality assurance issue with the TWINRIX.  The healthcare professional noted that there have been no changes in administration technique, needles, or individuals giving the vaccine and that the office has never had reports of this before.  The healthcare professional reported the events and product complaints with lot numbers AHABB107AA and AHABB107BA.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the events were possibly related to vaccination with TWINRIX.
w/in 5min of vax a 2mm wheel was noted above the inj site;DPH was given;f/u call wheel disappeared & pt is fine arm is back to nl;
I had irregular heartbeat and high blood pressure. It took longer to determine that I was having the issue with the high blood pressure. The numbers were in the 150/80. They have not recommended any medication yet. I went to the emergency room on December 03, 2022. They recommended that I follow up with a cardiologist. I saw the cardiologist on the 22nd and they did another EKG which was normal. I have a follow up visit scheduled for the 30th.
I received the vaccine without incident on the 19th.  I began to feel fatigued and sore arm at the vaccine on Thursday into Friday.  I skipped the gym due to fatigue and arm discomfort (figured normal).  Slept 12 + hours Thursday night, Friday night and Saturday night.  Sunday morning still very fatigued and tired.  Noticed my Garmin fitbit shows heart rate down to 50.  Not sure if the low heart rate and fatigue are related.  I had to rest after watering lawn yesterday and Friday (not normal for me) and chocked it up to fatigue.  However I had to sit down while preparing homemade spaghetti sauce and meatballs in the kitchen this morning (also not normal) and with conversation on phone  winded /cough when talking (also not normal).  I have had tachycardia related to medicine in the past and stopped (antibiotic and cymbalta), never had a low heart rate.  Wanted to report to help others if any correlation.  Have concerns about receiving the second dose of vaccine.   Years ago, 1992 I received the Hepatitis B Vaccine for nursing school and first shot was fine, second shot had severe fatigue and immunity levels were checked --was told at that time to not receive the 3rd dose as my levels were off the chart (immune response level).  Not sure if there's a similar test to check this before receiving the 2nd dose. Thank you.
57yo Male,  resident, declared dead 01/11/2021 , following a period of ill health related to diabetic ulcers.
Hyperesthesia/burning sensation in skin in neck, shoulders, arms shortly after influenza vaccine 1/19/2011. Progressed into back & legs. Extensive Neurologic evaluation. Treated with NEURONTIN x couple months. Symptoms took about 5 months to resolve.
Individual presented to vaccine clinic to receive second dose of Moderna Vaccine, was instead incorrectly administered Pfizer vaccination
herpes zoster; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 20-JUL-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a shingles like rash on left back that went around her left breast and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event herpes zoster was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event herpes zoster to be disability.
This spontaneous report as received from a registered nurse refers to a 10 weeks old infant. The patient's concurrent conditions, medical history and drug allergies were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
FLUSHING OF FACE; FEELS UNCOMFORTABLE, LIKE A SUNBURN; JOINT PAIN; FEVER; SORENESS AT INJECTION SITE; FATIGUE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, hashimoto's disease, seasonal allergies, tobacco allergy, trees allergy, and grass allergy. The patient experienced skin reaction when treated with cefaclor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 27-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced joint pain. On 27-MAR-2021, the subject experienced fever. On 27-MAR-2021, the subject experienced soreness at injection site. On 27-MAR-2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 102 F. On 29-MAR-2021, the subject experienced flushing of face. On 29-MAR-2021, the subject experienced feels uncomfortable, like a sunburn. On 30-MAR-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, fever, and fatigue on 29-MAR-2021, and soreness at injection site on MAR-2021, had not recovered from flushing of face, and the outcome of feels uncomfortable, like a sunburn was not reported. This report was non-serious.
Information has been received from a nurse concerning her son (now 15 year old) who in 1995 was vaccinated with MMR II (lot # not reported). Subsequently (in 1995) the patient experienced a rash. Rash went away in 24 hours after dose. The patient did not seek medical attention. No further information is expected.
PATIENT DEVELOPED ACUTE RESPIRATORY AND RENAL FAILURE AND EXPIRED 7/11/2021
Anaphylactic response; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction.  The patient's medical history was not provided. Concomitant medications were not provided.  On 16 Mar 2021, a few moments prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.   On 16 Mar 2021, the patient had an anaphylactic reaction and had to be hospitalized. She was still in the hospital as of 17 Mar 2021. Treatment information mentions 4 epinephrine pens and diphenhydramine.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, anaphylactic reaction, was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Pt recvd vax & devel leg swelling w/redness & irritability; also had high fever;
Pt recv vax on 11/2/98; on 11/5/99 pt exp knot/ red/ sore vax site w/ movement pain
Started to feel chest pain and shortness of breath 3 days after the vaccine. Ended up in the hospital 5 days after the vaccine and diagnosed with blot clots in the lungs.
sick; he just felt bad and unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 10Mar2021 (Lot number: EN6204) at the age of 82 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Allergic to Mercury" (unspecified if ongoing), notes: including thiomersal or thimerosal. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "sick"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "he just felt bad and unwell". Additional information: The patient weighs "around 170 lbs or something" and stands "5 ft. 9 in. or 5 ft. 10 in". The patient's allergy to mercury was confirmed when his doctor did a test using mercury on the left shoulder and mercuric oxide on the other shoulder and he broke out from his neck to buttocks. He wanted to know if the vaccine contains thiomersal or thimerosal. He was scheduled to received the second dose on 31Mar2021.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer who reported for herself. A 34-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3247) at right arm on 04Feb2021 at single dose for Covid-19 immunization. The patient received her first shot (lot number EL3247) at right arm on 04Jan2021. Patient's medical history included acid reflux. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Anxiety started three days after receiving the second shot (07Feb2021). Patient was shortness of breath. The patient had emergency room/department or urgent care and visited doctor or other healthcare professional office/clinic visit. Per ER, she was hyperventilating which caused her to have panic attacks. Patient had medication for anxiety. Outcome of the events was resolving at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
pt recv vax 30JUN95 & 27FEB96 pt devel a typical case of chicken pox w/15-20 large lesions;No further details were provided
Both instances I woke up n the middle of the night with difficulty breathing. Both instances I felt light headed. Went to ER both times. They didn't figure out the issues. My PCP thought it could be allergies.
Within a few days of receiving my first vaccine (Pfizer EN6201), I got a rash on my right thigh (5" x 9 1/2") and on my right upper abdomen.; The rashes were itchy and warm to the touch; The rashes were itchy and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Mar2021 14:30 (Lot Number: EN6198) as single dose (at the age of 71-years-old) for COVID-19 immunization. Medical history included allergies/sinus, high blood pressure, (allergies to) sulfa, and suspected granuloma annulare on 23Feb2021. The patient was not pregnant. Concomitant medications were taken but not specified ("This field will not allow me to list all meds"). The patient previously took doxycycline and tetracycline and experienced allergies. No other vaccine in four weeks. Patient reported that, "Within a few days of receiving my first vaccine (Pfizer EN6201, pending clarification), I got a rash on my right thigh (5" x 9 1/2") and on my right upper abdomen. The rashes were itchy and warm to the touch. On 23Feb2021, I began treatment for suspected granuloma annulare. That diagnosis was confirmed by a biopsy on 07May2021. I have been treated with topical ointments and injections, but the rashes have not abated. Furthermore, I continue to acquire new granuloma annulare spots (left groin, left thigh, left ankle). While I have had a localized granuloma annulare in the past, it had abated prior to the onset of this generalized granuloma annulare." The patient underwent lab tests and procedures which included biopsy: granuloma annulare on 07May2021. Therapeutic measures were taken as a result of the events which included topical ointments, injections "(I think it was ster." The events resulted in Doctor or other healthcare professional office/clinic visit. The patient had not recovered from the events.   The events were considered as serious (medically significant). Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
Baseball size area of redness- left thigh. Swelling, area hot to touch. Treatment: Prednisone 10mg x3 days, Keflex 125/5 1 tap QID x 10
A swollen armpit; Arm hurts; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's daughter) reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration in right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient has no medical history. There were no concomitant medications. The patient's arm hurts on 08Jan2021 and developed a swollen armpit on 10Jan2021. The outcome of swollen armpit was not recovered while arm hurts recovered on 10Jan2021.
Golf ball size rash around the point of injection. Lots of pain at the area of the rash. Also it is hot to the touch, itches, and tingles. Rash has gotten bigger and spread over more of my upper arm. Stool looks like coffee grounds.
who was 14 years of age received a booster vaccination of MENVEO; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA687A, expiry date 31st October 2022) for prophylaxis.   On 25th March 2022, the patient received Menveo. On 25th March 2022, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's comment: The patient received booster dose of Menveo at the age of 14. As per PI, booster should be given after 15 years of age once if at increased risk of meningococcal disease. The reporter wanted further guidance. The consent to follow up was given. The permission to contact healthcare professional was given. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The 14 year old patient received booster dose of Menveo, which led to inappropriate age at vaccination.