chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MATERNAL EXPOSURE DURING PREGNANCY; This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. No information was provided regarding the patient's concomitant medication. The patient's medical history included (low-grade squamous intraepithelial lesion (LSIL) cervical dysplasia, spontaneous abortion and current condition included migraines.  On 22-APR-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # N023828, expiry date: 25-JUN-2020) (route of administration and anatomical locations were unknown) for prophylaxis.  On 24-JUN-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis. Birth defect in previous pregnancies and infant complications were unknown. The patient had a history of two previous pregnancies and one of them was spontaneous abortion.  On 27-JUN-2019, the ultrasound showed viable pregnancy (maternal exposure during pregnancy). On an unknown date, pap smear test showed low-grade squamous intraepithelial lesion (LSIL) The last menstrual period (LMP) and estimated due date (EDD) was not known. The pregnancy outcome was unknown. The outcome of maternal exposure during pregnancy was unknown.
Syringe stopper pressed slightly just prior to the injection resulting in small amount of liquid loss. 3ml syringe with 1 inch needle used. Patient may have received less than the full 0.5 ml dosage of Moderna Covid-19 Vaccine for first dose.
Neuralgia, Chills, Pain at site of vaccination, sweating, headache.
chills, Fever, body aches, my coughing came back I think from covid Fine now
Client was fine right after injections, left and went home. Returned to clinic about 30 minutes later and was crying and very upset. Said her palms were itching like crazy, she said she could not stop scratching them, and she felt like she could not breathe. We brought the client back to a room, blood pressures was 112/62, pulse 90. Palms clammy and face red, client crying and very upset. States she could not breathe. We administered 50mg of diphenhydramine (lot # 096330, exp date 9/2018) intramuscular at that time. Nurse remained with patient. Patient stopped crying and was calming down at this point. She was able to take several big, deep breathes and stated that she was feeling better. By 3:45pm, client was breathing without problems and itching had stopped. Client and mother left clinic about 4pm, stating that felt fine and breathing fine and itching had stopped completely. Phone call to patient's mother on 7-18-2017. Mother stated that patient does not feel well today, but no problems breathing. Mother did give patient another BENADRYL pill last night. Mom stated no problems breathing or with itching.
Breakthrough case admission after 2 vaccines Moderna 1/13/21 Lot# 037K20A;  Moderna 3/10/21 Lot# 032H20A
*I'm not sure what brand of DTaP I was administered in 2010. I had the vaccine and 3 weeks later I had swollen joints bilaterally and couldn't hardly walk. I went to Ortho and they Dx me with sprained ankles and to take large amounts of ibuprofen. That didn't help. I went to rheumatologist a few weeks later and after blood work was completed. I was diagnosed with seronegative Rheumatoid arthritis. Prior to that I was a healthy 20 year old, athletic and was a nurse (active on my feet). I was started on methotrexate and steroids. I did that for years until I started getting worse. I never got a vaccination after that and I just found out the correlation within the past 2 years. I eventually got diagnosed further with Crohn's Disease and tried biologics and had a reaction to them. I have had 2 bowel resections due to this and it all stems from the DTaP vaccination.
sore; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer/non-health professional .  This case involves patient (unknown demography) who was sore (pain), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sore (pain) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
pt devel rt ankle pain & tenosynovitis the afternoon p/1st dose; took 2nd dose w/inc in pain & edema, rt knee became involved p/3rd dose; has had IM Typhoid previously
Fever; Redness at the injection site; Red knot at the injection site; Itchy at the injection site; Warm to the touch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE INDURATION (Red knot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE WARMTH (Warm to the touch at the injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE INDURATION (Red knot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE WARMTH (Warm to the touch at the injection site). At the time of the report, PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved and VACCINATION SITE INDURATION (Red knot at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE WARMTH (Warm to the touch at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided.
Patient of Hospice who requested to have Covid Vaccine. Our Community Paramedic, took the vaccine to the Hospice on 9/2/2021.  He administered the vaccine and waited 15 minutes to observe for reactions. No adverse reactions were noted. The following morning we received a call from the nurse at the Hospice House that pt was pronounced deceased on 9/3/2021 in early am.
Itching and rash all over the body. Started after 6-7 hrs of injection. Continuing even after 54 hrs of injecting the dose.   Tried general allergy medicine Benadryl and no impact.
Intense chills leading to uncontrollable shivering in the middle of the night for several hours
Itching, red and hot to touch. Was notified to take BENADRYL and ice area.
Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain; Headache; Severe muscle pain around the injection site; Severe muscle pain around the injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included diabetes mellitus from an unknown date, covid-19 from an unknown date. Concomitant medication included metformin. The patient stated the side effects were initially day one (30Dec2020) was this general aches, pains and headache. It almost started as if it was a Covid itself starting all over again because she had this disease already earlier this year and the headache and general ache and pains and pretty severe muscle pain around the injection site and also the general aches and pain. The second day (31Dec2020) was extreme fatigue, migraine that the never went away, body aching everywhere including joints and muscle everything. It almost felt like the Covid itself all over again. Patient took Motrin essentially around the clock something 6 (intent: 600mg) to 800 mg every 6 hours or so. The outcome of event migraine was not recovered, the other events was unknown.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site mass (left a little bump that's still there) and COVID-19 (after vaccination) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. September 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. In September 2021, patient experienced vaccination site mass (left a little bump that's still there). On Oct 6, 2021, patient experienced COVID-19 (after vaccination). At the time of the report, vaccination site mass (left a little bump that's still there): not resolved and COVID-19 (after vaccination) outcome: unknown. No concomitant medications or treatment medications reported. Patient doesn't know when he will get the second dose. Patient found out that he had COVID-19. It is possible he was  infected before the shot, but he doesn't know. Most recent follow-up information incorporated: On Oct 7, 2021: Follow-up information contained no new information. Sender's comments: This case concerns a 63-year-old male patient with no particular medical history, who experienced an unexpected event of special interest COVID-19 and unexpected vaccination site mass. The events occurred after the first dose of Moderna COVID-19 vaccine; however, the exact time to onset unknown since vaccination date not provided. Re-challenge unknown since there is no information regarding the second dose and occurrence of the event. The benefit-risk relationship of drug not affected by this report.
Information has been received from a physician concerning a 5 year old male patient who on 10/26/99 was vaccinated with a dose of varicella virus vaccine live. On 2/19/04, the patient was seen in the reporting physician's office because he had broken out with chicken pox and an onset date of 2/19/04 was noted. There were fifteen to twenty lesions, but the patient did not have a fever. The reporter described the patient's chicken pox as a mild case with very few lesions. The reporter stated there was no lab work and no hospitalization. Subsequently, the patient fully recovered. A product quality complaint was not involved. Additional information is not expected.
One week to the day of previous vaccination, dose #1, I developed a large area of redness surrounding the injection site.  It is warm, read and covers the upper portion of my right arm nearly to the elbow.
pt recv vax & devel a fever 0f 104 x 2 days;also devel inj site rxn characterized by redness, induration & some chest pain;tx w/Ibuprofen x 2 days w/o results;
after receiving vaccine, pt was informed to have a seat and wait for 15 minutes. patient's mother was at the drop off window filling out paperwork and preparing for the vaccination of her son too. Pt joined her mother and stood next to her mother and was talking and about 5 minutes later another patient reported that she saw pt rock back and forth on her feet and then all of a sudden fell backwards and hit her head on the floor. 911 and paramedics were called and they came within 5 mins.
This spontaneous report was received from an office staff member, concerning a 35 year-old female patient. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with a dose of GARDASIL 9 injection (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis, by an unspecified provider. It was reported, that the administration was outside the prescribing limits of age. No side effects were reported. Additional information has been requested.
Red welt on arm. Was really sore the first day or two after the vaccine. 8 days later it popped up again and has not disappeared yet but is less itchy (day 10)
Body aches, chills, headache, armpit swelling. Armpit swelling has only gone down a little, still aching in armpit and random aching in right armpit.
On 10/14/00 the pt complained of slightly elevated temp, on 10/15/00 the pt complained of rash to left upper thigh observed by parent. The area was red, blotchy looking, non warm to touch. Child denies "itching" or "burning" but states slightly sore to the touch. (With smile on face.) On 10/18/00, the rash remains.
Red rash on my arm that is gradually moving down my arm a little. warm to the touch. painful if I lay on it.
Pt was given wrong medication. Patient originally received 1st dose covid vaccine Pfizer 03/4/21 and was given Moderna for the 2nd dose in error. The patient was notified, administration process at the clinic was reviewed and amended.
Patient developed Bell's Palsy - as yet unresponsive to corticosteroid and B12 therapy.
Starting 30 minutes after receiving the Moderna vaccine, I experienced fatigue, achy muscles, and chills.
No additional AE details; vaccine stored outside of recommended range was administered; This spontaneous report as received from a registered nurse and an administrator, referring to a 6 years old male patient. Concomitant therapies included sterile diluent. The patient's historical condition and current condition were not reported.  On 20-APR-2022, the patient was vaccinated with incorrectly storge of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA (recombinant Human albumin)) (PROQUAD) (lot # U039258 with expiration date: 09-JUN-2023; dose, route and strength were unknown) for prophylaxis (product storage error). The temperature excursion below 6 Fahrenheit degrees (F) up to 14F (7.9F) for 4 hours 8 minutes 0 seconds. No previous temperature excursions reported. The reporter reported the office was unaware of the temperature excursion until she completed a data logger download on 02-MAY-2022.  No adverse events have been reported to the office at the time of the report.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA001061: US-009507513-2205USA000973:02158506 US-009507513-2205USA001205: US-009507513-2205USA001202: US-009507513-2205USA001043: US-009507513-2205USA001271:
The last few days my arm is hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The last few days my arm is hurting".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer concerning her 8 year old son with a history of severe anaemia as an infant and no drug allergies who on 02-AUG-2010, received a dose of DTaP. On 10-AUG-2010, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot #666368/0227Z). The first dose of VARIVAX (Merck) was administered a few years ago (lot # 666368/0227Z) with no reaction. On 16-AUG-2010, the patient experienced an injection site reaction at the VARIVAX (Merck) site 5 inches in diameter with red welts and very hot. The patient saw a doctor on 16-AUG-2010 and was started on KEFLEX capsules for possible cellulitis at the injection site. On 18-AUG-2010, "two days later", he experienced about 9 penny sized red circles with white centers, on both palms of his hands. The circles were puffy, no fluid in circles, with itching and burning. He saw the doctor again and the KEFLEX was discontinued and started on BENADRYL but there was no effect and it made him sleepy. He saw a doctor each day. He also saw a dermatologist on 19-AUG-2010, and was treated with an unnamed cream. Both doctors were unsure if it was related to the VARIVAX (Merck), but feel it might be since it started at the injection site. The patient had never had a reaction from any vaccination. He was scheduled for unnamed blood tests on 20-AUG-2010. At the time of reporting, the patient was not recovered. Follow-up information has been received from a person in the physician's office who reported that the male patient with no illness at time of vaccination on 12-AUG-2010 (previous reported as 10-AUG-2010) at 01:00 PM was vaccinated at left arm with the second dose of VARIVAX (Merck) (lot #666368/0227Z). On an unspecified date, the patient experienced redness around the vaccination site (7 x 7 cm) was lasting 3 to 5 days and then generalized hives were lasting 4 to 5 days. The patient treated with prednisone and ZYRTEC and in 23-AUG-2010 to 25-AUG-2010 the patient recovered. No further information is available.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 01-SEP-2016, the patient inadvertently received and a dose of VARIVX (lot # L011083, expiration date: 01-APR-2017) and a dose of PROQUAD therapy type was not provided (lot # M017335, expiration date: 05-DEC-2017) (route of administration and injection site were not provided for both vaccine). No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
He got a huge knot size of golf ball on the injection site with a red spotty rash the size of the knot. Acting fine as of now eating drinking and playing just sleeping a good bit and he is complaining his leg hurts.
About 36 hours after receiving the vaccine (5PM Sunday to 4:30AM Tuesday), I woke up with a slight fever, slight nausea, and urgent need to empty my bowls (no diarrhea, just constant emptying of bowels in smaller amounts). This progressed for about 5  hours (9:30-10AM) until I had an extreme hot flash/fever and severe nausea for about 30 minutes.  I was only drinking water and eating Tums ant-acid the entire time. By about 10AM the extreme nausea/fever wave had passed and I was finally able to eat something to settle my stomach and after about another 30 minutes, I was back to normal feeling.
LOW BLOOD COUNT; DEEP VEIN THROMBOSIS (RIGHT KNEE); CANNOT WORK DUE TO PAIN; GOUT; This spontaneous report received from a patient via a company representative concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1, suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 21-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-SEP-2021, a week after vaccination patient developed swollen right and left ankles. Later on, her right knee became swollen and she experienced pain in her right knee and right and left calves. She noted that the pain was excruciating in the right knee and she could not walk well and that the pain in the right calf was a lot worse than the left calf pain. Patient saw an orthopedist who extracted fluid from the right knee and tested it for infection and other things. The results showed it was gout. She stated that pain in her knee was excruciating so she went to the emergency room. The first emergency room visit was 3 to 4 weeks after she received the vaccination (date was not reported). During her time in the emergency room, a scan was done and determined that she had a blood clot in the right knee and the doctor diagnosed her with a deep vein thrombosis. Patient was admitted to hospital for a couple days and was given Eliquis. Date of hospitalization was not reported. After discharge, patient spent a weekend at home and presented back to the emergency room because she was still experiencing excruciating knee pain and her doctor was not getting back to her. During her time in the emergency room, bloodwork was done and determined that she had a low blood count and required a blood transfusion. Reporter was unsure if her sister (patient) had low platelets or a low blood count. She stated that her level was 6.1. Patient was admitted to the hospital for at least 2 days to determine if she had bleeding somewhere, causing the low levels. It was unknown if or what other tests were done in hospital. Patient has not recovered from the blood clot and it was still there. Patient was on prednisone for pain otherwise she could not work due to the pain. Patient was out of work for a month due to the pain.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis (right knee), and the outcome of gout, low blood count and cannot work due to pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20211238279-COVID-19 VACCINE AD26.COV2.S-deep vein thrombosis (right knee), low blood count. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
The patient was waiting in our post vaccination area and felt a sudden spell of dizziness while sitting in a chair. She fell forward but retained full consciousness the entire time. EMS services we called and took her to a near by hospital
Moderna COVID-19 Vaccine  Extreme fatigue started about 3 hours after the dose and continued well into the next day. Severe headache set in about an hour after the fatigue and went away in the morning, though fatigue still persisted. I took a nap and some ibuprofen but it did not help very much,
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 07-JUL-2015, the patient was vaccinated with an expired dose of GARDASIL (lot # H020901, expiry date 05-JUL-2015; dose, strength and route of administration were not reported). It was unspecified which dose number in the series this dose was. No adverse experiences were reported. This is one of the several reports received from the same source. Additional information has been requested.
pt recvd vax 15DEC93 @ approx 1130AM; mom returned to clinic 1145AM crying c/o being unable to wake pt up; pt was wrapped in a snowsuit; nurse removed suit & pt eyes opened; pulse 88 & resp 26/min; taken to MD c/o difficulty arousing;
2" red diameter round area. Started approximately 48 hours after injection, lasted approximately 2 weeks