chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom called on 11/20/18 and reported that MGM initially noticed pt to be "staring" about 6-7 hours after vaccination. He also had fever, up til 103 F at 6 pm. (Vague about exact time). Pt seen with mom. Some hx obtained from Grandma on phone. Grandma reports around 6pm, on the evening of immunizations, she noticed him in the crib with eyes open, "staring up". Picked him up and felt warm. She checked the temperature and it was 103F per MGM. MGM reports she gave him TYLENOL and watched him. Reports he had "no energy" /"limp", "weak" was not holding his neck, like he usually does, per MGM. Was moving his tongue. Denies any tonic-clonic convulsions with the episode. Acting like "zombie". Denies his tongue swelling/wheezing/resp. distress. Reports didn't call 911/doctor as thought it may be "normal reaction" to the shot. MGM reports she had watched a TV commercial about side effects of Dtap, few days prior and it seemed like that. She reports that she doesn't want to give him Dtap, next time. MGM reports she fed him, though and he took 1/4 of bottle and then slept for 3 hours or so. Mom reports she had work shift from 6-10pm that night. When, mom came back from work same night, she reports she checked temp. and it was still 103. (Axillary) (MGM reported that after about 1 hour of TYLENOL, temp. dropped to 99F). Mom wonders if fever came back again. Mom reports, for her, he had less energy. "He was here but not here". Mom reports she thinks his mind was somewhere else. Mom reports she waved her hand in front of him, waved his toy, but didn't seem as interactive. Mom reports he slept soon afterwards and slept through rest of the night. She reports Sx of less than normal energy level lasted less than 24 hours, and then he started getting back his energy. She reports that is why she didn't call doctor/take him for evaluation. On her way out, at check out desk mom mentioned that on Sunday, while she held him, felt like his legs were shaking. She reports she is not sure whether with her hand movement, it stopped. It lasted, maybe for 30-45 seconds. There was one more episode like that of similar nature few hours later, on Sunday as well (details not-specific and vague) and then it never happened. Mom reports she was scared, however, she told her mom about it but didn't call doctor /seeked care as it was very brief and he has been acting like himself right afterwards and since then. Mom reports it didn't look like a seizure. (Mom had a list of reported symptoms from MGM on her phone). We got MGM on speaker and got hx from her directly as well.
Information has been received from a physician concerning a 60 year old female who on 05-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck) and "had lots of swelling at the injection site, with bumpy rash in the middle of it".  The patient sought medical attention (office visit on 07-DEC-2007).  The patient had not recovered.  Additional information has been requested.
6 months after vaccine I lost my hearing in my right ear, sudden hearing loss with no forewarning. Saw doctor and was given COVID-19, RSV and Flu test and all were negative. Doctor didn't have any answers. Didn't get better over time, decided to go to an Urgent Care and upon examination they found a little fluid in my ear. Was give a prescription for Prednisone and went to an Audiologist for a hearing test, then referred to an ENT. The ENT raised my Prednisone dosage. A week later went back to the Audiologist and they found a little bit of improvement. Went back to the ENT and gave me an extended prescription for Prednisone.
Headache, joint pain in all joints, "locking" of fingers (unable to use hands), burning pain in joints.
Patient developed a nontender erythematous patch at the site of the injection, about 9-10 days after it was given.  This patch coalesced into several red NT papules, and parent described a vesicular lesion which was no longer present at the day of the follow up visit.
pt recv vax 6OCT97 & 7OCT97 pt mom indicated that daughter arm was sore & swollen to the size of a lemon;
About 24 hours after my second vaccination on April 23, 2021, I started to experience dizziness, which felt like spells of vertigo, too. Since then, I've had very short spells of vertigo anytime I am laying down or getting up.
PATIENT CAME IN STATING SORENESS OF HER ARM THAT STARTED THE NIGHT OF THE SHOT GIVEN. THEN STATES THAT ON 6/9 SHE BEGAN TO ITCH ALL OVER HER BODY. THIS WAS NOT RELIEVED BY ANTI-ITCH LOTIONS, SOAPS, OR BENADRYL. STATES THAT SHE HAS AN APPOINTMENT WITH HER PRIMARY CARE PHYSICIAN ON 6/11/21 FOR ANOTHER ISSUE AND WILL ADDRESS IT WITH HER DR AT THIS TIME.
30 to 40 minutes after injection, I noticed a mild case of hives on both arms, legs chest and lips. I get these types of hives from various other allergens. I took two Benadryl and it subsided within an hour. Has not returned.
Soreness after injection immediately after for 2 full days On day 8 arm again became tender and developed a raised, red, circular rash around injection site.  Currently on day 9 and rash is still present, slightly bigger but less raised
Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 16 month old male with no pertinent medical history and no known drug reactions/allergies who on 04-JAN-2011 was vaccinated with the first 0.5 ml dose of MMR II (lot#665427/0667Z) in left thigh. Concomitant therapy on the same day included influenza virus vaccine (unspecified) (manufacturer unknown). On 14-JAN-2011 the patient was brought into the office and had a rash from head to toe. The patient was treated with calamine lotion. There was no lab diagnostics studies performed. At the time of the report, the outcome was unknown. Follow up information has been received from the reporting medical assistant concerning the male who at 13:00 on 04-JAN-2011 received the above vaccine. At pm of 14-JAN-2011, the patient developed diffuse red macular rash all over the body and on the head. At the time of the report, the patient had recovered from his adverse event. The patient did not seek require emergency room/doctor visit. Additional information is not expected.
WE WERE MISINFORMED BY THE HEALTH DEPARTMENT REP THAT WE CAN ADMINISTER THE MODERNA VACCINE TO ANYONE YOUNGER THAN 18 YEARS AND WE GAVE THIS 16YR OLD PATIENT THE MODERNA VACCINE.  SHE WILL NEED HER SECOND DOSAGE, BUT WE WANTED TO KNOW WHAT SHOULD BE DONE? THE PATIENT HAS HAD NO REACTION TO THE VACCINE.
Swelling, red, sore, bruising, hot area above elbow but well below correct deltoid injection.
Heart arrhythmias; This is a spontaneous report from a contactable pharmacist via Pfizer-sponsored Regulatory Authority Support via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single for COVID-19 immunization. Her patient stated she was experiencing heart arrhythmias after the Pfizer covid-19 vaccine. She had a medical question. She wanted to know why was there potassium chloride in the Pfizer COVID-19 vaccine. Her patient wanted to know why would they put something in it that will kill her. The outcome of the event was unknown.   This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Arrhythmia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The same evening of the vaccination, I had a low grade fever and started to feel body aches.  The next morning I woke up with body aches, a headache, and nausea. By, midday I had a fever, severe body aches, and nausea. That night I could not sleep due to the nausea and chills. By Friday I've still felt nausea and chills.
Could not move, pain from back of neck to spine, down to lower back, hips, left leg & foot. After a week, left side of face numb, left arm weak & could not open left eye unless aided by hand. Nerves tingling with pain. Treated with prednisone, TYLENOL with codeine, LYRICA & physical therapies.
Swelling and pain in the primary knuckles of my hands--especially the right hand.   Unable to make a firm fist with my right hand--weak.   Ring finger on the right hand is particularly swollen and inflexible. I don't know what has caused this to occur.
Large 4 x 2cm bruise and erythemic nodule lasting greater than 1 week.
Pt described significant ankle edema with onset 4 days after receiving shot, duration of approximately 3 days.  While pt said she had experienced mild ankle edema in the past, she says she had never experienced ankle edema of such magnitude. Pt was concerned it might have been related to the vaccination.
"Moderna COVID-19 Vaccine EUA" - at minute 14 after the vaccine I got really light headed and funny feeling, my heart was racing but I was not having any trouble breathing.  The nurses at the site monitored me until my vital signs returned to normal.  I was very tired for a few days after and had a headache.  Sevens days later, 03.15.2021, I woke up to my arm being tender again and noticed a big red spot/rash right by the injection site of the vaccine.
Soreness at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received his first Shingrix vaccination in his left arm approximately two months before the date of reporting and experienced redness and soreness at the injection site. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020211996.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211996:same reporter, 2nd dose
This spontaneous report as received from a registered nurse refers to multiple different unspecified number of patients of unknown age and gender. The patient's medical history, current conditions, drug reactions and allergies were unknown. On an unknown date, the patients were vaccinated with PROQUAD (Merck) (dose, route of administration, anatomical location, and expiry date were not reported) that were stored improperly. No adverse effects reported. No product quality complaint was reported for PROQUAD (Merck). This is one of two reports received from the same source. Additional information has been requested.
Pt received J&J shot today. Pt stated that she is a "vaccine reactor" so we asked her to stay for 30 minutes just in case. At the 30 minute mark she asked if it was okay if she took benedryl when she got home because her throat felt a little itchy. After assessing the patient by asking questions regarding other symptoms, I decided to provide the patient with 25 mg of oral liquid bendryl. I asked the patient to stay for an additional 15 minutes which at the end of that interval, patient stated she felt much better. I informed her to call us if any other symptoms arise.
no energy/she has degenerated/she doesn't feel like doing anything; no appetite; woke up feverish in the middle of the night; bad case of chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy/she has degenerated/she doesn't feel like doing anything), DECREASED APPETITE (no appetite), CHILLS (bad case of chills) and PYREXIA (woke up feverish in the middle of the night) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced CHILLS (bad case of chills). On an unknown date, the patient experienced ASTHENIA (no energy/she has degenerated/she doesn't feel like doing anything), DECREASED APPETITE (no appetite) and PYREXIA (woke up feverish in the middle of the night). At the time of the report, ASTHENIA (no energy/she has degenerated/she doesn't feel like doing anything), DECREASED APPETITE (no appetite), CHILLS (bad case of chills) and PYREXIA (woke up feverish in the middle of the night) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-396682 (Patient Link).
Patient received booster dose one month earlier than recommended 6 month interval. Called patient to advise her she may experience more side effects than normal in the form of fever, headache, nausea, vomiting, fatigue, and muscle aches and pains. Patient was feeling fine when she was called.
red spot; his left arm and it had a hard spot on it; his left arm and it had a hard spot on it and it was hot; had a fever; arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 29Jul2021 (Lot number: FA7485) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 2021, when the patient was 13 years old, for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious) with onset 30Jul2021, outcome "not recovered", described as "red spot"; SKIN INDURATION (non-serious) with onset 30Jul2021, outcome "not recovered", described as "his left arm and it had a hard spot on it"; FEELING HOT (non-serious) with onset 30Jul2021, outcome "unknown", described as "his left arm and it had a hard spot on it and it was hot"; PYREXIA (non-serious) with onset 30Jul2021, outcome "recovered" (2021), described as "had a fever"; PAIN IN EXTREMITY (non-serious) with onset 30Jul2021, outcome "not recovered", described as "arm was sore".  Additional information: The patient had the COVID vaccine on 29Jul2021, and he didn't feel bad that day or that evening but the next day, (on 30Jul2021), his arm was really, really, really sore.  At the time of this report, the patient did not have a fever and it looks like it was pretty much all gone on his arm.   No follow-up attempts are possible. No further information is expected.
Patient fainted and hit head resulting in a contusion. Patient came to within a few seconds and recovered quickly.
1/27/21-pt. developed left arm pain 10/10 and Limited ROM, has been taking tylenol and ibuprofen without relief
Information has been received from a female who was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced an unspecified reaction. No further information was provided. Additional information has been requested.
Small, quarter-sized red spot at injection site.  Patient returned to pharmacy on 6/20/13, and showed pharmacist that spot had grown to about the size of a silver dollar.  Pharmacist instructed patient to take Diphenhydramine 25mg 1 po q4-6h, and add ice to the injection site.   Further instructed patient if no improvement noticed within 24 hours, check with physician.
After one month of getting my second dose, I woke up with fullness in my ears as well as slight fatigue, slight chills, and loss of appetite for 3 weeks. After 3 weeks, my appetite came back but still fullness. Visited 4 different doctors and was prescribed prednisone pack as well as nasacort and sudafed. After 10 fays, there was slight improvement. I was then referred to ENT and was given another round of prednisone for 10 days as well as Alkalol nasal rinse and Ipratropim Bromide nose spray. I can take allergy meds as well and Flonase. I am on day 4 of this next treatment and still have fullness and exacerbated tinnitus. I did have tinnitus before, but it is worse because of the fullness. I also have phlegm in my throat that is very hard to clear
At night I had some arm pain. I had heart palpitations. My heart rate was very high. I called 911, since I was feeling lightheaded as well. I tried to stay as calm as possible. I took deep breaths and tried to relax. But my heart rate wouldn't go down.  I went to the emergency room. I took some tests.    A couple of days later, I experienced the same symptoms again. My heart rate would go up to 165 when I was sitting down. This would last for 3-4 weeks when my heart rate would go up to 165. I experienced this up to 5 times a day - and this would happen even when I was sitting still or not doing anything. The EKG showed that my heart rate was normal, but there were times where it would just increase randomly.
On May 5, I had a slight sore throat in the morning, the symptoms persisted throughout the weekend. It felt like a head cold.  On May 8, 2023, I used a home COVID-19 test that came back positive. I called my doctor to have a telehealth visit. We discussed my taking the Paxlovid antiviral since I do have a heart condition. He prescribed the Paxlovid that I was able to start that day. I will be taking the last dose tomorrow morning.
7 days post vaccination noticed slight redness, itching and warmth at site of injection. Circled site to keep track of the redness. On morning of day 8 the redness had continued to spread, contacted primary care who made referral to urgent care to be seen as primary not yet familiar with vaccine. Urgent care MD made diagnosis of cellulitis and prescribed antibiotics (cephalexin ). All symptoms resolved within 24hrs of start of antibiotics.
Infant vomited at home x 3 and had diarrhea x 3 1/2 wks - parents feel it is from the Rotavirus vaccine.
It was reported that a 56 y.o. female PT received a TD adult vaccination on 10/19/02. On 10/22/01 the PT developed axillary node swelling, fatigue and left arm soreness lasting 1 wk. Treatment of Motrin and ice packs were used.
Information has been received from a physician concerning a 10-year-old female with no pertinent medical history or drug allergies who "had received the two doses of varicella virus vaccine live (Oka/Merck)". The last subcutaneous dose of 0.5 mL was "over a year a year ago". There was no concomitant medication. On an unspecified date, she developed episodes of clusters of blisters. Medical attention was sought via an office visit. The patient's pediatrician states that "these are chicken pox", however it was reported that an infectious disease doctor was not sure if the blisters were chicken pox. On 20-FEB-2008, the patient had IgG and IgM testing performed and had negative results. The outcome was reported as recovering. No product quality complaint was involved. The physician also reported that the patient's brother developed an adverse event following vaccine administration (WAES numbers: 0803USA02523). Additional information has been requested.
Patient came for booster shot. Received initial dose elsewhere. After administration noted, booster given too early. (only 13 days apart)
Patient tested detected for COVID during routine placement screening to Behavioral Health unit.  Mildly symptomatic - no hypoxia.  Discharged home.
The child was mistakenly given Kinrix, when she was actually only supposed to receive a  Dtap vaccine.  The child did not have an adverse reaction.  The child was due for her 3rd Dtap dose, and was not due for an IPV.
PATIENT FELT DIZZY AND ALMOST FAINTED WITHIN 5 MINUTES OF ADMINISTRATION. HE WAS VERY SWEATY AND AT FIRST HAD SOME ISSUE BREATHING WHICH RESOLVED AFTER A FEW SECONDS
Fifty minutes after the vaccine I had a feeling like my Heart was racing. It continued and then I had chest tightness and soreness. I went to the emergency room and I had Tachycardia and my heart rate was 167. I was discharged the next morning. I continued to have that problem for 5 days. I was advised not to have the second dose. I have not had any problems since then and cardiac tests were normal.
Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning a female neonate. The neonate's 21 year old mother on approximately 10-JAN-2012 was vaccinated with VARIVAX (Merck) (dose, route and lot number not reported). The mother at the time of receipt of the VARIVAX (Merck) she was not pregnant. At the follow-up visit the patient was tested positive for pregnancy, and further data collection revealed that her last menstrual period was 26-NOV-2011. Estimated Delivery Date was 01-SEP-2012. Follow-up information reported that the mother delivered a healthy baby girl on 12-Sep-2012 at 39 weeks' gestation (LMP previously reported as 26-NOV-2011 which would count as 41 weeks' gestation age). The vaginal delivery was without complications. The infant weighed 3203 grams, APGAR scores were 9/9. It was reported there was meconium stained fluid upon delivery. No fetal congenital anomalies were reported. The infant had neonatal jaundice post delivery (approximately in September 2012, exact date not reported). Outcome of the neonatal jaundice was not reported. Additional information is not expected.
Chest pain; This is a spontaneous report received from a contactable consumer, the patient. A 48-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 17:30 (at the age of 48-years) as single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to penicillin and Advil. The concomitant medications included warfarin (MANUFACTURER UNKNOWN) and Armour thyroid. The patient received these medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested for COVID-19. The patient experienced chest pain after 5 hours of vaccination on 19Mar2021 at 22:30. The clinical outcome of chest pain was not resolved at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
The morning after I got my 2nd shot, I was picked up by a friend at around 10 a.m. to have breakfast. While waiting for her, I started to feel a bit nauseated. When I got into her car, we had driven just about 5 blocks and I asked her to pull over so I could vomit. I hadn?t eaten, so it was just bike. I got back in the car, and began sweating profusely and was still feeling sick. She brought me home, and I had diarrhea and nausea for several hours. I rested all day and didn?t get medical help
fever, sweats, chills, headache, body aches, loss of feeling in limbs. Took 500mg of Tylenol once every 4 hours.