chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered two vaccines, Typhim VI and Menactra on 04/16/2008 at 5:30PM.  At 1:00AM on 4/17/2008 the patient awoke with pruritis and and a ill defined rash on his trunk, arms, and upper thighs.  There were no respiratory or other symptoms noted.  The patient presented to the Occupational Health Clinic at approximately 9:00AM on 4/17/2008 with the same complaint of itching.  He reported that he had taken no medications for his symptoms, although at approximately 7:00PM on 4/16/2008 he had taken Mobic 7.5MG for an ankle injury.  He reports that he just started taking this medication a "couple of days before" as prescribed by his orthopaedic physician.  There were no signs of respiratory distress.  After assessment the patient was given 50 MG of PO Benadryl.  On follow up with the patient at 10:30AM on 4/17/2008 he was asymptomatic.  The patient was told to follow up with his physician and to contact this provider if there were any further issues.
This spontaneous report was received from a registered nurse and refers to 20 patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot number L018351, expiry date 11-AUG-2017 (doses, route and anatomical sites of injection were not reported). Concomitant therapies were not provided. Information regarding the temperature storage, duration of excursion and previous excursions were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax; was unresponsive; having stiffening of arms & legs & raising self out of chair,lasting 15 sec;became responsive to name, BP stable, speech clear w/in 30 sec p/ adm of vax;sent to er; pt well now, stable;
Minutes after I got the vaccine I started to lose hearing in my left ear (it sounded like I was under water) which slowly spread to my right ear as well. My hands and feet went numb and I started sweating all over. I felt sick to my stomach and I felt like I was above the whole situation-- I could hear the people talking but I felt like I was somewhere else. After resting my head on the table for about 10 minutes I felt better and was able to move to a cot where I rested for another 20 minutes or so until I felt pretty much back to normal. I was treated by the medical team at the site who cleared me to go home.
Right after receiving the vaccine, I had some minor arm soreness, which went away. I experienced no other adverse effects until the morning of March 21, when I woke up with a significant feeling of disequilibrium. I had never experienced something like this before; when I was stationary I felt fine, but when I started to move my sense of balance was noticeably off. I stumbled around my apartment for a bit before heading to Urgent Care, where I was diagnosed with Benign Positional Vertigo.
Patient reported that within 3 hours of receiving the vaccine, he became short of breath and had chest congestion (with watery eyes and nasal congestion).
For a few days after vaccine, arm was very sore then that stopped. A week after the vaccine, injection site felt itchy and then became red and hot (about a 2" square around the injection site). That has continued for 2 days so far. I took a Benadryl on the 2 day and the redness subsided some.
Right deltoid where vaccines were given - Tdap and MCV - with erythema and edema, warmth approx 8 hours after vaccines which progressed over the next 24 hours. Suspected cellulitis so started of KEFLEX 500mg BID x 10 days and BENADRYL 25mg TID x 3 days.
severe pain (10) in right arm from the shoulder to the fingers; described as continous, stabbing pain;  unable to lift arm; NO range of movement in the right arm; redness at the site of the injection; difficulty breathing;  elevated blood pressure (121/90);  chills; fever; nausea.  as of 1/27/2010; constant pain the arm and very limited range of motion
sore arm 1st day lasted about 3-4 days;h/a 2nd day lasted 1 day;sore arm muscles calves to legs (both legs) 3rd day left knee & hip hurt 3rd day lasted 2 days;tired 3rd day & lasted many days;stomach cramp 3rd day lasted 2 days;no appetite
Received Pfizer vaccines on 2/23/21 and 3/16/21.   Tested positive for COVID-19 by PCR on 5/22/21 after known exposure to person w/ COVID-19. Unknown symptoms began on 5/18/21. Patient received casirivimab-imdevimab 2,400 mg (1,200-1,200 mg) IV on 5/23/21.
Information has been received from a nurse concerning a 13 year old female who was vaccinated with the second dose of GARDASIL, IM, 0.5ml. Subsequently the patient had a "seizure like" reaction. The patient was "back to normal in 2 to 3 minutes". The patient did not seek medical attention. Upon internal review, patient's "seizure like reaction" was determined to be an other important medical event. Additional information has been requested.
Pt  developed a fever 08/14/18 of 39C/102.2F. Pt. complained of left arm pain measured area of redness 8x5 cm wide. Pt states no fever since last night. Exam: Alert  well appearing. Left upper arm with erythematous patch, approximately 2x3in. Soft, mildly tender. No active drainage. No streaking.  Left arm FROM.
Myalgia, Fever, Chills, SOB Narrative:  Other Relevant History:
8 year old got his 2nd dose of Bexsero; is fatigued; fever of 101.8; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a 8-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd November 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. In November 2022, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fatigue and fever. On 23rd November 2022, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the fatigue, fever and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the fatigue and fever to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-NOV-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter reported that his/her sister's son got second dose of Bexsero vaccine yesterday (the day before reporting) and the patient now was fatigued and had a fever of 101.8 degree Fahrenheit.  The reporter asked do GlaxoSmithKline think the vaccine could cause the fever. Additional Supportive Information: The eight year old patient received a dose of Bexsero, which led to inappropriate age at vaccine administration. Follow-up would not possible as no contact details were available.
pt recvd vax; 1 day later, pt devel redness, warmth & induration at inject site;
This spontaneous report as received from a nurse refers to a patient of unknown age. On 22-JUN-2017 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L038018, expiration date 13-SEP-2017) and an improperly stored dose of ROTATEQ (lot# M031802, oral) for prophylaxis. Concomitant therapies included DTaP-IPV and PREVNAR 13. No adverse event was reported. This is one of several reports received from the same reporter. Follow up information has been received on 13-SEP-2017 from the nurse referring to the 8 weeks old male patient. The patient was vaccinated with RECOMBIVAX HB intramuscularly in the right thigh. It was reported that the refrigerator was out of temperature range. This is a corrected report.  This report was previously submitted with the incorrect Worldwide unique case identification number 'US-009507513-1707USA006507', and this new follow-up submission is to provide the correct identification number 'US-009507513-1708USA006935'. 'US-009507513-1707USA006507' is an existing case, therefore this safety report is not being nullified, just updated to reflect correct Worldwide Unique Identifier. Sender's Comments: US-009507513-1707USA006507.
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of VARIVAX (dosage, frequency and route of administration were not reported), lot#: N025933 (expiration date: 19-SEP-2019), lot#: N020686 (expiration date: 27-JUL-2019,) lot # N014630 (expiration date: 11-AUG-2019 "also reported on 11-MAY-2019", for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Sender's Comments: US-009507513-1802USA008838: US-009507513-1802USA008839: US-009507513-1802USA008840: US-009507513-1802USA008841: US-009507513-1802USA008836: US-009507513-1801USA014257: US-009507513-1802USA008837: US-009507513-1802USA008835.
10/23/2021 early afternoon, I noticed that I was very sluggish and that I was having a little tightness in my chest. I figured that it might have been another health issue in regard to my current health issues GERD, hernia, anxiety. 10/24/2021 I noticed that I didn't sleep very well. I was very uncomfortable with the tightness in my chest being more intense. I started taking Anti-Acid thinking it might be the GERD. By Sunday night, I was really feeling the pressure and I took the nitroglycerin and waited 15 minutes with no results, so I took another one. I just laid down and gave myself a chance to rest, hoping I would maybe feel better. 10/25/2021 I felt like I was being squished and I was having difficulty breathing. The pain in my chest was radiating to my neck. I called my daughter to take me to the ER, but the ambulance came instead. Was there from 10:00AM to 4:30 in the afternoon. They did a bunch of tests at the ER, and they saw some irritation and fluid around the heart. They gave me medication to relax and some for my GERD. It started to feel better but not entirely better. They prescribed me medication, but I was unable to take it because it made me nauseous and caused diarrhea. After release of the hospital, I kept trying to make the meds and it wasn't good because I became so dehydrated from diarrhea. 10/29/2021 I went to the doctor for a pre-op visit and they did an EKG and found something irregular and shipped me straight to the hospital where I was admitted for 5 days. They gave me prednisone and it has helped but I do not like the side effects that came along with them. It's been helping with the irritation since I cannot take the other medication. I no longer have the chest pain, tightness in chest, and shortness of breath and feeling fatigue.
Toe patient experienced no symptorns; on 2/25/2020 a patient was administered a dose of PROQUAD via the intramuscular route; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On 25-FEB-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # S022104, expiration date 12-JAN-2021 via intramuscular route for prophylaxis. The vaccine was reconstituted with a sterile diluent.  The patient experienced no symptoms.
Initially unable to use her right arm/Unable to physically lift her arm; Experienced weakness in her left arm, which is disrupting her sleep; Experienced weakness in her left arm, which is disrupting her sleep; Numbness, affecting her muscles in the left upper quadrant, although her lower arm hurts, she was sent to the cardiologist; Numbness, affecting her muscles in the left upper quadrant, although her lower arm hurts, she was sent to the cardiologist; This is a spontaneous report from a contactable consumer (patient, self-reported). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on Jan2021, as a single dose for COVID-19 immunization. The patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, she was initially unable to use her right arm, but this resolved within 2-3 days. She has experienced weakness in her left arm, which was disrupting her sleep. She was unable to physically lift her arm and asked if this was a side effect of the vaccine. The patient asked to figure out how to get rid of this and which doctor did she need to see. She shared she saw her HCP in April. She continued, before she started running to all of these doctors, she really needed to find out what she was dealing with. She saw her HCP in April, because of the numbness, affecting her muscles in the left upper quadrant, although her lower arm hurts, she was sent to the cardiologist. She went through several tests with the cardiologist. They did not find anything wrong there. She just going down this path-its too much. She was hoping you have another idea besides going to all different doctors. If you have other people who have this and now it has been resolved. The patient asked on clinical trials was arm weakness a side effects and received her second shot in other arm and did not expect to be six months in to not using her arm, shared that she did not go to the doctor regularly and last went three years ago. The patient recommended HCP to continue following up with health care provider team. The events resulted in physician office visit. Outcome of the event initially unable to use her right arm/Unable to physically lift her arm was resolved on an unspecified date and for all other events, it was unknown.  Information about batch/lot number has been requested.
Pt had dot on 6/25/18, upon waking up the next day (6/26th), the right arm felt "red", warm, tender to the touch and itchy. Today, 6/27th, the symptoms are still present.
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 06-DEC-2016, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ), oral, (dose not reported) from lot # M007311 (expiry date: unspecified)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 correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012721 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Local inflammation at injection site. (R) UE 9x14cm, (L) 3x4 cm.
This spontaneous report was received from a medical assistant and refers to a currently 4-year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX subcutaneously, lot # N026073 with expiration date on 20-SEP-2019 (dose and site of administration were not reported) and M-M-R II subcutaneously, lot # N023150 with expiration date on 24-AUG-2019, and lot # N011005 with expiration date on 05-APR-2019 (dose and site of administration were not reported) for prophylaxis. Administered doses of VARIVAX experienced the temperature excursion of 8.3 degrees Celsius for 1 hour 23 minutes. Administered doses of M-M-R II experienced the temperature excursion of 9.5 degrees Celsius for 1 hour 36 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA004566: US-009507513-1808USA002162: US-009507513-1808USA004565:
8 hours after shot: inflamed/pain left arm pit, sore upper left breast 15 hours after shot:  pain in left neck and headache on left side of head 19 hours after shot:  nerve pain in hips and back, start of muscle aches, "spacy, out of body" feeling, nauseous 26 hours after shot:  muscle aches in legs, hips, back, nerve pains, nauseous, heart flutter, burning in chest,100.9-degree fever 30 hours after shot: fever lower, some of symptoms less or gone after taking 2 asprin
got sick; felt really bad like she had the flu; felt really bad like she had the flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: She already had COVID a year ago and she has the antibodies but here is the problem; "injured" (unspecified if ongoing), notes: she was out of work because of injured. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "got sick"; MALAISE (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset Dec2021, outcome "unknown" and all described as "felt really bad like she had the flu". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter stated that the concern is my wife. she had one shot on couple weeks ago I guess, she went back to work, she was out of work because of injured (Further clarification unknown) and she has to get a shot to get back in and she got a shot somewhere prior to 16Dec at withheld (Further clarification unknown). So, she made the appointment, she got the shot, she got sick for two days, felt really bad like she had the flu and sometimes it does suppose me give you that. She already had COVID a year ago and she has the antibodies but here is the problem. Not clarified about Lot#.  If follow-up activities cannot be or are not conducted: No follow-up attempts are possible; information about lot/batch number cannot be obtained.
ALERT INITIALLY.  SOON C/O FEELING LIKE SHE WAS GOING TO PASS OUT (PHYSICIAN CAUGHT PATIENT AS SHE WAS FALLING FACE FIRST OFF EXAM TABLE).  WAS PALE X 1 MIN, BRADYCARDIC X 2 MIN.  PT WAS LAID ON EXAM TABLE WITH KNEES ELEVATED.  COMPLETE SET OF VITALS OBTAINED BY PHYSICIAN AND THOROUGH EXAM PERFORMED WITH NEGATIVE OUTCOME.  PT GIVEN POPSICLE AND WAS ABLE TO LEAVE IN 15 MINUTES.
Hives and dermatographia began 11/23.  Full body, including scalp, feet, hands, and upper lip.  Hives were extremely itchy and painful and skin seemed swollen and was hot to the touch.  Fingers felt very stiff and hands weak.  By 11/25, left arm (NOT the arm that received the injection) and wrist felt very sore.  After sitting for Thanksgiving dinner, buttocks also felt painfully sore.  Was fatigued that day.  On 11/26, conditions began to improve.  As of today (12/9), still experiencing some itchniess, hives, and dermatographia, but much more manageable.  Treatments: 11/23 - none 11/24-25 - Spray Benadryl, Eucerin Calming Cream, Colloidal Oatmeal bath 11/26-27 - Spray Hydrocortisone, 1 Claritin/day, Colloidal Oatmeal bath 11/28+ - occasional spray hydrocortisone
9 out of 350 employees did not respond following 3 hepta B vax.
Gradual onset of numbness, tingling, and weakness since about November 2009. Diagnosed with chronic inflammatory demyelinating polyneuropathy in Mar 2010.
The patient received 0.2ml of undiluted pediatric covid vaccine on 2/7/22 at 7pm. The father was contacted 2/9/22 and said she had a fever all day on 2/8/22. He thought she was doing better today but not sure, he wasn't at home. I explained to him the mistake, apologized profusely and talked to him about the CDC recommendation to monitor the patient and call me with any other concerns. I also explained I will be contacting the pediatrician to let them know what happened. He thanked me for the call.
Patient reports to feeling like heart was racing 5 minutes after shot that resolved shortly after.  She reports that symptoms resolved after a few minutes and since then has no tachycardiac complaints.  Reports to feeling fatigues x 24 hours after vaccinATION. Was reported that pt experienced Tacycardia!!
Redness, slight-swelling, warmth, and pain in left knee.  No previous injury, diagnosed RA, or other known issue with left knee.  Mentioned to physician during routine check-up, but he made no recommendations. Knee no longer swollen, red, or warm, but is tender when pressure is applied.
Rash across large upper arm, intense pain to bone from elbow up to shoulder blade on left arm, where site is is goofball like and hardened. Nausea, vomiting, fatigue, stomach discomfort
pt recvd vax;approx 30-45 mins later,itchy throat & dry cough for about 4 hrs;3 hrs later eyes became irritated & had yellowish discharge;in eve ached all over "as if tons of bricks hit her";in bed x 48 hrs;p/ 24 more hrs felt better;
This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with PEDVAXHIB (lot # L042836, expiry date: 24-AUG-2018) (route: intramuscular), that was improperly stored. The vaccine was stored at a temperature of 32°F to 35°F (34.8F) for 1 hour and 15 minutes, at 32°F to 35°F (35.4F) for 4 hours and 24 minutes, at 32°F to 35°F (35.4F) for 4 hours and 12 minutes, at 32°F to 35°F (35F) for 4 hours and 36 minutes, at 32°F to 35°F (35F) for 4 hours and 18 minutes, at 32°F to 35°F (35F) for 4 hours and 42 minutes, at 32°F to 35°F (35.4F) for 2 hours and 30 minutes, at 32°F to 35°F (35.4F) for 3 hours and 18 minutes, at 32°F to 35°F (35.2F) for 4 hours and 54 minutes, at 32°F to 35°F (35.2F) for 4 hours and 42 minutes, at 32°F to 35°F (35.2F) for 4 hours, at 32°F to 35°F (35.4F) for 2 hours and 24 minutes, at 32°F to 35°F (35.4F) for 2 hours, at 32°F to 35°F (35F) for 4 hours and 6 minutes, at 32°F to 35°F (35F) for 5 hours and 24 minutes, at 32°F to 35°F (35.2F) for 5 hours and 6 minutes, at 32°F to 35°F (35.2F) for 5 hours and 18 minutes, at 32°F to 35°F (35.4F) for 3 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse symptoms reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA011555: US-009507513-1707USA011601: US-009507513-1707USA011419: US-009507513-1707USA011607.