chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fracture of right distal radius after fall sent to follow-up with Ortho and a sugar tong splint and sling were placed as well as medication for discomfort in addition patient having mild symptoms after her recent Covid vaccine which caused her to feel dizzy and fall causing the fracture advised to increase intake of fluid and follow-up if needed       COURSE & MEDICAL DECISION MAKING Patient seen and examined is a 72-year-old female who reports complaint of falling today after a near syncopal event she relates it to feeling somewhat poorly after getting her Covid vaccination. Unfortunately after she fell she caught herself with her right arm and now she has pain in the right wrist no numbness or tingling. Labs and x-ray were ordered labs are grossly normal however the x-ray shows a distal radius fracture patient was placed in a sugar tong splint and sling discharged home with follow-up with Ortho and advised to increase fluid intake she has medication for discomfort and follow-up as needed
painful twinge on left thigh; shingles; rash on his left buttock and left thigh; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included back pain, pain in thigh and spinal disorder (lesion on spinal column).   On 16-JUN-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 22-JUN-2023, 6 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles) and rash (Verbatim: rash on his left buttock and left thigh). On 23-JUN-2023, the patient experienced pain in thigh (Verbatim: painful twinge on left thigh). The patient was treated with valaciclovir hydrochloride (Valtrex), lidocaine (Lidocaine Patch) and calamine (nos) (Calamine Lotion). The outcome of the shingles and pain in thigh were not resolved and the outcome of the rash was resolving.   It was unknown if the reporter considered the shingles, rash and pain in thigh to be related to Shingrix.     It was unknown if the company considered the shingles, rash and pain in thigh to be related to Shingrix.   Additional Information: GSK receipt date: 12-JUL-2023 The patient received his first dose of Shingrix and next day he had his usual physical therapy session for pre-existing back and thigh pain (due to a spinal lesion).  The patient noticed a rash on his left buttock. He had been outdoors the day before and thought the rash was due to bug bites. On 23 June 2023 he had a painful twinge on left thigh and noticed a rash there also. On 25 June 2023 he saw a physician at urgent care and the rash was diagnosed as shingles. He took Valtrex for 7 days and is using lidocaine patches and calamine lotion. The rash was fading, and the pain came and went.  Some days he had more pain than other days. He saw his primary physician on day of reporting and the shingles diagnosis was confirmed. Nothing else was reported. The reporter consented to follow up.
I had a stuffy nose, cough, and temperature regulation problems one night. I decided to take an at-home COVID-19 test on 06/24/2022, and it came back positive. I called my doctor, and they informed me to go to a telehealth visit online to consult a physician. I was prescribed PAXLOVID to help remediate my symptoms faster. I began taking my prescription that evening and completed my dosage. I tested negative on 06/30/2022; but a few days later on 07/03/2022, I tested positive again. I recovered after the initial infection, but since finishing the prescription, I've still had a cough, runny nose, and sneezing so often.
Night after vaccines, started with 101 degree fever, treated with Tylenol, malaise, felt funny. 2/21 through approximately 2.25. Then eyes became glassy, was listless, fever worsened, especially h.s. by 2/27/04, developed blisters, cramps, insomnia. 2.24.04 called MD; went to see doctor then to another doctor on Monday. Monday 3/1, diagnosed staph and treated. Child required dress up changes, Atarax, Tylenol with codeine, Bactoban ointment. Child's suffering continued about 2 weeks. Finally improved with Silumarn gHs QID. Never has had such an exacerbation before or after.
Information has been received from a registered nurse (R.N.) concerning a 19 year old patient who was vaccinated with a dose of adult formulation of RECOMBIVAX HB (lot # not reported).  The patient has not experienced any known symptoms.  Additional information is not expected.
This spontaneous report as received from a registered nurse who stated that (on an unknown date in approximately 2014 (also reported as this past summer)) she had about 10 13-17 years old, young patients of unknown age and gender who on an unknown dates were vaccinated with (Merck) VARIVAX 1350 U (dose, route of administration, lot number and expiration date were not reported) and MMR II (dose, route and administration, lot number and expiration date were not reported). On an unknown date the patients had negative titers for varicella, measles and mumps. The reporter stated that some of young people had negative titers for more than one of these illnesses. The outcome of adverse events was unknown. The relatedness between (Merck) VARIVAX, MMR II and adverse events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
5 x 1 inch bruise on inside of right forearm that lasted for 2 weeks.
Woke up with a headache, slight fatigue and achiness. Lasted the day till I went to sleep, woke up fine the next morning.
The first few days following the injection I had mild headaches, brain fog and injection site pain.  On September 28th I began getting tension headaches that came on anytime day or night.  Usually taking one 500 mg Tylenol did the trick and the headaches slowly subsided.  But about 50% of the time, I needed 2 to 3 500 mg Tylenol per day.  Slowly the headaches began lessening and it has now been 3 days without any headaches.  During my worst headaches, my brain also felt headache pain.  It was awful. I also had brief pain in my back as well.  I also felt chills at times and my right ear hurt as well at times.
Like I'm having a stroke; neck ache; nightmares; nervousness; Felt terrible with bad headache; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6200) via an unspecified route of administration on 15Feb2021 13:00 at single dose in left arm for COVID-19 immunisation. She received the first dose of BNT162B2 (lot number: EL9262) on 18Jan2021 13:00 in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was allergic to Formaldehyde, Coumadin. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021, the patient felt terrible with bad headache. On 18Feb2021 also felt terrible. On 17Feb2021 08:00, Like she was having a stroke. Headache, neck ache, nightmares, nervousness. Blood pressure was ok. Oxygen was ok. Pulse was ok. No treatment received for the adverse events. Events outcome was not recovered.
Seizure at school 10/30/13 a.m. fever 102. Transported to EC. 11/1 Rechecked by pediatrician and referred to neurologist. 5 year old, good general health. Received flu vaccine last Tuesday. Was fine that night. Went to school, teacher noticed him on the floor jerking, only lasted a few seconds to a minute. Went by ambulance to ER. No documented fever there. Notes says teacher said temp was 98.6 at school. In 2012, he received a flu shot on 1-30-12, was seen in ER 4 weeks later with fever and first febrile seizure. Received second flu shot in March 2012. Since this episode he has been fine at home - no fever, eating and playing normally. No family history of seizures.
Pain in left shoulder/back.  Resting hand on head was the only compfortable position.  Two days after on-set arm could not be raised, no pain to attempt to do so, but pain in shoulder was intense.  Saw a orthopedic who took X-ray (prescribed celebrex/oxycodone and a shot of steriods into arm.  No change.  Pain on shoulder area continued to be intense/inability to raise arm continued.  Saw family doctor and then orthopedic who sent for MRI.  No issues in MRI.  Sent for EMG.  EMG results showed significant abnormailieis in the left infraspinatus and deltoid muscles and minimal abnormalities in the left biceps.  Findings were of possible Parsonage Turner Syndrome (brachial plexitis).
Fever of 100+, chills, muscle aches, pain at site of injection, extreme fatigue, unable to lift arm lasting for over 24 hours.
Four hours after the injection, I became extremely dizzy and fatigued, somewhat unbalanced and nauseous.  I further developed a throbbing headache and occasional stabbing pain in my left ear and neck.  This lasted throughout the night and into the early hours of the next morning.  At this time, my symptoms are slowly dissipating.
No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 12 months old female patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 06-DEC-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
This case was reported by a consumer via interactive digital media and described the occurrence of painful rash in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced painful rash and erythematous rash. On an unknown date, the outcome of the painful rash and erythematous rash were unknown. It was unknown if the reporter considered the painful rash and erythematous rash to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. It was reported if the reporter knew that the patient would get this horribly painful rash that was still getting bigger after 5 days, he might have rethought it. Based on my patient's reaction to BEXSERO vaccine, the reporter could not say if his other kid would get it, and that he thought vaccines were so important, But this was not in the side effects.
Severe pain in left arm at site. Fever 102.8, blood pressure dropped so low, I passed out twice. Chills, Vomiting, Difficulty breathing over two days.
1sT Shingrix vaccination 2/5/19. Terrible reaction. every part of my Body HuRT. CONFINeD to BED. Lasted 24 houRS. Arm soreness too.   2nd Shingrix vaccination 5/14/19. WOrse reaction Than after 1st oNe. 4" Band of Bright reD around injection site, all around ARM. ExTreme aches, extreme FATigue For weeks.
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 Vaccine (first dose) on 14-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 Vaccine.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Second dose was reported as NA
Chest pain, throat tightening, pain with deep breath, dizziness, chills, fever, arm rash under injection site, muscle pains throughout back/legs/neck, lightheadedness, fatigue, nausea, difficulty holding head up. Several Sx lasted up to five days.
On 3/23/21 pt had SOB so went to went to the Hospital ER.  She had lab work, CT, Chest Xray, ECG 12 lead.  DX is pneumonia of right lower lobe of the lung.  She was given Augmentin and released after 7 hours and told to FU w/ PCP.  On 3/31/21 pt went to see her PCP due to having SOB.  She was given a Covid Test which was negative.  She was sent home and told to breath deeply and hopefully this symptom would go away.   On 4/18/21 she went back to the Hospital ER for SOB.   Pt was admitted with acute DVT and other blood clots as well as  pleural effusion of the right lung.  They did US on legs and Chest X-Rays.  They found fluid around her right lung which they drained.  She was prescribed Eliquis.  Pt was discharged on 4/21/2021 and was told to FU w/ PCP.  On 4/24/21 pt went back to the Hospital ER, because she had a bruising/blood clots in the groin area.  She had 3 blood clots on the left side and one on the right side.   They told her the bruising was from the Eliquis and they did a US.  She was told she had the same blood clots that she had during her hospital stay and they were right where they were before.  She was discharged.  On 4/29/2021 she went back to her PCP due to SOB.  She told her PCP about the DVT that was bothering her.  She was sent to another Hospital.  She had a stat Chest X-Ray- results were that her lungs were stable with inflammation around the right lung.  She was told to FU w/ PCP in July 2021 and go back to ER if she had another episode w/ SOB.
had almost passed out; room was spinning; light headed; nauseous; threw up; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (had almost passed out) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD, Breast cancer, Asthma, Supraventricular tachycardia and Mastectomy.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). On 24-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (had almost passed out) (seriousness criterion medically significant), VERTIGO (room was spinning), DIZZINESS (light headed), NAUSEA (nauseous) and VOMITING (threw up). At the time of the report, LOSS OF CONSCIOUSNESS (had almost passed out), DIZZINESS (light headed), NAUSEA (nauseous) and VOMITING (threw up) outcome was unknown and VERTIGO (room was spinning), HEADACHE (headache) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills; feeling a little warm/ She is cold, too; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm, near the top (in the muscle), at single dose for vaccination on 29Dec2020 at 12:45 pm at 61-year-old. Medical history included: hay fever allergies, allergic to prochlorperazine maleate (COMPAZINE). Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer vaccine. On 30Dec2020, the patient stated her headache started about an hour and a half ago. She started having the muscle aches and pains when she woke up this morning. She felt like she was getting a fever, but she was at work and couldn't take her temperature. She was feeling a little warm, she was cold, too. She was having the chills. The patient confirmed all of these symptoms just started happening this morning (30Dec2020). No emergency room nor physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
Chills, sore arm at shoulder.  Continued severe pain and could not raise arm at all.  Took Motrin for relief. Very weak and tired.  Should have gone to emergency room at onset.
STEMI with 100% blockage in LAD with clot. Emergency cath lab with stents. Symptoms started at 330am on 3-29-21.  Came to ED shortly after. Initial testing and labs were negative. Began to have severe symptoms shortly after. Multiple doses of nitro and morphine given for chest pain with no relief. Taken for emergency heart cath by 7am.
got them a week before Christmas / Suspected vaccination Failure; got them a week before Christmas; Painful, still have the pain even though no visible signs; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In DEC-2022, between 1 and 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got them a week before Christmas / Suspected vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: got them a week before Christmas) and pain (Verbatim: Painful, still have the pain even though no visible signs). The action taken with Shingles vaccine was unknown. The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by the patient via interactive digital media. The patient stated that he/she had the shot for Shingles about 2 years ago from reporting, they had a better shot now.  The reporter stated get the shot everyone. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
started with tingling in the legs, fever and chills the next day, muscle aches throughout the body and slight headache. symptoms cleared up within 24 hours.
Child received H1N1 vaccine, #1 dose, at 10:15 AM. Within 5 minutes patient dropped to the floor. This was not witnessed by an adult. Once observed by adult, within a minute, observer noted minor twitching of upper extremities. Heart rate was 80-88.
Oem minute after getting the shot, I started to feel nauseous. It got worse , I also got dizzy . My entire body was sweating ( dripping with sweat ). If I had been home, I absolutely would have been laying down. My heart was also racing. I then felt cold all over. My experience lasted about 10 mins and probably 7 mins into it, I did start to feel better. The experience was quite scary. I thought I could have ended up in the hospital.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX. On 24th April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain, blistering of mouth and blister. On an unknown date, the outcome of the pain, blistering of mouth and blister were unknown. It was unknown if the reporter considered the pain, blistering of mouth and blister to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient developed severe pain and blisters on jaw and neck. No further information was provided at the time of reporting. The healthcare professional (HCP) requested a follow up call from Medical Information (MI) on recommendations on how to proceed.
PATIENT LEFT PHARMACY AND WAS FEELING FINE AT ABOUT 3:50 PM. AT ABOUT 4:45 PM HER MOTHER CALLED AND SAID PATIENT REPORTED "NOT FEELING WELL", BUT DID NOT ELABORATE AND BEFORE I COULD QUESTION ABOUT SYMPTOM, MOTHER HUNG UP. OVER NEXT COUPLE OF HOURS I RECEIVED SEVERAL MORE CALLS FROM PATIENT'S MOTHER AND FATHER, STATING THAT SHE PASSED OUT AND HAD SEIZURES, AND DID NOT REGAIN CONSCIOUSNESS. THE EMT'S HAD BEEN CALLED AND HAD ARRIVED AND WERE TREATING HER. THEN SHE HAD BEEN TAKEN TO HOSPITAL WHERE SHE REMAINED UNCONSCIOUS. THAT IS THE LAST I HAVE HEARD TO THIS POINT.
Severe joint pain in ankles and feet that lasted about 2 months non stop (unable to walk a flight of stairs due to pain), also joint pain in shoulders and wrists that lasted about a month non stop (unable to hold my child, feed her, or change her), still get wrist pain every other month or so that lasts 24-48 hours.  Moved from joint to joint.  One day would be anterior right wrist, two days later it was anterior left wrist and right wrist was fine, month later and it was posterior left wrist.  Comes as fast as it goes without warning
it feels like something is biting her skin; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 45-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: SENSORY DISTURBANCE (non-serious), outcome "unknown", described as "it feels like something is biting her skin". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The caller is a pharmacist who stated she has a 45-year-old female patient that got the bivalent booster, and also had a TB test done a couple of weeks ago, who was complaining that it felt like something is biting her skin.  She did not get the vaccine at (withheld), and was not currently at the store, so no lot number available.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.