chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 4/3 patient developed neck pain and headache.  She had reportedly received her second dose of Moderna COVID vaccine within 1 week prior, but exact date unknown. She became acutely confused and reported tingling in her left fingers on 4/9 prompting presentation to Medical Center.  MRI was performed 4/10 reportedly showing an acute focal right corona radiata lacunar infarct. On 4/11 patient became more agitated and 4/12 developed worsening headache and global aphasia. Non-contrast head CT showed multiple areas of subarachnoid hemorrhage bilaterally. MRI brain felt to also have small areas of bilateral diffusion restriction throughout right more than left cerebral hemispheres with concern for leptomeningeal involvement.  She was transferred to another facility for higher level of care on 4/14.  LP on 4/16 with TNC 33 (95% lymphs, 3% monos, 2% macrophages), RBC 1425,  Protein 521, glucose 68. CSF gram stain/culture negative fungal culture and cryptococcal antigen negative, VZV PCR negative, HSV PCR negative, PCR meningitis/encephalitis panel negative, enterovirus culture negative. Serum VZV IgG positive but PCR negative, Lyme and treponemal antibodies negative, HIV Ab negative, ANA/ANCA/Sjogren's antibodies negative. Repeat LP 4/21 with TNC 43 (52% PMN, 35% lymphs, 11% monos, 1% baso, 1% myelos), protein 745, glucose 76). However, given high suspicion for viral encephalitis patient was recommended to complete a 10-14 day course of IV acyclovir by inpatient ID consult service (start date 4/16). She was also treated with empiric steroids. The neurology team is concerned for a possible vasculitis vs reversible cerebral vasoconstriction syndrome as potential etiologies.   Brain biopsy performed 4/23 to help clarify diagnosis, results pending.
Thrombocytopenia.  Hemorrhaging required hospital stay, IVIG treatment and blood transfusion.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age with is a renal dialysis patient. On 17-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry not reported), 0.65 ml, subcutaneously. On an unknown date in 2013, the patient had been diagnosed with shingles. Patient sought medical attention-evaluated by an unspecified physician. The outcome of shingles was unknown. Additional information has been requested.
PT EXP SHORTNESS OF BREATH AND CHEST PAIN; SELF REFERRED TO ER. D-DIMER ELEVATED. CHEST CTA SHOWS SOLITARY RIGHT UPPER LOBE PULMONARY ARTERY PULMONARY EMBOLISM. BILATERAL LOWER EXTREMITY ULTRA SOUND SHOWS THROMBOSIS FEMURAL ARTERY   NO PERSONAL OR FAMILY HISTORY OF BLOOD CLOTS AND NO HISTORY OF BLEEDING EPISODES OR LONG TRAVEL OR SEDENTARYNESS.
Narrative: 45 yo female Veteran reportedly developed a rash following the first dose of the PFIZER COVID vaccine. There are no details regarding the treatment  of her reaction or need for continued treatment. Only the information for her  second vaccine, which she received on 4/27/21, is in; no reactions  documented after the 2nd dose.
Sore arm/ Arm hurting bad; Couple hours when checked had fever 97.1 degree; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/ Arm hurting bad), PYREXIA (Couple hours when checked had fever 97.1 degree) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for an unknown indication.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm/ Arm hurting bad), PYREXIA (Couple hours when checked had fever 97.1 degree) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm/ Arm hurting bad), PYREXIA (Couple hours when checked had fever 97.1 degree) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.           No Concomitant medication were reported. No treatment information was reported.        This case was linked to MOD-2021-048225 (Patient Link).   Reporter did not allow further contact
Kinrix was administered to a 4-month-old patient; Intention was to give one vaccine for DTap and one for IPV but by mistake they gave Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   In JUL-2022, the patient received Kinrix. In JUL-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 4-month-old patient) and wrong vaccine administered (Verbatim: Intention was to give one vaccine for DTap and one for IPV but by mistake they gave Kinrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   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: 08-JUN-2023 The Vaccine administration facility was the same as primary reporter. The reporter reported that the intention was to gave one vaccine for DTap and one for IPV but by mistake they gave Kinrix as a combo instead. The reporter did consent to follow up via email. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that, they were intending to administered one vaccine for DTap and one for IPV and inadvertently administered Kinirix instead of one vaccine for DTap and one for IPV, which led to wrong vaccine administered.
Fatigue & Muscle Aches all over body developed later in day on 2/12/22. Bad headache, lots of body aches and pains (especially legs, neck, head, shoulders, and abdomen), nausea, loss of appetite throughout 2/13/22 Fatigue and body aches on 2/14/22 Continued fatigue, body aches, some chest pain on 2/15/22 In the six months following, I experienced increased chest pain that was undiagnosed. I had experienced chest discomfort prior as a Long Covid issue but it had simnifically lessened before this booster vaccination.
The next day I had muscle soreness in both my buttocks. this lasted 3 days,
Injection site redness; injection site swelling; injection site itching; warm to touch injection site; injection site lump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE WARMTH (warm to touch injection site) and VACCINATION SITE MASS (injection site lump) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE WARMTH (warm to touch injection site) and VACCINATION SITE MASS (injection site lump). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE WARMTH (warm to touch injection site) and VACCINATION SITE MASS (injection site lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Seemed like a bad cold, congestion and runny nose. I still have a cough today. My onset symptoms started on 04/18/2022.
I had 2nd booster (4th dose of Pfizer) at approximately 11:59am on 06/03/2022. By 01:30pm I was experiencing dizziness, extreme fatigue, nausea, night sweats, chills, skin hot to touch (I was afebrile), headache and overall body and joint aches. I am still experiencing those symptoms today, but to a somewhat lesser degree; however, enough that I can not work.
Patient hospitalized  for s/p  lumbar fusion within 6 weeks of receiving COVID vaccination.
Patient received Moderna per consent form, but his COVID card stated pfizer. Second dose pfizer was given to him at 21 days.
Info recv from attorney indicating pt recv Rota Shield & devel intussusception.  Intussusception was surgically reduced.
Recurrence of orthostatic hypotension that had been in remission( a year or more since last notable instance).  Exact recurrence unsure, but steady increase following a week after vaccination.   On June 5th, noticeable symptoms started to occur, with head rushing, dizziness, and heart rate rising.  Above the norm  On June 8th, severe instance, near loss of consciousness when standing up in a public place.  Heart rate exceedingly high with moderate chest pain following after. Tingling and buzzing in head as dizziness set in.    Following afternoon of June 8th incident, Trip was made to emergency room, POTS was tested for and not found, told to monitor health and use compression socks and exercises to improve blood flow.    Moderate improvement of symptoms, but recurring episodes multiple times a week, as well as irregularly high heartbeat while relaxed( recorded over 120 via smartwatch and self measurement while simply in conversation at a table multiple times).
Information has been received from a licensed practical nurse concerning a 12 month old patient of unknown gender. On 08-OCT-2014 the patient was vaccinated with second dose of VAQTA lot # K007791, expiration date 22-AUG-2016) (dose and route not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Syncopal event within 5 minutes after 4 vaccines administered.  Recovered from syncopal event within 15 minutes. Other than observation for 30 minutes no further treatment given.
When waking up next morning after vaccination noticed rash at site of vaccination and small itchy bump on inner L forearm. As day progressed migraine headache developed and more itching bumps appeared on arms, torso, and legs. Fatigued began after vaccination on 07/14/17 and lasted through 07/15/17.
The only thing I had initially was a sore arm. I'm not sure that it is 100% yet. On April 9th, I started having headaches. I had an MRI and it came back negative for any complications. I am still experiencing headaches. It seems like one continuous headache. It's better in the afternoon, but worse in the early morning and going into the early evening.
Pt recvd 3 doses of Hep B vax & following vax lab eval revealed tht SGPT level was 400; asymptomatic;
About 6:00 PM, I started to get chill.   About 10:00 PM, I had a fever, which went up to 102, until the next day.  I also had a real bad headache  and nausea.  During the next day  I was tire and slept thru the day.
Moderna Booster vaccine given instead of Moderna Bivalent Booster that the patient asked for.
This spontaneous report was received by a nurse, referring to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 14-AUG-2018, the patient was vaccinated with an improperly stored dose of VARIXAX injection, subcutaneously (lot number N010107, expiration date 28-MAR-2019) for prophylaxis. (Product storage error) (Poor quality product administered). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion of 2.5 degrees Celsius (-9°C to 8°C) for 18 hours 11 minutes. There was a previous temperature excursion of -9°C to 8°C for 3 hours 19 minutes. It was reported that sterile diluent administered concomitantly was properly stored. A data logger was involved. This is one of several reports received from the same reporter.
For about 24 hours I experienced fever/chills/fatigue/nausea/headaches/body aches/mild injection site pain.   These side effects occurred only with my 2nd dose (with the exception of mild injection site pain, which I had with both doses).
About three weeks after receiving the Pfizer Bivalent vaccine, I started having symptoms of a very sore throat, low-grade temperature, runny nose, exhaustion and sinus headache. I called my doctor after testing positive for Covid-19, and I was prescribed Paxlovid. I started taking Paxlovid the day after testing positive and after the third day, my symptoms started to go away. The last symptom to go away was the sore throat and that went away around day five. Nine days after completing Paxlovid, I started to experience a low-grade temperature, headache, runny nose, exhaustion and sinus issues. I tested positive for Covid-19 again. I called my doctor and told him that I tested positive again, but he did not prescribe any medication this time. Around three days after the second positive test, the symptoms started to resolve. The alone symptom that hung around for a while was fatigue.
Resident reviewed for incident. Resident received the second dose of the Moderna Covid-19 vaccine lot# 016M20A Exp 5/2/2021 on 2/5/2021 from clinic through pharmacy.  Resident had her temp/O2 taken on AM shift and was 98.6/93%, beginning PM shift 98.4/95%. A few hours later noted that resident to have chills and was shaking RN assessment completed and vitals taken resident noted to have temp of 102.2, oxygen 95%, pulse 110. Resident alert and oriented at that time and talking to staff. Reported findings to APNP with order to send to ER. 911 called, residents brother updated. Upon EMT arrival RN went down to residents room with EMT and resident had an emesis as resident was getting cleaned up resident went unresponsive. Pulse noted to still be present at that time, resident did briefly respond to sternal rub and then went unresponsive again. Resident full code and EMT transferred to gurney and said that if they lost a pulse in route that they would transfer to hospital B instead of hospital A being the closest facility. RN called brother and gave update. Facility notified from Hospital that resident had passed away.
the patient has been experiencing blurred vision since the administration of the GARDASIL 9 vaccine.; This spontaneous report was received from a Consumer and refers to a 42-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included bupropion hydrochloride (+) naltrexone hydrochloride (CONTRAVE).   On 25-SEP-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml/ 1st dose, lot #X004374, expiration date not provided but upon internal validation established  as 02-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 25-SEP-2023, reported as since the administration of GARDASIL 9 vaccine, the patient experienced blurred vision. It was reported that the blurred vision was improving. At the time of reporting, the patient was recovering from the event.   The causal relationship between blurred vision and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
itch then pain redness to my elbow  took benedril ice pack and Tylenol
mom called to report pt c/o itching in rt arm & devel a raised rash on rt upper on 8MAY98;
I started getting hot flashes and serve night wetting previous from herma-therapy.  I seen my Ogbyn about this issue.  They switch my herma therapy from pills to a patch.
Got dose of Moderna/ arm got swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Got dose of Moderna/ arm got swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Ulcerative colitis.    The patient's medical history was not reported.  Concomitant products included METHOTREXATE from November 2021 to an unknown date for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced VACCINATION SITE SWELLING (Got dose of Moderna/ arm got swollen). In 2021, VACCINATION SITE SWELLING (Got dose of Moderna/ arm got swollen) had resolved.            No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of retrospective clean-up activity received in the Moderna were missed to be booked-in.
Vaccine on 6/9/10, fussy PM 6/11/10 - 6/11/10 5PM not eating 6/12/10, vomited in ER - bloody stool - Intussusception diagnosed -> to hospital. Pt required surgery- oper and colon resection.
Redness increased to 6.5cm X 4cm and induration increased to 2cm X 1.5cm on the left thigh.
Joints filled with fluid in the absence of trauma, 100ml of fluid drained from the knee two to three weeks following vaccination, steroids injected into knee and oral steroid treatment given.
Pain and itching at injection site followed by severe swelling. ER doctors prescribed antihistimines and Motrin.
SEIZURE; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a parent via a company representative via social media concerned a 16 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  A week or so after vaccination on an unknown date the patient experienced seizure, inappropriate age at vaccine administration and off label use. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure, inappropriate age at vaccine administration and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211119833]-COVID-19 VACCINE AD26.COV2.S-seizure. 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).
Received flu vaccine 11/1/06 at Employee Health Flu Clinic. Informed Employee Health nurse on 11/6/06 that she noticed a blister on her R upper anterior thigh and some slight redness around it. Reported blister fluid filled. Denied pain, pruitis or any other symptoms. On 11/6/06 patient saw doctor and doctor not concerned. 11/8/06 developed 2 more blisters on her wrists.
back pain; Inguinal pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 17Mar2021 10:00 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "CVD and other" (unspecified if ongoing), notes: CVD and other. The patient's concomitant medications were not reported.  The following information was reported: BACK PAIN (non-serious) with onset 17Mar2021 10:00, outcome "not recovered", described as "back pain"; GROIN PAIN (non-serious) with onset 17Mar2021 10:00, outcome "not recovered", described as "Inguinal pain". The events "back pain" and "inguinal pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of back pain, groin pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medication (prescribed for heart) within 2 weeks of vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5-6 1/2 hours, post vax, the pt felt warm. Temperature was 103F (ax). Taken to ER and temperature there was 104.1F (R). Told fever was probably due to OM. Seen on 3/13/02 at pediatrician and was told he didn't seem to have OM. MD notes "probably related to immunizations". Temperature on 3/13/02 was normal.
Information has been received from a registered nurse concerning an 80 year old female who in 2002 received the first dose of PNEUMOVAX 23. On 11-SEP-2007, the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot #655499/0988F), 0.5 ml, IM in the left arm deltoid. Concomitant therapies were unspecified at the time of the report. On 12-SEP-2007 (the next day), the patient experienced a red and really large swollen area at injection site. The nurse stated that the patient also had what looked like an insect bite near the injection site too, so she was unsure if that could have caused the swelling. The patient was treated with over the counter BENADRYL and ice for comfort measures. On 14-SEP-2007, the patient called the office and stated that she was "feeling better". No product quality complaint was involved. Additional information has been requested.
Pt c/o being hot light headed @ 15-20 min after injection VS WNL. Drank soft drink without difficulty. Skin pink/dry. Child back to class (no further distress).
Day of vaccine 1/25/21-no symptoms.  Day 2-1/26/21-at 5 am started having excruciating pain in right shoulder, headache, body aches, nausea, fever, chills, and limited ROM with right arm soreness and stiffness.  Day 3-1/27/21-right arm severe pain, could not lift arm, limited ROM, headaches and body aches. Day 4-1/28/21-nothing, no symptoms.
Fast resting heart  rate (>100 bpm), chills, difficulty/pain taking deep breath, dizziness
Mom in clinic today. Reports LA (TDAP) site swelled, warm to touch and sore with itching. Started Saturday 7/30/16.
This case was reported by a physician via call center representative and described the occurrence of eosinophilia in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several days after receiving SHINGRIX, the patient experienced eosinophilia. On an unknown date, the outcome of the eosinophilia was unknown. It was unknown if the reporter considered the eosinophilia to be related to SHINGRIX. Additional details were provided as follows: The physician unable to provide patient's demographics. The age group was not reported but it was selected as adult as per vaccine indication. The patient had mild eosinophilia a few days after administration of SHINGRIX.
Pt went to a urgent care about 4 hours later with knee pain, bladder pain, terrible headache, and trouble breathing.  He said it was like having an asthma attack but worse.
On 6/16/98 pt recv vax and on on the same day pt exp chest tightness, light headedness, blood pressure 154/72, AP-96reg, R-24 slightly labored.  Pt escorted to E.R.  Pt remained stable.