chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ON 5/30/00, the pt developed ataxia, nystagmus, head bobbing, and motor deficiency and was hospitalized. The physician reported that the child remains extremely ataxic, and is unable to walk without someone holding him up. The physician did indicate that the nystagmus may be slightly improved, but to date all other signs/symptoms remain unchanged and are still present.  Follow-up dated 6/20/00 stated that on 5/28/00 the primary presentation was cerebellar ataxia. In addition, the pt experienced abdominal pain. The pt's maximum temperature was 98.6. On 6/1/00 a CSF sample was obtained and sent for analysis on 6/8/00. It was noted that no rash occurred at the injection site post vax.  Follow-up dated 6/22/00 from a physician stated that the pt was no longer ataxic and had almost recovered from his experiences. The physician stated that the only remaining signs/symptoms the child has are behavioral problems, specifically irritability. It was also noted that the PCR results for the CSF specimen indicated the CSF was negative for varicella.
Stomach cramps, lots of sweat, diaherrea: about 6:30pm.  Drank water went to bed. 7AM had more diaherrea and possible blood in stool.  12:30pm blood in stool. Plan for doctor visit Monday (11/16/2009).
Migrating itchy rash that pops up in one part of the body, goes away and then pops up in another. Very itchy, red raised rash
This spontaneous report was received from a registered nurse refers to two patients of unknown age and gender. On 13-FEB-2013, the patient was vaccinated with a dose of expired ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012) orally. It was not known which dose in the ROTATEQ vaccination series this dose was administered. No adverse effect reported. This is one of the several reports from the same source. Follow up information has been received from the nurse concerning an 8weeks female patient with no pertinent medical history, no drug reactions or allergies and with no illness at time of vaccination who on 13-FEB-2013 at 11:27 was vaccinated with the first expired dose of ROTATEQ, the second dose of RECOMBIVAX HB (Lot # 0384AE) IM, a first dose of PENTACEL (Lot # C4358AA) IM and a first dose of PREVNAR 13 (Lot # G15075) IM. Additional information is not expected.
pt came to healthcare providers office w/clinical varicella disease, p/vax months before;clinical illness is uncomplicated thus far;
A LITTLE BIT OF STUFFINESS/STUFFINESS; ACHINESS/ VERY PAINFUL SHOT THAT REALLY HURT BAD FOR LIKE 15 MINS; COLD CHILLS WITHOUT FEVER/CHILLS BUT NO FEVER; SCRATCHY THROAT; ON/OFF HEADACHE AT BASE OF NECK; EXTREME THIRST; PAINFUL ARM AT INJECTION SITE/INJECTION SITE PAIN; VERY FATIGUED/FATIGUE; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 140 pounds, and height was 65.5 inches. The patient's concurrent conditions included asthma, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Body temperature (NR: not provided) 98.3 F, 98.6 F. On 01-APR-2021, the subject experienced extreme thirst. On 01-APR-2021, the subject experienced painful arm at injection site/injection site pain. On 01-APR-2021, the subject experienced very fatigued/fatigue. On 03-APR-2021, the subject experienced on/off headache at base of neck. On 07-APR-2021, the subject experienced scratchy throat. On 07-APR-2021, the subject experienced a little bit of stuffiness/stuffiness. On 07-APR-2021, the subject experienced achiness/ very painful shot that really hurt bad for like 15 mins. On 07-APR-2021, the subject experienced cold chills without fever/chills but no fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from painful arm at injection site/injection site pain on 01-APR-2021, and on/off headache at base of neck on 08-APR-2021, and had not recovered from very fatigued/fatigue, cold chills without fever/chills but no fever, scratchy throat, extreme thirst, a little bit of stuffiness/stuffiness, and achiness/ very painful shot that really hurt bad for like 15 mins. This report was non-serious.
Received the injection on Wednesday afternoon. I woke up around 3am with an excruciating headache, started vomiting around 6am and continued until 7:30pm. The headache continued and as of this morning 1/4 the headache is still there and my stomach is not settled completely.
This spontaneous report was received from a pharmacist concerning an unspecified number of patients of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 02-JUN-2018, the unspecified patients were inadvertently vaccinated with an expired properly stored dose of PNEUMOVAX 23 injection, lot # M037669, expiry date: 09-MAY-2018 for prophylaxis (strength, dose, route, anatomical location and dosage schedule were not provided) (expired product administered). No adverse effects were reported. No product quality complaint was reported. Upon receipt of follow-up information received on 07-SEP-2018 it was determined that this case is now valid because the registered pharmacist confirmed that two patients received the vaccines on 02-JUN-2018 (MARRS: 1806USA002291). On 02-JUN-2018, a 68 year old patient was inadvertently vaccinated with an expired properly stored PNEUMOVAX 23. Sender's Comments: US-009507513-1806USA002291.
Patient was given the vaccine at 10:40am. He was being monitored and at 10:53am, stood up and immediately passed out falling face first. He came about immediately and refused medical attention but has a large swollen area on his forehead.
Hives and itching to right arm and redness to left arm shortly after vaccine. Patient taken to emergency department for evaluation.
Area of vaccine administration was red and warm to touch.  Area of redness getting large and red cord noted.
Within 6 hours of my 2nd dose vaccination, every joint in my body ached. My ankles, hips, knees, and wrists and lasted for 1 week. Then starting in July 2021, I began having extreme right shoulder pain and began seeing a physical therapist. In October I developed bursitis in my left elbow. I then went in to see the primary care doctor. I was referred to an orthopedic doctor who put me on meloxicam. It did not help any at all.
She got the vaccine and immediately she got the headache, loss of appetite, dizziness.  The next day she had the aches and pains, nausea, loss of appetite, vomiting and she is still going through it on 4/19/21 and this is her first day back to work.  She did have brain fog, nose was bleeding everyday and was put on antibiotics as her arm swelled up.  Her arm swelled up, and went to the ER who said that she had an infection in it, and gave her antibiotics and anti-inflammatories.     The infection did go away but the inflammation and swelling are still present.  She started getting numbness in her arms and legs, and had a CT scan which did not show any blood clots.   She is waiting on a referral to a neurologist to see what is going on with that.   She also has been having problems with her lungs, asthma has been acting up and gave her a shot to open her throat as it was slowing closing and gave her a steroid shot to stop the swelling as she was having difficulty speaking.   If she talks too much her throat gets irritated and starts to loose her voice.  She has been in and out of the ER and UC due to this.   She never had a fever, rash, or anything else.  She does still have a lot of weakness.
17 and a half received first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half received first dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half received first dose). On 03-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half received first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  It was reported that patient got first dose at the age of 17 and a half. The patient and her mother want the patient to get the second shot. Patient hasn't had any side effects, and she has not had any other COVID19 vaccinations.
When making  the appt, the patient marked yes  for immune compromised allowing her to make a booster appt at 4 months. The pharmacist reviewed the dates of the first doses, but did not make sure 5 months had passed since second dose.
Covid vaccine- injection site pain; her face and neck is red like a sunburn; her face stings; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number not known) via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had been allergic to Bactrim since that age of 20 and she had she blisters on her lips. The patient had her first dose of Pfizer Covid vaccine on Monday, 11Jan2021 and after that in Jan2021, her face and neck were red like a sunburn. She said she had injection site pain, her face stings and it has been two days out. She wanted to know if she should get her second shot. The outcome of the events was unknown.  Information about lot/batch number has been requested.
At approximately 1:50 pm received her vaccination. A few minutes later she exhibited signs of allergic reaction. Pharmacist attended to her, and after some questioning she exhibited signs of Anaphylaxis. At 1:56 an Epipen 0.3 mg/0.3 ml dose was administered and 911 called. At 2:00 we checked her BP and it was 132/78 and pulse 95. A few minutes later, before a second check of BP was done, the EMT took over.
Moderna Bivalent Booster 0.25mcg was given to patient, patient was to receive full dose 0.5mcg. Wrong dose given.
had a ?massive ? panic attack 2 days after receiving the covid vaccine.  He did not miss work.He also has a stated history of panic attacks.
The patient was given her vaccine at 1:05 pm and after her dose as she went to sit in the observation area she passed out. She fell to the ground and hit her head. She was unconscious for about 1-2 minutes and then came to.  EMS arrived to evaluate her and she was taken to the Hospital
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 20-MAY-2014, patient received improperly stored VARIVAX dose 2, from lot # H018451 expiry date: 09-OCT-2014. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Had tightness in chest, breathing difficulty after both shots were administered (more pronounced after first dose).  Have experienced symptoms of onset of vertigo several times in the ensuing months.  Had one episode of severe vertigo (May 29th that required an overnight visit to the emergency room at Hospital) .  Also get huge blood blisters (about 3/4 inch diameter) inside both of my cheeks.  My seasonal allergies have come back even though I was rid of them for about 10 years after a regimen of desensitization shots.
I was vaccinated on May 17. The first  3 days following my first dose of Moderna, my left arm (site of injection) was extremely sore. By day 4 I was feeling better. the on day 5, on May 21, I woke up with lymph node swelling on my left armpit. The following 2 days my arm became sore again and my lymph nodes were so swollen I could not raise my left arm. By Monday, May 24 (1 week post-vaccination) my lymph node swelling had subsided but not disappeared but noticed that my left deltoid had a numb/tingling feeling. By Monday evening I had noticed a mild red/bumpy rash on my deltoid. During the second week, lymph node swelling and rash subsided, however joint pain in my left elbow, wrist, and fingers began and my deltoid was still sore/numb. Week 3 following first dose vaccine, I had continued deltoid soreness and mild joint pain. Week 4 (current week) I have continued deltoid soreness/slight weakness and mild to moderate joint pain
This is a spontaneous report received from a contactable consumer or other non HCP, program ID: (172086). A female patient received the 1st, 2nd and 3rd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine); all single dose, for immunization. Medical history and concomitant medications not reported. The patient experienced illness/severe illness, with outcome of recovered. Therapeutic measures were taken as a result of illness. Additional information: The reporter's cousin and her daughter both received shots. They had a booster shot and were really severely ill. Caller stated the patient got over it with medicine within a week. The caller stated the patient brought the COVID-19 illness to first cousin and husband. It took about three weeks. They didn't have their shots and were afraid to take it. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Received Menactra 6/13/05, 6/14/05 left upper arm very sore and tender axillary nodes on left joint aches, fatigue.
Patient's girlfriend reporting approx. 30 seconds of full body convulsions and unresponsive state in seated upright position, with loss of postural control, followed by soaking sweats and warmth.  Possible post-ictal state with patient reporting he felt groggy afterward.  Patient does recall feeling lightheaded prior to the event.  Denies enuresis, defecation, bleeding from the mouth.  Denies head trauma.
loss of hearing in my left ear; muscle aches,pain,pain sore arm; Sore arm; really loud noises in my ears like tinnitus,annoying tinnitus/both tinnitus; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (really loud noises in my ears like tinnitus,annoying tinnitus), EAR DISORDER (sound like high pitched vacuum cleaner in my ears, background noise which is light, noise still bothers me in my ears), PAIN IN EXTREMITY (typical sore arm), PAIN (ache and pain) and MYALGIA (muscle aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced TINNITUS (really loud noises in my ears like tinnitus,annoying tinnitus) and EAR DISORDER (sound like high pitched vacuum cleaner in my ears, background noise which is light, noise still bothers me in my ears). On an unknown date, the patient experienced PAIN IN EXTREMITY (typical sore arm), PAIN (ache and pain) and MYALGIA (muscle aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, TINNITUS (really loud noises in my ears like tinnitus,annoying tinnitus) and EAR DISORDER (sound like high pitched vacuum cleaner in my ears, background noise which is light, noise still bothers me in my ears) had not resolved and PAIN IN EXTREMITY (typical sore arm), PAIN (ache and pain) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient's  lab data, current condition and contact information updated.; 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.
No additional AE; patient receiving VARIVAX after it was improperly stored; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 11-JUL-2023, the patient received 1 dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X001000, expiration date: 09-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). No additional adverse events reported.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: (maybe more needle phobia/history with all vaccines than a side effect)  patient has a history of fainting with injections/blood draw and warned immunizer.  today after vaccination patient did feel a little light headed, but did not faint.  patient felt nauseous and did vomit a couple of times, then felt better.  patient was monitored for 30 mins after vaccine and felt fine after.  patient's prescriber was contacted after the incident.
I spiked a fever of 101, had joint pain in all joints except fingers and toes, my muscles ached and spasmed a bit and a had an incredibly bad headache.
ON 04/12/2009, PT BROKE OUT ON FACE AND FOREHEAD WITH BLISTERS. WAS DIAGNOSED WITH HUTCHINSON VARIATION OF FACIAL SHINGLES. TREATED WITH ORAL ACYCLOVIR, PREDNISONE, CLINDAMYCIN AND PERCOCET. BLISTERING WAS SPREADING AND PATIENT WAS HOSPITALIZED 04/16/2009 AND STARTED ON IV ACYCLOVIR.  4/21/09 MR received for DOS 4/16-17/2009 with DX: Huthinson variation of facial shingles.  Pt initially presented to PCP with c/o facial pain and blistering on the nose with redness and swelling. Placed on antivirals however cellulitis developed and also placed on abx however progression continued. Admitted for IV antivirals and abx.  Ophth consult confirmed no zoster migrated to eyes. (+) neuralgia tx with pain meds.
No overall fever. Swelling 3cm in diameter surrounding site of DTAP administration. Redness & heat at site. 12-2-09 Assessed site day of notification to clinic. TYLENOL & BENADRYL ordered. No more DTAPS.
Depression, mood swings, change in menstrual cycle ( increase to 2X monthly), cramping, loss of hearing, infection eye + ear.
COLD; FEEL KIND OF BAD; SHIVERING; FINGERS HURT; HEAD HURT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced feel kind of bad. On MAR-2021, the subject experienced shivering. On MAR-2021, the subject experienced fingers hurt. On MAR-2021, the subject experienced head hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head hurt, cold, shivering, fingers hurt and feel kind of bad was not reported. This report was non-serious.
This case was reported by a consumer and described the occurrence of inappropriate schedule of vaccination administered in a female patient who received TWINRIX. Co-suspect products included ENGERIX B. On an unknown date, the patient received TWINRIX at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving TWINRIX and ENGERIX B, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown. Additional information: Caller reports that she received a TWINRIX vaccine from her provider. One month later she received only a hepatitis B vaccine, not TWINRIX. This does not follow the dosing schedule for TWINRIX or ENGERIX-B.
Patient experienced a 5 minute generalized seizure with fever, 24 hours following DTAP, IPV, HBV and PCV7. By time patient, age 7 month, arrived at the ER temperature was only 102 degrees F. A zone of 7mm redness noted about the PCV7 injection site, right thigh.
Breakthrough case admission after 3 vaccines Moderna 1/28/21 Lot# 028L20A;  Moderna 2/25/21 Lot# 004M20A;  Moderna 10/5/22 Lot# 027E22
Information has been received from a Registered Nurse (R.N.) concerning herself (a 62 year old female) with hypothyroidism and no drug allergies who on 29-JUN-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included TB test, BUSPAR, PROZAC and levothyroxine. The patient experienced severe nausea and vomiting, vertigo, profuse sweating, and had difficulty walking about 12 days after receiving vaccine (on 10-JUL-2009). The nurse was evaluated at a Hospital emergency room. Unspecified blood test, CAT scan and MRI of the head were performed. She was treated with antibiotics, antihistamines and VALIUM for an inner ear infection. She reported that she continued to experience vertigo. The patient had not recovered at the time of report. The reporter considered the adverse experiences to be disabling. Additional information has been requested.
Patient developed progressive weakness and numbness of both legs, unsteady gait, bowel/bladder dysfunction two weeks following vaccination; patient developed altered sensation below spinal level T2.  MRI spine showed abnormal signal consistent with probable transverse myelitis involving C3 to T10 levels; CSF with elevated WBC and protein also consistent with transverse myelitis. CSF negative for infection or other abnormalities. Patient is responding well to IV methylprednisolone with steady improvement.
pt recv vax & devel an inj site rxn characterized by swelling which extended from shoulder to elbow, & induration which extended from deltoid to bicep;pt also devel fever of unspecified degree;pt recovered @ date of this report;
Bright red rash roughly 2 inches by 4 inches on each injection site. Red to touch.
Lightheadedness, dizziness, insomnia, brain fog, brain zaps.
Measles like rash observation and hydration OTC: Benadryl and Calamine lotion