chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 2-3 hours after receiving PPSV vaccine the headstart called mother due to her "shaking" during her sleep, she was found to have a 101.1 fever and was taken to ER. In ER she was lethargic & hypotonic, O2 sats of 95%, HR 142, RR 42, BP 108/48. Was given oxygen via face mask at 2L and acetaminophen 200mg. After approx 90min of monitoring, her condition improved and she was discharged to home.
Pfizer-BioNTech COVID-19 Vaccine EUA  from 10 am Friday, April 30: Fever, headache from 4 pm Friday, April 30: Upper back pain (in one particular spot) spreading out to chest and teeth from 8 am Saturday, May 1: Skin rash on neck and chest
I had about 12 hours after the shot I had body aches and fatigue. It was gone by the next day. I was still functional, I took Tylenol and was fine. there was headache as well. About Nov 29th, I felt like I was having UTI symptoms and took antibiotic. Then my lower back started hurting and I went to the doctor. I have a history of ovarian cyst went to my OB and had an ultrasound on my ovaries it was normal, and an ultrasound on my kidney, liver, gallbladder and waiting for those results from my urologist. I started with covid symptoms on 12/28 and I tested positive for covid on 12/29th. on the evening of the 12/28 I had more aggressive fatigue than normal, body ache and headache. I had a mouth ulcer which I never get which was pretty painful. I had a low grade fever for a day. I also felt loopy too. Everything was better or improved by Jan 1 2022 but I have a little fatigue and lingering headache that hasn't gone away. The backache is definitely better, almost gone but slightly better.
She developed small bruises around her belly button on genitals and butt, they also went down both legs. The doctor checked her blood and urine. She has blood in her urine and has been diagnosed with anaphylactoid purpura (HENOCH-SCHOENLIEN purpura).   10/7/09 Received PCP records for 8/28/09. FINAL DX: rash & Henoch-Schonlein syndrome Records reveal patient experienced itchyrash all over stomach ache & diarrhea beginning 8/27.  Also with sore throat, nasal congestion & green nasal drainage x 4-6 days.
Pt recv vax & exp an episode of apnea, hypokinesia & hyporeflexia broken by a strike to back; in ER pt given DPH, Solumedrol & albuterol;
got the shot now suffering shingles/ suspected vaccination failure; shingles; painful; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received shingles shot few years ago and now suffering from shingles. The patient stated that shingles shot did not work for him/her. The patient also stated that shingles are very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
The day of vaccination (9/8) I started to have irritation in throat, uncontrollable urge to constantly try to clear throat and voice changes (this is similar to my reaction to latex just before anaphalaxis). Then the morning of 9/10 I work up with multiple swollen and painful lymph nodes in my left arm pit.
Mother reported pt had been scratching the rash it was diffused, pink and red splotches. facial edema present.. pt cried when mother tried to put Benadryl cream to sooth her.
This spontaneous report was received from a physician referring to a 10-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 07-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768: US-009507513-1709USA007325.
is a pleasant 66 y.o. male. Patient presents today with fever, chills, body aches, mild headache, fatigue. He has had no nausea, vomiting, diarrhea, reduced appetite, and reduced food/fluid intake. On examination, patient appears nontoxic, but does appear mildly ill. No tachycardia, stable blood pressure, normal oxygenation on room air. Lung sounds are clear, respiratory rate and effort is normal. Presentation highly suggestive of viral syndrome, likely COVID during the ongoing COVID pandemic. Patient is vaccinated, but is on immunosuppressants for liver disease so additional workup performed as above. This was reassuring, with exception of moderate acute kidney injury with elevated BUN and creatinine. Electrolytes stable. Liver function tests at baseline. COVID test was positive. Chest x ray reveals some mild changes suggestive of mild infiltrate versus atelectasis. Patient does not have purulent pedum production. Ambulation trial here with stable oxygenation on room air, and clinically appears well enough to be treated expectantly at home. Given AKI and medical history though, I did offer hospital observation for insurance of adequate hydration as well as repeat check of patient's metabolic profile. He would prefer to have this treated at home, and is willing to follow up with primary care physician for repeat laboratory testing. At home, he will drink plenty of fluids, use Tylenol as needed, may have small doses of Ibuprofen a few times per day, and must follow up closely with primary care physician. He is comfortable with this outpatient plan of care. Return precautions discussed, questions solicited and answered.
Issue: Patient states pain in the lower back between the butt and curve of the lower back. Feels like the pain is just below the skin. Patient has muscle tightness below that area making movement difficult.  Other: No fever. No chills.  No redness. No visual irregularity with the skin.
This spontaneous report was vaccinated from a pharmacist refers to 3 unknown patients of unknown age. On an unknown date, the patients experienced some sort reaction. The outcome of the event was unknown. The report considered the event to be related to ZOSTAVAX. Additional information has been requested.
Felt very sick to my stomach,  had chills, slight fever, went to bathroom around 2am, and very nauseous, next thing I woke up on bathroom floor, not to much time after, then around 6am woke up again to use the bathroom more sick to my stomach, felt very light headed, sweating and I passed out hit the corner of bathroom sink and cut my head, my BP was very low, my wife drove me to ER, I received stitches and many test, I had an allergic reaction, home now, still not feeling well, on Nausea medicine, was able to sleep, but still not feeling great.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or medical history was reported. On unspecified dates the patients were administrated unspecified number of improperly stored doses of MMR II (lot number J006137, expiration date 24-MAY-2015 and lot number K008814, expiration date 19-JUN-2016) (strength, route and dose were unknown). No adverse event was reported. Follow up information has been received from the registered nurse on 27-JUL-2015 concerning a patient of unknown age and gender. On 21-APR-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot# reported as J006137, expiration date: 24-MAY-2015, strength, route and dose were unknown). This is one of several reports received from the same reporter. Additional information has been requested. Patient's information, products and narrative were updated.
Information has been received from a consumer concerning his daughter, a 6 year old female with no medical history who "at 18 months of age" was vaccinated with MMR II, "one dose only". There was no concomitant medication. Subsequently the patient had a bad reaction to it. The patient seemed groggy and sleepy. The patient was also diagnosed with autism. At time of the report the patient was not recovered. The patient sought medical attention. Upon internal review, autism was determined to be an other important medical event. No further information is available.
29Aug89 pt vax w/ hepta B; pt became hot, sweaty, + fainted w/ shaking noted in arms.  The syncope, w/ n/v persisted for 36 hrs, arm also sore.  Dx of seizure not made.  Reaction referred to as vasovagal reaction by MD.
pt received pneumovax 10/28 left deltoid; now with what appears to be cellulitis at site; no known allergies to date
1st dose 30June2022, 2nd 4Nov2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 16-month-old male patient who received HAV (Havrix) (batch number 4CY9H, expiry date 28th April 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received on 30th June 2022).   On 4th November 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 4th November 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was 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: 04-NOV-2022 Reporter's Comment: The reporter was a licensed practical nurse. The reporter reported that the maladministration in the patient who received 2nd dose received on 04th November 2022. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional supportive information: The patient received 2nd dose of Havrix early than recommended time frame, which led to shortening of vaccination schedule.
Second dose not administered within 35 days interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not administered within 35 days interval) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 mg. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not administered within 35 days interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not administered within 35 days interval) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.
Patient began having seizures noticed first by baby sitter. When parents witnessed seizures, they called the pediatrician who ordered a CT scan and EEG. CT scan was clear, EEG showed seizure activity. Pt has since been followed by pediatric neurologist who has prescribed Topomax which has decreased # of seizures, but has not stopped them.
woke up 3 AM Friday was sore, ache, chills, the small blister noted that Friday evening injection site bump small blemish- scratched and it "popped" similar to a sunburn, it's flat now but a little itchy. Sore arm, body ache, chills - this is resolved 5/4-Placed follow-up call, pt reports that on the left arm the bump went down and not as raised as before, and it is not spreading and not painful. Pt reports took Tylenol ES and drank a lot of powerade and that helped. Pfizer 1st dose 4/8/2021 @ 1630 LOT#: EW0153. Recommend that if it gets itchy or red an apply topical otc anti-itch cream as needed.
PT BLEW HER NOSE IMMEDIATELY FOLLOWING ADMINISTRATION AND HAD BLOOD IN TISSUE.  NOSE DID NOT BLEED DURING REGULAR ACTIVITY, ONLY WHEN NOSE WAS BLOWN.
High-density hives everywhere on body below neck; swollen hands, feet, lips; partially constricted throat. Symptoms began evening 10/19/2018. Visited urgent care 10/20 at 10 AM. MD at urgent care issued diagnosis Urticaria, Rx Prednisone. Rx began immediately. NOTE: Cannot input manufacturer in item 17. Sanofi Pasteur/GSK.
Information has been received from a 56 year old female pharmacist with no pertinent medical history and with no drug allergy or reaction who on 19-MAY-2011 was vaccinated SC with a dose of ZOSTAVAX (Merck). Concomitant therapy included diclofenac and CRESTOR. On 19-MAY-2011 the patient had a local reaction to a ZOSTAVAX (Merck). Shortly after receiving the immunization the patient noticed a red area around the injection site. As the day proceeded, the area got bigger and redder. The next day, on 20-MAY-2011, it was the size of a softball and extended to her elbow. The area had a circumscribed white area around the outside. On 24-MAY-2011, the area was back to the original small red area and was improving. The patient did not seek medical attention and was not  given treatment. No lab diagnostics study was performed. No future information is available.
States "broke out in nickel size hives over entire body" 4 hours after getting shot. Took Benadryl and states they appear to be going away. Instructed to notify her MD.
Left sided ed started with pain in tooth #16,  Progressed to involving Left maxilla and madibel.  Intermittent with no trigger. no pattern  and no way to reduce the pain or stop it.  It lasts from 10-15 mins  The longest was 30 mins. At peak of pain it is in the  6/10 pain scale.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1 single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2022) Negative; (04Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician assistant concerning an 18 year old female with on 8/30/06 was vaccinated with the first dose of HPV (lot 653650/0702F). The physician assistant reported that the pt received the first dose of HPV, about 12 days ago, and she still experiencing injection site pain. The pt sought unspecified medical attention. It was reported that the pt was being treated with ibuprofen (Advil). At the time of this report, the pt had not recovered from the event. The reporter considered the event to be serious as an other important medical event (OMIC). Additional information has been requested.
Tachycardia   Patient states that she felt like her heart was racing s/p the vaccine administration. Patient is alert, oriented x3, NAD. Vitals: 136/85, HR 97, oxygen sat 97%. Lungs clear, Heart RRR. Blood glucose 140.
This spontaneous report as received from a medical assistant refers to a 12 month old male patient with ventricular septal defect and no drug reactions or allergies. On 07-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # K003423, expiry date 06-MAR-2016, 0.5 ml, subcutaneous. There was no concomitant medication. On 25-OCT-2014, the patient experienced a rash on his entire body that started on his legs and a fever. The patient went to the emergency room on 26-OCT-2014. The patient had a follow up visit with the physician assistant on 28-OCT-2014 and the patient still had a rash on his entire body and fever. The patient has not been seen by the physician assistant since 28-OCT-2014 so the reporting medical assistant did not know if the patient was recovered. The patient was given ZYRTEC, CALAMINE lotion, TYLENOL, MOTRIN as a treatment. There were viral culture, immunoglobulin G (IgG) and immunoglobulin M (IgM) laboratory tests performed (results not provided). The outcome of a rash on his entire by that started on his legs and fever is unknown. Relatedness between the rash on his entire body and fever and (Oka/Merck) VARIVAX was unknown. Additional information has been requested.
Headache, Myalgia,  chills  Narrative: #2 dose on 2/26 body aches fatigue ha. Home from work today and will rtw in am if sx resolve. No known covid contacts.   Other Relevant History:
Patient was given ZOSTAVAX vaccine and has a history of lymphoma. No adverse events have occurred.
Muscle and joint pain, numbness, fatigue, flu-like symptoms, tingling-aches all over body.
Information has been received from a registered nurse concerning a female in her late 30's who four to five weeks ago was vaccinated with the first dose of VARIVAX (Merck). The week after vaccination, the patient felt "out of sorts". Symptoms included difficulty concentrating at work. At an unspecified time period, she developed abdominal itching and by the third week following vaccination she had a rash covering her entire abdomen. The nurse stated that the patient described the rash as looking like "mosquito bites". The patient recovered without treatment. The patient did not seek medical attention and mentioned her symptoms to the nurse when she came to her appointment for second dose of VARIVAX (Merck). At that point the rash had resolved. The nurse decided not to administer second dose of VARIVAX (Merck). There was an antibody titer test with no results available. Additional information has been requested. 06/18/10 Follow-up information has been received from the registered nurse concerning the 45 year old female Director with rheumatoid arthritis and no known allergies who on 02-FEB-2009 at approximately 15:00 received the first dose of VARIVAX (lot # 661642/1135X), SQ in her left upper arm. On 3-MAR-2009 the patient was feeling "out of sorts-out of control". The patient stated that she kenw somethin was wrong but she didn't know how to fix it. The second week the patient felt better and stated that "the light switch turned back on". However she then developed an intense itching (no urticaria). This lasted approximately one week. The third week, she developed a mosquito-like patchy rash (no itching) which was sore. She could not put any pressure on it or touch it. She also developed small red "bumps" after the mosquito bite-like rash, which were not fluid filled or sore. On approximately 15-MAR-2009 she recovered. No further information is available.
improperly stored administered vaccine with ROTATEQ; no additional AEs; This spontaneous report was received from an licenced practiotioner nurse via office manager and refers to a currently 3-months-old male patient. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 26-APR-2021, the patient was administered improperly stored vaccine with rotavirus vaccine, live, oral, pentavalent rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml dose, lot number: 1691302, expiration date: 23-JAN-2022, orally for prophylaxis, which was supported by temperature stability evaluation. Other company product hib vaccine conj (tet tox) (HIBERIX) (exact dose, route of administration, exact dose and route of administration were not provided) was also reported as improperly stored and administered. Other vaccines given to a patient on the same day included: haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number: T001206, expiration date: 03-JUN-2022, intramuscularly, in right anterolateral thigh (RAT) for prophylaxis (exact dose was not provided), diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) lot number: 23yl4, expiration date: 04-APR-2022, intramuscularly, left anterolateral thigh (LAT) (exact dose wand insication were not provided), pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) lot number: cy4777, expiration date: 26-AUG-2022, intramuscularly, LAT (exact dose and indication were not provided).  The vaccine was experienced temperature excursion of 35.2 degree Farenheit for 480 hours. Previous temperature excursion was not detected. The digital data logger was involved.  The reporter stated, that the unit (refrigerator) with the vaccines was making a noise, therefore to prevent a loss of vaccines, on 09-APR-2021, they were transferred to a unit, which had insulin samples in it. Due to the amount of products in the unit, the temperature got down to 35.2 degree Fahrenheit (F) on one day (unspecified) (product storage error temperature too low). When a new unit was available and the temperature was at acceptable level, vaccines were put in the new unit on 04-MAY-2021. The reporter attached the temperature logs. The vaccines were stored at the temperature below 36 (F) (lowest registered temperature was of 35.2 F) for 480 hours (no previous temperature excursion reported). Adverse event and the patient's response were reported as none (0) (no adverse event). The vaccines was not available for return/evaluation due to the single dose. Operator was trained healthcare professional. All vaccines were used according to the instruction leaflet.  This is one of the six linked reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002859: US-009507513-2105USA002668: US-009507513-2105USA002966: US-009507513-2105USA002665: US-009507513-2105USA002516: