chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Improperly stored vaccines administered; This spontaneous report was received from other and refers to some patients. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 28-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, three dose series, lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 28-JUL-2023, 5 patients in total and additional patients were administered the affected hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from the lot involved in a temperature excursion at the same location (Product storage error). No adverse events reported (No adverse event).   This is a non-valid case due to no patient's identifiers.   Follow up information has been received from an other health professional on 09-AUG-2023 and refers to a 17-year-old female patient. Concomitant medications included meningococcal vaccine (lot # EN934, expiration date: 31-OCT-2024 via Left Deltoid) and meningococcal vaccine conj (lot # AMVA767A, expiration date: ??-DEC-2023 via Right Deltoid). The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via Left Deltoid.    This is one of several reports from same reporter. ; Sender's Comments:  US-009507513-2308USA001806: US-009507513-2309USA000747: US-009507513-2309USA000748: US-009507513-2309USA000743: US-009507513-2309USA000744: US-009507513-2309USA000745:
(R) arm red, swollen, blisters - red inj 10/8/07 was sore - swelling started 10/9/07 - blisters late Tues/early Wed (2 blisters noted). Seen in office 10-10-07.
did have shingles shot had shingles/suspected vaccination failure; Shingles affected vision; shingles on head/Shingles affected one ear drum; shock waves in head; 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. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: did have shingles shot had shingles/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles affected vision) (serious criteria GSK medically significant), shingles (Verbatim: shingles on head/Shingles affected one ear drum) and electric shock sensation in head (Verbatim: shock waves in head). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were resolved and the outcome of the electric shock sensation in head was not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and electric shock sensation in head to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles and electric shock sensation in head to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles on his/her head and affected his/her vision and one ear drum.  The patient stated that over 2 months to heal.  A year later he/she still had shock waves in his/her head and the patient did have a shingles shot 6 months before. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Reaction : Patient reporting prickly feeling 4 days after receiving vaccine, went to ER got shot of Decadron, got on steroids for 5 days. 3 or 4 days later felt better. 2nd dose same feeling but worse, after 3-4 days was given decadron pills. was also given Hydroxyzine. Felt better after 3-4 days again. 3rd Dose, same reaction, but felt even WORSE, 5 days later, was given 2 more Decadron shots. Was prescibed more Hydroxyzine. Still having reaction but feels a little better.
The patient felt lightheaded after his first dose of Pfizer.  The patient had run 14 miles and had not had much to eat or drink today. He died any pain.  AAOX3 and in no apparent distress.  Good ROM and neuros intact.   He denied that he was going to pass out.  Patient was provided water 3 bottles of water and a granola bar.  He was observed for 45 mins until he finished the water and granola bar. Patient stated he felt much better and left POV.
a person who received 2 doses of the vaccine in a fairly quick succession; A spontaneous report was received from a health care professional, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported the patient had received 2 doses of the vaccine in a fairly quick succession.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, it was reported that the patient received both doses of the vaccine in a fairly quick succession.  Action taken with study drug was not applicable as the subject had already received both scheduled doses  The outcome of the event, a person who received 2 doses of the vaccine in a fairly quick succession was resolved.; Reporter's Comments: This report refers to a case of "Product administration error" for mRNA-1273, lot # unknown. with no associated adverse events..
A day after the vaccination I started itching a little bit in random areas.; Then 72 hours small bumps have been popping up that seem like hives or bug bites.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO162) via an unspecified route of administration in the left arm on 08Apr2021 at 17:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks of vaccination. On 09Apr2021 at 15:00, a day after the vaccination, the patient started experiencing itching a little bit in random areas. Then seventy two hours, small bumps had been popped up that seemed like hives or bug bites. However, the patient had them at random areas of his body. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were  taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events itching and small bumps like hives were not recovered at this time of this report.  No follow-up attempts are needed. No further information is expected.
No known side effects; postmortem Covid-19 test negative  Date of death:  02/12/2021
This case was reported in a literature article and described the occurrence of uveitis in a 52-year-old female subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified). On an unspecified date the subject received 3rd dose of HEPATITIS B vaccine (unknown). Five days after vaccination with HEPATITIS B vaccine, the subject experienced uveitis and paralysis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after HEPATITIS B vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of HEPATITIS B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
Received pNeumoNiA shot on 10/30/19. By AM oF Next day hAd lARge AReA oF swelliNg, RedNess ANd extreme teNderNess. Saw MD on 11/1/19 ANd wAs diagnosed with cellulitis ANd placed on 5 dAys oF Antibiotic cephalexiN
2 days after injection large red, warm, itchy swelling in right arm. Still an issue 5 days later.
Patient received PNEUMOVAX w/no immediate complications. Returned home and was working on his garden (putting down decorative rocks), and noticed some pain in the left upper arm around 230pm. Thought this was muscle strain from his gardening work and decided to rest. Noted swelling to the upper arm around 530pm, pain increased over this time period. No prior vaccine reactions, received PREVNAR 13 vaccine 1/2017. No food allergies that he is aware of. Denies fever/chills. Some tingling in the digits on the left arm and difficulty with flexion and extension at the elbow due to pain. Per Urgent care clinic note, LUE: left upper arm tense with significant swelling from about 1.5-2 inches from acromion process extending distally through elbow. Area is mildly indurated, warm, and erythematous. Significantly tender to palpation. Hand grip strength is 5/5. Radial pulse is 2+. Hand is warm. Able to abduct and adduct digits of left hand without difficulty. Some difficulty making a fist D/T pain. Difficulty with flexion at elbow D/T pain. Likely infectious process rather than delayed hypersensitivity as he has received numerous vaccines in the past without issue. WBC WNL- Rx's PO clindamycin.
Starting the following day on 4/14/2020, employee started feeling light headed, headache, and dizzy as well as a sharp pain to site of injection. Injection site is warm to the touch, and red/swollen. Employee states she took Ibuprofen around 1500 hours. Today, 4/15/2020 employee still reports feeling lightheaded, dizzy, and still states she has a headache. Injection site still red and warm.
Headache - severe Tinnitus  Diarrhea Fever 102 Joint pain - hips Muscle pain - whole body Shaking Chills Feeling of dread/hopelessness
Large red welt in the general area of the vaccine site approx. 12 days after vaccination, Headache, nausea and general not feeling well.
8/29/2022  101.9 F - Fever @ 6:pm, 7.5ml Motrin 102.5 F - 10:00pm rapid heart beat, rapid shallow breathing.  7.5ml Tylenol 8/30/2022 - 8/31/2022 101.2 - 102.9 fever all day.  Routine administration of Tylen and Motrin.  Pt. has red dots on chest, back and face. 9/1/2022 102.5 F fever 8:00am.  Pt. complains of sore throat.  Motrin and Tylenol routine still in effect. Brought child to clinic.  Pt. was seen by Dr, Red throat confirmed.  STREP test was Negative.  9/2/2022 - 9/4/2022    Fever continues to return and Motin and Tylenol contiunes using 10ml each.  Pt. complains of sore throat.  Red dots found at back of mouth, on back, and on face.
Information has been received from a 65-year-old male consumer who on 18-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) 0.65 mL injection (Lot # not provided). Concomitant therapy included losartan potassium-HCTZ (MSD), AMARYL, simvastatin (MSD), GLUCOPHAGE and EFFEXOR. The consumer reported that on 18-APR-2008 he experienced dizziness, tiredness, anemia and leg pain. The consumer also reported that he drinks one glass of alcohol per day. At the time of this report, the consumer was recovering from these events. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information was received from a physician which reported that there was no documentation or phone call from patient concerning adverse reaction to zoster vaccine live (Oka/Merck). No further information is available.
Patient woke up 10 days after vaccines with what appeared to be bleeding in the white part of the far corner of left eye. Patient already had appointment with his pediatrician. MD told parents "He probably scratched eye in his sleep." On the next day, patient woke up with the same symptom on the right eye. Mother took patient to see his eye doctor. Patient examined and cleared from having scratches/anything that could have caused this. Optometrist advised patient's mother to file an adverse report for vaccines received.
Engerix-B vaccine administered to patient in left thigh on 4/8/2022 at approximately 0930. MD notified-no new orders.  Immunization representative notified. Patient's mother notified via phone call with interpreter.
Patient was playing basketball morning of 11/6 and complained of chest pain. She was running a lot and flushed in the face. She asked for a sub and sat out for awhile. She said the pain was mostly gone later that day. She plays more games today so will monitor.
Having a lot of rashes after having the 2nd dose; This is a spontaneous report from a Regulatory Authority via a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11May2021 at dose 2, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of Pfizer COVID-19 vaccine at single dose on 20Apr2021 for COVID-19 immunisation. On an unspecified date in May2021, the patient experienced having a lot of rashes after having the second dose. He's reporting this scenario after the second dose. No medical questions addressed by this program forwarded/referred to Medical Information. The clinical outcome of event was of unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Three days after the vaccine, I started throwing up everything I ate. After about a week of what I thought was the stomach flu due to vomiting, I went to the ER. After trying Zofran and Promethazine, nothing could keep my food in me. The doctors decided to go out on a limb and give me a gastric emptying test and the results were abnormal signifying Gastroparesis. During all of these testings (CT scan, ultrasound, emptying study and endoscopy), I was hospitalized from 4/17/21-4/20/21. After my second dose of Pfizer, my vomiting doubled from about 10-15 episodes a day to 25-35 vomiting episodes a day. My most recent gastric emptying study conducted in November  showed 23% retention at four hours. Currently, I am still vomiting 25-35 times a day. Before the shot, I never vomited unless on the rare occasion I was sick.
Severe body aches the following night after vaccination - then about a week later severe chest heaviness ( like a brick placed on chest ), hard time breathing, dry cough and severe tiredness some of the symptoms lasting over month now.   PCP though might be allergy but everything started after vaccination.
Experienced chills, body aches and very sore arm 30 hrs after injection.  Took 3 ibuprophen, went to bed at 9 pm. 2 hrs later chills were gone. By Saturday morning, arm was much less sore and body aches not as  bad. Totally gone by Sunday.
Information has been received from a registered nurse concerning a female with no medical history and no allergies who on 03-OCT-2006 was vaccinated intramuscularly with a 0.5 ml dose of Pneumovax 23 (lot #651357/0391F). There was no concomitant medication. Within hours of the vaccination, the patient experienced a localized reaction from the vaccination with redness, soreness and swelling at the injection site. She also developed a fever greater than 102 F and had nausea and vomiting for three days until she went to the emergency room and received IV BENADRYL and Prednisone. Nine days later, she still had soreness but her symptoms were resolving. It was also noted that she missed three days of work. No product quality complaint was involved. Additional information is not expected.
pt experienced a tender, palm sized raised bump next day. looks like it is resolving today (day 2)
Red blotchy swollen fingers and toes.  Really sore arm and severe headache.
On day one (9 FEB 2021) of my injection, I developed a red swelling at the injection site, a headache, fatigue, and swollen, tender arm.  By the next morning, day 2, I had a dime size bruise from the injection and the arm tissue was swollen and hard.  The swelling last 4 days.  The bruise lasted 12 days.   On the 7th day after (16 JAN 2021) receiving the Moderna COVID-19 injection in my left arm, I developed a red, puffy, bumpy rash on my arm, around where the injection was given.  It appeared after a routine shower, without any new use of products.  It was initially about 3 inches wide by 4 inches long, and almost crescent shaped.  We monitored the rash, as it increased in size over the next two days, growing to 4.5 inches wide by 6 inches long. The rash remained red, puffy, and bumpy during.  It never itched or wept any fluid.  Then on the 4th day of the rash, it turned light pink and diminished in color and area throughout the day, however, it was circled by a red ring outlining the rash.  The rash was still faintly visible on the 5th day and completely gone by the 6th day.  We also noticed it felt very hot to the touch and took the temperature of the site.  It peaked at 104 degrees Fahrenheit, while my head and neck temperatures peaked at 101 degrees Fahrenheit.
Vaccine given in error. Order was for Varicella (Varivax) which was misread and Dtap IPV HIb HepB (Vaxelis) administered. Pt had no adveres reaction to vaccine and will receive correct vaccine during 15 mon well child check.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 08-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided). The patient experienced a swollen warm red area about the size of an egg described as 2 inches by 3 inches and raised 1/8 to 1/4 inches at the administration site. The outcome of adverse events was not recovered. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Patient received a 3rd injection. Patient unreported that he had the completed Moderna course at a previous stay at the hospital. Patient was monitored and had no significant changes.
Immediate pain and tingling in arm down to fingers.  Frozen shoulder within days.  Saw Doctor for frozen shoulder pain and tingling 4/12/2021  also left shoulder x-ray. Which was normal Physical therapy visits  11.  4/26/2021 to 7/14/2021 Improved range of motion.  Pain and tingling in left arm and hand. Tingling in feet.  Weakness starts in left leg
PASSED OUT; SEVERE ABDOMINAL CRAMPY PAIN; CRACKED HEAD; This spontaneous report received from a patient concerned a 55 year old male The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and penicillin drug allergy.  The patient received COVID19 VACCINE AD.26.COV2.S (suspension for injection, route of admin not reported, batch number: 202a21a, expiry: UNKNOWN) dose was not reported, 1 Total administered administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, Saturday evening the patient experienced so severe pain, patient passed out, did not eat anything and did nothing out of ordinary that could have caused the severe abdominal crampy pain and hit his head (cracked head), sending patient to the ER (emergency room). It was reported that, he did not eat anything and did nothing out of ordinary that could have caused the severe abdominal and he did not know 100 percent that it comes from vaccine but nothing else was any different in his live other than vaccine. In ER they did laboratory tests included full blood test, chest X-ray, electrocardiogram and magnetic resonance imaging (MRI) of head and abdomen was normal (NR: not provided for all labs).  The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from severe abdominal pain on 02-MAY-2021, and the outcome of passed out and cracked head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210505687-JANSSEN COVID-19 VACCINE-Passed out -This event is considered unassessable. The event 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.
7/29/15 approx 5-6:00pm client noted soreness and took TYLENOL (500mg) x2. 7/30/15 more soreness noted at 7:00AM-7:30AM. At 7:00pm after work took TYLENOL (500mg x 2) for relief. Between 10:00-10:30pm noted continued soreness-Band-Aid removed. 7/31/15 8:00AM after shower noted redness and raised area at injection site. After arrival to work referred by employee to Health Dept for review. C/O sweating and hot. C/O wetness to neck and butt area. Very sore still.
Narrative: Patient heartedly developed a deep vein thrombosis approximately 1 week after receiving the Covid booster
56 y.o. female patient with history of HTN, HLD, anxiety, tobacco and etoh dependence presented to Hospital with dyspnea, found to have Covid and hypoxia   Acute hypoxic respiratory failure  Due to covid, and possible chronic lung disease  IS, wean as able May want to leave to take care of her cats, social work consulted for possible home 02  Recommend outpatient pulmonary function testing   Covid 19  2 days of cough, dyspnea  Requiring 4L 02 on admission, no baseline 02 requirement  Vaccinated x2, last 2021   Xray clear, PCR postiive 3/16  Cont dexamethasone, started remdesivir on admission Currently on RA, but with desaturations on ambulation Home O2, dexamethasone and albuterol  on discharge   Hyponatremia Hydration overnight    Tobacco dependence  NRT    EtOH dependence  Sober 2 months, no hx withdrawal  On opt vivitrol    Mood disorder Cont home escitalopram, atarax prn    HTN Cont BB   HLD  Statin