chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the 2nd dose vaccine, within 6-7 hours, I developed fever and flu like symptoms, fatigue, swollen arm, body aches, chills, headache, and pressure, pain and congestion  in the ears.  I also lost my sense of smell and taste and my left leg was swollen.  These flu-like symptoms lasted for about 3 days and started to improve.  My leg remained swollen. I went to see my doctor on 5/3/2021 for my regular appointment with my oncologist.  She noticed my swollen leg and sent me to get a venous ultrasound that same day. The ultrasound did not find any clots.  Currently, I am still having lingering fatigue and the swollen leg has not resolved.
No adverse symptoms reported; Physician Assistant reported the patient received an expired dose ofZOSTAV AX (S016663, expiration 8/27/2020) on 8/28/2020; This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not provided. Concomitant medication included sterile diluent.  On 28-AUG-2020, the patient was vaccinated with an expired dose of zoster vaccine live (ZOSTAVAX) (lot # S016663, expiration date 27-AUG-2020; strength, dose, route were unknown) for prophylaxis (expired product administered). No adverse symptoms reported.
pt started c/o numbness of lower extremities 15min p/mom left MD office approx 30min p/vax;PE 315PM 1 1/4hr p/vax loss of light touch & pain sensation in lower extremities L1-L2 distribution;DTR 2+ symmetrical motor tone nl;
feeling of weird skin irritation; a little bit of sore arm; noticed blood after receiving second dose; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (feeling of weird skin irritation), PAIN IN EXTREMITY (a little bit of sore arm) and SKIN HAEMORRHAGE (noticed blood after receiving second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced SKIN IRRITATION (feeling of weird skin irritation), PAIN IN EXTREMITY (a little bit of sore arm) and SKIN HAEMORRHAGE (noticed blood after receiving second dose). At the time of the report, SKIN IRRITATION (feeling of weird skin irritation), PAIN IN EXTREMITY (a little bit of sore arm) and SKIN HAEMORRHAGE (noticed blood after receiving second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081500 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081500:2nd  dose
Pt c/o chest tightness and difficulty breathing after received 2nd dose Pfizer Covid vaccine last night.  Appears fatigued but it alert and oriented, awakens easily. Reports some nausea and feeling shaky.
I received the injection Friday morning. A firm painful nodule occurred at the injection site by Saturday morning but it was not too bad and is resolving. Itching at the injection site occurred Saturday evening but not too bad (tolerable) and is not yet resolving.
Initial report received on 06-November-2013 from a pharmacist. A 77-year-old female patient, whose medical history included allergy to codeine, PCN and statin. Concomitant medications were not reported. The patient received a dose of FLUZONE HD (lot number U4781AA) via intramuscular route at left deltoid on 04-November-2013. On 04-November-2013, 4 hours later the patient went to the emergency room with disorientation, fever, chills, bloodshot eyes, and leg cramps.  Corrective treatment was not reported. At the time of this report the outcome of events was not resolved. List of documents held by sender: none
Patient was given the pfizer bivalent covid vaccine for dose # 3. She had received the moderna vaccine for doses #1 and #2. She did not experience any adverse effects at time of administration.
10 LBS WEIGHT LOSS; SHRUNKEN TESTES; FELT LIKE A DIFFERENT PERSON; LACK OF ENERGY; FLU LIKE SYMPTOMS; SEVERE TESTICULAR PAIN; SEVERE ABDOMINAL PAIN; FELT MOODY; LOSS OF BLADDER FUNCTION AND CONTROL; HORMONE LEVELS ARE OFF; TESTOSTERONE LEVELS ARE OFF; FELT VERY TIRED; This spontaneous report received from a patient concerned a 40 year old male. 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: 043A21A expiry: 21/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe abdominal pain. On APR-2021, the subject experienced severe testicular pain. On APR-2021, the subject experienced hormone levels are off. On APR-2021, the subject experienced testosterone levels are off. On APR-2021, the subject experienced felt very tired. On APR-2021, the subject experienced felt moody. On APR-2021, the subject experienced loss of bladder function and control. Laboratory data included: Hormone level abnormal (NR: not provided) Unknown, and Testosterone decreased (NR: not provided) Unknown. On 09-APR-2021, the subject experienced flu like symptoms. Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced 10 lbs weight loss. On 10-APR-2021, the subject experienced shrunken testes. On 10-APR-2021, the subject experienced felt like a different person. On 10-APR-2021, the subject experienced lack of energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on APR-2021, and had not recovered from severe abdominal pain, severe testicular pain, lack of energy, 10 lbs weight loss, hormone levels are off, testosterone levels are off, felt very tired, shrunken testes, felt like a different person, felt moody, and loss of bladder function and control. This report was non-serious.
Diagnosed autistic. We feel thimerosal accumulation caused autistic symptoms to developed. Diagnosed by neurodevelopmental pediatrician.  Nurse follow up on 06/28/04 states: "ADD: Global delay, hypothyroidism,   As per annual follow up report: same as previous report. Fine motor delay, gross moter delay, speech delay, PDD NOS diagnosis.
Probable myocarditis, based on cardiac enzyme elevation and pleuritic chest pain approx. 15 days post-vaccination.
Muscle soreness in arm of injection (started the day after and continues through today 12/7/2009, headache comes and goes.
24 hours after receiving the seasonal influenza vaccine in the left deltoid, this employee noticed slightly increased left supraclavicular lymph nodes.  She thought she may have felt chills, slight fever 10-18-22 but this resolved 10-19-22. She reports the swelling and tenderness is less today.  Please note, left deltoid, shoulder- no edema, erythema or tenderness,  no increased left axillary nodes no increased cervical nodes
She vomited and has been dizzy and light-headed. She called and left a message. I attempted to contact her, voice mail was left for her to call me back. Another employee in her training class did appeared to be ill (poss. stomach bug).
No adverse event; Bivalent vaccine administered after more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Oct-2022 at 8:30 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Oct-2022 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine administered after more than 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine administered after more than 12 hours post puncture).    No concomitant medications were reported. It was reported that individual vials and vial size was 5.5 ml. On 05-OCT-2022 vial was initially stored in the refrigerator. Post puncture vial was stored in room temperature. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius i.e 46 to 77 degree Fahrenheit) was 22 hours. No adverse events were reported.  Treatment medications were not reported.
vagal reaction p/1st dose of vax; no problems w/day 3 dose but c/o muscle aches & legs hurting; 14FEB92 f/u; no addtl event info, only pt details;
Fever (99), dry cough, severe muscle pain in left arm, chest and side of body
No adverse effects reported; Unspecified patient was administered an expired dose of MMR II; This spontaneous report was received from an office manager referring to an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 09-JUN-2017, the patient was vaccinated with an expired dose of M-M-R II, (rHa, lot # L019989, expiry date 01-JUN-2017) for prophylaxis. Other suspect therapies included STERILE DILUENT. No adverse effects were reported. The outcome of expired product administered and no adverse event was unknown. Additional information is not expected as no consent to obtain follow-up information was provided.
Muscle aches in the back and legs, chills, and pain and lump at site of injection.
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Patient noted tongue swelling 15 minutes after vaccine administration, administered self 50 mg of Benadryl through port. Notified professional staff on site of tongue swelling and "puffy" lips. After evaluation, swollen tongue and swollen lips confirmed. 0.3 Epi mg administered 30 minutes following vaccination.  Vitals  98% O2, HR 98, BP 134/102.  EMS contacted, arrived at 11:38 pm, left by ambulance 11:40 am in stable condition.
Mom phoned to clinic stating pt woke up with a fever (100.1), nausea, and a horrible HA. Second HPV received yesterday (1/13/16). First injection 11/8/15, mom states pt c/o HA day after injection.
I noticed that my night vision, my left eye is seeing colors really bright and my other eye is seeing colors really dark and some things are really hard to distinguish in the shadows. So my left eye is seeing them but my right eye, it's non-existence. If I look at something green: my left eye sees it at Lime; my right eye will see it as forest . At eye doctor, there was no treatment option. My day time vision is normal. Intermittent tingling in my limbs - it's random and it's hands and feet and that started a couple of days after the vaccine, as well.
When I went to lie down to sleep I was suddenly very aware of experiencing tinnitus. The only other times I have experienced this is when taking 2 ibuprofen, aspirin or Tylenol pills. Usually the ringing abates but the tinnitus has continued to this day 19 days later and it has not lessened.
A report has been received from a Pharmacist concerning a 45 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient received expired vaccine which started on 01-Dec-2014. The outcome of the event of expired FLUMIST QUADRIVALENT administered was unknown. The report was considered to be non-serious.
headache; dry mouth; fatigue; brain is not working correctly; feeling like a zombie,; Hypotension; Dizzy; short of breath; stomach was tight near the heart; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), DRY MOUTH (dry mouth), FATIGUE (fatigue), DYSPNOEA (short of breath) and ABDOMINAL DISCOMFORT (stomach was tight near the heart) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced DYSPNOEA (short of breath), ABDOMINAL DISCOMFORT (stomach was tight near the heart), HYPOTENSION (Hypotension) and DIZZINESS (Dizzy). On an unknown date, the patient experienced HEADACHE (headache), DRY MOUTH (dry mouth), FATIGUE (fatigue), FEELING ABNORMAL (brain is not working correctly) and FEELING ABNORMAL (feeling like a zombie,). At the time of the report, HEADACHE (headache), DRY MOUTH (dry mouth), FATIGUE (fatigue), DYSPNOEA (short of breath), ABDOMINAL DISCOMFORT (stomach was tight near the heart), FEELING ABNORMAL (brain is not working correctly), FEELING ABNORMAL (feeling like a zombie,), HYPOTENSION (Hypotension) and DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter. No treatment information provided.
Been feeling dizzy at times. Mild headaches, chills. On 2/5/2021 @ 7:25 had a severe sore throat that my left ear was in pain as well. Cleared by the following day.  On 2/10 @ around 5pm my legs started feeling heavy and my right side of neck heavy as well by 9:30 I my neck was in stiff and in pain started feeling chills and by 9:40 a temp of over 101. Was better by noon the following day.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned 5 patients.  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: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered on 13-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-DEC-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
SLIGHT SORE THROAT; SLIGHT ARM NUMBNESS; TINGLY ARM, FELT LIKE ARM IS ASLEEP; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included: bells palsy, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, expiry: 06-SEP-2021) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-AUG-2021, the patient experienced slight sore throat. On 16-AUG-2021, the patient experienced slight arm numbness. On 16-AUG-2021, the patient experienced tingly arm, felt like arm is asleep. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight sore throat on AUG-2021, was recovering from slight arm numbness, and the outcome of tingly arm, felt like arm is asleep was not reported. This report was non-serious.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 21-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Tingling of tongue, tickle in throat Benadryl 50 mg IM given Patient taken to ED
Triggered swelling, vomiting, extreme weight gain, aches, cold sweats and extreme fatigue.  Trigger dormant lupus that patient was unaware of.
Within 1 -1/2 post vax, pt developed a fever and shaking.  Pt had a fever of 101.3 F. He was listless.
My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting on Saturday, the day following the vaccination} in a sore right wrist and a much more painful right arm that steadily grew in intensity and spread rather rapidly into my upper torso.  By the following day (Sunday, 2/21) my breasts became very sensitive and I had severe pains across my back.  This may or may not have been the beginning of a banding type MS exacerbation, but by Monday, 2/22, it was clear that I was experiencing a full-blown and seriously disabling exacerbation. Both legs experienced the tingling and numbness I have had in a prior exacerbation, and by the time I was able to talk to Dr. (my neurologist) on Monday afternoon (2/22), the numbness had progressed upward into my lower abdomen and I was no longer able to stand at all.  It appears highly likely that the MS attack was triggered by the response of my immune system's reacting to the discomfort and severe body pains that occurred following the vaccination.  I told Dr. of the total loss of feeling and use of both legs and was experiencing a increasing numbness from toes up to abdomen.  Before ordering the high doses of corticosteroids used to stop my exacerbation, Dr. sent me to the Emergency Room for testing to make sure I did not have an infection that could be covered up by the steroids.  When this testing did not show any such infection, the ER administered an IV infusion of 1 gram of solumedrol, followed by gradually decreasing high oral doses of prednisone.  As of this date, numbness has started decreasing and some limited  utility of right leg has returned.  Still i can no longer stand and perform even the minimal movements to-and-from wheelchair to bed or toilet without substantial physical help (not needed before this exacerbation) from my sole caregiver, my husband.
client reported to EMS personnel that their lips, throat felt swollen and they were having difficulty breathing. patient transported to Hospital for further evaluation.
slight Grovers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "Bullous Pemigoid/blistering itching skin reaction/rash". The following information was reported: TRANSIENT ACANTHOLYTIC DERMATOSIS (non-serious), outcome "unknown", described as "slight Grovers".  Additional information: The patient got the first Pfizer booster while  was still taking dupixant and the patient was nervous about getting another booster. The patient also had slight Grovers.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300155651 Same patient, different dose and AE;
On 6/1/2022 my husband tested positive for COVID. Three weeks after he tested positive, I started feeling sick and was running a fever. On 06/21/2022 I took an at home COVID test and it was positive. I'm reporting my breakthru case.
Vaccine given on 8/13. 8/14, redness and swelling noted. 8/16 Redness/swelling increased to 13cm x 14cm on left arm. Itches. Started on Keflex and Hydroxyzine.
Pt received bivalent booster less than 2 months after receiving last monovalent booster.
Information has been received from a physician concerning a 20 year old female who on 09-JAN-2007 was vaccinated in the right arm with the first dose of GARDASIL (lot# not reported). On 09-MAR-2007 the patient was vaccinated in the left arm with the second dose of GARDASIL (lot# not reported). On 11-JUL-2007 the patient was vaccinated in the right arm with the third dose of GARDASIL (lot# not reported). Per the reporter, the patient experienced one large plantar wart on her right heel immediately following the second dose of GARDASIL. The patient was treated by a podiatrist and had the wart burned off, but 7 more warts branched out on the heel. These were treated with a combination of burning or surgical removal. The patient is still being treated by the podiatrist who feels this is related to GARDASIL. The primary care physician does not feel this is related to GARDASIL. The patient's warts have persisted. No additional information is available at this time. Additional information has been requested.
Reported that with AVA # 1 in Dec 1990 he developed a small knot in his left arm that never went away. He received AVA # 2 in the left arm but denied any lumps with the second injection. He reported that the lump was tender and in 1998 it doubled in size and was visible. He stated that it continued to enlarge and bother him until he had it removed in May 08. He denies any unusual scarring or wound healing and reported he had another lump that was removed at the same time from his buttock following a game globulin injection. In addition to his lipoma, the "patient" also reported that shortly following AVA # 2, he developed a rash on his arm near the injection site. He stated this rash lasted for 1.5 years and cleared after he was given some cream that was prescribed. Rash was confined to left arm only, and he denied any further reoccurrences since that time. He also reported that with each AVA he developed muscle aches in his left arm that was also associated with occasional twitching. Pain would last a couple of hours and will subside on its own. He now has less episodes of pain and twitching and stated they may occur about per month. Symptoms: Nodule, subcutaneous, Dermatitis, focal, Muscle Spasm, Muscle Pain.
Fever of 102, rash/swelling to bilateral cheeks, hives to upper/lower right leg and lower left leg. Reactions lasted a period of 36 hours. Gave 1.6ml of Infants Tylenol every 4-6 hours.