chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little blisters break out around the punctured site; The Darker spot is the injection point; He was weak as a kitten for about 2 days; The injection site was itchy; Totally exhausted; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (Little blisters break out around the punctured site), VACCINATION SITE SCAR (The Darker spot is the injection point), ASTHENIA (He was weak as a kitten for about 2 days), VACCINATION SITE PRURITUS (The injection site was itchy) and FATIGUE (Totally exhausted) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 011021A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, High cholesterol and Enlarged prostate. Concomitant products included SIMVASTATIN, HYDROCHLOROTHIAZIDE, DOXAZOSIN, FAMOTIDINE, ASCORBIC ACID, CALCIUM PHOSPHATE, LACTOBACILLUS NOS, VACCINIUM MACROCARPON (AZO CRANBERRY), POTASSIUM, VITAMIN C [ASCORBIC ACID], MULTIVITAMINS [VITAMINS NOS] and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE (OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE]) for an unknown indication, CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]).   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced VACCINATION SITE SCAR (The Darker spot is the injection point), ASTHENIA (He was weak as a kitten for about 2 days), VACCINATION SITE PRURITUS (The injection site was itchy) and FATIGUE (Totally exhausted). On 26-Jul-2021, the patient experienced VACCINATION SITE VESICLES (Little blisters break out around the punctured site). At the time of the report, VACCINATION SITE VESICLES (Little blisters break out around the punctured site), VACCINATION SITE SCAR (The Darker spot is the injection point), ASTHENIA (He was weak as a kitten for about 2 days) and FATIGUE (Totally exhausted) had resolved and VACCINATION SITE PRURITUS (The injection site was itchy) had not resolved.            It was reported that the punctured site was still visible. The patient was on the couch all weekend. The injection site was still itching. The patient did not receive any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant Follow-up contained new events Darker spot is the injection point and He was weak as a kitten for about 2 days. Patient DOB updated.
Information has been received from a physician via a company representative referring to a 70 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date in 2016, the patient was vaccinated with PNEUMOVAX 23 (0.5 ml, lot # reported as M018768, expiration date 15-OCT-2017) subcutaneously. On 21-SEP-2016, after receiving PNEUMOVAX 23, the patient experienced redness and warmth as her arm began to be swollen. The patient sought medical attention, while it was unknown if treatment was given for the events. The outcome of the events was unknown. The causality between PNEUMOVAX 23 and the events was not provided. Additional information has been requested.
Dizziness, Headache, Myalgia, Fever, Diarrhea, NauseaVomiting injection site pain
Continual ache in left arm shoulder area. Joint ache    Weakness. Radiate to back ache on left side
Information has been received from a RN concerning a 42 month old male who on 01Nov01 was vaccinated SC with a first dose of varicella virus vaccine live (lot 637957/1882K). Concomitant therapy that day included a third dose of hep B virus vaccine rHBsAg (yeast) (Engerix B) (lot ENG5173A2) (IM) and a first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 639916/0903L) given SC. Subsequently, during week of 18Apr2004, the pt developed a few lesions on scalp and chest. Follow-up reported that the pt had developed chicken pox. The pt recovered. No product quality complaint involved. The RN also reported on two other pt's who had similar experience after being vaccinated with varicella virus vaccine live (WAES0404USA02232 and 0404USA02309). No further information is expected.
Went to school to complete the Covid-19 series with patient in relation to completing clinicals for a CNA course. Before leaving office, I removed vial out of fridge from the only Box of Pfizer vaccine we had stocked. Due to the frequency of giving the bivalent  covid shot, I had in my thought process this was the correct vaccine to complete vaccination series. Verified with the other office vaccine coordinator of the Lot #. I withdrew the needed number of doses and placed in secure container to transport along with other necessary supplies. Upon arrival, I reviewed the questionnaire form and found no contraindication in the questions. I proceeded to administer dose in requested arm and monitored for 15 minutes as recommended. Upon returning to the office, as RN was entering it into the data center, she realized we had administered the incorrect vaccine. I immediately called nurse manager, and reported the incident in which she said she would contact necessary facility to see what the recommendation would be. Later that day, I attempted to contact guardian inform of the incident but was unable to reach anyone. I attempted to call the teacher of said patient to gain any other contact information available but was unable to reach and I left a message to call me back.
DIAGNOSED WITH AN ACUTE URI 2/28/1992 ON 3/3/1992 GIVEN FIRST SET OF SHOTS. 5/4/1992 2ND SET OF SHOTS SAME DAY SHE WAS DIAGNOSED WITH CHRONIC URI AND SINUSITIS. 1 MONTH AFTER RECEIVING 3RD SET OF SHOTS WAS DIAGNOSED WITH A VIRAL SYNDROME. DOCTOR NOTE SAYS ON AND OFF FOR 1 MONTH. 3 WEEKS LATER TAKEN TO ER AND DIAGNOSED WITH BRONCHITIS AND OTITIS MEDIA. 6 DAYS LATER IN A COMA AND HOSPITALIZED. CT SCAN SHOWS HER LUNG WAS SCARRED AND HAD COLLAPSED. WAS DIAGNOSED WITH SHAKEN BABY SYNDROME BUT LATER THAT NIGHT IT WAS RULED OUT.
Case number PHEH2013US013952, is an initial spontaneous report received from a nurse on 26 Jun 2013. This report refers to a patient of unknown age and gender. Medical history and concomitant medication was not reported. Nurse mixed the Men A lyophilized conjugate of MENVEO (batch number: unknown), with a diluent and administered it on 25 Jan 2013. Liquid component Men CWY was not administered. No adverse event was reported following this medication error.
inc warmth, induration & erythema lt arm extending 5cm from inj site, tender; no nodes;
Mom states pt cried uncontrollably for 4 hrs straight; mom phoned MD;
1. Permanent hypertension. 2. Stomach problems. 3. Brain disorder unknown causes.  3/19/07 Received medical records from VAMC which reveal patient experienced HTN for approx 13 yrs, traumatic LBP w/radiation to left leg since lifting heavy equip while active duty 2003 w/intermittent exacerbations, herpes labialis, heart murmur & hyperlipidemia/hypercholesterolemia, ETOH abuse.  Had been active duty for 15 mos in Iraq prior to being evaluated. Received multi sessions of PT for back pain w/good results. Had episode of vertigo in 11/06 following cold s/s which required hospitalization. Neuro consult revealed tandem gait ataxia. Final dx: benign positional vertigo vs vestibular neuronitis or viral labyrinthitis.  ENT/audiology w/u was WNL w/mild sensorineural hearing loss right ear & right vestibular hypofunction & patient referred for vestibular rehabilitation. Per annual follow up: Hypertension, articular pain (or joint), had suffered an acute CVA. I am sumitting a copy of my vaccination record with some of the manufacturer and lot number and the amount or cc administered.
horrific migraine; Chills; She is not feeling well; legs are really hurting her like cramps that's hurting; legs are really hurting her like cramps that's hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A female patient received bnt162b2 (BNT162B2), administration date 08Dec2021 14:30 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER: UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER: UNKNOWN), for Covid-19 Immunization. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "horrific migraine"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "She is not feeling well"; PAIN IN EXTREMITY (non-serious), MUSCLE SPASMS (non-serious) all with onset 2021, outcome "unknown" and all described as "legs are really hurting her like cramps that's hurting".   Additional information: Reporter stated, "More specifically earlier my daughter had the booster for Pfizer and about 2:30 this afternoon she was okay, just had a horrific migraine and then she had chills for couple hours no fever and then she's been up for hours now because her legs are really hurting her like cramps that's hurting. Is that normal? Reporter stated "I'm more concerned right now. She is not feeling well. So that's okay, alright. Thank you." Further probing could not be done as Reporter was unwilling to file a safety report hence limited information available over the call.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-up (15Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Palpitations increased drastically, I started increasing at 01:00 1/1/2021 and at it worse by 07:00 1/1/21 I was having about 1 very 3-5 seconds. I normally take metoprolol ER 50 to control them but I increased the dose to 75 mg and it helped where I was getting one per min or so. I did have a caffeinated drink at approximately 1800 12/31/20 but that?s not new for me.
3 days after second dose of Pfizer vaccine,  (01/30/2021), went to emergency room for facial droopiness and numbness on the left side. Was diagnosed with Bell?s palsy in the ED.  Currently taking prednisone (60 mg - once a day). Valtrax (1mg - 3x a day), Erythromyocin eye ointment (.5% - 4x daily)
I have experienced menstrual irregularities since my CoVid vaccine, including starting my period early, the day after my first shot, heavy bleeding, terrible cramping, and now two periods in three weeks (one week on, one week off).   I was not warned of this side effect and it only came upon my radar from an  article. Many subsequent news articles have made me aware of the widespread prevalence of this problem. The agencies who really should have made me aware of it have been radio silent. For that reason alone, I am firm in my decision to never take another CoVid vaccine or booster in the future. Failure of the FDA and CDC to share this information with women shows an absolute lack of regard for women and I feel duped. It?s disgusting really.
pt c/o rash & itching approx 5-6hr p/vax;family took pt to hosp ER where pt was treated w/DPH & Solumedrol;
Tingling in hands, arms, feet, legs, toes. Weakness in arm and leg muscles. Chest pain with deep breaths. Joint pain in fingers, toes, elbows, shoulders, knees, ankles. Spine pain with pulsating feeling. Headaches and migraines. Fatigue and nausea, dry heaves.
The night of the vaccine, I was just very lethargic and tired as anticipated. The next morning, around 11am, I had a slight fever of 99.5. Around 12pm, my skin became very very sensitive and painful/uncomfortable to touch, all over my body. By around 6pm, the skin pain was gone and the fever was as well.
discharge from the left eye which was described as conjunctivitis; soreness in the armpit which the patient thinks is the lymph node; left arm was sore/ soreness in the armpit which the patient thinks is the lymph node; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVITIS (discharge from the left eye which was described as conjunctivitis), LYMPH NODE PAIN (soreness in the armpit which the patient thinks is the lymph node) and MYALGIA (left arm was sore/ soreness in the armpit which the patient thinks is the lymph node) in a patient of an unknown age and gender 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 an unknown date, the patient experienced CONJUNCTIVITIS (discharge from the left eye which was described as conjunctivitis), LYMPH NODE PAIN (soreness in the armpit which the patient thinks is the lymph node) and MYALGIA (left arm was sore/ soreness in the armpit which the patient thinks is the lymph node). At the time of the report, CONJUNCTIVITIS (discharge from the left eye which was described as conjunctivitis), LYMPH NODE PAIN (soreness in the armpit which the patient thinks is the lymph node) and MYALGIA (left arm was sore/ soreness in the armpit which the patient thinks is the lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
24 hours after receiving the vaccine, she developed fever >101F, myalgias, fatigue, headache. Then noticed a lesion on her forehead. Seen in urgicare and then ER. By then had additional lesions on her Left forehead extending into her scalp as well as 1 on her Left eyelid. Diagnosed with Shingles in L V1 region and started on IV Acyclovir x 3 days. Then transitioned to PO Valtrex 1gram PO TID and discharged home. Still with headaches and not all lesions have resolved. No visual involvement as per ophthalmology.
Dupuytren's contracture; This is a spontaneous report from a contactable consumer reported for self. This 67 years old female patient (No pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Feb2021 00:30 AM Left arm at single dose (Lot en6201) for covid-19 immunisation. Medical history included Autoimmune diseases and celiacs, Known allergies: Codeine and wheat and dairy products. No covid prior vaccination. Concomitant medications included dexlansoprazole (DEXILANT) from 16Feb2021, Meloxicam, sertraline hydrochloride (ZOLOFT), and nicotinic acid (NIASPAN). No other vaccine in four weeks. She experienced Dupuytren's contracture on 26Feb2021, resulted in disability or permanent damage. No covid tested post vaccination. It is unknown if treatment received. Outcome of the event was not recovered.
SHAKES AND CHILLS LIKE THE FLU; UNABLE TO MOVE LEFT SHOULDER AND ARM; LOWER BACK PAIN; STABBING PAIN LIKE IN LEFT SHOULDER AND ARM; This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sciatica, slight asthma in summertime, and seasonal allergy, and other pre-existing medical conditions included patient is taking vitamins (unspecified).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 07-APR-2021 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced unable to move left shoulder and arm. On APR-2021, the subject experienced lower back pain. On APR-2021, the subject experienced stabbing pain like in left shoulder and arm. On 07-APR-2021, the subject experienced shakes and chills like the flu. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes and chills like the flu on 08-APR-2021, and unable to move left shoulder and arm, and was recovering from stabbing pain like in left shoulder and arm, and lower back pain. This report was non-serious.
Upper arm swelling, redness, itching after vaccinations. Started on 12/21/09.
got the shot, got shingles/Suspected vaccination failure; shingles; 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: got the shot, got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-APR-2023 The case  was received from the patient via interactive digital media. The patient got the Shingles shot and got shingles. No contact details were provided. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
she developed shigles dermatome T10 left side 11 days after Covid vaccine.
This spontaneous report as received from a physician refers to 5 patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with expired doses of (Merck) VARIVAX injection administered subcutaneously at dose 0.5 ml (indication, lot# and expiry date unspecified). The physician did not have the lot number or expiration date in front of him at the time of the call, but stated that all 5 doses were given less than 14 days after the expiration date. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Pt became lethargic, developed low-grade fever and itchy rash began on torso. All started 1 hour after receiving immunization. Condition continued with itchy rash spreading to thighs and arms by Sat. Sunday afternoon itch and rash on torso diminished. Pt began to feel better. Fever almost gone. Several rashes appeared on ears. Pt received Tylenol and Benadryl Fri, Sat and Sun.
Extreme swelling in underarm area (on the right side, the same side as the injection).
Short fainting spell; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EJ1686), intramuscularly on 14Jan2021 after 15:00 (her appointment was at 1510 but she had to wait past her appointment time before she received it) in upper right arm at single dose for Prevent Covid in hospital. No history of all previous immunization with bnt162b2 considered as suspect. No additional vaccines administered on same date of bnt162b2. Medical history included breast cancer from 9 years before 19Jan2021 (2012) and she has been Anastrozole since, she was only supposed to take Anastrozole for 5 years and when she was one month away from being done with it she had a Seizure and she was found to have a Tumor in her brain, she had had Srs surgery on her brain on 13Apr2016, she was prescribed Levetiracetam, a seizure medication, for two years and had not had any problem since. Concomitant medication included ongoing anastrozole taking for about 9 years for Post breast cancer. No prior vaccinations within 4 weeks. The patient previously took levetiracetam for seizure, she stopped taking Levetiracetam 750mg about 2 or 3 years before 19Jan2021, flu shot on 05Dec2020 for immunization at the age of 66-year-old. The patient reported that she had a short fainting spell around 8:30am on 19Jan2021 and she was not sure if it was related to the Covid vaccine. She described that she had been sitting for a while and when she got up she felt like this black curtain coming down which she has felt before in the past but she usually recovered and never lost control to where she fainted. Her husband was there to catch her. She clarified that she never passed out. She did not have any reactions in the past few days since she received the covid vaccine, she did not even have soreness at injection site. The event was not required a visit to Emergency Room nor Physician Office. Relevant Tests was none. The outcome of the event was unknown.
Student received Live H1N1 Flu Vaccine @ 1:35 p.m. At 2:00 p.m. she presented with tightness in the throat & difficulty breathing. Epinephrine & Benadryl were given. Paramedics arrived at 2:23 p.m. 12/8/09 ER records received for date 11/23/09. DX: hyperventilation syndrome, allergic reaction. CC: pt states received vax and within 1 hr c/o throat tightness, dizzy, labored breathing, tingling hands/feet. EMS gave Benadryl and pt seen in ER w/ sx improving.
Malaise; body aches; headaches; stuffy nose; pain in neck; Felling ill; pain in neck, joints; fever; chills; sore throat; stuffy head; Metallic taste in mouth; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on the 18Dec2020 14:00 intramuscularly right arm at single dose for Care for COVID patients. Patient medical history included Recently diagnosed with fibromyalgia and is taking medication. Family medical history was unknown; Both of her parents are deceased. Mother died from heart disease and father died from alcoholism. Concomitant medications included medication for fibromyalgia. Patient previously had flu shot probably in Sep2020. After she got the Covid vaccine she started to feel ill with fever, chills, sore throat and stuffy head. Patient received COVID-19 Vaccine on Friday (18Dec2020) from hospital. Began feeling ill last night (23Dec2020) with fever, chills, sore throat, and stuffy head. Wants to know if she needs to go get tested. Received COVID-19 Vaccine on 18Dec2020 at 14:00. Began to fill ill last night 23Dec2020. Had a metallic taste starting 19Dec2020 around 18:00 for a couple of hours. On 23Dec2020 around 18:00 started to feel malaise, body aches, and headache. Got home from work, went to bed, and had a full blown pounding headache with pain in the neck, her joints, and malaise. Had a stuffy nose and sore throat yesterday, 23Dec2020 around the time she went to bed. Prior vaccinations within 4 weeks was No. Vaccination facility type was hospital. vaccine administered at military site was no. The outcome of events was unknown.
On 1/17/2022 at 10am patient was given a dose of Pfizer 5-11 Covid Vaccine after the vaccine's beyound use date of 1/14/2022.  The vaccine had been stored properly up until the dose was given.  The patient's family was notified of the error immediately.  The incident was reported to Pfizer, our collaborative practice provider, and VARES.  The patient's mother reported no side effects or concerns on 1/19/2021.  A final draft of the collective of all these findings will be provided to the patient's family.  It is the professional conclusion that this patient has received dose 1 of the Pfizer series and should receive the 2nd shot in the series in 3 weeks.