chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The only adverse effect I had was gout in my left and right foot. It came on suddenly after physical exertion of physical activity. It kept me off my feet for 4 days. My doctor didn't think it had to do with my medications and it just recently cleared up as of yesterday 3/28.
Both shots administered in the left arm. Pt came in on 2/17/19 and complained that when she was immunized, the shot given on the top (which one it was is not documented) caused a sort of electrical shock sensation that went down her arm. After going home she continued to feel discomfort in her left arm including nerve pain and loss of strength in that arm. Upon seeing her doctor, she stated that the doctor treating her told her that the shot was administered too high (possibly in a tendon) resulting in a "pocket" of some kind (her description). At the time of the conversation she said she is doing better, but she wanted us to know that the person administrating the immunization should be notified and be educated in proper administration technique.
Patient had fever and swelling. Pt was told to take TYLENOL. She also put ice packs on the area.
This is a spontaneous report from a non-contactable health care professional via Pfizer sales representative. A 17-year-old female patient of unspecified race/ethnicity received TRUMENBA via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported. The patient on an unspecified date experienced flu like symptoms for a couple days, redness, aches, nausea. The events were non-serious and took place after use of product. The outcome of the events flu like symptoms, redness, aches, nausea was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Patient complained of numbness around mouth post vaccine. Oral diphenhydramine 25 mg  x 1 dose was administered and symptoms resolved
Patient was given a booster dose of 0.5mls instead of 0.25mls following the Janssen vaccine. Patient reported fatigue and headache.
Muscle weakness and twitching; Muscle weakness and twitching; Tingling in hands feet; Significant inflammation (arm is falling asleep at night) in back; Hot flashes, By the end of the month hot flashes every night; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes, By the end of the month hot flashes every night), PARAESTHESIA (Tingling in hands feet), INFLAMMATION (Significant inflammation (arm is falling asleep at night) in back), MUSCULAR WEAKNESS (Muscle weakness and twitching) and MUSCLE TWITCHING (Muscle weakness and twitching) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 042B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included FLUCONAZOLE, VALACICLOVIR HYDROCHLORIDE (VALTREX) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced HOT FLUSH (Hot flashes, By the end of the month hot flashes every night). In September 2021, the patient experienced PARAESTHESIA (Tingling in hands feet) and INFLAMMATION (Significant inflammation (arm is falling asleep at night) in back). In October 2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness and twitching) and MUSCLE TWITCHING (Muscle weakness and twitching). The patient was treated with BUSPIRONE for Adverse event, at a dose of 1 dosage form; VITAMIN D [VITAMIN D NOS] for Adverse event, at a dose of 1 dosage form and DICLOFENAC for Adverse event, at a dose of 1 dosage form. At the time of the report, HOT FLUSH (Hot flashes, By the end of the month hot flashes every night), PARAESTHESIA (Tingling in hands feet), INFLAMMATION (Significant inflammation (arm is falling asleep at night) in back), MUSCULAR WEAKNESS (Muscle weakness and twitching) and MUSCLE TWITCHING (Muscle weakness and twitching) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Antinuclear antibody: positive (Positive) ANA test came back positive.. In September 2021, Blood pressure measurement: 147/90 - 150/100 (High) Blood pressure started going up as well to the 147/90 150/100 range. In September 2021, Heart rate: 120 (High) Heart rate spiking to 120.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had taken buspirone as treatment drug HCPs, thought it was anxiety.
Red, raised, indurated arm approx. 1 week after receiving #2 Moderna vaccine
Patient is a 68 y.o. female with a history of DM2, CAD, HTN, HFpEF, hyperlipidemia, CKD, chronic pain and OSA who presented to Hospital 2/17/2023 after mechanical fall out of bathtub and unable to get up for 3 days. Found to have DKA, leukocytosis of 20, lactic acidosis, covid positive, mildly elevated CPK at 1.2K. Trauma imaging negative. Hospital course complicated by progressive hypoxia.    1. COVID19 Pneumonia: DOP 2/17/23. Cough and congestion, sore throat. Mild o2 usage in ED. Will do remdesivir for now but cautious with renal function/GFR. Wean o2 as able. Isolation. Dexamethasone started 2/19/23 for worsening O2 sats. Procal 0.48 on 2/19/23. Ceftriaxone and azithro for possible CAP/superinfection x 5 days ending 2/22/23 2. Acute hypoxic respiratory failure: Due to above. High risk for progression as family requestng discharge home with O2 while patient recently titrated to 6lpm. Pulm hygiene ordered. Given COVID infection, patient may require chronic O2 on discharge pending recovery course. Improving and weaned to room air 2/21/23.   3. DKA: DM2 per history with likely DKA from acute stressors. Gap closed and ketones negative for 48 hours but limited by poor oral intake. Insulin transitioned to subcutaneous with steroids. Discharge on lantus 25 bid and lispro 16qac + ssi. May need titrated down with end of steroids and some instructions given. F/u with PCP.  4. Sepsis: Present on admission. COVID with suspected cellulitis and possible UTI will cover with rocephin. Blood cultures 2/17/23 NGTD x2. UCX no growth.    5. Fall with Elevated CPK: Mild with being down for 3 days. Improved with IVF.  CT Head, CTL, CTAP negative for acute fractures. Right shoulder pain, XR 2/18/23 showed no fracture but degenerative changes, recommended ortho follow up as patient established for knees. 6. DM2: On metformin at home. Held. Management as above  7. CAD:Hx, statin bb continued.  8. HTN: Home coreg 25 reduced and losartan held. Titrate PRN.  9. HFpEF: Hx echo 9/2021 with ef 59% mild AS. No longer on diuretics at home. IVF completed.  10. Hyperlipidemia: home statin 11. CKD: CKD 3 per notes and suspect baseline creat 1.3-1.5. At baseline on admission.  12. OSA: Does not use cpap at home.  13. Code status: DNR CCA DNI on discussed with with patient with son at bedside.
Patient passed out and then went into convulsions his eyes rolled into the back of his head like he was having a seizure. He has never had any reaction like this before with any other vaccine about a month later he was hospitalized with weak legs he couldn't support his weight.  Very confused and forgetful.  He has had "spells" of confusion.
lymph node under left arm down to the left breast was swollen and painful; body aches; weak; lymph node under left arm down to the left breast was swollen and painful; temp of 99.4 to 99.9; chills; joints ached; fatigued; With in 3 hours of injection, I got hot and flushed in my face; This is a spontaneous report from a contactable nurse (patient). A 57-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not available) via intramuscular on right arm on 13Jan2021 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation at Workplace clinic. The patient's medical history included Asthma and Arthritis. The patient had allergies to medications, food, or other products (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. Historical vaccine included first dose of influenza vaccine at the age of 57 years in nasal on 02Dec2020 which was given within 4 weeks prior to the COVID vaccine and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown via intramuscular on left arm on 23Dec2020 14:15 (02:15 PM) (at the age of 57-years-old) at single dose for COVID-19 immunisation. On 13Jan2021 at 17:00 (05:00 PM), within 3 hours of injection, the patient got hot and flushed in her face. The next morning on 14Jan2021, she woke up and her lymph node under left arm down to the left breast was swollen and painful. The patient also had a temperature of 99.4 to 99.9 and had chills and body aches enough to keep her home from work. The patient had joints ache and felt weak and fatigued. This lasted for about twenty-four hours. The reporter assessed the events as non-serious. The outcome of the events was recovered in Jan 2021.  Information regarding lot/batch number has been requested.
Just slightly sore injection site first 24 hours. At 30 hours, developed chills and a temperature of 103. The following two days, still running a temperature of over 103. In addition, had headache and neck stiffness that could not be relieved by Acetaminphen.
I had my first dose of the Pfizer COVID Vaccine on 12/23/20.  I was exposed to COVID-19 on 12/28 and positive on 1/3/21.  I had a mild infection, but my chronic constipation was resolved and had easy stooling that week.  On 1/7/21 I was having right upper quadrant abdominal pain, radiating to bilateral kidney pain and it resolved by the 8th or 9th.  I asked for a health care visit because the discomfort was strong.   I received the second dose of the COVID Pfizer vaccine on 1/13/21.  No immediate problems but intermittent pain in upper right abdomen into my kidneys.   By 1/25/21 I had constant pain in my kidneys and in general my abdomen was bloated and tender.  I thought I had a kidney infection and was prescribed abx.  By the next day the pain was becoming more severe and I went to the ER the night of 1/26.  CT showed a mass in the live and extensive stool throughout the bowel - even though I had been eating and stooling normal for me with hx of chronic constipation.  I had to stop eating and completing clean out my colon.  The swelling in the my abdomen took about 2 weeks to subside and I was unable to eat for several days.  I was diagnosed with mild diffuse fatty liver disease, which had not been previous an issue.  MRI determined I have a cyst on my ovary also.
Grade 3 systemic reactions, much worse than the first time. Injection site (right arm) pain, swelling. Overall body pain, skin, muscle joint, Fever up to 101.6 for 36 hours, now running 99.5 on day 2 post injection, nausea, diarrhea, gas, bloating, dizziness, weakness, fainting, fatigue. Unable to function or to work.   Symptoms are again substantially worse than 10 other individuals vaccinated at the same time for dose 2.   I suspect my reactions may be dose to weight dependent. I am a very small adult, 4'9", 123 pounds. There may be cause to consider smaller doses for smaller people. That would also allow more doses to be available for the population.   I am a healthcare professional. Many lay people would probably not have been willing to take a second dose at this level of reaction.
Palm-sized discoloration around injection site; arm was very sore; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 12:00 in left arm at single dose for COVID-19 immunization. Medical history included hay fever, asthma, various allergies and high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included progesterone, metformin, atorvastatin and metoprolol. On 05Jan202115:00, the patient experienced palm-sized discoloration around injection site and arm was very sore for two days. No treatment was given to the patient for the events. The patient recovered from the events on unspecified date. The patient underwent laboratory test which includes nasal swab: negative on 07Jan2021. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
12 hours after woke up with red area 6 inches between elbow and shoulder 4 inches wide. It was itchy, swollen.  It lasted about 7 days.  2 days after used Betamethasone which helped.  Had a virtual visit with MD.
May 24, 2021 at bedtime I noticed I could not swallow my evening meds correctly, my wife noticed my left eye and mouth were drooping May 25, 2021  admitted to  Hospital, underwent many tests and it was determined that I had suffered a minor ischemic stroke May 26, 2021 discharged from hospital
Red, warm, itchy rash at injection site- 3" in diameter.  Still present two weeks after vaccine.
Information has been received from a Physician concerning a 57 year old female patient who on 07/13/00 was vaccinated with a 1st dose of Hepatitis B recombinant. On 07/14/00, the patient developed floaters (dark dots) in the visual field. The patient sought unspecified medical attention. The reporting physician noted the patient now sees them more often> There is no pain or reduction in her vision and the physician "feels this is not optic neuritis." It was also reported that the patient experienced visual block spots and sparks (flash and lights). The patient was referred to an ophthalmologist. Follow up information received from a physician stated, "I have not seen the patient since my last report".It was noted that the patient's next appointment with this physician is in February, 2001. Additional information has been requested.
NOTED ON 10/03/2017 WHEN MOTHER PRESENTED TO OFFICE FOR POLIO INJECTION THAT THE VACCINES WERE GIVEN EARLIER THAN RECOMMENDED ON 8-22-2017. CHILD DID NOT EXPERIENCE ANY ADVERSE REACTION, NO COMPLAINT VOICED FROM PARENT REGARDING ANY SIDE EFFECTS. MOTHER'S ONLY CONCERN WAS THE CHILD GOING TO HAVE ANY PROBLEMS RELATED.
Pt received Tdap 11-26-07 AM. Pt states on 11-27-07 he had fever > 102 F, body aches, headache and swelling at injection site.
Patient was given a booster vaccine of Pfizer. His first 2 doses were Moderna. This was caught before the patient left the clinic. He was informed and was having no symptoms or signs of a reaction.
Wife came in saying we gave the patient Pfizer, Prevnar, and Fluzone HD and if that is normal that we do that. Told the patient there is not contraindication to get all 3 together and these vaccines are indicated for him and we have no records that he had these and the patient consented to get these and the patient asked for these. The wife said he had the pneumonia vaccine and was upset that we gave all 3 vaccines and that her husband was out of it for a couple of days. Apologized to the wife and said there is no contraindication and these vaccines are indicated for the patient and he gave us permission to give these to him. The wife said the husband is fine now and she was wondering if 3 can be given at the same time. I told her yes all 3 can be given at the same time.
This spontaneous report as received from a medical assistant refers to a 4 years old patient. On 10-DEC-2012, the patient was vaccinated with an expired dose of M-M-R II, 0.5 ml, intramuscular (lot # 667962/1596Z, expiration date 18-NOV-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse reactions were noted. Additional information has been requested.
This spontaneous report as reported by a medical assistant refers to a 65 year old female patient with hypertension and high cholesterol. The patient was hospitalized and had a total knee replacement on June 2014. The patient's drug reaction/allergies included: codeine, monosodium glutamate (MSG), oxycodone, aspirin and thiopental sodium (manufacturer unknown)(MARRS 1407USA013369). On 11-JUN-2014, the patient was administered the first dose of PNEUMOVAX injection (dose, route, lot number and expiration date not reported) upon discharged from the hospital after a knee replacement. On 25-JUN-2014, the patient was seen in the office for her annual physical, inadvertently, the patient was administered a second dose of PNEUMOVAX 0.5 ml, intramuscular on left arm (lot number J008799 exp. 19-APR-2015) on that date because the office was not aware of the immunization at the hospital. Concomitant therapies included Lisinopril (manufacturer unknown), PRILOSEC and pravastatin sodium. On 26-JUN-2014, the patient called the office to report nausea, joint pain and stiffness, and pain with swelling at the injection site. She was evaluated in the office on 27-JUN-2014, and was advised to apply cool compresses to the injection site and to take unspecified anti-inflammatory medication. On 22-JUL-2014, the patient was seen in th office again due to persistent pain at the injection site. Unspecified blood work for inflammatory markers was drawn and results are pending. Outcome of nausea, joint pain and stiffness, and pain with swelling at the injection site was reported as not recovered at the time of the report. This is one of two reports from the same reporter. Additional information has been requested.
Pt has a PMH of CAD with stents, cardiac pacemaker, diabetes mellitus, and CKD stage III. He was found to be COVID positive post exposure to his son.
on 03/16 pt got vaccine, on 03/23 noticed slurred speech and an increase in blood pressure. Went to the ER  on 03/25- diagnosed with TIA
Pt got covid 19 vaccine 5/8/2021, within 24hrs had fatigue, anxiety, and no appetite, as time progressed FTT losing over 40lbs no matter how much she eats, insomnia and anxiety both increased as well since the vaccine. After complete work up labs, diagnostics cxr, pap smear cancer has been r/o and only new causative factor was the covid 19 vaccine. TX periactin and hydroxyzine along with high caloric intake and boost/ensure protein drinks daily and f/u bi weekly.
About a week or so after my first dose I started having muscle tightness and cramping in my legs and some ?electric? type radiating shots down my left leg starting up in my thigh down to my ankle.  I thought it was getting better but then a week or so after my second shot I began having worse leg problems (weakness, pains, pulsing, numbness, tingling).  It?s just gotten worse and I?m having tests done and seeing a neurologist.
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    No concomitant product was reported by reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication was reported by reporter.
Right thigh presented a 3" diameter erythema, tender, and indurated, this is where DTaP was given. TX Clindamycin.
5 days after second vaccination, I am experiencing allergic reactions on my face such as redness, itching, burning  and hives/welts. They occur daily and has been occurring for currently 3 days. 1st vaccine I had arm soreness, redness and swelling at injection site.
redness at injection site; General myalgia; low grade fever; left arm is swollen; Skin was hot to the touch on the left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th May 2021, the patient received the 1st dose of Shingrix (intramuscular). On 10th May 2021, 8 hrs after receiving Shingrix, the patient experienced injection site erythema, myalgia, low grade fever, swelling arm and feeling hot. On an unknown date, the outcome of the injection site erythema, myalgia, swelling arm and feeling hot were not recovered/not resolved and the outcome of the low grade fever was recovered/resolved.   The reporter considered the injection site erythema, myalgia, swelling arm and feeling hot to be related to Shingrix. It was unknown if the reporter considered the low grade fever to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. 8 hours after receiving 1st dose of Shingrix, the patient experienced general myalgia, redness at the injection site on her left arm, skin was hot to the touch on the left arm and the left arm was swollen and low grade fever which resolved after couple of days. The reporter stated that, she was was still experiencing these side effects. The Patient will contact her HCP if the symptoms did not resolve. The reporter did not consent to follow-up.
Client received an unnecessary Tdap vaccination today. RN did not see he had received a Td booster 02/25/2022 and was not due to receive another tetanus-containing vaccination today.