chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Covid arm" symptoms. Erythema, pruiritus around the injection site measuring about 4in long and 2in wide. Rash started on day 10 post vaccine. Rash has gotten bigger since and mild weakness and mild cold sensation is felt on deltoid muscle.
2 days later I had a dead arm, about 10 days later a rash and a severe nerve pain from theupper  arm all the way down to the forearm, like a sciatica feeling, very painful and keeps me up at night.
pt recv vax 10MAR97 in L;Monday afternoon site appeared red & swollen starting from size of fifty cent piece then to size of baseball-encouraged pt to see MD also pt feb w/t101;
feeling like going to pass out, Consumer/Patient had a reaction to GARDASIL 9/felt dizzy while at school for the whole week following GARDASIL 9 administration; confirmed GARDASIL 9 injection being really painful; Poor quality vaccine administered; Suspected product quality issue; This spontaneous report as received from a consumer referring to 10-year-old female patient. The patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.    On 22-FEB-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot # 1691180 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 15-NOV-2022; strength, dose, route were not reported) for prophylaxis by a health professional at physician's office.   The patient confirmed HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection was being really painful (vaccination site pain). The patient waited in physician's office for 5 minutes before leaving, the patient had a reaction to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), she felt like going to pass out. The patient also felt dizzy while at school for the whole week following HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administration. The reporter stated this was the first purchase of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) per prescription from the physician's required. One quantity was involved in the product's packaging and the product was not available for return back to manufacturer. The reporter asserted how affected HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) must be a bad batch and requested report once results were available regarding bad batch (poor quality vaccine administered and suspected product quality issue). The reporter also mentioned how attorneys required manufacturer to notify of the affected HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) batch status and had sent to Legal. The outcome was reported as not recovered. The causality between vaccination site pain and the suspect was not provided.  This is one of two cases received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001066:
High dose Flu vaccine for age 65 and older, given to 49 yr old. Called pt to inquire of condition - voice mailbox not set up.
On 4/27/01 mother called with information on child reaction, child slept all afternoon of vaccine (2/28/01) had rapid heart rate, Temperature of 104 for approximately 30 minutes, Tylenol given and fever reduced child ok next day after vaccine given. Mother said she had written note from Dr that child should not receive any more Prevnar.
The pt experienced swelling, redness. No fever was noted. At an evaluation the following day, the right thigh was warm, erythematous with marked swelling of entire right thigh. Parent applied compresses with com improvement. The pt took Benadryl.
Fever, well over 101 Chills Body aches Headache Swelling in neck/chin Stomach issues
Runny nose; fever of 100 degrees; Chills; sore throat; congestion; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller mentioned after taking the first shot, she had a runny nose, fever of 100 degrees, chills, congestion, sore throat. Wanting to know if it's possible that she was tested positive before taking the vaccine. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Patient reported feeling unwell, dizzy, dry heaving.  Patient was watched monitored and charge RN was notified. No additional intervention.
developed a rash at the injection site; got a little bit blown up; It was 2 inches square; it was all red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (developed a rash at the injection site) and VACCINATION SITE SWELLING (got a little bit blown up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medial history reported.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE RASH (developed a rash at the injection site) and VACCINATION SITE SWELLING (got a little bit blown up). At the time of the report, VACCINATION SITE RASH (developed a rash at the injection site) and VACCINATION SITE SWELLING (got a little bit blown up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication reported.   This case was linked to MOD-2021-031140 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: follow up was received on 22-apr-2021 No new information updated
Inadvertently received a dose of proquad that had expired; Inadvertently received a dose of proquad that had expired; This spontaneous report was received from medical assistant refers to an 8-year-old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy of the patient included sterile diluent (MERCK STERILE DILUENT). On 03-FEB-2020, the patient was inadvertently vaccinated with third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot# R020814 and expiry date 16-JAN-2020 (strength, dose, route were not reported) for prophylaxis (wrong product administered and expired product administered). No symptoms was reported. The reporter stated that the patient received first two doses of the vaccines at unspecified times from country. No product quality complaint was reported. The outcome of wrong product administered and expired product administered was unknown.
On 12/28/2021 I had sever abdominal cramping and bleeding like a sudden menstrual cycle. I haven't had a period in years. I went to the ER and the doctor diagnosed it as dysfunctional uterine bleeding. I was there for 6 hours. They did a urinalysis, ultrasound, a uterine and vaginal exam, CT scan and blood work. They prescribed me cephalexin for 7 days for a bladder infection they found during the urinalysis.  I saw my regular doctor the next day who gave me a referral to an OBGYN. I am also scheduled for a uterine biopsy on 01/05/2022. I still have cramping when I am on my feet for more than 30 minutes. I am not actively bleeding but am discharging bloody residue.
Mild injection site reaction with erythema and swelling/possible blistering. Swelling size just smaller than a baseball. No reaction was seen after first injection.
Patient fainted. Kept talking to patient and he eventually woke up after about 1 minute. Patient never stopped breathing.Patient stated that he was going to faint as soon as vaccine was given.
Left Arm sore ; Rising bumps on upper left Arm, Rash on upper left Arm, Extreme Itching and burning at times.
the reporter stated that several pt have devel inj site rxn consisting of large, red, raised, warm areas & tenderness following vax;
Was just brought to our attention (4/24/23) by database that this child was given an adult dose of Pfizer Covid vaccine back on 09/11/2021. There was no report from parent at that time of any adverse s/s of the dose. Parent was notified of the error today (4/24/23). Dr was also notified of the error today (4/24/23).
Child had a likely partial syncope within 5 min from vaccine administration, stable pulse and breathing during observation but feeling dizzy, very sleepy, reporting headache, feels mildly sweaty, was pale. Paramedics called and arrived approx 15min later, reported stable BP and released child to mother with advice to get him check by ER or PCP. Child walked away on his own.
Expired vaccine was stored in the refrigerator; No adverse event; patient received an expired dose as a 5th dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose as a 5th dose), PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 064a22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose as a 5th dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose as a 5th dose), PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received an expired dose as a 5th dose) and PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator).    Concomitant medications details were not reported by the reporter.  Vial size was reported as 2.5 ml. Vial was initially stored in refrigerator on 01-DEC-2022. Vial did not undergo any temperature excursion.  Treatment details were not reported by the reporter.
Woke up in early AM 2/16/11 - shivering and left arm hurt. At 3:30PM - can't raise arm overhead, tender to touch, red & warm site about size 50 cent piece. Temp 101.6, headache. No appetite. Nephrologist referred her to E.R., blood cultures x2 done, advised to take TYLENOL for temp. Referred to ER if increased temp. On 2/17 - reports malaise, severe headache - over eyes, (L) arm still sore. Temp 99.8 with TYLENOL.
I have inflammatory arthritis and went on prednisone for a flare up, with the plan to get on Humira.  I had a blood test and found out I had tuberculosis so I got on Isonaizid and promethazine for and priftin and got on Humira after and had another flare up.  The skin is falling off my penis and I've got urethritis.  My doctor said there is a chance it was the vaccine and nothing else except prednisone has worked.
Information has been received from a female pharmacist of unknown age referring to herself. The patient was vaccinated with her first dose, second dose and third dose of RECOMBIVAX HB (first dose: lot# K018796, expire date: October 2016; second and third dose: lot # L000717, expire date: 15-APR-2017, dose and route were unknown) on 07-MAY-2015, 16-JUN-2015 and 17-JUL-2015 (inappropriate schedule of drug administration), respectively. This was outside the recommendations per the RECOMBIVAX HB prescribing information. No adverse effects were reported. Additional information has been requested.
6/21/2023 - 6/24/2023 (3 days) evaluation of left hip pain post mechanical fall at the ALF patient tested positive on a transfer screen, and then on the same day tested negative on a transfer screen. no treatment was required. EN6198 3/1/2021 ER8727 3/22/2021 33030BD 12/8/2021
He got sick on 11/08/22. We took him to the doctor was diagnosed with an ear infection and was prescribed Amoxicillin. He still had the ear infection on 11/22/22, so we went back to the doctor, and he was also diagnosed with hands foot and mouth as well. He was prescribed Amoxicillin-Pot Clavulanate. He got better, then we went back on 12/2/23, because he was having ear trouble again and was having diarrhea. Due to being dehydrated, we stopped taking Amoxicillin until his stomach got better and then we started Amoxicillin again. This lasted until 12/31/22.
No additional AE reported; PEDVAXHIB and ROTATEQ were administered after a temperature excursion; This spontaneous report has been received from a vaccine provider, concerning a 5-month-old female patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 01-DEC-2022, doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number W006596 has been verified to be valid for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), expiration date reported and confirmed as 11-OCT-2024); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1892784 has been verified to be valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and confirmed as 03-DEC-2023 [lot number also reported as "18927884" which is not valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ)]), suffered a temperature excursion of 47.9 degrees Fahrenheit (F) for 47 minutes as a result of a reading from a Data Logger. It was reported that there was no any previous temperature excursion.   On 27-DEC-2022, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 2nd dose (lot number W006596, expiration date 11-OCT-2024), administered intramuscularly at her left thigh; and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2nd dose, (lot number 1892784, expiration date 03-DEC-2023), administered orally; both vaccines were administered as prophylaxis (Product storage error).  No additional adverse event was reported.
Hard lump by lower biceps reported by patient. Pt obtaining MRI per pt 10/22/15.
Pt noted right eye to be a "little pink".  Went to station and was prescribed VIROPTIC and ILOTYCIN drops.  01/26/2009 the right eye was worse (swollen eye lid, discharge (greenish), pustules on the eye lid--seen by optometry- Treated with VIGAMOX QUID; VIROPTIC Q2H;  ACYCLOVIR PO 5 times/day;  Seen by Ophthalmology on 1/28/2009-culture/PCR obtained.  Examined by optometry on 1/20/09 and ophthamolgy 2/5/09.  Symptoms: Red eyes, Pain, Lesions, Vesicle.  3/3/09 MR received for optometry visit 1/30/09 with dx: Vaccinia OD from localized vaccination.  Smallpox vaccination reaction.  Pt presented with 1 wk hx of eye pain, redness, discharge, itching and photophobia after spreading from recent smallpox vax. PE (+) for crusting, scabbing pustules along the lash margin. TX with viroptic.  Reports some R ear pain as well.
severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bilaterally; This is a spontaneous report from a contactable other hcp. A 81-years-old female patient (not pregnant) received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: sulfa. No covid prior vaccination. No covid tested post vaccination. The patient's concomitant medications were not reported. The patient experienced severe back and leg pain and paresthesias bilaterally on 05Jan2021. The events resulted in hospitalization. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a drug-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events severe back and leg pain and paresthesias cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
fever, chills, body aches and headache for 24 hours.  Sore arm and underarm
Pt c/o itchy shoulders, chest tightness and pain. Po Zyrtec given per Dr's orders. VS: BP 163/96, pulse 93, RR  22, 100% o2 RA. Pt dc'd home, advised to f/u with PCP if symptoms worsens.
Information has been received from a physician concerning an 18 year old male patient with acne and no drug allergy or reaction who on 16-MAY-2011 was vaccinated with the first dose of GARDASIL (Lot number 668554/0306AA; Expired date: 10-MAY-2013) and a dose of VAQTA (Lot number: 670377/0126AA; Expired date: 07-DEC-2013, dose in series unknown). On 22-JUL-2011, the patient received the second dose of GARDASIL (Lot number 668262/0841AA; Expired date: 18-APR-2013). Concomitant therapy included SEPTRA. Follow up phone call from the physician was received. The physician reported that the patient had no medical history. The last time he saw the patient was on 22-JUL-2011, when the patient received his second dose of GARDASIL. The physician also reported that there was no indication from the patient that he was troubled. On 27-JUL-2011 the patient committed suicide. The cause of death was asphyxiation by hanging. The death report that the physician received was that the patient had a normal examination. The Toxic screen indicated that there were no medications involved in the patient's death. The patient's mother had asked the physician if GARDASIL could have caused her son to commit suicide. The physician reported to the patient's mother that he did not feel that GARDASIL was the cause of her son's suicide. The physician stated that he was not aware of any reported deaths by suicide that were related to GARDASIL. Lot checks have been initiated for 668554/0306AA, 668262/0841AA for GARDASIL and 670377/0126AA for VAQTA. Additional information has been requested.
Information has been received from a consumer concerning a 13 month old male with no medical history and with pharyngitis at the time of vaccination who on 06-MAY-2004 at 11:00 was vaccinated in the left anterior thigh with a first dose of MMR II (lot # 645907/0511N). Concomitant vaccine therapy given in the right anterior thigh included a first dose of Varivax (lot #646235/0828N), a fourth dose of PedvaxHIB (lot# 647165/0915N), and a fourth dose of DTaP (lot #599B9). in the AM of 15-MAY-2004 the pt experienced a fever to 101, cough, running nose, conjunctivitis followed by a diffuse rash starting on cheeks, spreading to trunk and then to extremities. The pt was diagnosed with an "allergic reaction" in the ER. On 21-MAY-2004 (also reported as 18-MAY-2004) the pt recovered. It was noted that the pt had no adverse events following prior vaccinations. No further information is expected.
I have been suffering from shortness of breath with a feeling like my heart is skipping a beat, which is progressing to a tightness in my upper chest & some coughing, particularly at night.  I contacted my primary care Dr.; however, he told me it wasn't a side effect of the vaccine and that those should only last about 3 days anyway, and mine has not, so I wasn't seen, but I didn't not have these symptoms prior to the vaccine.
Office visit on 2/26/01, right deltoid red and warm to touch and painful. Seen by doctor and placed on Keflex 500mg X 10 days. Dx'd with allergic reaction secondary to TD vaccine.
Patient lost consciousness for under one minute. When he lost consciousness his blood pressure dropped and he fell forward (didn't hit the floor). He was given water to bring up his blood pressure and cool rags to cool him off.