chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 21-Nov-2020.  This case involves a patient of an unknown demographics who had flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had flu (influenza), (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was given flu 30 years ago, since with out the flu shot had no problem never been sick once.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
redness at injection site; itchy; arm swelling; circle at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm swelling), INJECTION SITE REACTION (circle at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE PRURITUS (itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (contraindicated to take oral Benadryl because of her Glaucoma).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm swelling), INJECTION SITE REACTION (circle at injection site) and INJECTION SITE PRURITUS (itchy). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE SWELLING (arm swelling), INJECTION SITE REACTION (circle at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: no significant information.
Narrative:  FATIGUE STARTED TWO DAYS AFTER VACCINE Symptoms:  & FATIGUE Treatment:
Patient complained of lips swelling and tongue tingling/swelling. BP 162/109, HR 123, RR 24, O2 sat 100%, temp 97.4. Patient taken to ER. Pt reported history of anaphylaxis to polio vaccine and TB as child. In ER, stated she was feeling anxious and hyperventilating during that time.  Symptoms are improved.
Patient professed swelling of the arm and extreme redness.  Healthcare professional prescribed Clindamycin.
Pain in muscle, initially; redness and heat at injection site. Improved by 10/15; then pain in bone reported 10/18. 10/21 still reporting some pain/swelling. Has MD appt on 10/24. Has been alternating cold/hot compress every 15 min up to 12 times daily.
Fever of 99.6; Legs are red hot; Legs are red hot; This is the spontaneous report received from consumer (patient). A 80-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: unspecified), via an unspecified route of administration on an unspecified date in Apr2021 afternoon as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patients legs were red hot and had a fever of 99.6, tonight. The patient had no idea. He was just informed that come back in three weeks for the second shot. The patient did not receive any treatment to treat adverse event. No lab test was performed. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a 31 year old white male patient of unspecified ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: 21-SEP-2021) 1 total, dose was not reported administered at left arm on 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date, the patient had symptoms of covid after receiving the Janssen covid 19 vaccine (suspected covid-19 infection and suspected clinical vaccination failure) (all events in dose number series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from suspected covid-19 infection and the outcome of suspected clinical vaccination failure was not reported. On 08-NOV-2021, the patient received additional booster dose of non-company vaccine included: mrna 1273 (Moderna) (dose number in series 2) (form of admin and route of admin were not reported, batch number: 939f21a, expiry: unknown) 1 total, dose was not reported administered at left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with dose of mrna 1273 (dose number in series 2).  This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000213038.; Sender's Comments: V0 - 20220137153- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
affected all my muscles and they're still tight; affected all my tendons; headaches; Initial information received on 16-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a patient (unknown demographics) who had affected all muscles and they were still tight (muscle tightness), affected all tendons (tendon disorder) and headaches (headache) after receiving INFLUENZA VACCINE and COVID-19 VACCINE.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site and a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient affected all muscles and they were still tight (muscle tightness), affected all tendons (tendon disorder) and headaches (headache) (non-serious, unknown latency) following the administration of vaccines.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "I got the senior flu shot in Sept. Since I always get one I did not expect the reaction I got. I am auto-immune for the coronavirus disease (COVID) vaccines The flu shot affected all my muscles and tendons, and they were still tight today. I still get headaches too. No more vaccines for me."  It was not reported if the patient received a corrective treatment.  The patient did not recovered for the reported events.  There would be no information on the batch number for this case.
This case was reported by a healthcare professional and described the occurrence of adverse reaction to vaccine in an adult female subject who was vaccinated with Influenza vaccine (unspecified),  (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, injection site and batch number). At an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced adverse reaction to vaccine. At the time of reporting, the outcome of the event was unspecified.
Havrix instead of Hep B; new borm administrated with Havrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 5-day-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd February 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Havrix instead of Hepatitis B vaccine at the age of 5 days, which led to wrong vaccine administered and inappropriate age at vaccine administration. No adverse event was reported. The reporter consented to follow up. No lot number and expiration date provided.
This case was reported by a consumer and described the occurrence of cellulitis of upper arm in a 55-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Co-suspect vaccine included Tetanus vaccine and influenza virus vaccine (unspecified) given in November 2011. These vaccinations resulted in arm soreness which began on unknown dates in November 2011. The subject reported that her usual treatment with TYLENOL and Alcohol resolved the arm soreness following unspecified influenza virus vaccination. The outcome of arm soreness following the Tetanus vaccination was not specifically reported. No further details were provided regarding these events. Concurrent medical conditions included allergy to molds and dust allergy (unspecified). Concurrent medications included LORTAB and other unknown concurrent medications (not reported as the subject felt this information was private). On the night of 9 March 2012 the subject received a dose of BOOSTRIX in the left arm following a cut to the finger. This was an extra dose of vaccine administered as the subject received a Tetanus vaccination in November 2011. On 10 March 2012, 1 day after vaccination with BOOSTRIX, the subject noticed a hard knot on her arm (upper arm knot), swelling (swelling of upper arm), redness (upper arm red) and upper arm pain that were from her shoulder almost down to her elbow. She used pain medication (Pain medication unspecified) and Alcohol for relief. Two days later, on 12 March 2012, the swelling and redness were reported to be worse. The subject reported that she was at a health facility when a billing associate saw her arm and voiced concern. A "medical person" at the facility viewed the arm and informed the subject she had had a reaction to "the vaccination." The subject then went back to the facility where she received the BOOSTRIX vaccination and was prescribed CEPHALEXIN after being told that she had an infection in her arm called cellulitis (cellulitis of upper arm). The subject was encouraged to follow-up with her primary care physician and to discuss the potential ingredients in BOOSTRIX for possible reactions to future vaccines. No additional information is expected as the subject refused follow-up with her physician. She stated that, "that's her private information."
Information has been received from a physician concerning an 8 year old white female with a dairy allergy who on 5/31/95 was vaccinated with the 2nd dose of varicella virus vaccine live, SC, (lot 608579/0407B). There was no illness at the time of vaccination. The pt's mother notified the physician's office that on 12/19/01, the pt developed 40-50 pox on body. It was reported that the pt "caught pox at school". Additional information from the physician noted that the pt had fully recovered and there were no further assessments done. The pt did not have any laboratory tests and did not require an office visit. No further information is available.
Received vaccine 11/17/2020 in my left arm. Immediate pain upon injection. Soreness stiffness swelling burning sensation on first day along with pain in my left arm. The day after the vaccine and currently I have severe chronic pain in my left arm and shoulder. The pain never went away. I have very limited range of motion on my left arm. My doctor referred me for an X-ray. Results were rotator cuff injury and tendinitis. My doctor then referred me to see a physical therapist and an orthopedic surgeon. I am still in chronic pain.
Patient in for Moderna 0.25ml booster dose. Nurse drew up and gave 0.02ml dose.  Patient returned from waiting area and given full 0.25ml dose
About 6 hours after injection, site got very sore and I haven?t been able to lift left arm. Arm is very tender to the touch and warm. I am also very sleepy for past several hours, and my blood sugar has been doing a roller coaster of highs and lows, and there hasn?t been any abnormalities to my eating routine.
no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 09-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA005873: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Rash Narrative:  Developed well demarcated ovoid rash, ~1x3 inches encompassing injection site. Described as erythematous, non-pruritic. No associated hives, swelling, sloughing or other adverse events. Started about 4-5 days after vaccination and resolved around 3-5 days afterwards. Saw PCP, who did not recommend any therapies.
Pt received 4 immunizations on 7/13/06, Prevnar, Hib, MMR and Varicella. He brook out in dark petechial lesions over most of body on 7/25/06 thru today. Lesions especially  noticeable in face and chin.
pt recvd vax;mo reportes episodes of unusual crying lasting approx 4 hrs;saw er MD just as episode finishing,found no problems;
101 temp., headache, left side of body achy with chills and knot @ injection site. Has been taking Tylenol every 4hours for fever.
SERIOUSNESS CRITERIA: OTHER MEDICALLY SIGNIFICANT.  Initial report received on 03 June 2008 from a physician.  A patient (demographic not provided) who had no concurrent illnesses, and who has past medical history of seasonal allergies and allergy to penicillin, had received on an Unknown date a first intramuscular injection of MENACTRA (Lot # U2613AA).  The site of administration was not provided.  Approximately 45 minutes post-vaccination, the patient developed chest pain and shortness of breath.  The patient was evaluated in the emergency room where wheezing was heard.  The patient was treated with BENADRYL, prednisone and one nebulizer treatment.  At the time of this report, the patient had recovered.
RESIDENT BECAME TACHYPNEA, SHALLOW BREATHING AND NON-RESPONSIVE PROUNCED DECEASED PER RN AS ORDERED PER MD
My son died within days after the second dose of the vaccine / autopsy remarks No known cause was found; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the parent.  A 21-year-old male patient received the second dose of bnt162b2 (BNT162B2) via an unspecified route of administration, administered in the left arm, on 18Feb2021 (batch/lot number: EN5318), at the age of 21 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient had no relevant medical history. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, via an unspecified route of administration, administered in the left arm (batch/lot number: E13259) as DOSE 1, SINGLE), administration date: 28Jan2021, for COVID-19 immunization. The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. following information was reported: DEATH (death) with onset 25Feb2021, outcome "fatal" described as "My son died within days after the second dose of the vaccine / autopsy remarks No known cause was found." The patient underwent the following laboratory tests and procedures: Nasal swab (SARS-CoV-2 test): negative. The patient's date of death was 25Feb2021. The autopsy revealed "no known cause was found" (death).; Autopsy-determined Cause(s) of Death: No known cause was found
Discomfort, increased discomfort with movement.  MD care and physical therapy; analgesics.
Shortly after getting his own shot, and immediately after watching his mom get her shot, child fainted. Lost consciousness for a few seconds, with eyes rolling back in head. Did not fall. Mother held him. Pale and a bit out of it when regained consciousness.  Called EMS for eval. BP and pulse WNL. O2 sat not available due to child refusing to allow on finger. EMT advised mother to contact doctor about incident. Mother declined further treatment. Waited in clinic for another 30 minutes. Child felt better. Mother felt comfortable leaving with child.
Patient was given first COVID vaccine on 07/13/2022 and received Pfizer. However, in the computer, it was documented as Moderna.  Patient was then booked for his next COVID vaccine in a Moderna Clinic and received Moderna. Patients COVID card stated he received Pfizer, which prompted us to investigate which vaccine was given initially. Patient was scheduled in 07/13/2022 during our clinic where Pfizer was the only vaccine available.  Parents were informed that patient received mix-matched primary series and that a third dose is indicated. Parents reported NO side effects or adverse reactions or events because of this error.
Patient received vaccine 8/16 in AM. That night (she reported) she was awakened w/ a HA. She developed a sore throat, cough, and couldn't "move her neck". For 2 full days she could not eat. Sx cleared Sunday 8/21/11 & she reported them to me 8/22/11.
Began experiencing "white noise" static-like tinnitus sound in my left ear 11/29/21. A few weeks later in mid December, this progressed into high pitched ringing sound tinnitus, with occasional buzzing and pulsatile sounds. Tinnitus is present all times of day at night. Late December, began noticing mild tinnitus in right ear as well. Tinnitus was debilitating to the point of depression.  Dec 17 saw an audiologist for testing; results showed moderate conductive hearing loss in left ear. I never had any type of hearing issues before November. Right ear normal hearing. Referred to an ENT who ruled out any fluid or issues with external ear structures.  January 2022 had a temporal CT scan which showed questionable early fenestral otosclerosis on left side.  Late January began use of a hearing aid on left ear.  Tinnitus may be due to otosclerosis which could have been developing prior to having the Pfizer vaccine. However, for the sake of research wanted to report it anyway. I have no family history of otosclerosis, it was not preceded by any illness or pregnancy, and seemed to arise very suddenly, which has been a confusing experience for me.  I continue to get tinnitus ringing 24/7 in both ears, L>R. Hearing in right ear remains normal.  I am now being followed by an audiologist, ENT, and Otologist.   This was my first booster dose. I previously got initial 2-dose series of Moderna in Jan & Feb 2021 without issues.
Narrative: 86 yo male with history of COPD (on 3L home O2), severe pulmonary HTN (type II & III),  HFpEF EF 62%, NYHA Class IV, DM2, HTN, HLD, OSA on home CPAP presented with fever, chills, dyspnea for 5 days. Five days prior to admission, the patient began noticing progressively worsening shortness of breath with associated fever and chills and myalgias. Before the fever, he took two Bumex 2mg PO as he thought he was having a heart failure exacerbation. However, he felt as though he did not improve with diuresis and continued to have progressively worsening SOB. In the ED, patient was afebrile HDS with somewhat soft pressures in 90s systolic up to 113/70s. COVID + despite full vaccination with Pfizer vaccine 1/25/21 and 2/17/2021. Labs were significant for Trop 0.26 which subsequently downtrended to 0.14, BNP 280, Cr 1.1, mag 1.6. WBC 3.85, plt 130s. CXR with mild interstitial pulmonary edema. EKG with NSR, RBBB, LAD, PVCs. The patient was admitted 8/7/21. Procalcitonin within normal limits, repeat CXR notable for pulmonary edema, no concern for superimposed bacterial PNA. Started on standard treatment for COVID: received 10 day course of dexamethasone 6mg daily, 5 day course remdesivir. Per latest evidence, covid patients benefit from full anticoagulation until off O2 or at baseline O2 requirements. Patient started on enoxaparin 40mg SQ BID until back to baseline O2 (3 days), then increased to 70mg SQ BID until hospital discharge. Continued Albuterol MDI q4h prn, Symbicort MDI daily, Tiotropium MDI daily (2.5mcg). D Dimer downtrended to 0.43 (from 0.93) and CRP to 2.9 (from 4.01). At discharge, back to baseline oxygen requirements (on 3L at home), stable for discharge home 8/16/2021.