chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed / serious case; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles (serious criteria other: serious per reporter). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingrix and developed another serious case in the last two weeks. Patient mentioned that because of that patient did not do vaccines, patient also stated that would not getting the Covid vaccine. This case linked with US2021AMR041410, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR041410:same reporter
Recieved DTaP-IPV, MMRV and HepA on 8/12/20 Developed large local reaction on Right arm at site of MMRV on 8/13/20. Treated Benadryl and Prednisolone. Developed lip swelling on 8/15/20 and seen in ER, treated with Benadryl. Lip swelling resolved. Developed varicella form rash on 8/16/20
I experienced a kind of mania after the shot. I am usually even ? it was not a brain fog. It was like a hyper, anxious, mania where I had trouble relaxing for about 2 days,  and after about 3 days I mentally felt normal and I could hear my normal cadence in my voice and knew that whatever I had been feeling those past days was strange and hyper.
w/in 3hrs of vax pt noted onset of blurred vision;p/ sx persisted,pt was seen in local ER,referred to ophthalmologist following day dx optic neuritis,resolving @ the time of specialist's exam;
pt recv vax & devel an inj site rxn characterized by a 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax lot#4978296;
1/6/21 Pt received vaccine and complained of difficulty swallowing  and rapid heart rate.  Pt received methylprednisolone 125mg IVP, diphenhydramine 25mg IVP, & famotidine 20mg IVP.  Pt reported improvement and was discharged.  Sent home on diphenhydramine and oral prednisone.  1/7/21 Pt unable to swallow her own secretions and experienced eyelid swelling.  Pt vomitted. Pt received epinephrine and Benadryl X 1 dose each.  Pt then transported to hospital via ambulance.  Reason for admission - acute respiratory failure secondary to anaphylactic reaction.  Decision was made to emergently intubate the patient for airway protection despite aggressive intervention.  Pt successfully extubated 1/8/21.  Plan to discharge home  and start Medrol Dose Pack 1/9/21.
No reported or seen adverse reactions; The patient received VARIVAX that was exposed from  -10°C to 8°C for 528 hours; This spontaneous report was received from a nurse prescriber and  refers to a 25 year old patient of unknow gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.        On 12-MAY-2021, the nurse received a new shipment of varicella virus vaccine live (Oka/Merck)(VARIVAX) which was accidently placed in the refrigerator instead of the freezer and not discovered until 02-JUN-2021. Vaccines were back in recommended temperature range at this time. Temperature evaluation was done by the agent and vaccines were supported for use. On the same date 02-JUN-2021, one varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032320, expiration date 22-SEP-2022, 0.5 milliliter, subcutaneously for prophylaxis was given to the patient. The vaccine was exposed from -10 to 8 Celsius degrees (°C) (3.7°C) for 528 hours. There was no previous temperature excursion. The call was made due to "data logger".  The reported, also mentioned that the patient waited 15 minutes prior to leaving office and had no reported or seen adverse reactions.
BUD 04/07/2022 vaccine given 04/08/2022.Pfizer advised actual BUD 04/09/2022. Advised by Pfizer within use date and no further action required .Patient advised.
Kinrix (DTAP-IPV) age range is 4-6 yrs old. Pt received vaccine at 2 yrs old. No adverse reaction was reported.
General malaise at beginning , mixed reports from doctors, By end of week one was admitted to ICU for heart failure, blood clotting  following remainder of organs were  failing. First admitted to hospital, after 6 days flown to another hospital, were he is still
Two days later came back with redness and soreness about 4 inches behind on flu shot site.
THE PATIENT EXPERIENCE SIGNIFICANT LOCAL PAIN AT THE INJECTION SITE. LATER IN THE EVENING, SHE COMPLAINED OF CHILLS, FEVER, AND GENERAL MALAISE. THE SYMPTOMS ABATED BY THE NEXT DAY.
Throat closing, breathing heavy, clammy, shaky, pale "swelling - edema hands" feet, nauseated, "doom" feeling HR 74 pale, RR 26 thready, BENADRYL 25 mg at 10:05, Epipen 0.3 mg given.
This spontaneous report as received from a Nurse practitioner refers to a 60 year old male patient with paronychia and no known drug allergies. On 09-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J013135, expiration date 17-JAN-2015) (dose and route of administration were not reported) in the arm. Concomitant therapies included KEFLEX and LOVAZA. On 10-APR-2014, the patient experienced indurated area around the injection site and fever. Nurse practitioner stated that the fever had resolved on an unspecified date however "there was still a little bit of induration on the arm". The patient was told to use warm soaks on the indurated area around injection site. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Diagnosed: Cellulitis on R arm per Dr at Urgent Care Treatment: antibiotic (pills) Symptoms: Right arm sore, pain, swelling, redness, hot to the touch, itchiness, fever (101 degree), chills, body aches - Redness on right arm started happening 6-8 hours after vaccination  - Redness on right arm started spreading on day 2 after vaccination  - Symptoms started 6 hours after injections   Outcomes: went to Urgent  care on 12/17/22 at around 9:00 Pm.   Progress: currently on day 3 of antibiotic. Symptoms persists of mild pain and itchiness on R arm for now. Redness and swelling on R arm has reduced. No fever, chills, or body aches.
achy and fatigue; achy and fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9264) at the age of 66 years for COVID-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medications included: LISINOPRIL taken for blood pressure increased. Vaccination history included: TETANUS VACCINE (Manufacturer: not provided, Lot Number: unknown, Route, Anatomical Location: left arm, No. of Previous Doses: not provided), administration date: 19May2022, for Immunisation. The following information was reported: PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "achy and fatigue". Therapeutic measures were taken as a result of pain.  Additional information: the patient had reactions to three out of the four Covid vaccines. After the first dose, the patient she was achy, and had fatigue; therefore, she took a nap.
This case was reported by a pharmacist and described the occurrence of muscle weakness in a 78-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included the subject's normal regimen of medications (unspecified). The subject had experienced some ongoing similar events which he considered to be related to statin use. On 27 September 2011 the subject received a dose of FLULAVAL (.5 ml, unknown route, right deltoid). On an unspecified date in 2011, less than one month after vaccination with FLULAVAL, the subject experienced muscle weakness and difficulty walking up stairs. The pharmacist considered the events were disabling. At the time of reporting the events were unresolved. The pharmacist considered the events were unrelated to vaccination with FLULAVAL. Follow-up information indicated that events of muscle weakness and difficulty walking up the stairs were unresolved and considered to be unrelated to FLULAVAL vaccine. It was additionally reported that the subject has had problems with muscle weakness in the past.
onset fever 15FEB97 red bumps on abd 5 vesicles 16FEB97, fever of 105.4;addtl red bumps on face, hands & feet 17FEB97 w/fever during noc of 104, fever in AM 103, emesis x 1 during noc;responding to APAP;tepid baths, & talking liquids;
Patient complained of facial numbness and tingling, sweating but no SOB. BP 130/72; O2 Sat 98%; HR 112. She got J&J vaccine. The ambulance was called and they came. Care was transferred to the paramedic but the patient refused to go to the ER.
Erythema Multiforme Major on all limbs- This was present after first dose; however, became worse after the second dose. Was sent to Urgent Care immediately due to increased coughing and fear of anaphylaxis reaction.  Was given IM Solumedrol, Epi Pen, and PO steriod taper
Dosing error. 16 year old given moderna vaccine when approved age is 18 years and older  No adverse effects. Reporting error to vaers per EUA criteria.
she had "normal side effects:; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (she had "normal side effects:) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she had "normal side effects:). At the time of the report, IMMUNISATION REACTION (she had "normal side effects:) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-578759, MOD-2022-578783 (Patient Link).
Pt vaccinated with TD 2-3 min later fainted-unconcious 30 sec p80, BP120/80. O2 15 min due to slow recovery. diaphoretic pale rx; had not eaten all day. Offered lemonade - vomited 2 mins later still not feeling well refused ER treatment.
Started with fever 4/17, diarrhea 4/18, had some vomiting 4/20, no one else at home sick. Diarrhea continues as of 4/23, parents had been using Pedialyte and dilute apple juice.
Itching at various areas from waist to head. Used benadryl. To relieve itching.
Starting the following it started with a really big hive that looked like a welt on my right arm, it was about half the size of my arm, Day 8 I left work early because I didnt feel right, My throat was closing up. Was treated at the ER for anaphylaxis. It persisted for a few days, was sent home with a epi-pens, I had to take meds for about a week,
31JUL92 pt erythematous macule @ site of vax w/fine macules to chest, abdo, neck & legs;
Headache, Fever, HYPERtension, chills, muscle and body aches; persistant hypertension Narrative:  employee states: received booster on 12/8/21 later that day experienced chills, low grade fever, headache, muscle and body aches, some fatigue and nausea. Continued to feel bad over the weekend and went to an Urgent Care on 12/13/21. Blood pressure was elevated. no history of hypertension. Blood pressure checked 12/16/21 160/110, left work and seen by private MD and placed on low dose BP medication. Again seen on 12/21/21 for continued elevated blood pressure.
Initial dizziness,  watched in hospital for 30 mins, discharged home in stable condition. Over subsequent 48hrs developed chills, sob, lightheadedness, palpitations.  Pt with incomplete control of SLE w/ occasional myocarditis. Has had SLE flare w/in past 6 months. Now w/ sx concerning for recurrent myocarditis & sick sinus syndrome.     Site  Left Deltoid   Route  Intramuscular    Dose  30   Unit  mcg    Expiration Date  FEB 28, 2022    Manufacturer  Pfizer Inc.      Covid-19 (Pfizer)   Published  AUG 23, 2021    Given  SEP 27, 2021
Pharmacy Immunization report showed an immunization error. Patient's father filled up a self attestation form for her daughter to receive the Pfizer booster.  Reviewed and found out that the patient is years old, non immunocompromised and not eligible for a Pfizer booster at this time.
Dizzy all day; Body rash on full torso and back; Headache; Achy; Sore arm; Fatigue for two days; A spontaneous report  was received from a consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, achy /pain, sore arm /pain in extremity, fatigue for two days /fatigue, body on full torso /rash and back, dizzy all day /dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, approximately 1 day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) headache, achy, sore arm, fatigue for two days. On 16 Feb 2021, the patient experienced the event(s) body on full torso and back. On 21 Feb 2021, the patient experienced the event(s) dizzy all day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fatigue for two days was resolved on 15 Feb 2021. The outcome of event(s), body on full torso and back was resolved on18 Feb 2021. The outcome of event(s), dizzy all day was resolved on 21 Feb 2021 . The outcome of event(s), headache, achy, sore arm was unknown.
On Wednesday, October 27, 2021 client came to vaccination POD for a Covid-19 Pfizer booster dose. Client received her first and second dose of Sinovac on April 16, 2021 and April 26, 2021 respectively. During assessment questions, client denied any allergic reaction to previous vaccines and no chronic medical history. Submitted medical consult via text to medical team. Per Vaccine Operations Lead, Doctor approved for client to receive Pfizer booster dose with 30 minute observation. Client received her Covid-19 Pfizer (LOT #: FF8839) at approximately 9:45 AM in her left arm. Client experienced no adverse reaction while waiting in Observation Area and left vaccination site with a steady gait at approximately 10:15 AM. VAERS completed on 10/27/21.
Pt C/O localized pain at injection site in PM after immun. At time of eval in ED at 2:30 on 10/15/2005. Pt had 10cm red, swollen, tender area right deltoid, afebrile, reported subjective fever at home.
Hospitalization  Patient was admitted to hospital after suffering with high fever and testing positive for COVID-19. In addition to pre-existing medical conditions patient has thyroid problems, enlarged prostate, a prosthetic eye and chews tobacco
dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.            No concomitant medication was provided  No treatment medication was provided  patient want to knowhow long does dizziness last??? It's been over a month from patient  2nd shot.
Received vaccine on 10/17/02. Soreness and redness at site was noted on 10/18/02. Persistent and worsening discomfort of whole arm over neck for a couple of months. MD evaluation and Rx'd antibiotic med. Problem continued. Orthopedic evaluation on 1/21/03.
Erythema 48hrs after immunization no induration; no other findings. Described as painful yesterday, itchy today.
Arm pain at injection site has not gone away several months after injection.  Red rash and swelling went away several days after injection, but pain continues.  Feels like a bruise from being punched in the arm.
Severe chills and shaking for about 40 minutes. Added extra layers of clothing and blankets but took a while to warm up.  Vomited once about an hour after the chills. Felt OK after getting everything out. Headache was treated by Tylenol. Severe fatigue which still persists about 20 hours later.
cold symptoms; severe muscle pain and joint pain; severe muscle and joint pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold symptoms), MYALGIA (severe muscle pain and joint pain), ARTHRALGIA (severe muscle and joint pain) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold symptoms), MYALGIA (severe muscle pain and joint pain), ARTHRALGIA (severe muscle and joint pain) and CHILLS (chills). At the time of the report, NASOPHARYNGITIS (cold symptoms), MYALGIA (severe muscle pain and joint pain), ARTHRALGIA (severe muscle and joint pain) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a 58-year-old female patient who received SHINGRIX) (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. On 19th January 2019, the patient received SHINGRIX (intramuscular). On 24th January 2019, 5 days after receiving SHINGRIX, the patient experienced injection site blisters and injection site erythema. On an unknown date, the outcome of the injection site blisters and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site blisters and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient has developed a blister and redness at the injection site after getting SHINGRIX.
C/O throat swelling  Gave IM benadryl at 3:05 O2 Sat 99%, BP 142/82, HR 51, RR: 18 Drank water and continued c/o throat swelling Gave EpiPen at 3:13  O2 Sat 98%, BP 160/108, HR 51, RR: 22 went to Hospital at 4:13  O2 Sat 100%, BP 182/99, HR 84, RR: 16
Throw up; Nausea/"feeling like I wanted to throw up"; Body ache similarly to the flu; Feels like I am sleeping more; Chills; Fever (102 degrees); Fatigue set in; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Body ache similarly to the flu), SOMNOLENCE (Feels like I am sleeping more), NAUSEA (Nausea/"feeling like I wanted to throw up"), VOMITING (Throw up) and CHILLS (Chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LIRAGLUTIDE (VICTOZA), PHENTERMINE, ROSUVASTATIN, FAMOTIDINE, IBUPROFEN (DUEXIS) and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Body ache similarly to the flu), SOMNOLENCE (Feels like I am sleeping more), CHILLS (Chills), PYREXIA (Fever (102 degrees)) and FATIGUE (Fatigue set in). On an unknown date, the patient experienced NAUSEA (Nausea/"feeling like I wanted to throw up") and VOMITING (Throw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. On 03-Apr-2021, INFLUENZA LIKE ILLNESS (Body ache similarly to the flu) had resolved. On 04-Apr-2021, PYREXIA (Fever (102 degrees)) had resolved. At the time of the report, SOMNOLENCE (Feels like I am sleeping more), NAUSEA (Nausea/"feeling like I wanted to throw up"), VOMITING (Throw up) and CHILLS (Chills) outcome was unknown and FATIGUE (Fatigue set in) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever went up to 102 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: No new information was received.
Painful rash developed on body, 4/22/19. Patient saw dermatologist 4/24 diagnosis as shingles, issued valacyclovir and tramadol.
24 hours after first shot, expected side effects - chills, dizziness, fatigue, arm soreness, headache, vision changes, light sensitivity. These lasted aprx 2-3 days.  Also starting 24 hours after injection, hot/raised welp aprx 3-4 inches in diameter at injection site (registering 101 - 102 with home thermometer). This lasted  a full week. Subsided for a day, and then came back to same size and heat. Contacted a doctor. They prescribed cefalexyn for diagnosed cellulitis. Hives on face and neck aprx 6 hours after first pill of cefalexyn. Have previously taken penicillin based antibiotics (amoxicillin) with no problems. Second teletherapy doctor prescribed an antihistamine and an asthma medicine (but I never filled). Hives cleared in 12 hours. Arm welp began receding slowly after another 2-3 days. Completely gone after another week (total of just over 2 weeks from initial injection). PCP recommended filling a prescription for an epi pen before getting the second dose of the moderna vaccine. I never got the second dose.
This has not been confirmed it is related to the vaccine. Vaccination was given 1/6. On 1/12, 6 days after receiving the first dose of the Pfizer (PEDS) dose, patient developed a rash/ hives on back. On 1/13, the rash/hives spread to stomach, and worsened on the back. They subsided with Zyrtec. On 1/14, the rash/hives spread all over the body-face, neck, arms, legs, trunk, etc. Patient went to the local medical Center and saw Dr. where she was examined and given a PCR test, which came back negative. Treatment is Zyrtec and Benadryl. Rash took about a week to clear, but has subsided.