chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever (?Tmax) beginning 3 days p/vax fluctuating assoc w/irritability & dec appetite;devel blotchy, pink, macular exanthem behind ears;mild cough & diarrhea;
Patient experienced nausea and vomiting the morning after Moderna vaccine.  She also stated that her skin was red, swollen, and itchy.  Lastly, she stated that she was experiencing tingling in her head.  She had not yet contacted her physician.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in heel in a female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. In January 2019, 14 days after receiving SHINGRIX, the patient experienced pain in heel. On an unknown date, the outcome of the pain in heel was not recovered/not resolved. It was unknown if the reporter considered the pain in heel to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. On around 21st December 2018, the patient received the dose of SHINGRIX. Two to three weeks later, she experienced sudden onset of bilateral heel pain. The symptoms were similar to those noted in plantar fasciitis. The pain had not gone away, it waxes and wanes but did not entirely disappear. The patient asked, whether there had been reports of delayed reactions that fit her situation, since she never had a history of such heel pain. The agent attempted to call the health care professional with phone number provided in request to clarify details, obtain date of birth, and inquire about batch/expiry date, however the phone number was not valid. Agent was unable to clarify details or obtain any additional details for adverse event.  Agent filled limited adverse event conservatively.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had four temperature excursions; one for 712 hours with lowest recorded temperature of 33 F (0.555555556 Celsius), other one for 216 hours with lowest recorded temperature of 32 F (Celsius) other one for 64 hours with lowest temperature of 34 F (1.11111111 Celsius) and other one for 64 hours with lowest recorded temperature of 31 F (-0.555555556 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Patient received vaccine on 1/8/2021.  On 1/9/2021 I checked on patient via phone for symptoms or problems and he reported none but mild soreness at injection site.  On 1/10/2021 family friend called me to tell me that patient had expired at about 8:00 pm.  Patient reportedly complained of "pain" unspecific and collapsed at home. Hospital reportedly told family that it appeared to be a "heart attack".
3/4/21 - Rash/ intense itching on back and fingers 3/8/21 - Facial Swelling/itching - intense eyes itching 3/15/21 - Reddness of face with itching/the swelling improved 3/19/21 - Skin peeling/itching 3/22/21 - Rash worsening/weeping yellow drainage
3 weeks post-injection patient chief complaint of left shoulder pain, difficult to raise arm.  Patient had no symptons after injection, no redness, no side effects immediately after im,imization.  Patient will follow up with prescriber, change in cholesterol medication on 12/5/2019, on monday 12/16/19
Client vaccinated with Moderna vaccines for Covid on 3/16 and 4/18/2021.  Symptoms of Covid developed 12/10 - cough, extreme fatigue, headache, dizziness, myalgia.
began 5/26/99 w/chickenpox lesions (20) on stomach & hips mostly;few on head, neck & back 2 on leg;afeb;
After receiving Flu Vaccine at 8am, employee walked back to the Flu clinic at ~9:20am and stated he didn't feel right after getting the Flu shot 1.5 hours prior. Reported nausea & chills. He was transferred immediately to the ED via wheelchair. ED MD reports employee had myoclonic jerks without focality, was pale with 2+diaphoresis. By 9:29am Tx: Normal Saline IV, Diphenhydramine 50mg IV push, Lorazepam 0.5mg IV push, EpiPen Auto injector  x1. Patient stabilized and was released to home with Prednisone 50mg QD x3 days at 12:45pm.
Symptoms: ulcers inside lower lip, mild swelling inside mouth, roof of mouth, tongue, throat, nasal swelling. Same reaction I've had to penicillin, etc.  No rash. Same symptoms occur with ACE inhibitor reaction.  60 mg Allegra taken every 12 hours made symptoms milder, but didn't go away.  Did not feel well in general, no appetite.  Today, March 6, almost no symptoms, it has been more than 12 hours since the last Allegra.
Dose administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The 2 vials that were first punctured on the 30-Nov-2021 and was put on the refrigerator since then and later was administered to 13 patients on 07-Dec-2021.    Treatment information was not provided.
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and reviewed the time  vaccine was recieved to date  and noted the vaccine expired 1 day prior.   Notified state Vaccine program.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent with the following info to verify that there is 2 additional days for expire time but the vaccine expire date has not had any extention time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is recieved the staff have to determine the expire date and then COVID vaccines are constatly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
Painful rash; Red rash; Itchy rash; Achy; Myalgia; Fatigue; headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH (Painful rash), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), PAIN (Achy) and MYALGIA (Myalgia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported adverse event). Concomitant products included HydroDiuril  Blood pressure medication for Hypertension, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced MYALGIA (Myalgia), FATIGUE (Fatigue) and HEADACHE (headache). On 20-Jan-2021, the patient experienced RASH (Painful rash), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash) and PAIN (Achy). At the time of the report, RASH (Painful rash), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), PAIN (Achy), MYALGIA (Myalgia), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
weakness in legs; pain at injection; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in legs), VACCINATION SITE PAIN (pain at injection) and FATIGUE (fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs), VACCINATION SITE PAIN (pain at injection) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK. On 29-Jan-2021, MUSCULAR WEAKNESS (weakness in legs), VACCINATION SITE PAIN (pain at injection) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
This spontaneous report as received from a physician via a company representative refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with a dose of improperly stored M-M-R II (dosing details were not reported) (Lot # L040960 with expiry date of 16-OCT-2017). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection   (I took 2 Tylenol and took a 3 hour nap) o Tired  o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection   (I took 2 Tylenol  a Benadryl and used my Ventolin inhalator) o Tired  o Watering eyes o Sore tongue o Headache o Nauseous  o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects      (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst  o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening  o Runny nose  Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body  o Diarrhea   Tuesday side Effects (Went to work) o Left eyelid twitch  o Swollen neck glands o Runny nose  o Sore throat  o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose  o Sore throat  Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.
This spontaneous case, initially received from other health professional (pharmacist) on 03-Oct-2018, concerns an adult, female patient of unspecified age. The patient's current condition included diabetes. On 27-Sep-2018, the patient was administered AFLURIA (QIV) [dose: 0.5 ml, route of administration: intramuscular, batch number: YF37706 and expiry date: 11-Jun-2019, anatomical location: not reported]. On an unspecified date in Sep-2018, 48 hours after the administration of the vaccine, the patient's sugar level was 200 (unit and normal range unspecified) and on unspecified date in Oct-2018, 96 hours later it was 400 (unit and normal range unspecified). At the time of this report, the outcome of the event was not reported.
Within 3 hours after receiving the shot I experienced a mild cough and sore throat to begin with followed shortly by intense sore throat feeling a lump in my throat. This was soon followed by diarrhea and severe vomiting that lasted for 3 hours. Also had fever, chills and pink eye symptoms with gook in both eyes.
Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA255269 (same reporter). This case involves an 18 months old female patient who received a 0.25 mL first dose of FLUZONE QUADRIVALENT (lot number, expiry date, route and site of administration were not reported) on 30-aug-2018 and second dose (lot UT6259JA, expiry date: 30-Jun-2019, via intramuscular route in the left thigh) on 06-sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 12-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
flu-like symptoms; not feeling well; not able to move around for 15 to 18 hours; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms, feeling unwell and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, feeling unwell and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling unwell and mobility decreased to be related to Shingrix.  Additional details were provided as follows: Post vaccination the patient experienced flu like symptoms such that she was not feeling well and not able to move around for 15 to 18 hours.  The symptoms were resolved.  The reporter did not have any further details. This is 1 of 3 cases reported by the same reporter for different patients. The outcome of influenza-like symptoms and feeling unwell were reported as recovered/resolved however in source document, it was mentioned as recovered/resolved with sequel.
joint pain flare up; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain flare up) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included BENZOIN for Allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (joint pain flare up). At the time of the report, ARTHRALGIA (joint pain flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rash beginning on neck and spreading up face, down check to waist and into hair line; Raised red bumps; splotchy; Slightly itchy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 09Mar2021 13:00 (at the age of 23-year-old) at dose 1, single for covid-19 immunisation. Medical history included eczema on hands and patient had no known allergies. Concomitant medications were not reported. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not have other vac-cine in four weeks. Patient did not have other medications in two weeks. On 12Mar2021 07:00 the patient experienced Rash beginning on neck and spreading up face, down check to waist and into hair line. Raised red bumps, splotchy. Slightly itchy. Rash appeared 3 days after vaccine given. Ad-verse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received treatment with Topical ointment and Benadryl for the adverse events. Outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Shortness of breath and chest pains after routine workout at the gym.  Got worse thru the day.  Went to ER in the evening.  Tests for heart attack and blood clots were negative.  Sent me home next morning feeling slightly better.  Next night (6/2) woke up at 3 am with shooting pains in right leg below knee.  Back to ER where they repeated heart tests and did sonogram of leg.  All normal.  Sent me home again.  Symptoms continue to this day with slight improvement.  Have follow ups scheduled with Cardio and Pulmonary.
Information has been received from a physician concerning an approximate 3-year-old patient that was "immune healthy" who was vaccinated with a dose of Varivax (Oka/Merck). At an unspecified date the patient developed herpes zoster ophthalmicus. The patient has permanent eye damage from the presumed herpes zoster. This is one of several reports received from the same source. Additional information has been requested.
uncontrollable muscle jerking and fever of 103 degrees. Went on for a few hours.
Shingles outbreak in dermatome that correlates with where vaccine administered; was given in left deltoid; broke out in left shoulder and pectoral area.
Per pt: recieved varicella vaccine at empoyee health - blistering at vaccine site" provider; After varicella vaccine on 5/1/15 she developed an indurated area with vesicles. She is also itching all over at times. She will be working per diem but has not started employement yet.
had brief tonic-clonic febrile seizures (all less than 5 minutes) x 3 the night following the administration of one year old shots.  Called 911 and told they were febrile seizures.  Subsequently saw our office and referred for evaluation to ED.  Had CXR and urine which were both negative.  Continued to have fevers to 105 for 3 days after shot administration.  Given atypical nature of seizures, will consult pediatric neurology.
received pfizer 11/12. came into pharmacy today and stated reacted to pfizer vaccine. she started vomiting 11/13 and eventually passed out. paramedics were called and she went to hospital for a couple of hours. stated she received zofran and was treated for dehydration.
Pt recvd vax 2 doses Engerix-B & did not respond;
Extensive shoulder pain starting in the middle of my shoulders and making it difficult to raise my arms which lasted three days.
VISIBLE FULL BODY SWEATS, CHILLS, LIGHT HEADEDNESS, ALMOST PASSED OUT. GAVE PATIENT WATER, COOL DAMP CLOTHS, AND KEPT THEM SEATED FOR OBSERVATION FOR 30 ADDITIONAL MINUTES. PATIENT FELT FINE AND RETURNED TO NORMAL AFTER ABOUT 5 TO 10 MINUTES AFTER ONSET OF SYMPTOMS.
Very strong cold, sore throat, watery eyes, severe headache, bone/muscle pain injection area pain.
Left arm induration, red and warm to the touch. Instructed to give patient Benadryl and put cold packs.
Treatment of COVID-19/has had all 5 Covid 19 shots from Pfizer/She has not gotten Covid in 3 years until now/it was positive; Treatment of COVID-19/has had all 5 Covid 19 shots from Pfizer/She has not gotten Covid in 3 years until now/it was positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Dec2022, outcome "unknown" and all described as "Treatment of COVID-19/has had all 5 Covid 19 shots from Pfizer/She has not gotten Covid in 3 years until now/it was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Negative, notes: home test that was negative; (Dec2022) Positive, notes: it was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has had all 5 Covid 19 shots from Pfizer and the flu shot. She has not gotten Covid in 3 years until now. She usually wears 3 masks but took it off for a moment and thinks that's when she contracted Covid. She relays taking a home test that was negative. Followed by more tests and it was positive but her nose bled so she was not sure if it was accurate. She reported issues opening parts of the Covid test kits. The patient also reported symptoms starting on Sunday night 18Dec2022. Monday not feeling so well. She has been prescribed Paxlovid and started taking it Thursday 22Dec2022 at 2:15 pm. She began with the morning dose. She took her second dose on Friday 23Dec2022 at 2:15 am.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.