chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylactic reaction; This serious case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a adult female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, an unknown time after receiving Influenza vaccine, the patient experienced anaphylactic reaction (Verbatim: anaphylactic reaction) (serious criteria GSK medically significant). The outcome of the anaphylactic reaction was resolved.   The reporter considered the anaphylactic reaction to be related to Influenza vaccine.     The company considered the anaphylactic reaction to be related to Influenza vaccine.   Additional Information: GSK Receipt Date: 22-MAY-2023 The pharmacist reported that 15 years ago from reporting date, a patient had a severe anaphylactic reaction to an unspecified influenza (flu) shot and had no further information. The manufacturer of suspect vaccine was unknown. The reporter consented to follow up.
RECEIVED FLU VACCINE AT SCHOOL CLINIC 10/10/23 AFTER RECEIVING FLU VACCINE AT PCP ON 9/19/23
C/o burning from R deltoid inj. site proximal to shoulder after withdrew needle. Applied bandaid + redness developed within 30secs to 1min from R distal deltoid to R antecubital fossa. Within 2 minutes of vaccine administered. C/o lightheadedness, nausea. BP 134/84, HR 78 decreased regular.
Pt reported immediate redness and lump to injection site and shortly after developed flushing to face/neck/arms with itching about 10 minutes after vaccine. Pt received Benadryl PO with recovery. Provider notified and approved course of treatment. No other f/u concerns at this time.
stiff calf muscle; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix. In August 2022, 1 day after receiving Shingrix, the patient experienced muscle stiffness. On an unknown date, the outcome of the muscle stiffness was unknown.   It was unknown if the reporter considered the muscle stiffness to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: The case was self-reported by the patient. The patient received first dose of Shingrix two weeks ago before reporting and next morning patient woke up and his calf muscle was very stiff. The reporter consented to follow up.
My baby was completely happy and active before his shots. After receiving his 2 month shots, he cried in a high pitched inconsolable scream for most of the time he was awake (between 4-5 hours). I gave him a childrens pain reliever and he was able to fall asleep later on that night. The next week he seemed uninterested in playing or interacting, whereas before he was active and happy. After a month and a half he seems completely back to normal. I'm really scared to give him another dose of vaccines at his next 4 month appointment.
Fever started around 10:30 AM on 10/12/2012 and progressed. She was given Infants Advil around 12:00 PM. That helped lower the temp for a little while. At 5:00 PM her temp was 104*F. Her fever then went down to 99.8*F when taken at 11 PM.
Faitigue, feeling faint, migraine which lasted for 4 weeks solid, each day migraine
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 26-SEP-2017, the patient was vaccinated with expired dose of ZOSTAVAX (dose and indication lot # M042503 expiration date: 18-AUG-2017). The dose was reconstituted with diluent that was not expired. No adverse effects reported. Additional information has been requested.
No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 3-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 27-APR-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location , and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion were reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
the Prevnar 20 they had an infiltrated inside the vial. Was not administered to any patients.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group,.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2605, Expiration Date: 31Jul2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "the Prevnar 20 they had an infiltrated inside the vial. Was not administered to any patients.".  Additional information: sample of the product was available to be returned, if requested. Informed caller to please retain their product and its packaging as it may be required if an investigation is required. It normally takes 3-10 business days to send out a mailer to return a sample.  Follow-up attempts are not needed. No further information is expected.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine date of refrigeration was 07-May-2021.  No concomitant medications were provided.  No treatment medications were provided.
Swelling very red painful growing spot at injection site, beginning a few hours after injection, soreness in entire arm beginning the morning after the injection more severe than with the flu vaccine, nausea two days past vaccination
LT DELTOID AREA WAS WARM TO TOUCH AND RAISED BELOW FLU INJECTION AREA.
Myalgia, extreme fatigue, exhaustion, site soreness, nausea Narrative:
PATINT INNAPROPRIATELY RECEIVED BOOSTER DOSE OF PFIZER VACCINE WHEN IT HAS YET TO BE APRPOVED TO BELOW 16YEAR OLD.
100 degree fever and hives all over legs, feet, hands, arms and face. It began at 7AM the morning after the vaccines were given and are still persisting 48 hours after the vaccines were given. Tylenol was given twice (every 4 hours) for the fever and Children's Benadryl has been given every 4 hours (total of 4 does so far) The Doctor on-call has prescribed prednisone for the hives, but it has not been given yet.
painful menstrual cycle with blood clots; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (painful menstrual cycle with blood clots) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (painful menstrual cycle with blood clots). At the time of the report, MENSTRUAL DISORDER (painful menstrual cycle with blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   Reporter did not allow further contact
Left arm 16x26 cm area of induration, erythema, tenderness for 2 days, worsening. A follow up report received 9/12/2002 adds: Admitted cellulitis left arm.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 13-AUG-2015 the patient was vaccinated with improperly stored (Merck) PROQUAD lot # L006388, expiration date 25-AUG-2016 (Dose strength, route unspecified). No adverse symptoms reported. No product quality complaint was involved. Additional information has been requested.
This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via unspecified route of administration in the left arm on 17Mar2021 at 14:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient had not tested positive for COVID-19 prior or since the vaccination. On 17Mar2021 at 19:00, the patient experienced soreness/pain, fatigue/lethargy and low-grade fever. Treatment was not received for the events. The Clinical outcome of the events soreness/pain, fatigue/lethargy and low-grade fever was resolving at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
received third dose from vial refrigerated for more than 30 days; received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-358921, MOD-2021-359183, MOD-2021-358773, MOD-2021-358799, MOD-2021-358800, MOD-2021-358841, MOD-2021-358865, MOD-2021-359032, MOD-2021-359764, MOD-2021-358773 (Patient Link).
Large bruise beginning on 1st day, very itchy rash on arm below injection site on 8th day
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical history was unspecified. The patient had no drug allergies. On an unknown date the patient was vaccinated with ZOSTAVAX (strength and route not reported, lot #K012923, expiration date: 29-NOV-2015). On an unknown date the patient experienced lump and redness at the injection site within a few minutes of receiving ZOSTAVAX. She took ZYRTEC to treat her symptoms. The patient sought medical attention by calling the pharmacist. The outcome of adverse event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Swelling and pain at site of injection. Injection site is warm to the touch. Range of motion is limited in the arm that received the vaccine due to pain.  Headache
Feel sick; 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 MALAISE (Feel sick) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feel sick). At the time of the report, MALAISE (Feel sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.
Tender Axillary lymphandopathy on 01/05/2021 (day 6) Injection site redness, swelling, induration, and itching on 01/06/2021 (day 7)
Diarrhea; Middle level back pain; Legs feel week; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), BACK PAIN (Middle level back pain) and MUSCULAR WEAKNESS (Legs feel week) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 020B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), BACK PAIN (Middle level back pain) and MUSCULAR WEAKNESS (Legs feel week). At the time of the report, DIARRHOEA (Diarrhea), BACK PAIN (Middle level back pain) and MUSCULAR WEAKNESS (Legs feel week) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-089588 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up information included AE outcome updated to recovered/resolved.
Patient was administered a vaccine that was 6 days past the beyond use date of 6/30/2022. The patient is potentially lacking efficacy from this dose of the vaccine due to this and may not be protected.
Mom states had rash beginning on legs 1APR92 then when woke up on 2APR92 had rash from head to toe; hospitalized by MD x 2 days; tx w/DPH x 2 days; final dx  peripheral rash versus viral inf versus allergic rxn;
within 24 hrs rash developed, turned into welps and hives on both arm, back and neck
Severe muscle aches three days after injection along with fever one day; lasted 4-5 days then 2-3 days ago began with severe muscle aches. Treated self with Ibuprofen and able to work.  Placed on Cipro by Primary provider today 11-18-09.
Upon speaking with patient here at the hospital she reports having vaccine on March 31, 2021 and reports experiencing clot that had been previously reported to CDC and she asked that this hospitalization be reported to hospitalization as concerns that it may be related.  Patient admitted for possible stroke/TIA symptoms resolving
Raised red welt about 7 inches long and 3 inches wide. Pt taking BENADRYL, ice on arm, and ibuprofen. Started 1-2 days after immunization, still present 5th day after.
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 2021, and dose was not reported, administered on 30-APR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On 16-AUG-2021, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.
Starting throwing up, she is not feeling too good; Nausea; Vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 20Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 21Aug2021 02:00, outcome "unknown", described as "Starting throwing up, she is not feeling too good"; NAUSEA (non-serious) with onset 21Aug2021 02:00, outcome "unknown", described as "Nausea"; VOMITING (non-serious) with onset 21Aug2021 02:00, outcome "unknown", described as "Vomiting".  Additional information: Reporter stated, "it's my wife (patient) she just got the Pfizer shot (Unspecified shot) yesterday, and around 2 o' clock this morning she started throwing up, she was not feeling too good. There was anything I can give her for nausea or vomiting?". Reporter is default as consumer or other non-health professional.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling, redness and tender to touch at injection site 12 hour post. Myalgia since injection. Patient was given steroids and antibiotics.
Patient was given off label administration of Moderna vaccine at age 16.  Vaccine is indicated only for age 18 years and older.
Large ring appeared around vaccination side day 9. Super itchy. Day 3-9 large golf ball lump under injection site
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Additional Details: Patient received shot on thursday and had fever, nausea, and diarrhea. On sunday he noticed a rash coming up all over his body. no problems breathing. went to dr today and told him it was hives. he received steroid pack to help and dr recommened 2nd shot while taking steroid
Brain bleed; Platelet count droppped to 40; Bruises all over the body; Organs shut down; A spontaneous report  was received from a consumer concerning a 64-year-old female patient, who experienced bruises all over the body (contusion) , brain bleed (cerebral haemorrhage), platelet count dropped below 40 (platelet count decreased) and organs shutdown (multi organ failure).   The patient's medical history included bacterial infection 2 days prior to receiving vaccine dose. Product known to have been used by the patient, within two weeks prior to the event, included antibiotics (not specified).  On 02 Mar 2021, the patient received her first of the two planned vaccine doses of mRNA-1237 (Lot # unknown) for prophylaxis of Covid-19 infection.  On 03-Mar-2021, the patient developed severe bruises all over her body.  On 04 Mar 2021, within 2 days after receiving the vaccination, the patient was rushed to the hospital where it was determined that she had sustained a brain bleed. She had all her organs shutdown and her platelet count had dropped below 40.  On 04 Mar 2021, it was reported that the patient died.  The cause of death was reported as organ failure. Plans for autopsy were not provided.   Action taken with the mRNA-1273 in response to the events was not applicable.  The outcome of the events, bruises all over the body(contusion), brain bleed(cerebral haemorrhage), platelet count dropped below 40(platelet count decreased) were unknown.; Reporter'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.  However, the patient's underlying history of bacterial infection could be a contributory factor.  Awaiting further clarification.; Reported Cause(s) of Death: Organ Failure
About 10 minutes after the injection I started feeling lightheaded. It did not feel like low blood sugar, but I ate a glucose tablet and drank orange juice. I sat for almost an hour and it was getting worse.  A nurse took my orthostatic vitals and when I stood up  I started to fall. I ended up going to the ER  so I could continue being monitored. My labs came back normal and the ED attending determined it wasn't an anaphylactic reaction.
1 1/2 hr p/inject itching fingers & hands then neck & all over fine rash trunk face flushed; treated in ER room; later @ 12 hrs resp wheezing-rx w/steroid;
In 1994, following the 3rd dose of Hep B, the pt subsequently reported symptoms of "tingling of hands and feet" in the beginning of 1994. The pt was seen by an OB/GYN in May, 1994 for headaches and the physician discontinued therapy with Ortho Novum. The headaches resolved. On 9/2/95, the pt was seen by a neurologist and was dx with multiple sclerosis. The reporter considered this experience disabling. Additional information has been requested.
Aches, fever, fatigue lasting two days. Swelling and pain, excessive heat at injection site lasting ten days. Fatigue still present today.
This spontaneous case, initially received from other non-health professional (consumer) on 07-Nov-2018, concerns a 75-year-old, elderly female patient. On 16-Oct-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported]. On the same day within 15 minutes after vaccination, the patient stated that she had a reaction to the vaccine. The patient experienced a lot of pain in left arm, upper shoulder and biceps. It was reported that, in the first week of vaccination, her arm hurt so badly that she could not even lift anything and could not even put on her watch. The patient tried to take TYLENOL and MOTRIN but nothing helped it. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
His leg swelled up starting the next morning, at least that's when we found it, and lasted 5 days. We gave him the recommended dose of children's Ibuprofen when it hurt him. It caused swelling from the knee to the hip with pain and heat. He also complained of itching.
Provider Summary "Patient was treated for sepsis due to COVID 19 pneumonia in setting of hypoxia with Decadron.  With elevated D-dimer of > 7,000 and intermediate probability patient was treated empirically for PE.  With advanced stage IV CKD CT Angio was not obtained.  Patient was transitioned from IV Heparin to Eliquis with plan to complete 3 months of anticoagulation.  Patient was continued on antibiotics with initial leukocytosis and possible RUL infiltrate on CXR.  He was discharged on Doxycycline and Cefdinir to complete 5 days of therapy.  By time of discharge patient had been weaned off supplemental oxygen and was feeling much better. "