chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first and second dose four weeks apart; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 24-MAY-2022  Reporter's Comment: The reporter stated that, his/her several in laws received first and second dose of Shingrix just four weeks apart.  The reporter simply reported themselves and several of their family members was receiving the first and second dose four weeks apart instead of the recommended minimum of 2 months for the second dose, after receipt of the first dose. The reporter did not consent to follow-up. Additional supportive information: The patients received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of vaccination schedule. This case had been linked with case US2022083417, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022083417:Same reporter
pt recvd MMR vax as a child; pt currently exhibited a lack of response to mumps; no further details were provided;
First night -Sat.-mild temp.  99.8 (my usual is 97.8), achy all over, sore arm. Next day- Sunday- 10Am, woke with the room spinning- dizzy, vertigo?  Went away in a minute or two.  During the day felt a little off, took shower, had dizziness again.  Had to sit down in fear of falling over.  Since then I have  had slight bouts of minor dizziness.  Just an unsure overall feeling that something isn't quite right. It is now Thursday, still feeling weird.
DOCUMENTATION STATE PT GOT FLU SHOT IN LEFT ARM AND PNEUMONIA SHOT IN RT ARM. PT STATES SHE WAS GIVEN BOTH IN THE SAME ARM AND IS HAVING CELLULITIS, REDNESS AND SWELLING AT THE INJECTION SITE. PT GOT PNEUMOVAX23 LOT UO02528 EXP 13/SEPT/2022 AT SAME TIME
Pentacel was expired on 10/12/2023, no additional treatment needed but recommended to parents to repeat the dose.
Flu; Rash on arm; This case was reported by a pharmacist via call center representative and described the occurrence of influenza in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza and rash. On an unknown date, the outcome of the influenza and rash were unknown.   It was unknown if the reporter considered the influenza and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called to report that the patient developed flu and rash on arm after receiving Shingrix. The reporter gave consent to follow up. The reporter did not have lot or expiration date.
pt recv vax 19AUG97 & 30AUG97 c/o itch & some warmth in area of inj site, lt upper arm, also vesicle noted on rt lower leg;tx w/keflex;
Pretty much been in bed most of the time; Body aches; Chills; Headache; Sheer exhaustion; Feels like he got hit by a Truck; This is a spontaneous report from a contactable consumer reporting for father. A 90-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm on 28Jan2021 as 1st dose, single (at the age of 90-years-old) for COVID-19 immunization. Vaccination Facility Type was reported as Clinic. Vaccine was not administered at another Facility. Patient medical history and concurrent conditions included: Ongoing prostate cancer with onset at least 15 years ago, extraction of 2 molar teeth which was done last week on an unspecified date in 2021, height shrunk. The concomitant medications included ongoing leuprorelin acetate (LUPRON) injection about every 4 months taken for prostate cancer with last dose administered last week. On 28Jan2021, patient was pretty much been in bed most of the time, had body aches, chills, headache, sheer exhaustion, felt like he got hit by a truck. The patient was administered his first dose of Pfizer COVID-19 Vaccine on 28Jan2021. The patient is normally incredibly active. He does all of his own lawn moving, snow shoveling and he still works. Starting the night of 28Jan2021 he had pretty much been in bed most of the time ever since. Most of the time since then he has had lots of body aches, chills-but no fever, headache and just sheer exhaustion. The patient went into work at the office for a couple hours Monday (01Feb2021), he pretty much slept all day Tuesday (02Feb2021). They called the patient doctor office, and the nurse gave a not real professional response to the events reported to her, that it is really common to have body aches for 2 weeks. They reported to the nurse that this is not normal for the patient. The nurse told them that this happens all the time; but advised them that if they think it is a problem to take him to the urgent care. They have not heard of people with the first Pfizer COVID-19 Vaccine being so knocked out. Some days he was ok, some days the adverse events were incredibly bad. A day before (03Feb2021) he was fine for a couple of hours, on Monday (01Feb2021) he was fine for a couple of hours. His usual statement regarding these adverse events was that he felt like he got hit by a truck. The outcome of the events was unknown.    Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Patient had a seizure the next day after vaccine. No treatment medications was reported.  This case contains information about patient-11 out of 63 patients.  Company comment:This is a spontaneous case concerning a 80 years old female patient, with no medical history,  who experienced the unexpected serious (medically significant) AESI event of seizure, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 bivalent BA.4/ BA.5 vaccination. At the time of reporting of the outcome of the event is unknown. No further information for medical review. The benefit-risk relationship of mRNA-1273 bivalent BA.4/ BA.5 vaccination is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
stored Moderna vaccine in their refrigerator and administered past the BUD date; BUD was 01-Nov-2021 but the vaccine was administered on 14-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 14-Feb-2022) and PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 14-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 14-Feb-2022) and PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Developed Acute Lymphoblastic Leukemia 3-4 months after booster shot for COVID vaccine
Received second dose of Covid 19 vaccine from Pfizer on 05/08. Patient had a small stroke on 05/17 that possibly caused concussion and motor cycle accident with transient aphasia.
Patient stated noticing rash to both legs on 5/13/08 mainly around ankle area.  5/15/08 Rash moved to both extremities up to thigh area. No redness or rash to vaccination site noticed.
Patient vaccine administration/screening form was not completed accurately therefore the patient  was given Bivalent Pfizer dose for 1st Dose of Primary Covid 19 Series.  Will follow CDC guidelines and give Pfizer Primary Dose in 3 weeks followed by a Bivalent Pfizer Booster Dose at lease 2 months after the 2nd Primary dose.  This error was discovered during data entry into the Vax portal.
muscle soreness began a few hrs p/inj;pt discovered about 1wk later had dec strength lt arm;pt able to quantify this as lifts weights on a regular basis;began to notice tingling, esp thumb & fore finger lt hand
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: systemic lupus erythematosus, and allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 42 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.
When I was given the shot I felt the shot go down thru my arm. Later that evening I could not lift my arm or lay on it without it hurting so bad. It woke me up at night and I still can not lay on my right arm. I can not raise my arm very high without my shoulder and arm hurting. I feel like I just got the shot. I have tried using ibuprofen and Tylenol with a heating pad. It was working but not anymore.The pain would go away for a couple of hours. There is still pain in my shoulder and arm.
was administered the powder portion of the vial reconstituted with another diluent; was administered the powder portion of the vial reconstituted with another diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number amva391a, expiry date July 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. 1 among the 5 patient was administered the powder portion of the vial reconstituted with another unknown sterile diluent , which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was 1 of 5 linked cases, reported by same reporter for different patient; Sender's Comments:  US-GLAXOSMITHKLINE-US2021237489:Same reporter US-GLAXOSMITHKLINE-US2021237485:Same reporter US-GLAXOSMITHKLINE-US2021237486:Same reporter US-GLAXOSMITHKLINE-US2021237484:same reporter
Patient was given injection on 3/3/21, symptoms started in AM on 3/4/21 with dizziness and headache. Patient was given meclizine by one of our providers from our clinic to help with the dizziness since patient experienced this with the first vaccine. Patient will follow up with a clinic visit if symptoms do not improve.
Information has been received from a medical assistant referring to a 15 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
In the left arm start a allergic reaction that progress to a cellulitis. Treatment, prednisone 10mg BENADRYL 25mg and AUGMENTIN 875mg.
(L) deltoid began hurting at 10 AM (3 hrs post vaccine); pain moved up shoulder to (L) side of jaw. Skin rash/eczema began 3 days later over legs, scalp. Felt achy over entire body & lethargic x 1 week. Pain in (L) arm & (L) shoulder lasted (1) month.
Severe chills - whole body shaking, severe nausea, could not sleep, and fatigue, for three hours straight. Could not sleep the first night. Night sweats for the next two nights. Foggy brain  and spacey for the next four days.
Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant product was reported.  no treatment product was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-122517, US-MODERNATX, INC.-MOD-2021-122557, US-MODERNATX, INC.-MOD-2021-122588 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122588: US-MODERNATX, INC.-MOD-2021-122557:
No adverse event occurred. The patient intended to get the Covid vaccine alone but a miscommunication led to a flu vaccine being administered.
floaters worsened; Condition aggravated; bloking vision; redness; arm was sore; heated up in the area of the injection; This case was reported by a consumer via call center representative and described the occurrence of eye floaters in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Influenza Shot (received on an unknown date). Concurrent medical conditions included eye floaters.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, 1 day after receiving Shingrix, the patient experienced eye floaters, condition aggravated, injection site erythema, injection site pain, injection site warmth and vision decreased. In April 2019, the outcome of the injection site erythema, injection site pain and injection site warmth were recovered/resolved. On an unknown date, the outcome of the eye floaters was not recovered/not resolved and the outcome of the condition aggravated and vision decreased were unknown.   It was unknown if the reporter considered the eye floaters, condition aggravated and vision decreased to be related to Shingrix. The reporter considered the injection site erythema, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows:  The patient stated after getting the 1st dose of the vaccine in last week from the date of reporting. The patient noticed the floaters worsened in his left eye the day after. The patient had a history of floaters, but this worsened and he compared it to looking through a spider web describing it as blocking his vision. The patient said it comes and goes. He visited an eye doctor over the weekend who could find nothing wrong. However, he had an appointment with his regular eye doctor later this week. A couple of days after getting the vaccine, his arm became red at the site of the injection and his arm was sore. It heated up in the area of the injection.  This lasted about three to four days.  The reporter gave consent to follow up. Emergency room visit required.
Fine red, papular, pruritic rash on 1st and 2nd digits both hands and dorsum both feet.
Bump at the site of injection; Pain at injection site that went down through his arm; Trouble to move the arm; Feeling bad; Nausea; This spontaneous case was received on 02-Nov-2023 from a pharmacist (reference number: SEQW23-03980) and concerned a 21-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 24-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for active immunization against influenza disease. The batch number reported was 374409 and the expiry date was 30-Jun-2024.  On 30-Oct-2023, at six am, six days after receiving Flucelvax Quadrivalent, the patient started feeling bad and then remembered he had a flu shot. The patient felt like there was a bump on the injection arm and was having trouble moving it. The patient also felt nausea and pain at the injection site that went down through his arm. The patient was treated with Tylenol (paracetamol) and Advil (ibuprofen).   At the time of the initial reporting, the patient had not recovered from the events. As reported, there was less pain than when it started.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: A 21-year-old patient developed vaccination site mass, pain in arm, decreased mobility of injected arm, abnormal feeling (reported as "feeling bad"), and nausea six days after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship and the absence of confounders, causality for vaccination site mass, pain in arm, decreased mobility of injected arm is assessed as probably related. Causality for the remaining events (abnormal feeling and nausea) is assessed as possibly related, due to plausible temporal relationship.; Sender's Comments: A 21-year-old patient developed vaccination site mass, pain in arm, decreased mobility of injected arm, abnormal feeling (reported as "feeling bad"), and nausea six days after receiving the suspect product Flucelvax Quadrivalent. Based on plausible temporal relationship and the absence of confounders, causality for vaccination site mass, pain in arm, decreased mobility of injected arm is assessed as probably related. Causality for the remaining events (abnormal feeling and nausea) is assessed as possibly related, due to plausible temporal relationship.
Severe lethargy, extensive myalgia, arthritis, headache, drenching sweats, chills, cognitive change, fevers, severe arm pain, nausea.  Severe for 4 days. Lethargy and arm pain for total of ten days.
Muscle soreness and joint pain with headache the following day for most of the day. Two days after the injection ,and for two days I experienced severe dizziness and abdominal pain producing yellow bile. I was unable to stand up for more than a couple of minutes for most of those two days. I was unable to eat and had only Pedialyte for most of those two days. I started to hallucinate mid day and had fever dreams that inhibited sleep. No treatment was given.
Genital warts  gone; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Genital warts  gone) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 036B21A) for COVID-19 vaccination.     The patient's past medical history included Genital warts (had genital warts for over 20 years). Concurrent medical conditions included Diabetes (Patient is diabetic). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), ENALAPRIL, PHENOBARBITAL, GLIPIZIDE, INSULIN LISPRO (HUMALOG), HYDROCHLOROTHIAZIDE, INSULIN GLARGINE (LANTUS), METFORMIN, METOPROLOL and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Genital warts  gone). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Genital warts  gone) had resolved.            No treatment medication reported. No adverse event reported. Patient provided consent for Safety to follow up, but no contact details provided.
patient states she had multiple adverse reactions after receiving her immunization.  She states her side of her mouth went numb approx. an 1/2  hour after leaving the pharmacy on the left side and injection was tingly  but went away after 15 minutes.  She was dizzy when she got up the next morning and had patches of red bumps  near her knees and on her arms that were itchy. Would describe more as bumps and not hives.  She also reported some soreness in her neck and back.
All information per patient's husband: patient started experiencing severe headache on the day of vaccination.  Headache continued for three days during which no medical attention was sought. Confirmed that patient never took any NSAIDs to treat headache during this time. On day 4, patient had a subdural hematoma accompanied by two seizures upon which she was flown to a hospital to receive treatment.  Husband did state that patient is on warfarin due to factor V deficiency and that treating physician thought that this was most likely caused by the warfarin, however that the vaccine could not be ruled out completely. Husband also said INR has always been within normal limits.
woke from sleep with shaking chills, fever to 102 in clinic: large local rxn (8 cm, indurated), pneumococcal vaccine site unaffected. fever to 38.1 in clinic. given 30 mg prednisone daily x 3 days
After receiving  Pneumovax 23 vaccine, about 2 days  later patient reported to the pharmacy of facial swelling, itching and redness. No trouble breathing or throat swelling.. It was recommended to the patient to seek medical attention. Hydrocortisone was prescribed to patient, which worked. After following up with the patient she stated her redness and swelling has subsided. No other issues reported.