chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender who on an unknown dates were administered an unspecified number of improperly stored does of PROQUAD (Merck) (dose, route, lot # and expiration date were not provided). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
throat feels very irritated and raw; voice has become hoarse in the last month; dry cough; Chills; felt the heeby jeeby; felt the heeby jeeby; This spontaneous case was reported by a nurse and describes the occurrence of the second episode of NERVOUSNESS (felt the heeby jeeby), THROAT IRRITATION (throat feels very irritated and raw), DYSPHONIA (voice has become hoarse in the last month), the first episode of NERVOUSNESS (felt the heeby jeeby) and COUGH (dry cough) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03K20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD (patient has always had irritation in her throat.) and Barrett's esophagus (patient has always had irritation in her throat). Concomitant products included AMLODIPINE for Blood pressure, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), METFORMIN, VITAMIN D3, PRAVASTATIN, MAGNESIUM, ZINC, CALCIUM and NITROGLYCERIN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced the first episode of NERVOUSNESS (felt the heeby jeeby). On 12-Feb-2021, the patient experienced the second episode of NERVOUSNESS (felt the heeby jeeby). On an unknown date, the patient experienced THROAT IRRITATION (throat feels very irritated and raw), DYSPHONIA (voice has become hoarse in the last month), COUGH (dry cough) and CHILLS (Chills). At the time of the report, last episode of NERVOUSNESS (felt the heeby jeeby), THROAT IRRITATION (throat feels very irritated and raw), DYSPHONIA (voice has become hoarse in the last month), COUGH (dry cough) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2020, SARS-CoV-2 antibody test: negative (Negative) negative. On 07-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) POSITIVE. On 08-Sep-2021, SARS-CoV-2 antibody test: negative (Negative) NEGATIVE. On 09-Sep-2021, Polymerase chain reaction: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that there was no hypersensitivity to vaccine concomitant medication includes OTC Vitamins  No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: updated reporters qualification, lab test (Covid PCR/TMA - D) was negative on 9 sep 2021, past covid test data(29-04-2020) .
Patient began to feel dizzy around 10 minutes of waiting after the vaccine administration.  Patient then began to vomit but could not get all of the vomit out of her throat. She then passed out.  Patient was lethargic and difficult to arouse. Patient's blood pressure was 122/80. Medics were called and arrived on scene and took patient to the ER.
Patient developed a rash, 10 days post vaccine. Rash started on face and spread to trunk and lower extremities. Rash was erythematous macules that blanched. Rash was generalized. Was seen at  Urgent Care on 8/28 and was diagnosed with possible measles. He was seen in our office on 9/1/2021, for follow up on rash. Rash is resolving, but still present.
patient developed itchy, swollen lips and torso over the course of the day- problem persisted for about 4 days
A report has been received from a Health Professional concerning a 6 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. Reporter reported that two patients were administered expired FLUMIST QUADRIVALENT which started on 30-Dec-2013. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Immediately upon being stuck with the needle, she felt numbness in her left arm and a sharp pain. Once the needle was removed, she had excessive bleeding where multiple gauze pads had to be utilized for pressure and she even bleed through the bandage that was placed.  - She returned to her place of employment, after the injection only to experience ongoing dull ache, intermittent sharp pain and limited range of motion.  - Today, she continues to have constant, ongoing dull aching pain and limited ROM. Pain is exacerbated with certain movements, which causes sharp pain to radiate from her shoulder down her left arm. She is also unable to sleep on her left side, apply pressure or deep touch to the left arm or drive with her left arm; it bothers her to lift a weighted object with her left arm, as she has experienced pain with lifting an 8 oz water bottle to drink from it.  Pt sent for imaging and prescribed ibuprofen.
Next day fever mild headache severe redness and aching left arm/during the week left arm itching  under armpits and wrist, went to physician on Friday 4/9/2021
received first, second and booster dose Pfizer Covid Vaccine; received first, second and booster dose Pfizer Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "received first, second and booster dose Pfizer Covid Vaccine". It was reported that caller started taking Paxlovid yesterday night (01Jun2022) and took second dose of Paxlovid this morning, 02Jun2022. The caller started having a rash all on stomach and both arms. The rash began today, 02Jun2022. She also previously received both doses and booster of Pfizer Covid 19 vaccine and also had a rash after each dose. It was queried that are there any similar ingredients in both products that may be causing the allergy. She mentioned that her doctor already told to stop it, and to take antihistaminic. She just wanted to know if there's something similar because it was basically the same reaction in both, rash in her stomach and arms, that could explain why she was getting this reaction, she was hesitant to get the second booster because this always happen, even with this medicine, she just wanted to know if there's a similar component, maybe the same family or source so that she can bring this information to her allergist. She took Paxlovid this morning, but since she was allergic she cannot take it anymore, she wanted to know if there are reactions between Paxlovid and Advil Cold and Sinus. It was queired that does Paxlovid has any reaction with Advil Cold and Sinus. The caller wants to find out why caller is having this allergy, wants to know if maybe there is something in both Paxlovid and the Pfizer Covid Vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Cx of pruritus & heat around injections within 30 minutes after receiving the injections in her (R) arm only. States area became swollen from shoulder to elbow & stated it looked like 2 bullseye areas took ADVIL about 5 & 9 prn. Woke up around 2 am with severe pain in (R) arm. Went to ER was given an injection of TORADOL & script for BENADRYL & hydrocortisone. 2-10-12 ov with client area is fine no swelling.
Initially was hard and red, read diameter of 2-3 in circle lasted for four days after shot, itchy. Itching continued here and there and on the seventh day itchy increase, hardness of injection area and redness started to appear. 1-2 in diameter
Information has been received from a registered nurse concerning an adult male with a drug allergy to aspirin and no medical history reported, who on 05-MAR-2008 was vaccinated intramuscularly with a second 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 655501/1035F). The first vaccine was administered on an unspecified date. There was no concomitant medication. On 05-MAR-2008, the patient developed a very sore arm, tiredness and fatigue. The patient sought unspecified medical attention. The patient was told to rest, drink fluids and take TYLENOL. No diagnostic laboratory studies were performed. At the time of this report the patient was recovering. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Currently had phlegm; This spontaneous case was reported by a patient and describes the occurrence of PRODUCTIVE COUGH (Currently had phlegm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Bone cancer.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (Currently had phlegm). At the time of the report, PRODUCTIVE COUGH (Currently had phlegm) outcome was unknown.            The concomitant medication was not reported by reporter. It was stated that patient had both doses of the Moderna COVID vaccine. He currently had phlegm, but it was clear. Patient was not taking chemotherapy right now because his last one had a bad outcome. He had been on 6 of them (chemotherapies). The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Pt was given DTaP and MMR. Pt was 81 years old when given the vaccines. Given the pt's age, he should get Tdap. DTaP is intended for peds pt's to 6 years old. MMR is not required for anyone over the age of 64. Most MMR is given to pediatric patients.  Pt was not even due for any vaccines. No reactions were noted and the pt did not have any adverse events that occurred because of these immunizations.
Patient received pfizer vaccine on 2/2/21 and 3/10/21. Presented to ER on 4/5/22. On presentation,  she has had weakness, also complaining of right knee pain.  Overall, she is hemodynamically stable. Observation for non-covid reasons. Found to be COVID positive on 4/5/22.  CT chest negative. She did complain of symptomatic shortness of breath despite normal oxygen and uses O2 p.r.n. Was placed on dexamethasone and remdesivir. Doxycycline and ceftriaxone were given as well. Discharged on 4/11/22
Hot Flashes; Night Sweats; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot Flashes) and NIGHT SWEATS (Night Sweats) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced HOT FLUSH (Hot Flashes) and NIGHT SWEATS (Night Sweats). At the time of the report, HOT FLUSH (Hot Flashes) and NIGHT SWEATS (Night Sweats) had not resolved.      No relevant concomitant medications were reported. No treatment information was provided.
My arm  has gotten very red at the administration site and it was previously not red. It does not hurt but is the size of 2 half dollars. It has increased in size in the last 2 days.
a speckled and splotchy rash emerged on my neck and shoulders, spreading up behind my ears, across my forehead, eventually covering my breasts, ribcage, spine, and upper back; my neck is very red; it is not itchy, but feels hot
30 minutes after receiving vaccine bilateral numbness/tingling to hands 60 minutes after "chemical taste" in mouth with dryness lasting entire day; 6-8 hours after headache; fatigue x 1-2 days; arm pain swelling x 2days
This spontaneous report was received from a physician via company representative refers to a 93 year old female patient. On an unknown date in 2009 (also reported as five years ago) the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date in April 2014, the patient experienced shingles. The physician stated that a number of dermatomes were affected by the shingles outbreak in the patient. The patient was treated with VALACYCLOVIR (manufacturer unknown). The outcome of shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Three days after receiving the vaccine, the patient woke up with itching, starting on her back.  The morning of 8/31 she noticed that a hives-like rash had started on her back.  She describes that it would spread, especially in places where her clothes rested and made her skin warm - back, buttocks, legs, arms.  She even had it spread up the back of her neck and onto her forehead.  The worst place her her back has developed scabs.  As of today, she will still wake up with patches of rash in the places her skin is warmest.  OTC benadryl was taken to reduce the itching.  She also tried body lotion and rubbing alcohol.
3 inch rash and itching around injection site. Haven't contacted physician yet because of weekend.
Nausea and headache.  Observed for additional time.  Thorough assessments and water provided. VS monitored.
Patient said, ER Dr said vasovagal Rxn. Patient was seated for injection. After I gave the shot I asked if she was OK and she said she felt dizzy, nauseous, hot, sweaty. I had her put her head down. It seemed to come & go. The store manager called 911. They gave her oxygen and convinced her to go to ER. They took her to the hospital at 2 PM.
8/29/21: Patient arrived at the ER from facility with decreased O2 saturations. Patient currently on 70 L O2 of heated high flow, patient transferred to inpatient hospice. Please note: Patient received first dose Pfizer vaccine on 12/22/2020 Lot # EL0140 and the second dose on 1/12/2021 Lot # EL1284
9/12/08 started with hives on both arms, both legs, back, shoulder, and face.  No fever. Mild malaise and headache.  Hives started on 9/12/08 and have gradually increased.  9/15/08 9:30 AM-- child has in excess of 300 lesions without drainage. Extremities grossly involved.  Very few lesions on trunk.9/16/08 made phone call X 2 to mom.  Left message and #.  No return call. Note: Patient has received 5 doses of DTaP--last doses 10/30/02.
The night of the vaccine administration, the patient's arm was red at the site and painful.  The next day (1/15/2022) there was no change noted to the site.  On 1/19/2022, the patient would not let anyone touch it or get near the injections site.  To the left of the injection site is yellow with a red like rash patch  going towards the underarm of the patient.  The patient has also been scratching at the site due to the itchingness.
In the middle of the night 30 minutes of chill and shivering. Next day very achy lower back, neck, and sore left arm. Very tired all day.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number, expiration date, dose and route were unknown). The vaccines were exposed to 30.2 F for an unspecified amount of time. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
lost efficiency; This case was reported by a consumer via other manufacturer and described the occurrence of therapeutic response decreased in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included prostatic disorder (Prostate issue). Concurrent medical conditions included blood pressure high. Concomitant products included finasteride, metoprolol and prednisone.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting finasteride, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had lost of efficiency. The permission to follow up was denied.
After the patient checked out and left the office, patient mother called the office back approximately 1014 am.  Patient mother stated that the patient had a possible reaction to vaccinations received today.  Symptoms:  Flushed skin, cold extremities, and pale lips.  Per Dr., patient should be brought back into the office to be assessd by her. New vitals obtained, WNL, patient alert and oriented x3, warm extremities, and skin color normal.  Patient given water and informed by Dr. to lay down for a few minutes before getting up to ambulate.  Patient mother educated on the delayed vagal response that some patients have after injections and to make sure that he gets plenty of hydration and some electrolytes throughout the day.
Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the injection site, dry mouth, shortness of breath. Took ibuprofen and Tylenol.
Patients with inappropriate schedules; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that multiple patients had been coming in with inappropriate schedules of the Shingrix vaccine. At the time of the report, the reporter had no information about the patients. The reporter consented to follow up.
due to not properly reconstituting the lyophilized component of PENTACEL using the liquid vaccine component with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 months old female patient and stated that the product was not properly reconstituting the lyophilized component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] using the liquid vaccine component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, it was reported that only the lyophilized component of PENTACEL was administered to a patient and was not properly reconstituting the lyophilized component of PENTACEL using the liquid vaccine component with no reported adverse event (product preparation error) (Suspension for injection) (latency: same day) (lot UJ805AA) (Frequency = once) (Strength = standard) via unknown route in unknown administration site for immunization.  It was reported that "Medical assistant stated that the lyophilized component was mixed with a sterile diluent the clinic uses to dilute MMR vaccine. There was no mention of the specific sterile diluent that was used. No further information provided. Sales representative mentioned that the clinic wanted to know what to do next with the situation."  Action taken: Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC 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.
The caller reports PROQUAD vaccine was administered 19AUG2021 following a supported temperature excursion on 28JUN2021; This spontaneous report has been received from a healthcare business professional, a chief executive officer, referring to a 13-month-old male patient. No information regarding the patient's medical history, concomitant medications or concurrent conditions was provided.  On 19-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) (dose, route of administration, vaccine scheme and anatomical site of vaccination were not reported; lot number T031603 has been verified to be valid, expiration date reported and established as 15-MAR-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 8.4 degrees Fahrenheit, during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion.
When I woke up the morning after the injection I experienced dizziness  on that one day.
Patient called in to let us know at the site of her Fluzone HD she had a red/swollen spot.
shortly p/vax & having blood drawn by fingerstick-pt became pale & somnolent lasting approx 30min-then seemed OK-no tx rendered;