chrisvoncsefalvay/vaers-outcomes huggingface dataset:
product storage error temperature too low, with no reported adverse event; product was administered to patient post excursion, with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves Adult and unknown gender patient to whom influenza quadrival A-B vaccine [Fluzone QIV] product was administered to patient post excursion and product storage error temperature too low, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza quadrival A-B vaccine Suspension for injection lot UT7683NA, UT7682JA expiry date: 30-Jun-2023 (strength, : not reported) via unknown route in unknown administration site for prophylactic vaccination and on the same day product was administered to patient post excursion, with no reported adverse event (poor quality product administered) and product storage error temperature too low, with no reported adverse event (product storage error).  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both events.  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 guidelines. 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.; Sender's Comments:  US-SA-2023SA057733:
2 hours after vaccination (2/19/2021) experienced nausea and massive diarrhea for about an hour.  Fever started around 5 to 6 hours later and continued for 36 hours. Area of arm receiving injection was hard, warm to the touch, and itched. After removing my shirt on Sunday the entire arm had a 4 inch red band almost the entire circumference of the upper arm.
2/11 Flu like symptoms all day,  2/12 severe pain upper right quadrant, nausea, went to ER, admitted and put on saline drip until 2/15, pancreatitis treatment.  taken off drip Monday 2/15, sent home with instructions to follow up with GI specialist and low fiber diet.
Pt recvd 2 doses of Hep B vax IM instead of immunoglobulin on 9SEP91 & 2 hrs following overdose of vax pt devel urticaria, SOB, dizziness, abd cramps & syncope; tx DPH, Pred, Tagamet & Solu-Medrol;
This spontaneous report as received from a female consumer of unknown age reporting of herself. Medical history and concurrent conditions were not reported. In March 2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiry date were not provided). Other suspect therapies included influenza virus vaccine (manufacturer unknown) the reporter stated ("almost died after getting it"). Concomitant therapies included aspirin. In March 2014 (after receiving the vaccine), the patient developed shingles. The consumer stated "I only have a few blisters bit it's very painful and I've lost 20 pounds. The consumer stated she saw her physician, on an unspecified date, in regards to the reaction. The physician prescribed Acyclovir for treatment. The consumer stated the Acyclovir "isn't working out too well". When asked if any laboratory or diagnostic studies were performed the consumer stated "my doctor takes blood tests all the time." The outcome of the events was reported as not recovered. Additional information has been requested.
brain aneurysm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTRACRANIAL ANEURYSM (brain aneurysm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INTRACRANIAL ANEURYSM (brain aneurysm) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 09-Apr-2021 due to INTRACRANIAL ANEURYSM. At the time of the report, INTRACRANIAL ANEURYSM (brain aneurysm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment details not provided. The patient was scheduled to receive the second dose on 19 Apr 2021.  Company Comment  Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 29-MAR-2018, the patient was vaccinated with expired VAQTA lot # M039202 with expiration date 11-MAR-2018, for prophylaxis (dose and route of administration were not reported). No adverse symptoms were reported. It was stated that the vaccine did not have any temperature excursion prior to administration.
Less than 24 hours from receiving multiple shots at one time, my 2-month old daughter developed a rash from head-to-toe that became worse as time progressed. Her skin became severely sensitive to where she would scratch her face and it would bleed. I have pictures and documentation of my daughter's adverse events so we can help bring the truth to light as to why these corrupt pharmaceutical and governmental agencies are allowing toxic chemicals to enter the bloodstream of our babies?!?! I will contact lawyers and get my daughter's stories heard. This should be a crime against humanity.
Patient developed asymptomatic rash consistent with erythema multiforme.  Completely resolved by 7/4 without interventions.
Crying for 8 hrs straight. Staring into space. Unresponsive. For 4 hrs stiff, tight for 2 hrs. Admitted at ER. R/o meningitis. Readmitted 2 wks later for pneumonia.
BLACKOUT/ FAINTING/ DIZZINESS; SEVERE ABDOMINAL PAIN/ ABDOMINAL CRAMPING; HANDS FELT "SUPER HOT"; FEELING OF BURNING; VOMITING; TINGLING SENSATION DOWN THE ARM; This spontaneous report received from a patient concerned a 30 year old white, non-Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no medical history, no known allergies and no drug abuse or illicit drug usage. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, and batch number: 202A21A expiry: unknown) dose was not reported, 01 total, administered on 10-SEP-2021 to the right arm for prophylactic vaccination. No concomitant medications were reported. On 10-SEP-2021, the patient experienced fainting and blackout which lasted for 2 seconds that was accompanied with dizziness and her hands felt super-hot, and there was a feeling of burning and tingling sensation down the arm, she vomited 12 times within an hour. The patient also experienced severe abdominal pain. The patient stated that it was the worst abdominal pain she had, and this made her go to the emergency room (ER). On same day at the ER the patient was given diphenhydramine hydrochloride(Benadryl) via Intravenous route, soon after that her symptoms were resolved. The doctor stated that either the patient had food poisoning or an allergic reaction. During the ER visit, she had blood test and urinalysis which all came out normal. After the ER visit, the patient went to her doctor/primary care physicians (PCP), and her doctor stated that it was unlikely that what happened to her was due to an allergic reaction to the vaccine because it did not happen quickly. Her doctor/PCP stated that some people get really sick whenever they get the vaccine (like normal flu symptoms). She was not prescribed anything. On 11-SEP-2021, the patient experienced abdominal cramping, it was very light and was resolved.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blackout/ fainting/ dizziness on 10-SEP-2021, and severe abdominal pain/ abdominal cramping, hands felt "super hot", feeling of burning, vomiting, and tingling sensation down the arm on 11-SEP-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210924068-COVID-19 VACCINE AD26.COV2.S - blackout/ fainting/ dizziness, severe abdominal pain/ abdominal cramping, hands felt "super hot", feeling of burning. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210924068-COVID-19 VACCINE AD26.COV2.S -vomiting and tingling sensation down the arm. These events are labeled per RSI and are therefore considered potentially related.
I got a metallic taste in my mouth.  I had drainage in nose, cough and was running a fever.  It got so bad; I went to Urgent care.  They did a Covid-19 test, which came back negative.  They also did a chest X-ray, which showed bronchitis and inflammation.  They give me Arborol and Prognose.  I also was taking over-the-counter medicine as well.  A week later, had a phone appointment because of the symptoms was getting worse.  I had legions on my hands and above my lip and at my nose.
Approximately 6 hours after vaccination, sharp pain began at injection site. Fever and chills, with some nausea (no vomiting). Highest fever recorded was 101.8. Fever persisted throughout the next day, while pain shifted to the right armpit and persisted for approximately 2 days. All fever, chills, nausea and pain completely gone within 5 days.
Large reaction measuring 2.5 inches by 1.5 inches. Possibly caused CTCL (cutaneous T cell lymphoma) to spread over the entire length of arms when it previously was confined to two patches.
on my way home from getting the vaccine my tongue swelled and nose started to tingle. i took 2 Benadryl. the tingling continued to my back for about 2 months everyday. occasionally my nose would tingle.
At 11:00pm on 03/23/2021 I started to feel sore from my shoulders to my knees. I also have a headache that is not relieved with ibuprofen or Tylenol. The sore muscles make it hard to walk. I did not develop a low grade fever, but I did have a few hot flashes. I?m more fatigued than normal and haven?t been sleeping well at night since the last dose of the vaccine.
No additional AE; Nurse called to report that an expired dose of PNEUMOVAX 23 was administered to a patient. Caller stated the dose expired on 9/30/2023 and was administered on 10/2/2023. Caller stated the product has not been involved in any temperature excursions. C; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 02-OCT-2023 the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # W019533 and expiration date 30-SEP-2023 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (expired product administered and no adverse event).
erythematous indurated area; mild cellulitis; no systemic signs only local; tx warm compresses & antihistimine for 14 days;
Nausea started at 6:30am the day after vaccination. Fever, aches, chills, headache, nausea started at 1pm the day after the vaccine and lasted until 8pm.
Swollen lymph nodes in the armpit area which caused pain in the armpit and arm area. First noticed  4 days after the injection and swelling got worse after that.
Left shoulder soreness worsening over 7 days after vaccine with severe pain starting at night.  Day 7 left brachial neuritis.  RX Medrol dose pak.  RX Amitriptylizine.  RX Vicodisine.
My husband and I got our third shots on Monday August 16, at pharmacy. All of our shots are from Moderna. Our #3 shots were from the same vial. My husband has had no reactions.  Here?s a summary of mine:  Day 1. By late afternoon, I began to feel weird?not just headache and joint pain but tremors in both hands and arms, a mix of chills and fever, and trouble walking. By that night, my whole body was shaking. I couldn?t sleep so took a sleeping pill (Trazadone) and eventually took another. Finally I fell asleep, but was woken up throughout the night by sharp stabbing pains in both feet, then cramps in both legs. The only remedy was to grab my feet and massage them and stretch out my legs to stop the cramps.  They would start again after a few minutes.  Day 2. I woke with a hoarse voice and severe muscle weakness and fatigue. By evening I could barely move. My hands and fingers were useless. The only way of getting in and out of bed was to crawl on my knees and elbows. I couldn?t read, watch TV, listen to audiobooks or music, or do anything but drink orange juice on my bedside table through a straw because I couldn?t hold a glass steady. I also lost bladder control, so dribbled my way to the bathroom. During this day and the next I experienced periodic crushing depression.  During these first days I was too fatigued and out of it to take my daily medications including anti-depressants. That made me depressed too.  Day 3. Still no appetite, hands still shaking too much to hold orange juice. Again, some pains in feet and cramps but not so extreme.  Had some difficulty forming coherent sentences and when I finally put the TV on I had trouble understanding what was being said. Still weak: that night I slipped getting back into bed and became wedged between the bed and my nightstand. I had no strength, was helpless, could not grab anything to pull myself up, and slept there for several hours until finally I could inch my way up and go back to bed.   Day 4. I could move again at last. Still shaking but muscle strength returned. Headache, eyes hurt. Orange juice and chicken soup.  Day 5. Better. Could get dressed and go downstairs to drink orange juice and sit. Deep fatigue. My handwriting was illegible.   Now.  Still fatigue but could drink coffee, use computer, read, and take semi-legible notes. I don?t want to drive yet but am otherwise getting back to normal.  But it?s been many days. In fact, I have not been so sick since I had infectious hepatitis 50 years ago, with a temperature of 105. Now, as then, I was too sick to be frightened or anxious.
Injection at 11:40am on Friday. Fever/chills at 2:00am Saturday morning. Fever broke at 10:00am Saturday. Extreme exhaustion throughout Saturday 11 hours of sleep Saturday night-Sunday morning made it all better. Able to golf Sunday & resume normal activities.
This is a spontaneous report from a contactable consumer. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809 and Expiry date was not reported), via intramuscular route of administration on 18Feb2021 (at the age of 65-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9264 and Expiry date was not reported), via Intramuscular route of administration on 28Jan2021 as dose 1, single for COVID-19 immunization. The patient received other vaccine in four weeks was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. Post vaccination the patient tested positive for COVID 19. On 13Aug2021, The patient experienced aches, pains, heavy cold symptoms, brief chills, headache, and loss of smell and taste. On 15Aug2021, the patient experienced positive pcr nasal swab. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 15Aug2021. It was unknown if patient received treatment. The outcome for the events positive pcr nasal swab positive was unknown and for the event aches was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Body aches; chills; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: PAIN (non-serious), outcome "unknown", described as "Body aches"; CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352467 same reporter/AE, different drug/Patients;
arm swelling/erythema/induration from shoulder to forearm, along w/ N/V/itching/pain. Went to ER, Rx'd Benadryl. N/V/pain resolved but still swollen/red
The upper half of the patient left arm around the shoulder area was swollen, red, and inflamed
Pt vaccinated with MMR/DT within 5 min developed chest tightness, nausea, exam revealed decreased BS, diffuse wheezing, VS stable, Administered Epinephrine/Alupent/Oxygen.
At immediate injection the injection site began to bleed and welt up to the size of a quarter. I appeared to have bruised. Patient was contacted 24 hours later to attest the swelling had decreased without any medication and a bruise (with soreness to the touch) remained. IBU was suggested for any discomfort.
About 4 years post vax, this pt developed "at least 20 lesions all over buttocks and especially in the rectal area. Lesions were itch and painful."
Hurting within couple of hours of injection, could not walk, seen in office 11/12/07.  Lt swollen to just below knee/tense, warm on L lateral quadrant, below inj. site.  Red-felt to be allergic phenomenon.
feel like I have been run over by a bus; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: feel like I have been run over by a bus). The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023. The patient reported this case via interactive digital media. The patient had his/her first shot yesterday (the day before reporting) and feel like he/she had been run over by a bus. The follow-up would not possible as no contact details were available.
no adverse event; patient receivedimprperly stored dose of rotateq; This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 30-APR-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (therapy type: Digital Data Logger) (ROTATEQ) one dose for prophylaxis (strength, dose, route, lot/ batch number and expiry date were not reported (product storage error). The administered dose of the vaccine experienced a temperature excursion of 35 Fahrenheit for a time frame of 8 hours as recorded by a data logger. The vaccines had no previous temperature excursion. The patient experienced no adverse event. No product quality complaint was reported. The outcome of product storage error and no adverse event was unknown.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2005USA000643:
Patient with recent diagnosis of Parkinsonian Syndrome. He was brought to the ED by EMS on 1/31/23 for evaluation of increased weakness and left sided abdominal pain. In the ED, a COVID PCR test was done which resulted positive. Patient was admitted 1/31/23 - 2/12/23. Discharge diagnoses included COVID-19 infection and acute hypoxic respiratory failure related to COVID-19/atelectasis, among other diagnoses. Initially his O2 sats were stable, however he did develop hypoxia and required supplemental O2 however he was weaned off. Patient has received the primary COVID vaccine series.
Patient received moderna vaccine on 3/10/21, 4/9/21, and 11/12/21. Found to be COVID19 positive on 1/20/22. transferred for worsening respiratory failure secondary to COVID-19 pneumonia.  Patient is vaccinated, he did test positive on 01/20/2022, symptom onset was 01/17/2022 and was hospitalized on once 01/26/2022.  He also did develop Aki on CKD stage IIIA.  Was being treated with remdesivir baricitinib, Decadron.  He did have a V/Q scan which did reveal low probability of PE.  After transfer patient was placed on BiPAP, continued to have worsening respiratory failure and eventually required intubation on 02/02/2022.  Eventually was pegged and trached on 2 15 2022.  Ultrasound of lower extremities did reveal a right lower extremity DVT therefore was started on therapeutic anticoagulation after which she did develop bleeding with acute blood loss anemia likely secondary to retroperitoneal hemorrhage.  Anticoagulation was withheld the resumed after which he did develop anemia again.  He required multiple PRBC transfusions.  He eventually had IVC filter placed on 02/14/2022.  Patient did have superimposed bacterial pneumonia and was treated with broad-spectrum antibiotic therapy, restarted having fevers on 02/10/2022.  Repeat cultures did reveal growth of yeast in sputum.  He did develop she shock likely a combination secondary to sepsis as well as hemorrhage from the retroperitoneal bleed and required pressors transiently.  Did complete course of vancomycin, Zosyn and micafungin.  Nephrology was consulted for the Aki on CKD stage IIIA which improved and was likely secondary to medications, shock.  Hemoglobins have remained stable, blood pressure is low normal and has required intermittent boluses of normal saline.  He was weaned of sedation and is able to follow commands and does not have any focal neurological deficits.  Will be transferred in stable condition to LTAC in hopes of weaning off ventilator.  At time of discharge patient's ventilator requirements were FiO2 of 35% and PEEP of 8. His anti-platelet therapy was discontinued which include aspirin and Plavix, patient may be resumed on prophylactic Lovenox for DVT while monitoring hemoglobins.  His antihypertensives were also discontinued due to borderline low blood pressures. Discharged on 2/25/22
Pt bled a little after injection, swelling/bruising noticed after injection. Advised pt to take TYLENOL for pain and apply ice to injection site ASAP. Pt developed flu like symptoms 2 days after injection.