chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 9 year old female, with no known medical history or allergies, who on 11/15/1999 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccinations. It was reported that the patient was seen on 5/2/2004 for a rash that began 4 days ago, on 4/28/2005. It was a generalized rash described as raised red, spreading and itchy. The rash was treated with calamine + camphor + Pramoxine hydrochloride Aveeno bath and cetirizine hydrochloride Zyrtec. There were no complications. The patient recovered on 5/2/2005. There were no laboratory or diagnostic tests performed. Follow up information from a health professional indicated that the rash began 4 days prior to 5/2/2005, on 4/29/2005. The rash was red, raised, itchy. It was diagnosed as varicella by the physician. The patient was reported as recovered on 5/2/2005. Additional information is not expected.
Horrible stomach pain bloating  which ended up being Appendicitis and I had to have surgery
Initial solicited report received on 12 November 2015 from an investigator participating in the study. This case involves a 36-year-old female subject who had vaccine exposure before pregnancy. The date of LMP was reported as 17 August 2015. The estimated date of delivery was reported as 23 May 2016. The mother and father's health status was not reported. The father's age was not reported. The current pregnancy history was reported as not applicable. The subject's previous pregnancy information was not reported. The subject's maternal drug exposure was not reported. The subject received a first 0.5 ml intramuscular dose of FLUZONE QIV in the left deltoid on 09 January 2014 (batch number U5338AA). The information about treatment for infertility, family history of congenital abnormality was not reported. The subject had no relevant non serious adverse event. The information about pregnancy complications was not reported. Prenatal testing was not reported. Pregnancy was ongoing at the time of report. Relationship to investigational product according to Company: associated. Relationship to investigational product according to Investigator: not reported. List of documents held by sender: none.
Day after vaccinations, patient has bilateral feet swelling, no redness or pain noted by provider, some increase of temperature at 100.3. Not other symptoms noted
The patient came in to receive his Pfizer Covid 19 Vaccine. He stated that this was his first dose and he had not received any other Covid vaccines. He also checked no on the questionnaire to the question that stated  "Have you previously received a Covid- 19 vaccine?". The registry was checked and the patient did not come up. The Pfizer vaccine was administered and the patient waited the 15 minutes for observation. He was fine after administration and left. After the vaccine was given, I went to bill the dose and his insurance rejected the claim, saying he had already received his doses.  Upon a second check of the registry, I did indeed see where the patient had received two Moderna doses in February 2021 and March 2021. We attempted to reach the patient immediately after and as well as the next day. He did not answer any of the number we had on file and the number he wrote down on his vaccine questionnaire was not a valid number. After speaking with the pharmacy that had given the first two doses, it was discovered that the patient had been coming in there multiple days a week to try and get a third vaccine because he  believed he needed  a third dose. We will continue to attempt to reach the patient to check on status.
Moderna vaccine was still in the fridge and expired-5 doses had been given; Moderna vaccine was still in the fridge and expired-5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was still in the fridge and expired-5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine was still in the fridge and expired-5 doses had been given) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was still in the fridge and expired-5 doses had been given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine was still in the fridge and expired-5 doses had been given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was still in the fridge and expired-5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine was still in the fridge and expired-5 doses had been given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reported that the patient had Flublok lot number QFAA2127 via intramuscular route in right deltoid and dose number was one on the same day when the patient received Moderna vaccine.   On 16 Dec 2021 Moderna vaccine was pulled from freezer. Beyond use date (BUD) of 15 Jan 2022 was printed in red and taped to the top of the boxes. Patient was notified of the error and patient denied adverse effects.  Treatment information was not provided.
Throat swelling (lymph nodes), pain-jawbone. Evaluated be EMS-Refusal to transport.
Profuse joint pain, nausea, vomiting and diarrhea began 36 hours after administration
Mother reports fussiness, not sleeping well, inconsolable crying (7 1/2 hrs)
Feb. 7 - 10:00 am Felt a lot of itching at site of injection.  5:00 pm Noticed pinkish bump and surrounding pink rash and slight swelling. Feb.  8 - Continued itchiness.  Bump/rash area was larger and redder,  oval-shaped, approximately  1.5" X 2". Feb. 9 - Redness and itchiness greatly reduced. Feb.  10 - Only faint pink noticeable. Feb.  11 -  All rash is gone. I did not seek any medical advise.  I read that this reaction has been observed but is not too common.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2016, the patients were vaccinated with improperly stored of PEDVAXHIB (lot # L042257 and expiration date 17-AUG-2018, lot # L051123 and expiration date 13-OCT-2018; exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that vaccines were exposed to temperature of 34.4 Fahrenheit degrees (F) for 10 minutes on 11-MAR-2016, 35.6 F for 10 minutes on 03-AUG-2016, 35.6 F for 10 minutes on 20-AUG-2016, 35.6 F for 10 minutes on 23-AUG-2016 and 35.6 F for 10 minutes on 26-AUG-2016 before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
patient started to develop a headache a few hours after administration.  the next morning the patient woke up and her face was swollen (eyelids puffy, cheeks and jawline puffy), dizzy, weak, had chills and looked pale.  She did not complain of trouble breathing, eating or drinking.  symptoms resolved later that day on 3-3-2021
Fever, Pain (Mostly My legs), Cough, Shortness of breath, and Phlegm. took Tylenol Severe Cold and Flue and Claritin - D 12 hrs. Lasted 24 hr. Started Saturday Night and ended Monday Morning. Feeling exhausted after the events.
CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever. This report was non-serious.
fever that is now around 100 degrees; chills; body aches; feel tired; This is a spontaneous report from a contactable consumer (patient brother). A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number was EW0171), (Age at vaccination 17yrs) via an unspecified route of administration, administered in Arm Left on 03May2021 08:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included food allergy of allergic to peanut from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 03May2021 the patient experienced feel tired, On 04May2021 fever that is now around 100 degrees, chills, body aches. Patient received no treatment for the event. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The response was received that Spoke from the FULL EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION PFIZER-BIONTECH COVID-19 VACCINE Prescribing Information Section 6.1 (Revised: 06Apr2021) to let caller know that fever, fatigue, chills, new or worsened muscle pain, and new or worsened joint pain were commonly reported side effects reported in the clinical trials. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-AUG-2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
ARM SWOLLEN AND SPREADING DOWN SIDE. WAS PRESCRIBED ORAL STEROID (PREDNISONE)FOR SWELLING.
got shingles twice even after I got the vaccine/suspected vaccination failure; got shingles twice even after I got the vaccine; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got shingles twice even after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Resident was found kneeling over walker with face down in the bathtub right before 1700.  Code called and initiated.  Resident pronounced dead at 1721 by EMS.
PT FELT OUT OF BREATH AND EXPERIENCING DIZZINESS. FACE WAS PALE. NOTICED THAT THE PT WAS ABOUT TO EXPERIENCE SYNCOPE, I TOLD HER TO LIE DOWN WITH HER FEET ELEVATED. AFTER 5 MINUTES, PT'S SYMPTOMS WERE RELIEVED AND DRANK WATER AND SAT FOR 15 MINUTES AFTERWARDS WHILE BEING MONITORED. NO FOLLOW UP WAS REQUIRED.
DIZZY; HEAD SPINNING; NOT FEELING HIMSELF; HYPERVENTILATING; SWEATING; WEAK; NAUSEA; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 235 pounds, and height was 61 inches. The patient's concurrent conditions included smoker, and abstains from alcohol, and other pre-existing medical conditions included patient took water pills twice a day. patient had history of illicit drug use. The patient was previously treated with oxycodone hydrochloride/paracetamol. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for drug used for unknown indication, ergocalciferol for drug used for unknown indication, and metformin for drug used for unknown indication. On 10-MAY-2021, the subject experienced dizzy. On 10-MAY-2021, the subject experienced head spinning. On 10-MAY-2021, the subject experienced not feeling himself. On 10-MAY-2021, the subject experienced hyperventilating. On 10-MAY-2021, the subject experienced sweating. On 10-MAY-2021, the subject experienced weak. On 10-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from weak, dizzy, nausea, head spinning, not feeling himself, hyperventilating, and sweating. This report was non-serious.
Severe heavy and irregular menstrual bleeding; passing blood clots; breast tenderness; no regular cycle, bleeding most days out of every month.
Soreness in left arm from the injection location down to hand with some numbness in elbow and fingers. Visited my doctor on 4/8/2021 who believed problem was a reaction to the injection and prescribed pain pills and a sleeping aid.
Patient given 2nd Hepatitis B vaccine too early in repeat schedule. Patient is in college and recently did titers which showed that she was not immune. She was repeating the series per nursing school policy. Hep. B vaccine given two weeks early. Patient was immediately made aware of situation. Patient was observed for 15 minutes and left without any adverse reactions.
no additional AE; a dose of PROQUAD on 11/12/2021 with a labeled expiry of 10/17/2021.; This spontaneous report was received from a nurse, referring to a 7-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 12-NOV-2021 the patient was vaccinated with expired one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T013536, expiration date 17-OCT-2021, 0.5 milliliter, strength and route were not provided) for prophylaxis (expired product administered. No known temperature excursions involved. Caller reports no additional adverse event.  This is one of two case from same reporter.; Sender's Comments:  US-009507513-2111USA005198:
Pt given MENACTRA and TRUMENBA 7/23/16 since being immunized started having dizziness that has not resolved possibly reactivated pts POTS. Postural Orthostatic Tachycardia Syndrome.
Delayed chronic hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Delayed chronic hives) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Delayed chronic hives). At the time of the report, URTICARIA (Delayed chronic hives) outcome was unknown.            The patient stated that she was on concomitant medications for years. Treatment medications reported were Anti-Histamines.   This case was linked to MOD-2021-407240, MOD-2021-407115 (Patient Link).
induration/lump Narrative:  Developed golfball sized indurated "lump" the day after vaccination. Resolved about a day afterwards and was associated with tenderness. No erythema, warmth, hives, pruritus, sloughing or other adverse effects noted. No therapies tried or applied to treat.
NAUSEA, SEVERE HEADACHE, VOMITING, DIZZINESS, WEAKNESS, FATIGUE
Three hours after 2nd dose developed redness and warmth at the neck, pain and swelling at the injection site,  as well as generalized fatigue. Approximately 16 hours after 2nd dose body aches, headache, significant fatigue lasting for 24 hours
Patient under age 18 was vaccinated with Moderna 020b21a, which is a vaccine error, on 4/2/2021. He received his second vaccine  Moderna  008C21A on 4/30/2021, Troubleshooting: Neither original dose vaccinator/screener nor second dose vaccinator validated birthdate.  Unreported as error, found in data mining. He was eligible for the second vaccine per standing orders. A policy requiring vaccinators/scribes to check age was instituted shortly after his first vaccine to prevent this from occurring again.
soreness in arm, struggle to raise arm back, forward to the side.  pain in muscle --aching and throbbing ...can't lay on my left arm.    Small triangle in my arm at site of injection
Narrative:  Pt is a 78y.o. male who died on 05/07/2021 w h/o bladder cancer, prostate cancer, metastatic malignant melanoma, hld, copd, cad, mitral valve replacement. Pt received Modern Covid-19 Vaccination 2/2 and 02/16/2021. Pt presented to ED with daughter on 04/22/2021 for pain control and increased level of care. Pt admitted with hospice consult, discharged to facility on 04/28/2021. Unlikely Moderna Covid-19 Vaccine caused/contributed to pt death.
Petechia 12/20, thrombocytopenia 12/21/ (Platelets 7 K). Fever 12/20 and 12/21. Platelets 12K on 12/23; back to normal on 12/27 (314K).
Extreme right foot and leg pain day after the vaccine shot. Pain improved slightly over time but came and went until it became unbearable. Deep Vein Thrombosis diagnosed 7/26/1976
On March 16th, two days after receiving my first dose of the vaccine, I started vomiting sporadically, or felt as if I had to. That lasted for 2 days. The following two days I had chills. The next day my heart started racing and I had shortness of breath. I saw my doctor on 3/23 and my blood pressure was high and remained high. As of today, my symptoms have subsided other than the occasional heart flutter and shortness of breath.
Arm was red/Skin red; Swollen arm/Arm was swollen; This is a spontaneous report based on the information received by Pfizer from Corporation (Manufacturer report number: USA-20200305623). A contactable pharmacist and a consumer reported that a 58-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at single dose for immunization; and lenalidomide (REVLIMID 25 mg, lot number: A2804A), oral from Aug2017 at 25 mg, 1x/day, (25 milligram, 1 in 1 D (day), from Jul2018 at 10 mg, 1x/day, (10 milligram, 1 in 1 D (day), from Nov2018 at 5 mg, 1x/day, (5 milligram, 1 in 1 D (day), from Oct2019 at 10 mg, 1x/day, (10 milligram, 1 in 1 D (day), from Nov2019 at 20 mg, daily, (20 milligram, 28 in 28 D (day), for multiple myeloma. Medical history included ongoing multiple myeloma. Concomitant medication included dexamethasone and ixazomib citrate (NINLARO). The patient experienced arm was red/skin red and swollen arm/arm was swollen on May2019. The action taken in response to the events for lenalidomide was unknown. Patient was treated with Anti histamines for the events Arm was red, Arm was swollen. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
5/2/21 - evening normal injection soreness. 5/3/21 - 10:00am abnormal heart rate noted 110bpm resting. Heart rate ranged between 100 - 130?s during sleep as noted on Apple Watch data. Very painful injection site and redness. 5/4/21 - 5pm heart rate back into 90 - 100 range.  Injection site redness increased in size approx baseball size and hot to touch and painful. 5/5/21  - Normal resting HR of 84 bpm.  Injection site red, size of softball, swelling and very itchy.
PATIENT COMPLAINED OF SORENESS OF UPPER LEFT ARM.  PATIENT WAS ADVISED TO APPLY ICE TO THE AREA AND IF THE SORENESS CONTINUED TO TAKE IBUPROFEN OR ACETAMINOPHEN. PATIENT WAS TAKEN TO A WALK IN CLINIC AND PRESCRIBED A MEDROL DOSE PACK ON 9/4/2015. XRAYS REVEALED NO DAMAGE TO BONE OR SURROUNDING AREA.
Massive headaches that ran over head, especially temple. I had never blood pressure issues except during pregnancy, now it flucuates up to the triple digits. Doctor put you on lisinopril but changed medications due to cough. The headaches are like massive migraine headaches. At first it would come and go and then daily, and now it just comes and goes whenever.
Pt. states that after receiving the 1st dose of Moderna 08/20/2021, started experiencing symptoms 08/21/2021 of 103.1 fever, Heart Palpations, high heart rate, and fatigue. Cardiologist recommended, Appt. 09/01/2021. Still continuing to experience symptoms.
Blood pressure issues; Fainting; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant) and BLOOD PRESSURE ABNORMAL (Blood pressure issues). At the time of the report, SYNCOPE (Fainting) and BLOOD PRESSURE ABNORMAL (Blood pressure issues) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: abnormal (abnormal) abnormal.         Concomitant product use was not provider by the reporter.  Treatment information was not provided.  Company comment: Very limited information regarding these events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information is not expected