chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 10 year old daughter with oesophageal acid reflux who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine along with varicella virus vaccine live (Oka/Merck) (MSD).  Concomitant therapy included (PREVACID).  On the week before second dose, the patient experienced cold symptoms and strep throat.  On 26-AUG-2008, the patient got a strep throat test, and the outcome of strep throat test was negative.  So, on 26-AUG-2008 the patient was vaccinated with the second dose of GARDASIL vaccine.  On 08-SEP-2008, the patient was taken to the ER with signs of appendicitis.  Since then, she took the CT scans, bloodwork, endoscopy, colonoscopy, and X-rays, and the outcome of those tests turned out normal, but her condition is getting worse.  On 09-SEP-2008, the patient developed rash on her belly and left eye.  The patient experienced stomach pain, abdominal pain, back pain, headaches, dizziness. It hurts the patient to lift her arms above her head, cross her legs due to pain during sleep.  The patient was given DICYCLOMINE (manufacturer unspecified) "in case she had irritable bowel", but this therapy resulted in dizziness.  Patient's adverse events persisted.  The patient sought medical attention in the ER.  Additional information has been requested. 12/11/08 Received PCP medical records.  FINAL DX: none provided Records consist of Neuro consult done 10/28/08 for HA, dizziness & abdominal pain which started approx 10 days after HPV#2.  Had gone to ER for abd pain on 9/8/08, w/u WNL.  9/19 RTC w/bilateral serous OM. 12/12 RTC w/pharyngitis.  GI consult for endoscopy, colonoscopy, CT & US.  Had psych eval which was WNL.  Ophtho eval.  No further records available.
Patient developed temp of 100.7-102,  chills, loss of appetite, abdominal pain and nausea, bodyaches, and slight swelling at injection site but no redness or warmth
weak; discomfort in my midsection as though I'm going to throw up; chills; This spontaneous case was reported by another health care professional and describes the occurrence of ASTHENIA (weak), DISCOMFORT (discomfort in my midsection as though I'm going to throw up) and CHILLS (chills) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak), DISCOMFORT (discomfort in my midsection as though I'm going to throw up) and CHILLS (chills). At the time of the report, ASTHENIA (weak), DISCOMFORT (discomfort in my midsection as though I'm going to throw up) and CHILLS (chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 06-OCT-2016, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX vaccine, the patient suffered reactionary arthritis manifested by migratory inflammatory arthritis and enthesitis, tender subcutaneous nodules, and purpura skin lesions a few days following the vaccine. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the use of the ZOSTAVAX vaccine, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The event of reactionary arthritis and purpura skin lesions were disabling. Additional information has been requested.
Normal sore arm in the beginning.  A week later, I heard/felt a pop in my shoulder.  My shoulder has been sore ever sense.  I have tried applying heat and cold, but hasn't helped.  Also tried anti-inflammatory. Pain is starting to move to my neck.
She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 28-OCT-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259: US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266:
This spontaneous report was received from an unspecified reporter referring to a female patient of unknown age who on 05-JUN-2014 was vaccinated with a dose of VAQTA (lot # J000985, expiration date 20-AUG-2015) in the left deltoid. These were their out of range temp logs and the vaccines that had been administered to the patient. Additional information has been requested.
pt stated vax site became infected & they went to ER & recvd ATB; 4AUG MD noted sterile abscess;
Moderna vaccine was administered outside of the clinic - reported by patient   PULMONARY EMBOLISM, UNSPECIFIED. 7/11/2021 CHRONIC HEPATITIS C  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 6/8/2021 CHRONIC HEPATITIS C  PULMONARY EMBOLISM, UNSPECIFIED. 7/11/2021 ATRIAL TACHYCARDIA  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 6/8/2021 ATRIAL TACHYCARDIA  PULMONARY EMBOLISM, UNSPECIFIED. 7/11/2021 MALIGNANT ASCITES  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 6/8/2021 MALIGNANT ASCITES  PULMONARY EMBOLISM, UNSPECIFIED. 7/11/2021 SMALL BOWEL OBSTRUCTION  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 6/8/2021 SMALL BOWEL OBSTRUCTION
The pt experienced hives with itching near site of vaccine. No spreading, no systemic symptoms.
MOM REPORTS THAT AFTER THESE VACCINES WERE ADMINISTERED HER SON DEVELOPED MEDICAL ISSUES AND SEIZURES.
Received vaccine 10/04/18. Experienced flu-like symptoms starting 10/05/18. On 10/06/18 woke up in the morning covered in hives and inoculation arm/deltoid very red.
Covid arm where her arm swelled up; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE SWELLING (Covid arm where her arm swelled up) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE SWELLING (Covid arm where her arm swelled up). At the time of the report, MYALGIA (muscle pain), ARTHRALGIA (joint pain) and VACCINATION SITE SWELLING (Covid arm where her arm swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. After her 1st shot patient had muscle and joint pain and after 10 days got Covid arm where her arm swelled up.   This case was linked to MOD-2021-346094.
Admin error. Vaccine was given to patient who was experiencing symptoms of shingles infection (rash on buttocks).  Per CDC, Shingles vaccine should NOT be given to patients with active Shingles infection. Patient is currently hospitalized and being treated for disseminated HSV infection.
11 days after my second injection, I developed a fever (100.9), intense body aches, chills, and severe fatigue that lasted roughly 36 hours, after which I was completely back to normal with no fever.
Hives on her neck; Redness; Swelling; Ears were burning; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on her neck), ERYTHEMA (Redness), SWELLING (Swelling), EAR DISCOMFORT (Ears were burning) and ARTHRALGIA (Joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced URTICARIA (Hives on her neck), ERYTHEMA (Redness), SWELLING (Swelling), EAR DISCOMFORT (Ears were burning) and ARTHRALGIA (Joint pain). At the time of the report, URTICARIA (Hives on her neck), ERYTHEMA (Redness), SWELLING (Swelling), EAR DISCOMFORT (Ears were burning) and ARTHRALGIA (Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included diphenhydramine for the relief of symptoms but no effect.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
flublok was administered to a patient under the age of 18/ was 16 years (with no reported adverse event); Initial information received on 21-Nov-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 16 years old and unknown gender patient to whom  flublok was administered  (with no reported adverse event) after receiving influenza quadrivalent recombinant vaccine[flublok].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On 06-Nov-2022, the patient received a 1 dosage form  of influenza quadrivalent recombinant vaccine (lot QFAA2238, expiration date:30-Jun-2023) (with unknown formulation, frequency, strength, route and  in unknown administration site) for influenza.   On 06-Nov-2022, 16 years old patient who received vaccine which was indicated for 18 and older people( Drug use in unapproved age group ) (with no reported adverse event) (product use issue) (latency: same day)following the administration of influenza quadrivalent recombinant vaccine  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Pain at site of shot,  which recurs, but is only bothersome.    Fatigue still happening, slightly lessening, but still sometimes causing , with mild exertion, Tiredness to the point of going to bed and sleep.  average sleep per night 9 hours.
Local, inflammatory response to DTAP left arm 11 x 14cm.  Treated with CLARITIN 10mg, Tylenol.
Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 65 years old male patient who received two does of vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication taken. On 07-Sep-2018, the patient received two 0.5 ml doses of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI985AC (expiry date: 30-MAR-2019) twice in the left and right deltoid. It was a case of actual medication error due to extra dose administered. No adverse event observed at the time of reporting.. 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 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.
Administered expired Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was on 14 Sep 2021. No temperature excursions reported. The patient did not report any other adverse events. No treatment information was provided.
Patient slumped over shortly after receiving her vaccines, fainted and sustained seizure like movement for approx. 3-5 seconds. Patient awakened immediately and was monitored for an hour afterwards by the school nurse. Patient felt better and went back to her classroom.
Hep B 20 mcg given IM right deltoid.  Pt. immediately c/o feeling pain to right deltoid; became dizzy, vasovagal; BP to 80 HR thready, Pt pale.  Diffuse swelling noted to right deltoid.
Patient presented with red swollen arm. Patient stated she wasn't able to move her arm and it is painful.
The first problem I noticed were flashes of light in my vision. Then it changed to floaters and sparkles on my right eye. I went to retina specialist. The primary vision doctor noticed a cataract problem with the left eye and then later when I went to visit the specialist for the right eye, they noticed the same thing in my right eye. I require surgery this week for the problem.
chest pain Narrative:  Patient received dose #1 of Pfizer COVID vaccine at vaccination site on 2/7/21 and subsequently presented same-day to Hospital with complaints of chest pain, mild shortness of breath , weakness and headache. He tested +COVID on admission that same day.
p/1st vax pt was sluggish & unresponsive for 3 days reported to MD 20OCT93; no lingering effects noted by mom;
Bilateral calf pain. Hurts to touch. No known muscle strain. No redness.
My face became "tingly" almost immediately, especially around my nose and side of my face; my throat felt like it had a lump in it and it felt as if I could feel my heart beating in that lump; my heart felt rapid/fluttery; my head hurt and I felt dizzy with slightly blurred vision.   I was kept at the facility extra time (around 40 minutes in total) and left with a friend to return about an hour or so later to drive home.   I did not have any difficulty breathing but did have some rashy/redness on my chest but that is not unusual for me when I am having any kind of distress.  The other s/s were not typical for me.
Starting ~12 hours after vaccination, developed nausea, headache, malaise, exhaustion, fevers (to 101.5), chills, sweats, myalgia, arthralgia.  Symptoms improved after sleeping.  Those that persisted were less severe myalgia and arthralgia, improved malaise.  Symptoms resolved entirely by 48 hours.
1. Chills, myalgia, soreness in arm, swelling in arm, by 4 hours after injection. 2. Continued as above plus acute severe vomiting epidodes at 2:30 am. Empty stomach, one time event occurance. 3. Contiued malaise, chills next 36 hours, afebrile. Stayed in bed throughout. 4. Swelling and redness in left arm, descending some, afebrile. Reported to pharmacy. Took 200 mg ibuprofen 5. Unresoved at this time 6. Seasonal flu vaccine administered at same time.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 13-OCT-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had multiple excursions varying from 28.9 degrees Fahrenheit (-1.72 degrees Celsius) (lowest recorded temperature) for 48 hours to 64.8 degrees Fahrenheit (18.22 degrees Celsius) (highest recorded temperature) for 24 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received 3rd dose of Prevnar at 9 months. However, dose was given too early since last dose was given to patient at 7 months of age. Patient will return to office in July to receive next dose of Prevnar.
Noticed a headache & general tiredness 5 days after injection. Developed itchiness & redness at injection site. Slightly raised hive appeared, no rash or hives anywhere else
Initial report was received from a patient on 26 October 2011. A 31-year-old female patient had received a FLUZONE injection in deltoid, lot number U3719AA on October 2010. In October 2010, the patient developed constant pain in her arm and up her neck at times, swelling and hot at injection site. She also experienced limited range of motion. No further informational was available at the time of the report. The patient outcome was reported as resolved/recovered. Follow-up information was received from a consumer on 30 January 2012, who is also the patient. The patient concomitant medications included fluticasone and PREVIFEM. No further information provided. Documents held by sender: none.
feel sleepy; headache; body ache; feels weakness; This is a spontaneous report received from a contactable consumer(patient). A male patient received BNT162B2 (COMIRNATY- solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 16Aug2021 night, at dose1, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine made by Pfizer on Monday night of last week, 12 hours later on 17Aug2021 he began to feel sleepy, headache and body ache, today he still had a headache and felt weakness, the patient wants to know if this is normal. He has been taking serum (PENDING CLARIFICATION). The outcome of the events for feel sleepy and body ache were unknown while for headache and body ache were not recovered at the time of report. The lot number for BNT162b2 was not provided and will be requested during follow up.
No other AE details available at this time.; Caller reported temperature excursion.; This spontaneous report as received from a registered nurse referring to a 4 years old patient of unknown gender. The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were unknown.  On 25-NOV-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status recombinant human albumin (rHA)) (strength and route were not reported, lot # T021638 has been verified as valid, expiration date was reported as 21-FEB-2021, but upon internal validation established as 21-DEC-2021) 0.5 ml for prophylaxis.  The administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced product storage error with temperature excursion: minus 13.3 degree Celsius, time frame: 4 hours and 15 minutes. There were no previous temperature excursions. The digital data logger was involved. No other adverse event details available at the reporting time.
mom states on day vax was given by bedtime pt had blister-type lesions on leg vax was given in; next AM had welts, fever 102; then devel diarrhea & vomiting; became dehydrated; sxs lasted 2 weeks; MD advised against further vax;
Moderna COVID-19 Vaccine EUA A few days after getting the first dose, I got blisters on both hands (palms & back of hands) and feet (top and bottom). The blisters were red, itchy, and painful. It was painful to bend my fingers, or hold anything in my hands. The blisters were also painful when I was walking & standing up. When I was washing my hands and feet, it was also painful. To treat it, I used Cortizone 10, Allegra, and Tylenol. The blisters lasted a total of 4 days and after they were gone, my skin started to peel off in areas where I got the blisters.