chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was stored in the refrigerator on 14-Dec-2022 and administered on 17-Jan-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 14-Dec-2022 and administered on 17-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 14-Dec-2022 and administered on 17-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 14-Dec-2022 and administered on 17-Jan-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator on 14-Dec-2022 and administered on 17-Jan-2023).    Concomitant products were not reported.  It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The vial size was reported as 10 dose vial, it was initially stored in the refrigerator on 14-Dec-2022. The vial did not undergo any temperature excursion.   Treatment medications were not reported.
Husband reports patient became short of breath, wheezing, coughing about 3 hours post flu shot. Eyes red. Took her to ER where she was given O2 and a shot of benadryl and toBld to take an OTC Benadryl in the am.
Developed erythematous and pruritic raised rash at injection site on Day 8 that expanded until Day 13 (almost resembled erythema migrans prior to resolution). Rash resolved on Day 14. Applied topical prescription steroids on Day 9, which did not significantly improve rash. Rash essentially self-resolved.  On Day 5 developed left axillary lymphadenopathy that self-resolved on Day 11.
Systemic: Dizziness/Lightheadedness-Mild, Systemic: Hypotension-Mild.
Patient reported stomach hurt and subsequently had syncopal episode, witnessed by mom, sitting on mom's lap. Quickly regained consciousness. Pediatrician in to assess. Patient layed down, color returned, answering questions appropriately, vitals stable. Mom educated on ER precautions. Took patient home.
Pt received PCV-23 on 1/11/2017. Noted left upper arm redness/pain that day- but reported it to allergy provider 1/13/17 and here 1/13/17. Arm red/tender/edematous.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In August 2015, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In July of 2016, the patient was treated by a physician for a persistent and severe vesicular rash, 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. Additional information has been requested.
Patient received 1st Dose Covid 19 Vaccine Pfizer  3/8/2021 Patient received 2nd Dose Covid 19 Vaccine Pfizer 3/29/2021  Patient brought family member for vaccine on 3/30/2021 and beleives she received the wrong 2nd Dose.  Patient beleives they received Moderna as a 2nd dose. Clinical documetation shows otherwise, but member is insisitent.  No complaints of any adverse reaction noted.
Dtap #5, IPV# 4, Hep A #2 were administered followed by Varicella #2. Immediately following Varicella administration, patient became limp, unreponsive, eyes rolled back, tonic/clonic movements lasting about 30 seconds. Patient recovered and was oriented X3, color was pale and was warm to touch. EMS notified, patient evaluated by first responders. Mother elected to not transport via ambulance. Mother took child to Emergency Room. Discharged with not significant findings. Appointment scheduled with pediatrician in one week.
I had my vaccination on 10/27/2022. I have a history of shortness of breath, near syncope and possible heart murmur. On 01/15/2023 I started to experience a thickness and heaviness in my chest. I have follow up with cardiology in 03/2023.
painful arm; itching at the injection site; swelling of the arm below the injection site; 1 of Shingrix on September 28, 2020 / dose 2 of Shingrix on October 29, 2020; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 28th September 2020, refer case US2020218701).   On 29th October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, injection site itching, swelling arm and drug dose administration interval too short. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, injection site itching and swelling arm were recovering/resolving and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the pain in arm, injection site itching and swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had painful arm, itching at the injection site, and swelling of the arm below the injection site.  The patient received 2nd dose early, which led to shortening of vaccination schedule. The events had improved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020218701:same reporter
A lot of pain, "intense pain" at the injection site; Headache; Symptoms similar to mild flu like body pain; body pain; This case was reported by a consumer and described the occurrence of injection site pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th February 2021, the patient received the 1st dose of Shingrix. On 16th February 2021, 11 hrs after receiving Shingrix, the patient experienced injection site pain, headache, flu-like aching and general body pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain, flu-like aching and general body pain were unknown and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, flu-like aching and general body pain to be related to Shingrix.  Additional details were reported as follows: The patient had the mild symptoms. The patient had a lot of pain and intense pain at the injection site, it was not swollen or red. The patient had headache and symptoms similar to mild flu like body pain. On the day of report, in the morning the patient still had a mild headache and took Tylenol. The lot and expiration date were unknown at the time of report. The reporter consented to follow up.
Called pt o/v follow-up at 4:30 pt report 7-27-11 fever, instructed pt to go to urgent care. On follow up next day pt stated they had not gone to urgent care, told pt to go to urgent care, pt report temp 102.7 degrees F. On third follow-up pt had gone to urgent care.
Information has been received from a physician concerning a 44 month old male patient with asthma and no known drug allergy who on 23-AUG-2007, 19-NOV-2007 and 30-JAN-2008 were vaccinated with the first, second and third dose of ROTATEQ (lot number 656188/1238F for the first dose). Concomitant medications included: PULMICORT and albuterol (manufacturer unknown). On 14-MAR-2011 patient had symptoms of diarrhea and vomiting so was presented to emergency room and was admitted as an inpatient to the hospital. Laboratory test was positive for Rotavirus. Patient was treated with IV fluids and released on 15-MAR-2011. The patient fully recovered on an unspecified date. No further information is available.
SIRVA (Shoulder Injury Related to Vaccine Administration); It was injected where her shoulder joint is instead of the deltoid; She had zero range of motion in her arm; A spontaneous report was received from a nurse who was also a 23-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced incorrect route of product administration, injection site movement impaired, and shoulder injury related to vaccine administration.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 02 Jan 2021, immediately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT number 026LA20A) intramuscularly for prophylaxis of COVID-19 infection. The vaccine was injected where her shoulder joint was instead of the deltoid, and the patient experienced incorrect route of product administration.  For the first 36 hours following vaccine administration, the patient reported zero range of motion in her arm. She began to regain some function after that. She was under the care of a shoulder specialist who took x-rays, prescribed a methylprednisolone dose pack, and diagnosed her with shoulder injury related to vaccine administration (SIRVA). She was not able to work. Additional treatment for the event included ibuprofen and acetaminophen.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were not reported.; Reporter's Comments: This case concerns a 23-years-old, female, who experienced a non-serious unexpected events of shoulder injury related to vaccine administration, incorrect route of product administration, and injection site movement impairment. The event of incorrect route of product administration occurred same day after the firs dose of mRNA-1273 (Lot# 026L20A) administration. There was no reported AE associated with incorrect route of product administration. The event of shoulder injury related to vaccine administration and injection site movement impairment occurred on an unspecified date after the first dose of mRNA-1273 administration. The treatment medications included Medrol Dose Pak, Ibuprofen and Tylenol. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patients mother reports he developed chills, fever 102, vomiting, stomachache, leg pain and cough.
Initial report received on 20/Sept/2012 from a health professional who is also the patient. The patient, whose age, medical history and concomitant medications were not reported, had received dose of FLUZONE INTRADERMAL vaccine on an unspecified date (lot number, route of administration and site of administration were not reported). The evening of the injection, his arm swelled and the injection site became hard, red and very hot lasting for about a week. Additionally, the patient developed blisters in his mouth and ears on an unknown date. No further information was available at the time of report. The patient's outcome was not reported. Documents held by sender: None.
Runny nose, sinus congestion 2 days after the H1N1 vaccine, BOM, Rx with ZITHROMAX 250 zpk & RANDEC DM syrup.  Pt stable.
anaphylactic reaction; This case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2019-2020 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than a year after receiving Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved.   It was unknown if the reporter considered the anaphylactic reaction to be related to Fluarix Tetra 2019-2020 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient received Flarix vaccine in fall of 2019 and had an anaphylactic reaction. The reporter did not consent to follow-up. This case was linked with case US2020AMR229295, reported by same reporter.
Information has been received from a physician concerning a 11 year old female with no reported medical history and no drug reactions/allergies who on 12-JUN-2007 was vaccinated with a dose of GARDASIL (lot # 657868/0523U).  Concomitant therapy included a dose of Tdap.  On 13-JUN-2007 the patient developed a moderately severe injection site reaction.  The patient was seen by a physician on 14-JUN-2007.  The patient was prescribed an unspecified antibiotic for the treatment of pain, swelling and redness in the left arm.  The patient fully recovered on an unspecified date.  No other symptoms or treatment reported.  Additional information has been requested.
INADVERTANTLY GAVE REGULAR DOSE FLU INSTEAD OF HIGH DOSE- (WAS AVAILABLE) CLIENT NOTIFIED BY RN
Pt vaccinated with Pneumonia/FLU developed swelling of arm progressed down arm to the wrist. The rt arm is red, hot, swollen, & painful to move. Red streak from arm pit rt to elbow, feels sluggish.
This case was reported by a nurse and described the occurrence of rash on lower leg in a 43 year old female subject who was vaccinated with Engerix-B for prophylaxis. The subject had no pre-existing medical conditions. There were no concurrent medications. On 08 December 2005 the subject received 1st dose of Engerix-B in an unspecified arm (lot AHBVB166AA). On 08 December 2005, the subject also received a "tuberculin skin test" at an unspecified site of administration (unknown manufacturer). On an unspecified date in December 2005, on or after 08 December 2005 and on or before 19 December 2005, less than one month after vaccination with Engerix-B, the subject experienced a rash on lower leg. The rash on lower leg resolved on an unspecified date on or after 08 December 2005 and on or before 19 December 2005. Follow up to this case was received on 06 March 2006. The nurse reported on follow up that, on 23 January 2006, the subject received the 2nd dose of Engerix-B. This is longer than the recommended interval of one month between the 1st and 2nd doses of Engerix-B. The nurse reported that the subjec, "has not had any problems" following receipt of the 2nd dose of Engerix-B. The nurse considered the rash on lower leg to not be related to vaccination with Engerix-B.
This is in follow-up to report (s) previously submitted on 12/21/2008. Information has been received from a licensed practical nurse concerning a 64 year old female who on 2 days ago was vaccinated subcutaneous in right arm with ZOSTAVAX (Merck) 0.65ml (LOT# 662971/1214X).  Today the patient seen at the office with 11x6 erythema and 2 1/2 x 2 centimeter lesions at the injection site, looks like a shingles break out.  The patient's adverse events persisted.  Nurse was not interested in the VZV ID program.  It was reported the patient sought medical attention: in office.  Follow up information was received from the licensed practical nurse who reported that the patient with no pre-existing allergies, birth defects and medical conditions was vaccinated in the right thigh with a first dose of ZOSTAVAX (Merc) on 14-OCT-2008.  Herpes culture was performed and the result was negative.  Additional information has been requested. Follow up information was received from the L.N.P. who reported that the patient was a 63 year old female. There was no illness at the time of vaccination. On 16-OCT-2008 the patient developed area around site red raised and central area vesicular lesions. Subsequently, the patient recovered. Follow up information was received from the L.N.P. who reported that the patient was fine and no problem at the time of this report. Additional information is not expected.
This case was reported by a consumer and described the occurrence of swelling injection site in an adult female subject who was vaccinated with Influenza vaccine (unspecified), manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included swine influenza (in 1999). Every year, since 1994, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route and batch number, unknown arm). Since 1994, within hours of vaccination with Influenza vaccine (unspecified), the subject experienced swelling injection site, swelling bump on arm and injection site redness. Over the years she had a variety of local reactions that occurred within a few hours or by the next day. The subject contributed these reactions to vaccines that were from a multi-dose vial, but not necessarily to the preservative. She stated that these may have been due to the technique and potential confirmation from the health care practitioner. Consumer was unable to provide details on the name, lot of vaccine and reported that she did not have any of these issues whenever she received a prefilled syringe flu vaccine. At the time of reporting, the events were resolved.
Child administered expired vaccine, called HD and vaccine manufacturer.  Merck recom. revaccination based on Providers review and recommendation as they have no data.  Vaccine expired 9 days previous to administration.
No adverse event; 11-month-old patient received a first dose (0.25ml) Bivalent Moderna COVID-19 vaccine from a vial with a pink cap on 15JUN2023; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (11-month-old patient received a first dose (0.25ml) Bivalent Moderna COVID-19 vaccine from a vial with a pink cap on 15JUN2023) and NO ADVERSE EVENT (No adverse event) in an 11-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (11-month-old patient received a first dose (0.25ml) Bivalent Moderna COVID-19 vaccine from a vial with a pink cap on 15JUN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 15-Jun-2023, NO ADVERSE EVENT (No adverse event) outcome was unknown. At the time of the report, WRONG PRODUCT ADMINISTERED (11-month-old patient received a first dose (0.25ml) Bivalent Moderna COVID-19 vaccine from a vial with a pink cap on 15JUN2023) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (11-month-old patient received a first dose (0.25ml) Bivalent Moderna COVID-19 vaccine from a vial with a pink cap on 15JUN2023).    No concomitant medication was reported.  No treatment information was reported.
After Dose 1 - mild headache, fatigue, arm soreness for 2 days After Dose 2 - mild headache, fatigue, arm soreness for 2 days.  Appendicitis resulting in appendectomy 4 days later
Later that day after the vaccine I got very sick for about 4 days.  I had the shakes, my body was hot and cold to the touch.  I had a fever, severe body aches and just felt as if I had the flu.  I was administed various cold meds to help.  My sugar was just up and down from like 275-130s for about 4 days and finally all symptoms subsided
Patient tested in outside ED 1/27/2022 for COVID. Patient was admitted 02/02/2022 where he continued to test positive. Paitent expired 2/7/2022.
First dose was ok. She had what she was told what would happen, it would just be like a sore arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17May2021 17:00 (Lot number: EW0183, Expiration Date: Aug2021) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing), notes: She feels she falls in range. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jun2021, outcome "not recovered", described as "First dose was ok. She had what she was told what would happen, it would just be like a sore arm.".  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.