chrisvoncsefalvay/vaers-outcomes huggingface dataset:
318 patients received dose from vials beyond 30-day use by date; 318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021)) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021)). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 07-May-2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult male patient who received SHINGRIX for prophylaxis. On 28th September 2018, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site rash and injection site muscle pain. On an unknown date, the outcome of the injection site rash and injection site muscle pain were not recovered/not resolved. It was unknown if the reporter considered the injection site rash and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient was a physician. The age at vaccination was not reported. The patient received a dose of SHINGRIX on an unknown deltoid. The patient experienced tenderness at injection site. The patient was provided the limited information to the reporter.
Right deltoid swollen red warm to touch febrile 101.8 rectal temp dr called was told was normal reaction 10/28/2016 child arm doubled in size warm to touch red child taken to urgent care placed on amoxicillin 1/2 tsp 1xday. For cellulitis on 10/30/2016 pediatrician notified patient was screaming in pain was worse child taken to hospital told patient had abcess and switched to clindamyacin 4ml 3xday. On 11/3/2016 child taken to pediatrician for reevaluation of arm pain and hardness in area no better was told to continue antibiotics give Motrin 7.5ml around clock and 5ml of Claritin and follow up Monday 11/7/2016 for evaluation see if needs to be drained.
This is a serious literature case, initially received on 19-Feb-2019, concerning a 65-year-old, elderly male patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. All serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician's diagnosis were reviewed. The patient had no historical condition. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 15 minutes after vaccination, the patient experienced airway swelling and cardiopulmonary arrest. Autopsy was performed, and the cause of death was reported as anaphylactic shock. The reporter assessed this case as serious (death).; Reporter's Comments: A 65-year-old, male patient developed airway swelling and subsequent fatal cardiopulmonary arrest, 15 minutes after administration of INN Flu Vaccine. The autopsy reported the cause of death as anaphylactic shock. Considering the plausible temporal relationship between vaccination and reported fatal events and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event 'anaphylactic shock' as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic shock.
twitching, spasms both thighs, muscle aches all over;twitching & spasms of both thighs, quivering in front or both thighs were presented by pt in ER p/vax;
HOSPITAL COURSE:   Patient was admitted for SROM at term with GBS+.  She was incidentally found to have COVID on admission.  She was vaccinated and boosted for COVID.  She was induced and delivered vaginally.  She had a fever at the end of Stage 2 and immediately postpartum and was started on IV antibiotics.  She defervesced within many hours and ABX were continued for 24 hours.  She developed no severe sx of COVID.  She did have a postpartum hemorrhage and is on oral Iron.  Her lochia is acceptable today.  Gestation info at delivery: 39 weeks 1 day Date of delivery: date  Birth Weight:  3.910 kg
Local vaccine reaction of VARIVAX on left tricep (red, warm to touch about 2 inches nodule at injection site with minimal pain). Advise TYLNEOL, BENADRYL x PRN.
sleepy; itchy throat; sore arm; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), THROAT IRRITATION (itchy throat), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy), THROAT IRRITATION (itchy throat), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and CHILLS (chills). At the time of the report, SOMNOLENCE (sleepy), THROAT IRRITATION (itchy throat), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Shingles; This is a spontaneous report from a contactable consumer (patient daughter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no. was not reported) via unspecified route, as 1st dose, single dose on 10May2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that patient had the vaccine shot on 10May2021, she developed Shingles on an unspecified date in May2021 (last week). Reporter also stated that patient had second vaccine on Monday, the 31May2021 so she wanted to know if it was safe to do it with Shingles. Patient did not take any medication yet for Shingles because she wanted to make sure before that if she could get the vaccine first and maybe she would start the viral medication after. Reporter googled it and there were many people to get this related to the vaccine. The clinical outcome for the event was unknown.  Information about batch/lot number has been requested.
Extreme shoulder pain immediately upon receiving shot.  Arm became sore and unable to move or lift arm.  I have extreme muscle pain around the shoulder. Mobility of the are is very limited and constantly aches. It is hard to sleep. I am about 7 weeks out from receiving the shot and my arm is still injured.  I was prescribed Meloxicam 15MG after visiting doctor on March 11, 2021. I was told I have shoulder tendonitis.
An adult dose of Pfizer Bivalent covid vaccine was administered to an 11 year old child.  Child did not show immediate signs of injection site reaction, nor did the child show immediate signs of allergy or requirement for immediate medical care.  Multiple follow ups have been attempted towards the parents to inquire about the wellbeing of the child.
pt had red bumps on legs since shortly p/shots given; bumps becoming greater in number & now over body; dx by MD eczema; given cream for which alleviated sx;
Patient was fully vaccinated as of 3/15/2021. Patient became symptomatic and became positive as of 9/22
No adverse reaction noted with patient; Temperature excursion in freezer, was instructed vaccines were okay to use; This spontaneous report was received from a certified medical assistant, concerning a 16 months old female patient.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose or anatomical location were not reported) with lot # reported as T007359 with expiration date on 29-AUG-2021, administered subcutaneously, for prophylaxis; she also received fist dose of hepatitis A virus vaccine inactivated (HAVRIX) (strength, dose, anatomical location and indication were not reported) lot # 7595K with expiration date on 30-DEC-2021, administered intramuscularly (IM); both at a public clinic, with public funds, by a trained operator. It was reported that there was nothing wrong with the vaccines which were used according to the instruction leaflet; however, they underwent a temperature excursion in the freezer before administration and the vaccine provider was instructed that the vaccines were okay to use (product storage error). No digital Data logger was involved. No adverse reaction was noted in the patient.  Lot number T007359 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA001768:
Lymphadenopathy, painful mass size of tennis ball reported in axilla of vaccinated side
Onset of itching, followed by hives over whole body except face until 11/19/2013.
Angioedema Thoart sweling Narrative: ED Visit with EPI Pen given
back of neck pain, shoulder pain and swelling above left clavicle since first vaccine (over 3 weeks) 7/10 pain
This case was reported by a consumer via call center representative and described the occurrence of sensation of blood flow in a female patient who received FLUARIX QUADRIVALENT (batch number DX4SN, expiry date unknown). On 11th November 2015, the patient received FLUARIX QUADRIVALENT. On 11th November 2015, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced sensation of blood flow and foot pain. On an unknown date, the outcome of the sensation of blood flow and foot pain were recovering/resolving. It was unknown if the reporter considered the sensation of blood flow and foot pain to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: On 11th November 2015, around noon, the patient received a dose of FLUARIX QUADRIVALENT. On 11th November 2015, in evening (several hours after) receiving FLUARIX QUADRIVALENT, the patient experienced feeling pulsating or transient pain inside of her foot (unknown foot). The patient experienced pain for the whole night on 11th November 2015 and for the whole day and night on 12th November 2015 and on 13th November 2015, by the noon the pain was subsided. The patient did not see any discoloration and the pain did not travel up her leg. The patient stated that, she did nothing that could trigger the pain in her foot. The injection site was unknown and no other information was available.
Patient noticed redness and some itching localized to right arm where a shingles vaccine had been given on 11-28-14 at approx 13:11 SQ. Patient seeking medical attention today 11-30-14 at 18:00. PA treatment recommendations of NSAIDS, ice and antihistamines.
fatigue, chills, sweats; lasted four days, starting on the 14th.   Got tested - negative.  Swollen glad on left side of neck lasted only a day.
Headaches all the time, dizziness, nausea, shortness of breath, wheezing, joint pains unusual tiredness, weakness, leg pain, generally feeling unwell and being sick all the time, stomach pains, depression, anxiety, the shot has caused me to fall (reported at the doctors that I fell and twisted my knee, this was after the first shot. I was getting up off the couch and I felt horrible joint pain in my knee, it made me fall because it hurt so bad, and also miss alot of school at the time, its really hard for me to work now.  I have pains all over and Drs still dont know why. My mom told me last night that her co workers friend has fibromyalgia from the shot and maybe that is what I have because of the shot.
Hypersensitivity of scalp only on left side, with occasional pain, several small blisters on scalp behind left ear, itchy & occasionally painful, intermittent pain in left ear canal. Self-treated with ibuprofen for pain. Cleared up completely after 4 weeks.
The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine were given on 08-Aug-2022 (BUD 30 days); No adverse event; We had the pediatric Moderna Covid-19 vaccine with a BUD of 07-Aug-2022, doses of that vaccine were given on 08-Aug-2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07-Aug-2022, doses of that vaccine were given on 08-Aug-2022.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine were given on 08-Aug-2022 (BUD 30 days)) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07-Aug-2022, doses of that vaccine were given on 08-Aug-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine were given on 08-Aug-2022 (BUD 30 days)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07-Aug-2022, doses of that vaccine were given on 08-Aug-2022.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine were given on 08-Aug-2022 (BUD 30 days)) 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 (We had the pediatric Moderna Covid-19 vaccine with a BUD of 07-Aug-2022, doses of that vaccine were given on 08-Aug-2022.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine were given on 08-Aug-2022 (BUD 30 days)).    No concomitant medication information provided. On 08-Jul-2022  the vial was initially stored in the refrigerator. The vial  had not undergone  any temperature excursions. The AE did not cause patient to seek medical care. No treatment medication information provided.
Bilateral orbital swelling. Treated with Claritin Reditabs and Prelone 20mg po.
Pt. seen at PCP on 2/13/17 for 2 mo WCE and rec'd routine 2 mo vaccinations. Seen in OV 2/15/17 with c/o vomiting and blood in stool x 2 (2/14/17). Afebrile; fussy/irritable. Sent for ABD. U.S. - normal. Pt. recovered; PCP considering no 2nd dose; none given.
premature menopause; ovary got shut down; lot of jerking; Involuntary muscle movements.; Almost 100 hot flashes a day all thru the night for every few minutes.; fever; chills; A spontaneous report was received from a consumer concerning a 37-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events almost 100 hot flashes a day all thru the night for every few minutes/ Hot flush,  involuntary muscle movements/ Dystonia,  a lot of jerking/ Tonic clonic movements,  fever/ Pyrexia,  chills/ Chills, premature menopause/ Premature menopause,  ovary got shut down/ Premature menopause.  The patient's medical history was not provided. Concomitant medications was also unknown.  On 10 Feb2021., prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly on left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, After 8 hours the patient experienced the event involuntary muscle movements, a lot of jerking, fever, and chills. She went to premature menopause at young age. Her ovary got shut down Estrogen is extremely low and FSH is extremely high. Almost 100 hot flashes a day all thru the night for every few minutes.   Treatment information was provided As offered birth control pills/therapy and hormonal therapy by the doctor. But she wants to take sometime before she start the treatment.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s). s Almost 100 hot flashes a day all thru the night for every few minutes/ Hot flush,  involuntary muscle movements/ Dystonia,  a lot of jerking/ Tonic clonic movements,  fever/ Pyrexia,  chills/ Chills, premature menopause/ Premature menopause,  ovary got shut down/ Premature menopause was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
The patient was not experiencing any adverse events at the time of the call; an adult patient received ProQuad and Varivax during the same visit; An adult patient was supposed to receive MMR II and Varicella but the patient inadvertently received ProQuad and Varivax; This spontaneous report was received from a nurse concerning an adult patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was supposed to receive Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), however they were inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (wrong product administered), administered for prophylaxis (strength, dose, lot #, expiry date, route of administration, and anatomical location were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, lot #, expiry date, route of administration, and anatomical location were not provided) (accidental overdose). The nurse added that the facility just switched to measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for child vaccines so inadvertently the patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and  varicella virus vaccine live (oka/merck) (VARIVAX). The patient was not experiencing any adverse events at the time of the call.
Fever, Headache, dizziness, arm pain, extreme exhaustion, chills, muscle and joint pain for 48 hours after the vaccine
Pt had a fever of 103.7, when pt came in for a follow up on 7/10/14 his temp ws 94.9 tympanic problem had resolved.
Three days after the vaccine, I began having severe muscle spasms in the right side of my neck, the right side of my spine and in my upper chest. These pains were excruciating to thed point where I could barely move without the spasms occurring. My husband had to help me use the bathroom. I was unable to lie down in bed due to the nonstop spasms. These brought me to tears. By Monday morning, the back and neck spasms subsided leaving the ones in the chest which persist today (Tuesday). My neck is sore and I have limited range of movement of my head. I am taking Advil for the residual pain.
Felt ill within hours of receiving vaccine - fever, chills. Progressed to sore throat and full illness by 9/17/2013. Continued to worsen. Diagnosed with viral pneumonia 09/21/2013.
Caregiver noted pt had a hx of seizure post Tdap in 1970's. Pt's caregiver noticed redness and swelling below pt's vaccination site on R arm at 1630 PM (12mins post vaccination). Pt transferred to the triage area. NP assessed. VS taken: BP 113/82, HR 92, SpO2 100% on RA, and resp 16. No signs of distress noted. Ice pack applied to R arm. VS retaken at 1654 PM BP 109/81, HR 63, SpO2 100% on RA. Redness and swelling improved No SOB or distress. Pt discharged from vaccination clinic in stable condition w/ redness and swelling improved. ED precautions discussed. Pt and caregiver expressed understanding.
This spontaneous report as received from a healthcare worker and nurse refers to unspecified patients. Medical history and concomitant medications were unknown. The nurse reported that improperly stored doses of GARDASIL were given to unspecified patients on unspecified dates. No adverse experiences were reported. No product quality complaint (PQC) was involved. The outcome was unknown. The case is also related to 1506USA009859, 1507USA001113 and 1507USA001115 (same reporter link). Additional information has been requested.
ABNL UTERINE BLEEDING DUE TO COAGULOPATHY 3/9/2023  &  3/1/2023  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
palpitations, racing heart, lightheadness, shaky, chest pressure began approximately 3 hours after vaccination.  Extreme fatigue and vertigo began the following morning.  All Symptoms persisted 03/01/21 went to Urgent Care and was sent to emergency room.  Gave her toradal and tylenol in ER.  Took NSAIDS and rested without relief symptoms.  Seen in PCP clinic on 03/15/21- started on indomethacin and colchicine.  Mild improvement noted in fatigue after completion of treatment, but otherwise symptoms have persisted.  Scheduled to see Cardiologist 04/16/21.