chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 3:38 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 3:38 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 59.85 years.  Concomitant products were not provided.  Batch number 041L20A administered on 11-Jan-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 09:00 am and 35 degrees Fahrenheit at 02:00 pm. Number of vials sent to clinic were 9. Vial moved to fridge on 08-Jan-2021 and beyond use date for these vials was reported as 07-Feb-2021. Vial was moved to clinic on 11-Jan-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
3 year old patient used his unbound free arm (left) to attempt to move/displace syringe in the middle of administration - tearing the muscle
Initial report received on 16 November 2009 from a health care professional. A 50 year old female patient developed soreness in the left axillary area with some swelling noted upon examination one day after receiving FLUZONE (lot number U3214AA) intramuscularly in the left deltoid on 12 November 2009. No reaction was present at the site of the injection. The patient's symptoms were progressing at the and the patient had not recovered by the time of the report. Follow-up information received 22 December 2009 from a health care professional. The dose of FLUZONE received by the patient had been a first dose injection. The patient had no significant medical history and she had not received any other vaccinations within four weeks of FLUZONE. The patient had been seen at the health sciences center and was diagnosed with "normal side effect of immunization". According to the reporter, the patient no longer experienced any difficulties and she had no further symptoms or complaints. The patient recovered. List of Documents held by Sender: none.
SUDDEN ONSET OF FEVER WITH CHILLS, HEADACHE, FATIGUE. NO RUNNY NOSE, COUGH, SORE THROAT, NECK PAIN, VOMITINGS. WAS FEBRILE TEMP. 102.8, NO FOCUS FOR FEVER, VACCINE SITE NORMAL. RAPID FLU TEST WAS NEGATIVE.
vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Patient said that arm feels as if it goes numb at injection site. The numbness comes and goes.
Having a delayed reaction of a bruise, tenderness and itchiness at injection site; "Covid arm"; Having a delayed reaction of a bruise, tenderness and itchiness at injection site; Having a delayed reaction of a bruise, tenderness and itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Having a delayed reaction of a bruise, tenderness and itchiness at injection site), TYPE IV HYPERSENSITIVITY REACTION ("Covid arm"), VACCINATION SITE PAIN (Having a delayed reaction of a bruise, tenderness and itchiness at injection site) and VACCINATION SITE PRURITUS (Having a delayed reaction of a bruise, tenderness and itchiness at injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Food allergy (Grapes and resins.). Concomitant products included LEVOTHYROXINE, OLMESARTAN MEDOXOMIL and ESTRADIOL, PROGESTERONE (BIJUVA) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Having a delayed reaction of a bruise, tenderness and itchiness at injection site), TYPE IV HYPERSENSITIVITY REACTION ("Covid arm"), VACCINATION SITE PAIN (Having a delayed reaction of a bruise, tenderness and itchiness at injection site) and VACCINATION SITE PRURITUS (Having a delayed reaction of a bruise, tenderness and itchiness at injection site). At the time of the report, VACCINATION SITE BRUISING (Having a delayed reaction of a bruise, tenderness and itchiness at injection site), TYPE IV HYPERSENSITIVITY REACTION ("Covid arm"), VACCINATION SITE PAIN (Having a delayed reaction of a bruise, tenderness and itchiness at injection site) and VACCINATION SITE PRURITUS (Having a delayed reaction of a bruise, tenderness and itchiness at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-185669 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Patient demographics, Concomitant medication, allergy details, second dose information and vaccination facility information were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-185669:First dose case
Information has been received on 05-FEB-2018 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 14-JAN-2016 at a health clinic, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications.  The patient was treated by a physician for a blistering vesicular outbreak which was diagnoses as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for 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.
pt w/sickle cell anemia was vaxed w/pneumococcal vax polyvalent which was later determined to be past the expiration date; No further details were provided;
Arm soreness, fatigue, nasal congestion. Slight at first, then worsening throughout the day following vaccination. Treated by nyquil and bestest for a day.
Patient received vaccine on 02/24/2021.  She was then admitted to hospital on 03/15/2021 with
pt recv vax;devel allergic rxn characterized by hives,wheezing and swelling of tongue p/ vax;tx w/ dph & sx resolved;
Suspected anaphylaxis.  Tightness in throat.  Treated with epinephrine 0.3 cc IM. Stable vital signs, no stridor, lungs clear to auscultation, no urticaria.  Patient transferred to EMS in stable condition.
Spreading redness and warmth.   240cm x 110 cm on 3/14/2021 at time of evaluation
pt reports 1 day of fever w/subsequent diffuse rash; rash persisted >10d;
Almost immediately after receiving a shingles vaccine, injection site developed hard, red lump - which was warm to the touch. Lump continues to be painful to the touch. Received the vaccine on 9/21/17 and today is 9/25/17. Hard part of the lump is about 3 inches by 3 inches. I'm a 50 year-old female, in generally good health. Since receiving the vaccine, lump has not reduced in size and continues to be red, swollen, painful and warm to the touch. My husband expressed concern when he touched my arm and felt the injection site reaction - he was especially shocked at the warmth of the red lump.
Information has been received from a consumer concerning her 16 month old daughter who on 22-AUG-2007 was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot#657780/0617U).  There was no concomitant medication.  On 29-AUG-2007, 7 days after vaccination, the patient developed a fever.  On 01-SEP-2007, 10 days after vaccination, the patient developed chicken pox.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  No further information is available.
CHILLS, FEVERISH, RUN-DOWN, FLU-LIKE SYMPTOMS.
this year was her booster shot; Could not get out of bed after taking it; Was very nauseous; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): AGN279331 (Allergan).  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation; atogepant (ATOGEPANT), since Nov2021 (Lot number: W05826, Expiration Date: Nov2023) for 2 weeks. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: Mar2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (dose 2), administration date: Apr2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Oct2021, outcome "unknown", described as "this year was her booster shot"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Could not get out of bed after taking it"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Was very nauseous". The action taken for atogepant was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On unspecified dates in 2014, the patients were vaccinated with a dose of PEDVAXHIB (dose, route, lot and expiration date were not reported) that were exposed to 52 F for 12 hours in February 2014. No adverse effect reported. It was also reported that the vaccine was supported via "in house" stability data. This is one of several reports from the same source. Additional information has been requested.
Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 1:03 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 1:03 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021 at 1:03 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment medicines were reported.  The patient did not have any adverse events and did not require any medical attention after receiving the dose.
Patient arrives at vaccine clinic and reports no issues with first dose. He questions the consent form question regarding pericarditis and says that he had pericarditis about 15 years ago. Nurse checking patient in for vaccine contacted supervising RN and asked her for the procedure regarding patients who have a history of pericarditis. RN supervisor contacted director who consulted with Dr. who stated patient was fine to receive vaccine if fully recovered from pericarditis. Patient states no issues / symptoms and wants to receive vaccine today. RN administered vaccine and patient sat in chair in observation area. After a couple of minutes patient stated "I feel like I am going to pass out" as he leaned forward out of his chair. Another patient helped him to the ground and he did lose consciousness briefly. Rapid response was called and patient assessed. Once patient conscious he denies any pain, trouble breathing, dizziness or vision changes. Vital signs stable at time. Rapid Response team arrived and took responsibility assessing patient/situation. EMT's arrived on site. Patient refused ED visit / transport and walked out of clinic on his own.
2 inch diameter patch at injection site; Reddish color at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPERSENSITIVITY (2 inch diameter patch at injection site) and VACCINATION SITE ERYTHEMA (Reddish color at site of injection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE HYPERSENSITIVITY (2 inch diameter patch at injection site) and VACCINATION SITE ERYTHEMA (Reddish color at site of injection). At the time of the report, INJECTION SITE HYPERSENSITIVITY (2 inch diameter patch at injection site) and VACCINATION SITE ERYTHEMA (Reddish color at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
Soreness to left shoulder, and surrounding area to include left scapula and bicep. Unable to lift arm above shoulder. Called Drs office 11/23/2016, was directed to take Ibuprofen and return to quick care if symptoms persist. 11/25/2016, unable to lift arm over head for more then a few seconds, weakness, causing headaches from surrounding inflammation. Returned to quick care 11/27/2016, prescribed 800 mg motrin. Directed to call DR if not better in a week. Motrin helps alleviate the pain, while taking this med. This is not a long term solution however, and pain returns when I stop.
Swelling of inside of cheek on left side - numb feeling - difficulty swallowing when taking pills. Duration from 10/9/13 to present.
Redness and swelling of arm.  Numbness of arm and fingers.  Very sore and painful arm.  Lack of mobility.
Headache, Arthralgia, Fever, SkinRash & Rash Narrative:  Other Relevant History:
Noticed a red warm spot at the site if injection the size of a 50 cent piece.
After immunizations, he started to feel dizzy and lightheaded and reported seeing flashes of lights and hallucinations.  He was treated with a steroid shot.
Patient came in pharmacy and  reported swelling from injection site to elbow, red ness in same area and high blood pressure for 4 days. when patient  came in pharmacy she had no symptoms and was feeling fine on 09/29/2021. however she said symptoms last her for 4 days from day she get vaccinated.
The sciatic pain increased dramatically after the first injection.  It was so bad that I was practically confined to my bed or chair/couch.  At first, I thought the increase in pain was due to my increasing activity level.  However, another round of steroids had no effect, and all of the other pain management strategies I normally use were ineffective.  It wasn't until the day before my second injection that I ran across information indicating that the inflammation created by the vaccine could cause joint and nerve pain.  When I arrived for the second injection, I asked the medical professional on-site about it.  She said that the vaccine could definitely have caused the severe pain I'd experienced over the last month.  She even suggested that some patients report that the second injection ameliorates negative effects of the first one. A few days after my second injection, the pain levels decreased and recently returned to pre-vaccine levels.
pale, gray limp w/clamminess;? of apnea-improved w/stimulation;episode poss 10" duration-911 called & observed after;
Series completion in September, current case of shingles/suspected vaccination failure; Mild shingles on face/Shingles from outside eye; Tingling; Pain; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix, Flu vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingrix and Shingrix and an unknown time after receiving COVID-19 VACCINE, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, tingling and pain. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, tingling and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, tingling and pain to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles, tingling and pain to be related to Flu vaccine.     Additional Information: GSK receipt date: 24-Jan-2023 Reporter's comment: The reporter reported the patient getting her 2nd dose of Shingrix in the September timeframe in between got her flu and COVID shots which she spaced out. The patient had a current case of mild shingles on left side of face from outside eye to lips.  The patient woke up a few days ago with tingling, pain and called her provider immediately. The patient was seen and prescribed a course of Valtrex which she was currently taking.  The reporter consented to follow-up. Additional supportive information: It was unknown if the reporter considered the shingles, tingling and pain to be related to COVID shots. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. As per reported information (mild shingles on left side of face from outside eye to lips), only shingles was coded as event as in shingles where outside the eye not inside.
I experienced much pain at the injection site but the worst was a pain in my upper abdomen that began about 9 hours after the shot and has persisted for 24 hours or so. Some relief with eating and ibuprofen. Pain still very real and uncomfortable.
Paresthesias of left arm occurring within 3 to 4 hours of injection. She didn't necessarily describe it as pain, just sort of a tingling or numbness.
severe fatigue for 2 days; moderate injection site pain ~12 hours after injection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 15:00 (Lot number: ER8732) at the age of 52 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Mar2021, outcome "recovered" (2021), described as "moderate injection site pain ~12 hours after injection"; FATIGUE (non-serious) with onset 28Mar2021, outcome "recovered" (Mar2021), described as "severe fatigue for 2 days". Therapeutic measures were taken as a result of vaccination site pain, fatigue.  Additional Information: The patient had no known allergies, that is no allergies to medications, food, or other products. The patient was not tested covid prior and post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was treated with ibuprofen 600mg q6h for the adverse events.   No follow-up attempts are possible. No further information is expected.
within a couple hours of receiving the vaccine i had a headache and felt tired.  at 3am that evening i woke up with muscle, joint, bone aches that lasted through the night, uncomfortable enough that it prevented me from sleeping. I took tylenol the next morning and it felt better.  by 2PM the next day I had a fever of 100.  It increased to 101.5 by 6pm.  i had chills, body aches, felt horrible (flu like).  it started to go down around 9pm.  I woke up the morning of the 16th feeling much better (vaccine was given morning of 14th), all symptoms gone, EXCEPT my armpit is hugely swollen and painful. it has grapefruit sized swelling and throbs.  it is under my right arm, which is the same side I had the vaccination on.