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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 2:08 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 27-Oct-2021 at 2:08 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 82.14 No concomitant medications were reported. On 27-Oct-2021 at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit and vial was initially moved to the fridge on 29-Sep-2021 and beyond use date was 29-Oct-2021. Product moved to clinic on 27-Oct-2021, and at 10:00 Am the temperature recorded was 32 degree Fahrenheit and vial was initially moved to the fridge on 05-Oct-2021 and beyond use date was 04-Nov-2021. Product moved to clinic on 27-Oct-2021.  Vial was stored on cooler 1, on 27-Oct-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45. 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 traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
On March 7, 2002, 35 days after my third hepatitis B vaccine, I woke up blind in my left eye.  The near total blindness lasted about 4 months.  The vision has gradually improved, but is far from normal.  I still go blind when I am in sunlight or bright light.  My indoor vision is limited.  I saw my primary physician a few days after the blindness set in.  She immediately sent me to see an emergency opthamologist.  The opthamologist told me I might have a brain tumor or MS and ordered a CAT scan.  Since this doctor was only an emergency doctor, I was told to see another opthamologist a few days later.  This doctor told me I might have MS and he ordered an MRI.  He told me what I had was optic neuritis.  He also referred me to a neurologist. The neurologist found no neurological problems.  The CAT scan was negative for abnormalities.  The MRI showed only the lesion on my optic nerve.  I have been having check-ups every few months with the opthamologist.  I saw a third opthamologist/retinal specialist in April/03.  He said I had idiopathic retro-bulbar neuritis.  I recently became aware through a friend of the connection between hepatitis B vaccines and optic neuritis.  This week I began researching the possibility on the internet.  I believe the vaccine was the cause of my illness, but I have not been to my doctor to discuss this yet.
- Major depressive episode - beginning the day after, I experienced a major depressive episode lasting approximately 10 days. I found myself crying on and off all waking hours, felt extreme sadness, and existential dread. I even experienced suicidal ideation, which has NEVER happened before. I have no history of depression prior to this.  I received no treatment - I let it pass.  - Eczema - I have never had a history of eczema, even as a baby. I began getting rashes around both eyes and a large patch on my neck beginning roughly 20 days after my vaccine. Red, inflamed, flaky, dry patches. Eczema is ongoing, I still have a large rash on my neck and tragus of my ears that I have to moisturize vigorously to control.
Patient states  later in the evening, she had experience generalized weakness and dizziness.  The dizziness got worse as the evening progressed.  She had bodyaches, decreased appetite and felt nauseated due to the headache.  She also had cellulitis on her right upper arm when the vaccine was administered.  Patient returned to office on 6/2/2020 and was treated for the cellulitis of right upper arm.  Patient contacted on today, 6/3/2020, states that symptoms are improving.
This patient was seen by a floating pharmacist for her first shot in the two part series. When the patient came back for the second dose in the series, she mentioned that when she got the first shot in the series, what she felt was a significant amount of the vaccine dribbled out of the injection site. She was worried that she didn't get the full immunity conference. I did my normal questions about her physical well being and she had visible rash around her eyes. Upon further questioning, she mentioned that she has eye problems related to certain drops she uses for eye conditions and she was in a cycle currently that she was having a reaction to. I continued to discuss this and told her to definitely follow up with her eye doctor bc her eyes looked like they were in acute distress. She assured me that this has happened before and that she would. Not more than 4 hours later she returned with a Valtrex rx for eye shingles. Now she worries that the first shot wasn't effective bc of the dribbling out of the medication and that the second one that was given was during a current outbreak and that she will not get full coverage.
Moderna Covid-19 Vaccine EUA.    I got my vaccine at 3:00 on February 11. My right arm was a little sore for about 24 hours.( but not as sore as when I got my flu shot in October.)  On Friday night the following week, I was on the couch watching TV and suddenly my upper right arm started itching.  I felt it, and there was a bump there, maybe an inch in diameter. I first wondered if maybe it was associated with the Covid vaccine, but it was a little lower on my upper arm than where I got the shot, and I assumed any reaction would occur shortly after I got the shot, not 8-9 days later.  I decided it was probably a bug bite. It still itched somewhat the next morning.  The itching went away later that day but the bump remained until the following day. (Sunday)  I didn't think anything about it until my husband told me yesterday that 2 friends recently had a similar delayed reaction after getting their Covid shots.  Today I did some research online that discussed "Covid Arm," and I wondered if maybe that was what happened to me.   I looked at the paperwork I received with my vaccine and it suggested either calling or emailing the FDA/CDC Vaccine Adverse Event Reporting System.  The reaction wouldn't prevent me from getting my second shot, but I thought it important that I report what happened.
Beginning 6 days after injection I noticed a couple of itchy bumps on my right arm. Over the course of a week, it morphed to take over my entire forearm in a blistering rash. Bumps also began to pop up on my stomach, buttocks, legs, chest and ears. I made an appointment with a doctor who prescribed an 11 day high dose taper of Prednisone and an antihistamine. While taking it, the rash subsided, but once finished, the rash began to come back. I currently have multiple itchy welts on my right arm, right hip, left arm, stomach and thighs. I had a follow up yesterday and was prescribed a topical steroid. I worry that I now have a chronic condition. It has been over a month since my second shot and the reaction is continuing and it is both painful and irritating.
The morning after her shot she felt unwell and did not get up for any meals.  She said she couldn't lift her legs and she could not tell when she had to go to the bathroom.  Prior to this shot she was able to walk with a walker ; she knew when she had to go to the bathroom and she got up by herself in the morning and knew what her routine was.  Now she is unable to walk and is totally incontinent.  She does not know her routine anymore and is waiting for directions from her caretakers on when to get up, when to go to the bathroom and sits in bed all day or is moved to a chair by caretakers.  She needs pillows propped around her in order to sit upright.
Waking up shaking; Feeling very ill; Patient received first dose on 05-Aug-2021 and Second dose on 26-Aug-2021; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Waking up shaking), MALAISE (Feeling very ill) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 05-Aug-2021 and Second dose on 26-Aug-2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 031m20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Aspirin), Penicillin allergy, Allergy to antibiotic (Antibiotic for a sinus infection) and Blood pressure abnormal. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for Blood pressure abnormal, ROSUVASTATIN CALCIUM (CRESTOR) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 05-Aug-2021 and Second dose on 26-Aug-2021). On an unknown date, the patient experienced TREMOR (Waking up shaking) and MALAISE (Feeling very ill). At the time of the report, TREMOR (Waking up shaking), MALAISE (Feeling very ill) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 05-Aug-2021 and Second dose on 26-Aug-2021) outcome was unknown.            Patient did not test positive for COVID-19 or diagnosed with it.  Patient was told to consume more water and hot tea. Patient was unable to take aspirin.   This case was linked to US-MODERNATX, INC.-MOD-2022-653962 (E2B Linked Report). This case was linked to MOD-2022-654032, MOD-2022-654088, MOD-2022-654100 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-653962:Same reporter
Chilly, pain in whole body, especially headache started around 11pm on vaccine day, disappeared at 4 days later. Fatigue started from that afternoon and still  continue now. Period stopped at the vaccine day (3/24/2021,it was  the second day of that period); new period started on 4/14/2021 and end by around 4-21-2021.  I didn't take any mediciine after vaccined. A small bump  about 1 cm3 was found in the left breast on 4/14/2021. Made an appointment to see doctor on 5-5-2021.
This spontaneous report as received from a physician, via other company Pfizer, refers to a currently 54 year old female patient. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot#, strength, dose, route and frequency was not reported). On an unknown date, the patient experienced drug hypersensitivity. The outcome of drug hypersensitivity was not reported. The relatedness between therapy with M-M-R II and the patient's event was not reported. This is one of several reports related to the same patient. Additional information has been requested.
Hour a receiving the vaccine her arm was in alot of pain that she couldn't move it, body became to be in severe pain, her face became paralyzed her arm and legs. She called the paramedic and they told her it look like she was having a stroke and she was rushed to the ER. She was dx with having GBS
slight headache; mild nausea; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26Nov2021 11:30 (Lot number: FK5127) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 1, SINGLE, Batch/Lot No: FK5127, Location of injection: Arm Right, Vaccine Administration Time: 09:30 AM, Route of Administration: Intramuscular), administration date: 05Nov2021, when the patient was 10 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 26Nov2021 23:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 27Nov2021, outcome "recovering", described as "slight headache"; NAUSEA (non-serious) with onset 27Nov2021, outcome "recovering", described as "mild nausea". Therapeutic measures were taken as a result of pyrexia. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a 76 year old male patient with hyperacidity and with no drug reactions or allergies reported. Approximately in 2011 (reported as "about 3 years ago"), the patient was vaccinated with a dose of ZOSTAVAX, 1 time injection (dose, route of administration, lot# and expiry date unspecified). Concomitant therapies included NEXIUM. The patient stated that he had shingles in February 2014, after getting the ZOSTAVAX vaccine. He stated it was on his right buttock, and was the size of "a half dollar". He also stated that he had a second outbreak of shingles in July 2014, in the same location. The patient sought medical attention and received the  treatment, he was put on unspecified antibiotics. No laboratory tests were provided. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Vomiting diarrhea for 30 hours along with confusion fever chills exahausted....did not feel like myself for almost 2 weeks
This case was reported by a nurse via call center representative and described the occurrence of pain in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain, malaise and injection site pain. On an unknown date, the outcome of the pain, malaise and injection site pain were unknown. It was unknown if the reporter considered the pain, malaise and injection site pain to be related to Shingrix. Additional details were provided as follows: The patient had reported experiencing malaise, feeling achy and that the vaccine was painful. Five out of 3 patients experienced the same events. This case has been linked with case US2018GSK152862 and US2018GSK152863 reported by the same reporter.
Red and round like a circle at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Red and round like a circle at injection site) in a 58-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, VITAMINS NOS and MINERALS NOS, VITAMINS NOS (CENTRUM JR [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site). On 10-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red and round like a circle at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (Red and round like a circle at injection site) was resolving. Unknown      The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.; 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.
Case number PHEH2015US026967 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 28-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 08 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Child had sudden onset of "tonic" seizure at school; unresponsive x 7 minutes; B/P=240/167, HR > 200 per school nurse, taken to ER per mother; neurology consult pending; no fever or prior history of seizures.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant medications and medical histories reported. On an unknown dates between 02-FEB-2016 and 02-APR-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX (pediatric dose with lot # K010216, expiration date 07-SEP-2016, lot # K021444 with expiration date 17-SEP-2016; adult dose with lot # L026598, expiration date 26-JUN-2017; lot# reported as M007763 with expiration date 15-SEP-2017; dose, anatomical location and route of administration were not reported). It was also reported that an improperly stored sterile diluent (lot# K023007 with an expiration date 24-SEP-2017, lot# L017417 with and expiration date 02-FEB-2018, lot # L015432 with expiration date 24-JAN-2018, lot # reported as L03221 with an unspecified expiration date; dose and route of administration were not reported) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 for 2400 hours. There was no previous temperature excursion and no data logger was involved. Lot# L03221 has been verified to be an invalid lot # for sterile diluent. This is one of several reports received from the same reporter. Additional information had been requested.
Mild case of (SJS) Stevens-Johnson syndrome. Vacc administered 2-28-14. Signs and sx appeared 3-3-14. TX: nystatin (oral) prior to vacc administ, hydroxyzine, MEDROL, ZANTAC, triamcinolone oint.
Severe eczema and rash on both hands, arms, face, neck, and leg., debilitating on hands, swelling, throbbing, puss, intense pain, unable to sleep. Itchy rash out of control. no creams or meds helping. eventually went to doctor and received 6 prescriptions and a shot. Very long slow process to recovery, still not fully recovered. Intense itching, bleeding, swelling, unable to hold coffee cup. Rash over large areas of the body.
Pruritis and erythema over bilateral arms about 15 min after administration.  Given 50mg of Benadryl.  Allowed to wait another 30 min.
Patient presented with body aches and fever post injection, that persisted for 24 hours. Patient presented with bilateral eye puffiness four days following injection.  The advised conservative therapy, hydration, and over the counter Tylenol as needed.  The doctor continued to follow up daily with the patient for two weeks post injection.
Facial spasms and twitching on left side of face. These lasted approximately 2 weeks followed by burning left eye with excess tears, eye goop, and blurred vision. Headaches likely from eye strain.  Now I have prescription eye drops to take for two weeks to hopefully clear this up.  I still have occasional twitching in left eye but not the larger face spasms. Also in the 2-3 days following the second shot suffered from body aches and head aches worse than I can remember with any cold or flu.  Left arm exceptionally sore.  Injection site remained red and either itchy or sore for 3 weeks. Side effects from 1st shot were very mild by comparison.  I simply had a sore left arm for 2 days.
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient's partner called on 02/04/2022 to explain Mr. received vaccine on 01/28/22 and passed away shortly after on 01/30/22. She informed that patient developed a lot of swelling at injection site after getting vaccine, went to hospital the day after, and died of a heart attack on 01/30/22.
Pt rcd flu vaccine (injection) given on 10/5/12 and developed "tightness" and extreme discomfort in neck and throat. Seen & tx'd for allergic Rx at ER.
Patient fainted and fell on the floor and hit his head. He lost consciousness for 1-2 minutes and regained consciousness.
20y/o w/ hx small pox vac on 22Sep08, c/o 2d retrosternal chest pain.  Pain 5/10 severity, non-radiating, non-positional, non-exertional. No prior hx of pain. Denies SOB, fever, chills, n/v/d. No hx HTN, HLD, DM, tob use, or fam hx of cardiac dz. PE only sig for known heart murmur. EKG with diffuse ST elevation and PR depression. CK-MB, Trop-I, myoglobin, and LDH all elevated. CXR w/o obvious cardiomegaly. Patient given ASA 325mg, and then ibuprofen 800mg Q8. Patient is stable currently.  Dx: myopericarditis.  MR received with DX:  Acute Myopericarditis.  Adverse Effect of Drug Therapy-Vaccine Smallpox.  Pt presented with chest pain, worsened by deep breathing. Pt noted to have increased pulse and low grade fever. Tx with Motrin.  F/u 10/15/08 with report of decreased stamina or exertional tolerance. Currently w/o CP.
MALE EXPERIENCE TINGLING IN HIS LEFT ________10 MINUTES AFTER VACCINATION. ONSITE EMS AND PHYSICIAN REQUESTED.  NO OTHER ADVERSE EFFECTS REPORTED BP FLUCTUATED 121/93 TO 148/93 HR FLUCTUATED  BETWEEN 100-130. SYMPTOMS HAD NOT RESOLVED AT 1036AM. ONSITE PHYSICIAL RECOMMENDED PATIENT BE TRANSPORTED TO E.R. FOR OBSERVATION DUE TO HISTORY OF A-FIB AND TIA'S. PATIENT REFUSED, SAID HE WOULD DRIVE HIMSELF AGAINST MEDICAL ADVISE. AFTER FURTHER DISCUSSION BETWEEN PATIENT AND SITE COMMANDER, PATIENT AGREED TO BE TRANSPORTED TO ER BY EMS.  NO ADVERSE REACCTION REPORTED TO VACCINES, HE RECIEVED FLU, PNEUMONIA AND SHINGES VACCINE IN 2020