chrisvoncsefalvay/vaers-outcomes huggingface dataset:
congestion; Soreness at the injection site on left arm; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion) and VACCINATION SITE PAIN (Soreness at the injection site on left arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C0A) for COVID-19 vaccination.     The patient's past medical history included Surgery (artificial heart valve) and Dental surgery NOS (received amoxicillin on 23JUNE2021 prior to vaccine). Concomitant products included AMOXICILLIN for an unknown indication.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced NASAL CONGESTION (congestion) and VACCINATION SITE PAIN (Soreness at the injection site on left arm). The patient was treated with GUAIFENESIN (MUCINEX) ongoing since an unknown date for Rhinitis, at an unspecified dose and frequency. On 28-Jun-2021, VACCINATION SITE PAIN (Soreness at the injection site on left arm) had resolved. At the time of the report, NASAL CONGESTION (congestion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received amoxicillin on 23-JUN-2021 prior to vaccine for a dental procedure and consumed Mucinex 3 weeks ago for cold symptoms, which was unrelated to vaccine injection as symptoms appeared prior to injection.  It was reported that the patient got the second shot and was fine.  Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up information received on 26-Jul-2021,  and received 2nd dose details, updated outcome of nasal congestion to resolved.
Fever; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and DIARRHOEA (Diarrhea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M2UA) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (Fever) and DIARRHOEA (Diarrhea). At the time of the report, PYREXIA (Fever) had resolved and DIARRHOEA (Diarrhea) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: high 100.1 degrees Fahrenheit. On 01-Mar-2021, Body temperature: high 100 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.; 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.
This spontaneous report has been received from a registered nurse referring to a unspecified patients of unknown age and gender. Information regarding medical history, drug reactions, allergies and concomitant therapies was not provided. On an unknown date, the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB, (strength, dose, frequency, and route of administration were not provided)  lot # M020100 and expiration date 07-MAR-2019 for prophylaxis. The reporter stated that the temperature range  of the vaccine  was >46°F but <77°F and the time frame was 56 minutes, also she stated that no previous temperature excursion was involved, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
Vaccine given on 09/02/2021.  Expiration date was 08/31/2021
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 10-MAR-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -2.77 Celsius Degrees for 480 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Herpes zoster activation-shingles. I went to hospital and they gave me antivirals
Rash devel following HIB TITER/MMR immun; Type of rash unk;
Information was received 15-AUG-2017 from a lawyer regarding a case in litigation concerning a male plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX on or about 21-DEC-2009 at a pharmacy in his residing state, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused him to contract a persistent strain of herpes zoster. On or about 04-DEC-2012, the plaintiff was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. He was prescribed valacyclovir, gabapentin and TYLENOL for management of his painful symptoms. It was claimed that as a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose as pneumonia vaccination. The patient's medical history and concomitant medications were not reported. It was reported that consumer was not sure if the product was PREVNAR 13 or other Pneumonia vaccine from other manufacturers. It was also reported that she had her second pneumonia shot on an unspecified date reported as last Tuesday and 2 hours after, her arms swelled and inflamed. On an unspecified date reported as today, she had a big red mark on her triceps area and it's uncomfortable. She tried applying ice packs and it's still there. She tried calling her health care provided but cannot be reached or the doctor was away and so now she called Pfizer to asked for the possible side effects after having a shot of our Pneumonia vaccine. The outcome of the events "big red mark on her triceps area and it's uncomfortable" was not recovered while unknown for the other events. Information regarding the batch number has been requested.
experiencing numbness in my hands; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (experiencing numbness in my hands) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (experiencing numbness in my hands). At the time of the report, HYPOAESTHESIA (experiencing numbness in my hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
This spontaneous report was received from a medical assistant and refers to unknown patients of unknown age and gender. There was no information regarding the patients' concurrent conditions, medical history and concomitant medications. On an unknown dates, the patients were vaccinated with five improperly stored doses of VARIVAX lot # M027343, expiration date 01-JUN-2018 (dose, route of administration were not reported) for prophylaxis. The vaccines were exposed to multiple above range, defrost cycles. The medical assistant did not have access to the temperature and time frame information at the time of the call. There was no previous temperature excursion. Digital data logger was involved. There was no adverse reaction. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA012060:
Severe Headache. Severe sharp stomach pains. Severe joint aches. Severe tissue pain from past breast surgery, which had not been present before. Other tissue pain. Dizziness, weakness, pain at site of shot. Was in bed for two weeks. Doctor said the symptoms would gradually diminish and end.    Eight months later they had barely diminished and I have lost a large percentage of my capabilities.  Trouble getting in car and getting up. Doctor is working on plan. Increased Bupropion. I'm taking vitamins and antiflametory meds. I did not have these symptoms before this vaccination. I actually felt as if I might die.
A FILLING NEEDLE WAS USED TO EXTRACT AND PREPARE 26 DOSES OUT OF A MODERNA VIAL SEQUENTIALLY UNDER 5 MINTUES TOTAL PREP TIME. MODERNA AND LOCAL DOH WERE NOTIFIED AND WE ARE AWAITING RESPONSE FROM MODERNA REGARDING STERILITY OF THE PRODUCT.  NONE OF THE POSSIBLY EFFECTED PATIENTS REPORTED ISSUES OR ADVERSE REACTIONS. VAERS BEING FILED BECAUSE OF LOCAL DOH GUIDANCE.
24SEP91 slept p/immun & awoke w/fever @ 3PM; 25SEP91 330PM PC to clinic pt has fever 102; Was 104 2 hrs ago; giving APAP t104-102; not voiding or drinking liquids; Diaphoretic; Sent to ER by family MD;
Developed chest pain, found to have elevated cardiac enzymes, ECG-myocarditis, echocardiogram-normal, pain relieved by NSAIDs. Discharge diagnosis: Myo-pericarditis. Returned to duty
didn't realize that he wasn't supposed to get the rotavirus vaccine (1st dose cut off is 3.5 months). Doctor explained this to mother during today's WCC and she apologized for it. He was fussy but thankfully did well. She did allow him to get a 2nd dose since he did fine with the 1st one 4 weeks ago, and Doctor explained to her that he will not be getting it when he comes back for his 9 mo WCC
Patient age 5 came into the Public Health Center with his mother, and twin brother on April 29th 2022 for his second dose of the Pfizer COVID Vaccine for 5 - <12 yrs. Due to oversight, Pharmacist inadvertently administered patient 0.2ml of undiluted vaccine. This error was discovered later when it was realized sufficient additional doses could not be drawn from the vial. Upon realization of the error, Pharmacist alerted administration staff, Pfizer via telephone, and the parent. Mother was informed of the error, increased risk of adverse reactions due to elevated immune response. Mother was offered additional resources from the CDC and the opportunity to talk with Pfizer staff. Mother was made aware that Pharmacist would call again on 04/20/2022 to follow-up on the condition of patient.
Nurse states she did not mix both vials of the adjuvant suspension component and the lyophilized gE antigen component.  Adjuvant Suspension Component was given only. Nurse states she realized she had not mixed them after administering the adjuvant only. Nurse contacted GSK and reported her error and informed this writer and PCP of patient. GSK states patient should wait 4 weeks before coming in for the correct immunization dose. PCP updated patient.
Patient received PROQUAD that had undergone temperature excursion; No additional AE reported; This spontaneous report was received from a healthcare worker and refers to a male patient of unknown age.  The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot #W006584, with expiration date reported as 11-DEC-2022 but upon internal validation confirmed as 23-AUG-2023, as prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature of 76.1 degrees Fahrenheit (F) for a time frame of 322 hours and 15 minutes. There was another previous temperature excursion, however no information was provided.  There was no additional adverse events.  This is one of three cases from the same reporter.; Sender's Comments:  US-009507513-2209USA009404: US-009507513-2209USA009412:02253610
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State of for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Same day onset for 24-48h fever, body aches, fatigue. Resolved after 48hours. 2 day post-onset of severe arm pain:  hot, swollen and red, welt extend from upper shoulder down to elbow and around side of arm.  Severe sensitivity to touch/pressure.  Unresolved after 5 days.
Dizziness that increased  throughout the day; rash in the form of red dots on both arms but more pronounced on the left arm which was the injection arm
A day after my 2nd dose of Pfizer covid vaccine, I noticed a lump on my leg with a dent next to it.  I went to my dr.  They did an ultrasound and mri and discovered it was a thrombosed subcutaneous varix at the lateral aspect of the proximal leg with peripheral enhancement and mild surrounding subcutaneous edema consistent with thrombophlebitis.  Dr decided on no treatment since it didn?t pose a risk.  I didn?t think to report this event until a friend had the same thing happen after his 2nd dose of Pfizer vaccine.
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 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021 at 4:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 4:05 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.   Age of patient was reported as 67.42.  No concomitant medications were reported.  Batch number 014M20A administered on 03-Mar-2021 had  temperature of 51 at 09:00 AM, 34 at 10.00AM and 35 at 01.00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-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
dizzy;tingling feeling all over;h/a;P56;BP 120/80;
Fever (T max 103 ax) erythema approximately 5 cm at injection site (R) arm, mild RUE swelling, decreased use. Ibuprofen, BACTRIM.
Severe swelling and lump at injection sight/ the lumpwas extremely tight feeling; Severe swelling and lump at injection sight, hot to the touch; The lump was extremely painful to touch; Soreness of arm went all the way down to elbow; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in right arm on 25Aug2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19, idiopathic intracranial hypertension (reported as idiopathic intercranial hypertension), common variable immunodeficiency and allergy to sulfa antibiotics. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included desvenlafaxine succinate monohydrate (PRISTIQ), clonazepam (KLONOPIN) and topiramate (TOPAMAX); all for unknown indications from unknown dates and unknown if ongoing. On 26Aug2021, the patient developed severe swelling and lump at injection site which was hot to the touch. Lump was about the size of a golf ball. The patient felt the lump to be extremely tight and extremely painful to touch. The events lasted for almost two weeks. It was reported that soreness of arm went all the way down to the elbow. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe swelling and lump at injection site, hot to the touch and the lump was extremely tight feeling and extremely painful to touch was resolved on an unknown date in Sep2021. The clinical outcome of the event soreness of arm went all the way down to elbow was resolved on an unknown date in 2021.
Patient on clinical trial via a personalized vaccine WLT03233103, last vaccine given was 4/17/19 Cycle 10. Patient was admitted on 4/25/19 due to deterioration, increase of difficulty communicating, difficulty swallowing & sleepiness, increase weakness & confusion. update 13Dec2019 Patient was transferred to another long term care facility, family noted that he was deterioration of his physical state, was less communicative, having difficulty swallowing, and increase sleepiness. Patient came in for Dr. visit to evaluate on 4/15/19, Dr sent patient for Admission for infection work up, and Head CT. Patient was on clinic trail of MTA vaccine, began on 7/24/18 Vaccine 1, had vaccine on 4/17/19 and Poly-TCIC following day, also was given Bevacizumab #1 4/10/19. PI, does not attribute SAE to the Bevacizumab, the MTA vaccine or the Poly T.C.I.C. The patient died in the setting of the tumor on 11/17/2019 at home hospice. The last study visit was on 7/18/19 when the family and PI discussed hospice care. Prior to the patient's death he had an additional MRI Brain scan on 6 JUNE 2019 that showed similar dilation of the ventricles and increased DWI hypersensitivity of some of the lesions that likely corresponded to tumor. However, A pathology report showed no tumor growth-the patient had The PI has determined this is possibly related to the study treatment
This case was reported by a consumer via call center representative and described the occurrence of injection site hives in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 19th March 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced injection site hives. On an unknown date, the outcome of the injection site hives was recovered/resolved. It was unknown if the reporter considered the injection site hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient experienced injection site hives which was recovered after two days. The reporter did not consented to follow up.
I received the Tetanus Vaccine and same day Dr. increased my paxil from 30 mg. to 40 mg. As soon as I received the shot I had a massive panic attack, that is why the Dr. increased my paxil.  I had panick attacks throughout the whole night.  Not long after, the next day or so, I noticed cuts on my tongue, I then noticed that my tounge when I was asleep was now shifting to the right and I would wake up biting my tongue causing continuous injury.  It has not subsided.  Also the site of the injection is still very painful and although I have had severe body pain for years, my therapy at the time, Celebrex, was giving me some relief, but since the injection, the pain is worse and the celebrex isn't helping much or not at all.  I also had a hypoglycemic attack this week and my eyesight has dimmed a little and there is a grayish hue since that visit.  My eyes also burn alot.
This spontaneous report as received from a physician refers to a 41 year old female patient. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 22-OCT-2016 the patient was vaccinated with M-M-R II (lot # M008589 and expiry date 16-FEB-2018) 0.5 ml, subcutaneously for medical clearance. On an unknown date of October 2016 (reported as with in 6 days of receiving of MMRII), the patient experienced severe thigh muscle pain, shoulder muscle pain, pain in the small joints of hand, and both knees pain. The physician stated that she told the patient's husband that the patient can take an anti-inflammatory for the events. The physician stated that the patient's husband called her on 11-NOV-2016, and reported that the patient is unable to care for her children due to the adverse events. The outcome of the events were reported as not recovered. The causality assessment was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
pt recvd 3 doses of vax & exp hives p/2nd dose;
Diarrhea, nausea, vomiting, chills, 99.6 degree temperature.