chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Event; patient received 0.25 instead of 0.5 mL dose of Moderna COVID-19 Vaccine Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 mL dose of Moderna COVID-19 Vaccine Bivalent) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 06-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 mL dose of Moderna COVID-19 Vaccine Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 mL dose of Moderna COVID-19 Vaccine Bivalent) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient received 0.25 instead of 0.5 mL dose of Moderna COVID-19 Vaccine Bivalent).    No concomitant medication was reported. Vaccination date of first and second dose was unknown. Patient did not report any adverse event. It was unknown whether patient received treatment or not.
First symptom of ALL Leukemia (thinning hair and paleness) was noted 9/13/2016. First low grade fever was noted 10/1/2016. Low grade fevers were noted throughout October 2016, always resolving themselves after a day. She continued to become more and more pale, loose more hair and get more tired. On 11/9/2016 she had sudden pain on her shin and went to the ER for multiple tests. Leukemia suspected on 11/10/2016 and diagnosed on 11/11/2016. Her oncologist stated that based on the number of blasts in her blood and marrow, they estimate her leukemia started about a week after her vaccination. It was the first vaccination she had had for varicella and she had had over a year in between her previous vaccinations.
ABOUT 5-10 MINUTES AFTER RECEIVING THE VACCINE, PATIENT HAS SHARP PAIN THROUGH HER HIPS, BACK, ARMS. SHE COULD NOT MOVE HER RIGHT LEG. SHE DESCRIBED IT AS THE HEAT WAS GOING IN AND THROUGH HER BODY. AFTER SITTING DOWN FOR ABOUT 10 MINUTES, THE SYMPTOMS SUBSIDED.
DEVELOPED CONSTANT RINGING IN BOTH EARS 5/20/21 PCP VISIT NOTHING FOUND, DEXAMETHASONE/DEPO-MEDROL INJECTION NO RELIEF 6/15/21 ENT VISIT, NOTHING FOUND, HEARING TEST SHOWS SOME LOSS AT CERTAIN FREQUENCIES, 10 DAY PREDNISONE TAPER NO RELIEF 6/29/21 STARTED LIPO FLAVINOID, NO RELIEF
FOLLOWING MORNING, DEVELOPED NAUSEA AND VOMITING LASTING APPROXIMATELY 6 HOURS.
Friday night, 3/14/03 ear ache and sore throat. 3/15/03 broke out in a solid red rash w/hives. Rash located mostly on face & neck, also on trunk, arms, & lower body.
Patient woke up with a rash on the inside of left elbow as well as a rash around neck starting on the left side.  Injection was in the left arm.
Vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022; No adverse event; patient received Moderna Covid-19 vaccine past the 30 day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine past the 30 day beyond use date.), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 041L20A, 029L20A and 060H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine past the 30 day beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine past the 30 day beyond use date.), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022) 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 (patient received Moderna Covid-19 vaccine past the 30 day beyond use date.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022).    No concomitant medication was reported.   Patient stated no adverse reactions were known from the received doses. Patient was administered with Second booster dose. Date the vial was initially stored in the refrigerator on 02-JUN-2022.The pharmacist was not aware of if vial undergo any temperature excursions. No treatment information was reported.
The initial burn felt like a staple was injected into my arm.  For the next week, I had a round red rash which was painful at injection site. I had a cough, felt like I had the flu and after 8+ weeks, still not feeling well. The injection site aches everytime I feel under the weather, or sneeze or cough.
Headache, Myalgia, Headache, chills, myalgias. Chills and myalgias now resolved. Headache continues rates pain 5/10 to temples and top of head. Pain Positional. Missed work today 1/11/2021 Narrative:
Shingrix 2 doses completed/Shingles / Suspected vaccination failure; Singles; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had completed Shingrix 2 doses in less than a year. The patient had singles. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The reporter did not consent to follow up.
Both legs became sore the day of vaccination on 3/29/01 and child developed a temperature of 101.9F. Both the fever and sore legs were better on the 3rd day.
Immediately had an pain at injection site, then 16 hours later had moderate to severe pain requiring ibuprofen, repeated ibuprofen 6 hours later and then again 6 hours later for arm pain.   Generalized fatigue and headache throughout starting 16 hours out from vaccine.
flulike symptoms,pain/redness/heat in bicep and below vaccination site,needle mark had red ring around it,worsening symptoms
On 9/22/10 at 10:35 AM, patient received ZOSTAVAX. On 9/23/10, patient started to experience itching all over his body from head to toe. He reports no sign of rash, took BENADRYL which helped a little. The itching would start up again about 4 hrs. His eyes and ears itch and burn. Will see an MD on 9/27/10.
Right lower leg has red mottling on the inside of the leg, from the knee area about 1/2 way down. Mottling increases with heat (after shower or bath). There is no pain or swelling. I have not seen a doctor but it does not appear to be going away
The patient had a syncope reaction from a seated position. The patient went limp, but did not fall from their chair.  The patient quickly regained consciousness and was instructed to remained seated with their head between their legs. The patient was responsive and denied any allergic reaction symptom, like difficulty breathing or itching.  After 10 minutes the patient returned to a normal seated position and drank water.  After 5 more minutes the patient was able to leave under their own power.
Herpes Zoster; This spontaneous report as received from a lawyer regarding a case in litigation and refers to a currently 69 years old female patient.  No information was provided regarding concomitant medications, concurrent conditions or medical history.  In March 2014 the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX)  for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On an unknown date, the patient experienced herpes zoster. The outcome of herpes zoster was unknown.   The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Occurrence of localized raised urticaria on the right hand 15 minutes after the vaccines were given.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 07-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot #1660991, expiration date: 27-APR-2021, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  On 04-AUG-2020, the dose of vaccine was exposed to temperature excursion at 1.1 Celsius degree (C) for 27 hours and 45 minutes and at 9 Celsius degrees for 1 hour and 15 minutes. There were no previous excursions reported. The call was due to digital data logger. No further adverse events were reported.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
3:00 on day of shot pt had chills fatigue and shaking, headache.
Erythema and swelling within 12 hours of the administration of DTaP #4 and IPV #3 in the left thigh. No fever but irritability. Erythema and edema measure 8 cm by 8 cm.
This spontaneous report was received from a healthcare worker refers to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L030160, expiration date 11-AUG-2017). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
tchy Arm; Red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (tchy Arm) and VACCINATION SITE ERYTHEMA (Red at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (tchy Arm) and VACCINATION SITE ERYTHEMA (Red at injection site). At the time of the report, VACCINATION SITE PRURITUS (tchy Arm) and VACCINATION SITE ERYTHEMA (Red at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
seen in office 27JUN97 c/o bump on lt thigh not painful;bears weight, crawl dx sterile abscess;PC 13JUL97 bump not better referred to MD for drainage;drainage was done on 17JUL97;
Narrative:  On 9/21/2020 patient experienced an acute stroke after receiving recombinant zoster vaccine (2nd dose) on 9/14/2020. MRI showed left cerebllar/post left pons/rt occipital lobe acute stroke. Patient continued to experience left sided residuals and dysarthria at follow-up with pcp on 4/28/21. Unknown if caused by recombinant zoster vaccine but happened in such close proximity to getting dose that it seemed important to report.
splotching rash, sl fever 19MAY-21MAY98 no itching;rash mainly on arms & legs spreading downward;no breathing problems;diarrhea & stomach upset reported;
Patient is a 74-year-old male past medical history significant for type 2 diabetes and hypertension presenting today for generalized weakness.  Patient reports feeling generally weak.  Patient says he fell forward and smashed his face earlier today due to weakness.  No palpitations.  No loss of consciousness.  Patient has slight nosebleed.  This is since resolved.  Patient is concerned about his general weakness.  Feels short of breath.  Wife passed message to EMS that patient may have COVID. 6:34 PM: Patient evaluated the emergency department for weakness.  Concern for hypoxia initial presentation.  Patient was placed on oxygen.  Patient has evidence of increased respiratory rate present as well.  Concern for infectious process/COVID/urinary tract infection.  We will get chest x-ray for pneumonia, COVID swab, we will get CBC, CMP, urinalysis.  Fluid bolus will be given.  Cultures and lactic obtained.
Patient had headache after each dose of vaccine. As this is a common reaction to vaccine, patient was not concerned. However, after headache worsened/did not resolve, patient you went to doctor, and doctor ordered MRI. Patient received phone call to go to ER d/t MRI results of blood clots in brain on 4/8/2021. Patient was hospitalized for one day and placed on high dose eliquis. Patient then went home. Patient woke up with rapid heart beat and chest pain on 4/12/2021 and was readmitted to the hospital for an additional day.
Information has been received from a medical assistant referring to multiple unspecified patients. Information on medical history, concomitant medications and drug allergies was not provided. On known dates, multiple unspecified patients were vaccinated with a dose of improperly stored PROQUAD (lot# M039448, expire date: 20-MAR-2018; dose unknown) for prophylaxis. The temperature of storage for PROQUAD was above -10 Celsius and below 8 Celsius for 1hour and 2 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA002284.
Developed swelling, redness and tenderness at injection site, got more swollen, red, warm with itching over the next several days. Induration measured 5cm x 4 cm, treatment for abscess on 9th day with Cephalexin 250 mg four times a day. Told to use moist warm compresses and take Ibuprofen 600 mg every 6 hours as needed pain.
This is a spontaneous, non-serious report received from a patient. A patient of unspecified age, sex, height and weight received the COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot# unknown/not reported) dose and start therapy date: not reported, for immunization. Medical history, concomitant medications and concurrent conditions not reported. On an unspecified date, patient experienced sore arm/sharp pain in leg, bit of nausea and headache. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from sore arm/sharp pain in leg, bit of nausea and headache. The company was unable to perform follow-up to request batch/lot number.
Systemic: Headache, Systemic: Other- Staff Member complained of metallic taste and headache. Instructed to lay down, BP was elevated, continued to rise. Contacted 911, patient transported to hospital, admitted and disharged next day.  Symptoms lasted 1 day
I ended up in the emergency room on 11/5 with a severe asthma attack and cough which hasn't happened to me in over 5 years. I have been in remission from any attacks.
Information has been received from a female consumer who "a year ago" was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently the patient developed shingles. The patient was hospitalized and almost lost her eye from shingles. The patient also stated that she almost died from shingles. At the time of the report, the patient's outcome was unknown. This is one of several reports reported from the same source. No further information is available.
devel nausea, vomiting w/in 24 hrs also had abd pain, has lost 12 lbs, unable to hold down food w/o meds; MD felt this is related to flu vax;
This spontaneous report as received from a pharmacy doctor student refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of MMR II (lot # K008814 exp date 19-JUN-2016) (doses and route not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Hepatitis B adult vaccine dosage administered to patient instead of Hepatitis B pediatric dosage.
This spontaneous report as received on 28-AUG-2017, from a female registered nurse concerning a one year old female child (as reported). The registered nurse reported the patient had the pertinent medical history of "sensitive skin". The patient had no concomitant medications.  The patient had no drug reactions/allergies. The registered nurse reported that the one year old child had an adverse reaction to VARIVAX (Lot number M049126, expiration date 15-DEC-2018 (as reported)) (Dose reported as "first dose", route of administration reported as subcutaneous, indication reported as "routine") administered on 08-AUG-2017 and parents noticed rash on child 10-AUG-2017 and 11-AUG-2017, described as white, then red, then scabbing on both elbows, left leg swollen with a red area on left lateral calf with scabbing. Medical attention was sought: The child visited the physician office 16-AUG-2017 and had two circular scabbed lesions, no blisters, and no scabbing or redness. Elbows had dried papules on dorsal surface with scabbing. Physician diagnosed Atopic Dermatitis Unspecified. On 21-AUG-2017, parents took child to an Urgent Care because child developed a rash all over body with big red pimple on right arm. VARIVAX administered to right lower arm on 08-AUG-2017. On 24-AUG-2017, parents brought child for another physician visit. Rash still present, red raised on both arms and parents said it "hurt". A bruise was noted on upper right arm with tiny red papules and scaling on right elbow with a few spots on legs. Physician diagnosed infant Papular and Acro Dermatitis with Gianotti-Crosti Syndrome 3 days after VARIVAX vaccine. (Information received also reported no treatment was given for the adverse event. No lab diagnostics or studies performed. Present status was reported as not recovered.) At the time of the receipt of this report, the outcome of the events was reported as not recovered. The child has an appointment with a dermatologist on 29-AUG-2017. Additional information has been requested.
No symptoms until Oct 11 that I had cough, sneezing, sleepiness and last lasted for a month, I went to the doctor and gave me antibiotics, they diagnosed RSV.
area @ pneumovax site became swollen & inflamed the day p/vax;saw MD;pt placed on ATB;saw pt again 10/20/99 & was feeling better;pt had 12-15cm ecchymotic area surrounding site;
Patient had vaccine on 8/28/2021. She was approx 13 weeks pregnant at the time. On 9/16/2021 Pt began to have swelling to posterior portion of neck and base of skull. The same are was very tender to palpation and with neck extension. Pt also start oral amoxicillin on 9/15/21 for acute sinusitis after having sinusitis symptoms x 10 days. No fever or other symptoms.
Immediately neck, face and right side of my head went numb like I had novocaine. Stayed numb for 3 days then lessened over several more days.
1:30 pm - Unconsolable crying and marked reddness on left thigh and heat. No reported swelling. Tremor of left leg during episode os crying.  Dr. Notified.  5-28-03 Painful crying when left thigh touched while mom was bathing.
Information has been received from a pharmacist concerning a 66 year old female with unknown drug allergies and unknown medical history who "last week" on approximately 13-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck). The patient developed chickenpox and diarrhea 36 hours after ZOSTAVAX (Merck) was given. The patient sought medical attention by speaking with the pharmacist. It was unspecified it lab studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
The swollen area at the vaccine site was a golf ball-sized on 5.14.22, pink, slightly raised, and tender to touch. Treatment was mupirocin, ibuprofen if needed for pain,  outline swollen area to assess if worsening and return to the clinic if signs of worsening infection (fever or red streaks). The parent was also advised to start oral antibiotics if symptoms persisted or worsened in the next 24-48 hours.