chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed dose; A spontaneous report was received from a consumer concerning a 70-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced missed dose/second dose past 42 days of first dose.   The patient's medical history was not provided. Concomitant product use was unknown by the reporter.   On 13 Jan 2021 , approximately 42 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in unknown site for prophylaxis of COVID-19 infection.   On 24 Mar 2021, the patient experienced missed dose/second dose past 42 days of first dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event missed dose/second dose past 42 days of first dose , were considered not resolved during the time of this report.; Reporter's Comments: This report refers to a case of Product dose omission issue,  for mRNA-1273, lot #: 013L20A,  with no associated AEs.
Lethargy, change in demeanor, (out of it) for 10 days, fever 104, rash on torso.
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient (age and gender not reported) who received a vaccine FLUZONE HIGH DOSE lot UJ023AA, expiry date: 25-Apr-19 (route, dose and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to vaccine underdose. It was also case of syringe leak. It was reported that the vaccine seemed to leak at the bottom where the needle attaches to. Pharmacist stated that there was not issues or anything out of the ordinary that she noticed when attaching the needle to the pen and she thghtened it down as she always does. Pharmacist stated that she is unsure if the consumer received the full dose or not. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
patient said the vaccine made him feel worse than having covid itself (he had it last year). he became so weak that he had to go to the ER. he said he felt like his whole body was seizing up. they did a bunch of tests on him and ended up sending him home and he is feeling better now and back to normal
Patient scheduled an appointment for a COVID booster indicating it had been > 2 months since any prior booster making her eligible for the bivalent booster.  A proper booster was administered without incident.  Upon recording the dose in database, it was discovered she had received the bivalent booster at another pharmacy on September 30, 2022.  At this time, the CDC has not recommended a second booster of the bivalent.    The previous pharmacy had recorded their vaccination on the backside of the COVID card which is not recommended from the Department of Public Health.   Patient has been notified of this extra dose and indicated she has not had any issues with prior COVID vaccinations.
Low grade fever at 99.8; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever at 99.8) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced PYREXIA (Low grade fever at 99.8). The patient was treated with ACETAMINOPHEN for Fever, at a dose of 2500 milligram once a day. At the time of the report, PYREXIA (Low grade fever at 99.8) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2021, Body temperature: 99.8 (High) Low grade fever at 99.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The normal body temperature was normally around 97.2.  No concomitant medications information was reported.
10/13/2012 @ 14:00:  redness, swelling at injections site Left Deltoid, dulling pain in L Shoulder day of injection.  10/16/2012 @ 0500: swelling at front left neck where it meets shoulder.  Appears to be a node. Size of a walnut.
DIFFICULTY IN WALKING; VERY STRANGE COUGH; NOT BEEN ABLE TO GO TO WORK; LOT OF CRAMPS; FELT VERY UNWELL; PAIN IN LEG; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced difficulty in walking, very strange cough, not been able to go to work, lot of cramps, felt very unwell, and pain in leg. Laboratory data (dates unspecified) included: Lab test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt very unwell, pain in leg, difficulty in walking, lot of cramps, very strange cough and not been able to go to work was not reported. This report was non-serious.
Initial and follow-up information has been received from a registered nurse concerning a 20 year old female student with penicillin allergy who on 06-AUG-2007 at 9:15 am, was vaccinated IM in the left deltoid with a 0.5 ml second dose of Gardasil (lot # 655324/0089U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 06-AUG-2007 at approximately 9:30 am, the patient experienced increased left arm pain and was unable to lift the left arm completely, muscle spasms in her arm along with numbness and tingling in her fingers.  She had alternated heat and cold application to the injection site.  She had massaged her arm with "icy hot gel and Jergens lotion."  On 15-AUG-2007 at 10:11 am, she telephoned the office and at 3:15 pm, the patient was examined in the office.  It was reported no redness or swelling.  The patient was referred to a neurologist of further evaluation.  The patient's symptoms persisted.  No laboratory or diagnostic tests were performed.  Additional information is not expected.
Detached retina; low blood count on and off; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL DETACHMENT (Detached retina) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Weight gain in November 2019. Concurrent medical conditions included Hypothyroidism since 2018, Metastatic breast cancer since November 2019, Chronic lymphocytic leukemia since 2005 and Glaucoma since 2016. Concomitant products included PALBOCICLIB (IBRANCE) for Metastatic breast cancer.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2020, the patient experienced BLOOD COUNT ABNORMAL (low blood count on and off). On 06-Apr-2021, the patient experienced RETINAL DETACHMENT (Detached retina) (seriousness criterion medically significant). The patient was treated with Surgery for Retinal detachment. At the time of the report, RETINAL DETACHMENT (Detached retina) was resolving and BLOOD COUNT ABNORMAL (low blood count on and off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood count: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient started palbociclib in Nov-2019; and she had a low blood count on and off. After a year, they moved her from 125 milligrams capsules to the 100 milligrams tablets and then everything was fine. The last time it went low was right around the time she got the Moderna vaccine. The patient's  counts went down after the vaccine but then they went right back up. Her doctor said she was much improved at the next blood draw and maybe her body was just trying to fight off the vaccine. On 06 Apr 2021, the patient had the detached retina. No concomitant medications reported.  The patient underwent surgery for detached retina.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Around the start of December, I started having dull interment pain above my left testicle. Around 12/15/22, it started hurting a bit more and by 12/19/22 I went to the emergency room because the pain was unbearable. They ran a urine sample and an ultrasound and diagnosed me with varicocele testicle. I will be seeing a urologist tomorrow to see what treatment we can do or if it will heal on it's own.
I came down with shingles - starting around Wednesday. On Friday or Saturday they gave me a prescription and they wanted me to wait longer with the viral medication (to not take it immediately) so it wouldn't affect the vaccine. Urgent Care was where I went. It was started to get worse though and so I started the medication on Sunday - the 31st of January. I took it for the seven days you take it and everything cleared.
About 5 hours after the booster shot, I began experiencing  very painful muscles and joints. Four hours later I began getting chills, sweats, severe headache, stiff neck,  Went to bed for 13 hours with little sleep due to major pain. I still felt tired when I got up. Painful, stiff neck and headache persisted for another 4 hours.  By 2pm on 01/21/2022 I was feeling like myself again.
Patient called today stating continued left arm pain following immunization on 9-24-09. States she has no strength and can not left her grandchildren with that arm. still "hurts"
Received shot in left arm, more pain than usual at shot site, shot site hot, couple hours later my index and middle finger went numb, arm started to hurt, next day whole arm was numb! I'm assuming this was because he hit a nerve. I called pharmacy and reported it to the Dr. Also, called the insurance Nurse. She recommended I go to emergency care. I did not. The third day my arm felt almost normal. Fourth day arm was back to normal. I feel compelled to report this so it doesn't happen to anyone else.
She got her vaccine, nothing immediately until approximately 8 hours later she started getting severe nausea with violent chills.  She had to lie down, put a hot water bottle and had a lot of covers on her.  her temp was 101, went to 102.  She had terrible neck pain, ridig and painful down to her shoulders.  Just terrible terrible nausea.  She took some Tylenol once she knew her temp was 102.  Later on she took Odansetron for nausea, which helped some.  Once her fever came down she was a little better, but was beside herself as she could not get comfortable.  It stopped and she thought she dozed off about 3 hours and at 3:15 she had a flood of nausea again very very bad and felt like she was getting chills again.  S She did not take hre temp again she just stayed in bed.  At 7:00 AM her daughter gave her 2 more Tylenol.  She was also dizzy in the middle of the night when she got up to use the restroom and almost lost her balance.  Felt she was dehydrated and started to drink fluids.  She doesn't feel well this morning, feels about 80% better, but thinks that the worst has passed.  She has not called her doctor.
A 19 month old female pt developed left arm redness, swelling involving large area, three days after receiving the injection of the fourth dose of Daptacel, lot number U1342BA and IPOL, lot number Y0638-2(expiry date 07Jul07) on 28Apr06. Both vaccines were administered IM into the left deltoid. The pt received in concomitant the IM injection of Hep A vaccine, lot 0936R, in right arm. Per reporter a 5/8", 25 gauge needle was used, however it was not specified for which vaccine. Per reporter, the reported lot number for Daptacel coincides with Tripedia, not Daptacel. This information was confirmed that lot number U1342BC coincides with Tripedia (expiry date 23Jul06). Confirmation of product received will be requested. Per reporter the pt had no illness at the time of vaccination. The pt did not have a fever and was not seen by a physician for this event. No diagnostic tests were performed. Recovery status of the pt was not reported. Same reporter in cases 200601015 and 200601016.
Patient presents  at ED 01/06/2022  for evaluation of cardiac arrest and fall at residence.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In OCTOBER 2012, the patient's healthcare provider at a physician's office administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. In NOVEMBER 2012, the patient was treated by her healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
INCREASED HEART RATE; SEVERE CHEST PAIN; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, about 7 hours after receiving the Johnson & Johnson vaccine shot, patient's heart rate increased rapidly (coded as increased heart rate) and he had severe chest pain, resulting in hospitalization(date unspecified). Patient's discharge papers showed that doctors ran tests but couldn't identify a cause other than the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the increased heart rate and severe chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0.20210444419-covid-19 vaccine ad26.cov2.s-increased heart rate,chest pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Workflow Notes: V0: completed. Case promoted.
Patient with history of kidney transplant initially presented to his outpatient provider approximately one month following vaccination. He had felt nauseated since receiving the vaccine, and when this persisted he went to see his PCP who ordered a BMP and found that his creatinine was 10.9 (baseline 1.9). Patient reported to emergency department following this lab result and was admitted to the floor and hydrated with IV fluids. Underwent biopsy of the transplant graft on 5/27. Patient was treated with plasma exchange x5 followed by a dose of Rituxan. On discharge patient had a creatinine of 6.8 with plans to follow-up with outpatient transplant provider.  Biopsy resulted following patient discharge and was consistent with acute antibody-mediated rejection.
This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ROTATEQ (lot number, dose, and expiry date were not reported), orally. On an unknown date, the patient vomited an unspecified amount of vaccine after administration ROTATEQ. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Patient first received the Moderna booster shot last Dec.1 and then accidentally was given another booster shot today Dec. 6; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Patient first received the Moderna booster shot last Dec.1 and then accidentally was given another booster shot today Dec. 6) 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 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient first received the Moderna booster shot last Dec.1 and then accidentally was given another booster shot today Dec. 6). On 06-Dec-2021, ACCIDENTAL OVERDOSE (Patient first received the Moderna booster shot last Dec.1 and then accidentally was given another booster shot today Dec. 6) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  Patient was suppose to receive a Flu shot today but the nurse accidentally administered Moderna booster shot instead of the Flu shot.
rash lasted 3 days w/less than 50 pox on whole body;sl fever (no temp, just tactile), lasted 2 days given ibuprofen;no complications & no rx meds given;
Immediate dizziness on site. After returning home, metallic taste that has persisted for 4 days, severe nausea, abdominal pain, diarrhrea, lack of appetite, marked insomnia. Nausea unresponsive to all pharmacological treatments, inclulding Phenergan, Zofran, Mirtazapine, Pepto-Bismol, omeprazole, and pain unrelieved by Toradol.
pt recv vax 16MAY95 & 17APR97 pt exposed to chickenpox pt devel a mild case of varicella w/12-14 fluid filled blisters & low grade fever;no further details were provided;
Pt recvd vax 28JAN94 & states took APAP as directed & used ice on site 1st day & warmth 2nd day; area of erythema is apporx 12cm x 15cm; temp today 100 oral; no loss of ROm; small 2 cm area adjacent also reddened & warm;
Patient was administered Pfizer and after about 5 minutes, she had an allergic reaction ( hives on most of her body and generalized weakness. I gave her Benadryl and she was later taken to the nearest ER by paramedics personal.
Vomiting, not feeling good, malaise, muscle pain, +fever, vomiting 99-100-99; incr BP 184/79, 136/76, 157/82 feeling better after 24 hours.  Given Tylenol.  Had refused medications while feeling ill after vaccination, medications taken next day with no problem.
Pt was given 3rd dose of Moderna Covid Vax in error on 3/11/2021 at the rehabilitation center. 3/12/2021 - according to nursing home pt was acting strange around 7:30 am.  Pt was scheduled to be picked up by family members at 9:00 am.  When family got there the pt was unresponsive and 911 was called.  He was transported by ambulance to Medical Center ER.  Pt was intubated. He had fever so was given 3 different types of antibiotics.  He was given for blood pressure medicine and Chest X-ray.  He was moved to ICU and considered critical.  Family was called in to make final decisions.  His organs were failing.  He was on ventilator at 100%.  On 3/16/2021 the family made the decision to remove him from the ventilator. He passed around 7 AM on 3/16/2021.
evening of inject noticed lump @ site of inject rt central thigh; fussy & temp (/ unk what) for 3 days; MOC gave APAP for 3 dasy; to date lump still present current temp 99.4; lump rt central thigh 2cm w/purple color in skin;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 15-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 20-DEC-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.