chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exttremely tired, slept 4/01-4/03 most those days, and slowly increased energy following days, but still required more rest than normal; pounding headache; sores on legs that itched, kind of like bumps that seeped if scratched too hard. Couldn't watch TV. Eyes had trouble focusing. Eight days after vaccine I got a few new itchy bumps, and stll low on energy, and have a headache that isn't as bad. Still having trouble thinking, brain isn't working as sharply.
PATIENT REFERS HIGH FEVER, DRY COUGH AND CHILLS. (FLU LIKE SYMPTOMS). PATIENT WENT TO HIS PRIVATE DOCTOR AND HE ORDERED A CBC AND DX THE PATIENT WITH A VIRUS (UNSPECIFIED).
Pt. had erythema and discomfort up the trapezius left arm. Seen in urgent care and referred to ER - received IV sodium chloride. Discharge oral antibiotic.
A non-serious spontaneous report of felt as if she was going to pass-out, mouth and jaw became tight, increased heart rate, and face and neck red has been received from a nurse concerning an adult female (age unknown), subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. History of allergies was not reported. The patient received FLUMIST on 29-Oct-2009. Approximately two hours after receiving FLUMIST, the patient's mouth and jaw became tight, she felt as if she was going to pass-out, and her face and neck were red. The patient was transported to the emergency room (ER). Her heart rate was increased while at the ER. The patient's symptoms subsided somewhat after a couple of hours, and she was sent home with orders to take diphenhydramine for four days.
From telephone correspondence received at Aventis Pasteur, Inc. on 8/28/02, it was reported that a 28 y.o. male PT was vaccinated on 8/21/02 with TD. Vaccination was given intramuscularly as a booster with a dosage of 0.5 ml. On 8/28/02, the PT developed a local site reaction of redness, swelling and tenderness 7 days post-vaccination. No treatment was prescribed by the physician. The lot number initially reported on the PT was U0394AB, which is DT ADS PED USP for pediatric use, not TD for adult. A follow-up phone call to the physician was made and she was advised of the same. The physician later called back and stated that "the nurse said she charted the lot # from a paper, not what was on the vial" and provided another lot # (U0382AA), which is TD for adult use. It was not reported whether the PT recovered.
I received a Diptheria, Pertussis and Tetanus shot. (Note that I selected the first DTAP option above, unsure if correct brand).  I merely had a sore arm within a few hours. However, when i woke up on 12.19.19 I suddenly felt paralyzed and could barely breathe. I could not leave my bed the entire day aside from one trip to the bathroom and it took all of my energy. Due to the feeling of near paralyzation, I was unable to eat the whole day or even move to use my phone or tv. I had a few sips of water. Bc of my shallow breathing, I was fearful that each next breath would not happen. Amazingly, woke up mildly fatigued but normal the AM of 12.20.21. Didn't call 911 due to insurance coverage.
Blurred vision, ringing in ears, hot, sweaty, "clammy". None responsiveness for about 5 minutes = possible syncope reaction.
Rash at injection site with 4 to 5 inch circumference.  Noticed the morning after the injection.  Warm to feel.  Rash has not disappeared two weeks post injection.  Have rubbed in Benadryl cream and Arnica gel.  Take Xyzal antihistamine daily
Patient is breastfed by mother, who was vaccinated on 3/10. Patient developed jaundice 3/11, and was admitted for evaluation of hemolytic anemia. Evaluation ongoing. Likely not related to vaccine, but occurred within 2 days of possible to vaccine components via breastmilk
felt "jittery" shortly after receiving vaccine.  Reports this has happened previously at dentist and during delivery of children.  VItal signs obtained, juice given.   BP 156/96 P 108  R 16  O2 sat 100% on room air.  Wheelchair to gurney where patient rested for approximately 10 minutes ( 110/68 on R side-P 85-R16-O2 Sat 100% RA)  when patient sat up, stated she felt fine, was laughing and talking appropriately.  VS stable (112/70-82-16 100%).  No longer jittery. Teenage child at bedside.  Assisted to car via motorized vehicle.
Shortly after vaccination patient experienced fever, increased pain at injection site with localized swelling of left arm. Went to local ED 12/14/06. Saw PCP, for follow-up. Treated with OTC Benadryl.
Acute urticaria-given Benadryl IM and Dexamethazone IM.
Heavy period  Trouble with vision  Eyelids swollen  Erratic Heart rate  Blood pressure  Shaking  Throat swelling  Tingling in feet/hands  No appetite  Weight loss  Pressure on chest  Cough  Ulcers in mouth Neuropathy  These symptoms have been going on and have not let up. Currently on Lyrica .
Hives around many areas of body including torso, legs, hands, feet, face. Low grade fever. Body aches. Sore throat.
Vaccine that administered beyond use date after the thaw process; Vaccine underdose(covid vaccine number-2nd / dose volume:0.25); This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine underdose(covid vaccine number-2nd / dose volume:0.25)) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Vaccine underdose(covid vaccine number-2nd / dose volume:0.25)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine underdose(covid vaccine number-2nd / dose volume:0.25)) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that no adverse events had occurred after administration of vaccine to the patient. No treatment medications were reported.
Pt presents with L deltoid redness, swelling, pain, localized numbness, and itching. Received COVID vaccine there one week prior. Reports it was even more swollen yesterday, but perhaps a little better today. No SOB, tongue swelling, n/v/d. Current presentation more consistent with delayed hypersensitivity reaction to COVID immunization rather than cellulitis. No concern for anaphylaxis. Provided diphenhydramine, ibuprofen, and hydrocortisone 1% cream from clinic; prescribed triamcinolone 0.1% if no effect from low-potency topical steroid. Counseled pt to expect resolution within 4-5 days, but to RTC sooner if increasing erythema, tenderness, swelling.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 06-FEB-2008, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 17-DEC-2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
10-13-17 patient reported redness, slight swelling, warmth on area about the size of a hand on her left arm by injection sight. Counseled patient to use cold compresses, 800mg ibuprofen, topical hydrocortisone cream, oral Benadryl and if area worsened or did not improve to contact us or physician. 10-15-17 patient reported affected area on arm had increased in size to about 1/3 of arm and was experiencing discomfort significant enough to disrupt sleep the previous night. Counseled patient to contact physician and/or urgent care clinic.
Dizziness and nausea - stayed lying down, and stayed home from school next day 5/19 - fine now 5/20
Hub failure upon vaccination. Patient did not receive any vaccine through needle, all vaccine leaked from hub failure.
12mins post vaccination pt reported feeling internally jittery (shoulder, arms and torso) Vitals: 16:00 115/64, 86, 18, 100%, 97.2F -- > 16:22 126/67, 74, 100%, 97.8F After ~15 additional minutes, pt stated that she was feeling better. Pt denied lightheadedness with ambulation.  Pt waited in general observation area to be pick up by husband.  Pt advised not to drive.  Pt stable and released from the vaccination site.  Recommended pt f/u w/ PCP.
This spontaneous report was received from a Registered Nurse refers to a 3 year old male patient. No medical history or drug allergies were reported. On 29-MAR-2011, the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 668602/1273Z, expiry: 30-SEP-2012) 0.5 ml, subcutaneously in the left leg (reported as left thigh). No concomitant medications were reported. On 16-JUN-2013, the patient experienced rash that consisted of lesions on his back and left thigh. Patient sought medical attention: was seen by physician on 19-JUN-2013. Patient was prescribed acyclovir 200 mg three times a day for 5 days on 19-JUN-2013. Laboratory diagnostics studies performed was none. The outcome of rash that consisted of lesions on his back and left thigh was unknown. Additional information has been requested.
Mistakenly gave 0.25ml's of Moderna Bivalent booster instead of full 0.5ml dose.
Within three and a half hours the left side of my face felt numb and heavy. A few hours after that I started having pins and needles sensation in finger and toes on my left side. Around 8:00pm my left ear felt like it was full and my hearing decreased until I woke up this morning. My ear still hurts a bit but I can hear slightly better than I did last night. Around two am I was woken from my sleep with heart pain and an irregular heart beat. I called my primary care physician to schedule an appointment. I have an appointment tomorrow morning.
Hot flashes, feeling hot and cold, nausea, headaches, pruritus, voice hoarseness
Nurse calling inquiring about a 4 year old receiving second dose ofMMR-11 but some of the medication was sprayed out (probably 0.025mL) before the dose was administered.; Nurse calling inquiring about a 4 year old receiving second dose ofMMR-11 but some of the medication was sprayed out (probably 0.025mL) before the dose was administered.; This spontaneous report was received from a nurse, referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 27-JAN-2021, the patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), administered at a dose of 0.025 milliliter (ml)  due to some of the medication was sprayed out before the dose was administered (incorrect dose administered and product container issue) (formulation, strength, route of administration and anatomical site of vaccination were not reported; lot number T000892, which has been verified to be valid, expiration date reported and validated as 08-JAN-2022). No additional adverse event were reported.
This spontaneous report was received from a nurse and refers to a 9 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown) for varicella prevention (dose, frequency, route of administration, lot #, and expiration date were not reported). The reporter heard from a coworker that the patient had developed shingles "even though they were 'up-to-date' on all of their childhood vaccines". The reporter was unsure if the child definitively received any Merck-manufactured vaccine(s). At the reporting time, the outcome of shingles (Herpes zoster) was unknown. The causality assessment between Herpes zoster and the suspect vaccines was not reported.
**Lot number is extrapolated as it was not recorded on pt's record. Pt received vaccine on on June 13th, pt whose lot number is listed received it on June 27th. History is from patient phone call Jan 31st 2018 and hospital record. Pt recieved PREVNAR and one week later developed flu like symptoms., Treated with azithromycin and resolved. States joint pain and weakness started 2 weeks after injection, included bilat shoulders, with prominent weakness. Unable to hold a cup of coffee with one hand due to pain and weakness. Unable to elevate arms. Arthralgias hips, knees low back, described as 'excrutiating'. Required help of a neighbor for IADLS. Admitted to Medical Center on November 24th, 2017. Troponin negative, hgb 10.1, absolute neutrophils 7.5, albumin 3.3, magnesium 1/3, CK 30. CRP <0.02, sed rate 42. EKG normal. Dramatically responsive to prednisone 10mg. Continues on prednisone 20mg as of this report.
Patient had seizures like symptoms after receving Pzifer Covid vaccine. EMS was called but patient was not transported.  Patient was released to home
Pt developed cough requiring RX for benzonatate, and was unable to go to work for a couple of days. Arm swollen and red, hard to the touch.
only received adjuvant portion; only received adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter (CPT) reported that patient had only received the adjuvant suspension portion of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was seeking medical guidance. Outside phone number GSK Medical Information given for future reference and warm transfer provided. Consented to follow up was provided. .
4 days after immunizations, developed white dots surrounded by red marks on abdomen.  5 days after imm, rash on abd. fading, more rash on sides and back.  No bruising noted. Per private provider:  not likely to be from immunizations, child Rx'd with liquid Claritin and Prednisone.  Unknown reason for rash.  7 days after imm., child still has the rash on sides and back, one spot on neck and two on arm.  Abd. rash con't to fade.  Child is "acting normal."
Patient had received a Moderna vaccine as their first dose. Patient returned for 2nd dose and was given Pfizer in error.
Hives that developed 24 hours after receiving the vaccine, no respiratory symptoms. Treated with Benadryl.
About 12 minutes after injection, patient started to feel a hot feeling to her left upper arm (that is where she her injection was given); She denied having any other symptoms. Hx of shellfish allergy once years ago- face swelling. Has eaten it since and has not had any problem; She had slight pink discoloration to left arm inferior to injection spot; Area was warm to touch and felt  "hot to patient). Patient was treated with Zyrtec and her rash and hot feeling to arm resolved.
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 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 3:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 3:40 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). 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). 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 66.01 for dose administered on 03-Mar-2021 and 66.09 for dose administered on 31-Mar-2021.   No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 51 degrees Fahrenheit at 09:00 AM, 34 degrees Fahrenheit at 10:00 AM and 35 degrees Fahrenheit at 01:00 PM and 36 degrees Fahrenheit at 03:00 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.  Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-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.
Day 1-3 severe headache, fever, fatigue, body aches I was in the bed for 2.5 days. Day 5 - severe chest pain landed me in the ER at Hospital - pericarditis caused by the vaccine. Day 21- finally got into see a cardiologist, started colchicine to try to reduce the inflammation around my heart and prevent it from coming back.  An echocardiogram is going to be performed on 4/14/21.  Also, right upper quadrant pain when taking a deep  breath, a ct scan is being scheduled.   Ive not been able to sleep laying down since day 5 following the vaccine. Chest pain, shortness of breath and right upper quadrant pain are all a result of the vaccine.
I have been in and out of the hospital since May 2021. It started 2 weeks after the second dosage of the COVID-19 vaccination with a severe ear infection and doctors could not figure out what the cause was. I have been put on numerous amounts of antibiotics and steroids and almost lost my hearing in its entirety because of this problem. It triggered bells palsy on the left side of my face. The infection spread and I ended up with a sinus infection that required surgery. A couple of weeks after surgery, I lost vision in one of my eyes and required hospitalization and the doctors found that my problems were due to inflammation in my blood vessels and inflammation in my kidneys. Since May 2021 I have been placed on numerous amounts of medication, have required hospitalization twice monthly, dealt with almost losing my hearing and vision, required surgery, and now I am dealing with problems with my kidneys.
This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On an unknown date, the patients were administered with VARIVAX (Merck) (dose, lot number, expiration date and route not provided), which underwent a temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse practitioner and refers to multiple patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M011117, expiration date: 07-DEC-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. On an unknown date the unspecified patients were vaccinated with (Oka/Merck) VARIVAX (dose: 0.5 ml, subcutaneous) that had continued to undergo defrost cycling in which the temperature has risen above the proper parameters. No adverse effects were reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This case is linked to case # 1406USA004630 and 1409USA004711 (same reporter link). Additional information has been requested.
Received Smallpox vaccination and developed erythematous pustules and vesicles down (R) arm (inoculated arm).
pt recv vax & 7 days p/vax pt devel sx indicative of measles, including gen rash, swollen glands, fever of 102-103;
An expired booster dose was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.