chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No symptoms or adverse effects being reported; a patient received unspecified dose in VARIVAX innnunization series that was improperly stored.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.  On 12-MAY-2020, the patient received unspecified dose in varicella virus vaccine live (oka/merck) (VARIVAX) (lot#S031495, expiration date reported as 07-OCT-2022, but upon internal validation established as 07-OCT-2021; dose, strength and route were unknown) immunization series for prophylaxis that was improperly stored. The sterile diluent (lot#S026377 with expiration date: 06-MAY-2022) was properly stored. No symptoms or adverse effects being reported.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion under 6.3 degrees fahrenheit (F) for 30 minutes. There was no previous temperature excursion. The digital data logger was involved to capture the temperature excursion.
Brachial neuritis Right side with moderate pain along myotome, anesthesia right medial elbow and forearm, and decrease in grip strenth/dexterity digits 3, 4 right hand
Information has been received from a 31 year old female (also reported as 28 years old) through the Merck Pregnancy Registry who is a smoker with borderline hypertension. On 14-SEP-2000 (also reported in August 2000) the patient was vaccinated subcutaneously with the 0.5 ml first dose of VARIVAX. There was no concomitant medication. She believed her day of conception was 09-SEP-2000. She estimated that she received the vaccine five days into her pregnancy. Unspecified medical attention was sought.   Follow-up information was received from the physician to report that the patient's last menstrual period was 24-AUG-2000, and her estimated delivery date was 24-MAY-2001. Diagnostic/Lab tests included ultrasounds on 01-NOV-2000, and 22-DEC-2000, and MSAFP on 27-DEC-2000, that were all within normal limits. The patient had 4 previous pregnancies, one full term birth, and a miscarriage at 10 weeks. The patient had no Varicella of Herpes zoster symptoms post vaccination. On 29-MAY-2001 the patient delivered a normal, healthy male baby weighing 8 pounds 10 ounces. Complications during labor/delivery included shoulder dystocia of the infant. Additional information has been requested.  The patient reported "There were no complications with the birth and the boy had been in excellent health. Last fall, 2007, it was determined by the school district that the boy was learning at a much slower rate than his classmates".  Additional information has been requested.
-Joint pain all over her body, with excessive in wrists, knuckles, and elbows -Naproxen- did not help
Information has been received from a pharmacist concerning a 12 month old patient who in April 2007, was inadvertently vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) (MSD).  This was reported to be "totally human error" and the nurse did not read the vial.  The patient tolerated ZOSTAVAX (Oka/Merck) "fine".  It was unspecified if medical attention was sought.  There was no product quality complaint involved.  No further information was provided.  Follow up information indicated that the event was human error, the there were not any labeling errors or storage issues.  The office uses a computerized system to distribute vaccines, however, the nurse just administered the wrong vaccine.  There was no any adverse event to report.  No additional information is expected.
Patient notified staff at 0955 she had developed sore thoart. she did not have prior to vaccine. right eyelid swelling appeared at 1000.  facial swelling at 1005.
painful shingles like rash on R arm blisted then scabbed responded to valtrex
I was administered the shingles vaccine so high up on my right arm that it went into the joint. I have tremendous pain to this day and cannot work the hours I used to and basic shores are impossible.
FEVER; COLD  SWEAT FLASHES; SORE; BOTH LEGS HURT; BOTH LEG HURT WITH MUSCLE ACHE; BODY ACHE; HEADACHE; CHARLIE HORSES; INJECTION SITE PAIN; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, high cholesterol, COPD, cigarette smoker (1 pack per week), non alcoholic, and iodine in raw shell fish. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced Charlie horses. On 08-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced flu-like symptoms. On 09-APR-2021, the subject experienced body ache. On an unspecified date, the subject experienced fever, cold sweat flashes, sore, both legs hurt, and both leg hurt with muscle ache. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on 13-APR-2021, and flu-like symptoms, and cold sweat flashes, was recovering from sore, and had not recovered from both leg hurt with muscle ache, body ache, Charlie horses, both legs hurt, and injection site pain. This report was non-serious.
Breakthrough COVID-19 hospitalization in patient that completed the primary series and had booster.  Pt with several comorbidities and was placed on comfort care and passed away while hospitalized.
Significant hair loss; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 05Mar2021 at 16:15 (at the age of 49-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 49-years-old), as a single dose for COVID-19 immunization. Medical history included autoimmune disease. The patient did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced significant hair loss. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event significant hair loss was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
it was rpt fr MD concerning a pt who was vax & subsequently pt exp a lack of response. addl info requested
Patient came back to the pharmacy counter approximately 10 minutes after getting his 3rd dose of Pfizer and reported that he was feeling dizzy and light-headed. He was encouraged to wait 30 minutes and was given a water and said he was starting to feel better after that time frame. Asked him to report back any further side effects.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with two doses of GARDASIL (route and lot number not reported). The patient developed severe migraines after the second dose. The patient was under a neurologist care and had not recovered. The neurologist advised the patient not to receive the third dose of GARDASIL. This is one of several reports from the same source. Additional information is not expected.
This study case was received on 01 April 2014 from the investigator in a trial. A 29 year old male subject with no relevant past medical history, developed chest pressure 5 days after he received the following vaccines: an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) and concomitantly, an injection of ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 17 March 2014. On 22 March 2014, five days later, the subject developed one brief episode of chest pressure which worsened with inspiration, considered mild in severity with no other symptoms. On 27 March 2014, a Troponin I level was reported as <0.10 ng/mL. An electrocardiogram on 27 March 2014 was reported as normal. The subject did not take any medications to treat the event. The stop date of adverse events was reported as recovered/resolved on 23 March 2014. No further information was expected to follow. According to the investigator, the event of chest pressure were considered an other important medical event and possibly related to the trial product. Documents held by sender: None.
FELT AWFUL; VOMITING/ THREW UP; DIZZY; HIGH FEVER; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; NAUSEA/ FELT LIKE THROW UP; This spontaneous report received from a patient concerned a 16 year old male. 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) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced off label use. On APR-2021, the subject experienced nausea/ felt like throw up. On 10-APR-2021, the subject experienced inappropriate age at vaccine administration. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced high fever. On 11-APR-2021 06:00, the subject experienced vomiting/ threw up. On 12-APR-2021, the subject experienced felt awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting/ threw up, high fever, dizzy, felt awful, and nausea/ felt like throw up, and the outcome of inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
pt hospitalized 5/2/22 for aspiration PNA; required intubation; ICU; complicated hospitalization by testing positive for COVID, COVID PNA , on 5/31/22; condition did not improve; palliatively extubated on 6/22/22 and pt passed away in the hospital
FLUVIRIN W/ THIMERASOL GIVEN TO OB PT. NOTIFIED PT ON 11/5/09. DENIES ANY ADVERSE EFFECTS.
Inconsolable crying reported by mom for 45 minutes. bilateral leg edema and "mottled" per mom. Localized reaction.  Carried to local ER.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date between 03-AUG-2015 and 24-AUG-2015, the patient was vaccinated with the second dose in the (Oka-Merck) PROQUAD series that was improperly stored (Lot # L007230, expiration date: 03-SEP-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/7/22 at approximately 10:10am. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient declined revaccination. No adverse side effects or event as result of dose reported.
Axillary swelling of the lymph nodes on the left side of breast bone, which was also the side of the vaccine injection. I didn't treat it because I read on medical websites that it was a possible normal reaction to vaccinations, although I've never had it happen with any other vaccinations. I also read that it normally dissipates in a few weeks, but it's been 4 weeks now and I still have the swelling.
Pt awoke the next morning with a rash on her cheeks - hive like rash.
Vaginosis in January 2013 follow vaccination (unsure of treatment but it went away); Abnormal pap smears consistently following vaccination; Precancerous cells in cervix Summer 2015 (no treatment due to pregnancy following soon after discover). Abnormal pap and positive for HPV in postnatal visit April 2016.
Sore arm shooting pain deep in my bones on left arm and right elbow weird vivid dreams tired slight fever body and muscle aches
really extreme high blood pressure (202/104); feeling very sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 04Jan2021 at a single dose for COVID-19 immunization. Medical history included strokes and bleeding disorder (gene that makes blood clot). The patient's concomitant medications were not reported. The patient experienced really extreme high blood pressure (202/104) and feeling very sick on an unspecified date. The clinical course was reported as: The patient received the vaccine on 04Jan2021 and experienced a lot of side effects, the most concerning of which was really extreme high blood pressure. The patient went to the emergency room (ER) on an unspecified date and her blood pressure was 202/104 on an unspecified date. The patient stated that she had been very sick and in bed for days. The patient had a follow-up appointment with her doctor on the day of the report. The clinical outcome of really extreme high blood pressure (202/104) and feeling very sick was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Mother reports child was "hot" and she had to arouse him form sleep to give him Tylenol and "cool him down". She said he didn't eat much since getting shots' "fever" lasted from 2 am till 8 pm and although he isn't limping is doing well now though has blisters where shot was given. Welt like blisters noted golf ball size area where DTaP was given.
presented with weakness, AMS; CXR: multifocal PNA, Labs:  CRP 18.96; Initially requiring 8 LPM O2; D-dimer 2.5; ferritin 4443; Tx:  Maxipime, rocephin, doxycycline, remdesivir,  Tocilizumab (1/28/); zinc, Vit C, solu-medrol, Down to 1 LPM O2 at D/C
Injection site inflammation. Injection site pain. Injection site redness. Injection site warmth. From initial information received on 24/Apr/2003 from the patient's parent regarding an adverse even occurring in the USA, it was reported that a five year old female patient received her fifth dose of DAPTACEL, lot number C0248AA on 21/Apr/2003. The route and site were not reported. The patient experienced a local two inch diameter reaction that was red, inflammed, warm to the touch and painful, that began 24 hours after the vaccination. The patient received two other vaccines that day, but the patient was not sure which ones were given. It was reported that the patient recovered from these events.
This spontaneous report as received from a registered nurse (R.N.), refers to a 19 year old patient (gender unknown) who on 22-JUL-2013 was vaccinated with a pediatric dose of VAQTA (Lot # not reported) 0.5 ml, intramuscular route). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Pain extending up into shoulder joint, down the bicep and back into the left scapula two days after the injection, with limited range of movement.  Pain extended down into the left hip 4 days after the injection.  Arthritis strength acetaminophen provides limited relief of should and scapula pain for about 5-6 hours.  The hip pain resolved after 3 days.  The shoulder and scapula pain continues.
Patient called pharmacy on 7/21/17, and reported that after receiving ZOSTAVAX, on 7/19/17, she had a headache, which lasted for about 2 days, as well as a hard, golf ball side bump that is red and itchy at the injection site. As per patient report, the headache was relieved by taking TYLENOL and has subsided. The hard, golf ball size lump is still apparent at the injection site. Advised the patient to take BENADRYL to relief itchiness and redness, and to report to Urgent Care if no relief in symptoms over the weekend.
2 hours after receiving vaccination, patient had nausea and vomiting. She states she had a subjective fever for the next two days, along with headache, body pain, fatigue, nausea, diarrhea, acid reflux and intermittent chest pain. At time of visit on 4/14/21, patient reported still feeling fatigue, body pain, diarrhea, nausea, headache and acid reflux. She did not have chest pain at time of appointment, but did have it the day prior.
Short-term memory loss; Swelling on left arm (size of a grapefruit); Redness on left arm (size of a grapefruit); This case was reported by a consumer via call center representative and described the occurrence of short-term memory loss in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2023, the patient received the 1st dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On 18th February 2023, the patient experienced short-term memory loss. On an unknown date, the outcome of the short-term memory loss was unknown and the outcome of the swelling arm and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the short-term memory loss, swelling arm and erythema of extremities to be related to Shingrix.  Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's comments: The reporter was the patient's brother in law.  The patient received her first dose of Shingrix in left arm. She had experienced swelling and redness on her left arm that grew to the size of a golf ball and then the size of a grapefruit. The swelling and redness had resolved. On 18 February 2023, the patient had experienced sudden short-term memory loss. She went to the Emergency Room (ER) on 18 February 2023, where bloodwork and culture was done. Urinary Tract Infection (UTI) was suspected but the culture was negative. The reporter was unknown for what had caused the short term memory loss. The reporter did not consented to follow-up. Additional supportive information: 4 days after receiving Shingrix, the patient experienced short-term memory loss.
Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung (POA: Yes) COVID-19 infection with not requiring oxygen. Continues azithromycin IV/ceftriaxone IV
Patient had complaints of cough and dyspnea over several weeks with acute worsening 12/1. Her daughter brought her to our ED found to be 68% on RA requiring NRB mask escalated to HFNC. COVID-19 testing was positive.  Of note, she did receive the J&J vaccine in September. CXR demonstrates bilateral patchy airspace disease and possible L effusion.
pt recv vax & w/in 1mo of vax pt devel a lump 3.5cm in diameter, @ the site of vax;A sterile abscess then formed @ the site, requiring drainage;pt recovered;
Patient fainted shortly after administration of vaccine. She was AAO, breathing normally, and responsive. 911 was called at time of event, ambulance was dispatched to scene for medical follow up of patient.
pt recv vax 22JUN95 & 20NOV97 pt exp a breakthrough case of varicella;the case was considered mild, less than 50 lesions;
After receiving the vaccinations the patient went home and began to have swelling in the left arm then fever, then swelling of the face, and left lower limbs.
The physician is reporting that the patient recieved improperly stored vaccine at an unspecified date; This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On unknown date, the patient was vaccinated with an improperly dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) one dose, lot number S007075, expiration date 06-SEP-2020 (route of administration was not reported). Administered dose of vaccine experienced the temperature excursion of 32.5 degrees Fahrenheit (°F) for 8 hours. Data logger was involved. There were no previous excursions reported.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-JAN-2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Per his mother, he had fever to 102 x 2 days, weakness, and lethargy x 2 days. Stayed in bed, unable to get up other than briefly for bathroom. Also had local erythema and swelling and soreness at vaccine site.
After the first dose of the vaccine I was very tired. My arm was a little painful after that shot. After the second dose of the vaccine my left arm hurt a lot after two days. I felt very cold all the time and my bones felt ice cold for three days. I have Rheumatoid Arthritis and was having a lot of joint pain especially in my knees. The pain and discomfort was mostly in my arms and my hands. One month after the vaccine I was still having the cold feeling with fatigue which came and went. Sometimes I felt extremely fatigued for a week at a time. My doctor gave me extra Meloxicam for the pain in my left arm especially. I have been trying to exercise and it seems to help. I have been diagnosed with High Blood Pressure recently. It has been six months since my vaccine. My Rheumatoid Arthritis is still worse at the moment and I take Meloxicam to help me sleep.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-FEB-2015 the patient was vaccinated with an improperly stored dose of Pneumovax 23 0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once.. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.