chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a rash on her left arm; Her left arm itched from the inside out; Ser left arm was swollen up; She had 101F temperature; she almost had a seizure; Her body was shaking from head to feet; she received 2nd dose 49 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (she almost had a seizure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO) for an unknown indication.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced INCORRECT DOSE ADMINISTERED (she received 2nd dose 49 days after the 1st dose). On 01-Jul-2021, the patient experienced SEIZURE (she almost had a seizure) (seriousness criterion medically significant), TREMOR (Her body was shaking from head to feet), RASH (Had a rash on her left arm), VACCINATION SITE PRURITUS (Her left arm itched from the inside out), VACCINATION SITE SWELLING (Ser left arm was swollen up) and PYREXIA (She had 101F temperature). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 01-Jul-2021, SEIZURE (she almost had a seizure), TREMOR (Her body was shaking from head to feet) and PYREXIA (She had 101F temperature) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (she received 2nd dose 49 days after the 1st dose), RASH (Had a rash on her left arm), VACCINATION SITE PRURITUS (Her left arm itched from the inside out) and VACCINATION SITE SWELLING (Ser left arm was swollen up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, Body temperature: high (High) Body temperature was 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not go to her doctor during the events but does plan to see her PCP.  No treatment medications were reported.  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.   This case was linked to MOD-2021-175840 (Patient Link).; 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.
Patient was mistakenely administered a half dose of the Moderna COVID-19 vaccine instead of a full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was mistakenely administered a half dose of the Moderna COVID-19 vaccine instead of a full dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient was mistakenely administered a half dose of the Moderna COVID-19 vaccine instead of a full dose). On 12-Dec-2021, ACCIDENTAL UNDERDOSE (Patient was mistakenely administered a half dose of the Moderna COVID-19 vaccine instead of a full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient reports experiencing no symptoms as of yet.
Approximately at 01:00AM on 02/26/2022, I started to have COVID symptoms. I tested positive for COVID on 02/29/2022.
SWELLING IN THE ARM OF INJECTION. SWELLING IS FROM THE SHOULDER TO THE ELBOW. PHYSICIAN HAS HAD HE ON ANTIBIOTICS AND SENT TO THE CARDIOLOGIST. WHEN PATIENT WRAPS THE ARM SWELLING MOVES TO LOWER ARM . TSHIRTS WILL NOT FIT HER DUE TO THE SWELLING .
Nursing staff alert us for a patient with a tachycardia Upon arrival patient is alert, conscious and oriented. She reports having an episode of tachycardia and feeling anxious. She is kept under observation. Patient reports improvement with symptoms and leaves the center.
pt recvd vax & a few hrs later started c/o pain in lt arm; presented @ ER w/swollen, red arm w/swelling starting just above lt elbow; devel swollen, red lt arm & hand by late evening 26MAR93; pt felt feverish; dx cellulitis; pt taken to ER;
heaviness on her chest; a fast, pounding heart beat; dizziness; a fast, pounding heart beat; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (weight: 190 with no unit provided) received bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Mar2021 (Lot Number: EW0150) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had a delayed reaction to her first dose of the Pfizer-Biontech covid19 vaccine. She reported feeling a heaviness on her chest, a fast, pounding heart beat, and dizziness, these symptoms showed up about 1 hour after her first dose, and lasted for 3 hours before resolving. She did not require medical intervention to treat her symptoms. She was due for her second dose tomorrow on 20Apr2021. The patient really wanna get the second dose and get fully vaccinated but she did have some side effects that range a little bit higher than the average. So her concern was if the reactions got any worse than she was experiencing, she might need to go to urgent care but if they don't get worse she can deal with it. The outcome of the events unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
The day of the vaccination I began to have pain in my left thigh. A couple of days later I had a rash on that thigh and lower back. On April 29 I had lab tests done and I tested positive for shingles.
About 3 hours, post vax, she became nauseated and vomited while at work (40F at assembly line); 15 minutes after vomiting, she returned to assembly line and felt faint and passed out for 15 minutes. Became conscious, answered questions appropriately to ER.
Had two vaccine, gets shingles all the time/Suspected vaccination failure; Gets shingles all the time; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, 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 Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's relative. The age at vaccination was not reported. The patient had the two vaccine and he get shingles vaccine all the time. The reporter stated that he/she was staying away from vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not reported.
Severe chills fever within 3 hours.; Severe chills fever within 3 hours.; extreme fatigue; muscle ache all over; severe headaches; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 14:15 as dose 1, single (Lot number: GH9694) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 05Oct2022, outcome "unknown", described as "extreme fatigue"; MYALGIA (non-serious) with onset 05Oct2022, outcome "unknown", described as "muscle ache all over"; HEADACHE (non-serious) with onset 05Oct2022, outcome "unknown", described as "severe headaches"; CHILLS (non-serious) with onset 05Oct2022 at 17:15, outcome "not recovered", PYREXIA (non-serious) with onset 05Oct2022 at 17:15, outcome "unknown" and all described as "Severe chills fever within 3 hours.". Therapeutic measures were not taken as a result of chills, pyrexia, fatigue, myalgia, headache.  Additional information: The patient did not have any other vaccine in four weeks. Four days later still have chills. The patient did not have COVID prior vaccination and was not COVID tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Per mother : 5/17/10 : Mom called secondary to B/L arms swollen/ reddened, L arm > R arm.
Headache, Arthralgia, NauseaVomiting, Palpitations, Fatigue, sore throat Narrative:
Information has been received from a health professional concerning a 5 year old female who as an infant had a milk allergy, who on 10-MAY-2007 in the morning was vaccinated in the right thigh with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot number 657034/0232U).  There was no illness at the time of vaccination.  Prior vaccinations included on 02-JUL-2003 a dose of MMR II (Enders-Edmonston, Jeryl Lynn, HPV-77) (MSD) and on 07-APR-2003 a dose of Varivax (Oka/Merck) (MSD).  It was reported that on 11-MAY-2007 (also reported as 12-MAY-2007) the patient developed a right leg that was red, swollen and warm to touch at the injection site.  The symptoms continued up to the 18-MAY-2007.  The patient's mom reported to the reporter that the redness continued up to the 25-MAY-2007.  No treatment was provided.  Unspecified medical attention was sought.  No product quality complaint was involved.  This is one of several reports from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/6/2007. In follow-up, it was reported that the patient recovered without incident. This is one of several reports from the same source. Additinal information has been requested.
Nausea, vomiting, dizziness and fatigue. Postural orthostatic tachy syndrome for over 3 weeks and still has it.
Case number PHEH2016US023414 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 58 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) on an unknown date. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
3 hours after administration, she developed tingling all over, with fatigue, lethargy, and pallor. No loss of consciousness. Has since developed fever to 100.4
Evening of July 3, 2021, was fine. Went to sleep at midnight. Woke up at 6am on July 4, 2021 with visual impairment, dizziness, nausea, vertigo. Waited to see if symptoms would subside. They did not. I went to ER and was admitted. After testing, result was: 4 x 2 mm focus of restricted diffusion in the central midbrain, located just to the right of midline, is compatible with a small acute infarct.
3/16 Telephone call from parent, states redness around injection site with a golf ball sized lump denies tenderness at injection site or fever. Noticed redness the morning of 3/17/06 and lump in the afternoon. States will watch injection site. Follow up phone call to mother 3/17, states took client to be evaluated by a doctor today, due to increased size of lump, size of a softball and increased area of erythema. Doctor stated the child has an infection from the injection, where the needle pierced the skin. Doctor stated child would be hospitalized if erythema increased. Ordered Keflex 500 mg po qid x 10 days. 3/20 follow up with mother induration and erythema have decreased in size, child not hospitalized.
After his vaccination, the next morning child had a temperature of 100-101 and hives.  Hives have continued on now for 4 days and he has not been in school.   2/14/2023- 7:00 AM fever & hives- gave benadryl.  4:25 PM hives swollen started again.  Hives on his face, hands, feet, parts of body, ears, and scalp.  Had to also do budesonide breathing treatment.  2/15/2023- 8:00 AM Benadryl due to hives temperature remained at 99-100.  2:00 PM Benadryl due to hives 2/16/2023- Morning no hives and temperature around 98-99.  Around 7:00 PM he broke out in hives on neck and lips.  Gave Benadryl.  Around 8:30 PM after bath he had a temperature of 100-101.  2/17/2023- Woke up at 4:00 AM and said his lips felt big.  He had a swollen face predominantly his lips and eyes. Gave him Benadryl.  At 8:00 AM, he was still swollen and gave him Benadryl and Prednisone 5ML at 9:20 AM.
Dehydrated; fingers getting spasms; can barley sleep at night; feel sick like have to throw up; feel hot; feel sick like have to throw up; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DEHYDRATION (Dehydrated), MUSCLE SPASMS (fingers getting spasms), INSOMNIA (can barley sleep at night), ILLNESS (feel sick like have to throw up) and FEELING HOT (feel hot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEHYDRATION (Dehydrated), MUSCLE SPASMS (fingers getting spasms), INSOMNIA (can barley sleep at night), ILLNESS (feel sick like have to throw up), FEELING HOT (feel hot), VOMITING (feel sick like have to throw up) and HEADACHE (Headache). At the time of the report, DEHYDRATION (Dehydrated), MUSCLE SPASMS (fingers getting spasms), INSOMNIA (can barley sleep at night), ILLNESS (feel sick like have to throw up), FEELING HOT (feel hot), VOMITING (feel sick like have to throw up) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported
PATIENT DEVELOPED A LARGE LUMP ON HER RIGHT BICEP JUST UNDER THE SITE WHERE THE SHOT WAS GIVEN IN THE RIGHT DELTOID. THE PA WHO EXAMINED HER SAID THE LUMP AND REDNESS THAT SURROUNDED IT WAS A HIVE AND LOOKED LIKE AN ALLERGIC REACTION. HE ADVISED HER TO TAKE ZYRTEC AND NAPROXEN OTC.
This spontaneous report was received from a certified medical assistant and refers to 2 patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On 26-AUG-2016, the patients were vaccinated with an improperly stored dose of VAQTA lot # M017982, expiration date 13-SEP-2017 (dose, frequency, route of administration were not reported). The patients' concomitant therapy was not reported. The administered dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Moderna Covid 19 Vaccine EUA at 2:40 went to bed @ 11:00 p.m. on 1/22 very tired didn't notice any bruises  woke up at 9:00 noticed at 10:00 a burn like  bruise on my left wrist, dark red purple color. bigger than a dollar coin Called PCP around 10:30 was told to take Benadryl two pills and pay attention to if it spreads or get more spots the spot got a little bigger but not painful or burning. Couldn't pick up my left arm it hurt very bad, ice the injection spot and slept all day
A couple days after vaccine administration, pt reported soreness and "pinkness not redness" around the injection site. Pt was counseled to apply a cold compress and take an OTC pain reliever. She is to monitor the site and if it gets worse, then they are to seek medical attention.
Patient developed painful right axillary lymphadopathy about 12 hours after injection with no alternative explanation.  It is subsiding but with ongoing pain and enlargement.
Pt fainted onto a bench about 30 sec after vaccine was administered.  Pt came to and fainted  again.  911 was contacted.  Pt regained conscience and was examined by paramedics.  Pt refused to be transported in an ambulance and reported feeling fine.  Pt was released to be picked up by a friend.
ADMINISTRATION OF AN EXPIRED JANSSEN VACCINE; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced administration of an expired janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired janssen vaccine was not reported. This report was non-serious.
swelling up of the arm; High fever; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 21-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), administration date 2020 (lot number: unknown) at the age of 20-years as dose number unknown, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling up of the arm" and PYREXIA (non-serious), outcome "unknown", described as "High fever". Additional information: The patient received the vaccine about a year and a half ago.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness and vomiting. On an unknown date, the outcome of the sickness and vomiting were unknown. It was unknown if the reporter considered the sickness and vomiting to be related to SHINGRIX. Additional details were reported as follows: This case was reported for one of the coworker who was sick and experienced vomiting as well. The age at vaccination was not reported. The reporter reported that all coworkers and her son got sick. The reporter indicated that the adverse events experienced by her son and coworkers were reported to the health department where they received the vaccination. The reporter would not provide additional information. This is 1 of 3 cases, reported by the same reporter.
Bilateral Ischemic Optic Neuropathy; Blurred Vision; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 12-OCT-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date (reported as shortly after received zoster vaccine live (ZOSTAVAX) vaccine), the patient suffered vision problems and was diagnosed with blurred vision and bilateral ischemic optic neuropathy. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations did not present prior to used vaccine. The patient also experiences mental and emotional distress due to resulted physical limitations and seriousness of his condition. The patient sustained severe and permanent personal injuries (disability). Further, as a tragic consequence, and suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient had suffered and incurred damages, included medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of optic ischaemic neuropathy and vision blurred were not recovered. The reporter considered optic ischaemic neuropathy and vision blurred to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, optic ischaemic neuropathy was considered to be a medically significant event.
8 hours after vaccination, felt tightness in chest, chills, and nausea. 17 hours after vaccination, felt body aches and headaches for a span of 12 hours.
Information has been received from a medical assistant concerning a male who on approximately 25-JUN-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a rash and headache. Details about the rash and the timing of the onset of symptoms is unknown. No further information is available.
No adverse side affects per patient at this time, wrong vaccination given. IPOL was given instead of HPV.  Provider informed of vaccination error and patient to return to clinic for proper vaccine.
Shingles.  On day 12 after the second shot of Pfizer Covid 19 vaccine, felt discomfort and a sensation that something was rubbing against the skin around the waistline. On day 16 developed a rash with red blisters on the left side of the waist.
Head to toe hives in large splotches all over. Roughly 50% or more of body that move around throughout the day.
The patient got the vaccine around 4 pm on 11/6/17 and she went home. When she wake up next morning, she notice the arm where she got injection is seem red and swollen so she go to the pharmacy. Patient is advised to go to the clinic to see the doctor, in a mean times she is going to buy pain relief OTC and BENADRYL OTC.
injection site began to itch about 5 days after injection.  It has begun to cease after about 10 days.