chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 68 year old female with hypothyroidism, osteopenia, hiatus hernia, fibromyalgia, Sjogren's syndrome and allergies to sulfamethoxazole (+) trimethoprim (Bactrim), ciprofloxacin (Cipro), cephalexin (Keflex), aspirin (+) oxycodone hydrochloride (+) oxycodone terephthalate (Percodan), tetracycline, and azithromycin (Zithromax) and tetracycline who on 21-Aug-2007 was vaccinated with zoster vaccine live (Oka/Merck) IM in the L arm (lot no. 658086/0761U).  Concomitant therapy included levothyroxine Na (Synthroid), salcatonin (Miacalcin), pantoprazole sodium (Protonix), tramadol HC1 (Ultram) and cholestyramine resin.  In 2007 the patient developed a red pimple-like rash with a discharge, that was itching and tingling around the rash on her chest, back, both arm and back of head.  On 13-Sep-2007 the patient was examined in the physician's office and she was prescribed hydroxyzine hydrochloride (Atarax) and methylprednisolone (Medrol) dose pack.  The patient was examined by a dermatologist but the results of the exam were unknown.  On 30-Sep-2007 the patient was seen in a local emergency room and the methylprednisolone pack was continued.  On 01-Oct-2007, the patient was examined in the physician's office and the rash was resolving.  The patient was advised to continue the methylprednisolone and she was also prescribed loratadine (Claritin) and diphenhydramine (Benadryl).  Follow up information was received from the physician concerning a 67 year old female, who presented to the doctor's office with complaint of a generalized rash.  Upon examination the patient was found to be well developed, well nourished, and in no acute distress, with papules on the anterior trunk, macular papular area of the left antecubital.  The patient stated that "the rash started eight days after receiving zoster vaccine live (Oka/Merck) vaccination".  The patient denied any other known trigger.  The patient was initially seen in the office (undisclosed date) with a rash of her left antecubital area and was diagnosed with contact dermatitis and prescribed medrol dose pack.  The patient stated that "two days after finishing the steroids the rash came back and flared up".  The patient was seen by a neighbor who is a dermatologist and was given a cortisone injection and other Prednisone Taper over a longer period.  Two days after completing the therapy the patient had a generalized red urticarial macular papular rash on her trunk and extremities.  The patient had gone to the emergency department for evaluation.  At the time of examination the patient was currently on day three of a 10 day steroid taper.  The rash had improved and the patient had several scattered papules on the trunk and left antecubital area.  An immunization reaction was suspected by the examining physician, and loratadine 10 mg a.m., diphenhydramine hydrochloride (Benadryl) 150 Mg HS was recommended.  The patient was instructed to follow up if further problems or no improvement.  Additional information is not expected.
This spontaneous report was received from a licensed practical nurse and refers to approximately 20 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored M-M-R II lot # K014833, expiry date: 14-SEP-2016, lot# L005290 expiry date: 17-FEB-2016 and lot # K018990 with expiry date: 15-OCT-2015. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient thought that we under dosed him as we got 6 doses out from Pfizer COVID vaccine vial. He decided to get Moderna dose at local unspecified pharmacy without telling either facility. His Pfizer COVID vaccine course has been completed at unspecified Medical Center. Department of health reached out to him to address the 2nd Moderna dose. No reaction reported after his 2nd Pfizer dose on 1/14/21.
Chest pain. Visit to hospital outpatient. Non specific muscle pain diagnosis. Tylenol Pepcid. I don?t think they took my chest pain and potential link to vaccine as a serious possibility. It started minutes after vaccine as a sensation. Pain onset and increase for hours and persisted for days leading up to visit and after.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unknown dates, the patients were administered improperly stored RECOMBIVAX HB (Lot # L045117 with expiration date of 16-OCT-2018), (dose and route were not reported), which were stored 1.8 C for 1 hour and 45 minutes. The vaccines did not have previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax & 26DEC94 3 days p/vax pt exp bilat swelling of ankles, knees, wrists, elbows, jaw, & fingers, chronic pain, sore throat, irregular fever, chills, hives & pruritus;seen in ER on 28DEC94 & dx serum sickness;non productive cough;
Pt with zoster like lesions on sacrum and posterior medial thigh on right side.
patients from a nursing home facility received expired doses of the Moderna COVID19; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients from a nursing home facility received expired doses of the Moderna COVID19) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 050e21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients from a nursing home facility received expired doses of the Moderna COVID19). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients from a nursing home facility received expired doses of the Moderna COVID19) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Upon internal review on 10-MAR-2022, significant correction was performed. Suspect product recoded as per RA. On 03-Mar-2022: Non-significant follow-up On 04-Mar-2022: Non Significant Follow-up
pt stated that she had an overall itchiness on both feet that were swollen and red like a neuropathy effect.  Pt states it is better now but still has some tingling and sensitivity on both feet.  Pt has not contacted PCP at this time.
Information has been received from an unspecified health professional concerning a 60 year old female with no medical history who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) injection. Six month after being given ZOSTAVAX (Merck), the patient developed shingles. It was unspecified if the patient sought medical attention. On an unspecified date, the patient recovered from shingles. No further information is available.
2 days after receiving H1N1 and seasonal flu injections, pt developed arthrogenic, swelling and pain @ L palmaris longis, thigh pain.
FLU VACCINE ADMINISTERED LEFT ARM-PAINWITH LIFTING OR EXTENDING ARM. COMPLAINED OF KNOT IN LEFT ARM. 3MM NOTED ON UPPER DELTOID, NO ERYTHEMA; TAKING IBUPROFEN, HOT & COLD COMPRESSES.
Woke Saturday to severe vertigo and unable to walk without holding on to something.  Lasted about 8 hours before subsiding, but mild dizziness continued through Sunday .  Nausea but no vomiting.  Profuse sweating that lasted 5-10 minutes.  Nausea continued throughout the day.
Vaccine administered from vial which has been punctured for more than 6 hours; A spontaneous report was received from a nurse  concerning a 44-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine administered from vial which has been punctured for more than 6 hours.   The patient's medical history not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine administered from vial which has been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a 44 year old, female patient. The patient's medical history is not provided. The patient experienced an unexpected event of vaccine administered from vial which has been punctured for more than 6 hours.  The event occurred on 30 Dec 2020 during administration of the first dose of mRNA-1273 (Lot number: 026L20A).  There were no reported adverse events. The sponsor considered the event as not related to mRNA-1273.
Received vaccine on 01/10/2002 and she developed swelling knees, muscle pain
Suspected to have precipitated Guillain-Barre, one practitioner also said abscessed tooth may have something to do with.
Partial dose of vaccine (less than 1/2 dose) was given in error and repeat dose has been rescheduled per CDC Guidelines.  Patient reported to RN she had no adverse reaction to vaccine. Attempted to locate a dose of Pfizer vaccine closer to her home, but none available.  She will have a friend drive her to appointment for revaccination.
Patient received, Moderna covid19 vaccine lot:3030592 exp:03/29/2024 @ 11/6/2023 at 12:15PM. Pt reached out to me @12:55PM. letting me know that her arm was feeling itchy and hives appearing. no SOB or difficulty breathing. We both went to CT to speak with a provider for advice, CT provider NP advised that reaction not concerning, but to take 25mg of Benadryl and if any worsening symptoms to report to ER. Pt was given 1 Benadryl 25mg tablet at 1:00PM. Advised of reaction. checked in the Pt at 1:30pm and reported to feel itchy but not as much. VEARS report also submitted.
On 11/12/2022 patient developed new onset seizure, altered level of consciousness, combativeness and he was admitted to hospital and was found to have elevated troponin, thrombocytopenia, and elevated liver enzymes. Pt is still admitted to higher level of care for workup.
Pt states that there was improper swabbing of area. Area check of arm became infected. A one-inch needle was used.
This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant medications were not reported. On an unknown date the doses of VAQTA (lot # K007827 with expiry date: 09-DEC-2016 and lot#K012457 with expiry date: 04-JUN-2017) were administered post excursion to those multiple patients. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Skin rash, whole body; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03May2021 at 00:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021, ten days after vaccination, the patient experienced skin rash, whole body which was subsidized by taking antihistamine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of skin rash, whole body which included treatment with antihistamine fexofenadine hydrochloride (ALLEGRA). The clinical outcome of the event skin rash, whole body was resolved on 13May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist referring to a multiple unspecified patients of unknown ages and genders. There was no information about the patients' concurrent conditions or medical history provided. Concomitant therapies included properly stored sterile diluent. On an unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX for prophylaxis (doses, routes of administration, lot numbers and expiration dates were not reported). The administered dose of the vaccine experienced a temperature excursion 15 degrees Fahrenheit to 46 degrees Fahrenheit for 3 hours, as recorded by a data logger. There was no adverse effect reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA011274.
Approximately 3 days after the vaccine I fainted in my bathroom, hit my head, and was knocked  unconscious. It was a slow blackout. I first felt nausea and thought I was going to vomit, then I lost sight, then control over my body. The last caused my fall.   I regained awareness on my own after several minutes (my parents were trying to force open the door my unconscious body had blocked), but I started experiencing issues with movement, coordination, and sight (my eyes were fixed upward). My parents moved me to our couch to lie down. After this, my memory is poor.   I was taken to the local Emergency Department, where I had numerous scans--all turned out fine. I was then taken to another facility where I was told my fainting spell was the cause of dehydration from the Bumetanide. I was released the day after I was admitted.
Extreme tinnitus, brain fog, dizzieness and stomach pain 1-4 weeks after. Extreme tinnitus has not resolved yet.
I received the vaccine at 7AM. I started feeling achy and had a headache by 10PM that night. My symptoms worsened. By the weekend, I had lost my taste. I went for a covid test, it was negative. The following week I worsened. Cough, headache,  body aches and diarrhea. By Friday 1/29/21 morning my daughter took me to the hospital.  I do not remember going, I was diagnosed with altered mental status. I was dehydrated and a chest xray showed pneumonia. I was discharged on 1/31/21, diagnosed with vaccine reaction, pneumonia and altered mental status. I currently still have a cough, get easily tired, no energy.
SEVERE REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) 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, the subject experienced severe reaction. The action taken with covid-19 vaccine was not applicable. The outcome of severe reaction was not reported. This report was non-serious.
I received the 2nd Moderna shot April 30th and experienced no energy, arms hurting, muscle aches, the next day after I received the shot. 60 days later I was in the hospital with congestive heart failure. I have no prior history of heart problems. It was while on vacation I woke up after just dozing off and I couldn't breathe, I told my husband to call EMS and then I remember going down a tunnel and woke up in ambulance throwing up a little bit of foam and then went down the tunnel again just to wake up in the Er with the nurses ripping my clothes off and a dr asking me if I took too much medication which I replied NO. I am a pain management patient from several back surgeries, scoliosis and degenerative disc disease. I was 57 at the time and I am one that was lucky to survive where a lot of people receiving the shot don't survive. I don't believe this shot is safe and I believe you are putting citizens at risk making people take this shot. I am currently traveling with my husband. Please leave a message and I will return you call soon after receiving message! I was admitted to hospital.
believes it is shingles caused by the Shingrix injection /  suspected vaccination failure; shingles; chills / shivering; rash to left genital area; rash to neck, and arms; Difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rash (to right thigh on and off for 30 years).   On an unknown date, the patient received the 1st dose of Shingrix. On 25th June 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and less than 4 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, chills, genital rash, rash and difficulty sleeping. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the chills, genital rash, rash and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, chills, genital rash, rash and difficulty sleeping to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient reported case for herself. The patient had a rash on and off to her right thigh for thirty years but never had a rash in the left genital area. The patient could not remember when she had her first Shingrix injection but she had no adverse reaction from it. However, she stated after she had the second injection she had a rash to her left genital area, neck, and arms. She stated that she also had chills, and shivering, and difficulty sleeping. The patient seen her physician who ordered acyclovir for this rash but wanted to report that she believes it was shingles caused by the Shingrix injection. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting The reporter consented to follow up.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild.
This spontaneous report was received from a pharmacist refers to a 65 year old patient. On 01-NOV-2013, the patient was vaccinated with an expired dose of 0.5 ml PNEUMOVAX23 (lot # 0556AE, expiry date 27-OCT-2013), intramuscular. No adverse effect was reported. Additional information has been requested.
fever; chills; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and MYALGIA (Body Aches) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and MYALGIA (Body Aches). At the time of the report, PYREXIA (fever), CHILLS (chills) and MYALGIA (Body Aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Passed out at 6:00 on 11/17/2021 .  Also, I had a high fever for 24 hours (102+), body aches, severe headache (still have) and excessive sleeping (slept for almost 36 hours)
Immediately, EE went to PCP and taking Advil and RX NSAIDS EE states it is not better . EE went to her her PCP who put her on RX NSAIDS . EE states it is not getting better. Appointment made with Occupational medicine for evaluation.
Angioedema around both eyes.  After several days of not getting better, I went to the Dr.  The Dr prescribed Methylprednisolone  oral Tablet 4 MG as directed orally for 6 days.  I just took my first dose.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male 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 (Janssen series-1) (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 11-SEP-2021) dose was not reported, 1 total, administered at left arm on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-DEC-2021, the patient experienced runny nose, slight headache, sinus pressure and started fever on 03-DEC-2021. On 04-DEC-2021, patient tested positive for Covid-19 and results in confirmed clinical vaccination failure. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000205631.; Sender's Comments: V0-20211215420-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
At approximately 3:00 PM, patient was waiting in clinic lobby as instructed for 15 min. post immunization, when she started shaking, loss of pinkness to skin and lips, slow to respond to conversation, unable to sit upright in chair. Patient was carried to exam room and laid down with feet elevated and ice pack applied to back of neck. At 3:25 PM Vital signs taken: BP 75/45, HR 50, Spo2 % 98. After rest, snack, and drink, patient returned to baseline. At 3:50 PM Vitals retaken: BP 85/56, HR 62, Spo2% 100.