chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to pharmacy to pick up script and show us her arm. She had a black/purple bruise at injection site and a large inflammed red area that was warm to touch and had spread around her arm from injection site. She complained that it itches very bad and is tender, but mostly itches. No rash anywhere else, her neck hurt the next day and she felt ill for the first two days. Her breathing felt a little heavy in the chest but she wasnt sure if it was due to any reaction or just her asthma. Patient was counseled on what to watch for and when to get to a hospital if need be was also showed benadryl and counseled on how to take. Patient bought some and said she will watch herself take the benadryl and continue icing it as before and would let us know and get to a hospital if anything changed or worsened.
Soreness of arm; Stiff muscles in movement of arm; Headache; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EAU), via an unspecified route of administration in the left arm on 30Mar2021 at 10:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, compromised immune system due to chemotherapy, high blood pressure (HBP), irregular heart rate, chondromalacia of both legs, chronic depression and bipolar. The patient previously received morphine and experienced a drug allergy.  Prior to the vaccination, the patient had undergone a COVID-19 test twice, on an unspecified date in the year 2020 and another test was on 01Sep2020; she tested negative both the times. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 17:30, the patient experienced soreness in arm, very stiff muscles in movement of arm. On the same day, the patient had brief headache that did not last. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On an unknown date in Mar2021, after the vaccination, the patient underwent a COVID-19 test (nasal swab), and tested negative.  No therapeutic measures were taken for any of the reported events. The clinical outcome of the events soreness in arm, stiff muscle in movement of arm were resolving at the time of this report. The clinical outcome of the event headache was resolved on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Redness, swelling, painful in the whole entire swollen area, bluish in color about the size of a half dollar, itching, hot to the touch.
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 3:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 3:46 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. 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) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (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 65.01 for dose administered on 28-Feb-2021 and 65.08 for dose administered on 28-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 degrees Fahrenheit at 9 AM, 26 degrees Fahrenheit at 1 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 27-Feb-2021  Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-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.
Information has been received from a registered nurse concerning a male who on the week of 08/20/01 was vaccinated with MMR II. On 08/24/01, it was reported that the vaccinee's wife developed a tiny red rash on her abdomen and chest and that she is pregnant. The pt sought unspecified medical attention.
Severely sore left shoulder. Could not move shoulder without pain. Difficulty putting on shirts/jackets.
Nausea, vomiting, difficulty walking,  unable to eat or drink; unable to clear secretions, difficulty breathing
DVT.  Driving vacation started on 8/27 and over 3 days approximately 18 hours were spent in car. Beginning on or about Sept 1st, area behind right knee became swollen and painful. Over the next few weeks the pain and swelling waxed and waned. On Sept 24th, the pain intensified and the left calf became swollen.  Sought medical help. Started Eliquis on Sept 24th.
PATIENT WAS ADMINISTERED THE JANSSEN COVID VACCINE AT APPROXIMATELY 10:30AM. IMMEDIATELY FOLLOWING REMOVAL OF NEEDLE AFTER INJECTION, THE PATIENT APPEARED TO FAINT FALLING FORWARD IN HIS OWN LAP. AFTER ABOUT 15 TO 30 SECONDS, HE REGAINED CONSCIOUS. WE ASSESSED THE PATIENT TO ASK IF HE HAD EVER EXPERIENCED FAINTING BEFORE  OR SPECIFICALLY DURING VACCINATION. HE HAD NO PREVIOUS EPISODES. WE QUICKLY OFFERED THE PATIENT SOME WATER AND CRACKERS WHILE HE REMAINED SEATED. THE PATIENT FELL FORWARD AGAIN AND APPEARED TO BE CONVULSING. ONCE HE STABILIZED, MY PARTNER STEPPED AWAY TO RETRIEVE WATER, AND THE PATIENT ONCE AGAIN FELL FORWARD AND BEGAN CONVULSING. ONCE HE STABILIZED, HE DRANK SOME WATER AND ATE SOME CRACKERS. HE MENTIONED THAT HE FELT EXTREMELY TIRED. WE INSISTED TO CALL THE PARAMEDICS FOR HELP,BUT HE DECLINED SAYING THAT HE WAS OK AND MAYBE THE NEEDLE TRIGGERED THE EVENT. AFTER WE OBSERVED THE PATIENT FOR 30 MINUTES AND HE ASSURED US HE WAS IN STABLE CONDITION, HE LEFT WITH HIS GIRLFRIEND. PATIENT WAS CALLED TWICE AFTER THE EVENT TO FOLLOW-UP BUT WE HAVE NOT HAD SUCCESS IN FOLLOW-UP.
Rash for 5 days, itching, blisters, then scabs. 8-10 lesions.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment:The doctor is prescribing monoclonal antibodies infusion for treatment of the infection and has cautioned that she can take only take the second dose of the Moderna vaccine 90 days after the infusion.
Fighting covid; Fighting covid; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4191108-00.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Jun2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single and intramuscular, administration date 01May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2021, outcome "recovered" (2021), DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown" and all described as "Fighting covid". The action taken for adalimumab was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
23 y/o male presents to clinic c/o itchy rash on palms of hands and soles of feet since yesterday. Primary SPV, AVA#1, Typhoid on 07MAR14. No aphthous ulcer in buccal mucosa. No fever, systemic malaise, CP or SOB. Onset of rash was on day #19 s/p SPV. Rash is pruritic. C/W non-specific benign dermatitis a/w SPV. Dr saw pt as well and agrees with Dx, even though day #19 is a little later than usual onset around day #14. Papulovesicular / pruritic.
On 01/23/2021, one week after getting vaccine, my arm was swollen, itchy, achy and red at injection site. As of 02/01/2021, it is no longer itchy or swollen, but it is still achy and slightly red. Most notably is the ache.
Two mo after receiving vax, pt devel influenza A infect, dx made Directigen Flu A Test performed in the MD office. This is 1 of 2 patients from this site to devel influenza A 2 mo following vax with lot #4978151.
Pt. developed swollen left cheek w/ persistent headache for 2 days after flu shot.
This spontaneous report was received from a registered nurse regarding four unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of VARIVAX (Merck) (dose and route were not reported, lot # L006385, expiry date 25-FEB-2017). There were no adverse effects reported. Follow up information was received on 02-OCT-2015. On 02-OCT-2015, a call was placed to the registered nurse and went directly to voice mail. A voice mail message was left requesting the nurse to return the phone call and requesting also for patients identifiers, lot number and expiration date and date of vaccination. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from the reporting nurse on 08-OCT-2015 and refers to a 14 month old patient of unknown gender. On 15-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck). The temperature excursion had place on 09-AUG-2015. This is one of several reports received from the same source. Additional information has been requested. Patient details and narrative were updated.
Fever up to 102, chills, intense body aches, extreme fatigue, headache.  Symptoms lasted 36 hours. Took Tylenol and ibuprofen for relief.
Pt had lost consciousness and fainted after getting up from exam table about 10 minutes later, no injury occurred. Pt had not eaten that morning.
The vaccine was ordered by porotocol to be given as a 0.5ml dose. The vaccine given was 1.0 ml
The patient received the vaccine and waited the required 20 min. She states she was in the Lab; her left arm began to itch and break out in small red bumps, from the top of the left deltoid down to her elbow. She states that her back and abdomen began to itch and break out. She went to the Pharmacy, picked up some over the counter Benadryl, and took one dose. The itch became less intense.  She returned to Immunization Clinic, and was seen by the Provider. He ordered Prednisone, stating that she had hives.
Swelling in arm , redness in upper arm towards injection site , tenderness , extremely hot to the touch, headache
This spontaneous report was received from a male consumer of unknown age reporting on himself. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On an unspecified date, reported as "a few years ago", the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, anatomical location, lot/batch# and expiration date were not reported). On an unknown date (reported as "recently"), the patient was diagnosed with pneumonia. The outcome of pneumonia was unknown. The relatedness between PNEUMOVAX 23 and the event was not reported. Additional information has been requested.
33 y.o. female presenting alone with complaint of Lt arm pain and intermittent headaches x 2 weeks. She is wondering if symptoms are related to Janssen COVID Vaccine that she received on 4/30 (Lt deltoid). Reports similar symptoms right after vaccination, but symptoms resolved completely. Two weeks ago, symptoms started again, including headaches and pain to Lt upper arm. No vision changes or neurological changes. Pain level at this time is zero.
(L) eye swelling, redness to entire body, wheezing. BENADRYL 12.5 mg, pt vomited up. Was re-dosed. Albuterol neb treatment, DECADRON 9 mg IM. Observed x 1 hour, stable.
This spontaneous report as received from a other health professional (registered nurse) refers to a female patient of unknown age. Patient was not pregnant. Current conditions and medical history was not reported. On an unknown date approximately in 2012 (reported as 2 years ago), the patient was vaccinated with ZOSTAVAX, intramuscular (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, the patient experienced a blue arm from the deltoid down to her elbow. On an unknown date approximately in 2012, patient received ZOSTAVAX by the intramuscular route rather than the subcutaneous. The outcome of blue arm from the deltoid down to her elbow was unknown. Causality assessment was not reported. Product quality complaint was not reported. Additional information has been requested.
sharp chest pain randomly; dizziness; slurred speech; severe joint pains; muscle pains; fast heart rate over 100 beats per min; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01May2021 15:00 (at the age of 36-years-old) (Batch/Lot Number: EW0172; Expiration Date: Aug2021) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 05May2021 13.00, the patient started experiencing sharp chest pain randomly, then had dizziness and slurred speech. Went into ER to check out and looked all fine per CT scans and MRI. Few days later, he started feeling severe joint pains and muscle pains. Last few days, he had fast heart rate over 100 beats per min (before his resting heart rate was 50-60). AE resulted in Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. No treatment received for AE. Reporter assessed the event as non serious. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included RT-PCR, covid test post vaccination (nasal swab): Negative on 11May2021. Outcome of the events was unknown.
Moderna 1/1/20, 3/25/21, 4/21/21. Positive on 3/31/22
Monitored the patient for 15 minutes in office no reports of adverse reactions on that day or current. Patient is doing well.
Pt given High Dose Flu. By next day complains of extreme muscle soreness, tingling numbness at rest in arm. Better with movement. Now 5 weeks ago continues with symptoms but pain not as bad but significant per pt. Husband similar symptoms.
Swelling of left arm, rash from vaccinated site (L deltoid) to down arm approx 7", excruciating pain, still recovering.
little bit of soreness at the injection site; fatigue; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. 004F21N and 05A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Chronic lung disease and Polyneuropathy.   On 09-Nov-2021, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 03-Jun-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue). At the time of the report, INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. Patient tolerated all shots well and has not gotten sick. Patient had a little bit of soreness at the injection site and fatigue with all of the doses. Events lasted about 1.5 days before resolving with each dose. Patient had taken another 4 doses of the Moderna COVID-19 vaccine as on 24FEB2021 with lot number 006M20A, 26MAR2021with lot number 026A21A, 28NOV2022 with lot number 016H22A and Last dose of unknown date or lot number.   This case was linked to MOD-2023-749422 (Patient Link).
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 12-JUL-2012 the patient was vaccinated with a dose of ZOSTAVAX that was stored at 21.6F for 25 days (600 hours). It was unknown if the patient sought medical attention. The patient was not experiencing any known symptoms. This is one of several reports received from the same source. Additional information has been requested.
She is under a lot of stress; She has not felt herself in the last two weeks/feels silly; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 70-years-old, at 2nd dose, single dose for COVID-19 immunisation and started to receive tofacitinib citrate (XELJANZ XR) in Dec2020 and ongoing for rheumatoid arthritis; methotrexate sodium on an unspecified date. Medical history included rheumatoid arthritis. Concomitant medications were not reported. The patient had not felt herself in the last two weeks, prior the report, in May2021. She asked if this was common with rheumatoid arthritis or the product. She had been told it could be the weather. She felt silly. She was under a lot of stress and it could be the stress. She asked if there were any reactions from methotrexate sodium, tofacitinib citrate and BNT162b2 combined in the system. The action taken with tofacitinib citrate and methotrexate sodium was unknown. The outcome of the events was unknown.   Pfizer is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swelling at injection site and surrounding tissue. Pain extreme redness itching used cortisone cream; ice packs.
Did not have any reaction until yesterday - extreme fatigue and lethargy x 2 days. Today - Circular, 5cm Diameter, Eerythematous, swollen and hot lesion appeared at injection site.
Sore arm; Only sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Only sore to touch) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A, 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Only sore to touch). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Only sore to touch) outcome was unknown.            No Concomitant Medication was provided.  No treatment  was provided.
This spontaneous report was received from a nurse prescriber via a company representative and refers to a female patient of unknown age. The patient had a history of breast cancer. The patient had no concomitant medications and it was unknown if she had any drug reactions or allergies. On 09-JUN-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous injection (dose, frequency, lot# and expiration date were not reported) for prevention of shingles. Other suspect therapy included sterile diluent (lot# and expiration date were not provided). On an unknown day in June 2017, the patient experienced swelling in her left eyelid accompanied with eye pressure and  injection site reaction. She sought medical attention and returned to the office on 13-JUN-2017, where she was prescribed diphenhydramine (BENADRYL) (dose unspecified). There were no lab diagnostics studies performed. The outcome of the events was not reported. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.