chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severely ill/illest I've ever been; abdominal pain/acute, severe stomach pain; on the floor in pain; diarrhea; uncontrollable vomiting; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (severely ill/illest I've ever been), ABDOMINAL PAIN (abdominal pain/acute, severe stomach pain), PAIN (on the floor in pain), DIARRHOEA (diarrhea) and VOMITING (uncontrollable vomiting) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Surgery (20 plus).    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced ILLNESS (severely ill/illest I've ever been), ABDOMINAL PAIN (abdominal pain/acute, severe stomach pain), PAIN (on the floor in pain), DIARRHOEA (diarrhea) and VOMITING (uncontrollable vomiting). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Vomiting, at a dose of 8 mg and DICYCLOMINE [DICYCLOVERINE] for Vomiting, at an unspecified dose and frequency. At the time of the report, ILLNESS (severely ill/illest I've ever been), ABDOMINAL PAIN (abdominal pain/acute, severe stomach pain), PAIN (on the floor in pain), DIARRHOEA (diarrhea) and VOMITING (uncontrollable vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Computerised tomogram: abnormal (abnormal) intestines was enlarged and inflamed.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that She received the vaccine while taking steroids . Concomitant medications was not reported .Patient also reported that She was on Steroids .   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received contains Treatment history , Medical history
Experienced swelled up arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Experienced swelled up arm at the injection site) in a male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Experienced swelled up arm at the injection site). At the time of the report, VACCINATION SITE SWELLING (Experienced swelled up arm at the injection site) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Patient complains of tachycardia at rest, palpitations, SOB, chest tightness. Patients BP elevated above her normal BP. HR 118-136 for over an hour at rest. 25mg Benadryl given IM and patient advised to rest, monitor HR/BP. If chest pressure, SOB increase, refer to ER.
Received vaccine around 10pm. Tremors began around midnight followed by vomiting. Patient's husband called a "hot line" and was told to go to ER. Patient refused to go stating she did not feel well enough. Patient saw Primary Care on 10-16-17.
hive/welt under right eye 100.5 temperature headache rashes/hives swollen lymph nodes left side of neck and under left arm unrelenting chills nausea itchy eyes fatigue
Site of injection was red and sore to touch immediately after injection. After several hours, the  area around the injection site began to swell. Mom noted increased swelling the following morning and the area of the arm around the injection site felt firm.  Mother directed to use an ice compress as needed and to monitor injection site for any increased swelling or discomfort.  Pt did not experience any fevers, shortness of breath, wheezing, hives, or rash.
Within 6 hours of receiving the vaccine, my throat started swelling up; I could feel my tonsils touching the back of my throat; This is a spontaneous report from a contactable health professional (patient). A 47-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 26Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included hydrocortisone, calcium carbonate/colecalciferol (VITAMIN D 2000), levothyroxine, and cabergoline (CABERGOL). Within 6 hours of receiving the vaccine, her throat started swelling up. She could feel her tonsils touching the back of her throat and had to be given diphenhydramine hydrochloride (BENADRYL) in ER. She had an issue with her throat swelling off and on for 2 weeks after the shot. It was the only new thing that was in her life. Adverse events start date was 27Jan2021. AE resulted in emergency room/department or urgent care. Covid test (nasal swab) was negative. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  Throat swelling,Tonsillitis. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
This spontaneous report was received from a nurse regarding several patient's of unknown and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unspecified dates in 2016, the patients were vaccinated with improperly stored dose of ZOSTAVAX (via subcutaneous route, dose, lot # and expiration date were not reported). ZOSTAVAX doses had been in freezer that had been out of range since 02-JAN-2016 according to the data logger. There was no adverse effects reported. This is one of two reports received from the same source. Additional information has been requested.
She was tested positive to Covid19.; She was tested positive to Covid19.; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 08Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the vaccine on 08Mar2021, however she was tested positive to COVID-19 on an unspecified date. Her husband was supposed to have the vaccine 10Mar2021 and supposed to have the first dose of the vaccine 17Mar2021. They told her not to take the vaccine within 90 days. She was scheduled for the second dose on 08Apr2021. She wants to confirm if it's the date she has to take the vaccine. The outcome of the events was unknown.  Information on lot number/batch number was requested.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain in my body) and HEADACHE (Pain in my head) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Pain in my body) and HEADACHE (Pain in my head). At the time of the report, MYALGIA (Pain in my body) and HEADACHE (Pain in my head) outcome was unknown. Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Patient received a 3rd dose of Moderna. 1st dose on 1/27/21, 2nd dose on 2/24/21, and 3rd dose on 6/14/21.
One week after immunization at injection site was red, scaly, warm to touch-area affected approx quarter size. Called primary doctor 10 days after shot. He advised to watch it. No treatment done then. Swelling decreased 14 days after shot. Then approx 3 weeks after shot noticed decreased arm strength which still is present today.
MRI demonstrates acute infarct in the bilateral cerebellar hemispheres, vomiting, dizziness, headache
Inadvertently administered the Pfizer vaccine after being in refrigerator for 33 days. Manufacturer label suggests the product should be in the refrigerator for no longer than a month.
Moderna 2/25/21, 3/25/21. Positive on 7/22/22
pt recv vax 7JUN97 & several days later pt exp mild swelling & pain;17JUN97 a serum pregnancy test was positive;
This spontaneous report was received from a patient's husband, concerning his wife, a 69 year old female patient with no medication allergies reported. On 03-JUN-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 in the arm (lot # and expiration date not reported). No other co-suspect therapy was reported. Concomitant medications were not provided. It was reported that the patient developed severe pain almost immediately after receiving the injection (unspecified whether the injection was subcutaneous or intramuscular). Her pain was reported to be concentrated at the injection site of the arm in which she received PNEUMOVAX 23 and about a "8" or "9" on a pain intensity scale of 1 to 10 with 10 being the most painful. The female patient was reported to be "more petite" than her husband. No laboratory tests were performed to the patient. At the time of the report, the patient was recovering from the pain. Additional information has been requested.
he developed a painful erythematous rash distal to the injection site; he developed a painful erythematous rash distal to the injection site; This spontaneous report as received from a pharmacist refers to a 67-year-old male patient. The patient's concurrent condition included hypertension. The patient had drug allergy to guafenesin and loratadine (reported as loratidine).      On 22-JUN-2020, the patient was vaccinated with 0.5 ml dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S033516, expiration date 29-JUN-2021, intramuscularly for vaccination. Concomitant therapies included azelastine hydrochloride (ASTELIN), cetirizine hydrochloride (ZYRTEC), lisinopril (manufacturer unknown), pravastatin and beclomethasone dipropionate(QNASL).     On 23-JUN-2020 (reported also as the following day), the patient developed a painful erythematous rash distal to the injection site. The patient was going to be seen by the physician later that day for possible unknown treatment. No treatment was given for the event at the reporting time. None lab diagnostics/studies were performed. The outcome of  the event was reported as not recovered.  The causality assessment between the event and the vaccination with  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)  was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033516; expirationdate: 29-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
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 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 3:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 3:11 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, 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.   The age of patient was provided as 21.22   Concomitant medication information was not provided by the reporter.  On 27-Apr-2021, Excursion time was 09 AM, temp was 35, total doses given for the day was 42, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 8 vial was moved to clinic. Vaccine BUD date was 19-May-2021.  Vial was stored on cooler 1, on 27-Apr-2021, Excursion duration At 8 AM: 41, 9 AM: 35, 10 AM: 36, 11 AM: 38, 12 AM: 43, 1PM : 43, 2 PM : 44, 3 PM: 43, 4 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
flu; sick; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient of unknown demographics who reported of being sick (illness) with flu (influenza), after being vaccinated with INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.    On an unknown date in 2018 (reported 2 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2018 (latency unknown) the same year following the administration of INFLUENZA VACCINE, the patient reported of being sick (illness) with flu (influenza). Post that the patient had never took the vaccine and had never been sick with flu again.   Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was resolved on unknown date for sickness and flu.   There will be no information available on the batch number for this case.
CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot number.  No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
The red spot on her arm is now 6 to 8 inches across arm and bubbled up red; By 3am the 3rd day she had a red spot a little bigger than silver dollar; Sore Arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.     This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), ERYTHEMA (By 3am the 3rd day she had a red spot a little bigger than silver dollar) and SWELLING (The red spot on her arm is now 6 to 8 inches across arm and bubbled up red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 029A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore Arm). On 29-Aug-2021, the patient experienced ERYTHEMA (By 3am the 3rd day she had a red spot a little bigger than silver dollar). On 30-Aug-2021, the patient experienced SWELLING (The red spot on her arm is now 6 to 8 inches across arm and bubbled up red). At the time of the report, PAIN IN EXTREMITY (Sore Arm), ERYTHEMA (By 3am the 3rd day she had a red spot a little bigger than silver dollar) and SWELLING (The red spot on her arm is now 6 to 8 inches across arm and bubbled up red) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-302416 (Patient Link).
Received TD 24-APR-89 Booster after getting laceration to toe.  Last TD was 26-APR-84.  Returned to office 25-APR-89 c/o pain and swelling at injection site, sore throat, headache, stomach ache and fever up to 101.2.  Treated w/warm soaks
Patient described the adverse reaction as not bad.  After the vaccine, after a couple of hours he felt a sting on the site of vaccination. Patient took off bandaid and noticed site of injection was red and skin looked as if it was starting to peel.  Patient reported no other symptoms besides being uncomfortable at the injection site. When he came in for second dose, I, the nurse noticed the peeling of the skin left a scar and was not given in the deltoid muscle, but rather to the side towards axillary.  Patient mentioned on prevaccination checklist, "not bad but some of my skin peeled off. my dad asked his fellow doctors and they thought it was because the dose was administered to the shallow front of my shoulder rather than to the side as is customary"
DTAP vaccine was expired at time of administration. Patient will return to receive up to date vaccine.
Lost complete sense of smell - Lasted 15 hr; smell and taste muted after they came back. 30 -36 hours after vaccine - Really bad nasal congestion - bad cough and those lasted 4 days. Urgent Care.  Tested for COVID -Sunday, 27th, afternoon. Tested negative for Covid.  Still do have muted taste and smell but don't have cough anymore.
COVID-19 Lot#- FE3590 Vial PAA165969 Exp 2/22 was placed in the freezer after we received it. It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2021 at 0830.  There were 22 patients who received the COVID vaccination during this time frame. The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 27 vials that were not used and have been set aside to waste.
1.  Initially (on/about 4/29/21), impairment in ability to use right hand 2.  This dissipated after a week plus, only to be followed during the week of 5/24/21, similar issue with left hand. 3.  Over weekend, 5/29-5/31, impairment in ability to maintain balance 4.  Went to ER on 6/1/21 -- MRI consistent with Multiple Sclerosis (no family history) 5.  Steroid treatment ineffective and condition materially worsened; moved from Hospital to Hospital on 6/4/21 6.  Plasma exchange therapy administered due to initial hypothesis of Tumefactiv MS 7.  Moved to Rehabilitation Hospital on 6/14/21 -- but condition worsened (CONTINUED)
4:15 2/18/2003 late afternoon MMR #1 given in lt deltoid SQ. Immediately after injection pt are in the area that MMR was given started with redness. Measurement after injection was 6cm X 5cm. No itching.  10-15 minutes after initial measurement site was 3.5cm X 3cm. Erythematous wheal then developed into a raised wheal. Warm to touch, moving arm well. Benadryl 1 tsp was given at office. 2/19 follow up pt arm better, no redness, no swelling by the time returned home on 2/17. Some hardness.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age, who was expose through her 61 year old boyfriend who on 21-AUG-2012 was vaccinated subcutaneously on left arm with a 0.65 ml dose of ZOSTAVAX (lot 0564AE exp: 21-MAR-2013). No concomitant medications were reported. The pharmacist stated that on 21-AUG-2012 a client was vaccinated with ZOSTAVAX and the patient called pharmacist to asked if ZOSTAVAX could be transmitted. The patient told to the pharmacist that his girlfriend was experiencing symptoms of shingles, unspecified what type of symptoms. The pharmacist stated that the patient vaccinated did not report any break out or adverse effects from the vaccination himself. The patient's girlfriend may follow up with her health care provider. The outcome of symptoms of shingles was unknown. The relatedness for symptoms of shingles was unknown for ZOSTAVAX. Additional information has been requested.
Patient had near syncopal episode immediately after administration of vaccine.  Had episode of vomiting.  Was able to eat an ice pop and pretzels in office and was able to leave office ambulatory on her own.
I began to have tremors throughout my whole body after getting the vaccine both times, the first time it lasted for probably about 2-3 weeks. At one point it got so bad that I visited the ER but got no results.