chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; 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) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 1:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 88.53 No concomitant medication was provided. It was reported that unknown number of patients were 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.   The BUD date was reported as 27-Jan-2021, Date vaccine moved to fridge was reported as 05-Jan-2021. No treatment medication was provided.
surrounding area was itching on 5/5/99;pt responded to itch & dug too deep into skin;area became red & swollen;T98.6;+ palpable induration lt arm non tender, no erythema;
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL lot # K006191, expiration date: 02-FEB-2017 (strength, dose, route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature was between >8C - 25C, for a time frame of 5 hours, 30 minutes. There were no previous temperature excursions. The call was  because of a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004386: US-009507513-1701USA004701: US-009507513-1701USA004703: US-009507513-1701USA004704.
SUSPECTED COVID-19 INFECTION (HEADACHE, COLD LIKE SYMPTOMS); REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via Pfizer concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 01 total, administered on left arm on 06-MAR-2021 09:00 for covid-19 prophylaxis. Age at time of vaccination 41 years old. Concomitant medications included Advil (ibuprofen) for drug used for unknown indication It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received additional dose of non-company suspect vaccine Moderna COVID-19 vaccine (elasomeran) (Dose number in series 2) (form of administration and route of administration were not reported, batch number: 012F21A CVS#1517 expiry: UNKNOWN) dose was not reported, administered on left arm on 22-OCT-2021 for covid-19 prophylaxis. On 22-OCT-2021, the patient revaccinated with different covid-19 vaccine (Dose number in series 2). The patient received additional dose of non-company suspect vaccine Pfizer (tozinameran) (Dose number in series 3) (form of admin and route of admin were not reported, batch number: GJ2524 GIANT 348 expiry: UNKNOWN) dose was not reported, administered on left arm on 15-SEP-2022 12:00 for covid-19 prophylaxis.  On OCT-2022, the patient experienced suspected covid-19 infection and she received covid-19 treatment of unspecified drug (form of administration and route of administration were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered from 07-OCT-2022 till 11-OCT-2022 for covid-19 treatment. 7 days after covid-19 treatment on 18-OCT-2022, symptoms again started with headache and cold like symptoms (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection (headache, cold like symptoms), and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
While camping I experienced extremely bad heart burn.  After trying all available means to control pain, called paramedics to make sure it wasn't a heart attack.  It wasn't a heart attack, but paramedics found 30-40% PVCs and advised going to ER to get checked out.  I have had PVCs for decades, but not at medically significant levels.  ER confirmed no heart attack, but recommended followup on PVCs.  Followup with specialists found no mechanical reason for high PVC rate, and I am schedule for heart ablation procedure to hopefully correct problem.  I do not know when the increase in PVCs occurred.  PVCs were lower before inoculation and higher after, but there is a several month period over which the increase may have occurred and the vaccination just happened to be in that period.  PVCs are not impacting my life and I would not even know I had them without the tests, but they are a long term health issue that need to be addressed.
Vaccine 6/21/01 3:30pm, 6/22/01am noticed vesicular bump ulnar wrist of arm vaccinated. PM was warm noted chest/back mottled rash - remained through 6/25. Headache 6/22 & 6/23. Arm axcillary noted enlargement /tenderness 6/22,6/23. Symptoms decreasing.
Fever 101.4 degrees Saturday & Sunday, and Red localized rash Still present.
patient received 100 mcg of moderna vaccine instead of booster dose of 50 mcg Patient was contacted and advised to call our office if any adverse events occur
large, raised & reddened area 96" x 4") surrounding inject site; inc warmth, tenderness w/sl itchy sensation in affected area; sx duration x 4 days, sx have slowly resolved;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 22-AUG-2016, the patient was inadvertently administered an expired dose of vaccinated with M-M-R II, albumin status of rHA, lot # K011189 (expiration date 12-AUG-2016) (dose, frequency and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
No adverse event(s) or  signs and  symptoms have occurred . the client had no discomfort.
Presented with fatigue, dec appetite; CXR normal; No significant resp symptoms; remained on room air, no indication for steroids or remdesivir
4 days post vaccine #2 I developed a rash/redness and swelling of injected upper arm. Effect is limited to upper arm.  Today is day 6 post vaccination. Rash/redness still exists. There have been no other reactions. There are no complications. Arm is fully functional
SHORTNESS OF BREATH; SLIGHT CHEST PAIN; LETHARGY; FATIGUE; FEVER; CHILLS; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced lethargy. On 11-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced slight chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, fatigue, lethargy, shortness of breath and slight chest pain was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Person presented for first dose of Moderna at a mass vax site on 4/20/21. This was given-- had some mild sob, seemingly anxiety. Stated that he does this often with shots. Give a dose of diphenhydramine. EMS checked out and he did not need anything further and refused transport. Was advised to talk to PCP before receiving dose 2. Upon a quality check to follow up with people who had not followed through with dose 2's, it was discovered that he had received a full series of Pfizer site on 3/28/21 and 4/18/21. Multiple attempts to reach him over several days-- no contact. Today, he answered and immediately hung up.
pt recv vax & presented w/varicella that consisted of approx 20 skin lesions;
Swollen gland in the neck, sore throat (left side), ear pain (left side), and swollen lymph node in armpit (left armpit)
Pt felt lightheaded and got pale, she sat down in a chair and I took her vitals which were normal BP/94/62 HR 68 and oxygen sat 98, her dad bought her a pop and after taking some time putting cold packs on neck and forehead and taking sips of her pop she felt better
Patient received second dose of the Moderna Covid-19 vaccine greater than 42 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna Covid-19 vaccine greater than 42 days after the first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna Covid-19 vaccine greater than 42 days after the first dose). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
SYNCOPE,PASSING OUT ,CAME BACK NORMAL AFTER FEW MINUTES
Fever - 100.1 deg F, photophobia, double vision pain in neck, headache.
I had a bloodshot eye; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 15Jan2021, the patient experienced a bloodshot eye. The outcome of the event was unknown.  Information about lot and batch number was requested.
tests positive for COVID after receiving the first moderna vaccine dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (tests positive for COVID after receiving the first moderna vaccine dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tests positive for COVID after receiving the first moderna vaccine dose). At the time of the report, COVID-19 (tests positive for COVID after receiving the first moderna vaccine dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) The patient was tested positive for covid after receiving first dose..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment medication was not provided.   This case was linked to MOD-2021-081346 (E2B Linked Report).; Sender's Comments:  MOD-2021-081346:patient 1
Information has been received from an MA concerning a 36 year old female with no chronic illnesses and a cephalexin (Keflex) allergy with hives and a shellfish allergy who in the morning of 5/8/02, was inadvertently vaccinated with pneumococcal vaccine 23 polyvalent, ID, 0.1ml, instead of a PPD ordered for work. Concomitant therapy included desogestral/ethinyl estradiol (Ortho-Cept), vitamins (unspecified), 50mg, 4 X a day. The pt was scheduled to be rechecked on 5/9/02. Additional information has been requested. A 15-day follow up report received 8/5/2003 adds: On 05/08/2002 at 15:15 the pt called and returned to the medical office with site swelling, tenderness and warmth (no neuropathy). The pt was treated with diphenhydramine (BENADRYL) 50 mg, 4 times a day. The pt was scheduled for a re-check on 05/09/2003. Follow up info was received frm the medical assistant who reported that the pt was also treated with ice. The medical assistant reported that the pt had recovered from her site swelling and tenderness.  Additional follow up information was received from the medical assistant who confirmed that the medication error resulted from a procedural error in their office. The nurse intended to administer the PPD tuberculin skin test to the patient but inadvertently vaccinated the patient with pneumococcal vaccine 23 polyvalent, using the "mantoux" administration procedures (0.1 mL of liquid injected IM). The reporter confirmed that there was no confusion regarding the appearance or name of the product and the error did not result from any confusion as to the proper dosing of the product.  No additional info is expected.
Child received shots at 2:00 pm on 9/10/2010. Client stayed 15 mins after shots. Mother stated taking child to McDonalds for lunch and play time. Mother returned to health dept at 3:36 pm stating child with swelling of the face. RN noted slight swelling and redness under left eye and left side of nose, no SOB or trouble swallowing. Child was crying. No other redness or swelling any other areas of the body. RN kept child 30 mins to observe. After this time no redness or swelling noted. Referred child to Peds. RN called on 9/13/2010 to check on child. Child was fine per mother. At time mother returned to health dept Dr contacted and instructions followed and VAERS report filled out.
Continuing peripheral neuropathy. On 4/21 I received my first dose of the Moderna vaccine in my right arm and within two minutes had a vasovagal reaction?tingling in my underarm, flush feeling face and stiffness and tingling in my upper lips.  That mostly subsided within 30 minutes as the dull arm pain set in.  Over the next 7 days my arm pain intensified some and moved up my shoulder and down my triceps and into my elbow. 4/28 I awoke with numbness and tingling in my pointer and middle finger of my shot (right) arm in addition to the arm pain and neck and shoulder muscle tightness. 5/8 Arm pain and finger numbness still present, I did some yard work that exacerbated the arm pain, and at this point it was the first day I recognized the pain as a specific intense nerve pain from my shoulder, down my triceps, across my forearm and into my pointer and middle fingers. From this point on the nerve pain and finger numbness/tingling persisted and included intermittent cold forearm/fingers. 5/11 Met with my primary physician who diagnosed me with cervical radiculopathy (C7). Prescribed physical therapy, prednisone and flexeril. 5/12 Had a massage w/aroma therapy, cryotherapy, and cupping. Provided some relaxation, but no change in nerve pain or symptoms. 5/14 First day of PT; neck and arms stretches, neck traction and nerve glides 5/17 Completed Medrol dose pack, steroids seemingly had no effect. Flexeril at night helped relax neck and shoulder muscles a bit. 5/20 (Today) Still have numbness and tingling in my pointer and middle fingers with specific nerve pain down my triceps, elbow, across forearm and into my two fingers that intensifies with activity and at night.  Intermittent cold sensation in right hand, underarm inflammation and tenderness, and general weakness of right hand and arm.
COVID-19 infection; Acute respiratory failure with hypoxia; Pulmonary embolism due to COVID-19; Pneumonia due to COVID-19
nausea; vomiting; diarrhea; sweating; This is a spontaneous report from a contactable pharmacist reported a 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization in Jan2021 at 33-year-old. Medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient experienced nausea, vomiting, diarrhea, and sweating; all in Jan2021 and was reported as non-serious. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
INCORRECT PRODUCT STORAGE; ADMINISTERED VACCINE STORED AT A MINIMUM TEMPERATURE OF (PLUS) 40.6 DEGREES FAHRENHEIT TO A MAXIMUM TEMPERATURE OF (PLUS) 48.7 DEGREES FAHRENHEIT FOR 32 MINUTES; This spontaneous report received from a health care professional 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: 202F21A expiry: 07-FEB-2023) dose was not reported, administered on 03-NOV-2022 for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported. On 03-NOV-2022, the patient experienced administered vaccine stored at a minimum temperature of (plus) 40.6 degrees fahrenheit to a maximum temperature of (plus) 48.7 degrees fahrenheit for 32 minutes. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine stored at a minimum temperature of (plus) 40.6 degrees fahrenheit to a maximum temperature of (plus) 48.7 degrees fahrenheit for 32 minutes and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20221118522.
Left side injection site (from varicella) erythematous and raised (occurred 10 days after injection).
Patient started experiencing dizziness, blurred vision, a "rush", increased blood pressure, feeling hot, tingling in arms, and appeared flushed. Occurred approx. 15 minutes after vaccination. Patient was given water and a snack and was told to take deep breaths. Blood pressure was monitored and returned to normal before patient exit. Patient was assisted by wife. No medications were given.
This is a prospective pregnancy case. This 34-year-old female subject was enrolled in a study. On 15th October 2014, the subject received Flu Seasonal QIV Dresden .5 ml. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu Seasonal QIV Dresden.
Patient woke in the middle of the night on April 2 with extreme pain in left arm. Pain subsided after the next few days, then reoccurred two weeks later. Pain subsided a bit over the next few days, but patient had extremely limited mobility in the left shoulder. Visited the doctor prior to receiving the second shot. Doctor recommended physical therapy, which patient began on June 7. Patient went to physical therapy weekly  until July 14. Patient has recovered most of her mobility in the left shoulder and still has some pain in her left arm.
Throwing up non Stop; intense nausea; headache; Soreness in arm.; fever; chills; Sweating; This is a spontaneous report received from a contactable consumer, the patient. A 31-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 26Mar2021 at 15:00 (at the age 31-years-old), as a single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as single dose for COVID-19 immunisation. On 27Mar2021, the patient experienced throwing up non-stop, intense nausea, headache, soreness in arm, fever, chills and sweating. The events resulted in doctor or other healthcare professional office and clinic visit. The patient had received treatment with ZOFRAN for the reported events. The clinical outcome of the event vomiting, nausea, headache, pain in arm, fever, chills and sweating was recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
APPROX 24 HRS FOLLOWING FIRST VACCINATION,(GIVEN SC IN THE RT DELT REGION) PT'S RT HAND DEVELOPED EXTREME SORENESS TO THE TOUCH AND LOSS OF GRIP. SYMPTOMS LASTED >24HRS. HE ALSO EXPERIANCED BODY ACHES.  BODY ACHES HAVE NOT SUBSIDED FOR THREE WEEKS. APPROX 24HRS FOLLOWING THE SECOND VACCINATION (GIVEN SC IN THE L DELT REGION) PT STILL EXPERIANCING "ALL OVER" BODY ACHES.  ALSO EXTREME TENDERNESS TO THE PECTORAL MUSCLES.  "VERY TENDER TO THE TOUCH" EVEN DIFFICULT TO TAKE DEEP BREATHS.  TENDERNESS IS "SLOWLY GOING AWAY" BUT THE BODY ACHES REMAIN.  PT DOES NOT C/O ANY FEVER.
Local reaction including redness, swelling, itching, and hot to the touch. Denies fever or SOB. Advised by RN to take Benadryl and ibuprofen, return to clinic if worsening.