chrisvoncsefalvay/vaers-outcomes huggingface dataset:
improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.  On 20-SEP-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1707457, expiration date 23-FEB-2022) and hib vaccine conj (ompc) (PEDVAXHIB) (lot# T026961, expiration date 02-APR-2023) (strength, dose, dose number and route were not reported) for prophylaxis after temperature excursion (product storage error).  The vaccines were exposed to temperature excursion of 48.7 degrees Fahrenheit (F) for a time frame of 74 hours and 10 minutes. No previous temperature excursion was involved. The call was due to a data logger.
Patient has not received the second dose of the vaccine and it has been more than 36 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine and it has been more than 36 days) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine and it has been more than 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine and it has been more than 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
mom states that p/each shot pt was more ill than the prev time;the last time temp was over 104;saw MD;
pt began vomiting in car on way home from clinic; cont vomiting all evening; was adm to hosp; recvd IV discharge 19OCT93;
Pain in shoulder and thoracic back, persisting for almost a year, physical therapy, anti-inflammatory medication, steroid shots
ITCHING. REC'D BENADRYL. LATER STATED SHE GETS ITCHY WITH ALMOST EVERY MED SHE TAKES, LIKE PSYCHOGENIC URTICARIA
Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 04-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            Concomitant medication provided was medication for diabetes NOS. No treatment information was provided.
4 days after 12-18-2020 vaccine, I became sick with Gi symptoms such as nausea, severe diaherra, dehydration, and anorexia which lasted for 6 days causing me to loose 5 lbs. The symptoms improved but with mild return following 2nd dose on 1-8-2021. Symptoms have continued but are improving.
Raised itchy rash on arm at injection site 6 days after injection but no other issues
Rash and high level of muscle pain at site of injection and myalgia throughout body. Pain began on date of injection (10/09/02) and progressively became worse.  Rash first noticed this morning--it has been expanding throughout day.
After first injection 1/14/21 only sore arm after injection.  After second injection 2/12/21, next morning 2/13/21 chills, moderate-severe heartache, moderate-severe body aches, muscle pain which subsided by morning of 2/14/21.  2/15/21 midday around 1:00pm significant facial itching, and red inflamed itchy area around the injection site
Positive TB test after. In 3/2021- I was negative per TB Gold test and after vaccine, tested positive for first time in my life.
PATIENT SAYS HER ARM HAS BEEN SORE AND BRUISED SINCE RECEIVING THE SHOT ON 11/4/15...SHE CAME TO REPORT IT 2/11/2015.
Face felt flush, irritated by mask. But after mask was removed my face continued to appear red and feel hot to the touch (no fever). (Both sides). Swelling of face became more evident (mostly cheeks) over the next two hours.Flush areas of face also felt numb/tingly. Mouth also felt numb-teeth felt like after dentist anestheic injection. began about 10:50, peaked around 1pm maybe. By 4 felt mostly normal.  Face stayed flush looking after no longer felt hot or numb. Just fatigue after.  Also some swelling/numbness at site of injection. But more mild.
Left upper arm with circular 8-9cm area of redness and edema.  No sign of cellulitis.  Treatment: cool compress/Tylenol pm.
dull ache in his left arm radiating down to his elbow and up to his shoulder and neck; Initial information received on 04-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 67 years old male patient who experienced dull ache in his left arm radiating down to his elbow and up to his shoulder and neck while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Sep-2022, the patient received 0.5 mL total dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT once (formulation, strength and lot number not reported) via intramuscular route in the left deltoid for prophylactic immunization.  On 29-Sep-2022, (latency: 20 minutes) the patient developed a non-serious event of dull ache in his left arm radiating down to his elbow and up to his shoulder and neck (pain) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  It was reported, "the caller experienced a cut on his leg during storm cleaning and went to his local Emergency Department for a tetanus shot. About 20 minutes after receiving TENIVAC, the patient reports a dull ache in his left arm radiating down to his elbow and up to his shoulder and neck for the last 5 days with little relief until today".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.
This adverse event happened with ALL 3 doses of the vaccine, with the exception that the reaction was worse with the first dose. (Dose 1 on 3/15/21, Lot # EN6204; Dose 2 on 4/8/2021, Lot # ER8729.) About 10-15 minutes after the first dose, my left hand began cramping up, with my fingers curling. I could not uncurl them. The EMT said I was having an allergic reaction and gave me a benedryll. After about 15 minutes, the symptoms subsided. However, over the next few days, my hand would cramp up with my fingers curled 3-4 times a day. Also, there were several times a day when I would be typing on my keyboard (which I do many hours a day) and I my reaction between thinking of typing a letter and when my finger would move to type, my finger would not move for a second. It was like my fingers were lagging like in a computer game. This problem went away after about two weeks. When I had the 2nd dose, the nurse who gave me the shot had me take benedryll immediately after the shot was given. This time I had the same reaction, but it was not as severe. And after a week or two, the problems ended. Now, with the third dose, I took benedryll immediately afterward and again I have having some "lag" between telling my fingers to move and when they react--when I type, am driving, and so forth. Sometimes they cramp a bit and I can't move them for a second. You would probably like to know if this has ever happened to me before. Yes, twice before when I'd had albuterol via a nebulizer. These are the only instances when I've had such a strange thing happen--after Pfizer Covid-19 shots and after nebulizer treatment of albuterol. In addition, all three Pfizer Covid-19 shots triggered migraine headaches, which I have treated with acupuncture and chiropractic care, which is my standard care whenever I have a migraine.
Pt received Hepatitis B vaccine #2 on 4/3/03. Pt had onset rash/hives in evening 4/5/03 - rash began left upper chest area - has now spread across entire torso and arms. Itching is a dominant feature. Pt had eaten a tuna sandwich and fries at a restaurant on 4/4/03. Pt referred to her physician.
Mom states pt started vomiting after vaccines, 3-4 hours after rec. & he did not stop, pt taken to ER. See record attached.
Mid to lower back pain on left side (same side as shot), at first felt like spasms and then was constant for two to three days. Neck pain on the left side also followed in the days after.  A week later, the neck pain is still there but the back pain has almost completely gone.
Site: Pain at Injection Site-Medium, Additional Details: patient reported that she experienced numbness after inection which disappeared afterwards, but she is still experiencing a stiff neck 3 days after receiving the vaccine and is concerned about getting the second dose. I recommended her for a follow up with her primary care which she said she doesn't have and to go to the urgent care if pain is unbearable. patient is concerned that she may have experienced a pinched nerve after the shot itself.
Client states that her left upper arm swelled and was painful for one day. She reports this is how she always reacts to flu vaccine. She used cold compresses and took advil.
This is a spontaneous report from a contactable consumer. A patient of unspecified age, race, ethnicity and gender was fully vaccinated for immunization on an unspecified date with PREVNAR 13 (unspecified number of single doses given). The patient medical history and concomitant medications were not reported. On an unspecified date the patient contracted invasive pneumococcal disease which was not caused by one of the 13 strains against which the vaccine offered protection. Outcome was unknown. The information on the batch/lot number has been requested.
This case was reported by a medical assistant and described the occurrence of an injection site reaction in a 34 year old female pt who inadvertently received an expired dose of Infanrix. On 5/17/04, the pt received the 1st dose of Infanrix in the left arm (lot DTPA57342-incorrect lot number). The expiration date for this lot of Infanrix is 4/4/04. Infanrix is not recommended for immunizing individuals 7 years of age or older. On 5/17/04, the pt also received a dose of hepatitis B vaccine. The site of the administration of hepatitis B vaccine was not specified. Approximately 3 days after the administration of Infanrix and hepatitis B vaccine, the pt experienced an injection site reaction characterized as redness "3 cm" in diameter. The injection site resolved on 5/22/04. The medical assistant considered the injection site reaction to be related to vaccination with Infanrix and hepatitis B vaccine.
I have 2 fever blisters on my lips; This case was reported by a consumer and described the occurrence of fever blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was recovered/resolved.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were reported as follows: The patient stated that had bad reaction to 2nd dose of Shingrix shot, ok till the time of report. The patient had 2 fever blisters on lips and the patient was wondering was that was related to shot. No other information was provided. The information regarding consent to follow up was not reported.
neck swelling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (neck swelling) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (neck swelling). At the time of the report, SWELLING (neck swelling) outcome was unknown.        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.   Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.
Anticipated invalid dose greater 37 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Anticipated invalid dose greater 37 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Anticipated invalid dose greater 37 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Anticipated invalid dose greater 37 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
asthma got worse badly; problems breathing; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (asthma got worse badly) and DYSPNOEA (problems breathing) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 00121A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHMA (asthma got worse badly) and DYSPNOEA (problems breathing). The patient was treated with FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHMA (asthma got worse badly) and DYSPNOEA (problems breathing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: results not reported (Inconclusive) Results not reported. On an unknown date, X-ray: results not reported (Inconclusive) Results not reported.         Symptoms started two to three weeks after second dose. Patient visited many health care practitioners, tried different medication. This has been going on for six months. Now patient was afraid of getting booster dose.
Suspected vaccination failure; patients experience a shingles outbreak after the patient completed the full 2-dose series shingrix; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included had no immunocompromising or immunosuppressing conditions.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: patients experience a shingles outbreak after the patient completed the full 2-dose series shingrix). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2023 The physician reported that the patient over 65 years old experienced a shingles outbreak after the completion of the full 2 dose series. The patient had no immunocompromising or immunosuppressing conditions. The outcomes of Shingles outbreaks was unknown and all other information was unknown. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up. This is one link case among 5 cases.; Sender's Comments:  US-GSK-US2023AMR089467:Same reporter US-GSK-US2023AMR089457:Same reporter US-GSK-US2023AMR089464:Same reporter US-GSK-US2023AMR089465:Same reporter
headache for one week; migraine for 72 hours; vomit for one day and diarhea; unable to bend fingers because of pain.  Denied chills.
Approximately 20 minutes after receiving FluMist, child had a seizure. Was walking next to father, leaving office, and child grabbed/punched father to let him know something was happening, then grabbed father's hand really hard. Father states he looked down at child who was having a seizure. Father held child during seizure, stating it lasted about 2 minutes and 20 seconds. Child's eyes were open, a little bit of frothy saliva on his lips toward end of seizure. Father states child was a bit rigid, but seemed to fight the seizure. Afterward he slept for about 30 minutes.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/13/2021 COAGULOPATHY, UNSPECIFIED TYPE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/13/2021 DELIRIUM  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/13/2021 ANEMIA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/13/2021 RIGHT FEMORAL NECK GARDEN 1 FX INIT
Erythema area right deltoid injection site palpable warmth. Improved sinse friday by history.
PATIENT HAD RASH ON ARM WITH IN 10-15 MINUTES AFTER INJECTION. PATIENT WAS GIVEN DIPHENHYDRAMINE INJECTION ON OTHER ARM. AFTER 10 MINUTES PATIENT SAID RASH START TO CLEAR AND FELT BETTER.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:17 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 3:17 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. The patient was administered vaccine that was stored at temperature between minus 80 degree F to minus 84 degree F. No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
The patient experienced a seizure after administration of first Moderna Covid-19 dose approximately 4-5 hours and was involved in a car crash resulting from the seizure.  The patient was taken to the emergency room Medical Center and was discharged in the afternoon with a diagnosis of vasovagal syncope. The patient also experienced a second seizure in his sleep later that evening and was hospitalized and discharged Wednesday of that same week (03/2 4/21). Witnesses of the car crash noticed patient had convulsed and crashed into three parked cars in a parking lot. His wife also witnessed convulsions during the evening seizure.
On Thursday, September 16th, 2022 we administered the new bivalent Modena Booster Vaccines to the following patients (listed below). Our Nurse Practitioner on duty was used to the ?0.25mg per dose' booster vaccines which yields 20 doses per vial. She was aware of a difference between the previous monovalent and the new bivalent but wasn?t aware of a vast difference. The bivalent vaccines appear to give 5 doses per vial (0.5mg per dose) versus the monovalent which yielded 20 doses per vial. Our provider was under the impression that it yielded 10 doses per vial. Since 10 doses per vial were administered each patient received 0.25mg instead of 0.5mg.   Each patient did not receive the recommended amount. The POC at the facility is aware of this. There were no adverse reactions noted and everyone seemed to be in good health status prior to our departure.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning an eight-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 06-Dec-2010. The patient received the expired FLUMIST on 09-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.