chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had 2 shingle vaccines and then shingles/suspected vaccination failure; shingles, not severe; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had 2 shingle vaccines and then shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles, not severe) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 10-Mar-2023 The case was received from the patient via interactive digital media. The patient had 2 shingles vaccines and then had shingles. The patient's case was not as severe and painful as most people had. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
when she took the band aid off, it looked as if she had been burnt and the scab was coming off; Itchy; broke out in a rash; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9266 and expiration date: not reported), via intramuscular, in Left Arm, on 19Feb2021 at 11:00 (at the age of 73-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included ongoing asthma and ongoing high Blood pressure. The patient's concomitant medications included asthma medication (unspecified). The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.  On Feb2021, when the patient took the band aid off, it looked as if she had been burnt and the scab was coming off and patient broke out in a rash. The patient hadn't called when it happened earlier because she was thinking perhaps it was a reaction to the Band Aid. The patient doesn't think it was a reaction. The patient is still very itchy. The patient confirms she is still itchy. She is not as itchy as it was, but she is still itchy. It was not as frequently as it was. The patient confirms the rash was still there. The outcome of the event Vaccination site scab was unknown, Itchy was recovering and Rash was not recovered at time of report.  No follow-up attempts are possible. No further information is expected.
Experienced vertigo, dizziness beardly able to walk or eat for three days, 4 days later I received physical therapy and it helped a lot. In total about 2-3 weeks of dizziness.
This was dads 2nd vaccine in the Moderna series. He experienced arm soreness and fever up to 100 degrees Fahrenheit for 48 hours including chills, fatigue, and lethargy. Since that time he has experienced confusion, loss of mental acuity,, loss of appetite, confusion, loss of short and long term memory. His ability to provide for his needs on his own have greatly diminished. Prior to the second injection my dad was fully supportive of his own care and mentally sharp. He does seem to be recovering at times, is once again able to take care of his personal needs, but doesn?t eat and is still confused. He doesn?t want to leave his chair..
SEVERE PAIN, REDNESS, ITCHINESS, SWELLING, RASH. ONSET ABOUT 3 DAYS AFTER AND LASTING 2 DAYS IN DURATION. REQUIRES ANTIHISTAMINE AND HYDROCORTISONE TOPICAL.
Heart inflammation, fever, headache, arm ache, chest pain, shortness of breath, pulsing pain throughout body, extreme pain at injection site, injection site was very hot to the touch, redness at injection site, swelling at injection site
Vaccine with 34F temperature administered to patient; Vaccine with 34F temperature administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine with 34F temperature administered to patient) and PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine with 34F temperature administered to patient) and PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient). On 05-Apr-2021, PRODUCT ADMINISTRATION ERROR (Vaccine with 34F temperature administered to patient) and PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT ADMINISTRATION ERROR (Vaccine with 34F temperature administered to patient) and PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient) to be not applicable.    Concomitant product use was not provided by the reporter.
Pt was given Daptacel instead of Adacel. I called pt 8/30/07 to ask how her arm was after 7/27/07 injection. She said it was really sore for a few days. She said the site was red-hot rashy. It is fine now. She did feel sick for a couple days afterward with GI complaints but thought it was from generic Prilosec.
Vaccine was administered. After all the vaccine had been put into the deltoid muscle, the patient passed out. He had a loss of conscious for 5-10 seconds. After a sternal rub, the patient awakened. While he was unconscious, the patient was somewhat stiff. He vomitted when he woke up and said he felt tired. He acted appropriately and answered all questions appropriately. Vital signs were stable at all times.
Pt. went to PCP with c/o                                                                              Pt. went to PCP with C/O of numbness of (R) arm and pain the day after getting Hep A/HPV 9. Numbness/pain was at the injection site. No Tx. required. Patient stated numbness/pain is gone today 2-17-17.
At the Center for COVID-19 vaccines, Pt. was administered a second booster dose of  Pfizer COVID-19 vaccine on 04/09/22,  three weeks and one day early, before the correct time allotment of four months from his first booster dose.  A dates form with dates listed for when patients should have received previous doses, so that the correct increments of time are followed, was given to Registration and to each of the vaccination stations in the adult vaccine area. The correct time increment of 4 months from the date of Pt.'s first booster dose was not checked at Registration or at the vaccination station.   The Pt. was observed for more that 15 minutes and experienced no adverse effects. Pt. reported feeling well at time of departure. N further issues reported.
Patient received vaccine on day of discharge 10/07/2020 and did not have a reaction prior to leaving within approximately 15 minutes. After being home patient reported to home care RN that she had a rash on her body. Home care RN instructed patient to go to the ER.
Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself.  A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine.  The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect.   The case will be reassessed if additional information becomes available.
Case number PHEH2015US011658, is an initial spontaneous report from a nurse received on 15 Jun 2015. This report refers to a 22 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412301A) intramuscularly on 11 Jun 2015. On 12 Jun 2015, the patient experienced post nasal drip drainage, coughing, sneezing, sore throat, swollen eyes and rash on arm of injection site followed by headache. On 13 Jun 2015, the patient experienced red swollen eyes and rash on arm of injection site. All these symptoms recovered as of 15 Jun 2015. Seriousness and causality of the events was not reported. Seriousness assessment of red swollen eyes was upgraded based on information in the source document.
Pt is 69 yo male s/p Pfizer COVID vaccination: dose 1 on 3/2 and dose 2 on 3/23. Pt presents to the ED after a fall. PMH of CAD and Parkinson's. Found to be COVID positive. Weakness deemed 2/2 to COVID, mechanical fall in the setting of Parkinson's. Reports possible exposure to COVID. He was treated with 4 days of remdesivir given risk factors, but he did not have any sustained oxygen desaturation below 95%.
03/12/2022, 5 days post vaccination, Family reports rash on child.  No SOB, no lip or tongue swelling reported. 03/16/2022 Follow up appointment for rash.   03/16/2022 Per Dr., Start "Children's Benedryl 12.5mg/5ml @ 2.5ml PO Q4hrs PRN for hives for 30 days (300ml) no refill". 03/06/2022, Hospital admission to the Pediatric ER.  Dx of VGE with emesis and diarrhea.  Patient discharged to home with Zofran and directed to follow up with Provider.
At 08:20, member was administered 0.5mL of Anthrax to right deltoid. About 20 seconds later, member became pale, light-headed, lost his balance and started to fall backwards. Member was caught and guided to the floor in a safely manner. Member's feet were elevated and member immediately "came to." He was alert and oriented. Vital Signs were stable. Physician Assistant and Nurse at member's side. Member was given an apple and some water. Pt remained in clinic for 30 minutes after vaccinations to make sure he had no reactions. No issues noted.
PT EXP PAIN AT SOI. FELT SEVERE STINGING. TREATMENT PT COUNSELING.
This non-valid spontaneous report was received from a registered nurse, concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On multiple unspecified dates on or after 21-FEB-2018, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, expiration date, strength, dose, route of administration, and anatomical location were not reported), administered for prophylaxis. The storage temperature and time frame were unknown by the reporter. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved.
About 5 months after my first vaccination (second vaccination was 2/3/21) I started experiencing difficulty recalling events , words, and information I previously would have recalled without a problem.  Experiencing a general brain ?fog?with no other explanation.
Gave me Covid-19 all over again ... lasted for 24 hours ... after effects are the exact same as Covid.
Initial and follow up information was received from a Registered nurse concerning to a patient (age and gender not reported). On an unknown date the patient was vaccinated intramuscularly (outside the recommendations per prescribing information) with a dose of ZOSTAVAX (Lot no. L035506 exp. 16-DEC-2016). The nurse reported that also a dose of PNEUMOVAX 23 (Lot no. L017406, exp. 26-FEB-2017) in the other arm. No adverse effect reported. Additional information has been requested.
Hives started from injection site, then to both legs. Claritin 10mg PO OD BID.
THE PT GOT 1ST DOSE AT A DIFFERENT PHARMAY , WHO PUT THE WRONG NEXT APPOINTMNET DATE 5. 8.21 SO PATIENT MADE AN APOINTMENT, AFTER GIVING A DOSE WHEN I WAS WRITING OUT THE SECOND DOSE ON THE CARD I NOTICED THAT PT RECIEVED 1ST DOSE ON 4.20
developed severe right scapular pain on 11/26/2021 13 days after receiving the Moderna booster dose.  Had associated dyspnea on exertion.  Symptoms worsened and included shortness of breath and chest pain.  Presented to the Urgency Room on 11/29/2021.   Testing included CT scan of chest confirming bilateral pulmonary embolism.  lab work included CBC, COVID test, BMP, troponin.  ekg also done. Started DOAC eliquis.  Pain worsened so was admitted to the hospital overnight for observation and pain management.  Additional labs included troponin,  BMP, magnesium, CBC.   Outpatient work up has included CT abdomen and pelvis, bilateral leg US to r/o underlying cause of unprovoked DVT.  has upcoming appointment with hematology as well.
Very tired, weak, fatigue easily which has improved, onset p/3rd vax, abn liver function tests which so far persist- onset before 3 vax 19APR91;
Pt had soreness in the area of injection, and redness in the general area. Pt stated the arm feels "sushy" or full of fluid. Pt also stated that she had flu like symtptoms, pain and achiness all over. The area was swollen as well. Pt was brought into the office to check site. There was redness around the injection site itself and some swelling.  Pt was told to ice the area and take ibuprofen.
This spontaneous report as received from a healthcare worker (certified medical assistant) concerning a patient of unknown age and gender. On 03-MAY-2013 the patient was vaccinated with MMR II thimerosal containing (lot # 670087/0399AA, expiration date 16-MAR-2013) (dose, route and anatomical location unspecified). No concomitant medications were reported. On 03-MAY-2013, the patient was vaccinated by another healthcare worker (certified medical assistant) with an expired dose with MMR II. No adverse effect was reported. This is one of the two reports from the same source (1305USA002787). Additional information has been requested.
Moderna COVID-19 Vaccine EUA  - 2nd dose  Severe flu symptoms - bad headache, achey joints, & nausea w. dry heaves
Patient waited 30 minute observation period as instructed per policy and left hospital.  On her way driving home, patient noticed left-sided facial numbness and turned back to drive back to hospital.   Patient was ambulatory with steady gait upon arrival back to the clinic, no slurred speech, facial movements symmetrical. Due to symptoms, staff encouraged patient to seek further care - RN escorted patient to ER triage based on post-vaccine symptoms for further evaluation.
Was immunized on the 9th and when she woke up on the 10th, she had hives on her neck, chest and upper right arm.   Gave Diphenhydramine and extra fluids.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly storage GARDASIL 9, lot number as reported M035486, expiration date 05-JUN-2019, lot number M023169, expiration date 13-JUN-2018, lot number M030380, expiration date 01-FEB-2019, lot number M036059, expiration date 03-JUN-2019, lot number M032650, expiration date 31-MAR-2019, (strength, dose, dose number, route and anatomical location were not reported), for prophylaxis. The temperature excursion was reported below 32 Fahrenheit degrees (0 Celsius degrees), time frame of 25 hours 5 minutes. The vaccines did not experience any previous temperature excursion. Digital data logger was involved. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA007383: US-009507513-1702USA002897: US-009507513-1702USA007380: US-009507513-1702USA007381.
This spontaneous report was received from a physician and refers to a currently 29 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, reported as "right before age 26", the patient was vaccinated with her first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. The reporter noted that the patient was missing doses because she was 29 years of age at the time of reporting and would like to complete the 3 dose series. No adverse effects were reported. Additional information has been requested.
Injection site redness, pain, swelling since the morning after vaccine was given. The redness has grown larger by the day since. We circle the initial size and have circled each day since. 11/7/2021 around 8pm - I notice that my legs have hives on them.
Left breast had a suspicious growth on ultrasound, had a biopsy in July result benign Adenmyoepithelioma.
approx. 10 min after injection felt light headed, flushed, and pre syncope. BP and HR were taken by staff and ER physician,, BP was hypertensive for me 145/90, 145/104, 137/89, 138/86, 132/91. I am normally 116/74. HR was 100. Oxygen was 100%,  At 12;33 was given 50mg IM x 1 Benadryl. 12:40 felt loopy and shakey.  12:54 moved to room in PACU and monitored by nurse. BP remained in the 130-140's until appox 1430 BP returned to normal 118/80 and Benedryl had worn off. My co-worker took me home.
Arthralgia of the left hand lasting approximately 2 weeks accompanied by severe fatigue with gradual decline and periodic reoccurrence of arthralgia.  Last occurrence of arthralgia was in November. Each occurrence was treated with ibuprofen at onset to relieve inflammation and joint stiffness.
Six days after injection:  Swollen upper left arm, cannot lift arm to the side, overhead is ok, but cannot extend to the side. Moderate pain to the touch, very hard 4 sq inches around the injection site. Icing whenever I?m sitting. Has not interfered with any ADLs.
Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage.  She passed away on 3/3/2021 at 3:05pm.
Felt a fire from the vaccination site to the palm and the pinky; redness of 5 inch in the injection site; Felt a fire from the vaccination site to the palm and the pinky; pain down arm to and pinky and palm, needle stabbing feeling; pain in the injection site; pain down arm to and pinky and palm; bump to up 3-5 inches; hot to touch; swelling; needle stabbing feeling; headache; This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a female patient who received Herpes zoster (Shingrix.    On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site warmth, injection site erythema, skin warm, radiating pain, injection site pain, headache, skin discoloration, discomfort, contusion, feeling hot and swelling. On an unknown date, the outcome of the injection site warmth, injection site erythema, skin warm, radiating pain, injection site pain, headache, skin discoloration and discomfort were recovered/resolved and the outcome of the contusion, feeling hot and swelling were unknown.  It was unknown if the reporter considered the injection site warmth, injection site erythema, skin warm, radiating pain, injection site pain, headache, skin discoloration, discomfort, contusion, feeling hot and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  No patient's identifiers, no lot number nor expiration date, no vaccination date was provided.  The physician thought vaccination was 3 weeks ago from 12 November. The patient was administered with Shingrix and at 2 am she felt headache that lasted 11 days.  Then in the middle of the night she felt pain in the injection site and felt a fire from the vaccination site to the palm and the pinky. Three days after the vaccination she had redness of 5 inch in the injection site.  The patient was recovered from all the symptoms.  Upon escalation to 2nd line, physician added that patient experienced pain down arm to and pinky and palm, needle stabbing feeling 3 hours, a bump to up 3-5 inches, hot to touch, and swelling.  She also mentioned this was already reported to CDC. The reporter consented to follow up.
He had titers drawn, TB skin test & vaccines for INFLUENZA & Tdap a part of his orientation to company. He fainted in completion of these tasks. He regained consciousness before we got him from chair to the floor. Once he was on the floor with his legs elevated he was coherent. He states he has fainted in the past after a cortisone injection to his shoulder. I saw him 3/8/12 no further problem.
1PM 6/11/21 PT REPORTED EXCRUCIATING PAIN SO SHE LAID DOWN UNTIL 6PM AND COULD NOT MOVE WITHOUT SERIOUS PAIN. SHE WENT BACK TO BED AND GOT UP AFETR NOON ON 6/12/21 REPORTING SYMPTOMS NOT GONE AND THE LONGER SHE WAS AWAKE THE WORSE THEY GOT. REPORTED SOB, SORENESS FROM BACK TO FRONT ON INJECTION SHOULDER, STANDING OR LEANING OVER CAUSING MAJOR PAIN FROM FRONT OF CHEST ALL THE WAY THRU TO BACK OF SHOULDER BLADE LIKE A DOULBLE EDGED 3 INCH BLADE KNIFE CUTTING THRU LEAVING PAIN THAT LASTS FROM 1 MIN TO SEVERAL MINUTES..COMPILES WITH AN ALMOST INABILITY TO BREATH AND WHEN I DO IT GETS WORSE... HURTS TO EVEN PICK UP CELL PHONE... JUST SITTING FORWARD CAUSES PAIN TO START AGAIN. REPORTED TOOK 2 TYLENOL 650MG  6/11/21 AT 5PM, MOTRIN AND TYLRNOL AT 12:45PM 612/21 SYMPTOMS GETTING WORSE.
Pentacel powder (HIB) never mixed with  diluent (dtap-IPV) so pt did not receive HIB portion of vaccine
Nurse reporting a temperature excursion for PROQUAD. Information obtained for vaccines that were administered to patients.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose (Product storage error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 ml, subcutaneous (SQ), lot # T016990 with expiration date 11-NOV-2021, for prophylaxis.   On 25-JUL-2021, a temperature excursion was occurred from 6°F to 14°F (7.3°F) during a time frame of 37 minutes. This temperature excursion was not previously reported.  On 10-AUG-2021, the product storage error was identified.  On 14-SEP-2021, a temperature excursion was occurred from 6°F to 14°F (9.9°F) during a time frame of 2 hours and 11 minutes.  On 15-SEP-2021, a temperature excursion was occurred from 6°F to 14°F (6.6°F) during a time frame of 59 minutes.