chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red rash, looks like ox; Sore arm; Sore neck; Sore upper quarter back; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced red rash, pain in arm, neck pain and back pain. On an unknown date, the outcome of the red rash, pain in arm, neck pain and back pain were unknown.   It was unknown if the reporter considered the red rash, pain in arm, neck pain and back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine and experienced a red rash an what looked like a few ox. The patient also experienced a sore arm, neck and upper quarter back. The patient asked was that usual. Additional supportive information: The follow-up would not possible as no contact details were available.
Throat infection swollen lymph glands neck Shingles outbreak right ear Difficulty breathing and swallowing
Information has been received from a physician concerning a 12 year old patient with no known drug allergies or any pertinent medical history, who on 24-JUN-2009 was vaccinated subcutaneously with 0.5 ml of a dose of VARIVAX (Merck). There was no concomitant medication. On 26-JUN-2009, two days after vaccination, the patient developed redness and warmth at the injection site of the left upper arm. The patient was examined in the office on 06/26/2009 and was diagnosed with cellulitis. The physician prescribed trimethoprim and SEPTRA. At the time of reporting the patient was recovering. The physician was unable to provide the VARIVAX (Merck) lot number, the sterile diluent lot number was 4127X. The physician is concerned that the cellulitis may be related to the sterile diluent and requests a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. (complaint ID 166286). This is one of two reports from the same source. Additional information has been requested.
Arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain". Additional information: The patient had no additional administered vaccines, administered on same date with the Pfizer vaccine considered as suspect. The patient had no prior vaccinations within 4 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PAIN AND REDNESS AND A KNOT ABOUT THE SIZE OF A DIME THE FOLLOWING MORNING AFTER THE SHOT. THAT EVENING HAD GROWN HOT, RED, AND INCREASED IN SIZE, THE SIZE OF MY FIST. LOTS OF PAIN AND SWELLING AND SEVERE ITCHING SINCE.
Cold; This spontaneous case was reported by an other and describes the occurrence of NASOPHARYNGITIS (Cold) 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.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) had resolved.            Concomitant medications was  not reported.  Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by an other and describes the occurrence of NASOPHARYNGITIS (Cold) 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.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) had resolved.            Concomitant medications was  not reported.  Treatment information was not provided.
Area around injection site inflamed the next day.  3? circular area - red, sore to touch  with a hard lump, itchy and - hot to touch.  Improved a bit every day. Redness fading but still itchy today (5 days after shot)
The patient received a 0.5 mL dose for their 1st booster dose. This dose was supposed to be a 0.25 mL dose making it a medication administration error. The patient experienced no adverse reaction.
pt recv vax & exp migraine & nausea for 12 days;sx subsided;
HER UPPER LEFT ARM IS SWOLLEN NEAR THE BICEP WITH A LINE OF REDNESS. TOLD PT TO ICE THIS EVENING AND TAKE MOTRIN AND APPLY A STEROID CREAM. iF WORSE TOMORROW, SHE IS GOING TO CALL PCP FOR KEFLEX FOR CELLULITIS. PRESENTED W/O FEVER OR ACHY.
Patient was administraded the second dose of Moderna Vaccine in the left arm. Lote 050C21A. In the recovery area near to 1:02pm patient verbalize that it's fine, she eat and take all the medication but she feel dizzy. We offer water but the patient denied. We ask to the patient the name and were she are and patient said that she don't remember her name or were she are.  Paramedic help to leydown the patient at this moment patient said she had chest pain and describe like burn. Present we SOB. Vitals was B/P 140/80, HR 110; SPO2% 93% and glucose 146. We call 911 and the patient was transport to the hospital.
No additional AE  information reported; a patient was administered the first dose of VARlVAX at 19 years old, but never received the second dose; This spontaneous report was received from a pharmacist referring to a 19 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.         In approximately 2018 (reported as approximately 2-3 years ago), the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml; strength, route, anatomical location, lot# and expiration date were not reported) for prophylaxis, but the patient never received the second dose (inappropriate schedule of vaccine administered). The reporter inquired if the patient needed to receive the second dose. No additional adverse event was reported.
The patient states that within 48 hours upon receipt of her second dose of the pfizer COVID-19 vaccine, her entire body broke out in a rash and she had itching all over her body where the rash had presented. She was given 2 courses of prednisone. The first course of prednisone did not resolve the rash/itching. She was also prescribed atarax for the itching. She was prescribed a second course of both of these medications since it did not resolve with the first course of treatment. After the completion of the second course of prednisone, the rash has subsided, but her skin is not yet "completely back to normal". The first course of a presnisone taper was on 8/13/2021. Then later received a second course on 8/26/2021.
PATIENT SAW A SMALL AMOUNT OF BLOOD RUN DOWN HER ARM AFTER VACCINATION AND IMMEDIATELY SAID SHE DIDN'T FEEL GOOD.  SHE THEN LOST CONCIOUSNESS AND SHOOK AS THOUGH HAVING A SEIZURE, WHICH LASTED A FEW SECONDS.  THE LOSS OF CONSCIOUSNESS LASTED APPROXIMATELY ONE MINUTE.  PATIENT SLOUCHED DOWN IN HER CHAIR BEFORE SITTING UP AND STARING INTO SPACE, NOT FULLY COHERENT.  SHE THEN REGAINED CONCIOUSNESS AND SEEMED COHERENT.  EMERGENCY SERVICES WERE CALLED AND HER VITAL SIGNS SEEMED NORMAL.  PATIENT VOMITED ONCE AFTER EMERGENCY SERVICES ARRIVED.  PATIENT WAS NOT TAKEN TO THE HOSPITAL AND WENT HOME WITH HER MOTHER.   AT A 5 HOUR FOLLOW UP THE PATIENT DID NOT HAVE FURTHER EFFECTS.
This spontaneous report as received from a Licensed Practice Nurse refers to an unknown number of patients of unknown age and gender. Medical history, current conditions and concomitant medications were not reported. Nurse reported that on an unknown date unspecified patients received improperly stored (Oka/Merck) VARIVAX (lot number and expiration dates were not reported). No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Body aches, fever, fatigue No treatment, symptoms resolved on own within 36 hours.
This spontaneous report as received from a healthcare worker refers to an 18 year old male patient. No patient's concurrent conditions, medical history or concomitant medications were reported. On 08-JUL-2015, the patient was vaccinated with a first dose of GARDASIL 9 lot # K026247, expiry date 29-JAN-2017, 0.5 ml, intramuscularly in the right arm. On 28-NOV-2015, the second dose administered was GARDASIL lot # K010215, expiry date 05-MAY-2017. in the right arm (dose and route were not reported). No adverse effects were reported. The outcome of interchange of vaccine products was unknown. The causality assessment between adverse event of interchange of vaccine products and suspect therapies was not provided. Additional information is not expected as there was no consent for further contact.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 20-AUG-2013, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a department of health facility, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated (by an unspecified healthcare professional) at a medical group (office) for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
CHILLS AFTER 1ST DOSE. 12-1-89 2ND DOSE GIVEN WHICH ONSET PAIN IN NECK AND ARM; MUSCHLE SORE(WHOLE BODY);LOW GRADE FEVER;KIDNEY PAIN;TENDER SPLEEN;NAUSEA;ITCHING;PAIN AT INJECT SITE;LYMPH NODES SWOLLEN;AS OF 12-20 PT FINE
This spontaneous report has been receiving from a healthcare professional referring to a patient of unknown age and gender. Information regarding medical history, drug reactions or allergies was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (route of administration, dose, lot# and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, the patient had an "allergic reaction" to ZOSTAVAX. No product quality complaint was involved. At the time of reporting, the outcome of "allergic reaction" was unknown. Additional information is not expected as no reporter details were provided.
STIFFNESS IN MIDDLE LOWER BACK AROUND SPINE; SEVERE ACHE IN MIDDLE LOWER BACK AROUND SPINE; SEVERE BODY ACHES,SHARP ACHES AND PAINS; UNCOMFORTABLE TO MOVING AROUND; HEAVILY SWEATING; LETHARGY; WENT TO BED EARLY BUT SLEEP WAS REPEATEDLY INTERRUPTED; CHILLS; INJECTION SITE ACHES LIKE A BIG FRESH BRUISE; FEVER; 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) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. On an unspecified date, the subject experienced stiffness in middle lower back around spine, severe ache in middle lower back around spine, severe body aches, sharp aches and pains, uncomfortable to moving around, heavily sweating, lethargy, went to bed early but sleep was repeatedly interrupted, chills, injection site aches like a big fresh bruise, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe body aches, sharp aches and pains, uncomfortable to moving around, chills, fever, heavily sweating, stiffness in middle lower back around spine, severe ache in middle lower back around spine, lethargy, injection site aches like a big fresh bruise and went to bed early but sleep was repeatedly interrupted 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.
Approximately 4 days after the injection, the patient developed a red raised rash beneath the right axillary area (injection was given in the left deltoid.  Continued to spread to both upper and lower extremities and on the entire trunk area.  No other symptoms other than very minimal itching.
she is in her 7th month of pregnancy; infection; This is a spontaneous report from a contactable consumer or other non hcp. This consumer or other non hcp reported information for mother. This is a maternal report. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. My wife was pregnant and she was in her 7th month of pregnancy. Recently she had some infection and she was on antibiotics. She was due for her 2nd Pfizer Covid vaccine shot today. Was there any concern taking shot while also taking the antibiotics. The patient's concomitant medications were not reported. On an unspecified date the patient experienced she is in her 7th month of pregnancy, infection. The mother reported she became pregnant while taking bnt162b2. Therapeutic measures were taken as a result of infection.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt said the next day when she took her Band-Aid off and it took off a piece of skin around the injection site.  She said it is itching and seems to be healing.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The physician reported that the patient received the first dose of GARDASIL (lot #, expiration date, dose and route not reported) on an unspecified date one and one half year ago and was in the office on 31-JAN-2013 to receive the second dose of GARDASIL (lot #, expiration date, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. No treatment information was reported. The outcome of the patient was unknown. Additional information is not expected.
Moderna COVID-19 Vaccine  Shortness of breath (from day of administration until today) Nausea and alternating diarrhea and constipation (from day of administration to today) Dizziness and light-headedness, weakness (from day of administration to today) Fatigue and pain in left arm (from day of administration to yesterday) Chest pain  (from day of administration to today) Insomnia (from day of administration to today)
Approximately 12 hours after injection, I experienced agonizing pain all throughout my body (9/10), as well as headache, nausea, fever-like symptoms, chills, fatigue which lasted for about 7 hours
Pediatric Pfizer vaccine was not mixed with dilutant before administration. Administrated by RN , Healthcare Service.
PATIENT INCORRECTLY RECEIVED MODERNA VACCINE AS A MINOR INSTEAD OF PFIZER.
This spontaneous report as received from a other health professional refers to unspecified number of patients of unknown age. It was reported that the GARDASIL of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients GARDASIL have been administered since date of last excursion of 27-JAN-2014 is with Lot number 0420AE and expiry date 01-DEC-2014. Additional information has been requested.
Patient complained of itching and hands were red.  Benadryl 25 mg po given and patient took her daily prednisone dose.  After 30 minutes itching resolved.
It was discovered that the vaccine  received was stored in a freezer longer than recommended by the manufacturer.  Per the manufacturer, since the potency of the vaccine cannot be determined, it's unclear of the level of immunity this dose was expected to deliver.  After consulting with our immunization experts, and with the vaccine manufacturer, it?s recommended to repeat the dose to ensure full protection.
Administered a vaccine to a child and did not notice until after I was done and putting the safety on that it was expired. We notified the patients mother and she was okay with it. We will re-administer another vaccine to the patient  at a later date. We are going to have a calendar with all vaccine expiration dates hanging up in the vaccine room to prevent from happening again.  Every time I log temperatures I will look at the calendar and look and see if any expired vaccines need to be removed.
STILL WAITING, SUBSEQUENT EKG, OKAY NOW.. WILL BE HAVING FURTHER TESTING TO SEEK FURTHER INFO  ON HEART.  PRESENTLY AM GOING THUR EXPECTED EFFECTS OF BACK TO SLEEP 14/16 HRS DAILY, SWOLLEN LYMPHS UNDER LEFT ARM ONLY, BACK HEAD PAIN WHEN RESTING, PAIN, PALMS HANDS,  SAME PAIN, LEFT AREA ABOVE EAR, INTERMITTENT HEADPAIN DIFFERENT AREAS OF SKULL...
I received my second dose of the Pfizer vaccine on February 23rd 2021. That same day I discovered I was pregnant. On March 26th 2021 at my 9 week appointment ultrasound I discovered that my baby had no heartbeat.
Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Error: Booster Given Too Early-, Additional Details: Patient stated that she had seen a cardiologist and determined that the patient had developed an arrhythmia due to the vaccination. The patient had to be placed on flecaninide and have an ablation done.
ACUTE RESPIRATORY FAILURE 4/18/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION HYPOXIA 4/11/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION
This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 63-year-old male patient who received RABAVERT (batch number 644011A, expiry date unknown) for prophylaxis. Concomitant products included RABAVERT, RABAVERT and RABAVERT. On 18th July 2018, the patient received the 4th dose of RABAVERT. In July 2018, less than a month after receiving RABAVERT, the patient experienced neuropathy (serious criteria GSK medically significant). On an unknown date, the patient experienced muscle pain. On an unknown date, the outcome of the neuropathy and muscle pain were unknown. It was unknown if the reporter considered the neuropathy and muscle pain to be related to RABAVERT. Additional information was reported as follows: The batch number for concomitant dose of RABAVERT was reported as 589011A. The patient was vaccinated with RABAVERT for a animal bite, where it was a squirrel bite. The reporter stated that, he received the first two doses of RABAVERT at an emergency room hospital at a different location, whereas the 3rd and the 4th dose were administered at a different location. The patient took the 1st and the 2nd dose, 3 days apart from each other. The patient was vaccinated with the 3rd and the 4th dose of RABAVERT a week apart from each other. On 18th July 2018, last Wednesday, prior to the date of reporting, the patient was vaccinated with the 4th dose of RABAVERT. One week prior to the date of vaccination of the 4th dose, the patient was vaccinated with the 3rd dose, 3 days prior to the date of vaccination for 3rd dose he had his 2nd dose and same for the 1st dose too. On the date of reporting, the patient called concerned about hearing of a recall of a rabies vaccine and was concerned if his product or any of its components were from recall. The patient did not provide the name of recalled product or company at the time of reporting, but however in the follow-up information the batch numbers were updated. The patient also noted during the conversation that he was having muscle pain and neuropathy which could also be rabies and was seeking if he needed other medication treatment if he had rabies. The patient was a lawyer, as stated by him; he received a call back from the Center for disease control and prevention (CDC) during the conversation and was unable to complete all questions. The patient was provided serial number (SR#) in order to call back again.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805428 was crossed linked to original case 201804863 due to same reporter.
This spontaneous prospective pregnancy report was received from a 26 year old female consumer referring to herself. Pertinent medical history and concurrent conditions were not reported. At the time of this report, the patient had none drug reactions or allergies. On 24-MAR-2015 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were unspecified). On an unknown date in May 2015 the patient was vaccinated with the second dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were unspecified). None concomitant therapies were reported.  On an unknown date, after receiving the second dose, the patient became pregnant with LMP of May 2015 (unspecified day). The pregnancy outcome  was pending so the fetal outcome was unknown. The patient did not seek medical attention, there were no laboratory diagnostics performed, and no treatment was given for the adverse event. Additional information has been requested.
4x6 in. area of erythema/induration with central pinpoint water-filled vesicles L deltoid - seen ~48 hours after vaccine given (started at ~24 hours post-vaccine).