chrisvoncsefalvay/vaers-outcomes huggingface dataset:
oxygen level severely drop; pain was so bad; rash is dry; shingles; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingles vaccine. On 7th September 2021, 8 days after receiving Shingles vaccine, the patient experienced pain (serious criteria hospitalization) and shingles. On an unknown date, the patient experienced oxygen saturation decreased (serious criteria hospitalization) and rash. On an unknown date, the outcome of the pain and rash were not recovered/not resolved and the outcome of the oxygen saturation decreased and shingles were unknown.   It was unknown if the reporter considered the pain, oxygen saturation decreased, shingles and rash to be related to Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The doctor said the patient to get the Shingles shot so that he/she could stay healthier. The patient did and got the full-blown bad case of shingles and experienced deep bad pain. The patient stated that less than 2 months after vaccination, the rash was very dry at the time of reporting and the pain was very intense at times.  The patient stated that it was day 56 at the time of reporting and did not know when it would end. Less than 2 months after vaccination, the patient had spent 2 days in hospital because pain was so bad it was causing his/her oxygen level to severely drop, as he/she live on oxygen 24/7. The patient stated that there was a second shot in the series, that was not supposed to have live virus. The patient stated that doctor was apologizing, and they could not believe the patient got the Shingles.  The patient stated that not to get the shot. Follow-up would not be possible as not contact details available.
This spontaneous report as received from a pharmacy technician concerning a currently 25 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 21-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 20Mar2021 10:30 (Lot number: 1111-20-ER8731) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing); "High cholestrol" (ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing); ROSUVASTATIN taken for blood cholesterol increased (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccination facility Type: doctor's office/urgent car. Vaccine administered at military facility: no  No follow-up attempts are possible. No further information is expected.
pain, all over the body; shivering; fever; not feeling good for 2 days; This case was reported by a pharmacist via call center representative and described the occurrence of generalized aching in a patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized aching, shivering, fever and feeling bad. On an unknown date, the outcome of the generalized aching, shivering, fever and feeling bad were recovered/resolved.   It was unknown if the reporter considered the generalized aching, shivering, fever and feeling bad to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter called to report that a lot number for Shingrix has caused too many adverse events for patients and that they would stop administering this lot since this was very unusual. The patient received vaccine and reached back complaining about pain, all over the body, shivering, fever and not feeling good for 2 days. The reporter knew that these were common side effects and was aware that this happens but was concerned due to the fact that 3 patients received doses from the same lot and they all 3 felt bad enough to call the pharmacy. The reporter consented to follow up. The reporter stated that they can share patient information but during follow-up by safety. This is 1 of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR128574:Same reporter US-GLAXOSMITHKLINE-US2021AMR128575:Same reporter
Joints and tendons hurting;  I had damaged tendons from older events; the damage feels like it is exasperating.  As I feel burning sensation (micro tears) on my lower back and shoulders.
Today visit notice on (L) deltoid slight reaction on KINRIX. No warmth, no swelling about 5cm redness only - faint around the site of KINRIX administration. Upper deltoid area.
This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 16-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced injection site induration, numbness of upper extremities, pain in arm and erythromacular rash. On an unknown date, the outcome of the injection site induration and erythromacular rash were unknown and the outcome of the numbness of upper extremities and pain in arm were recovered/resolved. It was unknown if the reporter considered the injection site induration, numbness of upper extremities, pain in arm and erythromacular rash to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported, but it could be 15 or 16 years old. The patient received BEXSERO vaccine on an unknown arm. The physician reported that the patient reported induration at the site, pain to her arm for 2 weeks, numbness to the arm which faded and few red spots around the injection site.
Shot was given around 2:00 pm on 12-19-07.  On 12-20-07 at about 10:30 am, a plum sized welt appeared on the child's left thigh around injection sites.  It was red, hot to touch, but did not seem to be painful to the child when touched.
This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that, vaccines administered at pharmacies that were stored in an unapproved freezer and thus might have been compromised. At pharmacy, digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  The beyond used date was reported as 02-Feb-2022. Moderna date ordered was reported as 03-Jan-2022. No treatment details were reported.
2 days p/shots high fever 103 until 24AUG92; kept getting worse to ER 15AUG92 undx; 17AUG to another MD; 20AUG to ER adm;
Patient symptoms after vaccination were diarrhea and stomach pain. Pt states she is starting to feel bloated and pt is having more pain with movement and touch. Pt desribes the pain as dull and a level 4/10. Pt has had 2-3 epsisodes of diarrhea. Pt was c/o nausea and feeling fatigued. Denies fever, vomiting, cough, congestion, runny nose, chest pain, headache, loss of appetite.
erythema; sore arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (erythema) and PAIN IN EXTREMITY (sore arm) 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 ERYTHEMA (erythema) and PAIN IN EXTREMITY (sore arm). At the time of the report, ERYTHEMA (erythema) and PAIN IN EXTREMITY (sore arm) 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.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
A non-serious spontaneous report of inadvertent administration of expired product was received from a non health professional concerning a eight-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The labeled expiration date was 12-Feb-2010; the re-assigned expiration date was 15-Jan-2010. On 18-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
2 days after shot and shortly after dinner had diarrhea and vomiting with shivers until 3am. When woke the next day everything was fine. No treatment and recovered.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 49 years old male patient who received a 0.5 ml dose of vaccines FLUZONE HIGH DOSE (lot UJ023AA) via intramuscular route in the left deltoid instead of FLUZONE QUADRIVALENT on 26-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
things went black; my blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high; severe dizziness; severe headache nausea; weakness; severe headache nausea; This is a spontaneous report from a contactable other healthcare professional (patient). An 60-year-old non-pregnant female patient received bnt162b2 (COVID 19, brand: Pfizer, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 11:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included Stent in LAD (Left anterior descending coronary artery). Concomitant medications included losartan potassium, lorazepam (ATIVAN), acetylsalicylic acid (BABY ASPIRIN) and furosemide. It was reported that, within 15-20 minutes went to stand up severe dizziness and things went black started to get severe on 07Feb2021 at 11:15 AM. On 07Feb2021 at 11:15 AM, Headache, nausea Nurse Practitioner that gave shot took her blood pressure was alarmed was over 200 checked other arm same called there team ER member to triage still B/P high and she could not stand up due to weakness dizziness apparently they called Paremedic/EMT advised in her best interest to be seen in Emergency department. they did not how ever ask if she belonged to a ambulance company which she do so know she have a bill of about 1,500 with ambulance company. was in the ED for about 4 hours till blood pressure can down. was given medication for nauseas, felt like she was hit by a truck. Patient had Cardiac montering/medication. No covid prior to vaccination. No covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events assessed as possibly related to the suspect drug BNT162B2______ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient had pain at injection site for 3 days after the vaccine, then had a migratory pain that began in his upper back and migrated to his his left toes over the 2 weeks after the vaccine administration and is now resolved
A serious spontaneous report of seizures and possible transient ischemic attacks has been received from a parent who is also a nurse concerning a seven-year-old female, subsequent to FLUMIST.  The patient had no medical history and was reported to have been very healthy.  The patient received a varicella vaccine on 27-Dec-2007 on the same date as the first FLUMIST vaccine administration.  On 30-Dec-2007, the patient was asleep and started having seizure activity reported as tonic-clonic movements, she stopped breathing and turned blue.  The episode lasted for approximately 90 seconds.  On 30-March-2008, the patient became unable to speak and had right-sided weakness and numbness.  The mother reported that the numbness resolved within 24 hours.  On 20-Oct-2008, the patient received FLUMIST again.  On 12-Jan-2009, an EKG showed abnormal electrical activity on the left side of the brain.  On 19-Jan-2009, a MRI revealed spots on the brain the could be consistent with TIAs.  The patient was started on OXCARBAZEPINE 300 mg BID for the seizures on 19-Jan-2009.  On 19-Feb-2009, the patient had an echoencephalogram, had a chemistry panel drawn, and a PTT for which results are pending.  The events are ongoing.  The mother stated that she does not think that the seizures nor the TIAs are related to FLUMIST.  The sponsor considered the events of seizures and possible TIAs to be serious (important medical events). Follow-up: Information not yet obtained through case follow-up. If information becomes available a VAERS report will be submitted.
Auxiliary lymphadenopathy on the left side of the body from  March 24 to  approximately March 29. Discomfort due to  left auxiliary lymphadenopathy in armpit and a visible egg shaped swelling.  Mild flu like symptoms of chills and joint aches occasionally from March 25 to March 26.
severe pounding h/a, malaise, myalgia, severe chills & dizziness, moderate loss of appetite, soreness of inj, pain in arm lifting motion, mild joint ache & nausea;T103.9 10hr p/vax;went to clinic next AM;given H20 for dehydration;noc sweats
5 MINUTES AFTER RECEIVING VACCINE, PATIENT FELL ON FLOOR. WHEN I ARRIVED TO INCIDENT I NOTICED A JERKING MOVEMENT TO PATIENT'S HEAD.  PATIENT WAS LYING ON SIDE NONREACTIVE, WOKE UP AND STATED "WHAT HAPPENED?"  THEN SAT UP.  I ASKED MOTHER IF PATIENT HAD SEIZURES, MOTHER STATES PATIENT IS FINE, JUST FAINTED.  USS BP 120/80 P 88 R 22 PATIENT RESTED FOR APPROX 10 MIN AFTER INCIDENT. STATES HE FEELS FINE. AMBULATED FROM CHLINIC WITH MOTHER L GRIEGER LVN
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6202), in right arm, on 16Mar2021 as dose 2, single (Lot number: ER8727), in right arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF884), in left arm and on 23May2022 at 11:15 as dose 4 (booster), single (Lot number: FM9992) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Pfizer COVID 19 Treatment from 03Sep2022 to 07Sep2022.
Expired vaccine was given. Vaccine expired 07/02/2022 and was given to patient on 07/07/2022. No adverse reactions.
Pain in the arm; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm) and FATIGUE (Feeling tired) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm) and FATIGUE (Feeling tired). At the time of the report, VACCINATION SITE PAIN (Pain in the arm) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant include Steroids.  Treatment information was not reported.   This case was linked to MOD-2021-316580, MOD-2021-316581 (Patient Link).
Patient reported on 2/4/22 that she has been experiencing shoulder pain since the time of the vaccine.  She has tried OTC tylenol and advil, and topical lidocaine with no relief.  She states that recently it has only gotten worse and it now making a "popping noise"
Body aches that started on the day of injection that has since resolved; patient has been agitated and having muscle spasms in her neck that started the day after injection that are persistent.
Patient came in for Pfizer Bivalent booster and instructed to wait for 30 due to anaphylactic reaction to Penicillin. Patient was vaccinated with Pfizer Bivalent Booster 0932 and began feeling chest pain at 0945, Patient is AxOx4 speaking in full complete sentences. Patient color was WNL and dry. Patient stated "When this happens I take my Nitro it's my standard order."  Patient self administered Nitro SL at 09:47. Patient was closely monitored. 9:52 stated " I feel a lot better the nitro helped" Patient was instructed due to high risk patient will need to go to ER. Patient agreed, ER was called and hand off report was given to ER RN.  Patient was transported to ER report was given to ER RN, patient is AxOx4 speaking in full complete sentences with unlabored breathing.
The patient comes in with a two-day history of fever, sleeping more, and ear pulling. Associated deep cough. No one else ill. He is not in daycare. No smokers. Past history is unremarkable for any chronic issues. He did have his one-year physical one week ago, which included an MMR and Varivax. Physical reveals an alert, apprehensive toddler in no distress. HEENT: Mucous membranes are moist. Eyes not inflamed. TMs gray and transparent with normal anatomy. Approximately a half dozen 2-mm sized reddish blanching papules are noted on the trunk. No adenopathy. Throat slightly reddened with no exudates. CHEST: Clear. HEART: Sinus tachycardia with no murmur. ABDOMEN: Soft and non-tender. ASSESSMENT: Viral syndrome with exanthem. This certainly could be part of an MMR reaction. PLAN: Tylenol or ibuprofen. Diet as tolerated. Recheck PRN.
No additional AE reported. No PQC reported. No further information was provided.; HCP reported that a patient received a dose of HAVRIX on 7/12/2022 and a dose of VARIVAX on 8/3/2022. Caller said the health department instructed the patient to repeat the dose of VARIVAX since HAVRIX and VARIVAX were given too close.; This spontaneous report has been received from a registered pharmacist concerning a 16-year-old female patient. Her concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 12-JUL-2022, the patient received a dose of hepatitis A vaccine inact (HAVRIX). On 03-AUG-2022, she received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (product quantity reported as 1) (inappropriate schedule of product administration). Both vaccines were administered for prophylaxis (strength, dose, route lot number, and expiration were not reported). The health department instructed the patient to repeat the dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) since hepatitis A vaccine inact (HAVRIX) and varicella virus vaccine live (Oka/Merck) (VARIVAX) were given too close. This was filed as a precautionary adverse event (AE). No additional AE was reported, and no further information was provided.
Vaccine was  given beyond the use  date by handful of days, no adverse issues at  all. patient fine