chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I still get them too/Suspected vaccination failure; I still get them too; Blisters are confined to a small area; Pain before blisters appear is real; This 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and pain. On an unknown date, the outcome of the vaccination failure, shingles, blister and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, the blisters were confined to a small area but the pain right before the blisters appeared was real. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Symptom onset began on 4/29/2021. Tested (+) on 4/29/2021. Symptoms included fatigue, congestion, cough. Case was interviewed by public health department on 5/3/2021 and family reported he was in hospital and was admitted on 4/30/2021. Deceased as of 5/14/2021. Unknown if in ICU or mechanically ventilated.
Prior to receiving  Pfizer Covid Pediatric vaccine mom cautioned that her son has in the past felt dizzy after receiving the flu vaccination and was apprehensive of this vaccine. She was cautioned by the RPH to have him wait 15 minutes which is the routine recommendation.  After receiving the vaccine he appeared a little pale.  Some minutes later  he was walking with mom and he felt dizzy and fell. He was still conscious and talking. His mom wanted him checked by paramedics hence they came and found he was doing well.
Background:  pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the pharmacy has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
pt states hives on hands, face & neck area started on Thursday afternoon 9JAN97 w/f/u w/PMD;
He was vaccinated with 1st and 2nd dose of the vaccine and tested positive; He was vaccinated with 1st and 2nd dose of the vaccine and tested positive.; This is a spontaneous report from Pfizer-sponsored program. This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced he was vaccinated with 1st and 2nd dose of the vaccine and tested positive on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date (he was vaccinated with 1st and 2nd dose of the vaccine and tested positive). Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
In the afternoon started to get very cold, tired and had a headache. By the time I got home I was freezing cold, very tired and still had a headache. Woke up 01-21-21, felt like I was in a fog, strong headache and felt like I had been hit by a bus. Felt n Narrative:
Patient had been experiencing right upper extremity weakness and tingling in his hands and feet starting on 12/20/22.  He presented to ER on 12/31/22 and underwent MRI brain revealed acute infarction within the left frontal and parietal lobes and left centrum semiovale. He underwent extensive testing including transesophageal echocardiogram, CT pulmonary angiography, implantable loop recorder, and limited hemeatologic workup which all returned broadly normal without causal evidence for this ischemic stroke.
Client got vaccination (TD) 07/08/2005 in left deltoid.  Immediately following, client with pain to left arm, radiating to left neck and wrist.  Pain increasing as days past vaccine date pass.  Woke up this AM unable to turn neck to right side, pain and stiffness.  Dull, intermittant headaches, started a couple days after vaccination.
extreme fatigue; fever; headache; severe body aches; This is a spontaneous report received from contactable reporter consumer or other non HCP. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 at 17:45 as dose 3 (booster), single (Lot number: FJ1620) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 ({vaccine_brand=Pfizer / BioNTech,, vaccine_brand_unknown=False,, vaccine_administration_date=23Apr2021,, vaccine_administration_time=01:15 PM,, vaccine_lot_number=EW0170,, vaccine_lot_unknown=False,, vaccine_dose_number=2,, vaccine_dose_number_unknown=False,, vaccine_location=Left arm},), administration date: 23Apr2021, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 ({vaccine_brand=Pfizer / BioNTech,, vaccine_brand_unknown=False,, vaccine_administration_date=02Apr2021,, vaccine_administration_time=01:15 PM,, vaccine_lot_number=ER8737,, vaccine_lot_unknown=False,, vaccine_dose_number=1,, vaccine_dose_number_unknown=False,, vaccine_location=Left arm}]), administration date: 02Apr2021, when the patient was 63-year-old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 04Dec2021 at 12:00, outcome "recovered" (18Dec2021), described as "extreme fatigue"; PYREXIA (non-serious) with onset 04Dec2021 at 12:00, outcome "recovered" (18Dec2021), described as "fever"; HEADACHE (non-serious) with onset 04Dec2021 at 12:00, outcome "recovered" (18Dec2021); PAIN (non-serious) with onset 04Dec2021 at 12:00, outcome "recovered" (18Dec2021), described as "severe body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, headache, pain.  Additional information: vaccine received, Unknown other medication in 2weeks, After the third shot (Booster), she experienced extreme fatigue, fever, headache and severe body aches for one week and moderate for the second week. she took a Covid antibody test at (withheld) on 02Jun2022 to see how much antibody load she still had to determine if she should get another booster. she had approximately 23,600 which is very high. she tested again on 07Sep2022 and it came back at 17,800. she donot want to be sick for two weeks from another booster. Do you recommend her get the combined booster or should her continue to monitor my antibody levels?
A non-serious spontaneous report of possible eye exposure was received from a health professional concerning a five-year-old male. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 27-Oct-2011, the patient received FLUMIST, some of which have gone in the patient's eye. 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.
Shot given at 4:15pm  Starting at approx 11:45pm, I experienced flu like symptoms of horrible muscle and joint aches, arm at injection site was red and extremely sensitive to touch, fever of 101 F   In bed all the next day.  Better the 2nd day but a bit wiped out.  Arm sore for 4 days.
Information has been received from a physician concerning his 16-year-old daughter who on 03/31/2001 in the afternoon was vaccinated with 0.5mL dose of hepatitis A virus vaccine inactivated (Lot #634931-0913K). On 04/02/2001 the patient woke up with complaints of a severe headache, vertigo, and fatigue. It was noted that "she was seen by many doctors including neurologists", and they "tried many medications". CT and MRI were normal. "Later" a spinal tap was done which was normal. The reporter indicated that the symptoms were better after 2 weeks but recurred again and again. The reporter noted that "she could not function she could not go to school". It was noted that she did go to school for a few days, but then developed severe dizziness again. The physician indicated at the time of the report that she was "not getting any better". The physician indicated that "she has been homebound and can not even graduate from high school. She used to be top five percent student in the class now she is disable". Additional information has been requested. Received on 06/11/2003: "Follow up information received from a physician indicated that on 04/02/2003 at 06:00, when the patient woke up, she had severe vertigo, dizziness, and headache.  It was noted that she was unable to go to school.  Her symptoms persisted for 2 weeks, and the patient slept extensively for about 20 hours per day.  The reporter indicated that "after that she was better but dizziness and headache recurred a lot during the past 2 years".  It was noted that the patient has been unable to attend school.  The outcome is not recovered.  Follow up information was received from a physician, the parent of the patient, which indicated that currently the patient still has chronic dizziness, headache, fatigue. She still needs to sleep 10-14 hours/day. She still has poor concentration. She has not been able to attend school during the past two and one half years, she used to be in the top 2% of students in her class. The physician also noted that, headache, and dizziness persisted or recurrent for two months. Missed school the rest of the semester. She got better after 2 months, but could no longer function at school. Poor memory. Poor concentration. There were no adverse events following prior vaccinations of the patient or her siblings.  The reporter indicated that the patient's symptoms were considered to be disabling.  Additional information is expected."
9MAR92 pc from mom states pt recvd vax & lt arm became infected; 10MAR92 pc to MD who states that pt was seen @ office 28FEB92 for a previously scheduled visit pt had dx of cold & hoarseness; rx Duricef for sore & swollen lt arm;
Patient came back to clinic not for a formal eval but to update staff on adverse event following vaccines. She recieved both Flublock and Shringrix in her right deltoid 10/6/19 and Prevnar 13 in her left deltoid. Later that day she had mild congestion/allergy symptoms, the next day she felt like she was "hit by a buss" body aches, chills, fatigued. She also has erythema to right deltoid measuring 1.5" high and 2" wide. She also has some intermittent nerve pain in right back/scapula area. Pt was instructed to take OTC allergy meds for any itching, Tylenol for any discomfort, and to apply cool compress PRN. If any symptoms worsen or new symptoms develop she should follow up with her PCP for a more formal exam.
No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     Acute illnesses at the time of vaccination and up to one month before and Chronic or long-standing health conditions was unknown.    On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION ERROR (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine and later on 12 May 2023, 18 pts received an additional 0.25ml).    Concomitant medication was not reported. Patient's age was reported as >65 years. The vaccine was administered in the deltoid site. On 11-May-2023, patient was contacted, and on 12-May-2023 patient received an additional 0.25ml. No treatment medication was reported.  This case contains information for the 11th of 27 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
chills and muscle aches 12 hours following second shot of Pfizer covid-19; chills and muscle aches 12 hours following second shot of Pfizer covid-19; This is a spontaneous report received from a non-contactable physician. A patient with unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient experienced chills and muscle aches 12 hours following second shot of Pfizer covid-19 vaccine. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 03-AUG-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M006156 with expiration date 15-FEB-2018, dose unknown, subcutaneous). The vaccine was improperly stored at 6 degree Fahrenheit for 11 minutes. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial report received from a nurse on 03 Sep 2010: This patient was vaccinated with MENVEO (batch number: 10003), 0.5 ml intramuscularly, on 04 Aug 2010. Following administration with vaccine, the patient developed a diffuse, red, itchy rash on the face, trunk and limbs of the body on 08 Aug 2010. The outcome of the events was not reported. Follow up report received from a nurse on 17 Nov 2010: The patient experienced severe rash on 05 Aug 2010 which was previously reported as 08 Aug 2010. After one month, diagnosis of strep throat with scarlet fever was made. The patient was given treatment with antibiotics. The patient recovered from severe rash on 05 Sep 2010 and the outcome of the event sore throat with scarlet fever was reported as condition improving.
Expired Moderna was administered on 11/19/2021 lot# 046C21A. Patient was called back to the clinic and vital signs were taken and were within normal range. Patient showed no s/s of any distress and when asked he states no s/s. Provider was notified and also Moderna manufacture and they will update with guidelines. Patient was release back to facility.
chronic condition; This spontaneous report has been received from a nurse via a company employee referring to an 80 to 80 plus years old elderly patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, route and dose details were unknown) for prophylaxis.         On an unknown date, the patient experienced a chronic condition (ill-defined disorder). It was not provided what the chronic condition is and when the chronic condition occur. The nurse would like to know if she should administer a third dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) to the patient.      At the time of this report, the outcome of the event was unknown. The causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Starting on Friday morning, 9/17, I started to feel very fatigued, my nose was stuffy, I had a headache and a low-grade fever (100.2). I slept most of the day. I didn't have an appetite and had diarrhea by the end of the day. On Saturday I felt better, but still had the stuffy nose, was tired and lost my sense of smell. On Sunday, same thing, and I lost my sense of taste. On Monday, 9/20 I went to an Urgent Care clinic and tested positive with Covid, then quarantined until 9/27.
Sudden onset deafness in left ear with continuous tinnitus in left ear, followed by occasional tinnitus in right ear.  Treated so far with Allegra and Flonase, oral prednisone, and steroids administered through the left eardrum.  Unsure if hearing in left ear will improve.  Unsure if tinnitus in both ears will stop.  A third hearing test is set for 6-10-21 to check for improvement.
Patient complained of severe pain in thigh, initially considered a possible pulled muscle.  Patient saw physician in office 5 days later and was diagnosed with shingles.
Dizziness; Vertigo; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Vertigo) and DIZZINESS (Dizziness) in an adult patient of an unknown 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 VERTIGO (Vertigo) and DIZZINESS (Dizziness). At the time of the report, VERTIGO (Vertigo) and DIZZINESS (Dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2021-278248, MOD-2021-278292 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: event severity and outcome added for patient 1, Other relevant details added for other patients. On 06-Aug-2021: followup was received and event outcome was updated also intensity was added for both events.
pt recv vax 12MAY97 & 2 days p/vax given pt exp pain in 1st 2 fingers;discomfort (paresthesias & dysesthesia;rt hand weakness;
Verbalized today had redness same day as vaccine and was worse the next day. Low grade temp. Verbalized redness to elbow. Was seen by ARNP. Antibiotics prescribed.
felt jittery & hot 1 hr p/inject; later in the evening devel t102 oral; rash on neck, palms, itching; aching, fever blisters developed 24 hrs p/vax;
Rash and flustering in the left arm extending almost to the elbow after receiving the fluarix and the gardasil 9 vaccine.
This spontaneous case initially received on 23-Aug-2016, was reported by a health professional and concerns a(n) 67-year-old female patient. Weight: 73.02 kg; Height: 65 cm. Administration of company suspect drug(s): On an unknown date, the patient received and injection of Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Oct-2015, the patient experienced (L) arm pain/[swelling and (L) bicep swelling (outcome: not recovered / not resolved). On an unknown date, the patient experienced erythema "S/P" flu shot, pain on bicep, pain on shoulder and swelling for 2 to 3 weeks (outcome: not reported).
1 week later - aches (arthritis was worse), leg cramping, general feeling of being unwell seems to come and go  still having pain in arm where injection was