chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of Suspected vaccination failure in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included shingles (since February 2020 in head). In October 2020, the patient received the 2nd dose of Shingrix. In August 2020, the patient received the 1st dose of Shingrix. In August 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced off label use. In October 2020, the patient experienced off label use. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), exacerbation of disease and pruritus. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, exacerbation of disease, pruritus, off label use and off label use were unknown. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, exacerbation of disease and pruritus to be related to Shingrix and Shingrix. Additional details were reported as follows: The age at vaccination was not reported however it could be 87 or 88. The patient had active episode of Shingles and vaccinated with Shingrix shot which led to Off label use. Since getting the 2nd shot, the patient stated the shingles as worsened and was affecting her right eye. The patient also had shingles on the left side of her face. The patient had a lot of itching in her eye brow. This case was considered as suspected vaccination  laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
This spontaneous report as received from a nurse refers to 3 unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On 06-SEP-2015, one unspecified patient was vaccinated with improperly MMRII lot # L001336, expiry date 13-JAN-2017 (route and site of administration, dose were not reported). On 11-SEP-2015, two unspecified patients were vaccinated with doses of improperly stored MMRII lot #L001336, expiry date 13-JAN-2017 (routes and sites of administration, doses were not reported). No adverse effects were reported. Therapy type of MMRII was determined to be rHA (recombinant human albumin). Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from nurse on 14-DEC-2015. This case concerns a 16 year old patient of unknown gender. On 11-SEP-2015, the patient was vaccinated with MMRII. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 73-year-old female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. On 17th July 2018, the patient received SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain, fever, fatigue, injection site erythema and malaise. On 18th July 2018, the patient experienced low blood pressure. On an unknown date, the outcome of the injection site warmth, injection site pain, fever, fatigue, injection site erythema and malaise were recovering/resolving and the outcome of the low blood pressure was recovered/resolved. It was unknown if the reporter considered the injection site warmth, injection site pain, low blood pressure, fever, fatigue, injection site erythema and malaise to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The pharmacist stated the patient called and said that the injection site was red, warm and sore. The patient was also experiencing malaise, fatigue and fever. The day after getting the vaccine she had low blood pressure, which resolved. The patient was recovering at the time of reporting.
No reaction to medication. Possible injection to wrong site. Subacromial space. Causing lt shoulder and neck pain, moderate pain.
Patient was injected with MMR, even though an MMRV (PROQUAD) was ordered.
allergic to the product; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of drug allergy in a 83-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced drug allergy (Verbatim: allergic to the product). The outcome of the drug allergy was not reported.   The reporter considered the drug allergy to be related to Shingles vaccine.     The company considered the drug allergy to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-NOV-2023 A patient was reported for her-self. She started treatment on an unreported date with shingles vaccine at an unreported dose, route and frequency of administration for an unreported indication.  It was reported the patient was allergic to the product.  No further follow-up is anticipated.
rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient experienced rash from Shingrix. Additional Supportive Information: The follow up would not possible as no contact details were available.
09Aug97 pt recvd vax as tx for lacerated finger. Next day pt went to ER w/tingling in left arm which extended across chest & into right arm. Pt also exp dizziness & lightheadedness & nausea p/eating. ER MD dx "Allergic rxn to Tetanus vax."
High fever (of 102.6 / 102.8), nausea and VERY RAPID HEARTBEAT - ranging from 100 BPM to 154 BPM during a 5-hour period following the vaccine. Now, 2 days post-vaccine, I also have a rash, primarily arm and chest/neck.
No symptoms at the end of 15 minute observation. 45 minutes later she developed hives on her torso front & back. She was back at work at the  Civic Center and she had a medical provider at their COVID vaccine clinic check on  her, They initiated treatment (100mg Benadryl) and further observation for 35 minutes and was sent home. She developed hives and swelling of tongue around 6:30 pm and got a ride to the Emergency Department for further care. Received Epinephrine x1 and Benadryl. was discharged from the ER at 0430ish. No symptoms since discharge.
Fever within 6 hours (103-104), neck swelled and got sore, headache. 12 hours, rash on neck and face within 4 days . Rash from neck to groin on front of body; upper back also had rash. Face swelled 48 hours after shot.
Pt recvd 3 doses of Engerix-B & exp no adverse rxn; HBSAB was neg p/completing the series; pt recvd a booster dose of Engerix-B on 6NOV91 & still had neg antibodies p/booster dose;
On evening following vaccine administration, left arm injection site sore and slightly red. Next day large, hot, swollen, red area at injection site. No streaks. No treatment needed.
This non serious case was received on 24 April 2009 from a health care professional. A 22 year old female patient received IPOL intramuscularly in the right arm (lot number A1218-2), MENACTRA intramuscularly in the right deltoid (lot number U2841BA), and YF VAX subcutaneously in the left arm (lot number UF430AA) on 21 April 2009. On 22 April 2009 the patient developed weakness, aches, joint pain, and a low grade fever. The patient had arm pain when trying to lift a book. At the time of the report the patient was improving. Follow up information was received on 20 May 2009 from a health care professional who clarified that the patient experienced pain in both arms. The patient recovered on 24 April 2009. No further information was reported. List of Documents held by Sender: none.
Ultrasound a problem 09/09/2021 Had a lump on side of her neck from their a ultra sound of the neck that showed a unglue in the left lobe of the thyroid  measure 3.6 cm scheduled a diagnostic biopsy that 09/20/2021 and the finding are a biean follicular nodule  No family history of thyroid problem.
On 2/18, the day after my shot, I experienced: redness and swelling and pain at the injection site, Fever 101.2 degrees, Severe body aches, Severe headache and Extreme tiredness.  By 2/19, I was still extremely fatigued and my arm was still red, painful and very itchy. By 2/20, back to my usual state of health.
12 hours after the pt was vaccinated he started experiencing vomiting/diarrhea lasting for about 6-8 hours. Pt was seen by a health care provider, this was the pt's second dose of anthrax, no problems with previous dose.
Chief Complaint:  Weakness   HISTORY OF PRESENT ILLNESS   a 54 y.o. male who presents to the Emergency Department complaining of weakness on the right side of the body that began yesterday morning. The patient in his own words sates that "the right side of the body is not doing what the left side of the body is" The patient reports a mild headache and states that he did not come into the ED sooner because he was hoping that the symptoms would subside. The patient does not report any loss of consciousness, vomiting, or confusion. The patient does have a history of atrial fibrillation.   The patient was seen in the triage region due to a resource deficiency in the back of the department   Chief Complaint:  Right upper and right lower extremity weakness     HPI: a 54 y.o., male who presents with with a past medical history of hypertension, current smoker and alcohol abuse presented to the ED today due to right upper and right lower extremity weakness that started yesterday at 11:00 a.m..  According the patient he thought it will get better in rested but did not improved this morning so decided to come to the ED.  he denies any slurring of speech, does complain of decreased sensation on the right upper and right lower extremity as well.  Denies any previous history of CVA.  No fevers no chills, no nausea vomiting, no recent trauma.  Patient is vaccinated for COVID-19 and also has received his booster 5 days ago.  He drinks about 12 beers every night, last drink was 2 days ago.  Denies any signs of withdrawal at this time.   Initial CTA head and neck was negative for any acute pathology.  Code stroke was not activated due to patient being out of window for any intervention.     Chief Complaint:  Weakness of the right side for 2 days   History of Present Illness: History was obtained from a review of the electronic record and discussion with the patient. a 54 y.o. male who is right-handed.  He has a history of hypertension, and ?irregular heartbeat,? is a daily smoker, and has a history of alcohol abuse.  According to the chart he has a history of atrial fibrillation.  He noticed several days ago that his right side was weak and he had trouble using his right arm and standing.  Yesterday he came to the emergency department and the working diagnosis was acute stroke.  Cranial CT scan was read as normal; there is an area in the left occipital lobe where there is increased attenuation.  He has been given aspirin, but not tPA because he was out of the window.  CTA was negative for large vessel occlusion, positive for scattered atherosclerosis.  Blood pressure was 170/111.   Past Medical History   He does not take aspirin.  He takes a beta-blocker for his hypertension.  No prior history of stroke.  Follow up with PCP
Lip swelling; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 29 year old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 19Apr2021 17:00 (Batch/Lot Number: EW0164) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 27Mar2021 17:30 (Batch/Lot Number: er8723) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took triaminic allergy congestion, bnt162b2 for covid-19 immunisation. The patient experienced lip swelling on 27Apr2021 07:00 with outcome of recovering. Therapeutic measures were taken as a result of lip swelling with Prednisolone injection  No follow-up attempts are needed. No further information is expected.
Oval lesion 4 x 2 1/2 inches on (R) upper thigh. OTC treatment.
ROTATEQ had a known temperature excursion; No additional AE reported; A patient was inadvertently administered ROTATEQ after the labeled expiration date; This spontaneous report was received from a nurse referring to a patient of unspecified age and gender. Information regarding medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.   On 07-JUL-2022, the patient was inadvertently administered an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliters (ml) for prophylaxis (route of administration, anatomical site of vaccination, and vaccine scheme were not reported; lot number 1742078 has been verified to be valid, expiration date reported and established as 06-JUL-2022) (expired vaccine used).   The reporter stated that the vaccine had a known temperature excursion (product storage error). No additional adverse event was reported (no adverse event).
pt recv vax 28APR98 & same day pt devel inj site swelling & redness;
I developed skin cancer at the site of vaccination. It was twice removed by a dermatologist, but, as of this date is still there. A flu shot it was given at store.
The day of vaccination, patient describes pain in lower deltoid muscle 12 hours after injection.  Described as a burning sensation that came on 12 hours after vaccination and stay consistent for 3 weeks now, after vaccination.  Patient initially iced that spot but has stopped doing that.  Patient denies taking any otc pain medication.
E87.6 - Hypokalemia I24.9 - ACS (acute coronary syndrome) (CMS/HCC) I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)
Patient woke up from her sleep with painful tingling in her lower buttocks and back of thighs on 1/23/21. Shingrix #2 given on 1/20/21. Patient also c/o fever, shivering, nausea, and stomach discomfort did not last longer than that day. Patient c/o intermittent tingling in lower buttocks and back of thighs x 10 days but feels the severity has lessened.
Began with fever of 101-101.5 degrees F on 11/10/10 approximately 9 days after MMR vaccine given. Next was rash that began on head & spread to torso. Next developed runny nose, cough & when went to Dr. on 11/17/10 - Koplik spots were noted. Also, noted red eyes.
1) 1st dose: Infection/rash on left arm treated w/doxycycline 2) 1st dose: developed Ulcerative Colitis four days later-diagnosed by colonoscopy on 3-23-21.  2nd dose on 3-21-21 increased symptoms. Hospitalized on 4-3-21. IV steroids administered. 2 infusions of Remicaid.
Passed out for 3 seconds after about 10 minutes of the shot then felt very nauseous sweating Patient did not eat at all called EMT AND they took her
Tingling in feet and lower legs, unusual bruising on lower extremities for at least 2 months following - still happening!
R side - neck feels swollen / numb, arm sore, medial leg to knee painful starting on 4/23 am. Provider recommended NSAIDS.
got COVID-19  after the first dose; got COVID-19  after the first dose; This is a spontaneous report from Pfizer Sponsored Program by a contactable consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On an unknown date, the patient experienced covid after the first dose. The patient wanted to know if she was able to get her 2nd dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
numbness; weakness; paresthesia; internal tremors; muscle pain; fatigue; inhibit her ability to live a normal life; severe neurological reactions; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inhibit her ability to live a normal life) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced NEUROLOGICAL SYMPTOM (severe neurological reactions). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inhibit her ability to live a normal life) (seriousness criterion disability), HYPOAESTHESIA (numbness), ASTHENIA (weakness) and PARAESTHESIA (paresthesia). an unknown date, the patient experienced TREMOR (internal tremors), MYALGIA (muscle pain) and FATIGUE (fatigue). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (inhibit her ability to live a normal life) and NEUROLOGICAL SYMPTOM (severe neurological reactions) had not resolved and HYPOAESTHESIA (numbness), ASTHENIA (weakness), PARAESTHESIA (paresthesia), TREMOR (internal tremors), MYALGIA (muscle pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent conditions were unknown. No concomitant medications were reported. No laboratory data was reported. The patient received the first dose of vaccination in January 2021. The patient experienced severe neurological reactions four days after receiving the vaccination. The patient reported that the symptoms left her barely able to function some days, and the internal tremors that created a type of fatigue that she had never experienced in her life. She reported that she was unable to fully participate in the activities that she enjoyed before being vaccinated. She reported that her life had been negatively altered due to vaccine. The patient was worried if she would develop Parkinson's or Multiple sclerosis or  Amyotrophic lateral sclerosis. Treatment information was unknown.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-244099 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-244099:Cross link - Patient 2 in article
Patient was accidentally given 0.5ml rather than 0.25ml, which is the recommended dose for patient's age. When dose was drawn up, administrator was unaware that the single dose vial had more than recommended dose in the vial, and drew up the whole vial.
7DEC97 low grade fevers;8DEC97 broke out w/pimply blistered areas, face trunk, arm total of 6 or 7 spots;
Burning almost immediately after injection while waiting during the 15 minute observation. No immediate swelling. Pinching sensation at site of injection throughout evening. Due to lack of visual change within an hour or two of injection, area not further observed. Next morning, observed injection site. It was/is swollen and with a small raised, white area at the immediate injection site. Red area surrounding pinpoint injection is approximately 2 inches in diameter and the area is firm with the firmness additionally extending beyond the red area.  Would not describe this as a rash. Reporting due to lack of information reported about "Covid arm" relating to Pfizer as compared to Moderna reports of same reaction.
her arm was itchy; her arm was puffy; her arm was red; a covid arm; her arm was tender; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (her arm was itchy), PERIPHERAL SWELLING (her arm was puffy), ERYTHEMA (her arm was red), RASH (a covid arm) and MYALGIA (her arm was tender) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included VITAMIN B12 NOS, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (her arm was itchy), PERIPHERAL SWELLING (her arm was puffy), ERYTHEMA (her arm was red), RASH (a covid arm) and MYALGIA (her arm was tender). The patient was treated with IBUPROFEN (ADVEL) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 15-Feb-2021, PRURITUS (her arm was itchy), PERIPHERAL SWELLING (her arm was puffy), RASH (a covid arm) and MYALGIA (her arm was tender) had resolved. At the time of the report, ERYTHEMA (her arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included for high blood pressure and cholesterol medication.   Reporter did not allow further contact
Within 1 minute of receiving vaccination, patient became lightheaded and passed out. Patient regained consciousness within 1 minute of passing out. Upon regaining consciousness patient reported a headache, dizziness, shakiness, and nausea. The patient appeared pale. The patient was given water and peanut butter crackers. After 30 minutes patient returned to normal and was able  to leave the pharmacy on his own.