chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have another male (patient) who had an acute CVA we send him to the hospital he had acute CVA, he had a right artery occlusion, he passed away; I have another male (patient) who had an acute CVA we send him to the hospital he had acute CVA, he had a right artery occlusion, he passed away; This is a spontaneous report from a contactable Nurse (Registered nurse with title of Infection Preventionist). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had an acute CVA and was sent him to the hospital he had acute Cerebrovascular accident (CVA), he had a right artery occlusion, he passed away. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed.; Sender's Comments: The information currently available is very limited. There is no sufficient evidence that the reported events may be related to administration of BNT162B2. Of note, medical history and concomitant medications were not provided to determine pre-existing risk factors or conditions that may have led to the events. Case will be re-assess once additional information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: patient had an acute CVA and was sent him to the hospital he had acute CVA, he had a right artery occlusion; patient had an acute CVA and was sent him to the hospital he had acute CVA, he had a right artery occlusion
Covid vaccine 3/9/21  Patient woke up in unbearable pain in the right arm the morning after vacination (3/26/21); Took motrin 800mg and it took the pain away for a little. Took Tylenol later on during the day and it had no effect. Lidocaine patch & using ice had no effect. Took vicodin this morning (3/27/21) and it helped a little.
Started with swelling and itching at injection site the night of injection (Monday.) Progressed to pain, itching and swelling next day. Wednesday morning woke with edematous, red, itchy rash to right upper arm. Nothing to trunk or face; no other complaints, no fevers.
arm irritated @ shot location for about 1/2 hr to an hr & felt feverish & nauseated for about 2 hrs p/shot;
first vaccination in January 2021 then contracted covid; had to wait 90 days before they could receive the second dose and now it is past the 90 days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (first vaccination in January 2021 then contracted covid) and PRODUCT DOSE OMISSION ISSUE (had to wait 90 days before they could receive the second dose and now it is past the 90 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (first vaccination in January 2021 then contracted covid) and PRODUCT DOSE OMISSION ISSUE (had to wait 90 days before they could receive the second dose and now it is past the 90 days). At the time of the report, COVID-19 (first vaccination in January 2021 then contracted covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (had to wait 90 days before they could receive the second dose and now it is past the 90 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-138798 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received contains no new information.
Tinnitus worsened after first dose of vaccine, and pronounced after 2nd dose of vaccine. No pain associated. Noticed some fluid in the inner ear, relieved by pinching nose and forcing exhalation into eustacian tube. Tinnitus remains after fluid in inner ear removed. Today is 4 days after dose #2.
SWELLING AROUND NOSE AND CHEEKBONES; SINUS CONGESTION; DIFFICULTY  BREATHING; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, borderline emphysema, and allergic reaction to MRI/ CAT scan injections. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on right arm on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced swelling around nose and cheekbones. On 20-MAR-2021, the subject experienced sinus congestion. On 20-MAR-2021, the subject experienced difficulty breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling around nose and cheekbones, sinus congestion, and difficulty breathing. This report was non-serious.
Pain and Redness/pink area about 4 inches around injection site.  Tightness/small knot at injection site. No fever or warm to touch at injection site.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age. On an unknown date the patients was vaccinated with a dose of PROQUAD (dose, route and lot number unspecified) that stored as high as 8F on multiple occasions beginning on 08-JAN-2013 and continued until 26-FEB-2013. The total amount of time out of range was calculated at 248 hours. No adverse effect reported. It was unknown if the patients had sought medical attention. This is one of several reports received from same source. Additional information has been requested.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-DEC-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 1104 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Lupus; Sjogren's syndrome; granuloma annulare; Infornation was received from a lawyer regarding a case in litigation and refers to a n erderly patient of unknown age and gender. On or about 01-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiry date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: granuloma annulare, Sjorgen's syndrome and lupus. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the events of Sjorgen's syndrome and lupus were considered to be medically significant.
Severe fever 102; Body so sore couldn't get out of bed.; Going to the restroom was almost impossible; Coldest I've ever been in my life.; Headache for three days straight.; Confusion; Dizziness; Sweat so much at night I had to drink electrolyte water to stay hydrated every half an hour.; Could not sleep what so ever.; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Apr2021 at 16:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took paracetamol (TYLENOL) and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included norethisterone (MINI PILL) for birth control, from an unknown date and unknown if ongoing. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 13:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 22:00 the patient experienced severe fever 102 (unspecified units) and body so sore that she could not get out of bed. The patient reported that going to the restroom was almost impossible and was the coldest she had ever been in her life. She had a headache for three days straight, confusion and dizziness. The patient sweat so much at night she had to drink electrolyte water to stay hydrated every half an hour and could not sleep what so ever. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of events. On 17Apr2021, the patient underwent body temperature test and the result was 102 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken for the reported events. The clinical outcome of the events severe fever 102, body so sore could not get out of bed, going to the restroom was almost impossible, feeling cold, headache, confusion, dizziness, sweating, and could not sleep what so ever was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt became ill w/nausea, vomiting, & fever p/receiving shot; Also a skin rash around immun local rxn;
fever x 2 days up to 104 & limpness x 4-5 hrs; lifeless x 2 days-no treatment; parent did not seek care-reported @ next clinic visit;
no adverse event; Improperly stored administered vaccine; This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 20-APR-2021, the patient was vaccinated with incorrectly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot # 1691180 with expiration date on 15-NOV-2022 (route of administration was unknown) for prophylaxis. The vaccine underwent temperature excursion of 28.8 degrees Fahrenheit for 2 hours and 35 minutes and 31.4 degrees Fahrenheit for 15 minutes. There was no previous excursions and the digital data logger was not involved. No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient reported to us on 10/12/16 that starting 2 days after she received both FLUVIRIN and BOOSTRIX from us, she experienced hives, itching, burning, warm sensation, rashes all over her body except her face.
This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date and experienced pain, refer case- US2021AMR249864). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Shingles vaccine. Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got bad with the vaccine and it was very painful. The follow-up would not possible as no contact details were available. Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR249864:Same reporter, 1st dose.
Soreness in left arm began the next day after the shot. It has continued for over a week now. There is and never was any outward sign of bruising or swelling. The soreness continues on the inside of the arm just below the shoulder through the bicep area. When I stretch the arm in any direction, there is a twinge of pain that extends from the lower shoulder area down to almost the elbow.
Bell's Palsy - Seen 6/28/2021  - Caregiver or patient concerns: o Cannot close her right eye well and cannot use the right side of her mouth well for 1 week. She is getting watery eyes, no pain in eyes. When she brushes her teeth water comes out the right side of her mouth. She has to take small bites of food b/c otherwise food comes out of her mouth. It is improving. Left eye and left side of mouth is ok. No arm or leg weakness.   o Pt vaccinated against covid, 1st dose 4/25/21,  2nd dose 5/21/21.
Pt reported pain continuing at injection site and went to MD on 11/11/20 and was told possibly cellulitis and given keflex and ibuprofen
Cause of death not documented. Significant comorbidities include dementia with neuropsychiatric behaviors including anxiety.
Symptoms began on 9/23/21, and progressively got worse.  Symptoms include: weight loss (7.8kg), vomiting, abdominal pain - very poor appetite - only sips or soup or Pedialyte and will vomit.  Fevers (Tmax 101) initially, but only for a few days, with last fever on 9/25.  Abdominal pain which is periumbilical.  Pain to bottom of feet, and parents report feet always feel cold.  Dizzy when he walks or stands up.  Vomiting 1-2 times per day.  "Lethargic" per mom. This is the 4th ED visit for this illness.  Has been on Reglan and Pepcid.  Not stooling (much), and when does, stool looks like hard pebbles.  Mid to lower back pain that causes him to hunch forward when he walks, per mom "he walk like an old man".
Case number PHEH2014US003623 is an initial spontaneous report received from a consumer (patient's parent) on 21 FEB 2014. This report refers to a 13-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number unknown) intramuscularly on an undetermined date in JAN 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
A report has been received from a Health Professional concerning a patient of unknown gender, who had been receiving FLUMIST Quadrivalent, 0.2 milliliters, Unknown. FLUMIST Quadrivalent started on an unknown date. It was reported that the patient administered FLUMIST that is stored under 35F to consumers-medication error, which started on 20-OCT-2015. The outcome of the event of administered FLUMIST Quadrivalent that is stored under 45F to consumers - medication error was unknown. The report was considered to be non-serious.
Severe (to the point of debilitation) joint pain, muscle aches and myalgia since vaccination day- ongoing today though slightly less severe.  Am able to moderate pain and inflammation with 800mg Ibuprofen every 5-6 hours for temporary relief, but still seems to come back if I?m not regularly eating pain meds (which is something I don?t normally do/like to do).  I also had a fever over 100 degrees for the first three days accompanied by chills and dramatic sweating events (hair wet like a shower, clothes completely soaked through to the point of being wrung out, bed linens and pillowcase also soaked to the point of removal).  Fourth day the fever broke, but again- the joint pain is still very prevalent and troubling.
Dizzy, slight confusion, nausea (history of vasovagal). BP 144/92 (pulse 97), O2 sat 100%.
Administered vaccine on 10/1/2022 with manufacturer expiration date of 9/30/2022.
Pt came to pharmacy today to show me the arm where the vaccine had been administered. Arm was red and swollen. The arm was almost streaked red down the back of her arm. Pt reported that about 1.5 days after she received the vaccine, she experienced all over body aches and pain. She states that her arm was so sore she did not even want to move it and contemplated going to the ER. Advised pt to continue icing inflamed area.
I21.09 ACUTE ST ELEVATION MI, ANTERIOR WALL 4/19/2023 ACUTE ST ELEVATION MI, ANTEROLATERAL WALL ACUTE ST ELEVATION MI, UNSPECIFIED I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 4/19/2023 ACUTE ST ELEVATION MI, ANTEROLATERAL WALL ACUTE ST ELEVATION MI, UNSPECIFIED
Vaccine may have been compromised due to temperature excursion event. Report filed with Pfizer. We are waiting for a response. No reaction reported from patient.
Pt felt very weak and dizzy before passing out for about 30 sec. Pt was given water and advised to rest before leaving.
2nd Vaccine received on Thursday,February 25. Right Arm sore at site which was to be expected but it worsened on Sunday, February 28. New symptoms on that day included: more redness, one large red, raised, swollen, itchy hive encircling the arm from shoulder to forearm (on right arm).  Persisting through today, Wednesday, March 3, 2021 but improving slowly. Treatments included cold compresses alternating with ice packs applied locally, and excedrin for pain, and  massaging and mild exercise of the arm.
Pt came into pharmacy asking for shingrix and had stated that he never received the shingles shot before. I gave the shingrix to him thinking it was dose 1, but further investigation (unfortunately after already given) showed that he already received 2 doses, making this a third dose.
Patient complained of  numbness at the very tip of her left index finger. Patient was advised to consult family physician Dr. who she saw for this situation on 09/27/2018.
Administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  On date of administration, vial was moved to fridge and vial did not undergo any temperature excursion.   There were no adverse events reported by the patients after the administration error.  No  treatment information was reported by the reporter.   This case was linked to MOD-2022-536016 (Patient Link).
Information has been received from a physician concerning a 76 year old male patient with temporal arteritis who on 29-JUL-2008 received a dose of ZOSTAVAX (Oka/Merck) subcutaneously. On 02-AUG-2008, the patient had pain related to temporal arteritis. The physician wanted to prescribed prednisone and wanted to see if there were any contraindications in giving it. The patient outcome was unknown. No further information is available.
Got the shots but years later got a shingles/ suspected vaccination failure; Got shingles slight case on his back; Miserable; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shots but years later got a shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles slight case on his back) and feeling miserable (Verbatim: Miserable). The outcome of the vaccination failure was unknown and the outcome of the shingles and feeling miserable were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient wife friend via interactive digital media. The reporter reported that the patient received Shingles vaccine but years later experienced shingles a slight case on his back. It was miserable. The reporter stated that somehow they are related to the chicken pox. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case had been linked with US2021AMR224094 by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224094:Same reporter
Chills, fever, muscle aches, headache, nausea, tiredness  Continued for 4 days  Symptoms resolved over the 5th day