chrisvoncsefalvay/vaers-outcomes huggingface dataset:
New and better drug and got them again/Suspected vaccination failure; Shingles weren't as bad; I have scared; Sharp pains; Burning; Pain from the nerve endings thrilled so bad; This serious 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.   The patient's past medical history included shingles (the patient had the shingles three times). Previously administered products included Shingles vaccine (the first time he/she got the shingles shot).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: New and better drug and got them again/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles weren't as bad), fear (Verbatim: I have scared), post herpetic neuralgia (Verbatim: Pain from the nerve endings thrilled so bad), pain (Verbatim: Sharp pains) and burning sensation (Verbatim: Burning). The outcome of the vaccination failure was unknown and the outcome of the shingles, fear, pain and burning sensation were not reported and the outcome of the post herpetic neuralgia was resolved (duration 28 days).   It was unknown if the reporter considered the vaccination failure, shingles, fear, post herpetic neuralgia, pain and burning sensation to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, fear, post herpetic neuralgia, pain and burning sensation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:16-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated he/she got shingles again and his/her doctor said that a new and better drug would make sure he/she did not get shingles again. The patient got shingles again but they were not as bad as the first two times and always on his/her left side.  The patient had scared and they took 28 days to stop with the pain from the nerve endings getting thrilled so bad.  They were so horrible.  The patient experienced burning and sharp pains.  The reporter further stated that horrible things to get. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Student called 9/7/16 at 8:30 am - reported fever and headache; RN called student 9/8/16 at 2:45 pm - she reports feeling better with no fever or HA.
Flu vaccine administered 10/11/02. 10/13/02 developed brown discoloration. Slightly red injection site and swollen.
Patient's mom reported that pt had a temp of 104 after the vaccine and then on Monday she had swollen eyes.  She had a swollen arm and is still feeling miserable.  Patient's mom gave her Benadryl.
Injection site started itching and then the itching spread and now her whole body itches including inside her ear.
Sore arm; Initial information received regarding an unsolicited valid non-serious case received from a consumer (patient) via Social Media and transmitted to Sanofi on 31-Oct-2020.  This case involves unknown age patient who experienced sore arm (Pain in extremity), while patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number Unknown) via unknown route in unknown administration site for prophylactic vaccinations.  On an unknown date, the patient reported that always got the INFLUENZA VACCINE and never have gotten the flu, just a little sore arm (pain in extremity) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was pain in extremity.   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for pain in extremity.  Lot number was not available for this case.
pt recv vax & became dizzy-placed supine, unresponsive but nl HR & + resp p/1-1 1/2hr eye opened;
Systemic: patient says his heart is racing now-Mild, Systemic: Tachycardia-Mild, Additional Details: TOld patient to see a doctor since symptoms are still bothering him
Fever over 100.00, chills, nausea, exhaustion, body aches, head ache
GOT MY FIRST DOSE OF THE MADERNA VACCINE  A WEEK AND A HALF LATER DEVELOPED RASH - ITCHY AT BEST AND PAINFUL IN THE ENTIRE LEFT ARMAT WORST TOOK IBUPROFEN FOR THE PAIN
Mother reported the next day, child had fever body aches. Also, had warm red swelling around injection site.
FELT WOBBLY; MILDLY SORE ARM; TEARY FOR NO REASON OR SOBBING (OVER EVERYTHING SEVERAL TIMES A DAY); EVERYTHING HURT HER FEELING; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included doesn't metabolize alcohol, and menopause, and other pre-existing medical conditions included patient had nothing wrong and had no ongoing medical issues, patient was not on medication of any kind and had not taken any medication after shot. the patient had pms (premenstrual syndrome) (wanted to cry over everything, no anger though). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced teary for no reason or sobbing (over everything several times a day). On MAY-2021, the subject experienced everything hurt her feeling. On 09-MAY-2021, the subject experienced felt wobbly. On 09-MAY-2021, the subject experienced mildly sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teary for no reason or sobbing (over everything several times a day), everything hurt her feeling, and mildly sore arm on MAY-2021, and had not recovered from felt wobbly. This report was non-serious.
Fever (Highest 102.4): 10/16/2021 to 10/17/2021 Malaise: 10/16/2021 to 10/18/2021 Body aches: 10/16/2021 to 10/18/2021 Nausea: 10/16/2021 to present Fatigue: 10/16/2021 to present Weakness: 10/16/2021 to 10/27/2021 Chills: 10/16/2021 to 10/17/2021 Headache: 10/16/2021 to 10/31/2021 Dizziness: 10/16/2021 to 10/22/2021 Vertigo: 10/17/2021 to 10/22/2021 Injection Site Pain: From 10/15/2021 to 10/23/2021 Treatment: Ibuprofen 600mg every 6 hrs., alternating with Tylenol 650mg  every 3 hrs. Gatorade and water.
Information has been received from a consumer concerning a male patient who was vaccinated with a single dose of MMR II on an unspecified date. Subsequently the patient developed autism after receiving MMR II. At the time of this report, the patient had not recovered. No additional information was provided. The patient sought unspecified medical attention. Upon internal review, autism was determined to be an other important medical event. Additional information is not expected.
Eye (RIGHT) swelling; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye (RIGHT) swelling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eye (RIGHT) swelling). At the time of the report, EYE SWELLING (Eye (RIGHT) swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  The treatment for the event  included peroxide and warn cloth.
This spontaneous report was received from a physician regarding two unspecified patients of unknown age and gender. Concurrent conditions were not reported and their medical history included positive herpes simplex virus (HSV). On an unknown date the patients were vaccinated with ZOSTAVAX (Lot #, route and frequency not reported). The physician reported that the patients did not return over the last two years and have not experienced any episodes of "cold sores" after having been vaccinated with the "shingles vaccine". At the time of the report the outcome of unexpected therapeutic effect was unknown. Additional information has been requested.
18 month old female patient received an expired dose of Daptacel, no AE; Initial information was received on 20-Feb-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves an 18-month-old female patient who received 0.5 mL dose expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5367AA and expiry date: 30-Jan-2020) via an intramuscular route in the left thigh for prophylactic vaccination, on 19-Feb-2020 (Expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); HIB VACCINE (HIB); INFLUENZA VACCINE (INFLUENZA); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO); and PNEUMOCOCCAL VACCINE CONJ (PCV13).  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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.
Per son pt experienced redness from shoulder to elbow and fever. He did not report this until 10 days later at that time patient had recovered.
10 miin after recieving vaccine patient noticed her lips and tongue becoming numb. and then 15 min later her chest felt heavy. Patient was given 12.5 mg of Benadryl at 9:00 Am and then took another 12.5 mg of Benadryl at 12:15Pm. Patient was feeling slightly better by 4:30pm.  I spoke to the patient the next day 10-5-13 and was no longer having any problems.
Patches of burning, itching and peeling skin (looks like eczema) not healing and worsening on left forearm. Recently contracted COVID-19 variant, body taking longer than normal to recover.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: approx 2-3  mins post vaccine states feeling hot, sweaty, and anxious. States previously fainted after injection.  1458 Assisted to lie on carpet in vaccination area. legs elevated on chair. States feeling better now. 1510 BP 117/74, P 93. Lungs clear to auscultation. Heart rate reg. No edema, pain or redness at vaccination site. enc to drink water. 1515 Assisted to sit in chair x 10 mins. 1526 Amb. in store. 1535 States he will leave to go home now. Home in stable condition.
suspected vaccination failure/Got the shot. And still ended up getting it; getting it on eye; lost some sight in eye; getting it on left side of face, head; pain; some places no feeling; 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), ophthalmic herpes zoster (serious criteria GSK medically significant), loss of vision (serious criteria GSK medically significant), shingles, pain and hypoesthesia. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, loss of vision, shingles and hypoesthesia were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, loss of vision, shingles, pain and hypoesthesia to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot and still ended up getting them on left side of face, head and eye. The patient still have had pain, and some places no feeling and lost some sight in eye. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
POSSIBLE COUNTERFEIT PRODUCT; UNBEARABLE PAIN AT THE INJECTION SITE FOR THE FIRST 15 MINUTES POST-VACCINATION/ONGOING LINGERING PAIN AT THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212AZIA, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced unbearable pain at the injection site for the first 15 minutes post-vaccination/ongoing lingering pain at the injection site. On an unspecified date, the patient experienced possible counterfeit product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unbearable pain at the injection site for the first 15 minutes post-vaccination/ongoing lingering pain at the injection site, and the outcome of possible counterfeit product was not reported. This report was non-serious. This case, involving the same patient is linked to 20211128020. This report was associated with a product quality complaint number 90000202127.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 17-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route, anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
EDD July 4, 2021  January 15th baby no longer had a heartbeat after two previous visits confirming heartbeat and EDD.
fever, rasah, shortness of breath, nausea, diarrhea, vomiting, headache, dizziness, loss of taste and smell. prescribed medicine
Received his first COVID vaccine on Saturday September 4th.  He complained to family about feeling ill afterwards.  He was found deceased on 9/8/2021.
intestinal discomfort; strong acid indigestion after dinner; threw up dinner within a couple of hours of eating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 at 18:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 80 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 2nd, Date: 10Feb2021, Time (24hr): midday, Anatomical Site of injection: Upper Left Arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer EM9810), administration date: 10Feb2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "COVID 19"; BNT162b2 (Dose: 3rd, Date: 13Oct2021, Time (24hr): midday, Anatomical Site of injection: Upper Left Arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer FE3590), administration date: 13Oct2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "COVID 19"; Bnt162b2 (Dose: 1st, Date: Jan2021, Time (24hr): 11 am, Anatomical Site of injection: Upper Left Arm, Route of administration: Intramuscular, Batch/Lot number: Pfizer EL3247), administration date: Jan2021, when the patient was 78 years old, for COVID-19 immunization, reaction(s): "COVID 19". The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset Dec2022, outcome "unknown", described as "intestinal discomfort"; DYSPEPSIA (non-serious) with onset Dec2022, outcome "unknown", described as "strong acid indigestion after dinner"; VOMITING (non-serious) with onset Dec2022, outcome "unknown", described as "threw up dinner within a couple of hours of eating".  Additional information: 1 and half week before 31Dec2022, had intestinal discomfort. Strong acid indigestion after dinner. Threw up dinner within a couple of hours of eating for several days.
Acute inflammatory demyelinating polyneuropathy or possibly Guillain-Barre syndrome occurring 4+ months following his influenza immunization.
Red, inflamed, itchy rash on right side of face only. Started out small and started to improve, but then progressively got worse and spread to a larger area 2.5 weeks after vaccine.
Fever (102.5), chills, achy muscles, increase blood pressure, increase pulse (138), nausea (received ZOFRAN), injection site. Painful & tender. Duration x 1 day. Ordered CMP, CBC, Sed rate.
Herpes Zoster; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) and for routine health maintenance (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered herpes zoster. As a result of this symptom, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster was considered as a disabling event by the reporter.
No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant medications details were not reported by the reporter.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable.  Treatment details were not reported by the reporter.
On the first injection of modern I had severe pain at the injection site  in the middle of the night and could not lay on that side for about a week. The pain did subside some but never truly went away.  When I received the 2nd dose in the left deltoid it was immediately painful. The next day the injection site felt hard with severe pain.  As of now I continue to have pain in the left deltoid and has severe sharp pain when making certain movements.
Information has been received from  registered nurse supervisor, via a company representative, concerning a 12 year old patient who on 13-FEB-2007 was vaccinated IM in the left deltoid a 5:00 pm with the first dose of Gardasil. Three hours later (8:00pm), the patient had developed hives on the face, back and bottom. By 8:30pm, the patient began to experience wheezing, but then "slept fine through the night". Treatment was not specified. The next morning (14-FEB-2007), hives "had subsided," but the patient "felt nauseous and tired." At the time of this report, the patient had not recovered. The nurse also reported that the patient will not be given the second and third dose of the vaccine. Additional information has been requested.