chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Still had shingles after being vaxxed/Suspected Vaccination Failure; still had shingles; Breakeouts on hip following sciatic nerve; deficient immune system; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (have had shingles 3 times). Previously administered products included Shingles vaccine (received shingles vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Still had shingles after being vaxxed/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: still had shingles), sciatica (Verbatim: Breakeouts on hip following sciatic nerve) and immune system disorder (Verbatim: deficient immune system). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure, shingles, sciatica and immune system disorder were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, sciatica and immune system disorder to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, sciatica and immune system disorder to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 01-March-2023 This case was reported by a patient via interactive digital media. The patient have had shingles 3 times.  The patient received original Shingles vaccine and Shingrix 2 dose of vaccine. The patient still had shingles after being vaccinated. The patient had deficient immune system and take IVIG infusions every 28 days.  The physician recommended to started on prophylactic Valtex daily to keep it from coming back.  The patient had breakouts on hip following sciatic nerve. It was not reported if the reporter considered the vaccination failure, shingles and sciatica to be related to Zostavax. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible, as no contact, details were available.
pt recv vax 26JAN99 & 3 days later devel fever of 101, a rash on face, abd cramping, dec appetite, & a small increase in diarrhea;pt pulls up legs, pt could feel gurgling in abd;
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5 mLVIs 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 1176 hours. The type of excursion was refrigerator and the vaccine status in excursion. 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.
Patient should have received 0.5 ml but instead received 0.25 ml of the vaccine.
headache, aches, fever, chills, b/l eye pain last for 3-4 days taken Tylenol for symptom management
Initial misuse report received from a healthcare professional on 23 April 2013. A male patient received first dose of MENACTRA in September 2007, second dose in September 2011 and then received third dose in April 2013. No adverse event was reported. List of documents held by sender: none.
within 15 minutes or receipt of the vaccine she began to experience " chest tightness" similar to when she has had bronchospasm in the past. She used her Xopenex inhaler and had resolution of symptoms after 30 minute observation.
Pt states that she is fully vaccinated for COVID. Now hospitalized after a fall and shortness of air requiring oxygen. Unknown manufacturer or dates of vaccine
FEELING VERY FATIGUED; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fatigue, and other pre-existing medical conditions included the patient was taking 4 prescription medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced feeling very fatigued. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from feeling very fatigued. This report was non-serious.
hypertensive urgency/tachycardia 230/125 Pulse 135 and some chills. Hydration all night. symptoms lasted all night. By mid morning, b/p went down to 170/100 HR 99.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not reported. Causality was related.
rapid heartbeat; hot flash; in need to make a bowel movement; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heartbeat), HOT FLUSH (hot flash) and GASTROINTESTINAL HYPERMOTILITY (in need to make a bowel movement) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HEART RATE INCREASED (rapid heartbeat), HOT FLUSH (hot flash) and GASTROINTESTINAL HYPERMOTILITY (in need to make a bowel movement). On 31-Mar-2021, HEART RATE INCREASED (rapid heartbeat), HOT FLUSH (hot flash) and GASTROINTESTINAL HYPERMOTILITY (in need to make a bowel movement) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Still has diarrhea 2 weeks later; Still has metallic taste in mouth; Breathing bad; Wheezing; Could not walk; Hands numb; Felt really sick; Can't stay awake; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Still has diarrhea 2 weeks later), DYSGEUSIA (Still has metallic taste in mouth), DYSPNOEA (Breathing bad), WHEEZING (Wheezing) and GAIT DISTURBANCE (Could not walk) in a 48-year-old male patient 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.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Still has diarrhea 2 weeks later), DYSGEUSIA (Still has metallic taste in mouth), DYSPNOEA (Breathing bad), WHEEZING (Wheezing), GAIT DISTURBANCE (Could not walk), HYPOAESTHESIA (Hands numb), ILLNESS (Felt really sick) and SOMNOLENCE (Can't stay awake). At the time of the report, DIARRHOEA (Still has diarrhea 2 weeks later) and DYSGEUSIA (Still has metallic taste in mouth) had not resolved and DYSPNOEA (Breathing bad), WHEEZING (Wheezing), GAIT DISTURBANCE (Could not walk), HYPOAESTHESIA (Hands numb), ILLNESS (Felt really sick) and SOMNOLENCE (Can't stay awake) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Tested 3 times,test were negative each time.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information includes Inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information received and patient stated that still not feeling well
An area of redness & subcutaneous lump noted in (L) deltoid reg measuring 1.5x2in & an area of induration & tenderness noted in the (R) deltoid reg measuring 2.2x3cm
tingling in both lower extremities and both hands.; swelling in knuckle of R ring finger and L index finger.
Severe headache woke me from sleep around 12:05 am - started taking extra strength Tylenol every 4 hours. This lasted roughly 12-14 hours after onset. Swelling of left side of neck, shoulder, and under left arm with noticeable inflammation of the Subraclavical Lymph Node. Swelling of the neck region has gone down some, but still quite significant along the collar bone and lymph node
lightheaded, dizzy, nauseous drank apple juice, improved has history of anxiety with needles
Low back pain, it is worse; This non-serious case was reported by a consumer via call center representative and described the occurrence of low back pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of injection site pain (received 1st dose on an unknown date, refer link case US2023AMR035986).   On 03-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 03-MAR-2023, less than a day after receiving Shingrix, the patient experienced low back pain (Verbatim: Low back pain, it is worse). The patient was treated with paracetamol (Tylenol). The outcome of the low back pain was not recovered/not resolved.   It was unknown if the reporter considered the low back pain to be related to Shingrix.     It was unknown if the company considered the low back pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR035986   Additional Information: GSK Receipt date: 06-Mar-2023 The reporter was the patient, a 65-year-old female.  She received her second dose of Shingrix and within a few hours she developed low back pain.  It was worse on day of reporting. She treated the pain with one Tylenol daily.  Nothing else was reported. The reporter declined to provide HCP contact information at this time as she was switching doctors however, they might follow up with the reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023AMR035986:Same reporter
nausea/vomiting, body aches, fatigue/malaise, chills, elevated temperature
Diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated patient received the first dose of the COVID 19 vaccine and now has severe diarrhea on an unspecified date in Jan2021. The reporter stated the patient hasn't been able to leave the bedroom for two hours and he gave the patient a dose of magnesium. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Whole boy itchy skin; Skin felt like sun tan burn; Headache; Some itchy welts on stomach; This is a spontaneous report from a contactable consumer (reporting himself). This 78-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in left arm on 17Feb2021 at 11:00 as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient received unspecified medications in two weeks of vaccination. The patient did not experienced COVID prior to vaccination. The patient did not test for COVID post vaccination. The patient was allergic to penicillin. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. On 17Feb2021 at 14:00, the patient experienced whole boy itchy skin, skin felt like suntan burn, headache, some itchy welts on stomach which was more severe than first dose. The evets resulted in doctor or other healthcare professional office/clinic visit. The patient took allergy consultation, prescriptions and Benadryl as treatment medication for the events. The patient not recovered from the events.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
This spontaneous report was received from a medical assistant and office manager and refers to 4 unspecified patients of unknown age and gender. There was no information about patients' medical history, concurrent condition and concomitant therapy. The patients were vaccinated with GARDASIL 9 (lot L043213, expiration date 28-AUG-2017) via unknown route of administration for prophylaxis (dose not provided). It was reported that GARDASIL 9 was improperly stored before vaccination. The storage temperature was 50 F and time frame was 1440 hours. No adverse effect was reported. This case is linked with 1612USA012285 (same reporter link). Additional information has been requested. Sender's Comments: US-009507513-1612USA012285.
Wheezing, shortness of breath, lethargic, fatigue. Albuterol nebulizer, steroids.
Blood tinged mucous in stools x 3 weeks. 12/21/06 Received medical records from PCP which reveal patient in good health & initially breast fed.  After vax, developed bloody stools for approx 10 days.  Eval at GI clinic at hospital. 12/21/06 Received medical records from GI clinic which reveal specks of bright red blood with every stool, 5-6x/day.  Continued to be breast fed as of 11/27/06 with 1 supplemental bottle.  Had watery brown blood tinged stool during exam.   Final DX:  probable milk protein allergy.
Bilateral upper and lower lip, hand and foot numbness; bilateral leg weakness; recurrence of migraines with aura, photophobia and phonophobia; orthopnea and positional palpitations
Received expired booster shot; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster shot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A, 040A21A and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster shot). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received by the patient   This case was linked to MOD-2021-433646 (Patient Link).
a stabbing pain in her ribs; "rubbery" sensation; a numbness on the back of her left thumb; cannot feel pain in it when she pinches it (thumb); headache; The injection site swoll up; injection site swoll up and got red with itching and pain in the area; pain in the area; injection site got red; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (a numbness on the back of her left thumb), SENSORY LOSS (cannot feel pain in it when she pinches it (thumb)), MUSCULOSKELETAL CHEST PAIN (a stabbing pain in her ribs), FEELING ABNORMAL ("rubbery" sensation) and VACCINATION SITE SWELLING (The injection site swoll up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE SWELLING (The injection site swoll up), VACCINATION SITE PRURITUS (injection site swoll up and got red with itching and pain in the area), VACCINATION SITE PAIN (pain in the area) and VACCINATION SITE ERYTHEMA (injection site got red). On 10-Apr-2021, the patient experienced HEADACHE (headache). On 11-Apr-2021, the patient experienced HYPOAESTHESIA (a numbness on the back of her left thumb), SENSORY LOSS (cannot feel pain in it when she pinches it (thumb)) and FEELING ABNORMAL ("rubbery" sensation). On 13-Apr-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (a stabbing pain in her ribs). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. On 11-Apr-2021, VACCINATION SITE SWELLING (The injection site swoll up), VACCINATION SITE PRURITUS (injection site swoll up and got red with itching and pain in the area) and VACCINATION SITE PAIN (pain in the area) had resolved. On 12-Apr-2021, HEADACHE (headache) had resolved. On 13-Apr-2021, MUSCULOSKELETAL CHEST PAIN (a stabbing pain in her ribs) had resolved. At the time of the report, HYPOAESTHESIA (a numbness on the back of her left thumb), SENSORY LOSS (cannot feel pain in it when she pinches it (thumb)), FEELING ABNORMAL ("rubbery" sensation) and VACCINATION SITE ERYTHEMA (injection site got red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.
As reported to me by Dr., patient 4/7/12 - fever, chills, (pain on 4/9/12) and shingles confirmed by culture on 4/10/12.
States the night he received first dose  felt a "tightening of arms and legs, went to bed and next morning awoke with aching/tightness both knees & elbows that lasts approximately 1/2 hour until he starts moving and becoming active. This has continued every day since that time and cannot relate to anything other then the vaccine he received. No treatment.
PATIENT REQUESTED THRID DOSE TO BE MODERNA - AND RECIEVED PFIZER-BIONTECH
This case was reported by a other health professional via call center representative and described the occurrence of elevated liver enzymes in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 7 days after receiving SHINGRIX, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was recovering/resolving. It was unknown if the reporter considered the elevated liver enzymes to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date was not unknown. The patient had elevated liver enzymes approximately 1 week after dose 1 of SHINGRIX. Repeat test was ordered since that time. Enzymes had come down, but unsure if back to normal. The reporter gave consent to follow up. Lab Comments: Lab test was done on an unknown date.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: coughing up phlegm-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Pt was told to wait 30 minutes due to allergy to iv dye.  Was talking on the phone 15-20 minutes and was not in distressed.  After getting off of the phone, patient walked over to pharmacist, experiencing come shortness of breath/ wheezing and requested an Epipen. I explained to patient that effects of the epipen and pt decided against it. Requested an inhaler due to being asthmatic. An albuterol hfa inhaler was provided and pt took 3 puffs. Breathing remained erratic.  Paramedics called.
Within 5 minutes after my injection my lips and nose became numb/numbing went up my cheek, forehead; Headache; a metallic taste in my mouth; my blood pressure was 180/100; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiration date: unknown), via an unspecified route of administration on 21Feb2021 12:00 on left arm at single dose for COVID-19 immunisation. Medical history included Low Thyroid and allergies to Ibuprofen. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient not diagnosed with COVID-19.Since the vaccination the patient had not been tested for COVID-19. Concomitant medication included Levothyroxine. On 21-Feb-2021 12:00 PM (Within 5 minutes after injection), patient experienced her lips and nose became numb. A nurse brought patient to a doctor where the numbing went up my cheek, forehead, my teeth after almost 5 hours patient was still numb. Patient also had a sight sore throat headache; blood pressure was 180/100 and had a metallic taste in my mouth. Patient visited the physician office but did not received any treatment for events. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Patient received adult dose of Hepatitis A vaccine instead of pediatric dose. Patient was monitored and released to parents. She showed no signs of adverse reaction.