chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of adverse reaction in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had been in contact with healthcare provider who had prescribed treatment. For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK011461.
pt recv 1st vax;exp sore throat & congestion; 05mar94,recv 2nd dose & exp sore throat & congestion;recovered;
PT STATES THE EVENING AFTER INJECTION HER ARM BECAME EXTREMELY RED, HOT, AND PAINFUL AND HAS NOT IMPROVED. THE FOLLOWING DATE SHE BEGAN TO EXPERIENCE NAUSEA, STOMACH, NECK, AND BACK PAIN AND HEADACHE. ON DAY 2 POST INJECTION SHE ADDED DIARRHEA TO HER SYMPTOMS AS WELL AS CONTINUING "FLU LIKE" SYMPTOMS. ON DAY 3 SHE RETURNED TO PHARMACY STATING HER SYMPTOMS HAD NOT IMPROVED AND SHE COULD NOT EAT AND FELT HORRIBLE. SHE SAID SHE DID NOT EXPERIENCE THESE SAME EFFECTS WITH 1ST INJECTION. SHE SHOWED A PICTURE OF THE REDNESS ON HER LEFT DELTOID AND SAID SHE COULD HARDLY LIFT HER ARM. SHE HAS NOT SOUGHT MEDICAL TREATMENT TO MY KNOWLEDGE.
Presented with tarry stool from nursing home. Known Covid + for approximately 1 week at hospital.
Patient has pea-sized lump, swelling, and redness almost 2 weeks following administration. Patient was using ice for swelling. Recommended to apply heat.
approx 10days p/vax pt exp a maculopapular rash on abd & blisters on lips & inner mouth, resolved p/approx 3-4days. addl info requested
Systemic: Allergic: Itch Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: 5 Minutes after the vaccine, pt lost consciousness for a few seoncds. pt showed some jerking motion. Pt was given water and benadryl. About 30 minutes after the shot, pt fully regained consciousness and back to normal
-Headache for 3 days, including the day of vaccination. -Numbness of upper extremities at night, but only on the third day of the vaccine (only once), no more has been presented.
After having RA symptoms managed for 23 years, I began having severe joint pain in knees, wrists, hands, feet, arms, shoulders.  Pain started as slow process and by the time I received second dose ( Feb. 21), had to phone my rheumatologist.
I noticed a few days after receiving my second dose, that I was having diarrhea every day. I was not able to stop it by using anything. I went and saw a gastroenterologist, and she told me to try Imodium. It did not work very well. As of today, I'm on Metamucil, but still experiencing diarrhea daily.
severe vertigo. I was hospitalized for 2 days. I still have lingering effects 2 months after first symtoms.
Allergic reaction; Racing heart rate; Feeling dizzy; Trouble swallowing; This case was reported by a consumer and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3N4F7, expiry date 30th June 2020) for prophylaxis.   On 23rd September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 23rd September 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced allergic reaction, heart racing, dizziness and swallowing difficult. On an unknown date, the outcome of the allergic reaction, heart racing, dizziness and swallowing difficult were unknown.   It was unknown if the reporter considered the allergic reaction, heart racing, dizziness and swallowing difficult to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Fluarix QIV vaccine yesterday and experienced an allergic reaction, within 10 minutes started having a racing heart rate, feeling dizzy, and trouble swallowing. The patient contacted with pharmacy but she was looking to report the reaction to the manufacturer as well. The patient would like a list of ingredients of this specific vaccine so she could know what to avoid in future vaccines.
Sustained a hemorrhagic stroke in the right basal ganglia on 3/10/21 requiring hospitalization
pt recvd vax & exp stiff neck, headache & malaise; pt taken to ER for tx;
No additional AEs reported.; patient received an expired dose of PROQUAD; This spontaneous report was received from a nurse referring to a 7-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 11-MAY-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant human albumin (rHA) injection (0.5 ml, once, lot#: U029296, expiration date: 19-MAR-2023; strength, route, and anatomical location were not reported) with sterile diluent for prophylaxis (expired product administered). No additional adverse events were reported (no adverse event).
Seizure within 24 hours of vaccines with fever; felt to be febrile seizure. Another set of seizures at 48 hours out without fever. 11/1/05 Per review of d/c summary add cranky/irritable. Seizure diagnosis confirmed. 11/1/05 Per review of medical record fever followed by seizures was confirmed.
Non-stop headaches; muscle aches; arm pain; joint pain; chills; fever; itchiness; fatigue; swollen lymph nodes; This is a spontaneous report from a contactable other HCP (patient). A 26-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL3242), via an unspecified route in the left arm on 08Feb2021 at 13:45 (age at vaccination: 26-year-old), as a single dose for covid-19 immunization. Medical history included known allergies: seasonal allergies, and allergies to mold/tree/pollen/grass/animal dander and the likes (enough to be advised to have an epipen). Other medical history included she may have PCOS, in process of finalizing a diagnosis, she does have ADHD/Anxiety and a history of asthma from her childhood that flares up every few years. The patient concomitant medications were not reported. Patient has no history of allergies to medications or foods. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL3247), via an unspecified route in the left arm on 18Jan2021 at 10:15, as a single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 09Feb2021 at 15:30, patient experienced every possible symptom on the list concurrently and still continue to experience a few today. Non-stop headaches, muscle aches, arm pain, joint pain, chills, fever, itchiness, fatigue, swollen lymph nodes and probably more. All of these occurred at the same time and she was still on bed rest with fatigue, headaches, and swollen lymph nodes. Adverse events have required her to take a significant amount of time off work. She was unsure of why her body was responding this way but now she was on day 5 of this experience and believe it should be worth noting. Therapeutic measures taken as a result of the events included ibuprofen, but her headaches and pains seem to persist even with medicine. The clinical outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates, since 19-AUG-2016, the patients received improperly stored doses of VARIVAX (lot # M002063 with expiration date 12-JAN-2018; lot # M004328 with expiration date 26-JAN-2018; lot # M009768 with expiration date 23-FEB-2018; lot # M014309 with expiration date 21-MAR-2018; dose and route were not reported). It was reported that the vaccine was improperly stored at -3.5 Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
LEFT ARM PAIN. I CAN ONLY LIFT MY LEFT ARM A SMALL AMOUNT WITH OUT A LOT OF PAIN.
Onset of dermographia about 2 weeks after vaccine. Skin feels tight/slightly itchy like a mild sunburn. Any pressure, rubbing, scratching etc results in red welts that fade within 1/2 hour though itchy the whole time.  Loratidine, Singulair, Benedryl, famotidine, Allegra are minimally effective - if at all.  Symptoms persisting.
4/19/23 ...After 23 hours....99.9 fever, chills for 5 hour...treated with Ibuprofen and Acetaminophen  4/20/2023...After 36 hours...rash, welt, itchy patch on left arm ..slowly spreading....treated with antitch cream...still present on 4/22/2023..
Local rxn, fever 104F, pt became slightly listless & lethargic 2nd day;
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-OCT-2012, the patient was administered with a dose VARIVAX (Lot # 0435AE, expiry 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
At 8am Jan 20th (30 hrs after shot) I woke feeling extremely strong and powered up, very energized and liken the mental energy to feeling like I was on steroids. Went downstairs to kitchen to make a cup of tea and it was then I realized my pulse was going extremely fast (about 180bpm). I didn't think much of it or get nervous, but went to sit down and work at my computer, hoping it would go away, After about 20 minutes I realized it hadn't slowed down, so I went back to my bedroom to get dressed in the event I had to go to an urgent care or hospital. On the way up the stairs to my bedroom I realized I was getting a bit light-headed.  After about another 10 minutes I decided to lie down and called up a "calming meditation" app to see if that could lower my heart rate. I was able to get my heart rate down to about 125 after the10 minute meditation and it returned to normal shortly thereafter. The second episode was on February 11th. This time I was woken up out of my sleep at 4:45am by an extremely rapid heartbeat. Again, about 180bpm. This time I was a bit frightened. I walked around the house for about 15 minutes and when it didn't go down  I decided to go out for a walk. I did about a 30 minute walk , I had some tingling in my hands, but by the end of the walk my heart rate came down to about 100 and dropped back to normal shortly after.
Parents found infant blue, face down in crib around 1145 on 8/12/07. Per Coroner Possibly SIDS. CPR Attempted. Infant Pronounced Dead at 1:30 on 8/12/07. 5/27/08-records received:Cause of death-Sudden Infant Death Syndrome. Manner of death-natural
Right arm swelling and pain. Taking Tylenol PRN Severe headaches - Taking Tylenol PRN
came down with Shingles; Excruciating Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: came down with Shingles) and pain (Verbatim: Excruciating Pain). The outcome of the shingles was not reported and the outcome of the pain was resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2023 This case was reported by a patient's child via interactive digital media. The patient got the shingles shot and immediately came down with shingles and he had been laid up over a month excruciating pain. The follow up would not possible as no contact details were available.
This spontaneous report was received from a registered nurse referring to a currently 14 year old patient of unknown gender. The patient's medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # N022584, expiry date: 15-JUN-2020) for prophylaxis. The vaccine underwent a temperature of 31.9 Fahrenheit degrees (°F) for a time frame of 10 minutes. There was no previous temperature excursions and digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA006754: US-009507513-1801USA007190: US-009507513-1801USA007191:
at 1805; associate c/o lightheaded and noted to be diaphoretic. BP was 138/92 with HR 85 and room air sat 98%. at 1830; reported feeling better. BP 127/83. HR 76. room air sat 100%. at 1845: felt better 143/101 1905: discharged to home. BP 136/92
patient fainted. smelling salts used, cold pack to neck area and pt put in lying position with feet up
Scattered vesicles and dry skin with ulceration. Symptomatic Tx. Chicken pox.
Chemical burn under left armpit after using hair removal cream that has been used several times before. No sensitivity or pain else where on the body where hair removal cream was applied but under left arm pit. Vaccine was injected on left arm. Used the hair removal cream several times with no issue. Had to remove the hair removal cream immediately due to the pain under the left armpit.
Severe tinnitus with jaw pain, ear pain, ear pressure and extreme sensitivity to loud/sharp noises.   My wife has same issues plus headaches with similar onset timing. She was vaccinated 2 minutes before me from same batch.
Shingrix adjuvant only without the lyophilized antigen; Shingrix adjuvant only without the lyophilized antigen; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received a dose of the Shingrix adjuvant only without the lyophilized antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No symptoms reported. The reporter was not in the office at the time of report and did not have any of the patient's information at that time. The reporter consented to follow up. This case was 1 of 12 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR179303:Same reporter US-GLAXOSMITHKLINE-US2021AMR179306:Same reporter US-GLAXOSMITHKLINE-US2021AMR179305:Same reporter US-GLAXOSMITHKLINE-US2021AMR179302:Same reporter US-GLAXOSMITHKLINE-US2021AMR179304:Same reporter US-GLAXOSMITHKLINE-US2021AMR179297:Same reporter US-GLAXOSMITHKLINE-US2021AMR179299:Same reporter US-GLAXOSMITHKLINE-US2021AMR179307:Same reporter US-GLAXOSMITHKLINE-US2021AMR179300:Same reporter US-GLAXOSMITHKLINE-US2021AMR179298:Same reporter US-GLAXOSMITHKLINE-US2021178442:Same reporter
pt recv ax 18APR96 & 11OCT97 pt devel a mild case that consisted of approx 20 vesicles mostly on face;
Pancreatitus , Hospitalized at a local hospital.     07/06/2021 - 07/18/2021 .
left side of her face swollen and droopy, warm to the touch; left side of her face swollen and droopy, warm to the touch; left side of her face swollen and droopy, warm to the touch; dose number=1/dose number=2: Moderna; dosenumber=3: Pfizer; dose number=1/dose number=2: Moderna; dosenumber=3: Pfizer; dose number=1/dose number=2: Moderna; dosenumber=3: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Jan2022 12:30 (Lot number: 33130BA) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin". Vaccination history included: Moderna covid-19 vaccine (Dose Number: 1, Batch/Lot No: 025B21A, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 31Mar2021, when the patient was 43 years old, for COVID-19 Immunization; Moderna covid-19 vaccine (Dose Number: 2, Batch/Lot No: 009C21A, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 26Apr2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 04Jan2022 12:30, outcome "unknown" and all described as "dose number=1/dose number=2: Moderna; dosenumber=3: Pfizer"; SWELLING FACE (non-serious), SENSORY DISTURBANCE (non-serious), FEELING HOT (non-serious) all with onset 05Jan2022 06:00, outcome "not recovered" and all described as "left side of her face swollen and droopy, warm to the touch". Therapeutic measures were not taken as a result of swelling face, sensory disturbance, feeling hot.  Additional information: She got the booster (dose 3) on 04Jan2022 and woke up the next morning (05Jan2022) with left side of her face swollen and droopy, warm to the touch. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Birth control pill within 2 weeks of vaccination. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.  Follow-Up: Follow-up attempts are completed. No further information is expected.
Day after receiving vaccine she noted swelling to area around injection site, slightly warmer to touch and slightly tender to palpation.  Iduration of 8.25cm x 6.5cm noted around injection site.   Denied pain to site with activity.  Denies fever, body aches, or chills.
Pins/needles in left hand/fingers and foot/toes starting 8/24/21; experience some numbness in left hand and foot PLUS constant pins/needles in left hand and foot which varies in degree througout the day; Soreness at injection site after about 12 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 10:45 (Lot number: Unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lifelong Migraines" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: Breast Cancer in 2009 and 2014. There were no concomitant medications. Past drug history included: Known allergy: none known. The following information was reported: VACCINATION SITE REACTION (non-serious) with onset 21Aug2021, outcome "not recovered", described as "Soreness at injection site after about 12 hours"; PARAESTHESIA (non-serious) with onset 24Aug2021, outcome "not recovered", described as "Pins/needles in left hand/fingers and foot/toes starting 8/24/21"; HYPOAESTHESIA (non-serious) with onset 24Aug2021, outcome "not recovered", described as "experience some numbness in left hand and foot PLUS constant pins/needles in left hand and foot which varies in degree througout the day". The events "soreness at injection site after about 12 hours", "pins/needles in left hand/fingers and foot/toes starting 8/24/21" and "experience some numbness in left hand and foot plus constant pins/needles in left hand and foot which varies in degree throughout the day" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site reaction, paraesthesia, hypoaesthesia.  Additional information: 21Aug2021 - Soreness at injection site after about 12 hours, as expected. Resolved within a couple of days. Pins/needles in left hand/fingers and foot/toes starting 24Aug2021. Seemed to improve on 29Aug2021, but returned in full and progressively worse since 31Aug2021. She now experiences some numbness in left hand and foot, constant pins/needles in left hand and foot which varies in degree throughout the day. The patient was administered vaccine in a pharmacy. The patient did not receive other vaccine in four weeks nor other medication in 2 weeks. The patient did not have covid prior vaccination nor was tested post vaccination. The patient had no known allergies.   Follow-up attempts completed. No further information is expected.
Initially pt felt edema and itching at injection site on day following vaccine, then next day woke up with an itchy rash on her chest and lower legs which persists, as well as today (02/19/10) she reports her scalp feels itchy but unable to determine if there is a rash. She took Benadryl which helped her symptoms, but refused to come in to clinic to be checked at this time so description of rash is not available.
Already reported immediate severe weakness, lethargy, withdrawal, delirium. Now adding 4 days later ... hypotension, nausea, vomiting, diarrhea, cramps, chest pain. ER visit and 2 day hospitalization. Abdominal CT indicated intestinal inflammation in the area of the Cecum. One week of antibiotics.
Malaise headache! Body ache! cough Tired! > 12 days.  its been 3 weeks now & arm - injection site still aches!!! I Feel unwell still
My whole face got extremely hot. I felt my face get tingly. Right side of my face went almost numb. Head felt tingly. Went away hours later.
Information has been received from a physician concerning a 4 year old female patient who in February 2007, "3 years ago", was vaccinated with a dose of VAQTA. The patient was also vaccinated with a dose of PROQUAD (Merck) and a dose of COMVAX (MSD). After receiving VAQTA, 3 years ago, in approximately February 2007, the patient developed a febrile seizure. The patient had sought unknown medical attention. Subsequently, the patient recovered from febrile seizure on an unspecified date. Upon internal review, febrile seizure was considered to be an other important medical event. Additional information has been requested.