chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had received Shingrix vaccine / afterward, pt had a shingles outbreak/ Suspected Vaccination failure; pt had a shingles outbreak; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a female 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix and at some time afterward, had a shingles outbreak. The reporter could not remember anything else about patient/case. The reporter consented to follow-up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Dizziness; Nausea; This case was reported by a consumer and described the occurrence of dizziness in a adult 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 dizziness and nausea. On an unknown date, the outcome of the dizziness and nausea were unknown.   It was unknown if the reporter considered the dizziness and nausea to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingles vacckine and experinced dizziness and nausea. The patient asked how long the side effects last and can do anything to minimize the side effects.
Patient awoke at 01:30 am on 1/31/21 with abdominal cramps, nausea, diarrhea x 3 stools, and chills with rigors. 01/31/2021 03:22 presented to ED for assessment with complaints of abdominal pain and shaking;  01/31/2021 06:29 patient discharged from ED - symptoms resolved;  ED Tx consisted of Acetaminophen 1gm IV x 1 dose; chest x- ray (neg); CBC (WBC 12.9); CMP (AST 77, ALT 94); Respiratory Panel 2.1 IVD (BIOFIRE) - Negative; EKG - A-fib rate 108;
Tingling lips that progressed to tongue and later to throat. Epinephrine.3 mg was given and pt sent to hospital via ambulance.
Fever, arthritis flare up, body aches and pains, sore throat, swelling of neck and throat.
8/14- really thirsty, weight 130lbs 8/18- still really thirsty, drank a ton of water 8/20- Woke up feet flipped in and ankle hurt, strained before walking 8/30- Tongue looked like hamburger, feet still flipping in when woke up 9/4- kidneys started hurting, drank cranberry juice 9/14- weighed 108lbs 9/24- still drinking a ton of water, trouble keeping food down  9/25- went to urgent care, sent directly to ER. Weight was 105, pulse high, trouble breathing. Extreme fatigue, no appetite, weak, sick to stomach. Blood sugar 727, Potassium 4.2, 3 IV bags of fluids. Admitted to ICU for 2 days. Diagnosed with Type 1 Diabetes.
I had my vaccination on 02/01/2021. At 8PM on 02/01/2021 I had slight fever, chills, and fatigue. This lasted for a couple of days. I contacted the nurse hotline and was informed to take Tylenol due to pain.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with doses of improperly stored PROQUAD (Merck), lot # L041627, expiration date: 20-APR-2017 (dose and route of administration were not reported). Administered doses of PROQUAD (Merck) underwent temperature excursions at 14.5 degrees Celsius for 6.58 hours. Information about the previous temperature excursions was not reported. There were no adverse effects reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Large swollen lump in groin area (left leg), irritated during day from sitting and was pussing white liquid at night for about a week.
This spontaneous report as received from a consumer refers to a 38 year old female patient with colitis, suppressed immune system, allergy to FLAGYL, allergy to azithoprine, allergy to amoxicillin, allergy to sulfa and allergy to REMICADE (MARRS # 1409USA009194). The concomitant medication was reported as flu shot in opposite arm, administered on the same day. In 2008, the patient was vaccinated with PNEUMOVAX 23, (lot number 661577/1161X expiry 06-DEC-2009) (dose, route were not reported). In 2013, the patient was vaccinated with PNEUMOVAX 23, (lot number J0007059 expiry 31-JUL-2014 date), (dose and route were not reported). In 2008 and also in 2013 (unspecified dates), the patient experienced an adverse reaction on the second day after receiving the PNEUMOVAX 23 on each occasion and the side effects included, body aches, 102 degree temperature, fatigue and general flu like symptoms that lasted for about a day. Her arm was very sore for two days. The patient experienced the same symptoms after each PNEUMOVAX 23. The outcome of 102 degree temperature, her arm was very sore, general flu like symptoms, fatigue and body aches was reported as recovered in 2008 (reported as lasted for two days). The outcome of 102 degree temperature, her arm was very sore, general flu like symptoms, fatigue, and body aches was reported as recovered in 2013 (reported as lasted for two days). Additional information has been requested.
No adverse event; received a 0.25 ml Moderna booster dose from  the 6m-4y vial; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (received a 0.25 ml Moderna booster dose from  the 6m-4y vial) and NO ADVERSE EVENT (No adverse event) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (received two Pfizer doses more than 5 months ago). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.   On 06-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (received a 0.25 ml Moderna booster dose from  the 6m-4y vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (received a 0.25 ml Moderna booster dose from  the 6m-4y vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (received a 0.25 ml Moderna booster dose from  the 6m-4y vial).    No relevant concomitant medications were reported.   Patient received two Pfizer doses more than 5 months ago. The patient was 7 years old. She was coming for the booster and received a 0.25 ml Moderna dose (from the 6m-4y vial) instead of the Pfizer on 06-Sep-2022.  No treatment information was provided.
Information has been received from a nurse concerning a 14 week male who on 01 Mar 2007 was vaccinated with his first oral dose of Rotateq (Lot# 1392F). The nurse reported that the patient received his "1st dose of Rotateq after 12 weeks of age". No adverse event was reported. No further information was provided. Additional information has been requested.
Moderna Covid-19 Vaccine EUA.  Immediately the injection became very tender and red and moving my arm became painful.   About 9 hours after I began experinecing fatigue, headache, muscle pain, joint pain, and nausea.  It was a particularly awful night, but I am feeling much better today and will be probably be over it by tomorrow.  I remain grateful f or the vaccine.
Experienced a severe, prolonged nosebleed on June 25. Blood was pouring from left nostril and mouth and took hours to begin to clot. Finally stopped in early afternoon on June 25. Started again in early morning of Sat. June 26. This was accompanied by intense pressure in forehead, behind nose and burning sensation in both eyes (visibly red). Gently blew nose as it was bleeding and passed a large clot the size of a quarter. From wife: We had to resort to using paper towels with sanitary napkins to try to soak the blood. Completely soaked 4 Always Infinity size 5 sanitary napkins in a matter of 10 minutes. Bleeding stopped around an hour later. Considering a minor medical visit due to reoccurrence, headache, eye burning and possible elevated blood pressure.
Abscess tooth; No Energy; Diarrhea; Chills all night; injection site red; injection site red and swollen; Injection site itchy; chills; Up all night; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), TOOTH ABSCESS (Abscess tooth), ASTHENIA (No Energy), INSOMNIA (Up all night) and DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced DIARRHOEA (diarrhea), INSOMNIA (Up all night) and CHILLS (chills). On 14-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy). On 15-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site red and swollen). On 23-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and CHILLS (Chills all night). On 24-Feb-2021, the patient experienced ASTHENIA (No Energy). On an unknown date, the patient experienced TOOTH ABSCESS (Abscess tooth). On 08-Feb-2021, INSOMNIA (Up all night) had resolved. On 09-Feb-2021, DIARRHOEA (diarrhea) and CHILLS (chills) had resolved. On 21-Feb-2021, VACCINATION SITE SWELLING (injection site red and swollen) had resolved. On 23-Feb-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, TOOTH ABSCESS (Abscess tooth), ASTHENIA (No Energy), VACCINATION SITE PRURITUS (Injection site itchy), INJECTION SITE ERYTHEMA (injection site red) and CHILLS (Chills all night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided. Concomitant medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Feb-2021: follow up information received it does not contain any new information.
Bad stomach ache, dizziness, nausea. Continued stomach ache and low grade fever until morning of 8/25/2016.
Narrative:  Patient received two doses of Pfizer COVID 19 Vaccine in Mar/Apr 2021. The patient presented to the ED on 4 June 2022 with confusion and cough. The patient tested positive for COVID 19 and was admitted with COVID 19 encephalopathy. The patient was treated with supportive care. The patient was discharged in stable condition on 6 June 2022.
Site: Pain at Injection Site-Mild, Additional Details: pt received laceration to left leg after kicking while attempting to inject covid vaccine, no vaccine administered, vaccine was administered in arm instead
My hands are both swelled up really big and I find them difficult to use; Swelled up at the joint in my shoulder; My arm swelled up at the point of injection and it is hot and sore; My arm swelled up at the point of injection and it is hot and sore; My arm swelled up at the point of injection and it is hot and sore; Joint started to hurt in my left arm where I have the injection; Pain in my left lung same side as the injection and it felt like there is a blockage in my system; Pain in my wrist and in my hand on the left hand side where I had the injection and then it began to swell up on my right hand as well and the joints and the wrist and my hand; Pain and stiffness in my neck; Pain and stiffness in my neck; I am in great pain; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Paitent swelled up at the joint in the shoulder and it woke patient up at night. The arm swelled up at the point of injection and it is hot and sore and then the joint started to hurt in the left arm where the injection then developed pain in the left lung same side as the injection and it felt like there is a blockage in the system and it lasted for about two weeks and slowly went away. Patient got incredible pain in the wrist and in the hand on the left hand side where the injection and then it began to swell up on the right hand as well and the joints and the wrist and the hand. So, the hands are both swelled up really big and find them difficult to use even to pick up a cup of coffee and this is going on continuing from the last 8 weeks and then, developed pain and stiffness in the neck and also the feet is swelled up and its pretty swollen up.The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days Severe headache x 2 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Mild headache x 1 day (OTC Ibuprofen 400mg PRN) Dizziness x 2 days (Ensured proper hydration) Body aches x 3 days  (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Malaise x 3 days
Felt so cold; This case was reported by a consumer via interactive digital media and described the occurrence of feeling cold in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22nd July 2022, the patient received Shingles vaccine. On 22nd July 2022, less than a day after receiving Shingles vaccine, the patient experienced feeling cold. On an unknown date, the outcome of the feeling cold was unknown.   It was unknown if the reporter considered the feeling cold to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUL-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received shingles vaccine on Friday (from the day of reporting). On Friday night, the patient felt so cold. The reporter wanted to know was it normal. Additional Supportive Information: The follow up would not possible, as no contact detail were available.
This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (lot # M034583 and expiration date 27-JUL-2018) and (lot # N000682 and expiration date 06-JAN-2019) for prophylaxis (dose and route of administration were not reported). The vaccines were stored in temperature between 15°F and 46°F for 3 hours and for 30 minutes the temperature was between 47°F and 77°F. The vaccines did not have a previous temperature excursion and the call was done because of the data logger. No adverse effects were reported.      Additional information has been requested.
act delusional/Asking for things that are impossible; results were positive for a UTI; This case was reported by a consumer via call center representative and described the occurrence of delusion in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2020, the patient received the 1st dose of Shingrix. In December 2020, 1 week after receiving Shingrix, the patient experienced delusion (serious criteria hospitalization). On an unknown date, the patient experienced urinary tract infection. On an unknown date, the outcome of the delusion and urinary tract infection were recovered/resolved.   It was unknown if the reporter considered the delusion and urinary tract infection to be related to Shingrix.  Additional details were provided as follows: The patient had the vaccine and approximately a week later he started to act delusional. The patient was asking for things that were impossible. The patient was admitted to the hospital on 16th December 2020 for 2 weeks and is in a rehap center. An urine test was performed and results were negative. A urine culture was done 3 weeks after the urinalyses and results were positive for a UTI. The reporter consented to follow up.
Pt given ZOSTAVAX on 10/20/14. On approz. 11/5/14 pt. developed prutitic, erythematous rash with myalgia-> positive for chickenpox.
Pt recvd Hep B vax w/o difficulty; pt suddendly c/o of feeling medication (burning sensation) in chest & started seizure activity; PB 140/90, ap pulse 50 & reg, color ashen; pt became cool & clammy, BP 80, pulse remained 50 & reg;
Pink and puffy area 2 inches around injection site.  This has come and gone every few days since injection.  It doesn't hurt anymore,  it only hurt the day after.  No itching or pain,  just the pink puffy area that comes and goes every other day or so.
11/22/21-Pt had covid on 11/11/2021. 11/12/21  Regeneron infusion
Low grade fever, chills, fatigue, body aches, sore red growing area swollen arm.  (redness is an area of 5"x3")
A non-serious spontaneous report of administration of expired FLUMIST was received from a healthcare professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. The patient received expired FLUMIST on either 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
After receiving my first shot of the Moderna vaccine, immediately I noticed that my legs felt very heavy. The same night, my calves were extremely sore and my left calf continued to be sore for days after getting the shot. Along with being sore, I felt this pulsating feeling in my calf that was constant throughout the day. This went on for about 10 days until the pulsating feeling traveled to my left thigh. It was very clear that the pulsating feeling was actually my muscle twitching. I could see my thigh muscle twitching very clearly through my skin. This twitching occurred all day, every day until the time of my 2nd shot. Three days after receiving the 2nd dose of the vaccine which I received on September 1st, 2021, the muscle twitching began again but in every muscle in my body this time. The twitching is sporadic and occurs in different muscle groups including my thighs, calves, buttocks, intercostal muscles, back, shoulders, forearm, triceps, chest, hamstrings, eyes, tongue and lips. The muscle twitching occurs at rest, while standing and while sitting. Some days the twitching is more intense and I can see I through my skin, other days they are less intense where I can feel them, however, they are not visible through my skin. There has not been a day where I have not experienced these fasiculations since receiving my first dose of the moderna vaccination.  It has been almost a total of two months of experiencing muscle twitching. I have seen my primary doctor, a neurologist and been to an Emergency room. I believe it is possible that the vaccine triggered a central nervous system response that is causing neuron excitability. My primary care doctor prescribed Diazepam 5mg to aid with the twitches, primarily at night so I am able to sleep, however, I can still feel the twitches mildly even after taking the medication. Certain locations such as my left thigh, and right upper back  seem to be popular locations for the muscle twitches. The twitches often occur the longest and the most often in those muscles. Lastly, sometimes, a dull ache/soreness accompanies the twitching. Usually in my entire arm or legs.
fatigue for a day or two; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US092572_NS (Company)  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "fatigue for a day or two". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9MAR93 start of erythema on lt thigh 3 1/2" x 3 1/4" diameter, induration 1 1/2" in diameter no drng; no fluctuance; non-tender; no treatment done-observe;
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information on concomitant medication, medical history and drug allergies was not provided.   On 23-FEB-2017, the patient was vaccinated with a dose of VARIVAX (lot# M032358, expiration date: 05-JUL-2018; dose and route unknown) and a dose of PROQUAD (lot# M031943, expiration date: 27-DEC-2017, therapy type: rHA; dose and route unknown) for prophylaxis (overdose). No adverse effects were reported. Additional information has been requested.
3/5-received oral typhoid, 3/6-evening-diarrhea started-loose brown, four times a day. 3/8-cramping on and off continues, 3/14-diarrhea-clear fluid for 5-10 minutes-large amounts.
Malaise, erythema 3 inches or more on right upper arm. TX - Tylenol 500 mg prn, Benadryl prn, ice to effected area.
Lot of sleepiness. Cannot walk. Haven't say a word in 6 days, doesn't et, doesn't play. Cant's hold up his head nor can he swallow.  Diagnosed with encephalopathy nos. 60 day follow-up states patient was diagnosed with developmental delay. He has brain damage in the Basal Ganglio.
Sore arm, body aches, chills, low grade fever, took Tylenol every four hours
Fever body aches, chills Narrative:  states: some body aches began around 2-3pm on 1/27/21 . then body aches, chills and low grade fever (100) after taking Motrin 2 hours prior, began feeling better evening of 1/28
This is a spontaneous report from a contactable pharmacist. A 61-year-old male patient received PREVNAR 13 (Lot number: 005197102, expiration date: Apr2019), and AFLURIA QUADRIVALENT, both via an unspecified route of administration on 07Sep2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that she had a patient come in and get vaccinated with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and influenza vaccine inact split virion 4v on Friday night, 07Sep2018. Within 10 minutes of getting the shots, he got some major cramping in stomach that went down to his leg at least 24 hours. He is doing better now. However, he wasn't sure if it was due to the vaccines and wanted to know if there was a correlation. The outcome of the event major cramping in stomach that went down to his leg was recovered on 08Sep2018.