chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Get the shot 6 months before then l went to Dr for sun poison, It was shingles/ suspected vaccination failure; Went to Dr for sun poison, It was shingles; 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, less than 6 months after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 18-Jun-2022. Reporter's Comments: This case was reported by a patient via interactive digital media. The patient signed to get the shot 6 months before. It was stated that it would not prevent shingles, but it would get a lighter case of it if visit to doctor within a week for further medicine. The patient thought it was a sun poison since patient was working on a roof for a month. The patient went to doctor and it was shingles. As no contact detailes were provided, hence follow up was not possible. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule time to onset for event and laboratory confirmation for herpes zoster were unknown.
Apparently, reaction started on 10/06/18...however pt just notified pharmacy today (10/21/2018) of the rash. Patient had itchy rash that started around waist and under bra strap area about 24 hours after flu immunization was administered. It spread to over areas of body over next 24 hours. Pt went to ER PCP and was told to take BENADRYL and was given Prednisone. She continues to experience the itchy rash, and has seen little improvement. (MD wanted to test for Alpha-Gal, but pt refused due to no tick bite.)
Reports pain in left arm, unable to reach overhead or lift above shoulder level. Denies any S/S at time of vaccination or until present.
Mucous in stools, vomited once, had one stool w/ blood in it.
Uncontrollable chills - couldn't hold a bottle of water or other Sever Throwing Up Sharp Stabing Pain in upper stomach area to my back - so sever was doubled over for some time Sever Aches Migraine
injection site still sore after 5 weeks; sometimes cannot lift arm above shoulder; if I do lift my arm above shoulder there is pain in the arm at the injection site.
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 26-JAN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002980: US-009507513-2104USA002978: US-009507513-2104USA002981: US-009507513-2104USA002976: US-009507513-2104USA002983: US-009507513-2104USA002974: US-009507513-2104USA002973: US-009507513-2104USA002975: US-009507513-2104USA002971: US-009507513-2104USA002972: US-009507513-2104USA002963: US-009507513-2104USA002982: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
At site of single Hep A injection, a superficial oval of desquamation occurred followed by satellite pustules. All consistent with a possible Staph secondary infection.
Sudden global inflammatory response possibly related to vaccine characterized by onset of the following symptoms within a 72-hour period with no other known cause, illness, environmental changes/factors:  Severe pain and soft tissue inflammation in joints (knees, ankles, wrists, elbows especially) absent of any known traumatic injury or overuse injury;  Easy bruising;  Photo dermatitis (never occurred before for patient)
VACCINES GIVEN ON 4/8/2005. PT DEVELOPED TEMP SATURDAY AFTER VACCINATIONS. TEMP PERSISTED UNTIL FRIDAY 4/15/05. TEMP HIGHEST ON THURSDAY 4/14/05 OF 103.2. PT SEEN IN OFFICE ON FRIDAY 4/15/05, DIAGNOSED WITH RIGHT OTITIS MEDIA. PLACED ON CEFZIL. PT TO FOLLOW UP IN OFFICE 4/25/2005.
On right arm: (cm) 11x9 erythematous slight raised macule.
18AUG93 1230PM (2 hrs post vax) pt was irritable, warm to touch, cried, began to tremble, did not respond to verbal stimuli; ambulance called because MD felt pt was having sz activity from fever; pt was taken to hosp ER;
Information has been received from an RN concerning a pt who on 8/13/00 was vaccinated with varicella virus vaccine live (site unknown) (lot 631471/1347J). The pt developed chickenpox the week of 4/23/01. It was unknown if the pt sought medical attention. Also reported was another pt (WAES01042688) who was vaccinated and experienced similar events. Additional information has been requested.
Information has been received from a consumer concerning a 2 month old female with no known medical history or allergies who on 16 Nov 2006 was vaccinated with a 2mL orafirst dose of Rotateq (human bovine). There was no concomitant medication. On 17 Nov 2006, 24 hours after vaccination, the patient developed a rash on her stomach and back. Unspecified medical attention was sought. At the time of the report the patient had not yet recovered. No labs were performed. There was no product quality complaint involved. Additional information has been requested.
Flu; This is a spontaneous report from Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Pt reported nausea and several soft bowel movements the night of vaccination.  Woke up next day with arm pain, redness at injection site.
hearing loss; my nose started to run non stop; type of vertigo symptom's; This is a spontaneous report from a contactable other HCP (patient herself).  This 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number el3249), via an unknown route, on 01Feb2021 (at the age of 76-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided) on unknown date for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included lisinopril and atorvastatin. The patient received the last shot on 01Feb2021. The next day ''my nose started to run nonstop''. The runny nose lasted for about 6 days. The next thing that happened was a type of vertigo symptom's that lasted for 4 days. On 12Feb2021 ''I woke up and could not hear out of my left ear''. The hearing loss was trying to come back but did not. The events required a physician office visit. She was treated for the events. On 23Mar2021, the patient performed a hearing test, but results were not provided. On 12Apr2021, a nasal swab was done and resulted negative. The patient had recovered from 'my nose started to run non stop' on 08Feb2021 and from 'type of vertigo symptom's' on 06Feb2021. The outcome of 'hearing loss' was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Severe abdominal pain, bloating, intestinal inflammation, aches, body, liver, right side, kidneys, chest/heart pain. Fever, slight nausea. Weakness, fatigue, chest pain. Headaches, continued 5 days plus (arm pain).
Days after getting vaccine she complained of a headache. Next night she threw up twice. Next day after that she had a sudden and extreme eye tic that cause her mental confusion and her eyes to widen and roll to the right side, over and over again. Behavior regression, headaches and tics. This has been 3 weeks of symptoms.
No Adverse event. The Covid 19 vaccine that was received was the 12 and older version and not the 5-11 yo version. Adult version was given inadvertently. Pt has had no problems.
Swelling, redness 5x6cm. Distal left upper right thigh. Induration.
vaccine  for ages 5-11  given in place of  vaccine for 12 years and above   for a 14 year old patient      no reaction or problems noted  Dr notified   will not repeat  vaccine due to this being third dose
Patient reported a reaction to her second dose of Moderna administered on 04/19/2021. Patient reported itchiness all over the body occurring six hours after vaccination. Patient denied rashes, difficulty swallowing, or difficulty breathing. Patient took Claritin before sleeping and felt "better" the next morning. Patient received her first dose of Moderna on 03/20/2021 and reported no allergic reaction. Patient has history of hypertension, hypothyroidism, and allergies to contrast dye. Patient takes unspecified medication for hypothyroidism. At 1059, RN elevated situation to Clinical Supervisors. Clinical Supervisors elevated to medical consult team. Medical consult team approved patient for her Moderna booster. At 1340, patient received a Moderna booster dose (LOT# 069H21A) in left deltoid. RN educated patient to wait in observation for 30 minutes and to alert staff for signs/symptoms of an allergic reaction. At approximately 1355, RN reassessed patient. Patient denied itchiness, rashes, difficulty swallowing, or difficulty breathing. At 1410, RN reassessed patient. Patient denied itchiness, rashes, difficulty swallowing, or difficulty breathing. RN educated patient on signs/symptoms of when to seek emergency care, to follow up with PCP, and to sign up on smartphone-based tool. At approximately 1413, patient left facility with unlabored respirations and steady gait.
fatigue; sore arm; This is a spontaneous report from a contactable nurse. A patient of unspecified age (reported as 59 unknown unit) and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration from an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue and sore arm. Clinical outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
patient has a fever of 103 degrees; This is a spontaneous report from a contactable consumer (cousin). An adult patient (approximately 25 years old) of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date (on the 2nd day after receiving his 2nd dose), the patient had a fever of 103 degrees. The patient underwent lab tests and procedures which included body temperature: 103 degrees. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt given 4th Hep B and 3rd Hep A because the card had not been updated properly; no adverse reaction at this time noted.
was admitted for hypertensive urgency & alcohol withdrawal management.  In regards to COVID, he was asymptomatic, did not require supplemental oxygen and did not require treatment.  Precautions were kept in place throughout his stay and he was instructed to do a 10-day quarantine from the date of his positive test which was 6/2.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient stated vaccines always give them vasovagal response. Patient had vaccine. Felt dizzy and had vasovagal ususal response. Had patient immediately lie down. Blood pressure was 141 76 with pulse 56. Symptoms resolved and patient was fine after 30 minute rest time.
Itchy red swelling at injection site.   Tried not to scratch.  Went away after 3-4 days.
I began with a sore throat; the next day, I had a stuffy and runny nose, a heavy cough, head congestion, and a worse sore throat. I went to the pharmacy to get a PCR COVID-19 test done on 05/13/2022. That next day on Saturday, it was worse that became a fever, body chills and muscle aches. As the days went on, my symptoms got worse including body chills, muscle aches, and more. I went to the doctor on 05/16/2022 to get my first dose of Paxlovid to begin my 5-day regime as well as an antibiotic for my chest congestion (I kept coughing up phlegm). The Paxlovid put a metallic taste in my mouth, but by day 2 or 3 of the regime, I was definitely feeling way better. After the regime was completed, I felt better and resumed my day.
Pt recvd 3 doses of Hep B vax 4OCT90; 5NOV90 & 10JUN91 & 22AUG91 titer was neg; booster dose was given 29AUG91; 4OCT91 titer was neg; 2nd booster given 10OCT91 outcome pending as of 3JAN92;
102 fever, full, body aches, chills, headache,  sore eyes, nausea
pt recv vax 14DEC95 & 10SEP96 pt devel a fever & 30 to 40 small vesicles resembling insect bites;MD felt they were chickenpox;It was noted that pt possibly failed to seroconvert;
Sometime in March or April I was going in for stomach issues, my doctor did a whole panel, and my thyroid was inflamed, and I have some neck pain. This is still on going as of today 08/20/2021; she gave me Levothyroxine.
sz < 15 mins, probably focal, stopped spontaneously, not associated w/fever;
1 hour after booster- metallic taste in my mouth; and at 3 hours after shot another taste of metal in my mouth. 30 hours after booster-- fever, fatigue,soar joints, diarhea. 3 days later my right ear starting ringing and hs not stopped ringing
After the first vaccine ( 4/1) , my lower back starts to flare up back. Dr. Said it is sciatica nerve pain and gave me steroid+ pain killer and send me to PT.  I continue to do Chiropractor.   My lower back pain continue... after 2nd vaccine,  not much reaction for few days. then by July, lower back pain connected to the lower back pain. Saw Dr again, pain killer+ muscle relaxer+ PT.  I continue to see Chiropractor, add acupuncture.
Got Flu/pneu shot 10/8/08, one day later 10/9/08- redness, pain, warm to touch, felt hot & cold for 2 days, nausea, 10 cm of erythema that is swollen, hot touch and red.  Utlrasound showed no abscess- gave SXT for 7 days.
I did not have an adverse reaction to the vaccine. I have a history of liver disease but my numbers where stable prior to the vaccine. In 03/2023, I started itching all over my body including my scalp with fatigue. Also, my liver enzymes had elevated after being stable for many months. I went to my doctor, and he thought he order an MRI with contrast. The results were good. Now, my medication is being adjusted to get my liver enzymes back to normal.
This spontaneous report as received from a nurse, refers to multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with a dose of PROQUAD (lot # L040415, expiration date 13-APR-2017) or VARIVAX (lot# L031068, expiration date 18-AUG-2017). On an unspecified date, the vaccines were exposed to temperature 17 Fahrenheit (F) during 55 hours. Additional information has been requested.
Under her arm hurt terribly under the muscle; Under her arm hurt terribly under the muscle; This is a spontaneous report from a contactable consumer or other non-health professional (patient) via Pfizer sponsored program.  A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jan2021 12:00 (Age at vaccination 75 Years) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications was none. There was no family history relevant to AE. Reportedly, no additional vaccines were administered on same date of the Pfizer suspect. There were no prior vaccinations within 4 weeks. AE(s) following prior vaccinations was reported as none, patient did not took vaccines, never took shingles, flu, or pneumonia vaccine. She only got what she needed as a child and the last shot she had was about 10 years ago, it was a tetanus shot. The patient reported she took the first vaccine and under her arm hurt terribly under the muscle and it lasted 2 or 3 days and then it went away. The report was related to a study or program. The investigation assessment was done. Reported she finally got her hcp to order blood tests for her. Patient finally took the necessary blood tests. Reportedly, patient took second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) on 07Feb2021 around 10:30 in left arm. Event did not require visit to emergency room/physician office. No relevant tests were done. The patient wanted to know who to write or talk to about having an adverse reaction after the covid vaccine. Patient was asking what to do about the reaction. The outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts needed. Further information has been expected.
Patient fully vaccinated (Jansen on 10/20/2021) Patient admitted to Medical Center and tested positive for COVID-19 on 1/11/22
Patient reports receiving 2nd COVID vaccine 3/17/2021, presented with 5 days of burning all over worse in the feet x 5 days 3/25/2021. Reports it's so bad keeps her up at night, mild relief when taking a cold shower, then returns. Reports given antihistamines from PCP , BP was elevated, and thyroid studies and A1C tests and they were normal, medication isn't helping. Physical exam normal. VS WNL, BP slightly elevated 130/90. Given steroid injection and prescription, neurology referral. CBC, CMP, Magnesium, Sed Rate, CRP labs ordered. CBC and Magnesium were normal. CRP/Sed rate were unable to performed due to age of specimen. CMP showed elevated glucose/creatinine, decreased GFR. provider that received those results referred pt to nephrology.
MOM NOTED REDNESS AND SWELLING OF LEG DAY AFTER VACCINE GIVEN- WORSE THE NEXT DAY AND WAS TAKEN TO ER WITH DX OF CELLULITIS, GIVEN CLINDAMYCIN. NEXT DAY AFTER 2 DOSES MOM CONTACTED OUR OFFICE AND WAS ADVISED TO HAVE PATIENT RE-EXAMINED, SHE WAS CONCERNED IT WAS NOT IMPROVING. EXAM SHOWED LARGE AREA OF ERYTHEMA AND INDURATION IN THE THIGH WHERE DTaP AND IPV HAD BEEN GIVEN. HOWEVER THIS WAS ACTUALLY DECREASED FROM THE AREA WHICH WAS MARKED IN THE ER. IN ADDITION THE AREA WAS NOT AND NEVER HAD BEEN WARM OR TENDER.THE PATIENT HAD NOT HAD FEVER AND WAS ACTIVE PLAYFUL AND ABLE TO JUMP ON THE LEG WITHOUT PAIN. THERE WERE NO ENLARGED INGUINAL NODES. I ADVISED MOM THAT THIS WAS PROBABLY A SEVERE LOCAL REACTION TO DTaP AND TO HOLD FURTHER DOSES OF CLINDAMYCIN. PHONE CONTACT WAS MADE 24 HOURS LATER AND THE PATIENT IS CONTINUING TO IMPROVE.
High fever 103.5 (Saturday 2:00 AM). Rash face, neck, buttock, legs (12/2/18 9:00 PM). Given BENADRYL (12/2/18 - 9:00 PM). Ibuprofen Saturday - at Urgent Care.
pt recvd vax & exp itching, numbness, & tingling of rt arm;
Changes in mensuration. First month after shot I missed my period. Second month it came but was very light. Third month it was late and ever since then I?ve been getting it on and off randomly (roughly every 2 weeks for a few days)   For reference, my cycle has always been consistent 28 days. My whole life. Never had any changes to it.
swelling erythema affecting whole thigh @ site of vax extreme irritability, incessant crying w/in 6 hrs p/vax;
Patient complained of rashes, blisters,  and pain on the left side of his face and ear. Patient came to see his doctor and diagnosed with shingle infection. Patient was given Valacyclovir 1g three times a day for 7 days. Patient is improving, still showing rashes and blisters on face and ear.
Diagnosis of pericarditis made while deployed approximately 2 weeks after vaccine administered. Follow up on 7/6/05: No additional comments.
Test positive for COVID 3 months prior to dose 4 COVID-19 vaccination; Since testing positive have been having Myalgia, that's progressively getting worse, and shortness of breath; Have started taking Celebrex, Tramadol and Advair.
PT WAS IN THE ROOM TO GET VACCINES WITH AN OLDER SIBLING. VACCINES WERE PULLED FOR ALL CHILDREN. MENINGICCOCAL (PULLED FOR AN OLDER SIBLING) WAS USED AS THE DILUENT FOR THE PROQUAD. PT SHOWED NO ADVERSE SIGNS OR SYMPTOMS.
Received  Moderna vaccine, 2nd dose 4/19/2021. On 4/24.2021 experienced a stroke .  Pt awoke morning of 4/24/2021 with "severe vertigo and vomiting".
Arm pain and soreness began 05/23/2021 around 12:00 pm and ended 05/25/2021 around 12:00 pm. Headache began 05/23/2021 around 12:00 pm and ended 05/25/2021 around 9:00 am. Low grade fever began 05/23/2021 around 08:00 pm and ended 05/23/2021 around 10:00 pm.
Chills, nausea, headache & muscle pain lasting approx. 12 hours
CT PRESENTED TO THE EMERGENCY DEPARTMENT 5 DAYS AFTER RECEIVING THE INFLUENZA VACCINE WITH PAIN AND REDNESS IN LEFT SHOULDER. CT STATES SHE DEVELOPED PAIN A DAY AFTER GETTING THE INFLUENZA VACCINE. CT REPORTS THE AREA IS ITCHY AND SHE HAD BEEN SCRATCHING AT IT QUITE A BIT. CT WAS DIAGNOSED WITH LEFT ARM CELLULITIS.