chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of blood in stool in a 2-month-old male patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, unknown after receiving ROTARIX, the patient experienced blood in stool (serious criteria GSK medically significant). On an unknown date, the outcome of the blood in stool was unknown. It was unknown if the reporter considered the blood in stool to be related to ROTARIX. Additional information received: A 2-month-old male experienced bloody stool after receiving ROTARIX. Per sales representative, this event has been reported to VAERS.
ONGOING PAIN AND DECREASED RANGE OF MOTION OF LEFT ARM FOLLOWING INJECTION 8 DAYS AGO. INJECTION GIVEN IN POSTERIOR SHOULDER VERSUS MID DELTOID. {form filled out on 04/03/18-online form filled out 04/06/18}. TREATMENT: ROM EXERCISES; IBUPROFEN, ICE. CONTINUE TO MONITOR IF NO IMPROVEMENT RTC IN 1 WEEK FOR FURTHER EVALUATION AND IMAGING.
extremely bad dry mouth; lips were going numb; facial numbness; rash from his neck to his nipple line; BP was 180/110 / BP stayed around 160/100; felt an "amped" feeling; felt flush; uncomfortable; This is a spontaneous report from a contactable healthcare professional. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), dose number 1, intramuscularly on 21Dec2020 14:00 at a single dose on the right arm for COVID-19 immunization. Medical history included gluten allergy with causes dermatitis herpetiformis, osteoporosis, and fibromyalgia. The patient previously took Benadryl and experienced allergies. Concomitant medications were not reported. The patient reported that immediately after receiving vaccine on 21Dec2020, he felt an "amped" feeling and felt flush. It was uncomfortable but not alarming at first. About ten minutes after shot, he started to have extremely bad dry mouth. He went back to work, but he went back downstairs after feeling like he was getting seriously ill and his lips were going numb. His BP was 180/110. The facial numbness went away but his BP stayed around 160/100. He was asked to go to ER, but he refused because he would have to pay for it and he was feeling better. He also noticed after going back upstairs that he had a rash from his neck to his nipple line. The doctor asked for Benadryl, but he was not given due to possible Benadryl allergy. He went home and his BP returned to normal 2 hours later. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. The outcome of the events was recovered in 21Dec2020 for blood pressure increased and facial numbness, and recovered on an unspecified date for the other events.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the BP increased and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Developed an anaphylactic reaction to flu shot. Administered Epipen and BENADRYL. Sent to ER for further monitoring.
This is for documentation only. Patient stated she received her 1st dose of Pfizer on May 13th, 2021. Confirmed by her daughter. However, the state reporting system says she got Johnson and Johnson. Patient received dose of Pfizer today. No apparent adverse reaction at this time. Patient was held for 30 minutes. No problems.  Patient did not bring her vaccination card to appointment
Very large and very painful swelling of the lymph nodes in the armpit of the arm that received the vaccine.
Information has been received from a physician concerning a 13 year old female patient who on 12-AUG-2008, was vaccinated with the first dose of GARDASIL (Lot # 659184/0843X) for prevention of HPV. The physician reported that the patient fainted after receiving GARDASIL. The physician noted that the patient was already sweating and anxious prior to receiving the vaccine. At the time of the report, the patient had recovered. The patient sought medical attention by the physician. This is one of two reports received from the same source. No further information is available.
Positive Covid Test.  Mild sore throat and headache for approx 2 days.  General fatique for a week.  Received Paxlovid within 12 hours of the positive test.
Information has been received from a healthcare worker concerning an approximately 80 year old female patient with allergies to shell fish, alendronate sodium (MSD) (WAES # 1007USA03489), enalapril maleate (MSD) (WAES # 1007USA03493), ZIAC, codeine and "NICOVACT" and no pertinent medical history, who on 04-JUN-2007 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck). There was no concomitant medication. The healthcare worker reported that on 07-JUL-2010 the patient developed pruritic rash on her right upper chest and back covering a large area after administration of ZOSTAVAX (Merck). No laboratory diagnostic tests were performed. At the time of the report, the patient was recovering. The patient sought via an office visit. Additional information has been requested.
I noticed in July I had tingling in my left leg, left and left side of the face. It was persistent and didn't go away in a couple of days so I visited my PCP.
Evening of the day, DTP/OPV/HIB were administered, mom phoned to state the pts face was blotchy & that pt was irritable; by time reached MD on call sx subsided; no tx;
Information has been received from a physician concerning a 19 year old female who on 06-NOV-2008 or 07-NOV-2008 was vaccinated with the first dose of GARDASIL.  The physician reported that the patient received another vaccine on the same date on the other arm, but the name and manufacturer of that vaccine was unspecified.  After receiving the vaccination, the patient's arm was swollen about 6 inches and was very red.  The physician reported that the patient has recovered and would not be receiving any more dose of GARDASIL.  The patient sought medical attention.  Additional information has been requested.
Patient presented at 14:17 with urticaria on right forearm, pruritis on back, trunk, bilateral arms, scalp and facial flushing. Denies shortness of breath, chest pain, headache, difficulty swallowing and difficulty breathing. 14:22 BP 122/78, P 86, O2 99% RA, R 18. 14:24 administered 25 Mg Benadryl PO. 14:30 BP 116/76, P 81, O2 100% RA, R 18, patient reports improvement of symptoms. Advised patient to seek medical attention if symptoms worsen, additionally advised patient to consult with allergist prior to 2nd dose administration, patient verbalized understanding. Patient left at 14:45 with boyfriend in stable condition, no respiratory distress, patient refused medical transport to hospital.
Moderna COVID-19 Vaccine EUA Soreness in the arm the evening of the day given the shot.  The next morning I had a mild headache and chills.  I put on warm clothes and turned the heat to 76, which I never do.  The headache and chills were gone by 8:00 pm.
Breathing started to be laborious 6 days after Phyzer booster on 16 Feb 2022, got worse, heart failed , no oxygen . Blood clots
MY RIGHT UNDER ARM AND SIDE WAS PAINFUL, THEN SEVERAL DAYS LATER A RASH APPEARED ON MIDDLE OF BACK AND WENT UNDER RIGHT ARM AND ON RIGHT BREAST AREA. MOST OF THE RASH HAS DISSAPPEARED BUT STILL A SMALL AMOUNT ON BACK. PRESCRIBED DESONIDE 0.05% CRE ACT APPLY FOR 10 DAYS  -  ValACYclovir 1GM TAB AUR TAKE 1 TABLET BY MOUTH 3 TIMES DAILY FOR 7 DAYS.  DIAGNOSED AS SHINGLES.
The pt experienced swelling to the right arm and shoulder area, redness and hot. The injection site was oozing. The pt went to the clinic for treatment. They referred her to ER for treatment. Treatment was Cephalexin. The pt returned for follow-up and is much better.
Evening of 7/24 mother noticed a dot near her butt inside/on her diaper area. Morning of 7/25 grandparent noticed multiple (3-4) dots near same area. She was scratching her diaper area in the morning of 7/25. Patient took nap from 12-3pm and when she woke up, she was covered in hives - she was itching her face, her stomach and back were covered in spots, then she had random spots on her neck, arms, legs and feet.
rash all over;red blotchy, itching;no fever or other systemic rxn;
fever & muscle pain are reported in a pt who recvd flu vax-pt recvd 0.25cc on 6NOV93 & on 10NOV93 began to exp fever 103 for 48 hrs; muscle pain was in pt's neck & limbs;
Vaccinated at flu clinic held at hospital infection prevention office. Complained of vomiting one hour after getting vaccination. BP 113/61 Pulse 59. No further vomiting - only once. Stated he had a GI bug one week prior. ED at 1154. Left without instructions 1513.
pt recvd vax 19OCT95 & 20OCT95 pt devel a t104.6 & exp febrile convuls in the early morning of 21OCT94;pt was adm to hosp w/mild pahryngitis & post auricular lympahdenitis;lab eval revealed WBC count of 12.5 w/a lymphocytic shift;
Mother of patient stating that patient had rashes all over body the night after vaccines given, on 8/25/10.
Twenty minutes after injection left arm became very heavy, sharp tingling sensation and increased pain. Drove home, started dinner. Took Advil 2 tabs for pain. At 4:30 ate macaroni & cheese. Lay down and fell asleep for 1/2 hr. Became nauseated, abdominal cramps and diarrhea lasted until 6 pm. Arms, legs, and feet cold and tingly. Then began to feel a little bit better. Next day no arm pain felt back to normal self.
Flu vaccine administered 11/2/15 at 1600 by 1800 right arm and nad hand swelling, pain, decrease movement. On 11/09/15 patient was seen in Occupational Health. Patient received flu vaccine on 11/02/15 in Occupational Health at approximately 1600. She reports that about 1.5 hours after the vaccination (approximately 1800) she experienced pain, swelling, and decreased mobility due to swelling in right arm and hand requiring her to leave work. She took ibuprofen 800 mg and an undisclosed antihistamine when she arrived home. After 4 hours there was no relief and she took and additional ibuprofen 600 mg. She was unable to report to work on 11/03/15 and called in for absence. She repeated the ibuprofen 800 mg with undisclosed antihistamine in the A.M., then later repeated the ibuprofen 600 mg without relief of symptoms. On 11/04/15 she had decrease pain and swelling and was able to return to work but by afternoon was having return of symptoms. On 11/05/15 she was seen in ER. She was given IV Clindamycin after culture of hand done. Previous lab work was consulted and found she was positive for RA. MD in ER told her that the Flu vaccine caused an exacerbation of her RA condition causing the swelling and pain She was started on Prednisone 60 mg daily for 5 days and then 50 mg daily for 5 days. Also she was prescribed Meloxicam 7.5 mg daily. She states by 11/7/15 she was better with less swelling, pain, and able to close hand. Note from MD for Return to Work on 11/16/15.
13 hours after the vaccine I experienced a fever, slight body aches, sore arm and tiredness which lasted for 24 hours
Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent. From 07-JUL-2017 to 09-AUG-2017, the patients each was vaccinated with improperly stored doses of ZOSTAVAX (dose and route unknown, M037654 with expiry date 29-NOV-2017, N014018 with expiry date 04-JUL-2018 and L024999 with expiry date 03-JAN-2018) for prophylaxis. No adverse effect was reported. The vaccines were under the temperature ranged of -14 degree Celsius to -10 degree Celsius for 24 hours, -9 degree Celsius to 8 degree Celsius for 24 hours and 9 degree Celsius to 25 degree Celsius for 24 hours. There was no previous temperature excursion. A data digital logger was used. Sender's Comments: US-009507513-1709USA004451: US-009507513-1708USA006160.
sensation or flushing into both arms and across chest with flushing of face and arms that lasted about 10 minutes and gradually subsided
5/26/21 @ 6:00PM - Headache and fatigue.  Went to sleep right after symptoms started. Woke at 4:35AM on 5/27/21.   5/27/21 @ 5AM - felt disconnected; 4:00PM - started getting body aches in knees mostly, slight nausea; 5PM took temperature @ 99.1°F; 6PM 2nd temp taken @ 100.0°F; 3rd temp taken at 7:35PM @ 99.3°F.  Experienced fatigue, fever, body aches on 5/27/21. Laid down starting at 5PM that evening and woke up at 8:30AM on 5/28/21.  Temp is normal now at 98.3, and no adverse effects being felt at this time.
When the shot was administered there was a hot burning sensation/pain.  Throughout the first day the pain continued to get worse and by the morning I could not move my arm without extreme pain. Started to alternate Tylenol/Advil every 2 hours as well as an ice pack every 3 hours.  This was continued for the first 5 days.  For the last 4 days I have been able to reduce my Tylenol/Advil to 4 times per day.  Pain increases at night when I'm trying to sleep and continue to use the Tylenol/Advil throughout the night as well as icing.
5 days later and my husband got the shot same exact time ended up with a incapacitating bout of vertigo; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "5 days later and my husband got the shot same exact time ended up with a incapacitating bout of vertigo".  Additional information: This consumer reported for a male patient (husband). After the vaccine one, Pfizer 1st vaccination 6 days later in evening of the first shot she awoke about 7 hours later after she went to sleep at night she couldn't breath like someone put a pillow on her face and she couldn't get air and it woke her from a sound sleep, 5 days later she ended up not feeling, meaning that is she had her symptom 5 days later and her husband got the shot same exact time ended up with a incapacitating bout of vertigo and she was calling to see if we had any other report of these kind (side effects)."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was receivd from a nurse regarding a 12 year old male patient. There was no information on medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with M-M-R II (dose, route, product lot#, expiry date not reported) and two measles virus vaccine live (product details not provided). No adverse effects had been observed or reported. The reporter did not clarify in which location or on which dates the immunization were administered and did not agree that there was any misuse. The reporter also enquired about administrating PROQUAD (Merck) to the patient to complete the rubella and mumps vaccinations so that the patient would receive 2 doses of mumps and rubella vaccine. There was no product quality complaint involved. The outcome of the event was unknown. Additional information is not expected as there was no consent to contact the reporter.
nausea, dizziness, fever, SOB, flush, large red area on LUE;
Pt reported to pharmacy on 11/13/14 complaining of shoulder pain and unable to lift  her arm very high. I told her to see her doctor.
Left side of face went numb (on and off), no feeling in left hand or left side of face. No treatment. No muscularly connections.
On 08/25/08 TD was administered to the patient intradermally, in the left inner forearm, instead of a PPD test.  The patient immediately experienced pain, erythema, swelling and induration at the injection site.  The PPD test was performed correctly in the right arm on the same day.  The patient called the clinic back on 08/29 to report that a nodule had formed and she was experiencing itching and warmth at the injection site.
expired dose of Ipol was inadvertently administered to a patient/No AE; Initial information was received on 05-May-2020 regarding an unsolicited valid non-serious case from the other health professional.  This case involves a four-month-old female patient who received expired dose of IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL), HIB VACCINE CONJ (TET TOX) (ACTHIB), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and oral ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination on 05-May-2020.  On 05-May-2020, the patient received a second 0.5 mL dose of suspect IPV (VERO) lot P1A461M, expiry date 03-May-2020 via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  An expired dose of IPOL was inadvertently administered to a patient.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain in upper left arm in area of vaccination, but not just right after the vaccination, but lasting to this day, two months later, and actually inhibiting motion of the arm (as when swinging arm horizontally as part of exercise routine). The pain is only felt when I use the arm in the particular motion described. I have done nothing for it, hoping it would just go away; but it seems to be permanent, and not sure what could be done anyway. Now don't know whether to get second SHINGRIX shot. I would hate to be crippled in both arms!
Patient was administered proquad with expired steril diluent, no adverse even occurred. Occurance was reported to Manufacter and was advised that there was no need to readministed vaccine. Spoke with MD and was advised that patient would be okay, not to readminister vaccine.
Urticaria developed on upper legs and spread through body.  Treatment is cetirizino and diphenhydramine.
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored ROTATEQ (strength, dosing details, anatomical location, lot# and expiration date were unknown). There were previous temperature excursions but, no information was provided on previous excursions. The temperature excursions were detected by a data logger. No product quality complaint was involved. Additional information has been requested.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Woke up at 8am with soreness at the injection site.  Started feeling feverish at 3pm.
Patient received a high dose flu vaccine in error as he had already received a flu vaccine on 10/13/2022.
Clusters of vesicular rash on coccyx area, left gluteal cleft & left perineum, 1.5 cm diameter.  For last 5 days.  Itching sensation prior for approx 24 hours.  Pt applied Neosporin for 3-4 days.
pain radiating from a lump at injection site upward to shoulder and, to a lesser degree, down through forearm limited range of movement with extreme discomfort when full movement is attempted This condition has continued without improvement for over a year.
Within seconds of giving both injections, the patient fainted while sitting and bumped her head on the immunization desk. Pharmacist attempted to alert patient, had an associate call 911, and the patient regained consciousness on her own with 15-20 seconds of fainting. Once the patient regained consciousness blood pressure was taken (137/85 PR of 60) and the patient was monitored until the EMS arrived.
Rt. arm was swollen, red, hard & hot to touch. Mom also said child was sleeping alot.
I had lower extremity pain from the hips to my toes. I experienced pain and swelling where I wasn't able to walk. I didn't take any medication for the symptoms. I wasn't able to work because my feet were so swollen. I tried to elevate my legs to reduce swelling but there was no change. I spoke to my doctor on 03/29/2021. I was scheduled for a appointment where I was referred for further testing for bilateral blood clots, autoimmune disease, Sed Rate, d-dimer, Thyroid, and Lipids. All test came back negative. Severe symptoms persisted for several few months and thereafter the symptoms started to subside and then approximately in September 80% of my symptoms subside. From September to current the symptoms have continued to slowly improve. Currently at 90-95% recovery. Still have some remaining residual leg lower leg swelling.
Mom reported child had high fever (temp not measured) & gave APAP; Pt had trembling of hands & light sz; Seen by MD; Pt to have no more pertussis;
Initial report received on 28 October 2011 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject's vaccine history included 3 doses of PENTACEL; lot number C3290AA received on 29 September 2009, lot number C3251BA (invalid lot number) received on 30 November 2009, lot number C3545AA received on 01 February 2010, and one dose of TRIPEDIA; lot number U3040AA received on 30 November 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 19 September 2011, approximately nine months after the last dose. On 26 September 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting. Laboratory testing included positive PCR on 06 October 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 06 October 2011 for five days. The subject was not hospitalized. At the time of final contact on 14 October 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 26 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.