chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shot was given very high up on arm, was sore 4 hrs, later and next few days then spread out into shoulder and in next 5 wks, pain went to neck and down arm. I did exercises and took pain relief but neither is working to stop the hurt. Was told I have frozen shoulder. Cannot sleep on (L) side.
Case number PHHY2016US027453, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609755) website on 29 Feb 2016. This report refers to a 35-years-old female patient. Past medical history and current conditions were not reported. She was vaccinated with FLUVIRIN (batch number: 157901) intramuscularly in left arm on 01 Oct 2015. On 02 Oct 2015, she experienced pain around the rotating left shoulder. She also reported that she missed work for the first two days and used adhesive tape to wrap around the upper arm to give support. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (administration route, lot numbers and expiration dates were not provided). No concomitant therapies were reported, neither was any adverse event. This is one of several reports from the same reporter. Additional information has been requested.
Pt states that since he received flu shot on 9/26/16 he has uncontrollable sneezing and runny nose and had decreased his quality of life.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time). On 26-Aug-2021, PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine refrigerated on 20 Apr 2021 and temperature changes 42 F were noted.  No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
Client was vaccinated with Pfizer vaccines on March 7 and March 31, 2021.  Covid symptoms started 9/1 with runny nose, nasal congestion, and cough.  Tested positive for Covid with PCR on 9/6/2021.  Reported as a case of breakthrough Covid in a fully vaccinated person.
reporter reports inc # of adverse events in pt who recv pneumococcal vax;specific events were not identified;
Patient experiencing swelling on left supraclavicular area. Patient denies any other symptoms at this time.
Pre-filled  syringes of Moderna were sent in subcutaneous syringes and not not intramuscular. Dose was administered intramuscular via a subcutaneous syringe.
Patient has muscle pain in her shoulder and she is not able to lift up her arm. She is currently seeing an orthopedic doctor for her pain.
History of Present Illness: is a 42yo female who presents to clinic today for evaluation of redness and swelling that developd since last night on her left arm. She endorses some discomfort extending down the arm and into the hand. Denies itching at this time. She received her first dose of COVID-19 vaccine/Moderna 8 days ago. She states that she initially had a slightly sore arm but no other injection site reaction until now. Denies fever, chills, difficulty breathing/swallowing, scratchy sensation of throat. Denies injection site reactions to other immunizations in the past. She has applied ice to the area and Tylenol. She also denies recent injury or break to skin.   Physical Exam: General:  well developed, well nourished, in no acute distress.   Lungs:  clear bilaterally to auscultation.   Heart:  regular rate and rhythm, normal S1, S2 without murmurs, rubs, or gallops.   Msk:  no deformity, normal gait.   Pulses:  pulses normal in all 4 extremities.   Skin:  16 cm x 14 cm area of swelling with erythema and increased warmth. Skin is intact. Patient notes area is lower than actual injection site. Outlined with skin marker.  Psych:  alert and cooperative; normal mood and affect; normal attention span and concentration.    Problem # 1:  Other serum reaction due to other serum, initial encounter (ICD-999.59) (ICD10-T80.69xA) Outlined area of erythema. Advised patient to use Benadryl and topical steroid cream such as hydrocortisone or triamcinalone. May continue to use Tylenol or ibuprofen as needed. Per UpToDate, delayed injection site reactions to COVID-19 vaccine should not be treated with systemic corticosteroids given potential to reduce immune response. Advised patient to monitor for spreading erythema, fever, "scratchy" sensation to throat and present to ED if she experiences difficulty breathing or swallowing.  Patient Instructions: 1)  Area marked - watch for spreading of redness outside of marked lines. 2)  Use Benadryl as needed. 3)  Apply topical cream such as hydrocortisone or triamcinalone.  4)  Advise having second COVID vaccine dose in opposite arm. 5)  Monitor for fever, difficulty breathing/swallowing, worsening redness, pain at site. If having difficulty breathing/swelling go to nearest ER.  6)  Patient to call if any questions.
MOM NOTICED LARGE SWELLING IN THIGH STARTING AT HIP DOWN TO AND INCLUDING THE KNEE ABOUT 24 HOURS AFTER SHOT.  ALSO HAS BLOTCHY REDNESS, WARMTH, HARDNESS AND TENDER TO TOUCH.  MOM STATES CHILD HAS BEEN VERY CLINGY AND IRRITABLE.
Pt. left the immunization clinic and returned home.  After returning home the patient called the health department to report that while leaving the health department (3rd Floor) while taking the steps he experienced the onset of sharp pain in his lower back and pain in his hips.  He made his way to the car and began to drive home.  On his way home he reports the pain in his back and his hips became "very intense".  After driving the 5 minutes to his home he states he had difficulty getting out of the car due to the pain.  While on the phone with this nurse at the Health Department, approximately 15 minutes after leaving, the patient reports he is feeling better.  He states the pain has decreased by 90%.  I encouraged him to contact his physician if the pain persists.  If a physician is not available he should seek medical assistance at the Urgent Care Clinic.  I will return a phone call to the patient tomorrow to ensure he is feeling better.
As of today I am being referred to a breast cancer specialist, and pending a diagnosis. Both breast areolas became hypersensitive to touch on friday, March 28th. On Saturday the pain level reached a 9 despite using the maximum levels of ibuprofen, Tylenol, and Advil. I contacted the nurse line at the veterans' administration and they referred me to the emergency room, which made the referal to the breast cancer specialist. The second adverse effect is dizziness with nausia consistant since may 5th.
Severe burning sensation in left forearm with shot one, shot two.  Severe burning Left side of vaginal area next to inside of left leg (PUDENDAL NERVE) with shot two
Erythema at injection site "burning" to left arm, both arms, now legs and eyes. No rash, no swelling and no fever, VSS. Advise; Monitor.
The evening of 11/12/2021, I was very tried and did not have an appetite. I had cold like symptoms and woke up in the middle of the night with chills but I did not have a temperature. for three to four days I had a severe headache and my arm was very sore I could not lift it.
I first gave influenza vaccine in left deltoid, then immediately administered pneumonia vaccine in right deltoid. Patient said she immediately had "metallic taste" when given pneumonia shot.  She then began to flush bright red on face and extremities and said she "felt dizzy".  I gave her (2) diphenhydramine 25mg capsules.  Patient rested about ten minutes (her pulse was taken periodically) and then said she felt fine (skin color looked normal at that time, also). She called later in evening to report that she felt fine and we followed up with her again the next morning.
No additional AE reported.; Medical Assistant called and reported that a dose of MMR-II was administered on 7/2/2021 and expired on 6/30/2021./ lnadvertently administered post expiry; This spontaneous information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 02-JUL-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 mL, as prophylaxis, lot number reported as 020161 with expiration date reported as 30-JUN-2021 (strength, frequency, route of administration, and anatomical location were not reported) (expired vaccine used).  No additional adverse events reported.
SWEATING; CHEST TIGHTNESS; FATIGUE; JOINT ACHES; NUMBNESS IN BOTH HANDS; EXPLOSIVE DIARRHEA; VERY BAD FLU/FELT VERY SICK ALL DAY/FEVER/DIFFICULTY BREATHING/POUNDING HEADACHE/MUSCLE ACHES/ACHY ALL DAY; FELT WEIRD AND DIFFERENT; GUT STARTED RUMBLING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced felt weird and different. On 30-SEP-2021, the patient experienced gut started rumbling. On 30-SEP-2021, the patient experienced very bad flu/felt very sick all day/fever/difficulty breathing/pounding headache/muscle aches/achy all day. On 30-SEP-2021, the patient experienced joint aches. On 30-SEP-2021, the patient experienced numbness in both hands. On 30-SEP-2021, the patient experienced explosive diarrhea. On 01-OCT-2021, the patient experienced fatigue. On an unspecified date, the patient experienced sweating, and chest tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gut started rumbling, and explosive diarrhea on 30-SEP-2021, joint aches on 02-OCT-2021, and numbness in both hands on 01-OCT-2021, was recovering from felt weird and different, had not recovered from chest tightness, very bad flu/felt very sick all day/fever/difficulty breathing/pounding headache/muscle aches/achy all day, and fatigue, and the outcome of sweating was not reported. This report was non-serious.
Information has been received from a medical assistant and a pediatrician concerning a 17 year old female patient for the pregnancy registry for GARDASIL with no pertinent medical history and no known drug allergies, who on 31-OCT-2007 was vaccinated with the first dose of GARDASIL (lot# 653978/0955F) 0.5 ml intramuscularly. There was no concomitant medication. It was reported that the patient found out she was pregnant in "December 2008" after receiving the first dose of GARDASIL. Patient sought medical attention from unspecified OB. On 29-AUG-2008 the patient received the second dose of GARDASIL (lot# 660553/0070X) 0.5 ml intramuscularly after delivering a healthy baby on June 2008. Follow-up information received from the medical assistant who reported that the patient has had a history of 1 previous pregnancy and 1 full term delivery. The infant was born 30-JUN-2008, Apgar score of 1, normal, with no congenital anomalies and with no other complications or abnormalities. Follow up information received on 06-FEB-2009 from a pediatrician who reported that the patient has a history of mononucleosis and UTI. Number of previous pregnancies is 0 (previously reported as 1); number of previous live births is 0 (previously reported as 1). The date of the last menstrual period is 08-OCT-2007. On 24-NOV-2007 patient was on treatment with KEFLEX 500 mg twice a day, for 5 days for the treatment of urinary tract infections. Ultrasounds performed on two different occasions with normal results. On 27-JUN-2008 a biophysical profile was performed. Complications during pregnancy included premature rupture of membranes and irregular fetal heart rate, fetal arrhythmia. Failure to progress during labor/delivery therefore a cesarean section was performed. The baby was born 37 weeks from LMP, weighed 6 pounds 11 ounces and was 19 inches tall. Infant was normal with no congenital anomalies. No further information is available.
BLEEDING BUMPS/HIVES; TERRIBLE ITCHING; HIVES ALL OVER BODY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 14:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride, hydrocortisone acetate, and paraffin, liquid/petrolatum/wool fat. On 13-MAR-2021, the subject experienced bleeding bumps/hives. On 13-MAR-2021, the subject experienced terrible itching. On 13-MAR-2021, the subject experienced hives all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives all over body, terrible itching, and bleeding bumps/hives. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Large, painful, local rxn. 8 cm diameter raised about 4 cm, Well demarcated. Out break of HSV #1 - lips and mouth.
enlarged supraclavical lymph node enlargement on same side as vaccine dose; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot 5730, expiration date unspecified), intramuscular on 21Dec2020 13:30 at single dose (left arm) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. On an unspecified date, after initial dose, the patient experienced enlarged supraclavical lymph node enlargement on same side as vaccine dose 24 hours later and lasted 17 days. There was no treatment for the event. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. The patient had no other vaccine in 4 weeks and no other medications in 2 weeks. Outcome of event was recovering.
Two days after on lower left side of mouth gums became swollen and would bleed when brushed. Has been like that since 11/18 and is now 11/21. Yesterday night 11/20, upper left side of gums is swollen and whenever brushed bleed and are sore. Soreness lingers even without being brushed. Salt water rinses do some initial aid in relieving pain, but overall has not reduced the soreness or swelling. Condition also makes eating difficult as food and jaw movements disrupt the gums.
Temperature over 102, myalgia, weakness, swollen and hot pink injection site, with effects including temperature over 100 lasting more than 48 hours.
pt recv vax 7JUL93 & 21JUL83 devel bruising & petechiae on face, trunk, arms & legs; platelet count was 14,000; 24JUL93 hospitalized w/thrombocytopenia; upon exam t99.4, pulse 132 & resp 40;
This spontaneous report was received from a licensed vocational nurse and refers to an unspecified number of patients of unknown age and gender. On an unknown date, an unspecified number of patients were vaccinated with improperly stored M-M-R II (route of administrations, doses, lot numbers and expiry dates were not reported). It was reported that the vaccines were exposed to worst case 85F for 42.5 hours. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Seizures began 2 weeks after 2 month shots. Hospitalized x 4 days. 60 day follow up states the pt has not recovered. Pt continues to have seizure every day.  Annual follow-up on 01/05/04: "Vaccine recipient has not recovered from the adverse events that were reported for this vaccination.  Pt still with seizure disorder and developmental delay."
Patient reported that he had 4 seizures after receiving the vaccine.  The first was at approximately 12:30 then another about 15 minutes later.  There was one more that evening and another the next day.
Patient is 17 years old. EUA for Janssen vaccine is for 18 years and older and vaccine was administered to a patient who was under 18 years old
Initial misuse report received from a doctor on 01 October 2013. The 5 months old patient had received FLUZONE and vaccine was administered to incorrect age of patient. No adverse event was reported. List of documents held by sender: none.
DOS: 5/4/21 Patient received vaccine 4/27/21 administered by , APRN. Patient reports that she woke up on 4/30/21 with fever (tmax 101.1), headache, and dry cough. Over the course of 5/1/21-5/3/21  she developed significant hoarseness with her voice. She denied sore throat, described more as "itchy".  She has not had a confirmed Covid-19 case in the past. At DOS she expressed that she felt greatly improved compared with 4/30/21 but work sent her home and requested she get evaluated for illness.
Initial information received on 27-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case is related to case- 2019SA089330, 2019SA089331, same reporter. This case involves a 22 months old male patient who received an expired DAPTACEL vaccine. The patient's past medical history and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; and HEPATITIS B VACCINE on 24-Mar-2019. On 24-Mar-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C517AA, expiry date 23-Mar-2019 via intramuscular route in the thigh nos. It was an actual medication error due to expired vaccine used. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
pt recv vax 31MAR97 & in the middle of the noc 2APR97 pt exp h/a, fever, abd discomfort & emesis;pt recovered that same day;
diagnosed with the auto immune Hashimoto's disease; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date in Apr2021, 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 and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single for covid-19 immunisation. It was reported that, the patient completed the 2 vaccine shots back in April2021. 5 months later, the patient was diagnosed with the auto immune Hashimoto's disease. The outcome for the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
11 hours after the vaccination I felt achy all over, my legs felt limp and lump on my arm was sore.  Temperature measured 98.6.  I took two Tylenol and went to bed.  I got up two times during the night to go to bathroom.  I felt more achy all over and unsteady on my feet. Did not want to get out of bed next day, so slept until noon.  At noon my temperature was 100.4. I took 2 Tylenol every 6 hours.  Had a very achy, miserable day and just rested.  Was somewhat better by bedtime and had a better next night of sleep. Next day am still achy but much better.
The day following the patient's injection he experienced neck pain in the trapezius with inability to touch chin to chest. Patient continues with pain now four days later. He reports taking acetaminophen for the pain. He came to see his PCP to evaluate the pain.
Urticaria developed within 24 hours of receiving the Tdap. - SOB or difficulty breathing Pruritus resolved with Benadryl given 4mg Dexanthasone and 80mg Depomedrol
INJECTION SORENESS; BASEBALL SIZED WELP ON ARM; FEVER AT INJECTION SIDE.
Information has been received from a RN concerning a 15 month old child who on 02/10/04 was vaccinated in the left leg with a dose of MMRII (Lot # 646740/0822N). The nurse reported that the pt experienced a local site reaction and developed redness at the injection site. The pt was observed and no treatment was needed. The reporter has requested a lot check. The records of testing prior to release of this lot (646740/0822N) have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The nurse reported another child who experienced a similar reaction after therapy with MMRII (WAES # 0402USA01555).  The nurse also reported that triplets experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01433, 0402USA01540, 0402USA04541).  The nurse reported another child who experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01546).  It was noted that the triplets had the worst reaction.
Expired Bexsero was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB39AA, expiry date 30th January 2006) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The health care professional reported that expired dose of Bexsero was administered to a patient. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Pt recvd HIB 22OCT90 & on 28MAY92 pt was taken to ER p/sudden onset of vomiting & high fever which lasted 5 hrs; CSF culture pos for H. Influenzae type B; dx HIB meningitis; hospitalized 12 days;