chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was determined by the practitioner the patient was too young to receive the dose; This case was reported by a other health professional via call center representative and described the occurrence of intercepted product administration error in a 15-year-old female patient who received Men B NVS (Bexsero) 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 an unknown date, the patient did not receive Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intercepted product administration error. On an unknown date, the outcome of the intercepted product administration error 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: 04-Apr-2022 Reporter's Comments: Office manager reported that a Bexsero dose was drawn up for a patient but not given as it was determined by the practitioner the patient was too young to receive the dose. Further details were not provided to the reporter who stated she was not sure which day this occurred.  Submitting potential near-miss to safety with limited information provided.  The reporter consented to follow up from safety. Additional Supportive Information: The practitioner avoided the dose as patient's age was too young, which led to intercepted product administration error.
sore arm; felt exhausted; out of energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (felt exhausted) and ASTHENIA (out of energy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 320M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (felt exhausted) and ASTHENIA (out of energy). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (felt exhausted) and ASTHENIA (out of energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not provided.
joint pain in knees persists to this day, over a month now, after receiving my third COVID vaccine.
Immediately after receiving her shot pt arm got localized red, itchy, hot reaction at injection site. We put ice pack on it for 15-20 minutes and it resolved completely. Pt said this happens with her allergy shots also.
This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (Pain in her organs. Literally everything hurt, like my organs), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain) and ARTHRALGIA (Arthralgia) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN (Pain in her organs. Literally everything hurt, like my organs), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain), ARTHRALGIA (Arthralgia), HEADACHE (Headache), MYALGIA (Myalgia), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, PAIN (Pain in her organs. Literally everything hurt, like my organs), CHEST DISCOMFORT (Chest tightness), DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal pain), ARTHRALGIA (Arthralgia), HEADACHE (Headache), MYALGIA (Myalgia), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2020, SARS-CoV-2 test: positive (Inconclusive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.
Covid + on 10/25/2021. Received Pfizer vaccine with 1st dose on 04/09/2021 and 2nd dose on 04/30/2021.  Per H & P: Assessment/Plan  Moderate symptomatic hyponatremia --124 on presentation, currently 125, repeat pending Acute hypokalemia, resolved Acute leukocytosis, resolved Generalized weakness, secondary to above  Sinus bradycardia, asymptomatic.  Hypertension, stable on presentation, slight elevation at this time.  Degenerative joint disease  History of osteoarthritis  Postherpetic neuralgia, on gabapentin  Plan  Admit patient to ER  Vitals: Per protocol   Activity: As tolerated  Nursing Orders: Per protocol  Diet: Regular  IVF: 0.9% normal saline at 55 cc/hr   Hospital Meds: Appropriate home meds resumed.  Labs: CBC with diff, BMP q 6 hours, magnesium, phosphorus  (repeat BMP pending)  *Goal Sodium of 130 by 1700  Imaging: CXR reviewed  Micro: urine culture pending  DVT PPx: Enoxaparin  Consultation: PT/OT, Nephrology  Chief Complaint  Weakness/Fall History of Present Illness  Patient is a 96-year-old female with past medical history of hypertension, CAD, sinus bradycardia, degenerative joint disease, and postherpetic neuralgia who presented to the emergency department with acute onset of weakness and a mechanical fall.  Patient notes increased weakness for the past several weeks.  She was seen in the emergency department on 10-5-21 after her initial fall and subsequently left AGAINST MEDICAL ADVICE.  At that visit patient did have a sodium level of 125.  At time of evaluation patient was only complaining of right-sided low back pain and fatigue.  She denied any chest pain, palpitations, shortness of breath, nausea/vomiting, or abdominal pain.  Patient's daughter was contacted and verified that her mother has been increasingly weak for the past 2 weeks however, does have ongoing baseline fatigue.  Patient does follow regularly with her primary care provider and has had no new  signs or symptoms of an infection. While in the emergency department patient had an EKG obtained showing sinus bradycardia with a first-degree AV block she was also found to have low potassium level which was replaced along with symptomatic hyponatremia.  Patient was started on IV fluids and nephrology was consulted.
Information has been received from a retired physician referring to himself, a male patient of unknown age. There was no concomitant medication, medical history or drug reactions/allergies. On an unspecified date in 2006, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (lot #, expiration date and route were unknown; 0.65 ml/1 dose). On an unspecified date in May 2016, the patient developed a rash on his left thigh, between his knee and groin. On an unspecified date in 2016, he saw an unspecified dermatologist, who diagnosed the rash as shingles. Treatment was given for the event but no lab diagnostics studies were performed. It was reported that the rash was painful for 1 week, but lasted for 6 weeks. At the reporting time (reported as "now"), the rash had resolved, but the patient continued to have areas of hyperpigmentation where the rash was provided. The causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# M043669, expiration date 15-JUN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 54 minutes. There was no previous temperature excursion. Digital data logger was involved. The outcome of the event was not reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA004753: US-009507513-1709USA008502: US-009507513-1709USA008503.
A pediatrician reported that a male child received his fourth dose of Prevnar on 07/31/2002 at 12 months of age.  On 02/20/2003, at 19 months of age, the child developed a fever of 103F, and subsequently experienced a seizure.  He was hospitalized that same day.  Treatment medications included amoxicillin and Flovent.  The child recovered and was discharged on 02/23/2003.  No further information was available at the date of this report. Follow-up information received from the physician on 08May2003 included the pneumococcal isolate serotype. A pediatrician reported that a male child received his fourth dose of Prevnar on 31Jul2002 at 12 months of age. On 20Feb2003, at 18 months of age, the child developed  a fever of 103 deg. F. which led to a seizure. He was hospitalized that same day. A blood culture was performed; S. pneumoniae was isolated. Treatment medications included amoxicillin and Flovent (fluticasone). The child recovered, and he was discharged on 23Feb2003. A blood sample was sent to the CDC for serotyping; the pneumococcal isolate was identified as serotype 7F.
Pt had COVID in Early January 2021.  He had mild symptoms and recoverec.  On  March 1 2021 had his first Moderna. Covid shot.  Next day,  ( March 2)   headaches. fevers, chills and chest pain.  Pt had EKG  findings of STEMI myocardial infarction.  He was sent to the cath lab from the cath lab he was admitted.  Finding of normal coronary arteries.    However, he appeared to have developed a cardiomyopathy compared to a prior study.  He had a echo  on March 3.  . Appeared to have a  cardiomyopahty with estimated EF or ejection fraction of 40%. He had normal cardiac function three years earlier .    On March 3rd his EKG normalizec.  He was sent home on March 4
@ 21 mos pt began displaying autistic traits (fleeting eye contact, hand movements, language delay & preference for solitary play);pt not formally dx w/autism; per follow-up dated 10/25/00, the patient continues to experience autistic tendencies such as lack of or fleeting eye contact, language delays, social interaction impairments, and perseverative behavior.
2 hour post: dizziness/light headed 3 hours post: above + severe migraine, extreme fatigue 5 hours post: above + flush, chills, body aches (all the above last ~48 hours)  Next day: arm pain at injection site (lasted ~5 days)  1 week post: large rash at site of injection, pain w/ touch, and itching w/o hives (symptoms still continuing today 1/19)
Mom noted left upper arm redness and swelling.  He was also itchy.  There was no pain.
Patient was given at vaccine approved for 65 and older yet patient was only 60 years old. Patient reported no Adverse events.
I am weak with headaches and my legs go numb and fall asleep just sitting around the house.
A key stuck to her arm where she got Moderna; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (A key stuck to her arm where she got Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (A key stuck to her arm where she got Moderna). At the time of the report, IMMUNISATION REACTION (A key stuck to her arm where she got Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. It was reported that her ex-boyfriend called earlier to report and the patient did not have a reference number for previous report. A key stuck to her arm where she got the Moderna COVID shot. It stuck to arm where she had needle, and the other arm, it fell off. Ex-boyfriend got the Pfizer COVID vaccine and tried it and the key did not stick to his arm. She wanted to know why is the key sticking to her arm where she got the shot.  No treatment medication was reported. This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation
PATIENT REPORTS SYMPTOMS OF FEELING JITTERY, ELEVATED BLOOD PRESSURE 149/109 AND HR 107 AND CHEST SORENESS.
Pt stood up per MA did then fainted. Fell to the floor and hit her head on door. Lost consciousness for 5-10 seconds and then came to - sent to ER.
adult received pediatric Engerix-B; adult received pediatric Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 20-year-old male patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd December 2021, the patient received the 1st dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 22nd December 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The health care professional reported adult refugee patient aged 20 year and 6 months inadvertently received the dose of pediatric Engerix-b (10 mcg), which led to accidental underdose and adult use of a child. The reporter consented to follow up. This case has been linked to the case US2022001259 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022001259:Same reporter US-GLAXOSMITHKLINE-US2022001260:Same reporter - Deleted US-GLAXOSMITHKLINE-US2022001262:Same reporter
Herald patch appeared all over the body. It started at day 2 of the 2nd Vaccination dose.  Small patches started to appear and then within a two weeks, it was spread all over the body (chest, abdomen, back and limbs). The itchy patches are still present to date and new ones are appearing.
Warm, erythematous rash over vaccine site on left deltoid, evaluated and started on antibiotics for cellulitis 3 days later.
pt recv vax & felt chest tightness about 6PM;had SOB & wheezing bronchodilator & steroid given;
Ongoing chest pain for about a week starting about two weeks post first Pfizer shot. Went to cardiologist and diagnosed with pericardial effusion. Pain self-resolved, but still some intermittent pain.
ill-defined area of redness and induration in 8" in diameter (L) anterior thigh no tenderness
Patient felt dizziness and giddiness . Onsite EMS was called vitals were taken BP 113/79  99% O2 room air  BG 144 HR 76. Patient refused evaluation/care. Left aginst medical advice.
At dinner time child vomited and fever was 100 degree Fahrenheit.  Mother gave Ibuprofen every 6 hours and fever continued off and on.  This morning vomited again and fever went to 102 degree Fahrenheit.
Almost passed out BP 102/70 pulsestrong and regular.  Pick up by mom.
Patient called a few days later and reported that arm was red below injection site. It is not red around or above - only below. No pain was reported.
No pregnant. Vaccine site initially sore. Pain increase starting about 10 pm same day. Painful from injection site, around bicep and in armpit. Lymph node in armpit slightly swollen. Area on bicep below injection site swollen. Redness around the front of the arm.
pt recv vax 1SEP96 & 1OCT96 pt exp a failure to seroconvert based on lab values;
Low grade fever, 100.8, aches and pains in joints, Headache and pressure, felt like parts of my body were being zapped at onset of symptoms. Very tired the entire next day. I took tylenol throughout the day and woke up the next morning feeling fine.
Right and left tricep myalgia. Back of neck painful to the touch. Physician recommended TYLENOL PRN pain (pt. family).
Received Moderna vaccines on 3/14, 4/11/21 COVID-19 positive by PCR on  1/20/22 admitted to hospital on  1/19/22 d/t worsening SOB, rising lactate, decreased O2 sats
Pre-vaccine: Pt premedicated with Benadryl 25mg and Tylenol due to past reaction to Flu vaccine 30 min post-vaccination: Throat and ear itching, and elevations in HR and BP. Given Benadryl 25mg. Declined ER evaluation. 1 h post-vaccine: SOB requiring 2 nebulizer treatments. 3 h post-vaccine: Left clinic and received a ride home where pt began to experience diarrhea and extreme fatigue. Took an additional Benadryl 25mg and slept. Following day: Pt husband stated pt was wheezing during the night. Continued to experience SOB and went to ED; no medications were given there. A few days later: Ongoing respiratory symptoms. Went to urgent care and was given PO steroids. Pt reported residual respiratory symptoms persisted for 4 weeks post-vaccination. Pt seen by PCP and Allergist and was advised to AVOID getting another COVID vaccine. A vaccine exemption form was filled out and submitted by a provider.
w/in few hr of vax pt had high pitched screech x6hr, inconsolable;
pt recvd MMR vax in 1987 & had prev been vaxed w/MMR in 1971 & JUL93 quantitative titer revealed no immunity to meales; No further details were provided;
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot number M018453 and expiration date of 28-JUN-2017 for prophylaxis (dose, route of administration were not reported). No adverse effects were reported.
Hives around injections site on front of right thigh, back of right thigh and right buttocks.  Also on back of arm. Pediatrician recommended administering 1/2 tsp Benadryl every 4-6 hours.  Administered one 1/2 tsp dose of Benadryl at 12:30AM.  Hives went away after first dose within 4-6 hours.  No additional Benadryl administered.  Increased fussiness and inability to take typical/routine afternoon nap the day vaccine was received.  Slept 1.5 hours longer than typically sleeps at night after receiving the vaccine.  Unusually tired the day after (3/18/12) receiving the vaccine (3/17/12).
it's been depressing; Severe muscle aches; I have rheumatoid arthritis and it's making this flare up; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female none pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 on 03Oct2021 11:00 AM at age of 43-year-old Left arm (Batch/Lot number: FE3592) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included Rheumatoid arthritis, known allergies: Bactrim and Penicillin, Covid prior vaccination. Concomitant vaccine was not reported. No other medications in four weeks and in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 12Sep2021 11:00 AM Left arm at age of 42-year-old (Batch/Lot number: FF8839) for COVID-19 immunisation. Severe muscle aches since the 2nd shot on 03Oct2021. Also bones and joints feel inflamed and are aching. She had rheumatoid arthritis and it's making this flare up and has been non-stop since 03Oct2021. It's making life very uncomfortable and she had been on a heated pad/blanket this symptom has not stopped and hoped it stops soon but it's been a month feeling miserable. She can't stand up for longer than 1 hour the pain is so bad can't stand long. She felt like was in 90s it's been depressing and can't function and be a Mom properly. All Adverse events start date was 04Oct2021 9:00 AM. No Covid tested post vaccination. No treatments were received. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Information was received on 14-JUN-2017 regarding a case in litigation concerning a female of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On or about 02-NOV-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUN- 2015, the patient broke out with vesicular pustules on her face and in her eyes. On or about 15-JUN-2015, she  was treated by a physician for ongoing and worsening symptoms of this outbreak,  which was diagnosed as severe herpes zoster. The physician gave the patient a note precluding her from returning to work for a period of three weeks due to the severity of her condition. The shingles had spread to her eyes, and the patient was referred to ophthalmologic specialists; who diagnosed that herpes zoster had resulted in damage to the eye and have deemed the patient as clinically blind. The patient received ongoing treatment for her painful symptoms, and is permanently disabled by her blindness and severe facial scarring. The patient is unable to resume working due to her condition and has become largely homebound as a result. As a direct and proximate result of these malfunctions, the patient has suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, she  has suffered and will continue to suffer significant medical expenses, and pain and suffering, lost wages, and other damages. Blindness and severe facial scarring were considered disabling. Upon internal review the event of shingles spread to her eyes, damage to the eyes and the patient as clinically blind was determined to be medically significant.
Fever (101.5) lasted 24 hrs.  Treated with infant Tylenol but it did little to bring down fever.  Approx 2 hrs after shots began non-stop crying that lasted nearly 2 hours.  Remains irratable with decreased appetite, 36 hours after shots.  Very sleepy baby but sleep is restless and wakes often.  Slept for 10 hrs the night shots were given, normal is 5-6 hrs.
Client reported a rash on back of both legs the evening after vaccine was given. Following day others around patient noticed she had a flushing of her face.
Sharp pain under the left rib cage (around spleen area) when bending, laughing, etc. It started the night after receiving my second shot of Pfizer vaccination.
Upon injection, patient had immediate soreness at injection site, followed by swelling and pain radiating down her arm. She also experienced lightheadedness, dizziness, and nausea. We put an ice pack on the area and provided apple juice, as well as observing the patient for 30 minutes afterwards. The swelling and pain went down at the injection site to baseline levels and patient was no longer dizzy/nauseated upon leaving.
pt recvd vax & 5 hrs later exp numbness in the hand & dizziness followed by nausea & vomiting;
Patient suddenly lost voice, called M.D. & was told to take BENADRYL lost voice over 5-10 minute period resolution 4 hrs. after BENADRYL.
4days p/vax pt devel a fever of 103f, vomiting & diarrhea