chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3-4 HOURS AFTER RECEIVING TDAP AND TYPHOID PATIENT DEVELOPED SEVERE BODY ACHES.  CAME TO SICK-CALL 8-10 HOURS LATER WITH NORMAL EXAM BUT COMPLAINS OF MUSCLE PAINS
Site of injection L arm. c/o L hand hot, deep ache forearm to wrist.  DTaP.
Child felt warm, temperature was taken:100.6F via armpit. Less than 5 minutes later seizure began and lasted 15 minutes. Child became limp and slid off the sofa into a contorted position. Face was pale/blue, difficulty breathing. Jaw was clenched, eyes rolled in the back of his head, grunting sounds. 9-1-1 was contacted and child was transported to the emergency room. Ordered to follow up with pediatrician who stated circumstances surrounding the progression, duration and age of child during this first seizure were abnormal to be considered a febrile seizure and ordered a consultation with neurologist. Neurologist ordered multiple tests (document below) which have all come back as unremarkable.
13JUN97 pt presented w/inc liver function tests (LFT's), positive anti-nuclear antibodies (ANA) neg hep B core antibodies (anti-HBc), positive hepatitis B surface antibodies (anti-HBs) , & bilat knee arthralgia;w/u for rheumatoid arthritis
This spontaneous report as received from a Nurse refers to unspecified number of adult patients. The reporter reported that at a "sister facility", an unspecified number of adult patients has been administered two pediatric doses of VAQTA (lot # was not reported) in place of one adult dose of VAQTA. Nurse reported that there were not adverse effects reported that she was aware of. Additional information has been requested.
On 7/13/17 in the evening, a nurse noticed an approximately 1" firm, non-tender, circular reddened area with an approximately 2" non-tender, circular mildly reddened area surrounding other reddened area at back of left upper arm which client reports is "itchy" where VARIVAX was administered.  It is still present on 7/14/17 at 8:00 AM.
p/2nd dose of vax pt had mild sinus h/a then progressed next day to aching joints, h/a, chills, fever 101.2, 102.3;fever broke;on 5th woke up tired but feeling better-fever gone;
Joint pain, inflammation in arms,legs, hips, shortness of breath for week, hight heart rate and blood pressure, chest pains,
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Seizure-Mild, Systemic: Weakness-Mild, Additional Details: patient had a seizure about 10 minutes after receiving the moderna vaccine. the seizure episode lasted 30-60 seconds. the patient regained consciousness, but experienced lightheadedness, weakness, nausea, headache, and chills. patient was provided with a benadryl 25 mg, orange juice, and a cookie. patient felt better afterward. patient will follow up with a physician at an urgent care.
covid vaccine breakthrough case; All Pfizer dose 1  3/24/21  ER8733; dose 2  4/22/21  EW0169; dose 3  4/8/22  FK9893.
The patient came to the pharmacy to receive the COMIRNAT COVID vaccine. Her partner was to receive RSV, COVID, and flu. When compounding the RSV vaccine that meant for her partner, the vaccine was accidentally given to the patient, so she received RSV instead of COVID.
the day after receiving the vaccine the patient developed a fever TMax 101.7 and loss of taste, these later developed into congestion, general malaise, body aches. the pt sought out her PCP who is running covid and flu testing.
Pt became very sleepy 2-2 1/2 hr; s/p vax slept afternoon; did not eat @ 1015 day of vax; t104; Pt awakened from sleep w/high pitched cry; unconsolable x 1 hr;
Have large about nickel to quarter size red bumps with white pus areas around my left ankle.
pt is a 37 year old pregnant female (27 weeks 5 days). came to the office today for her covid vaccine as recommended by her obgyn. patient was taken care of by a float MA and was given the entire vial of covid vaccine, all 6 doses. once the MA realized the error she informed me as RN clinical supervisor. Patient had no adverse reaction to the vaccine itself. she had no issues at all. watched patient here at office for over 3 hours.
Seizure like activity without any personal or family history. All vitals and tests were normal when taken by EMT and RN at the hospital.
Vaccine administrator inadvertently administered 0.3 ml of Pfizer instead of 0.2 ml Pfizer. No immediate adverse reactions reported. Telehealth visit conducted on 11/17/21 to follow up with patient. Per month, patient doing well, no fever or reactions, went to school. Informed mother that patient may experience more side effects due to dose. Prescribed Tylenol per mother's request.
TOOK VIVOTIF EVERY DAY INSTEAD OF EVERY OTHER DAY; This spontaneous case (PVX2019-1578) report was received from a pharmacist on 18-Jun-2019. It describes a consumer who "took Vivotif every day instead of every other day". The consumer was receiving Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took Vivotif doses every day instead of every other day.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif every day instead of every other day" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif every day instead of every other day" was considered as not applicable.
When I took the first Moderna  Covid-19 Vaccine (04/05/2021). It was a shot in my left arm. I experienced explosive diarrhea, constipation, then severe nausea for days after. Once those symptoms subsided, I began to experience pain on the right side of my right hand, extending to the side of my right wrist in the area of my wrist bone. The pain continues to this day. I have seen two hand specialists, both took x-rays. Nothing was found. The first specialist referred me for an MRI. However, the cost of the MRI was over $400. I bought a wrist brace from that physician. The cost was $175. It did not help to improve the pain. So I saw a second hand specialist, same routine. The x-rays found nothing. I received a cortisone shot to help relieve the pain. It helped the severity of the pain in my hand. However, I still have pain on the side of my hand extending to the base of my wrist. This did not start until after I took the Covid-19 vaccine. I took my second dose, and have also taken my booster shot.
Symptoms started 6 hours post vaccination: headache, fever (102 F) muscle and joint pain, chills and fatigue, this symptoms lasted for 12 hours the they went away for 48 hours. Symptoms came back: extreme muscle and joint pain and headaches, nausea, fatigue and sever brain fog. I experienced a ?water? sensation  inside my head every time I would move my head I would have sever nausea.  After 5 days I got medical attention on 2/25/2021. Doctor encouraged me to call and report my symptoms.
Client stated at 10:48 she noticed chest tightness, then a hot&cold sensation in her throat,neck and then down the remainder of her body.  Stated she has had COVID 2 times and has viral myocarditis from COVID and gets chest tightness at times.  Blood pressure 132/80.  11:13 states easing up on the chest tightness.  Will continue to monitor.  11:23 Chest tightness improved states she is ready to go. Was asked to go to ER just for safety. Said she did not want to.  Stated she has had a cardiac work up and it was not necessary.  Blood pressure 122/80 Pulse68. Alert and orientedx3, respirations even and unlabored.  Skin pink,warm and dry.  Was informed if she would not go now, to please go with any further problems.
Tightness of throat and dyspnea (pt pregnant) Solumedrol IV.
Patient described ~3-4 hours after receiving her shot that she experienced  swelling behind her eyes and legs that lasted into the next day, and brief swelling of the tongue that wasn't severe and subsided over night.
Pain in left calf muscle on 3/31/2021 for about 4 days; again on 4/15/2021; and again on 4/19/2021. Talked to a phone nurse, who recommended going to emergency care. Went to ER. Doctor. After a course of anticoagulant medication, Pradaxa (dabigatran etexilate) for 45 days, the clot dissolved. No further symptoms.
83 yo F with htn , dementia at baseline non verbal wheelchair/bedbound, dm, was brought to the ED because of somnolence, fever and sob and found to have + covid 19 pna.  Was initially npo, and had foley placed and I and O cath initially.  She passed foley dc trial and passed swallow to pureed c honey thick liquid.   Throughout her hospital stay she remained non verbal at times moaning in bed, at times not.     She was seen by palliaitve care and qualifies for hospice both with and without covid 19.  Her actual o2 requirements are around 1 liter to room air.  There was discussion of custodial snf instead of home because patient is a total care needs patient, however daughter prefers for her to go home.   An outpatient life care planning eval was sent       Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  Alzheimers, covid 19 pna   Complications: none
Information has been received from a registered nurse concerning a 13 month old male with no known allergies or pertinent medical history who on 29-MAR-2007 at 11:00 was vaccinated SC in the right thigh with a first dose of ProQuad (lot # 656160/1396F). Additional suspect vaccination administered at the same time included a third dose of Comvax (lot # 654908/0999F) given IM in the left thigh and a first dose of Vaqta (lot # 656017/1280F) given IM in the right thigh. There was no illness at the time of vaccination. On 09-APR-2007 at 14:00 the patient developed a red pinpoint non-raised rash on his trunk. The patient's mother called the office to report this. A follow-up call with the patient's mother on 10-APR-2007 indicated that the rash was almost completely gone that morning.  The patient had no other symptoms. The patient recovered on 10-APR-2007. The patient had no adverse events following prior vaccination. Additional information is not expected.
Red raised itchy rash about four inches long, 2 inches wide, irregular border Went to doctor. Put cortisone cream on. Rash went away after 4 days.
Temp 97.8 axillary. Hives - within 24 hr of receiving vaccination and on her bottom, thigh and arms. Given BENADRYL 2.5 ml on Tuesday.
a slight stiff neck; little soreness in her left arm; headache; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (a slight stiff neck), PAIN IN EXTREMITY (little soreness in her left arm), DIZZINESS (dizziness) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (a slight stiff neck), PAIN IN EXTREMITY (little soreness in her left arm) and HEADACHE (headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (a slight stiff neck), PAIN IN EXTREMITY (little soreness in her left arm), DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment medications were provided.  Crosslinked to MOD21-147667 & MOD21-147668.   This case was linked to MOD-2021-333577, MOD-2021-333655 (Patient Link).
residual headache; felt about 50% of his usual self; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for Covid-19 immunisation, reaction(s): "No side effects". The following information was reported: FEELING ABNORMAL (non-serious) with onset 01Apr2021, outcome "unknown", described as "felt about 50% of his usual self"; HEADACHE (non-serious) with onset 02Apr2021, outcome "unknown", described as "residual headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Parent states the patient received adult dose of vaccine instead of childrens' dose. ADMINISTRATION ERROR!
mom states that p/pt recvd vax broke out w/rash & high fever; was taken to the MD; stated the MD was not sure what caused the rash;
Patient 0.25ml Fluviron vaccine meant for >4yrs. Box marked but not actual vial. Patient had no Reaction
Patient reports disoriented, cold feeling to chest, Heart Palpitations, numbness in fingers, tongue thickness, "feels weird".  Macular Rash mid sternum noted by on site physician.  No respiratory distress noted.  No epinephrine administered.
(Date unknown) 08/2021 serve cough, shortness of breath - lasted 6 weeks.
Breathing issues, lung started filling with water, right arm movement-odd, later couldn't move right arm for a short time, pain, later mental health issues.
Urticarial rash began day after vaccine. Still present 7/24/13.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 24-OCT-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
A Pfizer Covid-19 vaccine was administered beyond the use date.  Moving forward we have clearly labeled all vaccine boxes to represent expiration date.  Also, have spoke with staff to pay closer attention to these details so this incident do not occur in the future.
11/16/2001 Called to report itching/whelps starting today. Taking Benadryl with some relief. Has follow up appointment on 12/10/2001 for hoarseness and swelling of throat. Taking Nexium 40 mg PO. 1/02/2002 Pt advised she saw MD and he did not feel there was relationship to itching and hep B. felt it was due to Nexium has been discontinued.
This spontaneous report has been received from a pharmacist concerning a 67 year old male patient. The patient's concurrent conditions included allergy to LEVAQUIN. None pertinent history was reported. On 19-May-2016, the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU, (lot # L037791, expiration date of 30-DEC-2016), (dose and route of administration were not provided). The patient's concomitant therapy included CRESTOR. On 25-MAY-2016 (reported as today), the patient went back to the pharmacy and reported that he had been experiencing forearm pain in the injection arm since an unspecified date in May 2016. The patient self administered MOTRIN as treatment for the adverse event. There was none laboratories diagnostics studies performed. A product quality complaint was not involved. At the reporting time, the outcome of forearm pain in the injection arm was not reported. The causal assessment of forearm pain in the injection arm to ZOSTAVAX was not reported. Additional information has been requested.
Fever of 103.5 , severe headache, body aches, chills, distorted vision,  left arm pain and soreness. Unable to use left arm for the most part.
pt recv vax 15JAN97 & 16JAN97 pt presented to MD office w/a fever & a swollen red arm w/a few red lines that started from the axilla to the elbow;
Information has been received from a consumer concerning a male who at 15 months of age was vaccinated with a dose of MMR II (lot not reported). It was reported that the child declined rapidly thereafter. The child was subsequently diagnosed with autism. Unspecified medical attention was sought. Upon medical review, the pt's autism was considered an other medical event. Additional info has been requested.
This spontaneous report as received from a nurse refers to unspecified patients. On unknown dates the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot #, expiration date, dose and route unspecified). No adverse effects were reported. Additional information has been requested.
Sore arm to the point I could not raise it above my shoulder for 24 hours Fever for roughly 3 hours on May 16th Chills for roughly 3 hours on May 16th Muscle aches for 12 hours on May 16th Headache for 12 hours on May 16th
This case was reported by a nurse via out of hour services and described the occurrence of pruritus in a adult female patient who received BOOSTRIX (batch number 2T923, expiry date unknown) for prophylaxis. On 5th September 2018, the patient received BOOSTRIX. On 5th September 2018, less than an hour after receiving BOOSTRIX, the patient experienced pruritus and several minutes after vaccination, the patient experienced headache and nausea and less than a day after vaccination, the patient felt flushed. The patient was treated with antihistamine. On an unknown date, the outcome of the pruritus, headache, flushing and nausea were unknown. It was unknown if the reporter considered the pruritus, headache, flushing and nausea to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter is a nurse who was patient. A female patient reported that within 20 minutes after receiving a BOOSTRIX injection, she experienced itching. After 45 minutes, the patient said the itching became worse. Ninety minutes later, she reported nausea. Minutes later, the patient reported headache. The patient also said, she felt flushed. The patient took an antihistamine and itching improved. She reported that, she had never had any reaction of this type to any previous vaccination in her life.
Skin peeled on lips, hands, feet. Raise in blood pressure. Dr. had me use cortizone creme.  Lasted 3 weeks with  some scars still showing
on 5/21/19 reports chills with fever to 100.3 po . Next day knee foot ankle and hip pain.  Then reports rash.
A spontaneous report has been received from a Health Professional concerning a 7 year old, Female subject. FLUMIST (intranasal) started on an unknown date. The reporter stated that the patient was accidentally administered with expired FLUMIST which started on 05-Feb-2015. The outcome of the event of accidentally administered expired FLUMIST is unknown. The report was considered to be non-serious.
Information has been received from a nurse practitioner referring to 1 year old female patient with no known drug allergy. The patient's birth weight was 7 lb. 7 oz. The patient had Vulvitis at time of vaccination. Concomitant therapies included VARIVAX and hepatitis a virus vaccine (unspecified). On 21-APR-2016 at 14:46, the patient was vaccinated with M-M-R II lot # reported as L042818 dose 1, subcutaneously in the left thigh. The vaccine was improperly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
hearing loss; other zoster related injuries; body rash; Information was received from a lawyer regarding a case in litigation concerning a patient of unspecified age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On an unknown date (Reported as "On or about 41404"), the patient was inoculated with zoster vaccine live (ZOSTAVAX), administered by a healthcare provider at a pharmacy, for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date (Reported as "subsequently"), the patient was treated, by unspecified healthcare providers, for hearing loss (Deafness), body rash, and other zoster related injuries (Ill-defined disorder). The outcome of the events was not provided. Causality was related.  Upon internal review, the patient's deafness was determined to be a medically significant event.
This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reporting for his son reported a male patient of an unspecified age and ethnicity received the third dose of TRUMENBA via an unspecified route of administration on an unspecified date at single dose for immunization. The reporter stated that the patient got 3 doses of meningococcal group b rlp2086. The patient's medical history and concomitant medications were not reported. The patient previously took first dose and second dose of TRUMENBA both on unspecified dates. The patient experienced chills on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Body is feeling hot and weak; Can't eat anything; Arm is sore hard and painful; The more she tries to talk, the more she feels like she can't; restless; Starts feeling dizzy when she stands up; Running a fever; Extremely nauseated; Has a bad headache; Feeling tired and restless; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING HOT (Body is feeling hot and weak), DECREASED APPETITE (Can't eat anything), PAIN IN EXTREMITY (Arm is sore hard and painful), DISCOMFORT (The more she tries to talk, the more she feels like she can't) and RESTLESSNESS (restless) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FEELING HOT (Body is feeling hot and weak), DECREASED APPETITE (Can't eat anything), PAIN IN EXTREMITY (Arm is sore hard and painful), DISCOMFORT (The more she tries to talk, the more she feels like she can't), RESTLESSNESS (restless), DIZZINESS (Starts feeling dizzy when she stands up), PYREXIA (Running a fever), NAUSEA (Extremely nauseated), HEADACHE (Has a bad headache) and FATIGUE (Feeling tired and restless). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Body is feeling hot and weak), DECREASED APPETITE (Can't eat anything), PAIN IN EXTREMITY (Arm is sore hard and painful), DISCOMFORT (The more she tries to talk, the more she feels like she can't), RESTLESSNESS (restless), DIZZINESS (Starts feeling dizzy when she stands up), PYREXIA (Running a fever), NAUSEA (Extremely nauseated), HEADACHE (Has a bad headache) and FATIGUE (Feeling tired and restless) outcome was unknown. Not Provided      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 concomitant medications were provided.
pt recvd vax; extremely fussy, loss of sleep, excessive crying,started on Friday, cont Sat; no tx, just TLC & apap;
Breakthrough case admission after 5 vaccines moderna 2/26/21 lot# 025A21A;  Moderna 3/26/21 lot# 045A21A;  Moderna 11/8/21 lot# 058F21A;  Moderna 4/4/22 lot# 025L21B;  Moderna 10/22/22 lot# 062F22A