chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 15 year old female who on approximately 26-SEP-2007, was vaccinated with a dose of Gardasil. It was reported that in approximately 26-SEP-2007, the patient experienced injection site tenderness. The patient contacted the physician by phone but no treatment was recommended. At the time of the report, the patient's injection site tenderness persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a registered nurse concerning a 15 year old female who on 25-SEP-2007, at 16:00, was vaccinated IM, into the left deltoid, with a second dose of GARDASIL (lot #658583/1063U). It was reported that in approximately 26-SEP-2007, the patient experienced injection site tenderness. On 03-OCT-2007, the patient's mother contacted the physician by phone to report that her arm was still sore. There was no redness, numbness, tingling, local warmth or swelling and range of motion was OK. The patient's mother was advised to have her daughter use arm and take ibuprofen regularly and use warm or cool compress. At the time of the report, the patient had not recovered. Additional information is not expected.
Client was Due for  the second dose of Moderna which was given in error (Client is 17 years old) . Parent was made aware of the error at the time of the event. according to Administration and Error documentation the second dose must be given. Deviation and error recommended as off label.
Patient was given IPV (sc #4), Hep A #2 (IM) on left upper arm on 07/18/2003.  Next day he was taken to ER because left upper arm and forearm became swollen.  He was given antibiotics intramusculary and was placed on per mouth antibiotics.  Diagnosis: allergic reaction (local).
2/18/21 11 pm Weak, aches 2/18/21 11:30 pm Chills, Shaky, Fever 101*  Tylenol 2/19/21 12:55 am Fever 101.6 2/19/21  6:20 am Fever 102.4*, Weak, Headache  Tylenol 2/20/21 12:45pm 12:45pm Fever 101.4, Weak, Headache, Tylenol 2/21/21 Through 2/24/21  All day  Weak, Shaky, Muscle Cramps  in Neck, Left Shoulder to Shoulder Blade X-Strength Tylenol 2/25/21 Weak
Vomiting, diarrhea, rocking back and forward. Skin flare up picky, pulling out the hair, very fusses. Needed BENADRYL.
tingling and jolting pain down left leg starting in lower back, pain level 10 out of 10, unable to work remainder of day and the following day, pain resolved later Tuesday, back to work Wednesday
Patient reported fever; Chills; body ache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Patient reported fever), CHILLS (Chills) and MYALGIA (body ache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PYREXIA (Patient reported fever), CHILLS (Chills) and MYALGIA (body ache). On 26-Oct-2021, PYREXIA (Patient reported fever), CHILLS (Chills) and MYALGIA (body ache) had resolved.            No concomitant information was reported.. No treatment information was provided.  Patient spent the day in bed.   This case was linked to MOD-2022-583834 (Patient Link).
Customer started to bleed immediately after being injected. A bump formed at injection site. It looked like blood was trapped under his skin at injection site. Patient waited in pharmacy with no other reaction  except for bump at injection site.
pt recv vax;found to be pregnant;meds taken during pregnancy:erythromycin, amoxicillin,prenatal vitamins,pseudoephedrine & acetaminophen;@ 40 wk of gestation,delivered baby w/ an undescended testicle;
Had 2 seizures subsequently (new onset, no prior history), and has sensations of "fluttering" heart rhythm, associated with mild tachycardia (approx. 100 bpm) seen on cardiac monitoring. 8/11/08 Neuro consult received dated 7/21/2008. Exam WNL. EEG(-).  9/08/2008 Cardiology consult received dated 7/31/2008 for eval of dizziness and lightheadedness with racing heart sx.  Pt previously seen for eval of syncope in which a rhythm disturbance was r/o. Sinus tach found on event monitering but does not explain dizziness, syncope. Likely neuro-cardiogenic events. Orthostatic BPs showed orthostatic tachycardia syndrome. to increase fluids, salt and add leg strengthening exercises.
This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (rinvoq seems to aggravate Cold sores), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication. Concurrent medical conditions included Cold sores (taken medication for cold sores for 15 years). In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ORAL HERPES (rinvoq seems to aggravate Cold sores), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). At the time of the report, ORAL HERPES (rinvoq seems to aggravate Cold sores), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) outcome was unknown. No concomitant medication was reported. It was reported that the patient was taken medication for cold sores for 15 years but rinvoq seemed to aggravate them. Her covid vaccine cause sore arm and fatigue. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided.
Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on 15-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    It was unknown if the patient was ever diagnosed with or tested positive for COVID-19.  Concomitant medications of the patient were not reported.  The vial was initially stored in the refrigerator on 14-Mar-2023. The vial did not undergo any temperature excursions.  HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-Mar-2023. There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at the time of reporting.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Fever, chills, nausea, headache beginning the morning after vaccine was administered. Symptoms were largely alleviated with rest and over the counter fever reducer/pain reliever
I started to feel really drowsy, sore throat, stuffy nose, red blotches on my chest, bright red, hot cheeks, sweaty and around 5:00 PM I started to gradually get a stiff neck.  More than 24 hours later, I am still feeling these symptoms and my neck hurts to turn side to side, up and down.  I have been taking Motrin 800 to relieve the pain, and haven't had success.
Upon check out, status post 15 minutes sitting in observation area, patient reported a headache. Patient describes a left-sided headache with 3/10 pain. Patient denies any other symptoms. Patient instructed to drink fluids, rest, and contact PCP if any worsening or current symptom,  or in the case of any other/concerning symptoms.
COVID vaccine Lot 33025BD, removed by Agency from freezer 12-17-21 at 930am, administered to patient at Baseline Primary Care on 1-17-2022 after 930am. NO adv rx from pt
Her hair is falling out after receiving second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Her hair is falling out after receiving second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Her hair is falling out after receiving second shot). At the time of the report, ALOPECIA (Her hair is falling out after receiving second shot) outcome was unknown. Not Provided          no concomitant medications are reported. treatment to the events not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up case booked in
PATIENT CALLED PHARMACY THURSDAY MORNING COMPLANING OF LEFT ARM PAIN THAT BEGAN TUESDAY NIGHT AFTER RECEIVING FLU VACCINE TUES MORNING AROUND 11:30.  PAIN WORSENED BY WEDNESDAY NIGHT AND PATIENT COULD NOT SLEEP.  PATIENT STATES PAIN IS CONSTANT AND RADIATES DOWN LEFT ARM TO HAND AND IN LEFT SHOULDER BLADE.  PAIN HAS NOT SUBSIDED AS OF TODAY AND WILL BE SEEING HER PRIMARY CARE PHYSICIAN TODAY AT 2:30PM.  PATIENT HAS TRIED TAKING TYLENOL AS WELL AS USING AN ICE PACK FOR THE PAIN.  NOTHING HAS HELPED RELIEVE HER PAIN.  SUSPECT POSSIBLE NERVE DAMAGE DUE TO VACCINE ADMINISTRATION.
I experienced fatigue, brain fog, anomic aphasia, chills, heart palpitations, insomnia, memory loss and poor peripheral vision.
This is a spontaneous report from a contactable physician via Pfizer Sales representative. A 70-year-old male patient received a single dose of PREVNAR 13 on 01Nov2016 for immunisation. The patient medical history and concomitant medications were not reported. Two years before (in 2014) the patient took PNEUMOVAX for immunization.The patient developed pneumococcal sepsis on 22Dec2016 with outcome of unknown. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment.
Narrative:  Per primary care provider: Patient had a shingles vaccine done 11/30/2018 developed ascending pain from the right arm to the neck and similar pain 3 days later on the left arm with persistent neck stiffness and headache which is progressively gotten worse today. Vital signs are stable--patient needs evaluation in the emergency room due to acute symptoms to rule out meningitis
This case was reported by a nurse via sales rep and described the occurrence of fever in a 15-year-old male patient who received BEXSERO for prophylaxis. Co-suspect products included MENACTRA for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose and MENACTRA at an unknown dose. On an unknown date, 1 day after receiving BEXSERO, the patient experienced fever and general body pain. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the fever and general body pain were recovered/resolved. It was unknown if the reporter considered the fever and general body pain to be related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO and MENACTRA on the same day. The patient had body aches and fever of 103 degree Fahrenheit the day after immunizations. The nurse had them alternate ADVIL and TYLENOL to manage fever and the patient was fine after next day. Lab Comments: Lab test was done on an unknown date.
Moderna COVID-19 Vaccine EUA   Fever fluctuating between 101 and 102 degrees F. These symptoms lasted for approx. 8 hours, between 11:00 PM and 7 AM:  extreme weakness (unable to get out of bed; difficulty rolling over); extreme cold and shivering; profuse sweating; delusions between dreams; inability to sleep; severe muscle pain (every movement hurt, like a wore brush being run across whatever muscle moved).  Anxiety and panic attacks because I did not know that the side-effects could be so severe until talking to others who had similar experiences today. Those who I've talked to prior to today had some reactions, but such bad ones. The side effects on the fact sheet are not described in terms that made me think these would be mild. However, mine last night were worse than any other illness I've had in my life. Not having the strength to move and at the same time feeling as though I was freezing to death with lying in a puddle of sweat brought on a lot of fear--I felt sure I would not make it through the night, and could not even reach the phone to call anyone, which made it more terrifying.  After 7 AM today, falling asleep during work; sweating and chills; muscles ache and pain; exhaustion after performing simple tasks (making tea, eating cereal, etc.); fever between 100 and 102 degrees, fluctuating throughout day.
He woke up in the middle of the night and was vomiting. He also had diarrhea. I took him to the doctor, and they diagnosed him with Norovirus. They did not test him for Norovirus. It just a visual inspection. They did prescribe medication. He tested negative for Flu and COVID-19. He is feeling better now.
Diarrhea.  watery bowel.  started to firm up just before the 2nd dose on 4/7/21 but 2 days after the 2nd dose, it came back just as loose and watery.  This has continued.  I have tried drinking lemon juice to slow the diarrhea but it has not stopped.  If it does not resolve in the next week ( based on the reaction from the first shot), I will go to the doctor.
Fever, chills, loss of apetite for 2 days, extreme pain in shoulders that transversed down my arm, hive on arm given the shingles shot.  Gradually felt better after 2 days
Five minutes after immunizations given child had a systematic reaction to the vaccine. The child broke out in a rash all over his body.
The pt experienced irritability, followed by regression of language and social behaviors, constant diarrhea and rash on cheeks. The pt also experienced a lack of eye contact, resistance to being touched or held and high-pitched screaming. The pt was diagnosed with autism on 9/26/96 and on 10/97 with celiac disease. 60 day follow up states the pt has gastrointestinal damage and neurological damage.
Seated client c/o redness of arm about 10 minutes following injection.  Client ambulated by provider and spouse to exam room to lay down on exam table. Client reports feeling dizzy. VS taken. Client hypertensive 174/104 , HR 66, temp 98.7 Oral, rr 22. Lung sounds clear bilaterally. AOx4. Client denies SOB, swelling, confusion, nausea. Client sat up with assistance to have one bite of cracker and a sip of apple juice. No coughing.  Client complained of dizziness again, client was positioned laying down again. Client then complained of "burning" sensation in throat. EMS called. EMS arrived 6-8 minutes. Provider gave report to EMS. Provider and EMS personnel helped client ambulate to the stretcher 2 rooms away.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. On 08-APR-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and route unspecified). On 15-FEB-2012, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
I first got gradually spacey and sore feeling late at night. Around 3:30 am I experienced Extreme shakiness, cold and muscle spasms.  This lasted about a half hour and gradually got worse. I took a Baclofen and an Advil and was able to go to sleep after another half hour of shaking. The shaking was very bad, like I couldn't control any of my muscles. The next day I could not get out of bed until about 9 pm. I felt like I'd been in a car accident. Every muscle and joint hurt and I was extremely tired. I also got very hot before I was able to get out of bed. This general terrible feeling lasted into the next day until about 9 or 10:00 pm. This happened with the 2nd COVID shot I got that was Pfizer also, but this time it seemed to last longer. The Moderna shot (my first booster) didn't do any of these things, but it made me sick to my stomach for a day. The Pfizer vaccine seems to just completely disagree with my body
The side effect that hit the hardest was the muscle/joint aches. I also had a mild fever for the following  2 days. The injection site was also very sore after the second dose. The muscle/joint pain was mostly in my legs and feet.
210PM pt was pushing shopping cart-became disoriented, sl tremors, hypotonia,temp nl in ER;
Runny nose, cough, then wheezing. Taken to hospital for wheezing and was given breathing treatment and prednisone. 11/20/09 Medial records received for date 11/18/09. DX: wheezing. Pt presented to ER. Pt parent states pt. had H1N1 vax on 11/16. Then on 11/17 pt. had runny nose then cough, low grade temp. Assessment: wheezing all lobes, global retractions, nasal flaring. Breathing tx given.
Moderna COVID-19 Vaccine EUA 8 days after dose 1 of the vaccine, red, itchy rash appeared around injection site. It is slightly swollen
Patient experienced generalized anxiety disorder. Onsite EMS was called vitals BP 149/93  100% O2 room air HR 84  Patient refused evaluation/care  released against medcial advice.
Pt recvd DTP/OPV/HIB TITER; @ that time, exp no adverse rxn; HIBTITER was on backorder for 2 months so pt was given HIB conjugate vax for 2nd dose on 19APR91; w/in 1 hr pt exp lethargy, irritability & oral temp 104.4;
Red itchy streak down arm just below injection site. Began 2 days after injection and began itching about three days after injection
This is a spontaneous report from a contactable pharmacy technician reporting on behalf of a contactable pharmacist communicated to a Pfizer sales representative. This pharmacy technician reported the same event for three patients. This is the third of three reports. A female patient over 65 years old of unknown ethnicity received PREVNAR 13 for Protection against pneumococcal pneumonia via an unspecified route at single dose on unknown date. Relevant medical history and concomitant medication were unknown. On unknown date the patient experienced swelling of injection site. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017231461 Same reporter, same drug, same event, different patients; US-PFIZER INC-2017231547 Same reporter, same drug, same event, different patients.
19-year-old male no past medical history brought in by father with complaint of shortness of breath, chest discomfort, palpitations, tachycardia x2 days.  Symptoms began 1 day after vaccination.  EKG revealed diffuse ST elevations, machine read as *ACUTE MI*.  Patient was given 325 mg ASA, placed on O2, and  transferred to ER via 911.  Patient was hospitalized overnight for observation.  Troponins were elevated at 13.  Patient had full cardiology work-up and cath lab that did not reveal any arthrosclerosis or underlying heart disease.  Diagnosed with myocarditis, discharged on metoprolol and aspirin. Has pending follow-up with cardiology, currently still with mild symptoms.
suspected vaccination failure; received both doses /in 2018 / has had multiple cases of shingles since vaccination; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 75 or 76 years. In 2018, the patient received both the doses of Shingrix and since vaccination the patient had multiple cases of shingles. First case of shingles was in 2019. This case was considered to be a suspected vaccination failure case, as the details regarding time to onset and laboratory confirmation for shingles were  unknown.