chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Vial of Modern vaccine expired on 7-30-21, patient's first dose was adminstered with expired vaccine on 8-2-21. Moderna does not recommend any action besides monitoring and patient receive second dose.
Patient became light headed and fainted immediately after getting vaccination. He was cold, clammy and became responsive immediately. He was sitting up on the exam table and he was immediately laid down. Medical observation x 20 min after fainting. BP decreased and HR decreased but after observation, he was bak to his baseline with his mental status, BP and HR increased.
This spontaneous report as received from a medical assistant via a vendor refers to a 18 month old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date the patient was vaccinated with an expired dose of VAQTA (dose, frequency, route, lot # and expiration date were not provided) for prophylaxis. Additional information has been requested.
started filling bad pain and soreness on my arm on 1/14/2021. 1/15/2021 notice the spot of injection is swollen (quarter coin size) and half arm is swollen.  Area getting more red now and hurting a lot and itching. Starting to get body ache like if am getting a fever.
Burning and itching sensation on my back beginning on Saturday evening, February 6... 2 days after the vaccine shot. Got worse by Sunday evening with feelings of all nerve endings exposed and ?creepy crawling? on my right arm.  Unable to sleep.  Saw dermatologist, Doctor on Tuesday morning. Prescribed Triamcinolone Acetonide topical cream.  Did not think it was shingles at the time.  I have used the cream for 10 days... the itch and pain have gotten worse.  Today, texted her pix of the  area on my back - under right shoulder blade and two spots on my right breast. She diagnosed shingles for sure and prescribed  Valacyclovir - 21 tablets  -3 x a day for 7 days.  I have now begun that protocol.  Once I saw Doctor.... stabbing pains began under my right shoulder blade....saw primary doc., Doctor.. she too did not think it was shingles at the time.... prescribed a muscle relaxant- it did not help... stopped taking it after two doses I am worried about getting dose 2
patient was by mistake given a Quadracel that expired; Initial information received on 23-Aug-2019 regarding an unsolicited non-valid non-serious case received from a non-health Care Professional.  This case involves a 4 years old male patient (also reported as 4 years and 1 month) who was mistakenly vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant medication at the time of vaccination.    On 22-Aug-2019, the patient received a single 0.5 ml first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5248AA (expiry date: 21-Aug-2019) via intramuscular route in the left deltoid.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
Her original due date of Dose 2 was 05May2021 but it scheduled for 20May2021; rash on right ankle, spread upward to leg; rash as being slightly pruritic; rash as being slightly red; red bumps above the skin; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (rash as being slightly pruritic), RASH ERYTHEMATOUS (rash as being slightly red), URTICARIA (red bumps above the skin), OFF LABEL USE (Her original due date of Dose 2 was 05May2021 but it scheduled for 20May2021) and RASH (rash on right ankle, spread upward to leg) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history provided.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced RASH PRURITIC (rash as being slightly pruritic), RASH ERYTHEMATOUS (rash as being slightly red), URTICARIA (red bumps above the skin) and RASH (rash on right ankle, spread upward to leg). On an unknown date, the patient experienced OFF LABEL USE (Her original due date of Dose 2 was 05May2021 but it scheduled for 20May2021). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 10 days of bendadryl, 25 mg tablet daily; FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of Pepcid, twice a day and CORTICOSTEROIDS (STEROIDS) from 27-Apr-2021 to 06-May-2021 at a dose of 10 day regime of Steroid taper. On 11-May-2021, RASH PRURITIC (rash as being slightly pruritic), URTICARIA (red bumps above the skin) and RASH (rash on right ankle, spread upward to leg) had resolved. At the time of the report, OFF LABEL USE (Her original due date of Dose 2 was 05May2021 but it scheduled for 20May2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. The patient stated that original date of Dose 2 was 05May2021,but was scheduled on 20May2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-155649 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155649:Cluster case
7/21--7/22  33y.o. At 40w0d by L=8wk sono.  Pt reports feeling contractions since having her membranes stripped at OB appt this morning, she was 2cm. 7/21 SVD healthy baby. Ok for home today Instructions and call parameters and follow up reviewed. covid precautions and encouraged partner to test and isolate for 5 days
A 6 mo-5 yrs Moderna Covid Bivalent Booster was chosen to administer patients first Covid vaccine.  It as brought to my attention that this was a Boosters only dose, requiring patient to receive what used to be the Adult Moderna Covid Bivalent Booster, but is now required for patients of all ages to receive as their first dose. Since it was a boosters only dose, this would be appropriate to administer after patient received the initial doses of the Moderna Bivalent Booster. This vaccine was administered at 12:23 after verifying with patients primary care provider, MD. Patient and mother waited 15 minutes following administration to monitor for any adverse reactions. Patient did not have any adverse reactions or side effects after administration.
Pt returned to pharmacy today 7/1/18 with redness and swelling in upper left arm. He said the symptoms started that night after the vaccine was administered 6/29. His wife received the same vaccine, same lot, and had no reaction besides local soreness. Advised pt to visit urgent care for possible infection. NP, sent Rx for BACTRIM DS. I called and spoke to on-call Dr.about drug interaction with one of pt's other meds. Changed to doxycycline. Pt will pick up today.
Patient came back 1 week after and reported a big red rash area below deltoid  which is more likely close to elbow area. Patient complained it was itchy and painful. She claimed that the rash appeared on 9/19 and started spreading on 9/20.  I recommended the patient to see the doctor immediately since it might related to infection or other diseases. Patient came back and was prescribed antibiotic. I spoke to the doctor who examined and prescribed the medication at urgent care. Per MD, it is cellulitis it might be related to side effects of vaccinations. Patient will start the course of antibiotics for 10 days.
first evening, rash developed inside elbow of right arm.  patch of small red bumps, itchy. Third day after shot this rash disappeared with no treatment, but papular rash bumps appeared on arms and legs. Wrist of right arm was first eruption. Very itchy. would get new eruption almost daily.  Now, April 17 still getting new eruptions on arms and legs. Have about twenty - thirty in all.   Right ear upper edge developed itchy patch at  day 10.   Mainly on arms and legs have two on trunk of body.    Saw Dr. 21 days after shot .  Said it was papular rash and not to get second moderna shot.
migraine; unable to walk; nausea/vomiting; nausea/vomiting; Muscle pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), GAIT INABILITY (unable to walk), NAUSEA (nausea/vomiting), VOMITING (nausea/vomiting) and MYALGIA (Muscle pain) in a female patient of an unknown age 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraine), GAIT INABILITY (unable to walk), NAUSEA (nausea/vomiting), VOMITING (nausea/vomiting), MYALGIA (Muscle pain) and FATIGUE (fatigue). At the time of the report, MIGRAINE (migraine), GAIT INABILITY (unable to walk), NAUSEA (nausea/vomiting), VOMITING (nausea/vomiting), MYALGIA (Muscle pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported No treatment information was provided.
Got FLUZONE High Dose around 5:00pm on 10/17/16. Patient came in 10/19/16 around 12:45pm showing a major round bruise. She states she noticed the bruise starting around 8:00 pm the night she got the shot. Redness came well below the bruised area and a knot formed. The bruised area is the size of a half dollar. The redness and knot went away by the time she came into us. Pt. got shot in  right arm. Takes Aspirin, but has never had this happen before.
Hives head to toe, confluent areas in groin area, face, itchy and sweating, vomiting, stomach pain. Left arm at 3 vaccine sites pea sized swelling and induration larger area of redness around PCV13 site.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt pass out out. Was sitting down for about 8 minutes after vaccine and got up to walk and passed out. HR went to 44, bp 90/60 and 02 sat was 93. Later recovered within 30 minutes.
103 fever, sweats, chills, tired  Called and spoke with doctor, encouraged water and gator aid as well as Motrin
Client received Pfizer booster on 10/2/2021 by pharmacist at client's place of employment. A few minutes after receiving booster, he complained of shortness of breath, itching and numbness in hands and feet. Pharmacist administered epinepherine 0.3cc SQ and called EMS. EMS evaluated client and he recovered. Symptoms subsided. Client offered to be taken to emergency room but he declined. Client observed until stable. Client stated he never had a problem previously with COVID-19 or any other vaccine. He previously received Pfizer vaccine on 3/29/2021 and 4/19/2021. Call to client on 10/28/2021 and 11/2/2021 for follow up.  He is doing well with no problems and has had no return of any symptoms.
fever of around 101, steadily declined over 48 hours.  Fatigue, gone after 4 days
Information has been received from a registered nurse concerning a 13 year old female who on 19-MAY-2009 was vaccinated SQ with a second 0.5 mL dose of VARIVAX (lot # not reported). It was reported that the patient's arm was very red and swollen and sore at the injection site. On an unspecified date the patient had recovered. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a elderly female patient who received SHINGRIX. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a month after receiving SHINGRIX, the patient experienced general body pain. On an unknown date, the patient experienced fatigue. On an unknown date, the outcome of the general body pain and fatigue were unknown. It was unknown if the reporter considered the general body pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 84 or 85 years. The patient received SHINGRIX vaccine three weeks before the date of reporting, in left arm and was feeling body aches and fatigue. The patient felt that the symptoms were getting worse. The patient has denied permission to contact their physician.
PT RIGHT ARM WAS RED, WAR AND SWOLLEN. PT'S MOTHER APPLIED A WARM AND COOL COMPRESS. CHILD WAS GIVEN CHILDRE'S TYLENOL AND MOTRIN.
On 11/25/22, I had lingering Bronchitis symptoms. I have had this before, so I recognized the symptoms immediately. I went to urgent care, and they tested for Pneumonia and the results came back negative. I was prescribed 5 days worth of prednisone and I did not feel better after taking all the prednisone. I contacted my doctor again and he prescribed albuterol and cough medicine, but I am unable to recall the name of the cough medication. After taking these medications, I started feeling better in about 4 days.
After receiving the 1st vaccine, I noticed bumps on my upper stomach. A MD thought this was a topical skin yeast infection and gave me nystatin ointment to treat. After my 2nd injection, the rash continued to spread on my stomach and then start on my wrists-the doctors though it was either the yeast infection rash not responding to Nystatin, or a 'vaccine rash' from the Covid injection I recently received. They told me to use steroids and it resolved a  few weeks later. However, I know have occurring rashes in the same areas now.
Patient arrived to our facility with  acute cerebral venous thrombosis with bilateral hemorrhage. Went for thombectomy and extensive (>10 cm) cerebral venous sinus thrombosis involving the superior sagittal sinus and right transverse sinus was removed. Also had thrombocytopenia at presentation.
Headache. Denies c/p, swelling, itching. Extended observation. BPs 173/88 (HR 89), 181/87 (HR 86), O2 100%. Stable gait w/one person assist. Stable and released.
Pt received half of a meningococcal vaccine, which was mixed with saline water diluent.  Patient parents  were contacted and there is no sign or symptoms of  a reaction reported at the time of telephone call.
received Moderna Covid-19 vaccine at the age of 17 years old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna Covid-19 vaccine at the age of 17 years old) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna Covid-19 vaccine at the age of 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received Moderna Covid-19 vaccine at the age of 17 years old) had resolved. 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 medication was reported. No treatment details were provided.
Three days after receiving my second dose of the Covid vaccine I started to notice a rash on my forearms. This rash progressed to all over my stomach/chest/back. I went and saw a dermatologist 8 days after getting the vaccine and they diagnosed me with pityriasis rosea. This can take 6?8 weeks to go away.
This spontaneous report was received from a physician and refers to a patient of unknown age (also reported as "0") and gender. No information about the patient's pertinent medical history, concomitant medications and concurrent conditions was provided. On 28-APR-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ oral solution, lot # M041181 (dose, and expiry date were not specified) for prophylaxis. The administered dose of ROTATEQ underwent a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There was no Digital Data Logger involved. No previous temperature excursion was reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all available information has been received. Sender's Comments: US-009507513-1704USA001661:
Pt received the Covid monovalent booster which was the only available vaccine at the time of visit. Have not receivedd the shipment of the bivalent covid vaccines. Communication regarding the new approved covid booster recommendation was still being clarified and distributed by the leadership team and the current standing order was not in force at the time of vaccination. Clients were contacted and notified that this resets the timeframe for their future booster dose and were advised to return after 2 mos for the bivalent booster dose.
After receiving the vaccine, patient reported swelling 2 hours at the injection site and also a papular and petechial rash on both upper arms (bicep) area. Confluent red rash just below the neck posterior and anterior upper torso.  Rash was still evident and border of Band-Aid still visible along with a more defined circular rash in the area where injection was placed.  Patient only took naproxen for muscle pain (has a history of weight lifting as well) and reported to same day clinic on 11/6/2015.
On 4/4  sense of taste went away and hasn't returned . Also has Brain fog . problems with sense of smell.
Approx. 10 minutes after vaccination patient was pale, clammy, dizzy and said he was having trouble catching his breath. His breath, he said he had trouble seeing and that his arm felt numb. His mother requested Paramedics be called. While waiting for Paramedics, Pt's Blood Pressure was taken (94/63, 98) Pt was let to drink some water and color came back to his face. Paramedics came approx. 10-15 minutes after and reported normal vitals signs & O2 saturation. Pt left to home.
Pt previously vaccinated with VZV started to break out on one of 10/28/03 with one spot on neck-mom states also had fever-itchy 2-5mm erythematous blisters continued to spread down arms and back approximately 30 spots total seen in office for dx of vericella.
pt stated that 3 days after taking the covid vax that he started getting  bad sores on left side above the groin area which is spreading.  Pt went to his PCP on  2/12/2021.  He was prescribed Nystatin cream100,000 usp and Cephalexin 500 mg x 2 daily for 7 days.  Pt is going to FU w/ PCP on 2/25/2021 to get more antibiotics since they are not improving.
diarrhea; nauseous; joint pain; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), NAUSEA (nauseous), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bleeding (brain bleed before the vaccine which lead to brain surgery and a long recovery) and Surgery (Brain surgery).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (nauseous), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (Headache). On 06-Mar-2021, DIARRHOEA (diarrhea), NAUSEA (nauseous), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
On 924/2000 within 24 hrs I exp headache, muscle pain, dizziness lay down in bed. Then on 9/28/2021 other severe symptoms started chest pain, chest tightness, palpitations, dizziness continued through 10/1/2021/ It started for a couple days get better. On 10/6/2021 I started back having headaches, difficulty breathing again. Later that evening on 10/7/2021 went to ER had a EKG, blood test and given Aspirin. The ER doctor recommend me to see the Cardiologist. I have seen my PCP got a CT scan done for blood clots. As of today I'm still exp the same symptoms and have to scheduled for a Cardiologist appt.
This spontaneous report as received from a consumer refers to a 60 year old male patient. On 13-JUN-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included telmisartan(MICARDIS).  On 14-JUN-2017, 2 days after onset of therapy the patient experienced injection site erythema. The outcome of injection site erythema was reported as not recovered/not resolved. Causality was not provided.
PT'S BACK OF LEFT ARM BECAME RED, SWOLLEN, ITCHY, PAINFUL, AND HOT TO TOUCH. SITE MEASURED 8 CM AROUND INJECTION SITE ON THE NEXT DAY.
AT 3:00am on Monday 3/15/2021 I woke up with severe headache & body aches.  I was disoriented & lethargic.  My friend came over took my blood pressure it was 144/75  I was freezing and the room was 80degrees  I had absolutely no appetite. My head felt like it was going blow up  Next day was Tuesday 3/16/2021 I woke still groggy & bad headache but now I was hallucinating & i was burning up & sweating profusely Next day 3/17/21  still out of sync  & very disoriented  Thursday 3/18/21 had video dr appt at 1:00pm  he told me to ride it out gave me something to sleep & some tramadol for pain Friday 3/19/21 started coming out of it  I felt like i was dying if thats what it feels like
Developed pyoderma gangrenosum (by biopsy) on the anterior abdomen and posterior back.
Pt sitting down after a shot. got light headed, woozy, and likely passed out.  Patient wore glasses, and hit his face.  Glasses caused a minor cut on his face. Pharmacist went to patient, stayed with G.I. until stable. Prior to shot... Pt expressed anxiety before requesting a shot.  Was asked to sit for a period after the shot.  Patient did not sit down, but wanted "fresh air" and went outside.
Patient had a syncopal event a few minutes after receiving 3rd GARDASIL injection. Lasted about 1 minute. Did fine with first 2 injections.
I developed GI bleeding which grew worse over months. I was diagnosed with Crohn's disease in July 2010. I was also diagnosed with Type 1 Diabetes in October 2010.
Pt developed chickenpox despite varivax. Typical rash with mild viral syndrome. Recovery is expected.
Swelling and erythema left deltoid. Large area 6-10cm by 4-6cm in area where DTaP given.