chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events reported.; Nurse reporting a dose of Improperly stored V ARIV AX has been administered; This spontaneous report was received from a registered nurse referring to a 12 month old patient of unreported gender.      No information regarding the patient's pertinent medical history, drug reactions or allergies or concomitant therapies was provided.  On 19-JAN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (product storage error) at a dose of 0.5 milliliter for prophylaxis (lot number U020244, expiration date 28-JUN-2023; route of administration, vaccination scheme frequency, concentration and anatomical location were not reported). It was later found that the administered dose of the vaccine experienced a temperature excursion of  6 Fahrenheit degrees up to 14 Fahrenheit degrees (13.8 Fahrenheit degrees) for 1 hour 45 minutes and 0 seconds and of 14 Fahrenheit degrees up to 46 Fahrenheit degrees (14.4 Fahrenheit degrees) for 0 hours 25 minutes and 0 seconds. There were no previous temperature excursions. No additional adverse events reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA000685: US-009507513-2202USA000846:
Flu shot Thurs 9/9/10 3PM. SAT 9/11 2PM Headache and pain to left ear & neck. Went to ER. Tues 9/14 (L) side of face numb. Wed 9/15 decreased sense of taste, lips numb, blurred vision in left eye. Went to PCP who diagnosed Bells Palsy believed to be R/C a virus. PCP gave RX for FAMVIR and prednisone. As of 9/23 s/sx resolving.
No adverse event; HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL); This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) in a 24-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     The relevant medical history/conditions, allergy, concomitant diseases and risk factor was unknown.    On 29-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)).    Patient did not receive other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information for patient 12 out of 12.   This case was linked to US-MODERNATX, INC.-MOD-2023-737355 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737355:Master case
Client came today for 2nd Covid shot with husband and explained she got "frozen shoulder" with her 1st dose that began 1 week after the shot was administered. Client had told me she was having physical therapy on the right arm, but would prefer the shot in that arm so she could sleep on the other side. I did not ask more about the injury. Today. 4.6, she told me her shoulder tendon had been loose which was causing her muscle to be loose in that shoulder, so the inflammation could have gone into the bursa causing capsulitis or something similar. The client was not complaining, but did inform me so I can report the adverse effect. Her husband got the shot the same day at the same time and did fine.
Intermittent nerve pain in left side of face, slowly increasing for three days and then slowly decreasing.  Pain was in both upper and lower jaw and ran back to the left ear.
Patient called today to report that she continues to have left arm/shoulder pain since her Prevnar vaccine in September. The pain started the day after administration. Tylenol improves the pain temporarily.
patient became hot, light headed, nauseous, and felt her ears clog up a few minutes after she received her shot. she was given an ice pack to put behind her neck and she put her head between her legs. after 15 minutes she was fine. after 20 minutes she was able to get up and walk. after 30 minutes she felt fine to leave.
This case meets vaccine breakthrough criteria review.  Also previous infection in 10/2020. SxS include with cough and fever, neutropenic.
Two weeks after my second anthrax vaccine shot, I lost the strength in my right leg and could not use the ships ladders. I was flown for medical testing, then sent to another location for more testing. There, I was misdiagnosed, to having conversion disorder so I could get back state side. My mild-stroke was found when I was state side. I had an annual stroke the following two years. The second mild-stroke took more arm strength on my right side and the third mild-stroke switched sides took left ear and steady tingling in left arm.  - 4/28/06 Review of medical records indicates final diagnosis of cerebral infarction with residual RLE weakness, hypothyroidism, and hypercholesterolemia. Also experienced falls with injury due to unsteady gait. Per review of correspondence from patient, he states 2nd anthrax was received on 8/8/96 and AE began approximately 2 weeks later or 8/30/96. His stroke was diagnosed on 6/2/97.   First stroke gave my right foot drop second stroke took my speak third stroke gave my left arm tingle and some lose hearing in left ear The vaccine should not be given.
Approximately 15 minutes after administration, numbness and tingling felt going down right arm into right hand. Approximately 15 minutes after that, numbness and tingling moved to right neck and right face.
5 year old female received 1st dose of Pfizer Covid-19 vaccine and was inadvertently administered 12+ dose of Pfizer instead of 5-11 year old dose.
headache Patient presented to ED with fever, headache, weakness, and confusion one day following immunization (''a few weeks ago") and was intermittent. The pain was getting progressively worse. Patient reported feeling off balance for a couple months. He endorsed weakness and fever that started in close proximity to ED presentation. Temp 101 in ED. CXR show signs consistent with atypical infection.
On 7/10/16, patient developed a fever. He began to cry inconsolably for days on end, to the point of vomiting. 7/11/16 he was seen by the Clinic. It was noted that on 7/1/16 that Varicella had been given, despite me saying numerous times he had received multiple vaccines. He presented with fever, rash, vomiting, (viral) upper resp infection. Dr stated that this was viral exanthem, despite my objections that this was a reaction. (Dr even noted that I agreed with findings. That is a false statement.) On 7/13/16, he was seen again, and erythematous papules were noted on entire body, still fever, disrupted sleep, etc. By 12/1/16, patient had regressed in speech and motor skills. It was noted that he had speech delay, behavioral changes, loss of communication, and he was referred for autism diagnosis. On 10/11/17, patient was again seen by the clinic. Fever, rash, etc. Told it was an URI. On 10/12/17, he was dx with chickenpox. 3/6/18 noted MRI showed lesion on brain.
I had cold symptoms, cough sneezing laryngitis and headache. I waited five days to test and was positive. i was treating a lot of the joint pain with Ibprophen.  I was positive for 11 days.  I still have cold like symptoms.
Two weeks after Booster: Abdominal pain, bloating, obstipation. Resolved in one month, constipation continues Diaphragmatic spasms, palpable and visible at xyphoid and right inferior costal margin. Resolved within one month DOE, still persistent Full lab workup (labs normal),  in  including Cardiac calcium scan (100% normal), Echo Cardiogram showing new (compared to routine echo  one year prior) moderate diastolic dysfunction with preserved EF, decrease in EF from 65% to 50% Cutaneous Hyperesthesia, persistent Rhinitis,  persistent Fatigue, persistent Orthostatic Hypotension, persistent
No additional AEs reported; GARDASIL 9 was administered after a possible temperature excursion; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 02-SEP-2021, the physician received a shipment of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that was delayed for a day during shipment. On this same date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL, lot # 1687293, expiration date on 30-APR-2023, for prophylaxis (strength, route of administration and anatomical location were not reported).   Then, the physician received an email stating that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) should not be used as it might had encountered inappropriate temperatures during its delayed shipment; therefore, vaccine was administered after a possible temperature excursion (product storage error). The temperature and time frame was unknown and no previous temperature excursions were reported. No additional Adverse Events were reported.
After Intranasal Influenza, patient developed dizziness, vertigo, headaches.
I started to feel more and more tired kind of lethargic. I went to see my doctor after the first shot because I thought it was stress related from work. I let my doctor know I felt run down. He had some labs done to rule out anything that may be going on. He ultimately ruled everything out as fatigue. After the 2nd shot it was getting harder to sit still my back was bothering me and I was experiencing back pain. I thought it may have been related to a previous back injury from a car accident I had years ago. The tightness got more intense I went to visit my chiropractor and the pain did not get better. I went to see my rheumatologist and I did not need a cortisone shot in my knee for the first time in 3 years. I let him know that I had difficulty standing from my chair. I explained I need to push off in order to stand up. He determined I had myositis. I had an MRI completed and other labs he let me know I had polymyositis. After my first visit Dr. called in a prescription for prednisone and hydroxychloroquine. I went to see Dr. the following business. When I go down the stairs I have to hold the handrail and it is more difficult to walk upstairs.  My doctor asked me if I had recently fallen because polymyositis is normally associated with a fall. But I have not fallen as I have been working from home. I had also experienced shortness of breath which I had checked out on 6/22/2021 at Urgent Care in. They recommended I have a CTA completed to rule out PE in my lungs.
Tachycardia and lightheadedness  occurred about 10 minutes after injection and lasted for about 30 minutes
pt recv vax;devel a fine, "bumpy" rash all over body, including hands & feet;mom advised to have child seen by hlth care provider;
Sore arm began evening of vaccination (not as sore as with first dose in series). Did not treat. Mild headache began evening of vaccination, advanced to severe headache throughout the next day. Treated with Ibuprofen 24 hours after vaccination. Pelvic/lower back/neck aches began evening of vaccination, around 10pm. Pain was significant enough to cause insomnia during the night and did not improve during the day after vaccination. Pain improved considerably after dose of ibuprofen mentioned above.
Site: Swelling at Injection Site-Mild, Additional Details: Swelling on arm about 1 cm away from injection site, felt like a hard raised bump and was tender/sore, occurred immediately, Patient said 3.5 hours after vaccination swelling had gone down and she was just feeling a bit sore
pt had blood glucose of >100 on 24NOV96 dx w/diabetic ketoacidosis (DKA) & as a result of no prev dx became dehydrated suffering brain injury & sz w/major developmental delays (3mo current development);stomach tube for 1/2-2/3 calarie; Annual follow-up received on 09/27/00 states pt is unable to walk, cortical blind with seizures.
Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported) via unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unknown date, the patient had experienced heart palpitations since receiving the vaccine. He described them as similar to how his heart might feel after a long run or exercise, but he feels it while he was at rest.  The outcome of event was unknown.  Information about lot/batch number is requested.
The patient came to the office complaining of a hematoma located on the medial aspect of her thigh just proximal to her knee. the patient denied having knocked the area or punctured it. She could not account for its appearance and it was not the injection site of the vaccine. The bruise was in the shape and had the coloring of a bullseye. The outer ring was brownish purple, the inner part was more whitish. The center felt hard to the touch but was not painful. No special treatment was administered for the bruise.
Pfizer-BioNTech COVID-19 Vaccine EUA Five minutes after I received the vaccine, my arm was sore and my throat felt a little tight. Then, I started to feel kind of lightheaded and my legs were weak. I let the staff know and they offered me benadryl but I declined. I waited about 35 minutes then I went home. I continued to feel lightheaded and weak for about 4 hours and I also began to fill nauseous. My arm continued to be sore for a few days and I ran a fever of around 100 from the following day 1/9 and I am still running a fever now on 1/12.
When receiving the vaccine he complained of having soreness; A spontaneous report was received from a male consumer, age unknown who received Moderna's COVID-19 vaccine and experienced soreness when receiving the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) in the right deltoid for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient experienced soreness. Treatment for the event is Unknown.  The second dose of mRNA-1273 was scheduled for 26 Jan2021.  The outcome for the event is Unknown.  The reporter did not provide causality for the event.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Admitted for septic shock 2/2 pna vs cellulitis. COVID test positive after admit and was dx with COVID pna. Cefepime, vanc, remdesivir, mechanical ventilation. Progressively declined and expired after cardiac arrest.
Extremely sore at injection site.  Fever, chills, all body joints extremely sore,  heavy breathing with flu-like symptoms.
patient have been administered from an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient have been administered from an expired dose) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient have been administered from an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient have been administered from an expired dose) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  Vial did not undergo any temperature excursion issue.  The vials initially stored in the refrigerator on 08 Mar 2022 was administered 1 dose on 29 Mar 2022 and 4 doses on 31 Mar 2022.  The vials initially stored in the refrigerator on 30 Mar 2022 was administered 2 doses on 05 Apr 2022 and no other side effects were reported.  No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow-up received: Vaccine administration dates updated in narrative.
confirmed VZV infection by PCR of skin lesions on 8/30; patient was diagnosed with leukemia; vesicular lesions; This spontaneous report was received from a physician via former company representative refers to a 18 year old patient. The patient's concurrent condition included leukaemia. Information on medical history, concomitant mediactions were not reported.  On 30-JUL-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, anatomical location, route, lot # and expiry date not reported) for prophylaxis. On 02-AUG-2019, the patient experienced leukaemia. The patient started chemo including a 28-day course of prednisone. Subsequently, on an unknown date in August 2019, the patient experienced rash vesicular, which started out on the neck and was initially considered as a possible case of acne (vesicular lesions). On 30-AUG-2019, the patient experienced varicella infection (VZV infection) and it was confirmed by polymerase chain reaction (PCR) of skin lesions. It was also reported that it would be helpful to confirm that this was vaccine strain. The former company representative suggested the physician, if he would test the sample or would suggest another hospital physician. The reporter also stated that the patient was doing well after the course of prednisone. The rash had resided and there were no longer any lesions from which to obtain a sample. The only available sample was the one used for PCR testing. The outcome of rash vesicular was considered as not recovered. The outcome of leukaemia was considered to be recovering and the outcome of varicella was unknown. Causality assessment was not provided.  Upon internal review, the event leukaemia was determined to be medically significant.
Child was brought to school w/ concent form signed  by parent and and proxy by vice-principal to be vaccinated with covid 19 vaccine Pfizer 12 year old and older .  Pt was vaccinated.  Pt is 11 years  and 11 months old.
2 days post immunization, acute swelling, redness and slight warmth to L upper arm to elbow.
Migraine onset from night of shot until Sunday following 4/21/2021, heavy breathing, blurred vision, off balance, muffled hearing, extreme fatigue, body pain
More likely than not the COVID vaccine was involved with his recent pancytopenia.  Patient found to have worsening pancytopenia with no other cause. First found on routine cbc lab on 6/25/2021 by PCP. Repeated multiple times with worsening blood counts. Referred to me, Hematology, and underwent bone marrow biopsy (8/5/2021) for diagnostic purposes which was normal consistent with an inflammatory or consumptive cause to the pancytopenia. Lowest platelets documented at 48,000 on 8/5/2021 (easy bruising but no bleeding), lowest wbc 2,600 with ANC 1300 on 8/16/2021 (no infections, fevers or chills), and lowest hemoglobin 11.3 on 8/3/2021 (no symptoms of anemia). Not recovered
extreme nausea; extreme fatigue; sleeping 22 hours a day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Aug2021 15:45 (Lot number: EW0202) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 12Aug2021 18:00, outcome "not recovered", described as "extreme nausea"; FATIGUE (non-serious) with onset 12Aug2021 18:00, outcome "not recovered", described as "extreme fatigue"; HYPERSOMNIA (non-serious) with onset 12Aug2021 18:00, outcome "not recovered", described as "sleeping 22 hours a day". The events "extreme nausea", "extreme fatigue" and "sleeping 22 hours a day" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, fatigue, hypersomnia.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not have any known allergies. The concomitant medications or other medications the patient received in two weeks included Multivitamin. The facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. 48 hours after first shot, the patient experienced extreme nausea and sleeping 22 hours a day. She was still sleeping and it has now been 24 days with extreme fatigue.   No follow-up attempts are possible. No further information is expected.
MA, administered Hep A to five day old child in error. Hepatitis B had been ordered.