chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of FLUMIST administered to a child less than two year was received from a health professional concerning a 23-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 01-Nov-2011, FLUMIST was administered to the patient less than two years of age. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Red raised puritic rash first on palms of hands then spread to chest, abd. and back. PCP dx of Thimerasol rx but the vaccine and diluent are preservative free. Steroid injection and cream RX 5-15-17.
BODY ACHES, NAUSEA, FATIGUE Narrative: ALSO NOTE AFTER FIRST INJ (1/23/21) EXPERIENCED FATIGUE AND CHILLS
Headache, NauseaVomiting, sore arm, still has soreness on second dose appt Narrative:  Employee experienced severe headache next day. Stated she  vomited from headache pain. Had a very sore arm and can still feel soreness to the right arm 4 weeks later.
pt recv vax;began screaming, high pitched cry for approx 3 hr p/ vax;inconsolable for 4 hr;PC to PMD who said dph;stopped crying approx 1 hr later;
Initial report received from a health care professional on 15 October 2013. A 49-year-old female patient, with the history of diabetes mellitus, hypertension, had received a dose of ADACEL vaccine (lot number: U4688B) in left deltoid region on 11 October 2013. It was reported that, on the same day after vaccination the patient experienced swollen lymph nodes, supraclavicular and axillary lymph nodes and pain. Corrective treatment was not reported. At the time of this report, the event was ongoing at the time of report. Documents held by sender: none.
Pt received Varicella vaccine 5/22/03. Pt has developed chicken pox lesions as of 3/05.
Buzzing sound in the ear. He feels pressure is his ear and can hear very feebly.
Approx 10-15 mins p/vax pt returned w/rt arm swollen & warm radiating from deltoi area down to wrist; pt was taken to hosp; c/o no pain in arm was able to move & use arm freely; tx DPH;
All this was reported to RN by the Patient and Leader notified us of her hospitalization. Appears to be Guillian Barre Syndrome.  Numbness in foot started within 24 hours of vaccination and proceeded up her legs over several days, in contact with her provider over time, when it got to her belly button she was advised by her provider to proceed to the ED.  She was hospitalized for at least 5 days and received IVIG.  She did get to the point she could not walk.  Prior to discharge she did walk with help and a physical therapist.  She was still having arm tingling and leg tingling prior to discharge.
My second shot was given on the back of my arm close to my underarm about 2 inches  away.  I woke up early in the morning on the 23rd with severe pain in my arm. I turned on my left side and laid my arm down my side. Pain subsided. This has happened 3 times since July with waking up with that arm in severe pain with the last time being September 14th. I've also been experiencing headaches and neck and shoulder pain.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who sometime in June 2012, was vaccinated subcutaneously with an usually dose of MMR II (dose and lot number not reported) that was reconstituted in an expired diluent. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
High pitch ringing tinnitus started in both ears 2 days after the Moderna Bivalent Covid-19 vaccine.  The ringing was heard that evening and then not noticed again until the next evening and it has been constant since then.   I also had the flu vaccine on 10-19-22.  ENT Dr. gave me Decadron 8mg IM on 11-2-22.  Then, a prescription was started on 11-3-22 of Medrol 4mg 6 day dosepak.  I have completed day 3 of the steroids so far, but the ringing in my ears has persisted constantly and seems most prominent on the right side. The day after this Covid-19 vaccine, I had side effects of low grade fever, fatigue, nausea and vomiting but that all resolved by7pm.
Pins and Needles in the Joints; Muscle Pain; spine pain; hand pain; Chills; Fatigue; Shaking; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint Pain), PARAESTHESIA (Pins and Needles in the Joints), MYALGIA (Muscle Pain), SPINAL PAIN (spine pain) and PAIN IN EXTREMITY (hand pain) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ARTHRALGIA (Joint Pain). On 17-Feb-2021, the patient experienced PARAESTHESIA (Pins and Needles in the Joints), MYALGIA (Muscle Pain), PAIN IN EXTREMITY (hand pain), CHILLS (Chills) and FATIGUE (Fatigue). 17-Feb-2021, the patient experienced SPINAL PAIN (spine pain) and TREMOR (Shaking). At the time of the report, ARTHRALGIA (Joint Pain), PARAESTHESIA (Pins and Needles in the Joints), MYALGIA (Muscle Pain), SPINAL PAIN (spine pain), PAIN IN EXTREMITY (hand pain), CHILLS (Chills), FATIGUE (Fatigue) and TREMOR (Shaking) outcome was unknown.            Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Arthralgia, myalgia, chills and fatigue are consistent with the product safety profile
Myalgia, Fever, Shooting leg pain with heaviness. Nausea w/o vomiting. Temp 101, Shortness of breath Narrative:
seizure, MS relapse. pt was hospitalized for a week and then in rehab for a month. hospital notes not received as of yet. tx not known at present. currently back to baseline
Initial report received via search of the literature on 16 April 2013. This case contains information for 1 of 22 patients whose clinical data were provided. Information regarding the other 21 patients is captured in case numbers 2013-05188, 2013-05251-05254, 2013-05256-05263, 2013-05268-05269, 2006-03230, 1995-00224, 2003-02926, 2011-03827, 2006-03086 and 1995-00668. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. Regarding this case which involved a 65-year-old male patient who had received Trivalent inactivated influenza vaccine (manufacturer unknown; lot number, route, site and date of administration not reported) and 14 days later reported the onset of GBS. No further information was provided. Outcomes were not reported. Documents held by sender: none.
Body rash appears after 33hours; feels very hot; itchy; This is a spontaneous report from a contactable consumer, the patient. This 58 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN9581), dose 1, single dose, via an unspecified route of administration in the left arm on  08FEB-2021 at 10:45 (at the age of 58 years-old) for COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. There was no relevant medical history reported. Historical vaccine  included flu shot on 18Jan2021. Concomitant medications included calcium sulfate dihydrate, dryoptieris crassirhizoma rhizome, ephedra Spp, herb, forsythia suspensa, glycyrrhza glabra root, houttuynia cordata herb, isatis tinctorial root, lonicera Japonica flower, menthol, pogostemom cablin herb, prunius SPP, seed, rheum SPP, rhodiola crenulate (LIAN HUA QING WEN) capsules.  On 10Feb2021 at 15:00, the patient experienced body rash after 33 hours, was itchy and very hot. No treatment was received for body rash, itchy and very hot. The clinical outcome of body rash, itchy and very hot was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient developed acute deymylinating encephalomyelitis (ADEM) 1 week after vaccintion. This syndrome is known to rarely occur after vacination.   Symptoms.: confusion, acutely progressive quadriplegia. This was followed by respiratory failure and cardiac arrest likely due to his brainstem inflamation rather than underlying cardiac or pulmonary pathology given negative cardiac work up.
Pt c/o low grade fever, body aches, chills, headache. Had to leave school. Pt has hx of + PPD. Seen today here in clinic by Dr., given 600mg Motrin. F/u in 1 week. ER precations given if headache/fever persist, or worsen.
Slightly erythematous, indurated area where vaccine given: left upper arm and fever of 103.0 (temp)
Erythema and swelling over injection site. Erythema, warmth and pain over large area of upper arm especially over bicep.
FEVER, CHILLS, UPEER RESPIRATORY DISTRESS FOR 2 DAYS, PULSE/OX LEVEL OF 90 FOR 2 DAYS, UNABLE TO WORK FOR A WEEK DUE TO BEING LETHARGIC AND EXTREMELY TIRED. AND COUGHING AND NASAL/SINUS CONGESTION
Rash on her arm and stomach; Fever; Chills; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her arm and stomach), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (GIANVI) for Birth control, ESCITALOPRAM OXALATE (LEXAPRO), METFORMIN and BUSPIRONE for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced RASH (Rash on her arm and stomach), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, in the middle of the night. At the time of the report, RASH (Rash on her arm and stomach), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Sore arm) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Email address was updated.
Moderate arm pain occasionally zinging down into fingers; Significant fatigue; This is a spontaneous report from a non-contactable nurse, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 05Feb2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. The patient had known allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Jan2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient previously received celecoxib (CELEBREX) from an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021, the patient experienced moderate arm pain occasionally zinging down into fingers and significant fatigue which started the following day and lasted approximately 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events significant fatigue was resolved on 07Feb2021; while that of the event moderate arm pain occasionally zinging down into fingers was resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
No additional AE; administered an expired dose; This spontaneous report was received from other health professional referring to a patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 09-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # T006167, expiration date 19-FEB-2022, for prophylaxis (expired product administered) (strength, dose, frequency and route of administration were not reported) . Concomitant therapies included sterile diluent. No additional adverse event reported.
had a rash on face, neck and a V shape in the front of their chest and some in their back and it is itching/ red and itchy; (rash) is red/little more red; kind of dizzyness; fatigue; a lot of nausea; muscle aches; This spontaneous case was reported by a physician and describes the occurrence of RASH ERYTHEMATOUS ((rash) is red/little more red), DIZZINESS (kind of dizzyness), RASH PRURITIC (had a rash on face, neck and a V shape in the front of their chest and some in their back and it is itching/ red and itchy), FATIGUE (fatigue) and NAUSEA (a lot of nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, GLIPIZIDE, SIMVASTATIN (NORVASTATIN), LOSARTAN, HYDROCHLOROTHIAZIDE and DILTIAZEM for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (kind of dizzyness), FATIGUE (fatigue), NAUSEA (a lot of nausea) and MYALGIA (muscle aches). On 23-Mar-2021, the patient experienced RASH ERYTHEMATOUS ((rash) is red/little more red) and RASH PRURITIC (had a rash on face, neck and a V shape in the front of their chest and some in their back and it is itching/ red and itchy). On 17-Mar-2021, DIZZINESS (kind of dizzyness), FATIGUE (fatigue), NAUSEA (a lot of nausea) and MYALGIA (muscle aches) had resolved. At the time of the report, RASH ERYTHEMATOUS ((rash) is red/little more red) and RASH PRURITIC (had a rash on face, neck and a V shape in the front of their chest and some in their back and it is itching/ red and itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not take any treatment medication, was thinking of taking Benadryl.   This case was linked to MOD21-060907 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Non-Significant Follow up appended for Document attachment-no new information
pt recv vax & mom reported to nurse w/the child;pt had face had hives on it-mostly around the mouth & hand, nose as assessed pt the hives cont to form around the neck;pt was sent directly to ER;
patient briefly passed out after shot. she was okay after I gave to her. he passed out while watching mom get her flu shot
Developed R leg redness, swelling, itchiness, warmth, edema on or around May 4th that was getting worse. This was 15 days after receiving the 2nd dose of Moderna COVID19 vaccine. Cephalexin 500 mg Q6H for possible cellulitis was initiated on May 7th and DVT was ruled out by ultrasound also on May 7th. There was never any fever. Symptoms were getting worse and 4 days later the antibiotic was changed to doxycycline 100 mg Q12H. There was still no fever. Dr. (PCP) suspected acute venous etiology and not infectious process. Referral to Vascular Surgery made. The patient had the ultrasound, specifically, of the R lower extremity venous incompetency. In the impression of the vascular surgery physician "results demonstrate R leg deep system incompetence, superficial reflux of the great saphenous vein." Recommendation was to schedule thermal endovenous ablation of the R great saphenous vein. Approval from the insurance company is pending at the time of this AE report.
Chest pain for at least 2 days  Diagnosed as pleurisy   Irregular menstrual period
Hepatitis A given at 2 months old by mistake. Needed Hepatitis B #2.
On April 19, 2021, I had a really bad headache with blurry vision. I was dizzy and started throwing up. My husband called the ambulance I was taken to the Hospital. They told me that I had a ruptured aneurysm and that I would need surgery to fix it, they transferred me to another hospital where they did the surgery the next day. I was in the hospital for 2 1/2 weeks in the ICU and 2 days in a regular room.
pt recv vax;1st day of fever all day;apap given;fussy,crying all day;leg swollen more than a/;mild convuls,lasting for sec; throwing head back, arching back & spasms; no further convuls;
Initial unsolicited report received from a healthcare professional on 11 August 2015. A 37-year-old female patient had received a third dose of IMOVAX RABIES and a dose of TENIVAC (dose, batch number and site of administration were not reported) via intramuscular route on an unknown date (post exposure series). Medical history, illness at time of vaccination, pre-existing physician-diagnosed allergies, birth defects, medical conditions and concomitant medications were not provided. Previous medications included two doses of Imovax. On an unknown date, after vaccination, the patient had developed myalgia, chills, nausea, pain and stiffness in her neck. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient was not recovered from the events. Documents held by sender: none.
Information has been received from a healthcare worker referring to an unspecified patient of unknown age and gender. On 15-SEP-2015, the patients was vaccinated with an improperly stored dose of VARIVAX (lot # L008269, expiration date 11-MAR-2017, dose and route were unknown). No adverse effects reported. No PQC involved. This is one of two reports received from the same source. Additional information has been requested.
really horrible pain in her right leg primarily hip and knee/escalated 10 times after the second shot; cannot get out of the bed without a walker; really horrible pain in her right leg primarily hip and knee; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really horrible pain in her right leg primarily hip and knee/escalated 10 times after the second shot), DYSSTASIA (cannot get out of the bed without a walker) and ARTHRALGIA (really horrible pain in her right leg primarily hip and knee) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (really horrible pain in her right leg primarily hip and knee/escalated 10 times after the second shot), DYSSTASIA (cannot get out of the bed without a walker) and ARTHRALGIA (really horrible pain in her right leg primarily hip and knee). The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (really horrible pain in her right leg primarily hip and knee/escalated 10 times after the second shot), DYSSTASIA (cannot get out of the bed without a walker) and ARTHRALGIA (really horrible pain in her right leg primarily hip and knee) outcome was unknown.            No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.    This case was linked to MOD-2021-075508.
Left arm become number after Moderna infection into left deltoid 3 days post injection, middle 2 fingers contracted and patient could not straighten it. She went to PCP for evaluation and had splint on finger to straighten. As of 4 weeks later when presented for dose # 2, she stated the issue had not completely resolved.
Fever 100-101 and full body body ache. Lasted 12 days.  Used OTC fever reducers which did not help.
Spots on my backside; Itching; Irritation; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: Spots on my backside), pruritus (Verbatim: Itching) and skin irritation (Verbatim: Irritation). The outcome of the rash, pruritus and skin irritation were not resolved.   It was unknown if the reporter considered the rash, pruritus and skin irritation to be related to Shingles vaccine.     It was unknown if the company considered the rash, pruritus and skin irritation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a patient via interactive digital media. The patient got the shots and still got spots on backside/ 3 times now. Patient experienced just itching at first and then irritation and stated it will take forever to go away. Patient did not experienced pain. The follow-up could not be possible as no contact details were available.
At 5:30 pm: very bad chills, that continued with entire body feeling extremely weak, achy, and tired. Temp a little over 102. The next day 11/11:  body still weak, achy, tired.  Face and eyes swollen. On 11/12: eyes still swollen underneath the eyes, but less weak and achy. On 11/13: eyes less swollen, felling a little stronger.