chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed literature report (initial receipt 19-May-2015) concerns a 17 year old female patient with a medical history of anxiety and fibromyalgia and was referred to a sleep centre after being diagnosed with narcolepsy and cataplexy. The narcolepsy symptoms began approximately four years prior to presenting to the clinic with excessive daytime sleepiness, sleep-related hallucinations and cataplexy but no sleep paralysis. A subsequent overnight polysomnogram revealed an AHI (Apnea-Hypopnea Index) <1, PLMI (Periodic Limb Movement Index) 14/hr, sleep latency of four minutes and sleep efficiency of 92%. The next morning MSLT (Multiple Sleep Latency Test) demonstrated a mean sleep latency of 2.6 minutes and 2 out of 5 sleep onset REM (Rapid Eye Movement) periods. She scored 20/24 on her Epworth Sleepiness scale. The patient was positive for DQBI*06:02 allele and CSF (Cerebrospinal Fluid) hypocretin levels were not obtained. Baseline EEG (Electroencephalography) did not demonstrate straight epileptiform activity and brain MRI (Magnetic Resonance Imaging) was normal. In the fall of 2013, approximately four years after her first cataplexy symptoms, the patient received the Influenza virus vaccine (manufacturer and batch number not provided). Within twenty minutes of influenza vaccination administration, she began experiencing cataplexy symptoms that lasted for approximately twenty-four hours. Her status cataplecticus manifested as episodic and instantaneous loss of tone in her lower extremities without loss of consciousness. The episodes were captured on home video. Her daytime sleepiness and cataplexy were much improved on sodium oxybate, armodafinil and sertraline. Outcome was not reported. Reporter comments: The reporter stated that the influenza vaccine may have served as a trigger of status cataplecticus in this patient with known narcolepsy.
Headache, Myalgia, Arthralgia, Fever, SkinRash,  Rash & Urticaria Pruritus Rash painful to palpation
10 minutes after receiving vaccines appeared weak, unbalanced, responding slowly to verbal command, eyes rolling
Quit breathing during sleep. Would gasp when picked up. Laid back down and breathing became shallow again until she stopped. Gasped upon being picked up. Did not wake up with all the up and down. Was completely limp. Slept holding her upright and jolting her when her breathing would become too shallow.
Mildly sore arm; This is a spontaneous report from a contactable consumer (patient). A 70-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 10Feb2021 15:00 (age at vaccination 70-years-old) as single dose for COVID-19 immunization. Medical history included asthma, and hypertension. Patient concomitant medication were not reported. The patient had no known allergies. No other vaccine received in four weeks. Patient has taken other medication in two weeks. On 11Feb2021, patient experienced Mildly sore arm. No treatment received for adverse events. The patient stated that she had not been diagnosed with COVID -19 prior to vaccination and since the vaccination, the patient been tested for COVID-19. On 14Feb2021, the patient underwent lab tests and procedures which included Nasal Swab, sars-cov-2 test: negative, Rapid test. The outcome of the event was recovered on an unspecified date.  Follow-up (11May2021): Follow-up attempts completed. No further information expected. Information about lot/batch number is not available.
Pt received influenza vaccine in right arm and pneumovax in left arm at clinic.  Documented in chart that pt did not have a reaction after immunizations.  Pt presented to clinic 24 hours later with swollen, painful, warm, erythematous, macular rash on RUE.  Reaction was first noted 1 day after shot in the same area of injection.  Pt was not febrile.  Pt denied allergies to eggs and has had the flu vaccine in the past without complications.  Physician suspected that it was cellulitis and possibly an infection.  Pt was given cephalexin, APAP, and diphenhydramine.  Pt reported 4 days later that the reaction had improved.
Erythema at point of injection extending 4 cm - tender, warm, no induration. Pain extending up to shoulder and down to elbow.
2nd dose was not administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose was not administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 11-AUG-2023 The 2nd dose of Shingrix was not administered yet. The Vaccine Administration Facility was the same as primary reporter. The reporter did not consent to follow-up. Till the time of reporting , the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Severe shoulder pain, frozen shoulder, nearly fainted multiple times, profuse sweating, chills, muscle cramps in hands and one calf, dry heaves, vomit, shakiness,big BM. Husband fanned me, put cool rag on head and neck, called sister who is an RN and took two Advil every two hours.Went back to bed for several hours often getting up with the same symptoms minus the BM.
Developed red, blistering rash. Skin was seemingly raw and painful to the touch.
Joint swelling in hands and feet.  Rash to waist.   No treatment sought.
I had a sore throat like it was inflamed and my lymph nodes were swollen. I went to Urgent Care in  about 2 weeks after the vaccine. The rapid strep test was NEG.
Herpes zoster; This initial spontaneous report regarding a case in litigation was received from a lawyer, a male patient of unknown age, and his spouse. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. On an unknown date in 2014, at approximately 70 years of age, the male patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The outcome of the herpes zoster was not provided.
ACUTE DVT OF RIGHT PERONEAL VEIN 12/15/2022  -  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Developed rash at the injection site one week after the injection that lasted for about a week. Then, developed a larger rash on towards the inside of the same arm. This rash did not appear until two weeks after the injection.
Patient received a Moderna (2) dose instead of Pfizer. The patient had no symptoms and felt fine after observation time.
I21.4 ACUTE NON ST ELEVATION MI 7/3/2021 ARTHRITIS I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/3/2021 ARTHRITIS I21.4 ACUTE NON ST ELEVATION MI 7/3/2021 OSTEOARTHRITIS OF BILAT KNEES I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/3/2021 OSTEOARTHRITIS OF BILAT KNEES I21.4 ACUTE NON ST ELEVATION MI 7/3/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/3/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 7/3/2021 ACUTE NON ST ELEVATION MI    PULMONARY EMBOLISM, UNSPECIFIED. I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/3/2021 ACUTE NON ST ELEVATION MI    PULMONARY EMBOLISM, UNSPECIFIED.
Patient started noticing the pain on his left arm and 8 inch long bruise around injection site and trembling of his left hand. He is still trembling and complains that the pain still comes and goes.
vomiting, diarrhea, dehydration; required aggressive fluid resuscitating in ER;given 60cc/kg IV fluid
This spontaneous report has been received from a registered nurse referring to a child of unknown age and gender. Information regarding medical history and concurrent conditions was not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose, frequency, lot #, and expiration date were not provided). Concomitant therapies were not provided. In January 2016, the nurse stated that she was notified of a case of breakthrough varicella in this child who was vaccinated with VARIVAX (Merck). At the time of reporting, the outcome of breakthrough varicella was unknown. The relatedness between the event and VARIVAX (Merck), was not reported. This is one of two reports received from the same source. Additional information has been requested.
chills; nausea; This spontaneous case was reported by a nurse and describes the occurrence of NAUSEA (nausea) and CHILLS ( chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included BISOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PANTOPRAZOLE and VITAMIN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea) and CHILLS ( chills). At the time of the report, NAUSEA (nausea) and CHILLS ( chills) outcome was unknown.        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.   Treatment information was not provided.   This case was linked to MOD-2021-076024 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Apr-2021: Added concomitant medications
Arm sore at injection site, with fatigue starting later in day on 3/23. Severe headache started evening of 3/23, with slight fever and continued fatigue and continuing through 3/24. Extreme nausea and slight fever throughout the day on 3/25.
pt recv vax 23MAY94 & dx as delayed;AUG96 pt seen again by MD dx autistic features;mom consulted a nutritionist who performed a blood test;results of the blood test indicated orimune given 23MAY94 was contaminated & caused child's autism
None reported. No adverse reaction.  VAERS form completed due to expired H1N1 vaccine given.
Patient experienced rash, bad headache, fever, cough, chest pressure and sensitivity to touch.
Mild nausea, mild headache on Feb. 24 plus  extreme joint and whole-body muscular aches that continue a week and two days after the 2nd injection
p/receiving vax lt arm, local react of redness, hives noted p/1-2mins; no resp distress ntoed; color pink skin warm & dry; cold compress applied & pt observed x 20 mins; instructed to call MD if s/s return or inc
pt to ER w/varicella-like rash on legs & lower abd p/vax (unk time period between vax & presentation to ER) no signs of cellulitis;
Flu-like symptoms, migraines, 101 fever, rash and hives. Took over the counter medication. Started day after vaccination, symptoms cleared by day five, still having occasional headaches
This spontaneous report as received from a medical assistant refers to multiple unspecified patients who on an unspecified dates were administered with ROTATEQ (dose, frequency and indication not reported) that went through a supported temperature excursion. No adverse effects reported. This is one of several reports received from same source. Additional information is not expected.
Second dose less than 25 days apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days apart) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose less than 25 days apart) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medication was reported.
Violent diarrhea, nausea, and severe body aches lasted 8 hours. Nausea and body aches lasted almost 2 days. Severe arm pain still after 2 days
I had a temp of 102 starting at 10pm and lasting until 9am. I woke up at 1am with a temp of 102.7, drenched in sweat, and shaking so badly my partner thought I was having a seizure. I did not seek treatment, because I was able to sleep after taking Tylenol and having my partner use cold washcloths and ice packs on my neck, forehead, back, and chest. I also attempted to take a shower, but I was so weak I required assistance to walk to the bathroom. I had similar side effects the next night although less intense.
missed my vaccine scheduled/ it is about 3 months since I took the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed my vaccine scheduled/ it is about 3 months since I took the first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed my vaccine scheduled/ it is about 3 months since I took the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed my vaccine scheduled/ it is about 3 months since I took the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.
I was completely in remission from Crohn's Disease but since the vaccine I have been having flare ups again. When I woke up in the morning I had experienced looser and bloody stool. on 03/26/2021 I brought a stool sample to the doctor. He confirmed it was a flare up and prescribed a topical stereo cream  Budesonide. I has improved since then, but has not gone away completely.
On/off hives.  Breakouts will appear in random spots on body (e.g. hands, neck, back, etc). Will disappear and reappear again at random. Appears if skin is irritated by touch, scratches, etc.
Received vaccine approximately 3 pm 3/17/04. Within 2 hours throat scratchy, developed hoarseness & feeling of thickness & congestion in throat. Temperature 99.2 took Advil. 3/18 severe hoarseness no rash took Benadryl. To doctor 3/19/04 at 4pm at doctor on 3/19 given Steroid injection, prescription for amoxicillin, Prednisone pack. I. by doctor to continue the Albuterold inhaler and Avar inhaler, 3/22 less hoarness, feeling better, 3/23 voice improved almost normal.
sleep for two days; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 77-years-old (non-pregnant) female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration in arm right on 03Feb2021 13:45 as unknown, single dose for COVID-19 immunization. Medical history included subclavian artery stenosis from an unknown date and unknown if ongoing, arteriosclerosis from an unknown date and unknown if ongoing and allergy to penicillin. No other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for covid post vaccination. The patient concomitant medications were not reported. On 05Feb2021, 36 hours after the injection and the patient experienced all the side effects except fever and nausea and needed bed rest and sleep for two days and was worried about what will happen with the second dose of the vaccine. Will she get all the unpleasant effects again and could it be worse enquired. The treatment was not received. The outcome of the event was recovered.   Information about lot/batch number has been requested.
Rapid heart rate on first day; then hives on torso, shoulders, and legs developed on 3/5/2021 around 10:00 p.m.
Developed redness and mild swelling at injection site and generalized body rash 17 days after.
Rash and hives-on 9/30 late morning after vaccination. Patient applied BENADRYL cream at home, counseled to take oral but patient did not.
Red, itchy, raised splotch on arm at injection site; Brown circle on skin (on stomach and arm - not sure it?s caused by the vaccine though. Just appeared however so thought I?d mention).
Information has been received from a pharmacist via company representative referring to two patients of unknown age and gender. The pertinent medical history and drug reactions or allergies were unspecified by the reporter. In the last two years, the two patients developed pain, erythema and swelling at the injection site within 2 days after administration of ZOSTAVAX. Both patients contacted the pharmacist and were referred to be evaluated by their unspecified physicians. Both patients were treated with unspecified antibiotic medication and recovered form the events. The causality of the events was unknown. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions, or allergies were not reported. On 20-AUG-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N023146, expiration date: 24-AUG-2019 (exact dose, route and site of administration were not reported) for prophylaxis. The vaccine was diluted with an improperly stored sterile diluent (manufacturer unknown) lot# N030026 (also reported as #030026), expiration date: 04-JUN-2020. The vaccine and sterile diluent were exposed to temperature in the range of 9 Celsius degrees to 25 Celsius degrees for 13 days. Temperature excursion was not detected by a data logger. There was no previous temperature excursion. No adverse events were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1808USA011459: US-009507513-1809USA001805.
Information has been received from a physician concerning a 65 year old female with no pertinent medical history, drug reactions or allergies who on 04-JUN-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ZETIAL, calcium (unspecified) and vitamin D (unspecified). On 06-JUN-2008 the patient experienced Shingles. At the time of the report the patient was recovering from Shingles. The patient sought medical attention by coming to physician. No product quality complaint involved. Follow-up information was received on 01-JUL-2008 from a practice manager concerning a patient who on 04-JUN-2008 was vaccinated in the left side with a 0.5 ml dose of ZOSTAVAX (Oka/Merck) (Lot #659406/0298X, expiration date 25-JUL-2009). On 06-JUN-2008 the patient developed rash in the left groin. Then blisters appeared in the left groin. The patient also had pain rated a 5 out of 10. She was treated with acyclovir cream. At the time of the report, the patient had recovered from the event. Additional information is not expected.
Rash & itching at the injection site developed after 48 hrs. Treated with Benadryl cream & cold packs.  It resolved after 3 days.
CHILLS; HEADACHE; FEVER; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced nausea. On 03-APR-2021 10:30, Laboratory data included: COVID-19 antigen test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, fever, and nausea on 01-APR-2021. This report was non-serious. This report was associated with product quality complaint: 90000175236  The suspected product quality complaint has been confirmed to be this record indicates a medical adverse event for the patient. there is no product quality issue reported. approval to void this record due to no pqc identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0:Medical Assessment comment not required as per standard procedure as the case is assessed as non-serious.
Local reaction w/ erythematous rash. Admitted to hospital. IV Vanco --> BACTRIM. 4/8/09-for DOS 2/20-2/20/09-DC DX: Cellulitis-presented to ED with 3 day history of worsening rash on left leg. Awoke with redness and swelling at vaccine site and started to limp. Developed a fever to 102.8. Vomited and groggy, rash spreading beyond injection site.
This spontaneous report was received from a medical assistant refers to five unspecified patients of unknown age and gender. Five unspecified patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, five unspecified patients were vaccinated with improperly stored (at a maximum 49.1 F for total 66 hours 37 minutes) PEDVAXHIB, lot # M001814 (expiry date: 15-OCT-2018) (dosage not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
DTaP was administer to Right arm on 07-17-07, and returned to clinic on 07-19-07, and right deltoid area was firm to touch and extra warm, reddish in color and complain of itching. vaccine used: Infarix.  Referred to a clinic or family care center to be seen today by a Physician.