chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had flu mist in her nostril and before it was administered she freaked out and wouldn't let me do it. Since I already opened it and it touched patient I had to waste it.
Expired of first shot; This spontaneous case was reported by a consumer and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Expired of first shot) in a female patient of an unknown age 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 INCOMPLETE COURSE OF VACCINATION (Expired of first shot). At the time of the report, INCOMPLETE COURSE OF VACCINATION (Expired of first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  This patient reported if the first shot is expired, do they have to have two shots?  Treatment  information is not provided..   Reporter did not allow further contact
9/6/21: Patient arrived at the ER due to shortness of breath and increased weakness having multiple episodes of hypoxia at home with oxygen saturations in the low to mid 70s. Patient was diagnosed with COVID on 9/1. Over the last week she has had increase in weakness and shortness of breath.  She also has a intermittent cough.  Symptoms started about a week and half prior to arrival to hospital.  Her oxygen saturations were 89% on room air in the emergency department.  She was on 94% and satting well.  Remainder of vitals are within normal limits.  Lab work revealed potassium of 3.4 and blood sugar of 183-she is on steroids on outpatient basis for COVID.
feelings of decreased levels of consciousness; bouts of dizziness; headaches; Information has been received from lawyers and a consumer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).  On an unknown date, the patient experienced bouts of dizziness, headaches and feelings of decreased levels of consciousness. As a result of these symptoms, the patient was seen and treated under medical provider. The patient did not recover from the events. As per the reporter, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were disabling.   The reporter considered the events was related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of feelings of decreased levels of consciousness was determined to be medically significant.
Patient reported itching/redness all over body including arms, legs and stomach. Took a few BENADRYL and has been getting better.
Complained of tenderness in left breast within 24 hours of vaccination.  Also complanined of tenderness swollen lymph nodes under left arm (axilla).  Breast tenderness continued for 12 days - then disappeared
Chills, aches 20 hrs post shot, fever/chills (102 degrees temp) body aches, headache, flu symptoms 24 hrs-48 hrs post shot-malaise for following day.
about 7 to 8 days after receiving the first Moderna vaccine the arm where i recvd injection site became red, swollen, inflamed again and after a few days that went away then i was extremely tired, not feeling well and last night started to have weird dreams. Not sure if i should recv the second dose which is scheduled in a few weeks time.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022 at 1:58 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 17-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The patient received vaccine past its 30 day. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment medication was provided.
Fatigue, pruritus, rash on face, conjunctivitis. OTC ZYRTEC 10 mg daily; Valacyclovir 1 g TID x 7 days; Referral to ophthalmology.
tingling/burning/hot sensation to posterior scalp within a few minutes of vaccine administration.  then sensation spread to body, arms, and legs. then noticed red hands, arms, and legs.
Tingling in toes 8 hours post vaccination, next day progressing to ankles, then hips to fingers. General weakness, sore throat and SOB. Hospital Occ Health Nurse sees patient in hospital hallway and asks how are you feeling after your shot yesterday. Patient reports weakness and Occ Health Nurse takes to ED and advised to go to higher level of care at Medical Center ED. Patient states fever 101F. MD notes absent Achilles reflexes, but intact reflexes otherwise. MD notes limb weakness and MD comments with questionable effort . Patient hospitalized on 10/6. Lab work only remarkable for low hemoglobin (which is normal for this patient). Spinal tap was normal. EMG 10/10 - abnormal - polyneuropathy with mixed axonal and demyelinating features, can not rule out primary demyelinating polyneuropathy. Neurological examination: Exam is very inconsistent. Cranial nerves: II - Visual fields full to finger confrontation at bedside. Pupils equal and reactive. III, IV, and VI - Extraocular movements intact after verbally asking the pt to look to the right, he was able to do so after hesitation. No nystagmus. V - Sensory branches intact. VII - Asymmetry of the lip with weakness on the right. VIII - Hearing intact bilaterally. IX, X and XII - Tongue and uvula mid position. XI - Shoulder shrug is symmetric. Motor examination: BUE 4/5. RLE 3/5. LUE 3/5. Coordination: Good arm movements on finger-to-nose bilaterally. Reflexes: 2+ bilateral patellar reflexes. 0 bilateral Achilles. 2+ BUE. Withdrawal to Babinski bilaterally. Sensory examination: further improved today. Sensation loss to temp up to T9-T10 right abdomen and T9 left abdomen. Moved up to bicep bilaterally. Sensation diminished in hand bilaterally but preserved up to forearm. Gait/Station: Pt not ambulated due to falls risk. Patient started on Plasma exchange 10/12, every other day times 5 days. 10/20 (date of this report) still hospitalized, but starting to feel better, no definitive diagnosis at this time.
This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 08-OCT-2018, the patient was vaccinated with a dose of improperly stored vaccine VARIVAX (lot # N034552 with expiration date 05-DEC-2019) (exact dose and route of administration were not provided) for prophylaxis. The VARIVAX was reconstituted with properly stored sterile diluent, (lot # and expiration date not reported). The VARIVAX experienced a temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion details. No adverse effects were reported. This is one of two reports received from the same reporter (linked to case: #1810USA007227); Sender's Comments: US-009507513-1810USA007227: Original Case: 1810USA004911.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium; symptoms lasted 1 day
(L) upper extremity erythema & edema to forearm level. Fever to 103. Treated with BENADRYL, MOTRIN, & ice packs.
Face swelling, fever, vomiting muscle and joint pain. I also have what looks like hives on my eyelid. I?ll still achy.
Information has been received from a pharmacist (PharmD) concerning an approximately 51 year old female who on 23-OCT-2006 was vaccinated with a dose of Pneumovax 23 (Lot # 651401/0619F).  Subsequently, the patient experienced itching and developed a local site reaction that was determined to be cellulitis.  The patient sought unspecified medical attention.  The patient was placed on unspecified antibiotics.  At the time of this report, the outcome was unknown.  A lot check was requested by the reporter.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information is not expected.
The adverse event was that an expired Janssen COVID-19 Vaccine has been administered to the patient. There were no adverse event, symptoms or any health related issues regarding the patient. Only that the vaccine has been given after the expiration date, nothing else.
The first night vaccine developed telengectasias on my face. A couple of days later petechaie and extreme left arm soreness.  A few days after that I had small splinter hemorrhages in multiple fingernails. A week later I developed Raynauds syndrome which then evolved to vasculitis in my fingertips.  I had to go to urgent care when first started and multiple trips to Rheumatologist and have been on and off steroids and vasodilators due to vasculitis in my fingertips. I have splinter hemorrhages and small clots in my capillaries in my fingertips that are cutting off blood supply even without cold vasospasm.
body aches; temperature; Nausea; joint pain; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (body aches), PYREXIA (temperature), NAUSEA (Nausea) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced MYALGIA (body aches), PYREXIA (temperature), NAUSEA (Nausea) and ARTHRALGIA (joint pain). At the time of the report, MYALGIA (body aches), PYREXIA (temperature), NAUSEA (Nausea) and ARTHRALGIA (joint pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
This spontaneous report as received from a registered nurse refers to a 12 year old male patient. On 22-JAN-2013, the patient was vaccinated with the adult 1ml dose of VAQTA (lot number reported as H010269, Exp 03-NOV-2014, number of prior dose not reported) in his left deltoid, and also the pediatric 0.5ml dose of VAQTA (lot number reported as H010145, Exp 27-FEB-2015) in his right deltoid. No adverse effects at the time of reporting. Additional information has been requested.
Left building and had cigarette after donation and receiving shot. Came back in and became lightheaded, pale and diaphoresis. Hadn't eaten in last 6 hours. Had her sit down, ice packs applied to chest and neck and water given. Felt OK to leave in 15 minutes.
sore arm; fatigue; 13 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (sore arm), FATIGUE (fatigue) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm), FATIGUE (fatigue) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old). At the time of the report, MYALGIA (sore arm), FATIGUE (fatigue) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date,patient got second dose of the Moderna COVID-19 vaccine.   Concomitant product use was not provided by the reporter.    No treatment information was provided.
has arm pain that goes all through my arm up into my shoulder; Redness, swelling and bruising at the injection site; Redness, swelling and bruising at the injection site; Redness, swelling and bruising at the injection site; This spontaneous report was received from a consumer regarding herself as a 68-year-old, elderly, female patient. The patient's historical drug included penicillin, historical condition included penicillin allergy and her concurrent condition included pre-diabetes. The patient's concomitant therapy included metformin. On 15-APR-2019 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), single 0.5 ml dose (strength, frequency, route of administration, lot # and expiration date were not provided) for prevention of pneumonia (prophylaxis). On 15-APR-2019, the patient experienced redness (injection site erythema), swelling (injection site swelling) and bruising (injection site bruising) at the injection site that went away the next day. But, the patient still experienced arm pain (pain in extremity) that went all through her arm up into her shoulder. On 16-APR-2019, (also reported as next day) the patient had recovered from the events injection site erythema, injection site bruising and injection site swelling. No treatment was given for the adverse events. The patient had not recovered from the event pain in extremity. Causality assessment was not provided by the reporter. There was not involvement of product quality complaint (PQC).
hives; This is a spontaneous report from a contactable healthcare professional (patient). A patient of unspecified age and gender received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The second dose of vaccine was administered in a hospital setting. The patient's medical history and concomitant medications were not reported. The patient developed hives on 16Jan2021. Antihistamine was given in hospital and was sent home. On 17Jan2021, the event did not improve and was directed to HCP.   Information about lot/batch number has been requested.
KNOT/REDNESS/SWELLING LOCALLY THE DAY AFTER EVENT, LASTED 4 DAYS.  NUMBNESS ON SAME SIDE AS VACCINE MIDDLE FINGER HAPPENED 2 DAYS AFTER, LASTED 3-4 DAYS. SWOLLEN LYMPH NODES ON VACCINE SIDE HAPPENED 2 DAYS AFTER , LASTED 3-4 DAYS. LOWER BACK WEAKNESS HAPPENED THE DAY AFTER, LASTED 3-4 DAYS.
Client c/o feeling lightheaded immediately after receiving the vaccine.  Client seen and assessed by EMT.  Vital signs are:  BP 122/79, HR 92, O2 98, BS 85.  After 15 minutes of observation, client verbalized that symptoms had diminished and was cleared to go home by EMT.
Pfizer Covid 12+ bivalent vaccination was administered to patient instead of second dose of Covid 12+ primary series vaccine as incorrect vial was pulled for MA.
Neuropathy in feet weakness to the point of difficulty walking. Feeling of severe sinus infection. Back pain.
A few minutes after giving vaccine to patient, discovered that the vial I used was actually one that was from the day before that was not discarded at close of business last night.  The vial was removed from the fridge at 10:18am on 10/27/22, punctured at 10:34am and would have hit 12 hours at 10:18pm on 10/27/22.  Vaccine was administered on 10/28/22 @2:28pm.  I immediately notified patient and explained to her my next steps.  I called Pfizer for advice on when/if pt should repeat the dose.  They could not tell me, said they would send me forms (I'm still waiting  on them) to fill out and have their supply chain quality team get back in touch with me. I notified patient's provider, filled out an internal report and filled out this report.
Approximately two minutes post vaccination, patient appeared pale, clammy, and diaphoretic. Patient then lost consciousness for a few seconds. Legs were immediately elevated. Ice packs applied to nape of neck. Patient regained consciousness on his own with no intervention. Water provided to patient. VS initiated Q3. HR slightly low but non significant with set one.  A&O x3. After approximately 10 minutes, patient  reported feeling completely better with no symptoms.  Patient escorted over to observation for an additional 15 minutes. Patient left observation on his own  ambulatory, with steady gait, reportedly feeling better.
Seriousness criteria other medically significant (OMIC). Initial report received on 8/3/2006 from a nurse. A 26 year old female pt who had a wound to her finger had received a first dose of Adacel, lot number C2559AA, on 8/1/2006. The route and site of administration of the Adacel was not reported. The pts would to her finger was treated the same day with Omnicef. The following day, the pt developed a fever of 104 degs F, and her arm was swollen at the Adacel injection site. Tylenol was prescribed, and the fever remained high the following day. The temperature reading the following day on 8/3/06, was not reported. Per the reporter, the pt was to be re evaluated by the physician if the fever remained high. The recovery status of the pt was reported as unknown.
herpes zoster; Information has been received regarding a case in litigation from a lawyer referring to a currently 73 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 30-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) at an internal medicine medical office for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a nurse practitioner for the following injury resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the event was unknown.
Vac in left shoulder but adverse arthritic reaction in right forearm up thru to shoulder blade.   Arm totally equal to left one after recovery from bolt inserted to reattach end of elbow bone to forearm bone in 1963.   Until day after 2nd Pfizer vacccination.   As of 9/18/2021, 7 months later, arm still arthritic and handicapped in even minor use like reaching into passenger's seat for small object.  I have had 2 steroid shots 3 mo apart,  chiropractor treatment, various OTC ointments
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster,
A BIT TIRED; A LITTLE SORE AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, once a total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced a bit tired. On MAR-2021, the subject experienced a little sore at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a little sore at injection site and a bit tired was not reported. This report was non-serious.
Mom said pt had fever 103, & body was flushed red all over & that pt could not move entire body & vomiting lasted about 16-18 hrs; did not take pt to MD called MD & on 5JUN92 felt was allergic reaction;
pt recvd vax & on 29sep94 noticed hives; to hlth dept; hives spread all over; pt saw MD for itch;
I had a severe headache starting in the evening. The pain was constant, dull, and felt like it was coming from the center of the head. I don't have a history of headaches, so this was unusual. After going to bed at 11PM, I woke up around 2AM from the intense pain. I could not sleep for a couple of hours in the night and I took Nyquil, which helped a little bit. I considered going to the emergency room, but decided to wait until morning to make the decision. I was able to go back to sleep and then slept until 11AM. I woke up feeling weak and groggy, although it may have been due to the Nyquil. The headache was improved and gradually diminished throughout the day. The next morning, it was completely gone and I felt back to normal.
about 6 hours after injection, i started getting chills and extreme fatigue. this lasted throughout the night with mild fever peaking at 100.8 F. muscle aches, fatigue, and persistent dizziness continued the following day. most symptoms resolved by the 36hr point.