chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received third dose of Pfizer vaccine following previous completion of Pfizer vaccine series at off campus vaccination clinic location. The error was noted during documentation into patient's electronic medical record following return to medical campus. Patient was contacted and reported that she had lost her vaccination card  for her First dose. Upon receiving her second dose at civilian immunization clinic, the clinic provided her a new proof card. She presented her proof card to military medical clinic to update immunization status and was instructed by staff that her proof card requires two vaccinations to be documented prior to updating Imms status. Patient arrive to vaccination clinic and made her own decision to endorse receiving only a single Pfizer vaccination for purposes of receiving an additional dose in order to have a second dose recorded on her vaccination proof card. This resulted in a third dose of COVID vaccine for patient. Guidance will be posted and required to be read prior to administration of vaccine regarding proper procedure for updating or validating vaccination proof cards to prevent further inappropriate third doses. No identified harm was done to patient following administration.
Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 61-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HG4629) at the age of 61 years, in left deltoid for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 10Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left deltoid for immunisation. The patient's relevant medical history included: "Frozen shoulder", start date: Jun2023 (unspecified if ongoing), notes: Frozen shoulder started in Jun2023. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 10Oct2023, outcome "recovering", described as "Diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea. Additional information: Took Imodium as treatment.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Pain in the arm, around the shot side, started in about 3 hours post the vaccine and lasted for a few days. High fever and severe overall muscle pain started about 12 hours post the 2nd shot (Moderna) which lasted for about 6 hrs. I couldn't sleep and hardly got up during the fever happened.  But these symptoms mostly disappeared in 24 hrs . I took the over-counter Advil about 3 times during the fever happened.  Some fatigue continued for about one day.
This was my second dose btw. Arm pain after first dose. No other noticeable symptoms. Second dose: Headache almost immediately after being given the vaccine. Followed by arm pain/ache in BOTH arms, fatigue, lung pain, hip pain, general feeling of being unwell or having the flu. Went to work the next day. Still not feeling well. Felt even worse as the day progressed (with symptoms listed), went home early. Slept for twelve hours. Same symptoms the next day. Oddly, my symptoms seemed to relax a little after I ate lunch. Then returned a few hours later.  Tomorrow will be 7 days after dose. I still have arm pain in both arms and extreme fatigue.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/29/2021 and 2/24/2021. Presented to ED on 10/6/2021 complaining of shortness of breath x3 days, diffuse body aches, chills, nausea, vomiting, and abdominal pain. On presentation satting 94% on room air. Patient started on dexamethasone.  Patient's respiratory sats decompensated on 10/9/21, requiring intubation.  Patient continued to decline and expired on 10/16/2021.
This case was reported by a physician and described the occurrence of chest tightness in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 2nd dose of TWINRIX (details unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced chest tightness. At the time of reporting the outcome of the event was unspecified.
Patient stated that arm is bruised at injection site, painful at injection site, and painful at shoulder. Patient also mentioned difficulty lifting arm. These symptoms have continued for 7 days despite treatment with tylenol and ice pack. Patient also mentioned swelling in left foot starting at day 6. Patient unsure if this was related.
In the morning of Day 8 (1/29/21), a large red rash area (~ 3: in diameter), and slightly itchy, appeared at the injection site, accompanied by soreness and stiffness in that area , similar to being bruised.  I applied Caladryl Lotion at bedtime.  Same condition on Day 9 (1/30/21), but as day has progressed, the rash has diminished and it is less sore now, still slightly itchy.    On the day of injection about 5-6 hours after injection, I was sore and had a stiff muscle at site of injection  -- a tad bit more than I experience typically with the  seasonal flu vaccine, but I had no rash.  The sore/stiffness lasted only about 30 hours.  After that everything was fine until Day 8!
Patient has been living in nursing home facility for management of bipolar disorder since November 2019. Up until July 2021, patient has been independent at the facility with ambulating, feeding, toileting, talking and taking smoke breaks even. After Covid vaccine, patient started to get weakness and shuffling his feet. Over the next couple months, he declined rapidly to the point of being seen in the ER multiple times to rule out anything acutely neurological. He had 7 falls in this time frame uncharacteristic for him as well. He was admitted to the hospital on October 15 for a second opinion on his neuro status. He was also found to have atrial fibrillation with RVR during this ER visit. At the time of report, patient is still hospitalized, albeit in sinus rhythm, confused, unable to ambulate, disoriented, requiring assistance to feed, and incontinent which has been his "new" baseline since July
Received DTaP after exposure to HIV at work. Two weeks following shot (Rt) arm became swollen, painful elbow pain, shoulder pain, quarter sized red rash around injection site. Rash gone, shoulder/elbow still sore, improving.
Red, swollen around Pneumonia injection site. Pain above left elbow. Fever of 101-102 for 2 days. Tried Ibuprofen, no relief. Pt had complained of body ache before receiving immunization but still wants Pneumonia shot.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2006, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
tested positive for COVID-19 on August 28th; congestion; cough; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19 on August 28th), NASAL CONGESTION (congestion), COUGH (cough) and PYREXIA (fever   ) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced NASAL CONGESTION (congestion), COUGH (cough) and PYREXIA (fever   ). On 28-Aug-2021, the patient experienced COVID-19 (tested positive for COVID-19 on August 28th). At the time of the report, COVID-19 (tested positive for COVID-19 on August 28th), NASAL CONGESTION (congestion), COUGH (cough) and PYREXIA (fever   ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product were reported No treatment medication was provided
Red, raised area to right upper arm. There was some soreness to the arm as well. Patient developed worse URI s/s on 6/30/09 as well.
I?m a 58 Woman in menopause,  Two days after the first vaccination I got a full menstrual bleed last in five days and all symptoms. That was in the month of August.  The months following September and October developed bleeding again this time spotting in full-fledged menstrual symptoms for two or three days.
Info has been received from a physician concerning an 8 year old female who was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt developed a very mild case of breakthrough varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
About an hour and a half after receiving my vaccine, I was sitting down, when I placed my hand on my neck and noticed that my heart was racing a bit. I just monitored it for a while. I did notice a bit of pressure in my sternum. The elevated heart rate continued until around 03:00PM, but after that, it seemed to only occur when I would stand. It would shoot up to 120-130 beats per minute and would calm down when I sat down. That continued on throughout the week and until I was able to see my primary care physician 6 days later, along with some intermittent chest pain. She prescribed metoprolol to treat my heart rate until I can get in to see my cardiologist. Since then, I've had fatigue, brain fog, and light headedness when I am up and walking for too long, but the metoprolol has improved things significantly.
Found unresponsive the next morning face down in bassinet. Survived unresponsive ~ 1 week.
TEMPORARY BLINDNESS; A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     It was reported that patient had temporary blindness from his nasal flu vaccine when he was in the service. (preferred term: Blindness transient).     It was unknown if any action was taken with Flumist.    The outcome of the event temporary blindness was unknown.    The reporter considered the event temporary blindness serious due to important medical event.     Device Information:     Product As Reported: FLUMIST  Product Role: Suspect  Device code: Adverse Event Without Identified Device or Use Problem; Sender's Comments: Blindness transient is not listed in the company core data sheet of Quadrivalent/Live attenuated influenza vaccine (Q/LAIV). Due to limited information on relevant medical history, concurrent diseases, concomitant medications, exact start date of suspect drug, exact start date and circumstances leading to the events, complete etiologic and diagnostic workup ( Complete Ophthalmic examination, Imaging studies) it is not possible to make a conclusive assessment of the causal relationship of the event and suspect drug.
5-10 minutes post vaccinating while waiting 30 minutes pt began hyperventilating with fluctuating LOC. Family member reported hx of allergies so she was waiting 30 minutes, EMS onsite, pt began drooling so EMS took her to local hospital. Nurse reports v/s remained stable. I have not heard back from pt or family as I attempted follow up calls and emails.
Received a call from Medical Center informing us that the patient has developed Guillain Barre Syndrome.
noticed swollen, puffy eyelids upper and lower about two days after vaccination.  Symptoms are worse in the AM after waking and subside during the day but do not go away completely.  Condition has persisted for several months
all may veins show from site of injection across chest arms neck and sides of face! has not gone away I am deformed now and it has effected my emotional well being!!!!!!!
Patient verbalizes that 3 days after being inoculated a pain begins in the gum and teeth and on the 4th day hives came out in the arms and right armpit and lower legs and buttocks.
I took my first vaccine shot on 09/09/21 and was diagnosed  positive with COVID-19 on 9/15/21. I was pretty sick for about a week and i began having chest pains and tightness and shortness of breath on  9/23/21. I went to my primary care provider on 9/24/21 and they did an EKG on me and told me I had evidence of a mild heart attack based on my readings. They immediately had me transported where i spent the next 2 days and they confirmed i had a heart attack. They did a cath procedure to verify there was no additional blockage or need for stints and found nothing but blood clots in my heart caused by inflammation of my heart muscle due to the Moderna vaccine. I have never had any previous heart issues before this incident and I have been in healthy condition. I am currently on Xarelto blood thinners for an unknown amount of time for the future.
Pain in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter. No laboratory provided by reporter
Received AVA #3 and Tdap on 6/29/09 as routine vac update. (He denied any recent or current URI symptoms.) That evening he noted onset of fatigue, generalized body aches, left arm pain and tenderness (at vac sites). He also c/o night sweats with his wife reporting he was moaning and seemed restless. Pt awoke fatigued, reported to work noting increased pain, swelling, redness to left deltoid/upper arm, and generalized body aches to knees, hips, back, with "flu like s/s". He denied any rhinorrhea, congestion, sore throat, HA, fever, n/v/d, sob, cp, paresthesia, or rashes. He took TYLENOL ES and MOTRIN 800 mg with minimal relief of s/s (muscle/body aches). Later that day (Tues) he was unable to move Left arm due to pain with no restriction to grip and no paresthesia. His pain was 10/10 unrelieved with meds resulting in a poor nights sleep. His s/s continued thru Wed with easing of pain, decrease in swelling, redness, and generalized body discomforts with use of MOTRIN 800 mg BID. He did note a "stumbling gait" Wed morning reporting no energy to get out of bed or walk. He denied any further gait disturbance since. He also c/o fatigue since receipt of above 2 vaccinations Monday: had difficult time sleeping. Pt reports feeling exhausted and required naps after 8 hours work Tuesday. He complained of a poor nights sleep Tues evening; however was less fatigued Wed not requiring a nap but still tired. He had been taking MOTRIN for pain/swelling which did allow him to sleep Wed night. He reported feeling better today (Thursday 7/2/09) with fatigue level now 1-2/10 from 10/10 a few days ago. 7/2/2009 evaluation noted left deltoid/upper arm with 2 well healing puncture marks to central deltoid region (pt stated AVA was anterior w/Tdap site posterior). There is at 0.5 inch circular erythema surrounding each puncture site with extending "reversed L" shaped erythema extending down the left upper arm then anteriorly (5 inch height vs 1-3 inch width.) Left arm circumference is 15.5 inches with right arm 14.5 inches. Pt is right handed. No axillary lymphadenopathy, no pain to shoulder girdle or left elbow with palpation. Erythemic area's area warm to touch. Musculoskeletal system was intact with c/o pain with shoulder at 90 angle but could push thru and extend arm upright over head. Full ROM right shoulder w/o limitations and to neck. Grips left = right with no weakness or sensory loss. Cap refill <2 sec bilaterally. Skin warm and dry. Radial, brachial pulses = bilaterally regular rate and rhythms 76.
lower back is in horrible pain; I can barely walk; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunisation. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "lower back is in horrible pain"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "I can barely walk".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
bad joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (bad joint pain) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (bad joint pain). At the time of the report, ARTHRALGIA (bad joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
FACIAL EDEMA, RASH ON HANDS @ 48 HOURS AFTER SHOT. TREATED WITH BENADRYL. RESOLVED BY DAY 5
started to develop injection site soreness on the night of vaccine then by 10am the next day was having all over body aches, nausea, headache which continued to get worse and by 3pm that day had nausea, vomiting , severe body aches and cramping all over, fever, headache, and a hard warm lump at the injection site. was applying heat  to cramps and taking Tylenol which was not helping much for body aches, did not want to take ibuprofen due to nausea. by noon on the 3rd day most of it was resolved
inappropriate age at vaccine administration; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age at vaccine administration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
(See attached). 10/12/09 Hospital records, DC summary, received service dates 11/26/08 to 12/03/08. Assessment: Guillain-Barre Syndrome. Patient noted achiness in her back and down into her legs one week ago. Pain increased and developed in palms and fingertips, generalized tingling sensation in toes and finger tips. Patient presents with burning sensation in lateral thighs and aching feeling in calves. Fingertips and feet are numb. Urinary frequency. Little sleep at night. Muscle weakness extremities, deceased temperature and pain sensation. Wide-based, ataxic gait. Needs assistance with ambulation. IVIG.  ICD-9 Codes: 357.0 Ac Infect Polyneuritis, 781.3 Lack of Coordination, 782.0 Skin Sensation Disturbance, 788.41 Urinary Frequency, 781.2 Abnormality of Gait.   10/14/09 Neurology consult records received, service dates 11/25/08 to 8/25/09. Assessment: Guillain Barre Syndrome. Patient presented with a 1 week history of weakness, pain, and achiness in back and legs. Pain in palms and fingertips, tingling and parasthesias.  Tingling progressed to the toes.  She also developed imbalance and weakness with several falls.  Reflexes are absent throughout.  Upon follow up from hospitalization:  remains unsteady, using a cane.  Unable to drive.  Feet feel like bricks.  Needs assistance with ADL's (showering).  Pain can be incapacitating. Knee pain since fall 6 weeks ago.  Absent reflexes in LE's, diminished reflexes in biceps.   Gait is shaky. 8/25/09-Compared with the initial study on 11/26/09 the degree of demyelination and axonal loss is worse, likely a reflection of continued injury to the nerves during the acute phase of her illness.
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient age was reported as 33 years and 6 months.  It was reported that vaccine was administered beyond use date to patients. There was no adverse reaction noted or reported regarding these administrations.  No treatment drug information was provided.
Pt was at a mass vaccination clinic (well over 800 in attendance).  Brought back to our pharmacy to process.  Unfortunately, vaccine was already given.  Pt reports no adverse reactions.
No adverse affects. I received a text message on my non-smart phone with a link to complete my v-safe health check-in. However, I cannot click on the link because my phone is NOT a smart phone. HOW DO I THEREFORE COMPLETE MY V-SAFE HEALTH CHECK IN?