chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27Jan 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27Jan 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 27Jan 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27Jan 2022) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had acute illnesses and chronic or long standing health conditions.     On 27-Jan-2022 at 4:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Jan-2022 at 4:50 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27Jan 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 27Jan 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 27Jan 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 27Jan 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  A series of patients approximately 540 patients received lot number 066H71A past its 30 days expired date. Vaccine was administered up until its manufacturer expiry date of 04-Apr-2022.  The patient received vaccine past its 30 day expiry date on 27-Jan-2022 at 16:50:56.  No treatment medication was reported by reporter.
Patient is a 64 year old male who while serving as a consultant for ministry of defense reform began his rabies series on 6/19 and 6/26/03. He reports being in good health until 7/4/03 when he awoke with numbness of his fingers and toes and weakness (he was able to only do 5 of his usual 20 push-ups). He was seen by a PA who suspected either a viral syndrome or an adverse reaction to Mefloquine. He was instructed to discontinue the Mefloquine. Over the next 3 days he continued to have progressive motor symptoms and was seen at the hospital where he was given prednisone 20mg PO daily for three days with no change in his symptoms. On 7/13/03 he was transferred for neurology evaluation. He underwent a CT of the brain-normal; a LP-glucose-60; protein-120; cell count: 1RBC, 2 WBC, N-16%, M-51% and L-33%, CK-227, and an ESR-1. He was given a diagnosis of probable GBS and air evacuated to a neurology ward. Nine days post vaccination, he awoke with numbness and tingling of fingers and toes and weakness (only able to do 5 pushup-usually does 20), an occipital headache 2/10 on the pain scale, achy, pains from the left side of his neck into his shoulder with radiation to his left upper arm 3-4/10 that improved with Naprosyn. By 7/14/03 his symptoms progressed to include left facial droop, inability to close his left eye, increased motor weakness of both upper and lower extremities, an ataxic gait, several tachycardic episodes and constipation.
~15 minutes post vaccination patient began to have "pins and needles" originating in left arm and then moving to legs. Also states that she had sensation of feeling "off balance". This did not get worse with change in position or head movement. It progressed to feeling "shaky".  VS were obtained and were HR of 68 and regular, BP of 134/82, RR of 14. Pupils PERL with normal EOM. Good tactile sensation bilaterally. Moving extremities with purpose. Skin color was initially normal but became pale while feeling shaky.  Patient was placed in a near supine position in her vehicle and was observed 1:1. She was given apple juice which improved her shakiness and she regained color in face.  She was able to get out of vehicle and ambulate without assistance with a steady, independent gait. She stated that she was back to her baseline before leaving.
devel of fever 101-102, stiffness/pain on shoulder muscles, mild diarrhea, numbness of hands/feet 4-5 hr p/vax;
Case number PHEH2014US015056 is an initial spontaneous report received from the physician on 25 Jul 3024. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medication were not reported. The patient was vaccinated with a dose of MENVEO (batch number: not reported) intramuscularly on unspecified date. it was reported that Men A lyophilized conjugate was reconstituted with saline instead of the Men CYW-135 liquid conjugate. No adverse events were reported after the maladministration.
Patient presented for slurred speech/stroke like symptoms. Patient received booster shot today at outside facility. Stroke alert was called and patient eventually received tPa for presumed stroke.
Dizzy, couldn't walk straight, for 8 hours better at 5pm. Red circle around injection - gone now feel fine now. Never had reaction before
Hot to touch, Redness, Swelling to the size of a golf ball, Patient reported fever. Temp was 99 an hour after he took IBU on 6/09/2020.
Moderna COVID-19 Vaccine EUA: Severe arm pain approx 14 hours after injection. Followed by (30 hours after injection): all over muscle aches, diarrhea, chills, fever max 101.5. Stopped suddenly around 42 hours (after injection). Currently have large erythematous indurated area around injection site. Still sore but not nearly as bad as before.
This spontaneous report as received from a registered nurse refers to a 61 year old male patient. The patient had no pertinent medical history, concomitant medications, drug reactions or allergies. On 08-JUN-2018, the patient was vaccinated with M-M-R II, subcutaneous injection, lot # M032487, expiry date: 05-JUL-2018 for prophylaxis (reported as vaccine) whose dose was not reported. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) via subcutaneous route whose indication, lot number and expiry date were not reported. On 15-JUN-2018 reported as after 7 days of vaccination the patient developed rash. It was reported that patient had seen the health care provider. No lab diagnostics or studies were performed and no treatment was given for the adverse event. The outcome of rash was reported as not recovered. The reporter did not provide the causal relationship of adverse event with M-M-R II vaccine and sterile diluent (MERCK STERILE DILUENT). There was no product quality complaint (PQC) involved in the report.
Roughly 34-36 hours after receiving my first dose of the Moderna vaccine I started having chills and could not get warm.  I took my temperature thinking I was running a fever, but temperature was 97.3. I went and soaked in a really hot tub of water trying to get warm. After a little while (20-30 minutes) I started feeling achy all over. I went to bed feeling really horrible with chills and achiness, but I could not go to sleep. Finally, sometime after midnight, I fell asleep. When I woke up the next morning I felt fine. The chills and achiness from the previous night were gone with no lingering effects.
Fainted, fell and hit head on ground. Possible concussion, pale blue lips, nausea, blurry vision.
At  check-out from vaccine clinic, pt reported that her tongue was tingling.   Consulted with pharmacist - 12.5 mg po Benadryl elixir given.  Pt waited an additional 15 minutes and then reported feeling better.  Pt was returning to work and stated she would follow-up with medical attention if condition returned or worsened.   Pt verbalized understanding of discharge instructions.
ARM LUMP FROM THE COVID VACCINE; Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and VACCINATION SITE MASS (ARM LUMP FROM THE COVID VACCINE) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Plaque psoriasis. Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, the patient received dose of INFLUENZA VACCINE (Intramuscular) at an unspecified dose. On 26-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2022, the patient experienced VACCINATION SITE MASS (ARM LUMP FROM THE COVID VACCINE). In 2022, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) and VACCINATION SITE MASS (ARM LUMP FROM THE COVID VACCINE) had resolved.            No concomitant medications were reported Patient had been on Skyrizi for two and half a years. Patient got the Flu vaccine on Sep 2021 and got a psoriasis flare up and it resolved. On 2022, patient got Moderna Covid vaccines and had a Covid arm lump from the vaccine a week after patient got it. Patient had psoriasis flare up a few weeks later and it eventually resolved. It happened with Flu vaccine too. It was reported that patient had taken Skyrizi pen on monday 06-Jun-2022. Patient cleansed skin with alcohol swab, had Skyrizi pen with gray cap one pointed up, pulled of the gray cap, held the pen down on her thigh for entire 15 seconds, heard the click after pushing the button and held for another three to five seconds, then saw the yellow and lifted the pen and bunch of medicine leaked out. Patient saw a red dot and mark. Patient had an issue with pen. No treatment drugs were reported.
pain on my left side; 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 MYALGIA (pain on my left side) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (pain on my left side). At the time of the report, MYALGIA (pain on my left side) had resolved. Not Provided          No concomitant medications was provided by the reporter. Treatment medications steroids was used 6 days. Action taken with mRNA-1273 in response to the events was not applicable   Reporter did not allow further contact
16Jul90  pt vax;  25Jul90 devel low-grade fever.  27Jul90 temp inc 106.6F.  Tx w/ APAP & cold sponge baths.  Temp ranged from 103 - 105.6F.  Spinal tap performed.  Spinal tap traumatic, so spinal fluid was bloody.   See worm...
Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant information was reported. It was reported that none of the patients were pregnant. Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022. This case is reported for 14th patient out of 20 patients. No treatment information was provided.
Patient received Daptacel, ActHib, and Influenza vaccines at 15 month appointment in the morning. At 1350 the patient developed difficulty breathing, facial swelling, and rash. The patient received Benadryl and Epi-Pen IM. Then presented to the emergency department and also received steroids.
Severe nausea for several weeks after the injection.  The symptoms started on that Thursday evening.
pt had coronary event 12 hrs p/vax autopsy showed only CAD-pt had sudden death clinically
Client returned to class and returned c/o itching and sl. SOB. VS taken. BP elevated. BENADRYL 25mg dispensed x2 doses = 50 mg PO.
Mother of child described increased irritability the day the vaccine was given but no other interward reaction. Td given instead of flu vaccine.
Migraine 1 day after injection; Headache; arthralgias; myalgia; chills; low grade fever; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose at left arm for immunization. Medical history was none. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient experienced migraine 1 day after injection, headache, arthralgias, myalgia, chills, low grade fever on days 1-6 post injection which are improving. Patient received Ibuprofen 400 mg daily for events. The report is considered non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 5/30/2006 pt began having episodes of dizziness. These occur everyday and are intermittent throughout the day. She also had tinnitus and occasional tingling in hands and legs. She has been given a preliminary diagnosis of Meniere's disease, but this is unconfirmed. Impression: acute onset vertigo with no change in spite of using antibiotic tables. Normal neurological examination. Veritgo could be from the inner ear but she does not have any nystagmus or other vestibular symptoms or signs. Could be migraine variant. She never had any headache. Referred to neuro-otologist. Dr. MRI brain: normal. Symptoms began 3 1/2 weeks after Menactra probably incidental. krk 11/9/06-Dr's notes received. Impression:based on a left reduced caloric response findings are consistent with a left peripheral vestibular lesion. Vestibular evoked myogenic potential: abnormal suggesting a left saccular lesion. Taken together with patient's other vestibular laboratory testing, vestibular evoked myogenic potentials further confirm a left sided vestibular abnormality that appears to involve both the seimcurcular canals and otolith organs.  Per 60 day follow up: Pt still has daily episodes of dizziness and vertigo. She has been seen by multiple physicians/specialists. Diagnosis is still unclear-working diagnosis is atypical MENIERE'S disease.
18 minutes after 2009 - 2010 seasonal flu vaccine c/o feeling faint. After 1 1/2 hour observation and po hydration states she was feeling better nausea & weakness subsided after 1 1/2 hours.
24 hrs p/inject devel soreness, redness, & swelling rt upper arm, (hot to touch); persisted for 7 days; no blisters or peeling; no systemic sx; itchy;
Headache, Myalgia, NauseaVomiting, HA, BODY ACHES AND NAUSEA Narrative: HA, BODY ACHES AND NAUSEA after 2nd Pfizer COVID Vaccine requiring loss of work.
pt recv vax 6NOV98 & dx w/IUP (+ UCG) 12NOV98;negative UCG 26OCT98;
Patient indicates he was feeling very anxious before receiving the shot. Reports that he is overall healthy but had a  blood pressure reading of 133/86 at a wellness fair and had an appoint with a doctor to evaluate his blood pressure on 04/01/2021. Denies any known illnesses or health conditions. Reports that about one minute after receiving the vaccine he became very light-headed, dizzy and sweaty. Denies any SOB, throat swelling. The next thing the patient remembers is" waking up with a bunch of people looking at him. An ambulance on-site assessed the patient and felt he should be transported to a local emergency room to assess. The ambulance staff had blood pressure readings of 90/50 and 80/51 . The patient reports he felt "much better" after arriving to hospital. Indicates he was hydrated with fluids  and had an EKG while in the ER. His blood pressure reading at the ER was 133/86. Patient reports that the ER doctor indicates that he most likely had a "Vaso vagal syncope episode.". The patient indicates that he did not receive any medications and was told to follow-up and keep his appt. on 04/01/2021 in regards to his high blood pressure. reading.
w/in 20 minutes of receiving Engerix-B pt exp weakness, dizziness, pain in the arm, nausea; these sx became worse w/each one of the vaccines in the 3 dose series;
increase in uric acid levels; experienced some of the worst pain; I developed this pain in the right foot, with a little in the left but the right foot; couldn't even walk; pain in my ankle, its like someone took a sledge hammer to my ankle; This is a spontaneous report from a non-contactable consumer(patient) via medical information team. A 70-year-old male patient received bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history included gout. Concomitant medications were not reported. Historical vaccine included bnt162b2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. It was reported that the patient was asking if his symptoms were a possible side effect from the covid vaccine or if it caused an increase in uric acid levels and if it will go away. The patient received the 2nd dose of the Covid vaccine on the 26th or 27th later clarified it was the 27th, and afterwards he experienced some of the worst pain he has ever experienced with his gout. The patient initially had no symptoms after being vaccinated, but last week, on the 16th or 7th the patient developed pain in the right foot, with a little in the left but the right foot. He could not even walk. The patient had such pain in ankle and it like someone took a sledgehammer to her ankle. Now the patient had gout, but he was watching what he should eat, and did not eat anything on these multiple lists that the doctors provided. The patient not had alcohol in 4 years, which he thought was what used to impact him. The patient stated other than this foot he was feeling fine. The reporter stated that his friends had the shots, some Moderna and Pfizer, and they said that they had chills and all pain, swelling but reported that he didn't have anything initially. The reporter stated that half dozen guys call him that got the shot, 1 guy got Moderna, a double dose, he had a slight rash on his face, he was a 70-year guy, who said his head did not feel right, like he was in the twilight zone. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initially hives at site of injection that night. Then went away. Next day hives on both sides of body, then swelling of arm and vomiting on 10/13/2016- upper arm was almost double in size- red, hard, warm.
Arm became numb & cold & later fever & chills. Today still feels weak. Disoriented.
few minutes after patient got vaccine, he fainted, he was pale, dizzy. we laid him down on the floor and after 1-2 minutes he open his eyes and start talking. we observed him for 30 more minutes.
Low grade fever; Fatigued; Arm swollen; Rash at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jan-2021 and was forwarded to Moderna on 10-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 29-Dec-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Low grade fever, at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigued) outcome was unknown.      Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Valid information received; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pain, aches; 1st shot almost a year ago, never got the 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine and received the 1st dose of Shingles vaccine. On an unknown date, not applicable after receiving Shingles vaccine and less than a year after receiving Shingles vaccine, the patient experienced pain and incomplete course of vaccination. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received first dose of Shingles vaccine almost a year ago and the side effects were pain, aches which lasted a couple of days so the patient never got the second shot of Shingles vaccine. The reporter asked do he/she get any protection from the first shot of Shingles vaccine. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.