chrisvoncsefalvay/vaers-outcomes huggingface dataset:
used two vials from the freezer after 30 days to administer them; used two vials from the freezer after 30 days to administer them; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (used two vials from the freezer after 30 days to administer them) and PRODUCT STORAGE ERROR (used two vials from the freezer after 30 days to administer them) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (used two vials from the freezer after 30 days to administer them) and PRODUCT STORAGE ERROR (used two vials from the freezer after 30 days to administer them). At the time of the report, EXPIRED PRODUCT ADMINISTERED (used two vials from the freezer after 30 days to administer them) and PRODUCT STORAGE ERROR (used two vials from the freezer after 30 days to administer them) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported  On 17-MAY-2022 the vial was initially stored in the refrigerator.  Treatment information was not reported.
tests positive for COVID; tests positive for COVID; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tests positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The reporter was asking when the fully vaccinated patient and tested positive for COVID can received the booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Nausea day 1 accompanied with loss of appetite and hot flashes, Day 2 rash and itchiness at injection site, chills while sleeping, muscle aches, headache, fatigue, Hot flashes after chills went away
See enclosed report of neurologist who Dx Guillain Barre. The patient is an 18-year-old man who came with complaint of having tingling and numbness in legs and hands, and he also mentioned having some headache. The patient was then admitted. On examination, it was noticed the his reflexes were depressed. The patient was seen by a doctor, and lumbar puncture was done. The CSF protein was elevated. The patient was started on plasmapheresis, and another doctor was consulted for that. He received seven cycles of plasmapheresis. His symptoms improved. He also received one dose of IV immunoglobulin, and the doctor was consulted on that. The patient was able to ambulate and was doing good, so we will discharge him home. We will arrange for home physical therapy. Tylenol 500 milligrams p.o. q 6 hourly p.r.n. He was advised to follow up with his doctors.
Feeling faint, pale, wheezing, difficulty swallowing, tight throat, tachycardia. Elevated B/P.
Pt upon finishing dialysis tx and receiving vaccine injection began feeling weak . Pt was unable to stand and had to be transported in a wheelchair. Pt remained sitting for about 30 minutes c/o of severe fatigue. Pt drove himself home from clinic. At home pt reported feeling very confused and lethargic. Pt stated that family was unable to understand his speech and that he was not making sense. Pt returned to clinic for HD tx and reported that he still felt some fatigue (ambulating w/o assistance but was feeling better than before and also reported that he was functioning normally cognitively again.
Stopped interacting, began staring in to space, no longer acknowledging when spoken to, stopped smiling, laughing, playing, etc for approximately 3 months.
Full body ache, low fever, headache, arm soreness. Could not attend work the following day because of flu-like symptoms.
Muscle pain, weakness, tinnitus, headache, BP 200 range hypertension crisis, difficulty breathing, chest tightness, couldn?t walk, loss of bladder control, GI and upper right side pain, autoimmune phenomenon, vasculitis, chest wall muscle pain, neuropathy hands and feet, snow vision, brain fog, lost consciousness 1x and woke to husband clearing vomit from my mouth to start CPR, bruising of unknown origin.
FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious. This case, involving the same patient is linked to 20220625319.
Information has been received from a 50 year old female consumer with an allergy to flowers who was vaccinated with the first dose of RECOMBIVAX HB. She received dose one on 14-OCT-2010 (lot # 1484Y), dose two on 15-Nov-2010 (lot # 1491Y) and dose three on 14-Apr-2011 (lot # 0482Z) at the Health Services department at her work. The initial two doses in the series were recorded as pediatric doses "x 2" in her records. The patient reported receiving only one injection each time. The patient stated she received the full series but a titer taken on 16-May-2011 was non reactive/non immune. After her initial vaccination on 14-Oct-2010, she experienced arm pain and "flu-like symptoms" that persisted for several days then resolved. She also experienced a sensation "like I almost passed out" when the dose was administered. She recovered fully in a few days without treatment from these events. After the second and third dose, she only experienced mild arm pain that resolved the day of the injection without treatment. The expiration date recorded on the chart of the first dose given on 14-Oct-2010 with lot 1484Y was 11-Sep-2010, which the patient believes proves it was expired at the time administered and may be the reason she did not respond. Per OMC the expiration date for lot 1484Y was 11-Sep-2012 so not expired at the time of administration. Unspecified medical attention was sought. No further information is available.
Information has been received from a registered nurse concerning about 5 12 month old patients who were vaccinated with MMR. Subsequently, the patients then developed some or all of the following:  rash, conjunctivitis, fever and cough. Unspecified medical attention was sought. Additional information has been requested.
Rash on arm and chest. It was itching. Started 1-2 days after vaccine. Lasted 1 week after vaccine. Tried cortisone 10 and took plenty of showers to help with itching
Within hrs of the vaccine, pt exhibited high pitched screaming,spitting up,low appetite.Within 48 hrs, pt. experienced seizures and dx of meningitis.Pt was hospitalized.Dxed with atopic encephalopathy.
Nausea; racing heart rate; restlessness; Dizziness; Shaking; breathlessness; This is a spontaneous report from a contactable consumer  reporting for herself.  A 28-years-old female patient received bnt162b2 (BNT162B2 ; Lot # EK9231) vaccine , via an unspecified route of administration on 27Dec2020 at single dose for Covid-19 immunisation .  Medical history included drug hypersensitivity to amoxicillin sodium  on an unknown date and unknown if ongoing.  There were no concomitant medications.   The patient experienced about one minute and a half after receiving the vaccine racing heart rate on 27Dec2020 with outcome of recovered , restlessness  on 27Dec2020 with outcome of recovered , dizziness  on 27Dec2020 with outcome of recovered , shaking on 27Dec2020 with outcome of recovered , breathlessness  on 27Dec2020 with outcome of recovering , nausea on 28Dec2020 with outcome of recovered.  The patient underwent lab tests and procedures which included heart rate: racing   on 27Dec2020.  The patient received diphenhydramine (BENADRYL) to treat dyspnea.
pt recv vax 23APR96 & 7MAY96 pt exp gen rash w/15-20 lesions;no further details were provided;
Itchy; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PRURITUS (Itchy). On 05-Apr-2021, PRURITUS (Itchy) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-067234 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067234:1st dose
very swollen right foot; she's got some kind of an infection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (very swollen right foot) and VACCINATION COMPLICATION (she's got some kind of an infection) in an 86-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 PERIPHERAL SWELLING (very swollen right foot) and VACCINATION COMPLICATION (she's got some kind of an infection). At the time of the report, PERIPHERAL SWELLING (very swollen right foot) and VACCINATION COMPLICATION (she's got some kind of an infection) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   It was reported that they had an appointment for the booster shot on 27Dec2021.   Most recent FOLLOW-UP information incorporated above includes: On 26-Dec-2021: Non significant Follow-up received
pt recv vax; began crying 45 mins p/ vax; fever 100;mom had been giving apap;call MD;felt asleep;was crabby in am;rt leg  red & swollen p/ getting shot but dec that eve;
This spontaneous report as received from a other refers to a patient of unknown age. On 24-JUL-2017 the patient was vaccinated with ROTATEQ lot # M002252, oral for prophylaxis. On 24-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event.
Awoke from excruciating pain in shoulder where vaccination was received up in to chest area and neck as well as extending all the way down into left hand and fingers. Felt like these areas were on fire and electricity was shocking nerves. Tingling, burning, numbness, hypersensitivity...
I received my first covid vaccine on 6/9/21 around 3:35 pm  and around 30 minutes after shot,  I started itching a little and noticed a rash on both forearms between wrists and elbows and both shoulders had a small rash. But the rash on my forearms were red and raised. I felt like I was getting the hives with feeling itchy and light headed so my son drove us home as I was having a hard time focusing. When I got home, I took a antihistamine and a Tylenol. A few minutes later I started feeling relief and by a couple hours later the rash was gone. I did feel my chest tighten while I was itchy but I wasn't sure if it was because I was worried/anxious. This morning (next day) everything seems normal, no symptoms.
swelling under his left arm; swollen lymph node; very tired; achy; foggy; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in March 2020, refer case US2020AMR141197).   On 22nd July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd July 2020, less than a day after receiving Shingrix, the patient experienced tiredness, pain and foggy feeling in head. On 23rd July 2020, the patient experienced swelling arm and enlargement of lymph nodes. On an unknown date, the outcome of the tiredness, swelling arm, pain and foggy feeling in head were not recovered/not resolved and the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the tiredness, swelling arm, pain, foggy feeling in head and enlargement of lymph nodes to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and was very tired, achy and foggy.   These side effects seem to be getting better but when he awoke this morning, he noticed a large swelling under his left arm and doctor thinks it may be a swollen lymph node. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR141197:same reporter
3 1/2 - 4 hrs after shot, felt really dizzy - almost like passing out. Turned pale and had short bout of excessive sweating.
PPD was placed on 08 March 13, and that evening the site was flat.  Patient took a shower the next morning and put lotion on her skin, by that night on the same day as lotion was applied, the site started to itch.  On Sunday morning, wheals (blistering) formed over the site, it continued to itch profusely.  On Monday 11 March 2013, patient followed up at immunization clinic and was sent to Flight Medicine. Topical medication was prescribed and used.  Problem soon resolved.
Pt received tetanus shot (Tdap) am 5/31/07 when treated by nurse at urgent care. Developed chest pain PM 6/3/07. Seen in ER 6/4/07 PM with elevated CK, CK-MB, Troponin and temp 100. and ECG changes. Cath was normal arteries but left ventricle hypokinesis, EF c/o diagnosed with myocarditis.  6/26/07 Received hospital med recs which reveal patient seen in cardio clinic on 6/11 & in ER on 6/12.  Had been hospitalized at another facility.    Cardio clinic note of 6/11 reveals pt developed chest pain 4 days s/p vax w/low grade fever.  Was doing well on med s/p d/c from hospital w/no chest pain & no sob only fatigue.  Exam revealed ekg changes of  involution & t-wave inversions in a pattern characteristic of evolving ischemia from myocarditis.  Meds were titrated & was scheduled for f/u echocardiogram & f/u.  Patient seen in ER on 6/12 for chest tightness which had made him extremely anxious.  EKG & CXR were unchanged.  Labs includeing cardiac enzymes were WNL.  Repeat echocardiogram was done & showed improvement of ejection fraction but still abnormal LV function.  Started on GI med as was on NSAIDS & released from ER w/continued cardio clinic f/u.  7/17/07 Received 2nd hospital medical records which reveal patient admitted 6/4-6/6/07 after experienced dull, constant, substernal chest pain.  Had been seen in ER 4 days earlier for cut on hand by broken glass &  received tetanus booster at that time.  Transferred for cardiac cath which showed normal coronary arteries but LV dysfunction.  Tx w/meds & d/c to home to f/u w/cardiology & pcp. FINAL DX: acute myocarditis; left ventricular dysfunction, ejection fraction 40%; brief runs of non sustained V-tach, resolved prior to d/c.
Received Anthrax #2  3 days ago. Positive rash to rt upper arm. Area of induration 33cm X 23. Crosses elbow. Does not extend into shoulder.  No streaking, headache, fever, SOB or fatigue.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt felt throat get tightened which resolved after a few minutes, felt tingly in the arm which did not completely resolve while pt was at pharmacy
No adverse event; 4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022) 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 prophylaxis.  No Medical History information was reported.   On 31-Aug-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Oct-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022) 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 EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022).    No concomitant medication was reported.    No treatment information was reported.
Headache, NauseaVomiting, Malaise, chills Narrative:
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that the facility where she worked, there had been temperature excursions with freezer. It had been happening for weeks since April 2022. The batch numbers were reported as 065K21A and 045L21A. The storage condition at the time of the excursion was reported as frozen storage. The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus 18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The vails were stored in frozen state at the time of reporting. The visual inspection noting any vaccine state change was reported as no.  No treatment information was reported.
feeling of - something is going on but not a definitive location.; mild headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling of - something is going on but not a definitive location."; HEADACHE (non-serious), outcome "unknown", described as "mild headache".  Additional information: It was reported that the patient had mild headache. Might be increase temperature although he did not take temperature. The patient just overall feeling of - something was going on but not a definitive location.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
"flu " like symptoms-fatigue, lethargic, feverish, body aches,  chills pain at site, with redness,warmth
15 minutes after itching, bottom lip swollen, rash on bilateral knees. Pt received Prednisolone and Benedryl in ER. was also sent home on same meds
8/18/2021: admitted with a COVID breakthrough presenting with cough, SOB, and covid-19 viral pneumonia. Pt states her husband was unvaccinated and contracted covid in July. She states symptoms began as sinus pain and she was receiving treatment from her pcp for sinus infection but continued to have higher and higher fevers so she tested herself at home and was covid19+ 3 days ago.  Note: previously vaccinated with Pfizer COVID-19 vaccines, 2nd dose in April 2021. Discharged 8/21/2021
fever 103 of unk origin (poss viral synd) w/febrile sz activity for the first time occurred in 3 days post vax;
Vaccine stored in the freezer, instead of the temperature range indicated on the package (2-25ºC).  Vaccine administered to patient without knowing it was stored improperly.
Patient had 100.3 temp 16 hours after vaccine administration; This is a spontaneous report from a contactable consumer or other non hcp. A 12-year-old patient of an unspecified gender received bnt162b2 (BNT162B2, Batch/Lot number was not reported), via an unspecified route of administration on 2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On2021, The patient experienced patient had 100.3 temp 16 hours after vaccine administration. The patient underwent lab tests and procedures which included body temperature: 100.3. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.