chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Certified Medical Assistant (C.M.A.) refers to 4 patients of unknown age and gender. On an unknown date the 4 patients received improperly stored ROTATEQ (lot#, strength, doe, frequency unspecified). Temperature excursions for the vaccine were supported with in-house stability data. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Initial unsolicited case received from a consumer (patient himself) on 29 Dec 2016. This case involves a 79 year old male patient who was vaccinated with a dose of FLUZONE QIV (Batch number: UI673AC, Expiry date: 30 Jun 2016) administered intramuscularly in left deltoid on 14 Oct 2016. The patient had no illness at time of vaccination and preexisting physician diagnosed allergies, birth defects, medical conditions were reported as glaucoma. The patient's concomitant medications were unknown. On 21 Oct 2016, one week after vaccination the patient began having numbness and tingling in his right hand, which then began to occur in his left hand a few days later. On an unknown date, post vaccination the patients fingers and hands were swollen and at night the patient experienced shooting pain in both arms. On an unspecified date, post vaccination the patient was seen by primary care physician (PCP), the patient had an appointment scheduled with a neurologist and the patient had a test for carpel tunnel syndrome which was positive. The patient's other lab tests were not provided. The patient was advised to take Ibuprofen which helped to decrease the swelling and shooting pain in his arms at night. The outcome of the events were reported as not recovered (it was reported as the numbness and tingling are still present in patient hands and fingers). List of documents held by sender: none.
LOOKS PALE; FEELING SICK; HEADACHE; TEMPERATURE 102.4C; DIZZINESS AND WHEN TRIED TO SLEEP DIZZY; BODY ACHES; FEELING COLD; SWEATY; PRESSURE IN HEAD; PRESSURE IN EARS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's past medical history included dehydration, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 08:40 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102.4 C.  On 08-APR-2021, the subject experienced dizziness and when tried to sleep dizzy. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced feeling cold. On 08-APR-2021, the subject experienced sweaty. On 08-APR-2021, the subject experienced pressure in head. On 08-APR-2021, the subject experienced pressure in ears. On 08-APR-2021, the subject experienced feeling sick. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced temperature 102.4c. On 09-APR-2021, the subject experienced looks pale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness and when tried to sleep dizzy, feeling sick, body aches, headache, feeling cold, sweaty, pressure in head, temperature 102.4c, looks pale, and pressure in ears. This report was non-serious.
Felt physically sick after both of the shots; The next day after both shots she was feeling ill; Extremely fatigued and wiped out; Felt bad and was on the couch for 2 days; This is a spontaneous report from a contactable consumer or other non-HCP. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in Right Arm on 05Mar2021 as DOSE 1, SINGLE (at the age of: 69-year-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient felt physically sick after both of the shots. The next day after both shots she was feeling ill. On an unspecified date the patient experienced extremely fatigued and wiped out and felt bad and was on the couch for 2 days. AE require a visit to Physician Office. Prior Vaccinations (within 4 weeks) If applicable, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine was administered. The patient underwent lab tests and procedures which included computerised tomogram: negative, echocardiogram: unknown on 24Jun2021, magnetic resonance imaging: negative on 18Jun2021, mammogram: negative on 19Jun2021, ultrasound scan: unknown on 24Jun2021. The outcome of event the next day after both shots she was feeling ill was unknown while outcome of rest all event was recovered on an unspecified date.
Patient fainted & fell to the ground. Was slightly stiff in upper extremities, dusky in color. Episode lasted <2 minutes. 911 called patient sent to local E.R. Vomiting x1.
Presents with nosebleed and diffuse petticae. Also has epistaxis and thrombocytopenia. Pateitn reports symptoms for 2 days.
Coughing; Headache; Slight loss of smell; Body aches; slight temp (99.5); congestion; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 31Mar2021 at 10:45(at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and seasonal allergy. The patient received medications within two weeks of vaccination which are unspecified. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. On 03Apr2021 at 00:00 the patient experienced nasal congestion, Coughing, Headache, Slight loss of smell, Body aches and slight temp (99.5). The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event nasal congestion, slight temp (99.5), coughing, headache, slight loss of smell, body aches were not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A report was received from a health professional on 29 October 2001 regarding a female patient over 65 year old who experienced an injection site reaction after receiving Fluvirin vaccine in 2000.  The patient had previsously received Fluvirin with no ill effects.  The patien developped 4 cm area of red swelling around the site of injections.  The event was reported to be resolved.  There was insufficient information to determine the reporter's causality assessment.
Narrative:  Admission Date: AUG 29,2021 Discharge Date: AUG 30,2021 Admit Diagnosis: COVID PNEUMONIA, PULMONARY EMBOLI 76yoM with PMH significant for spontaneous pneumothroaces in his 20s s/p pleurodesis, ex smoker now with COPD, psoriasis, T2DM, NTM lung infection following with ID, and vascular dementia presented with COVID PNA 8/29/2021 despite being fully vaccinated with Pfizer's COVID vaccine on 01/22/2021 and 02/12/2021. Patient recently presented 8/26/21 with cough, congestion, and a positive COVID PCR. He was not hypoxic on room air at that time, and was discharged home after administration of Regeneron mAb. Three days later, 8/29/2021, patient presented with worsening cough, dyspnea. He reported that for the past two months, he has had intermittent hemoptysis as well. Denies NVDC, diaphoresis, fever, chills, abd pain, chest pain, numbness/tingling, further or progressive hemoptysis, changes in urinary or bowel habits. In the ED, patient is normotensive with all VSS, satting 98% ORA. Labs are significant for COVID +, D-Dimer 0.92. VBG significant for mild hypoxemia 7.4/41/18(L)/25.6. CT chest demonstrated acute pulmonary emboli to segmental branches of the right upper lobe, multifocal GGOs c/w COVID, stable RUL cavitary lung lesion with possible superimposed atypical/fungal infection. He was admitted. - Lovenox 80mg BID and then transitioned to apixaban 10mg twice daily for 7 days followed by 5mg twice daily for 6 months (planned). - Deferred Dexamethasone therapy as not on supplemental O2 - Deferred Remdesevir therapy as not on supplemental O2 The patient was discharged in stable condition on 8/30/2021.
first evening started feeling a minor headache, what felt like a minor fever, chills and overall not feeling well. The next day, Jan. 13 felt more headache, fever took temperature it was only 97.6, chills all day, overall tiredness, generally not feeling good. By the evening of Wednesday Jan. 13 started feeling better with less syntoms. Thursday Jan 14 felt about 95% good.
A non-serious spontaneous report of fever has been received from a consumer concerning a six-year-old female, subsequent to FLUMIST. The patient was healthy at the time of vaccination. Concomitant medication was not reported. The patient received FLUMIST intranasally on 13-Dec-2009. On 16-Dec-2009, the patient developed fever of 38.8. The patient had not returned to the doctor. The outcome of the event was not reported.
Vaccine was administered 12/30/2020 and as of 930am 12/31 I was throwing up and running a fever. I left work at 10:30 after realizing how bad I felt and went home. I slept for roughly five hours, from 11am to 3:30ish and then continued to throw up. I could not life my arm past my chest because it was so swollen and sore. I stayed at home and skipped new year's, going back to sleep around 1030pm. It was not fun
it's like the worst stomach flu I've ever had; shortness of breath; physical chest pain; so tired; A spontaneous report was received from a non-healthcare professional concerning a 33 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced it's like the worst stomach flu I've ever had, shortness of breath, physical chest pain, so tired.  No medical history was reported.  No concomitant medication was reported.  On 08-Jan-2021, prior to the onset of the events like the worst stomach flu I've ever had, shortness of breath, physical chest pain, so tired, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) via an intramuscular route in right arm for prophylaxis of COVID-19 infection.  On 13-Jan-2021, the patient experienced like the worst stomach flu I've ever had, shortness of breath, physical chest pain, so tired.  Laboratory details was not provided.  Treatment medication was not reported.  Action taken with mRNA-1273 in response to the events like the worst stomach flu I've ever had, shortness of breath, physical chest pain, so tired was not provided.  The outcome of the events like the worst stomach flu I've ever had, shortness of breath, physical chest pain, so tired was not provided.  The reporter did not provide the assessment of the events like the worst stomach flu I've ever had, shortness of breath, physical chest pain, so tired to study drug.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Pt's left deltoid at site of DT is red, warm and swollen. Suggested Benadryl OTC and cold compresses with rest. Mom called and said pt's arm is still red-purple and "hot" to touch. Pt had some reaction with Tetanus at kindergarden shot and they told mom to continue cold compress and take Benadryl and if symptoms worsen to call back. Pt still has pain and itching; redness is improved per mom. Doctor dx'd injection reaction and Rx'd Zyrtec.
Fever, chills, headache, body aches and pain, nausea, fatigue, inability to stand w/o feeling of passing out, generalized weakness all lasting 2.5 days
Blood clot; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that she found out that 2 other people she knew were having the same symptoms. Consumer clarified that they had a blood clot, stated that she didn't ask them if they were having any other symptoms. Later, consumer stated that her neighbor who was 93 years old got a blood clot 3 days ago. The other person who got a blood clot was much younger and got it right after getting the vaccine. Consumer verified that these were the same 2 people she was talking about earlier and they both got the Pfizer Covid vaccine. The outcome of event was unknown.  Information about Lot/Batch number has been requested.
Information has been received from a nurse concerning a 19 year old female with a history of penicillin allergy who on 22-JAN-2008 was vaccinated with the first dose of GARDASIL (lot # 659653/1448U) via IM route. On 03-APR-2008 she receive the second dose (lot # 659964/1978U) and on 23-SEP-2008 received the third dose (lot #661044/0548X), both via IM route. Concomitant therapy included hormonal contraceptives (unspecified). The patient was hospitalized for possible cardiac problems after administration of 3 doses of GARDASIL. On 18-OCT-2008 the patient started to stagger and her speech became "funny" and 30 minutes later she passed out. The patient was transported to the hospital. Emergency medical technician determined patient developed bradycardia. She was admitted to hospital on 18-OCT-2008. As of the reporting time, she was still in the hospital. She was experiencing complex seizures and severe orthostatic hypertension. She was diagnosed with possible cardiac arrest and may need an implantable cardioverter defibrillator. On an unspecified date, the magnetic resonance imaging (MRI) showed normal results, electrocardiogram showed normal slow and toxicology screen was negative. The patient had not recovered. The reporter considered the events to be disabling, immediately life-threatening and to be other important medical events. A lot check has been requested. Additional information has been requested.  1/27/09 PCP records received including multiple diagnsotic studies from 10/2008 for syncope/unresponsiveness/bradycardia. In for annual exam 11/5/08. ROS note states "Drs think the problems she had were from a blood vessel in brain and reaction to meds" Not sure if Gardasil started the whole thing off. Exam WNL.   2/11/09 Tag2 received. 2/20/09 MR received for DOS 10/20-26/2008 with no definitive DX as pt was transferred to higher level of care for further w/u. Had been admitted with admission dx of syncopal episode with orthostatic hypotension and bradycardia. ER visit 12/2/08 with dx: seizure. Pt presented 10/20/08 after collapsing at work. Prior to collapse pt had been staggering, felt lightheaded and dizzy and had abnormal speech. Had been feeling unwell x several weeks with pleuritic chest pains, palpitations and night sweats. Bradycardic (32), RR 4-6/min, hypotensive and unresponsive en route to ER. Gradual return of sensorium in ER although drowsy. Had several more episodes in hospital with orthostatic sx. Pt c/o precordial chest discomfort. Cardiology consult PE (+) systolic murmur 2/6. Marked dysautonomia. Further episodes where pt passes out with eyes rolled back, preceded by numbness of the L side of body. Onset of H/As with light and sound sensitivity. Transferred to higher level of care for further diagnostic W/u. Returned 12/2/08 following a seizure. 2/27/09 MR received from transfer hospital with D/C DX:  Atypical non-epileptic spells.  UTI. Pt received from tranfer hospital for further eval of spells of unresponsiveness with R arm movement with unknown etiology. Pt had witnessed spells under EEG monitoring with no correlation to seizure activity. Tx for UTI due to bacteria present in urine.
In 2002 he received the first two of 8 doses of anthrax vaccine. Two weeks after one of them he developed a pruritic, scaly patch about 3 inches in diameter below his right axilla. It persisted about a year and never returned. However, this year he developed a severe, painful, pruritic condition of his extremities and wondered if the pruritic patch in 2002 was related. He had a previous history of the painful/pruritic condition before the anthrax immunization, but not severe and only every few years. The place where he received the immunizations is not known.
Moderna vials for the primary series and they were administered instead of the Bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna vials for the primary series and they were administered instead of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Moderna vials for the primary series and they were administered instead of the Bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna vials for the primary series and they were administered instead of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna vials for the primary series and they were administered instead of the Bivalent booster).    No concomitant medications were reported.  It was reported that the patient had already received the primary vaccination series and received vaccine from Moderna vial instead of Bivalent booster dose. The reporter had a couple of vials of the primary series in stock, out of which it was administered.   No treatment details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-668653, US-MODERNATX, INC.-MOD-2022-668670 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668653:Patient 1, Same reporter US-MODERNATX, INC.-MOD-2022-668670:Patient 2, Same reporter
Patient was admitted to hospital with cellulitis of lower extremities.  Patient developed shortness of breath, dry cough, low grade temps, and hypoxia.  Patient tested positive for Covid and treated with remdesivir.
Intense coughing and wheezing, followed by headache. No treatment, medical facility closed.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient received Moderna vaccine past its 30 days expiry date; Dose Number 2, Administered Amount (mL) 0.25; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date), ACCIDENTAL UNDERDOSE (Dose Number 2, Administered Amount (mL) 0.25) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2022 at 2:00 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 26-Feb-2022 at 2:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date) and ACCIDENTAL UNDERDOSE (Dose Number 2, Administered Amount (mL) 0.25). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine past its 30 days expiry date), ACCIDENTAL UNDERDOSE (Dose Number 2, Administered Amount (mL) 0.25) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Ethnicity reported as (Privacy).  Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   No treatment medication was reported by reporter.
Initial health care professional report received on 05 Mar 2010: This patient received FLUVIRIN (batch number 102145P1) unknown dose, intramuscular, on 01 Mar 2010. On 01 Mar 2010, the patient inadvertently received a dose of Novartis FLUVIRIN that was stored at temperatures above refrigeration. It was reported that the vaccine had reached 80F in temperature over the time period of a weekend. It was reported that no adverse reaction occurred and the patient was referred to MD. It was reported that death did not occur and no hospitalization due to the adverse event. The outcome of the event was not reported.
The patient came in on 10/13/2022 for his first Shingles vaccine. He has no recollection that he came in this day for this shot. He remember inquiry about the shot but never got the shot. In reality, he filled out the immunization consent form and signed out as if he paid the zero copay at the register. The pharmacy manager double check the quantity of hand and everything is correct. It says 18 vaccines on hand and that is how many we have. If no shot have been given, there will be one extra shot on hand. The patient claims he  has no adverse reaction when the pharmacy manager spoke to him. She advises that there needs to be a 2-6 months break between his 1st and 2nd shot so she advises him to come back in 2 to 6 months for the second shot to count toward the immunization schedule.
Starting 1am (8/20/21) after receiving vaccine- Severe coldness, goosebumps head to toe, painful throbbing at injection site, low back and joint pain, and headache. Needed heating pad and three blankets to warm up, removing layers as I warmed up. A few hours after I woke up extremely hot with a fever of 100.1 and worsening headache, joint and low back pain. I was in bed all day (8/20/21) with alternating hot and cold with persisting headache, joint and low back pain. Later in the evening, around 7pm 8/20/21, the coldness,  joint and low back pain subsided. Hot flashes with rises in temperature and severe headache still persisted through out the night and into the next morning. The time as I am writing this is 10:00am on 8/21/21 symptoms continue- hot flashes, sweating and raise in temps (99.0-99.8) continue along with terrible headaches that wont let up even with the use of Motrin.
Patient c/o diff breathing, started to hyperventilate. Pt was to exam rm v.s. taken strong peripheral pulses became sweatey tachycardia, VS taken 138/80, 100% O2sat. Pt was coherent responding to questions. Nurse remained with pt. He had eaten since AM, provided fruit and liq. B/P 120/80 P 80. Pt states feels better increased HOB, observed pt with father at 6pm. Pt was alert and oriented entire time here in the office.