chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 10-Aug-2022; No adverse event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 10-Aug-2022).    No concomitant medications was provided by the reporter. The vial did not undergo the temperature excursion. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment medications was provided by the reporter.
Difficulty awakening; tingling to hands; difficulty standing up; difficulty with mobility; unable to answer questions; hyperglycemic; incoherent; vomiting; weakness; dizziness; increased white blood cells; increased lactate value; Concomitant medication included an unspecified vaccine given on 08Apr2021; Concomitant medication included an unspecified vaccine given on 08Apr2021; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 08Apr2021 13:45, as single dose, for COVID-19 immunization, at a hospital. Medical history included asplenic, diabetes, Ehlers-Danlos syndrome (EDS), and autism. The patient did not have COVID-19 prior to vaccination. The patient previously took gabapentin and lactose and experienced allergies. Concomitant medications included an unspecified vaccine (reported as "other vaccine") given on 08Jan2021; and other unspecified medications. On 08Apr2021 at 22:00, the patient experienced difficulty awakening, tingling to hands, difficulty standing up, difficulty with mobility, unable to answer questions, hyperglycemic, incoherent, vomiting, weakness, dizziness, increased white blood cells, and increased lactate value. These events resulted to physician's office and emergency room visits; and hospitalization for one day (unspecified date). Treatment for the events included IV fluid and IV antibiotics. The patient had COVID nasal swab on 09Apr2021 and tested negative. The patient recovered from the events on an unspecified date.  Information on batch/lot number was requested.
Was given 3 needles on day of vaccine appointment. I was injected 3 times with vaccine and had to go to the hospital within 48 hours with SEVERE symptoms including, Arm and leg paralysis , numbness to right and left side of body, Vomiting's, nausea, migraine , loss of consciences over 10 times within 48 hours of being given the vaccine. vision loss and difficulty breathing. severe dehydration.   was treated in hospital with IV Fluids and medication. Discharged 10 hours later.
Pt arrived to vaccine clinic in doctors conference room at approx. 11am. Pt read over covid vaccine consent and screening questions. Pt stated she had an allergy to crab and I advised pt to stay for full 30mins instead of 15mins. Pt vaccine was adminstered and pt sat in chair for observation. At approx 11:10am pt stated she felt "tingling and numbness around mouth" 25mg benedyrl and a RRT was activated. RRT responsed and escorted pt to ED.
19FEB92 pt recvd Engerix-B & 1MAR92 pt exp generalized myalgia & weakness & also joint weakness; events described as being fairly severe & persisted about 4 wks; tx Advil;
Patient up to date on COVID vaccinations with incidental COVID detected test found upon d/c planning.  Provider d/c note below:  "Patient is a 97 YO widowed male living relatively independently at a senior living community with past medical history significant for 10 year remote pack year smoking history, prostate cancer with no known recurrence, urinary incontinence, hypertension, coronary artery disease, peripheral vascular disease, remote TBI, chronic kidney disease stage 3 and hyperlipidemia presented with acute onset of dysarthria, question of aphasia, dysphagia, left facial droop and left sided weakness found to have an acute right MCA stroke.  Patient and family declined TPA in the ER.     The patient was evaluated by PT/OT and was suppose to initially be discharged to facility. However on 7//27/22 the patient became obtunded and unresponsive. CT head showed 1.  Small acute/subacute infarct in right parietal lobe. New since previous. 3 mm focus of parenchymal hemorrhage suspected in this lesion 2.  Small acute/subacute infarct right occipital lobe, new since previous. The family decided to prusue comfort care and hospice was informed. The patient tested positive for COVID and therefore he was discharged home with Hospice."
5in x 10in oval red area to upper left arm. Warm to the touch. Made Dr apt with her pcp for further eval today.
Vaccine given in left shoulder. About 30 minutes later, began feeling slight tingling in the left pinkie finger and numbness in the lower part of the left palm. Within a couple of hours, those feelings subsided. Twenty-four hours later, my left pinkie finger felt slightly sore as if it had been overworked. But otherwise, am fine.
vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concurrent medical conditions included Seasonal allergy.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not reported.   This case was linked to MOD-2021-240635 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received: Contain Non- significant information.
bad rash all over the back; Swollen lymph node on the left side; Pain in the left breast/chest; Pain in the left breast; Booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown), administration date: May2021, when the patient was 36 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), administration date: May2021, when the patient was 36 years old, for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks; was not diagnosed with COVID prior to vaccination; had not been tested for COVID since vaccination; and had no known allergies. The following information was reported: IMMUNISATION (medically significant) with onset Dec2021, outcome "not recovered", described as "Booster shot"; RASH (medically significant) with onset 13Dec2021, outcome "not recovered", described as "bad rash all over the back"; LYMPHADENOPATHY (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Swollen lymph node on the left side"; CHEST PAIN (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Pain in the left breast/chest"; BREAST PAIN (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Pain in the left breast". After the booster shot, the patient developed bad rash all over the back and received steroid after consulting with healthcare provider. The patient also experienced swollen lymph node on the left side and pain in the left breast/chest. The events were reported as non-serious and did not require hospitalization. The events "booster shot", "bad rash all over the back", "swollen lymph node on the left side", "pain in the left breast/chest" and "pain in the left breast" were evaluated at the physician office visit. Therapeutic measures were taken as a result of rash. The patient was treated with methylprednisolone (MEDROL) and cetirizine hydrochloride (ZYRTEC). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tingling in feet then legs abs arms I suffer from tics and tremors other words tremors I am currently under doctors care and on medications that my doctor has to keep adjusting
Ringing in ears, like a buzzing sound; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of ringing in ears in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number G3T43, expiry date 07-JUL-2024) for prophylaxis.   On 21-APR-2023, the patient received the 1st dose of Shingrix (left arm). On 23-APR-2023, 2 days after receiving Shingrix, the patient experienced ringing in ears (Verbatim: Ringing in ears, like a buzzing sound). The outcome of the ringing in ears was not resolved.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.     It was unknown if the company considered the ringing in ears to be related to Shingrix.   Additional Information: GSK receipt date: 27-Apr-2023 The reporter was a pharmacist calling on behalf of a patient. The patient received his 1st dose of Shingrix last Friday from reporting and reported that the patient came to the pharmacy yesterday, on 26-APR-2023 complaining that he started ringing in his ears like a buzzing sound on Sunday, 23-APR-2023.  The ringing had not stopped till the time of reporting, when reporter last spoke to the patient. Consent to follow up with healthcare professional.
Soreness in vaccinated arm that remains to this day. Relieved by Ibuprofen but returns after Ibuprofen wears out.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: The age at the vaccination was not reported. The healthcare professional reported that the patient developed shingles. No further details were reported regarding the event.
This spontaneous report as received from a healthcare worker refers to a 4 years old patient. On 15-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (0.5 ml, subcutaneous, lot # not reported) which was improperly stored dose exposed to a maximum of -9C for total 2.5 hours. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of report, the status of patient ws unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
PAtient came in for 1st dose Pfizer and my technician pulled Pfizer bivalent from fridge and it was not triple checked before administration.
feeling crappy/feeling terrible; feeling tired; have a headache most of the day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling crappy/feeling terrible), FATIGUE (feeling tired) and HEADACHE (have a headache most of the day) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031279) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (1st dose, Lot number: 023M20A) on 24-Feb-2021, Moderna covid-19 vaccine (2nd dose, Lot number: 048A21A) on 24-Mar-2021, Moderna covid-19 vaccine (3rd dose) on 01-Dec-2021, MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (4th dose) on 02-Nov-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On 10-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 11-Oct-2023, the patient experienced FEELING ABNORMAL (feeling crappy/feeling terrible), FATIGUE (feeling tired) and HEADACHE (have a headache most of the day). At the time of the report, FEELING ABNORMAL (feeling crappy/feeling terrible), FATIGUE (feeling tired) and HEADACHE (have a headache most of the day) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient did not think that it was nothing serious but have feeling crappy.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745364 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745364:Husband's case
Received injection in left arm, started getting weak quad muscles, harder to walk. Left quad started weakening first, now both. The symptoms have worsened and my muscles are weak making it hard to walk without pain. Also a rash developed on my left upper thigh. I am able to walk but it is sore like I have been jogging for hours and pulled muscles.
SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNWON and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sore arm. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
pt recv vax 1JAN98 & pt became very dizzy;also felt like pt was going to faint, looked green & was sweating;31JUL98 recv 2nd dose of vax-pt lying down & did much better in tolerating the vax;
9 day later devel fever 102 & rash & lymphonodes size of marbles on neck & head;
Information has been received from a physician concerning a 7 month old patient who was exposed to a woman that developed shingles following subcutaneous vaccination with varicella virus vaccine live WAES0504USA01512. It was reported that the patient then developed chickenpox. No other information was provided. Additional information has been requested.
Oral Typhoid vaccine. Only after last dose. Sharp stomach pains lasting 5 days. For 2 days they came on frequently, then for three days only after I ate. I nearly went to the hospital. I have previously had adverse reactions to the typhoid injection (Flu symptoms the first time, and swollen lymph nodes the second time). That's why I took the oral vaccine this time. I have had many other vaccines and never had any reactions.
Patient became pregnant within a couple of weeks after receiving the first Moderna COVID vaccine, and as her pregnancy progressed, infant has been found to have multiple congenital birth defects- see info below from Medicine consult and echocardiogram.  11/9/21 Perinatology notes- 27w2d, US showing severe IUGR, complex congenital heart defect with single AV valve, large ASD, VSD, dilation of RV consistent with unbalanced AV canal defect, additionally persistent left SVC, suspected right sided aortic arch and vascular ring. Feet suboptimally imaged. NIPT sent (this returned normal), referred to Pediatric Cardiology and Fetal Care.  Fetal echocardiogram 11/22/21- abnormal cardiac axis of 94.8 degrees, cardiomegaly, Moderate dilation and mild hypertrophy of right ventricle with normal systolic function. Mild hypoplasia of left ventricle, apex forming with qualitatively normal systolic function, small to moderate membranous septal defect, mild-moderate hypoplasia of mitral valve annulus which has appears parachute and has abnormal chordal attachments crowding the left ventricular outflow tract. Mild-moderate dilated tricuspid annulus with mild TR, trivially hypoplastic aortic valve annulus with no anterograde stenosis. Mild hypoplastic ascending aorta, transverse arch and isthmus. Right aortic arch with suspected aberrant left subclavian artery and large left PDA- vascular ring. Right juxtaposition of left atrial appendage. Persistent left superior vena cava to a dilated coronary sinus with no bridging vein.
diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable physician, the patient.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 21Dec2020 as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 22Dec2020, the patient was diagnosed with COVID-19.  The clinical outcome of diagnosed with COVID-19 was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The patient was diagnosed with COVID-19 one day after he received vaccination with BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE). There was not a reasonable possibly that the event was related to vaccination considering the temporal gap between the vaccination and the event onset.
A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a nine-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 20-Feb-2011. The patient received the expired FLUMIST on 28-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received TWINRIX for prophylaxis. Concomitant products included TWINRIX. In May 2017, the patient received the 2nd dose of TWINRIX. On an unknown date, unknown after receiving TWINRIX and TWINRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to TWINRIX. Additional information received as follows: The age at vaccination was not reported. In May 2017, the patient received the first 2 doses of TWINRIX and she got sick and had surgery (unspecified) and never got the third shot of the TWINRIX. She wondered if she should get it at the time of reporting. No further information to provide.
About 2-3 days after the first vaccination in April 2021, I had a strange loud 'squeal' in my right ear that would increase rapidly in decibel and then power back down and go away. After several weeks of this as a random event, it started to do the same thing in the left ear but not with the same intensity. About two weeks after the second vaccination in October 2021, I began to experience random ringing in both ears that has increased in intensity over time and can be more intense in one ear at times than the other or visa versa. Now, there is basically a constant low grade 'background white noise' in both ears but tends to be more pronounced in the right ear over the left in general.
Medical Assistant reported that PROQUAD and V ARlV AX was Inadvertent Concomitant Administrated to a one year old patient; No additional adverse events reported; This spontaneous report has been received from a medical assistant concerning to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route of administration, strength, lot # and date expiration were not provided) for prophylaxis and inadvertent on the same date with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, strength, lot # and date expiration were not provided).
This case was reported by a other health professional via call center representative and described the occurrence of laceration of hand in a adult patient who received FLULAVAL QUADRIVALENT (batch number 9N2X7, expiry date April 2017). On an unknown date, the patient received FLULAVAL QUADRIVALENT .5 ml. On an unknown date, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced laceration of hand and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of hand was recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the laceration of hand to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by an Office Manager. This case was associated with product complaint. The age at vaccination was not reported. The caller stated that unnamed doctor cut hand while preparing vaccination. The caller declined to provide doctor's name. Doctor injured self while preparing vaccine. No patient involved. No event date available. The caller requested not to receive safety report mailing and related quality complaint. The reporter stated 1 broken vial discovered. Cracked vial was discovered prior to preparation. Caller reported original package was not damage. No damage noted to blister tray but evidence of leakage noted. The glass pieces were available for return with damaged vial. The product was stored separately from its original packaging. No product still present in vial. No needle used. The extended crack was noted at base of vial. Reporter stated that other person opened the product box. The person administering vaccine was experienced doctor of medicine. The product was purchased from GlaxoSmithKline directly. No administration and no patient involved. The product was available for return. The Credit Request Template was complete to arrange credit.
Pt recved vax approx 1230PM then had sz w/o fever @ approx 530PM; d/c from hosp 22APR92 doing well;