chrisvoncsefalvay/vaers-outcomes huggingface dataset:
27 hours after vaccine, my left eye started to itch and felt dry. Overnight it began to swell to the point of being closed shut by 4:00am on 3/19. It was also warm and throbbed slightly. I took a Benadryl by 4:30am. Swelling reduced slightly. I took a 2nd Benadryl by 11am swelling reduced slightly.  It is 316pm and eye is still swollen and warm to touch. Not swollen shut though. Swelling is all along eyelids, under and above eye and inner corner of eye.
Patient was given a flu shot.  Immunized & unsure if the syringe was filled with FLUVIRIN or air (0.5 ml)
Post vax, the patient developed on her left cheek, a macula papular zoster in a less than 1 inch patch. The patient was being treated for an ear infection at the same time.
About a week after the vaccine the lymph gland in my armpit on the same arm that I received the shot swelled up about half the size of a golf ball. Also had some fatigue that seemed to accompany this, though that could have been a coincidence with many late night interruptions to my sleep schedule because of on-call responsibilities at that time.
Received a Janssen vaccination on 4/7/21 from a home visiting nurse from the County Health Department. On approximately 4/13/21, the family noticed slight signs of an issue, with patient slumping towards the right, and showing some signs of weakness on right side of body. Family contacted the PCP,  who advised to take her to the ED. Family was hesitant to do that because patient had been bedridden for past few years. She seemed to improve somewhat on 4/15/21. Then the morning of 4/16/21, the family found her on the floor of her bedroom. She appeared to have had a moderate to severe stroke. Right side of body paralyzed, cannot speak. Uncertain whether mental faculties further deteriorated. PCP ordered a hospice facility for care. Stroke likely caused by blood clot but unsure if related to JJ vaccine. She has not been evaluated in person by her health care providers.
Occurring in Right Arm approx. daily: Muscle spasms, shaking arm and hand, pain shooting down arm into wrist (painful enough to make me stop what I am doing), unable to make a fist, muscle weakness.
Rec'd first dose on January 18, 2021, and three days following the first dose (January 21, 2021), severe arm pain in both arms (entire arm) at 2:30 P.M., accompanied with a few light chills.  No fever.  Pain remained for approximately 3 hours.  Took 1 Advil which relieved pain.  On February 23, 2021, following the second vaccine dose (administered on February 16, 2021) I experienced same arm pain in both arms at 5:30 A.M.   The pain was less severe and felt in upper arms only.  Duration approximately 1 hour.  Took 1 Advil which relieved pain.  Two days later (February 25, 2021) at 6:30 A.M., slight upper arm pain returned and remained 30-60 minutes.  Took one Tylenol which relieved pain.
STARTED FEELING TIRED AND WITH NO ENERGY ON 03/23/03. OVER NEXT SEVERAL DAYS DEVELOPED CONFUSION AND FURTHER LETHARGY.  SPENT 03/26-03/29/03 SLEEPING OR RESTING.  FELT USUAL SELF BY SUNDAY, 03/30/03.
A non-serious spontaneous report of gave full dose of H1N1 in one nostril was received from a registered nurse concerning a 11-year-old male. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Moderna vaccine was ordered on 01-Nov-2021 and 15-Nov-2021.  The beyond use date of the vaccine was reported as 01-Dec-2021 to 15-Dec-2021.  The reporter reported that they had a group of 13 pharmacies that had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware that in some of the freezers there was a temperature excursion that their data logs showed.   They wanted to reach out to see if the vaccines had been compromised. The vaccines had never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures.  The reporter asked whether they need to take any action in relation to the doses administered since the vaccines were stored in an unapproved freezer without a digital data logger. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  No treatment information was provided.
Vial was initially stored in the refrigerator on 29Sept2022/administered on 05-Nov-2022; No Adverse Event; Patient received expired dose of Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022/administered on 05-Nov-2022) and NO ADVERSE EVENT (No Adverse Event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022/administered on 05-Nov-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022/administered on 05-Nov-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 29Sept2022/administered on 05-Nov-2022).    No concomitant medications were reported.  Vial size was 2.5ml The vial was initially stored in the refrigerator on 29-Sep-2022. The vial did not undergo any temperature excursions. The patient did not experienced any adverse events.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-669845, US-MODERNATX, INC.-MOD-2022-669850 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669845:Same reporter US-MODERNATX, INC.-MOD-2022-669850:Same reporter
Started with itching all over, as the day progressed shoulder and arm swelled, lost feeling in hand, shot area grew much larger, turned red, hot and very itchy.  Extreme head aches, body aches, joint pain, nausea, light sensitivity.
Patient received the injection and then stood up and walked about 8-10 steps and yelled 'Mom' as she fell to the ground. Her mother ran to her side and tried to pick her up off the ground. Staff at the clinic - Nurse and EMS, instructed mom to leave her daughter laying on the ground and elevated the patients legs, while assessing vital signs. The patient opened her eyes and was talking within 30-45 seconds, she then jumped up and started walking and went down again. She continued to talk as we kept her laying on the ground for about 10 minutes. EMS was called for a second assessment. Patient was not transferred to the hospital, she went home with mom. Follow-up call to mom found that she had no other adverse events. Mom followed up with Pediatrician, the thought is most likely a vasovagal syncope event. The pediatrician instructed mom to have the patient lay down for all future injections.
Swollen, hot and painful leg for 3 days following injection. She could not bear weight on leg or tolerate clothing on her skin on right leg due to pain. Treatment was children's Tylenol and children's Advil along with cold compress.
previously health, hospitalized on 3/11 for gastroenteritis, recovered well, received second shot of covid vaccine on 3/18, subsequently deteriorated in a TCU and died within one month.
vaccine expired on 7-17-2019. Merck was contacted to see if they had and extended expiration date. they did not and recommended revaccination
Report received from a medical assistant on 13-OCT-2010 (received via Merck WAES: 1010USA01621). An 18 month old child (initials unknown, date of birth unknown) received a 0.5ml dose of AFLURIA (batch unknown) on an unknown date. The patient's medical history and concomitant medications were unknown. The patient did not die. The event outcome was unknown. No other information was provided. The reporter did not give a causality assessment. The case was reported as non-serious. The company considered events unassessable. Information derived from this AE report does not change the current safety profile of the product.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot # unspecified) in October 2011 and the second dose (lot # unspecified) on 12-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Severe arm pain hours after injection; body aches; fever (99.7 degree); This is a spontaneous report from a contactable consumer(patient). A 38-year-old female non-pregnant patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number: EN6955), via an unspecified route of administration in right arm 06Mar2021 at 15:15 (at the age of 38-years-old) as 1ST DOSE SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 06Mar2021 at 18:00 the patient experienced severe arm pain hours after injection, body aches and fever (99.7 degree). It was reported that treatment was not taken. The patient underwent lab tests and procedures that included fever: 99.7 degree. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a 77 year old female patient refers to herself. Consumer was part of the Clinical trials for ZOSTAVAX in 2005. In 2005 the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route, lot # and indication were not provided). On 06-NOV-2014 the patient experienced shingles on her left side of her stomach. There was looking for revaccination information. No other information collected. The outcome of shingles on her left side of her stomach was reported as recovering/resolving. No treatment was given for the AE. The patient sought medical attention. Additional information has been requested.
patient presents to the ER with 2 to 3 month history of cough which started 2 weeks after vaccination. diagnosed with bilateral pulmonary emboli - no other precipitating cause identified
5 hours after receiving the vaccination severe headaches ,nausea vomiting no appetite extreme fatigue.  Also had all the same effects after receiving the 2nd vaccination on 8/21 .
A little more short of breath than usual; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (A little more short of breath than usual) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DYSPNOEA (A little more short of breath than usual). At the time of the report, DYSPNOEA (A little more short of breath than usual) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Red rash around injection sight, 03/05/2021. 6 days Itchy- Benadryl cream 03/05/2021 - 8 days tender to the touch, warm, hard like knot 03/05/2021 - applied ice pack
Patient called on 10/16 to tell his arm (L) was warm and swollen with some pain, I referred him to an ER - He was on vac. AE rec'd 2 rx's. From ER, cephalexin and pred. I called him on his cell phone on 10/16 - he said he was doing fine.
Dizziness and headaches in the days following the vaccine. I have a history of migraines that bring about the same dizziness and headaches that the vaccine did. Treatment is rest and migraine medication. Should go away in the week.
TINNITUS IN RIGHT EAR; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, Laboratory data included: Hearing test (NR: not provided) Unknown. On 05-MAR-2021, the subject experienced tinnitus in right ear. The action taken with covid-19 vaccine  was not applicable. The outcome of tinnitus in right ear was not reported. This report was non-serious.
Lt arm experienced arm edema to tip of hand. Reported some respiratory difficulty. Resolved with Benadryl.
chest pressure; shortness of breath; low heart rate; low energy; dizziness; spikes of higher heart rates; This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: En6203), via an unspecified route of administration, administered in right arm on 28Feb2021 17:00 (age at vaccination: 37 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included endometriosis. The patient was taking birch control pills. The patient did not have any other vaccine in four weeks. The patient on 02Sep2020, underwent sars-cov-2 antibody test (nasal swab) which was negative. On 28Feb2021 22:00, the patient experienced chest pressure, shortness of breath, low heart rate, low energy, dizziness, spikes of higher heart rates. Everyday since it's gotten a bit worse, low heart rate, low energy, dizziness was worse at night and in the morning, sleeping heart rate has been in the low to mid forties. With also spikes of higher heart rates. While laying in bed it would be in the forties then jump to 90 and back down then up again, all in the middle of the night while not moving. The adverse events resulted in physician's office visit and emergency room visit. The patient did not receive any treatment for the adverse events. The patient did not have covid prior vaccination. The patient underwent lab tests and procedures which included: on 23Feb2021, sars-cov-2 antibody test (nasal swab) which was negative. The outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.
Metallic taste 20 hours after second dose of Pfizer vaccine. Other side effects: mild fever, some sore throat, body pain. During the first night: chills to the point of shaking and insomnia.
Patient with 2 Moderna COVID vaccines last dose, 03/06/21, who admitted to hospital with N/V.  Incidentally found to be COVID detected - no respiratory distress during stay.  Provider discharge note below:  "Patient presented to the ED with complaints of a 2 day history of abdominal pain, nausea and vomiting.  He has an extensive surgical history, and also history of recurrent SBOs, most recently in March of last year, which have all resolved with conservative management.  He also had an AKI on admission, which resolved by HD #2 after fluid resuscitation.  Follow-up AXR after contrast challenge showed contrast throughout the colon.  Patient's NGT was removed and diet advanced, which he tolerated.  Patient passed flatus and had a bowel movement prior to discharge.   The patient was incidentally found to be positive for COVID-19 upon admission, but had no respiratory issues nor complaints.   Patient will be discharged home in stable condition."
Woke up with nausea and stomach bothering him. Late afternoon muscle aches, paleness and vomiting.
Patient developed grade 2 diarrhea one day after 3rd vaccination.  Possibly related to Gardasil and unexpected.  Patient has recent history of diarrhea unrelated to vaccine.
p/vax eyes swelling & drainage on 8/1/99 & pt taken to ER 8/2/99;eyes still swollen then;pt given DPH in Er & script of amoxicillin for OM;had some rhinitis;T99.8, pulse 108, resp 24;
c/o h/a 1 hr p/vax mom reports slept for 36hrs; awake for water & use bathroom, t105 @ 9PM; Had Tempra @ time of vax & refused to take more till 1030-11PM; Pt heart was racing;
12x12cm indurated, erythematous plaque w/swelling from pneumovax;tx w/pred
Pt recvd vax 29JUL92 & devel weakness, fatigue, chills, h/a, vomiting, diarrhea, & aching in spleen; pt stated that felt ill for 7 to 10 days;
Vaccine expired on 29 Apr 2022 and stored upto 10 May 2022 (expired vaccine stored and then administered); expired doses administered to 8 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered to 8 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 29 Apr 2022 and stored upto 10 May 2022 (expired vaccine stored and then administered)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Johnson and Johnson COVID-19 Vaccine on 07-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID-19 Vaccine.   On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered to 8 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 29 Apr 2022 and stored upto 10 May 2022 (expired vaccine stored and then administered)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses administered to 8 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 29 Apr 2022 and stored upto 10 May 2022 (expired vaccine stored and then administered)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported. Patient received first booster dose on 15 Nov 2021 and second booster dose on 10 May 2022.  It was reported that the vial was initially stored in the refrigerator at the same date that the dose was administered. The vial did not undergo any temperature excursions.
This initial spontaneous case, was received from other-non health professional on 20-Oct-2017, concerns 5-year-old male patient. This was 01st out of 03 reports. On 18-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, batch no: 179403, expiry date: Jun-2018, route of administration and anatomical location: not reported). On 18-Oct-2017, 5-year-old male patient was administered with FLUAD which was explicitly coded as inappropriate age at vaccine administration. The reporter assessed this report as non-serious.
had a brief syncopal episode within minutes of receiving the vaccines above.  Completely resolved in 15 minutes.
Day #1: Fever 102.5, rigors, headache, malaise. Day #2: Fever 100.2, malaise, fatigue, headache.
Nausea, Lightheaded, sweating, dizziness, increased blood pressure,  left ear pain and left tonsils felt swollen,  felt ?off?
the adult patient received a pediatric dose of RECOMBIVAX due to a human error; the adult patient received a pediatric dose of RECOMBIVAX due to a human error; This spontaneous report was received from a certified medical assistant and refers to a 51-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 24-FEB-2021, the patient was inadvertently vaccinated with a pediatric dose of hepatitis B vaccine (recombinant) thimerosal free (RECOMBIVAX HB) 0.5 ml, once, lot # S002770, expiration date 04-NOV-2021 (route of administration and anatomical location were not provided) for prophylaxis (accidental underdose, wrong vaccine administered). combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S002770; expirationdate: 04-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Temp 97.8. Developed pain in arm 2 - 3 hours B/P 110/50 after injection. Felt achy feverish P 80 that evening. AUGMENTIN XR 1000mg po BID x 10 days #20/3RF. Area had erythema heat & swelling.