chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM; dose administered past manufactures expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     It was unknown if the patient was diagnosed or tested for COVID-19. It was reported that whether patient had acute illness at the time of vaccination and up to one month before, chronic or long-standing health conditions and allergies were unknown.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:40 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:40 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM).    No concomitant medications was reported.  Patient received the second booster dose on 03-May-2022 post the expiry date. Vial was pulled from freezer at 10 AM and was again put in refrigerator until approximately till 1:45 PM on 03-May-2022. The vial did not undergo any temperature excursions.  No treatment information was provided.
Seizure 1 week after MMR, Prevnar, Varivax. Febrile seizure with mild pneumonia; twin exact reaction with 15 minutes same shots
Initial report received on 05 November 2013 from a health care professional. A 65-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number U4783AA, expiration date, route and site of vaccination was left shoulder) on 30-Oct-2103. It was reported that 65-year-old female patient have received the FLUZONE HD. On 30-Oct-2013, patient experienced pain with immunization. Felt it was too high on arm and increased pain day of vaccination with difficulty movement but now just soreness and cannot lift arm higher than her chest. List of documents held by sender: none
The day after vaccine I started to have a burning, stinging skin reaction on right side of torso. Thinking it was hives, I applied cortisone cream and took Zyrtec. This continued through following week. I went to my personal physician and was diagnosed with shingles though I never had any outward rash or blisters.  Just skin sensitivity . I was prescribed  triamcinolone acetonide cream 0.5% which I have been applying twice daily. I have not had an outbreak but have had minimal internal pain that feels like strained or pulled muscle in the same area.
Nausea <15 min post immunization. Resolved after oral fluids and light snack.
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. No treatment drug was reported.
c/o dizziness upon arising beginning 1 week after vaccine and continues as of the date of this form. Has appointment scheduled with his doctor for evaluation.
covid/AG 1/3 positive; covid/AG 1/3 positive; Dose Number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Lot number: FF2589) at the age of 34 years as dose 3 (booster), single, administration date 18Mar2021 (Lot number: EL3247) as dose 2, single and administration date 25Feb2021 (Lot number: EL3247) 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: IMMUNISATION (medically significant) with onset 05Nov2021, outcome "unknown", described as "Dose Number: 3"; VACCINATION FAILURE (medically significant) with onset 03Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 03Jan2022, outcome "recovering" and all described as "covid/AG 1/3 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course: It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown the patient diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective  cannot be ruled out
Pt recvd vax 24MAR92 lt deltoid on 25MAR92  pt came to clinic lt deltoid swollen, red, hot, itching; Taken to ER; dx allergic rxn;
No additional AE reported; VARIVAX was administered to a patient after a temperature excursion; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, once, lot #W022293, expiration date: 13-JUL-2024, administered for prophylaxis (dose, strength, and route of administration were not provided). It was reported that the vaccine underwent temperature excursion prior to administration (product storage error). No additional adverse event was reported (no adverse event).
Injection site pain Tiredness Headache (pressure) Left arm muscles  Chillers Fever 100.4 Injection site swelling  Injection site redness  Nausea  Feeling unwell
Pt complained of having a very sore lower back, headache, fever, chills, sweats muscle aches and a generalized feeling of malaise and weakness, heavy sweating, fatigue.
arm swelled up; sensitive to touch; extremely sore; lethargic; blood sugar not in control; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (lethargic), PARAESTHESIA (sensitive to touch), BLOOD GLUCOSE ABNORMAL (blood sugar not in control), VACCINATION SITE PAIN (extremely sore) and VACCINATION SITE SWELLING (arm swelled up) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 15-Mar-2021, the patient experienced LETHARGY (lethargic) and BLOOD GLUCOSE ABNORMAL (blood sugar not in control). On 19-Mar-2021, the patient experienced PARAESTHESIA (sensitive to touch) and VACCINATION SITE PAIN (extremely sore). On an unknown date, the patient experienced VACCINATION SITE SWELLING (arm swelled up). At the time of the report, LETHARGY (lethargic), PARAESTHESIA (sensitive to touch), BLOOD GLUCOSE ABNORMAL (blood sugar not in control), VACCINATION SITE PAIN (extremely sore) and VACCINATION SITE SWELLING (arm swelled up) outcome was unknown. Not Provided          patient applied ice using Tylenol and Benadryl.   Reporter did not allow further contact
Left arm was sore; Left arm was warm; Blisters above the injection site on shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm was sore), BLISTER (Blisters above the injection site on shoulder) and FEELING HOT (Left arm was warm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced BLISTER (Blisters above the injection site on shoulder). On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm was sore) and FEELING HOT (Left arm was warm). At the time of the report, PAIN IN EXTREMITY (Left arm was sore), BLISTER (Blisters above the injection site on shoulder) and FEELING HOT (Left arm was warm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information were not provided.
About 30 minutes after vaccine, started to have a hard time breathing, short of breath &   "chest felt heavy" while at work at desk.  Called an ED response- taken to ED was monitored for 4 hours, then released to home. That evening  experienced fatigue, headache, muscle/body aches, feverish,  which continued  on 1/19 ,1/20, 1/ 21. felt better on 1/22/21 afternoon.
high fever; minor headache; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for a female patient (girlfriend) that, a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on 20Mar2021 as a DOSE 2, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced high fever and minor headache on an unspecified date. It was reported that, the reporter was asking for his girlfriend who already got the second dose last Saturday 20Mar2021. She was experiencing high fever and a minor headache. Outcome of both the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The Moderna vaccine was taken out of the freezer and placed in to the refrigerator on 9/8/2021. The vaccine was administered beyond the 30 days of which the vaccine is recommended to be kept in the refrigerator.  No adverse reaction occurred during the 30 minute waiting period or reported after the clinic date.  This participant reported history of allergy
treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "CKD stage 3a" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Started as general leg weakness and progressed to being unable to stand/walk/drive and included right arm weakness.  I was first seen by a doctor in June thinking it was a back issue.  I was then referred to a neurologist who then referred me to a second neurologist.  I was eventually diagnosed in July with C.I.D.P. and by this time required assistance doing basic activities such as dressing/bathing etc.  I was confined to a wheelchair and unable to work.  September 7th I was started on IVIG infusions daily for 5 doses.  I was also undergoing physical therapy.  I have had several physical therapy sessions and another IVIG infusion October 21st.  Symptoms have slightly improved but still unable to walk/drive/work/ etc.
This spontaneous report as received from a pharmacist refers to a 74 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. On 05-MAY-2016, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Concomitant therapies included metformin, simvastatin (manufacturer unknown), losartan potassium (+) hydrochlorothiazide (manufacturer unknown), glipizide, levothyroxine sodium (manufacturer unknown), citalopram and canagliflozin. On 05-May-2016, the patient developed an itchy, red rash that is about 3 inches long at the injection site following the administration of ZOSTAVAX. The patient received hydrocortisone cream and BENADRYL. There were no lab diagnostic studies performed. The patient sought medical attention by pharmacist contact. No product quality issue was involved. The outcome of the events was reported as not recovered at the time of the report. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Information has been received from a health professional concerning a  27 year old female who on 10/30/2004 was vaccinated with a dose of varicella virus vaccine live. On 11/13/2004 the pt was diagnosed by a dermatologist with chickenpox. Unspecified medical attention was sought, no further information was given at the time of this report and the pt's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Approximately 10 minutes after vaccination, patient's brother yelled out for help. The pharmacy cashier then observed the patient convulsing. Her body was leaned back on the bench, with head tilted back a bit. When I came out, patient appeared very pale. I immediately ran back into the pharmacy, instructed a fellow employee to reach out for assistance from front end management, and I called 911. While on the phone with 911, I walked out to check on the patient. At that point, she appeared to be coherent and said she was okay, and doesn't need any medical help. At that time, her brother explained that a reaction like this had occurred in the past when she got other vaccinations/injections so they were familiar with the symptoms. We continued to monitor patient for further reactions. After about 30 minutes, patient appeared to have no further reactions and left.
Extreme muscle fatigue and soreness; Extreme muscle fatigue and soreness; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable nurse, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the right arm on 16May2021 at 16:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Concomitant medications taken within two weeks of vaccination included bupropion hydrochloride (WELLBUTRIN) and fluticasone propionate (FLONASE) both from unknown date for unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 29Jan2021 at 12:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 at 04:00, the patient experienced extreme muscle fatigue and soreness. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events extreme muscle fatigue and soreness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient developed a knot on the right side of the neck. She then developed Bells Palsy and went to the ED. Patient went to ED for left facial drooping, numb lips and left eye watering.  An MRI was done on 5/8/2021 which showed abnormal enhancement of the left seventh cranial nerve that may be seen with Bell's Palsy or Ramsay Hunt Syndrome. The enhancement also extends along the greater petrosal nerve. Patient was recommended to follow-up closely with neurology.
Diagnosed on March 31, 2021 with (left side) Cerebral Venous Sinus Thrombosis following approximately 1 week of extremely bad headaches on the left side of head, unlike my normal migraines. I have no history of a clot disorder.
at approx 4:30pm started to feel nauseous and vomited x4.  Rash appeared approx Sunday morning under my breasts, still there on 9/8/21 (but has not spread to any other area)
After (Privacy) a minimal level of tinnitus, after I received the first and second dose it intensified, after the 3 shot it is so bad I can no longer function as a human being. I can't sleep, I can't eat, I can not perform life's normal duties. The level of tinnitus is so great it could make someone become suicidal. I have random tunnel vision in both eyes. Migraine headaches causing vomiting. Several Migraine headaches per week which causes nausea and vomiting. Muscle pain and constant joint pain. Myocarditis. The tinnitus is worst than anything, it has gotten worse since the 3rd booster, fever chills, and vomiting and fatigue. Loss of concentration.
Pt rec'd Tdap injection at approx 4:50 pm and approx 5-10 minutes later he was standing, felt "light-headed" and then had LOC.  No head trauma as he was caught during fall.  While he had LOC -> his eyes were "rolled back" and he felt "rigid".  Pt awoke within a few seconds and was well-oriented, talking normally.  No loss of bowel/bladder.  VS normal after LOC.  Rested, drank juice and d/c home by 5:20 PM.
1st dose 8 months ago, 2nd dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 8 months ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's comment: The pharmacist reported that the patient had not received the second dose of Shingrix yet. The reporter did not answer if follow up was okay, she only knew the patient gender, no other details at time of reporting. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report as received from a registered nurse refers to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-JUL-2015, the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX, lot number reported as J008026, expiration date: 30-JUN-2015, (dose, route of administration and injection site were not reported). It was the patient's second dose in the series of (Oka/Merck) VARIVAX. No adverse effects were reported. Additional information has been requested.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). At the time of the report, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was provided.
excessive sleeping x 3 days;crying out occasional would arouse & take formula-going back to sleep p/this
Eight days after receiving my Moderna Covid 19 Vaccine my arm at the injection site swelled and became hot to touch and red. I also started feeling like I was going to faint. The redness has spread on my arm but the redness is subsiding. The feeling faint lasted for about 8 hrs. I feel better today. I did not notify my physician since I started feeling better. I took a Zyrtec when I noticed my arm turning red.