chrisvoncsefalvay/vaers-outcomes huggingface dataset:
606 doses were given after expiration date; Vaccine is placed in refrigerator 29 Oct 2021, expired product date on 13 Oct 2021, administration date on 02 Nov 2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator 29 Oct 2021, expired product date on 13 Oct 2021, administration date on 02 Nov 2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator 29 Oct 2021, expired product date on 13 Oct 2021, administration date on 02 Nov 2021). On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator 29 Oct 2021, expired product date on 13 Oct 2021, administration date on 02 Nov 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. On 29-OCT- 2021, vial was stored in the refrigerator. No temperature excursions was noted. No adverse events were noted. No treatment medication was provided.
With 4 hours stated arm was the size of a football.  Had pain, redness, warmth.  Had no fever.  Felt weak.  < 24 hours after shot the arm was still 4.5 cm larger in circumference.
On Friday, the patient showed symptoms of Covid. (name) felt exposure from a student; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. This consumer reported similar events for two patients. This is 1st of two reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The concomitant medications were not reported. The patient was vaccinated with Pfizer Covid 19 vaccine on Tuesday 26Jan2021 and had no reaction. On Friday 29Jan2021, the patient showed symptoms of Covid. "(name)" felt exposure from a student. On Saturday night 30Jan2021, patient was administered with immunotherapy due to their comorbid medical conditions. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number could not be requested. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112464 same reporter, event/different patient
No adverse reaction, reporting that child got vaccine when not of the approved age of 18.  Patient only 17 at the time of vaccination
Red circular rash, warm to touch, and patient reported pain and itching. I recommended a visit to urgent care or providers office to be evaluated. In the meantime, I told pt to use cold compress, benadryl, and tylenol.
Pt received expired vaccine on 11/08/22. No adverse reactions reported as of 11/11/22.
vaccine stored in the refrigerator past 30 days; Vaccinated with the Moderna Vaccine after the expiration of 3/25/22; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with the Moderna Vaccine after the expiration of 3/25/22) and PRODUCT STORAGE ERROR (vaccine stored in the refrigerator past 30 days) in a 49-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included NORETHISTERONE (CAMILA), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), GLIPIZIDE, METFORMIN and TERBINAFINE for an unknown indication.    On 20-Apr-2022 at 8:43 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with the Moderna Vaccine after the expiration of 3/25/22). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine stored in the refrigerator past 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated with the Moderna Vaccine after the expiration of 3/25/22) and PRODUCT STORAGE ERROR (vaccine stored in the refrigerator past 30 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported  The vial was initially stored in the refrigerator on 25-Feb-2022 The vial did not undergo any temperature excursions. Patient did not test positive for COVID within last month. It was reported that patient had no known drug allergies (NKDA). It was reported that HCP confirmed that the patients were not experienced any side effects yet.   This case was linked to MOD-2022-545267 (Patient Link).
severe fatigue; muscle and joint ache;, severe narrowing of arteries in left leg,"claudication";  hydrocele, left testicle. These have continued ,and worsened, since the 2nd 'jab.'
Mild swelling, redness at injection site. Not warm to touch. Full ROM of arm. Reaction typical of Meningitis vaccine
Pt experienced red, swollen, tenderness at injection site. Pt also reported ache at site that caused her difficulty in sleeping and nausea but no vomiting.
but the patient did received an entire vial of the vaccine instead of one dose; This is a spontaneous report from a contactable nurse.  A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 16Sep2021 a t the age of 67-years-old as dose 1, single for covid-19 immunisation.  Medical history included ongoing end stage renal disease, ongoing heart failure. There were no concomitant medications. The patient did received an entire vial of the vaccine instead of one dose on 16Sep2021. It was states that the patient remains in care at the long term care facility and is being monitored. The reporter wants to know what they need to do with this patient, anything to watch out for. The second dose of the vaccine should still be given as per the recommended schedule.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events  and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Although I thought the left arm (Td vaccine) might get sore, by 10:30 PM, the right upper arm was getting very sore,; by 11:30 (when I went to bed), I was shaking with sever chills, which last for next 2+ hours.  Got little sleep all night. My arm was so tender (& slightly swollen) I couldn't lay on it. No fever, but the next day I still felt groggy, with a headache & weak all day, napping for hours. Only today do I feel much better (although arm is still tender).
Sudden onset diffuse rash all over body with in 5 minutes, eyes swelling, 911 called. Benadryl 25mg IM RUQ given at 11am rash cleared somewhat and send to ER via ambulance.
Suspected vaccination failure; shingles; Broke out; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Polio shot (received in childhood.).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and skin breakout. On an unknown date, the outcome of the vaccination failure, shingles and skin breakout were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and skin breakout to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  After receiving dose of Shingrix, patient experienced shingles (broke out). The caller also mentioned that she already asked her doctor and hospital but does not have definite answer for her. This case was considered as suspected vaccination failure, as information about shingrix dose number, laboratory test confirmation for shingles infection and time to event onset was unknown.
pt recv vax 10JUN97 & 13JUN97 pt devel 10 lesions;
Patient reported experiencing LEFT lower back pain that he described as stiffness ~15-18min following vaccination. Evaluated by me and during that time reported pain/stiffness had resolved for a total duration of ~15-20min without any treatment.
p/vax pt exp generalized aching; myalgia type of symptoms; 10 days later presented w/dizziness; nausea; vomiting; diarrhea; no treatment given;
16 y/o female with NO PMH and no h/o similar prior experiences/syncope c/o "feeling tired" ~3 min after receiving the 1st dose of pfizer vaccine. Pt LOC, "gently" falling onto the floor, landing on her face ~5 min after receiving the vaccine. Pt reported feeling tired before LOC, not associated with any other symptoms (dizziness, changes in vision/hearing). LOC lasted ~10 seconds, pt immediately returned to baseline. She was sat up with the help of her mother and nurse and the clinical lead was notified. Pt was laid down on a cot, VS were taken, ice was applied to her pressure points. Pt reported complete resolution of symptoms within ~5 min. Pt was progressively moved from lying down to sitting to standing. Pt denies eating or drinking anything today and was given fluids and snacks.  Pt was monitored for a total duration of 45 min. Pt was driven home by parents. Pt was advised to eat and hydrate today and for the next dose. Pt and parents were advised to call PCP / 911 if symptoms return/persist/worsen or if pt develops concussive symptoms. Pt was instructed to inform the nurse that she fainted ater 1st dose and to prophylactically lay down prior to receiving prior to second dose vaccination.
About 15 minutes after immunization, pt had a warm sensation rush over her. Had to stop reading, mild light headed, increased heart rate. Remained at pharmacy for about 50 minutes. Had some water, walked around pharmacy without incident. Pt felt OK and left. Pt went home to eat, noticed her feet appeared blotchy and previous symptoms returned. Contacted MD. Pt advised to go to ER. ER gave BENADRYL IV. Listed as acute allergic reaction. Oral antihistamines. As of 10/13/14, pt feeling much better than last week, but still tired/cold symptoms/scratchy throat/pain and itchy on left hip/buttock.
Very painful, stiffness of arm, took Tylenol extra strength to control severe pain. Reported back to Doctor.  Saw 2 doctors - recommended caution on taking extra strength explained in detail why a lower dosage is more favorable.  Advise to return or go to ER is condition worsen.  Advised it may be at least two weeks before arm return to normal.
Heavy bruising and moderate soreness at injection site 2 hours after vaccination. One bout of Diarrhea 3 hours after vaccination. Chills started 11 hours after vaccination and continued for 8 hours. Treated with 2 Bayer aspirin every 4 hours. Full body aches (Included head, eyes, back, arms, legs, and general all over body muscle ache) started 11 hours after vaccination and continued for 19 hours. Treated with heat and massage pad, and 2 Advil every 4 hours, but discomfort was not relieved. Occasional: irregular heartbeats. Constant: limbs felt strangely heavy, quickly tired on ordinary short walks, felt out of breath, weak, no energy. Ongoing 2-14 days after vaccination. No treatment received.
Case number PHEH2014US020245, is an initial spontaneous report from a medical assistant received on 06 Oct 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medication were not provided. She was vaccinated with an intramuscular dose of expired MENVEO (batch number: A13017) in error on 02 Oct 2014. No adverse reactions have occurred following this medication error (expired vaccine used).
After receiving my first vaccine my Ulcerative Colitis flared up after being in remission for several years.   I went to Urgent department several times, received  steroids and other medication. The day after my second shot, I woke up with excruciating pain in my left shoulder(Felt like I had a stroke), hand and wrist.  As time went on I also had pain across my shoulder, sternum(heart area), slight trouble breathing, neck pain, and eventually excruciating back pain.  I am unable to do many day to day activities and have extreme difficulty with other to include getting dressed, getting in and out of bed, and other self care, household activities, and work duties.  I have taken lots of medication to includes 3-4 rounds of steriods(with no advancement).  My hair is falling and other side affects have happened.  My doctor, said my problems are as a result of vaccination administration and the vaccine itself.
Tingling on face, arms, tongue, hands, lips, numbness as well,  very high blood pressure.
The product was refrigerated on 29OCT2021 beyond expiration date 13OCT2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The product was refrigerated on 29OCT2021 beyond expiration date 13OCT2021) and EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 29OCT2021 beyond expiration date 13OCT2021). At the time of the report, PRODUCT STORAGE ERROR (The product was refrigerated on 29OCT2021 beyond expiration date 13OCT2021) and EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. No adverse events were reported. No temperature excursion was reported.
My infant son whom I am nursing was irritable on the evening of my second dose.; My infant son whom I am nursing was irritable on the evening of my second dose.; This is a spontaneous report from a contactable Pharmacist. This contactable Pharmacist reported for her son that, she received the second dose of COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection, lot# and expiration date not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. The patients past medical history were not reported. Concomitant medication was not reported. On an unknown date, the reporter (mother) experienced headache, fatigue and chills. The reporter also stated that her infant son whom she was nursing was irritable on the evening of her second dose. The clinical outcome for the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021445156 mother
strong reaction to the full dose booster; Full dose booster; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (strong reaction to the full dose booster) and ACCIDENTAL OVERDOSE (Full dose booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced VACCINATION COMPLICATION (strong reaction to the full dose booster) and ACCIDENTAL OVERDOSE (Full dose booster). At the time of the report, VACCINATION COMPLICATION (strong reaction to the full dose booster) outcome was unknown and ACCIDENTAL OVERDOSE (Full dose booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Known allergies and other medical history were none. No other medication in 2 weeks. Paxloid started on 16Jan2023 and stopped on 20Jan2023 for treatment of COVID-19 The information on the batch/lot number for [BNT162B2 NOS], has been requested and will be submitted if and when received.
This case was reported by a other health professional via call center representative and described the occurrence of adverse event in a patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number GD47F, expiry date unknown) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The webform was received which contained a potential adverse event. The healthcare professional reported verbatim, he works with an allergist who asked him to contact to see if you have had any reports of adverse reactions to the FLULAVAL QUADRIVALENT vaccine.
Information has been received on 07/09/2001 from an attorney concerning a male pt. Medical history was not provided. The pt received 3 polio vaccines taken orally between 1959 and 1960. The pt since has developed pleural mesothelioma. This event was considered serious due to the development of cancer.
I was vaccinated with my first Moderna shot at 3:30 pm on 4/10. I had mild to moderate nausea immediately following injection that lasted for about an hour. Approximately one hour after injection, I began to experience abdominal cramping that started out mild but escalated to severe over the course of a couple of hours. The cramps continued until about 10:00 pm that day. Exactly one week later on 4/17, the injection site became red, swollen and itchy. That same day (still 4/17), I experienced abdominal cramps again that started at approximately 5:30 pm and lasted until about 10:00 pm. The cramps were not as severe as the previous week but were acute for about an hour (between 7 and 8 pm). The following day (4/18), the injection site was extremely red, swollen, hot, itchy and painful - it felt kind of like a spider bite. The swelling has since gone down some but it still present as of today (4/20).
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to allergy clinic for follow-up four months after immunization. Within five minutes of immunization patient reports diarrhea and throat itching. Within ten minutes reports injection site feeling hot, hives, rash, and itching all over body then developed tongue and lip swelling, coughing, and post nasal drip. Patient went to the emergency department, given epinephrine, famotidine, methylprednisolone, and diphenhydramine, monitored for a few hours, and discharged to home. Patient has not experienced any similar symptoms since immunization.
her daughter got infected, with Covid, in between her shots.; her daughter got infected, with Covid, in between her shots.; This is a spontaneous report from a contactable nurse (patient's mother). A 15-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date in 2021 (at the age of 15-years-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an 16Jun2021, after the vaccination, the patient experienced covid-19. Caller states her daughter is not having any other symptoms. Caller states may be her daughter got infected, with Covid, in between her shots. Caller states though, that she thought it was a coincidence, that this effect happened about an hour, after her daughter, got her vaccine. On an unspecified date, the patient underwent lab test which included covid 19 test: unknown. The clinical outcome of the her daughter got infected, with Covid, in between her shots were unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on known drug safety profile and the temporal relationship, there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.
Diarrhea, chest pain, dizziness, headaches, and un controlled blood pressure
I woke up the morning after the second injection with numbness and muscle weakness in the back of my lower right leg and the back of my upper right arm.  I could not feel the back of my lower right leg or the back of my upper right arm.  Over the course of the next three days, I could not walk a straight line and was veering to the right.  I also developed acute Tinnitus in both ears, but much worse in the left ear.  I could not sleep or make out what people were saying to me.  My blood pressure also went crazy resulting in me being placed on blood pressure medication, which I am still taking.  Over the next 5 weeks, the numbness and weakness progressed to the same areas on my left side, with severe numbness on the bottom of my right foot.  I could barely walk and could not even climb 3 stairs.  After two rounds of steroids and 4 months later, I still have moderate numbness and weakness on both sides. The numbness is in the lower legs and upper arms.  The weakness  extends down both arms to my hands and on one side to the bottom of my right foot.  The Tinnitus is debilitating.  I have it in both ears, but it is still worse in my left ear.  Although it doesn't  feel like the noise is coming from my ears at all, but rather my brain.  The sound is a high pitch electrical frequency sound.  My brain feels like it was electrocuted.  From the onset of my symptoms, it has felt like a neurological reaction, as if someone turned up my nervous system several notches.
Syncope, vasovagal episode post vaccination.  BP 96/66 HR 67, 98% RA.  Patient released when felt better and VSS.