chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine that was given was past its beyond use date of 31 days after placing into the fridge (it was given on day 32 ). After calling the manufacturer (pfizer), the medical team explained that there was off label data supporting the stability of the vaccine for an additional 15 days after. However, they told me it was still considered a vaccine error and needed to be reported. There are no reported adverse effects from giving the vaccine this way.
Expired Vaccine administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to a patient) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to a patient). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to a patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Spoke with wife who gave information on patient. Pt c/o hurting arm immediately after shot, which is no unusual, but later arm worsened and could not lift over head, Called MD who prescribed Celebrex. Has taken all weekend not any better. To call MD again today.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 17-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    On 05-Nov-2022, the patient received first dose of monovalent vaccine (Batch/Lot number: AR9236B and Dose/volume: 25 micrograms).  Concomitant product use was not provided by the reporter.  The route of administration of suspect Moderna monovalent was reported as Mono and bivalent was reported as BI. No adverse effects were noted.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 17-DEC-2014 the patient was inadvertently vaccinated with expired dose of ZOSTAVAX (dose and frequency not reported) (lot # J011337 and expiry date: 13-DEC-2014). No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Metal taste in mouth immediately then burning theough chest and abdomen on forst day. Could lift arm by second day, extreme fever chills and fatigue monday, hospitalizationon tuesday due to extreme headache and vision loss
Subsequent to receiving vax the pts experienced an injection site abscess. It was reported that the abscess was present in the pts who were vaccinated in the thigh and those vaccinated in the arm. Unspecified medical attention was sought. The abscess varies in size and reportedly can be felt two months post vax. Additional information has been requested.
administered the vaccine she asked the patient if she was 65 older but later realized the patient was 63 with no reported adverse event; Initial information received on 01-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 63 years old female patient whose nurse administered the vaccine of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] she asked the patient if she was 65 older but later realized the patient was 63 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Nov-2023, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number: U8162BA, expiry date: 30-Jun-2024, strength as standard) via intramuscular route in the left deltoid as prophylactic vaccination (product administered to patient of inappropriate age) (Latency: same day)  It was reported "Caller stated that she has already contacted the patient and would like to know the next steps she needs to take. All reps were assisting other callers Case placed in proxy for a call back. Caller stated that if someone calls her back before 4 pm she can be reached at the office number, if someone calls her after 4 pm she can be reached on her cell phone. The Pharmacist reported that when asked the consumer reported that they were 65 years of age; that it was not until after the vaccination and the patients information was placed in the system it flagged as being too young for the FLUZONE Quadrivalent High-Dose; that the consumer was called to report the event and the consumer asked the pharmacy how old is she and they were told they were only 63-years old; that the consumer's doctor was contacted about the event as well; and that the consumer is on oxygen."  Action taken was not applicable.  At time of reporting, the outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt within two weeks of vaccine had and episode of Bell's Palsy affecting left face. Pt has had s/s of Bell's Palsy for three weeks now.
Client stated immediately after injection she experienced spasm pain up and down left arm (inject site), felt arm got weak. Stated it lasted approx 5 mins and Sx's went away. Stated about 11:00 weakness returned; pain returned - stated pain was spasm-like up to shoulder. Currently pain continues. Currently states she is able to move left arm - c/o shoulder hurts with movement. Denies fever, denies redness at inject site. States she has mobility of arm.
Information has been received from a physician concerning a male over 65 years old who on approximately 22-APR-2007 was vaccinated with ZOSTAVAX. On approximately 22-JUL-2007 the patient experienced mild outbreak of shingles. The patient visited the physician's office for an examination. The physician performed a biopsy to ensure that the patient had shingles and not something else. Patient received the vaccination at a local pharmacy. On approximately 29-JUL-2007 the patient recovered. Additional information has been requested.
Arm for the ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm for the ache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm for the ache). At the time of the report, VACCINATION SITE PAIN (Arm for the ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Exactly 7 days, post vax, he was brought to the doctor's because of a fever and he kept sleeping a lot. The doctor said he had an upper respiratory infection. He was dx'd with autism at 3 years old. He started regressing, after developing normally, around 2 years old. He has lost all speech and has a lot of other problems now. He toe walks consistently, his eye contact has decreased significantly, he has stereolyptic hand movements, he plays with toys in an inappropriate manner and has practically lost all interest in foods he once ate.  Per doc 212027, 60 day follow up, patient is now autistic. He is 4.5 years old and still does not talk. He has stereolypic behaviors. Parent believe that these vaccinations have caused their son to become autistic. He spoke at one time state the document, now he does not speak at all. Per follow up Pt has not recovered. Pt is still considered autistic. He has been receiving sensory integration therapy for the past 4 months which is making a big impact on him but it is costing us a fortune every month. We really cannot afford to pay for this therapy but we want our son to one day function normally so we are trying to get finacial assistance in whatever way we can. Thanks to the medical field our son is autistic. Pt was developing normally up until 2 1/2 years old. he received his shots and went backwards almost immediately. It saddens us to see how uncaring the medical field is about this. It's because of them that he is the way that he is.
presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to initially be systemic SEs from the vaccine but found to have re-collapse of the BI on chest CT with probable post obstructive pneumonia. still admitted as of 2/23/2021
This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The pharmacist mentioned vaccine shortage in a call about the appearance of the powder vial. No patient or additional details were provided in the call. It was reported after reviewing call notes.
Vasovagal episode Pt became pale bradycardic and diaphoretic He responded with juice and crackers  Repeat vital signs BP 124/64 P 74 97% on RA
no adverse effects; a patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 06-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S009759, expiration date 27-SEP-2020 (exact dose, injection site and route of administration were not reported) for prophylaxis. The sterile diluent used to reconstitute the vaccine was properly stored. Administered dose of vaccine experienced the temperature excursion of 15 to 46 degrees Fahrenheit (17.6 degrees) for 56 hours and 40 minutes. Administered dose of vaccine experienced previous temperature excursion of 6 to 14 degrees Fahrenheit (6.2 degrees) for 10 minutes. The digital data logger was not involved in recording the temperature excursion details. There was no adverse effects reported.
Red rash 4 cm x 1 1/2 cm on left upper arm. 2nd small nodule palpable.
Some hours after vaccine - early evening - I developed 4-5 loose stools and had loose stools to 2013, when I developed constipation as well. I was told by an examining SS Dr.? - I had colitis. (R) arm upper was severely painful - despite soaks and KEFLEX. To this day site is sensitive w/ bursa sac and site is visible. (Pain on occasion w/ occas. weakness). (Still cramps - lge stools - loose and hard). There is no treatment given me for colitis that ever effective. Dr. did prescribe a pill that left me in a stupor (sedative f/ stomach) and sleepy for days - totally ineffective. (I am uncertain if this party is still in practice). Pain on occasion - w/ sensitivity to this day, w/ visible vaccine site. Ther is no meds for these vaccine injuries that are effective; I have learned to live w/ these non-consensual and irreversible dental implant injuries that left me toothless and w/ a calcified upper plate. I also sustained irreversible allergies from drugs - i.e. VOLTAREN - blood vessel injuries rept'd present mentioned Dr. w/ (R) cheek rosacea and itchy (red) lesion typical of dermatitis on occasions; i.e. gentamycin - severe dry eye possible retine (R) eye tear. (I need RETAINE eye drops immediately upon awakening); metronidazole gave me full blown rosacea and metformin - (very irritating) reopened peptic ulcer (told present Dr. results all of the above meds including XANAX f/ some anxiety and Parkinsons - it caused depression - I am feeling better now). Court (9/28/2004) (small claims) - very ill that day. Case ended - I was ill, w/o court appointed lawyer and no monetary resources SS, A, Snap, Medicare benefits; however, don't you think I should be compensated justly for damage to my occupational and social "loss of quality of life" due to vaccine injury?
pt recvd vax shots condition worsened causing a failure to thrive condition; diarrhea & vomiting became worse; also ran a fever; lossing weight & dehydration;
Rash, fever - Information has been received from a health professional concerning a 14 month old male, with no known drug allergies. who on 26 Feb 2001 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 635125/0400k.  Concomitant vaccines included one dose of varicella virus vaccine live MSD lot 635980/0446k and hib conj-hepatitis b vaccine MSD lot 636992/1174k.  On 09 Mar 2001 the patient developed a red rash, without blisters or lesions, on her abdomen and neck and low grade fever.
fever of 38C; severe fatigue and malaise; severe fatigue and malaise; mild headache; Pain in the injection site began within a few minutes and gradually increased reaching it's maximum around 8 hours after the dose.; Neck pain was also significant; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 05Jan2021 12:00 PM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 09:00 PM (Arm Right) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included asthma and generalized anxiety disorder (GAD). The concomitant drug was reported as Escitalopram. The patient experienced pain in the injection site began within a few minutes (05Jan2021 12:15 PM) and gradually increased reaching it's maximum around 8 hours after the dose. Neck pain was also significant (05Jan2021 12:15 PM). Fatigue, malaise and mild headache started around 10 hours (05Jan2021 22:00) following vaccine administration. Almost 24 hours following administration (06Jan2021 12:00) a fever of 38 C started and persisted for about 6-8 hours. It subsided but severe fatigue and malaise (that prevent me to do daily activities) are still persisting greater than 48 hours following administration. The outcome of severe fatigue and malaise was not recovered. The outcome of Headache, Pain in the injection site, Neck pain, fever of 38 C, was recovering. No treatment received for the adverse event. No COVID prior vaccination and no COVID tested post vaccination.  Information on Lot/batch number has been requested.
Rigors, fever nausea, vomiting. diarrhea Severe muscle spasming/contraction, headache
10/11/2021 - Received first Moderna vaccine at 06:30pm 10/12/2021 - Injection site sore. Fatigue. 10/13/2021 - Injection site extremely sore. Fatigue. Headache. 10/14/2021 - Injection site sore. Headache, fatigue, and fever. 10/15/2021 - Injection site soreness mostly gone. Fatigue also diminishing.  10/16-17/2021 - no indication of adverse event. 10/18/2021 - Noticeable hair shedding.  10/19/2021 - hair shedding, morning headache.  10/20/2021 - hair shedding, morning headache, overall malaise and fatigue but functional.  10/21-26/2021 - the above symptoms continue now with severe dry eye, double vision, blurred, vision, and eye pain.  10/26/2021 - Hair continues to fall out, shedding out in clumps, dry eye is severe and needs treatment, fatigue continues, motivation and mental focus are low.
erythema, ecchymosis, pain & edema @ inject site are reported in a pt receiving vax sx occurred 12 hrs p/vax & resolved w/in 48 hrs of vax;
Legs were burning; Felt very tired; Shingles; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a question about the vaccine. The patient took COVID-19 vaccine and had a reaction. The patient had to take second shot of vaccine this morning (19Feb2021) but wanted to talk to someone if the patient should take it or not. After the patient took the vaccine, the patient was having a really bad headache for 5 days and the legs were burning on an unspecified date. The patient felt very tired and was later diagnosed with shingles on an unspecified date after having COVID-19 vaccine. The patient wanted to ask if he/she should take the second shot of COVID-19 vaccine this morning or not. The patient had an appointment at 9 o'clock this morning to get that shot and wanted to know if he/she should get it or not as the patient had active shingles. The patient recovered from "Headache" on an unspecified date. The patient had not yet recovered from "Shingles". The outcome of the other events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
body-wide hives, chest pain,, shortness of breath, swollen hands and feet, dizziness, upset stomach, vomiting, low grade fever, fatigue, sore throat. The night after vaccine I got hives, a fever, and chills. Took Benadryl and Asprin and slept. When awoke, fever broke but all the other symptoms began and remained for the entire day. Woke up this morning, all symptoms remain aside from chest pain, though the hives are considerably worse.
Arm - Red, Swollen, soreness, hot and Below injection site red rash  Afternoon - my son said it was like his insides were shaking...( jittery feeling)   Evening - Legs rocking back and forth and head moving all over the place  Next day - rocking and jitters stopped - still red hot pain swollen and inflamed injection site  Felt better and mostly back to normal with no pain 4 days later
Chills, joint aches, excessive fluid under arm where shot was administered, swelling and redness at shot site
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 including Paxlovid from 20May2022 to 25May2022 and experiencing sore body and bad taste in mouth.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received her vaccine. Within twenty seconds she started feeling faint, dizzy, clammy. Positive loss of consciousness for ten seconds. Inhaled ammonia and patient regained consciousness. EMS Called. 0750 68/36, HR 36, 100% RA. Ammonia given again. Patient alert and oriented. Water given to patient. EMS arrived. 0752 79/51, HR 51 100% RA. 0756 99/65, HR 61 100% RA. 0803 109/68 HR 63. Pt educated on what to do if this were to happen again while at home and when to call 911. Pt refused to be transferred to hospital. Pt educated on signs of reaction and not eligible for second dose and to contact physician for further follow up if needed. 0810 113/67. HR 64. Patient's husband with patient. Ambulated without difficulty with belongings to car.