chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pediatric dose was given to adults mistakenly; COVID-19 vaccine administered to patients post temperature excursion; Poor quality product administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) 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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter. This case contains information for the 99 of 104 patients described by the reporter.   This case was linked to MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  MOD-2022-669791:Master case
Pt developed one lesion on his forehead.  The next day the pt developed lesions on his arms, legs, and abdomen.  There were approximately 40-50 lesion total with no other signs of illness.
Patient reported swelling of throat at 15 minutes post vaccination.  Patient  denied shortness of breath, difficulty breathing, and no hives were present. No adventitious lung sounds were noted bilaterally.  Patient  vitals signs were normal and stable.  Event lasting approximately 30-40mins.  Patient  was treated per verbal order of provider,  with diphenhydramine 25mg PO, every 15min up to 2 doses if symptoms do not subside. Symptoms subsided and patient was cleared by provider.   Pt was prescribed Loratadine 10mg PO for allergy and Triamcinolone  Acetonide 0.1% cream for external ointment.
Had severe aches/chills that started about 12 hours after the vaccination (which was expected as a potential side effect), but then a heavy menstrual period started about 4 hours after the other symptoms started. It started off very light, but has been heavy since. I have a history of irregular and heavy menstrual cycles, but they have been lighter and regular since getting the Mirena IUD in May. LMP was 10/14/21 through 10/20/21, so this one is a couple weeks early.
When I received my 2nd shot on 02-22-2021, I could feel it moving down my arm.  Within a couple of hours, it had settled in the back and inside of my arm, just above my elbow.  The area was about 5 inches long and about 3 inches wide.  About 7:00 that night, I was getting chills, then a fever and a severe, piercing headache along with body aches.  My temp is normally about 97.3 degrees, but for the next 36 hours or so, it ran between 97.6 and 100.4  degrees.  I began taking Tylenol when it reached 100 degrees.   On 03-01-2021, I ran chills again, with my temp getting up to 99 degrees.  I also got that severe, piercing headache again. It lasted nearly 24 hours.   Since that day, I have had that piercing headache a few times, but it hasn't lasted long.   (NOTE:   I have had very few headaches in my lifetime.  The last one was probably about 15 years ago, when I had the flu.)  Also, about 3 or 4 days after receiving that 2nd shot,  I opened a drawer in my dresser and the pain shot down from the tips of my fingers to my wrist.  By that evening, the pain had  continued down to that spot just above my elbow, where the shot had settled.  My fingers,  hand, wrist and arm hurt very badly for the next 3 days.  The pain did not go past that spot on my arm where the shot had settled.  The next day it didn't hurt as badly and the next day, the pain was gone.    Also, my 89 year old mother had her 2nd shot the same day as I did and had no affects at all, not even a sore arm.  My 72 year old husband also got his 2nd shot that day and only the area where he got the shot was sore.
Couldn't do anything; Sweating like crazy; Light-headedness/ Dizziness; zero energy; Some joint pain; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number and expiration date were not reported), dose 2 via an unspecified route of administration on 20Apr2021 (age at vaccination: 75-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient stated that two weeks later, he began having reactions which included zero energy and couldn't do anything. The patient also stated that after 45 minutes he was done and had to went to bed, having sweating like crazy, dizziness, and light-headedness. The patient stated these had been going on for over a month. The patient also experiencing some joint pain. The patient denied redness or pain at the injection site and didn't have any redness in his arm. The outcome for the events of sweating like crazy, light-headedness/ dizziness was not yet recovered and other events was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Patient came in for her Pfizer booster. Patient was given the Monovalent booster when she was needing the Bivalent booster.
Patient received the vaccine at 9am on 12/24/2020. Later on 12/24 he had a "bad headache" which did not impede him from participating in his planned activities on that day. When he woke on 12/25  the headache had resolved but he began having significant injection site pain that persisted until 12/26 at 6pm when it resolved and again the pain did not impede him from participating in his planned activities on 12/25 or 12/26. at about 6pm when the injection site pain resolved he began experiencing a feeling of "being unwell". He described this as a panic attack with feelings of impending doom, worries that he was having a stroke such that he told his wife that he felt he should go to the ED (he did not go to the ED), feeling shaky but whit no visible evidence of tremor or restlessness, and an out of body experience (specifically depersonalization). He had no physical signs of a stroke or TIA. He reports that this lasted one hour then he fell asleep at 7p on 12/26 and slept until 8am on 12/27. When he woke on 12/27 he was back to baseline without any persistent feelings of being unwell or panic. He does not have a history of panic attacks and he does not use any mood altering substances. He is not a somatically focused individual so this experience was atypical for him.
pt recv vax 31AUG98 & had small emesis x 1 on way home;overnoc noticed onset of nonpruritic papular rash on bilateral forearms & abd;
Patient is a 29-year-old woman who works here at Hospital in the ER area.  She has no significant past medical history except for kidney stones, previous episode of gallstone pancreatitis who apparently was in her usual state of health until this past Friday 04/24/15 while working in the ER she accidentally stuck her left thumb with a needle that she just used to give an IM injection to a patient in the ER.  She said immediately made the needle stick bleed and wash in with soap and water. The source was tested and was negative for HIV and as per protocol she received Tdap shot on her left deltoid area; 24 hours later she started to notice increasing pain and swelling on that area which also was warm she said.  She started to have fever and chills with temperature up to 102 and by the next Monday she went to facility to be checked.  It was thought that she has cellulitis of the left upper arm related to the previous Tdap shot and she was started on Levaquin 750 mg daily.  She was taking Tylenol and Motrin for pain and fevers.  However, by the next day at night she came back to the ER complaining of persistent subjective fever and chills and increasing swelling of that area.  She had a dose of Teflaro 600 mg IV, she got 1 L of normal saline.  Blood cultures were taken and she was put on minocycline 100 mg twice a day plus Percocet as needed (Levaquin was discontinued).  Yesterday she noted that her left arm cellulitis was getting better but by the nighttime it was noted again the swelling was worse, more red, more painful and she was advised to take an extra dose of minocycline (she took 300 mg of minocycline on 04/29/15).  She went this morning to follow up with facility and because of persistent symptoms, feeling nauseous, dizzy (which may be related to the higher dose of minocycline) plus persistent cellulitis (although she said today it looks somewhat better) a decision was made to send her to the ER for further evaluation.  She had already soft tissue ultrasound of the left arm which showed no evidence of abscess or fluid collection.  She received in the Emergency Room 1 g of vancomycin plus Toradol 30 mg IV.
Visible calf muscle cramping, muscle aches, stomache pain, headache onset within 3-4 hours of administration of quad flu vaccine to previously healthy 15 year old male. Treated with gatorade, ibuprofen and rest. Symptoms worsened over 24 hours and have begun to improve, but are not fully resolved 3 days out.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unspecified date in 2014, unspecified number of patients received unspecified doses of PEDVAX, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, PNEUMOVAX and ROTATEQ were improperly stored (event captured in MARRS# 1405USA012894, 1406USA00955, 1406USA000956 and 1406USA000957 respectively). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Chills, body aches, headaches, fever, fatigue, pain in my left arm
After receiving Johnson & Johnson vaccine patient complained of itching to her face and arms. No symptoms of distress. Vital signs within normal limits. Dr called & informed. Patient given Benadryl 50mg and Pepsid 40mg. Layed on the cot. At 11:50AM patient said her itching went away. Dr came and checked on the patient. Patient sent home.
This spontaneous report as received from a pharmacist refers to an approximately 62 years old female patient. Pharmacist reported that on an unknown date, his wife (patient) was vaccinated with ZOSTAVAX, dose (unknown), frequency (unknown), route of administration (unknown). No concomitants were reported. On an unknown date (also reported as the next day), she developed a rash from the site of injection to her wrist. VZV packet not sent since patient recovered on an unspecified date. Causality assessment was not provided. Pharmacist declined to answer any additional questions about himself or his wife. No further information was provided. This report is linked to 1402USA006792, 1402USA007824 and 1402USA007825 by the same reporter link. Additional information has been requested.
During the same week of receiving the Johnson & Johnson COVID-19 vaccine, I was diagnosed by two doctors with "jock itch", a very severe rash on my inner thighs and genitals, which lasted for over a month! Never in my life have I ever had a rash. This is not a coincidence.
The patient was inadvertently given the high dose flu vaccine instead of the regular age appropriate vaccine. The error was discovered after the patient had left and attempts were made to notify the patient and check in to see how she was doing, without success.
Left knee became sore, stiff, inflammed and lasted for over a week. Issue was enough to not be able to actually walk on the left leg for about 5 days
Developed fever 104.7 about 24 hours after FluMist vaccine. Also c/o lethargy and congestion, headache, and eye hurting. Seen in office 9/8/06 T 98.1. Symptoms resolved 24 hours later.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-month-old female patient who received HAV (Havrix) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   On 21st February 2023, the patient received Havrix. On 21st February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 22-Feb-2023 The medical assistant stated that the two patients were given expired doses of Havrix on day before reporting.  The reporter consented to follow up. There were no further details provided.  This case had been linked with US2023029952 same reporter. Additional supportive information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2023029952:Same reporter
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 23-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Pfizer Vaccine - caused blood pressure to spike to 180/100 and it is still high. I have no history of high blood pressure. I visited the ER and my blood pressure went down to 154/90. my normal blood pressure range is 120/70 to 120/175.
Myalgia, Fever, CHILLS, INSOMNIA 2ND TO PAIN IN RIGHT DELTOID(INJECITON SITE)
Child had bumps on legs on Sunday, 2/5/2000, and broke out with hives on 2/6/2000, on legs and hips. Began vomiting at 01:00 on 2/8/2000, and 2 x more this morning. No temperature.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 4 (booster), single (Lot number: GJ6739), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid for COVID 19 treatment from 13Jan2023 to 17Jan2023. Patient had no known allergies.
passed out for 20-30 min 2 days after receiving covid vaccine; headache; fatigue; This is a spontaneous report from a contactable nurse. A 15-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0180), via an intramuscular route administration on 18Jun2021 (at the age of 15years) in right arm as DOSE 1, SINGLE for covid-19 immunization. Vaccine was administered at pharmacy or drug store. No medical history was reported. Patient had no known allergies. Concomitant medications included celecoxib (CELEXA) used for an unspecified indication. Patient was not diagnosed with COVID-19 prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. On 20Jun2021, the patient passed out for 20-30 min 2 days after receiving COVID vaccine and had headache and fatigue. Patient visited Doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. The patient had not taken any treatment for reported events. The outcome of the events was recovering.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely 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.
An expired dose that had been left in the fridge the previous evening was administered the a patient the following morning
25JUL91 pt started crying as soon as parent & pt returned from receiving immun & continued inconsolable screaming for 3 hrs; Mom put pt into car to take to MD but pt fell asleep & stopped crying;
Information has been received from a nurse practitioner concerning a female patient who on 26-MAR-2007 was vaccinated with a dose of Gardasil. On 26-MAR-2007 the patient experienced generalized body aches, which made her go to bed to sleep it off. Medical attention was sought. The felt better the next day. No product quality complaint was involved. Additional information has been requested.
06/09/2021, neuro consultation neuropathy worsen was not able to sleep hand and arms was numb and hands numb and motor coordination. Initial evaluation she has done scan of MRI head and neck nerve conduction study coming up and lab work and that is what is going on. 08/001/2021 Prescribed  B12 shots 4 weeks and another 4 weeks.
Acute disseminated encephalomyelitis; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE DISSEMINATED ENCEPHALOMYELITIS (Acute disseminated encephalomyelitis) in an 81-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   LITERATURE REFERENCE:      No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE DISSEMINATED ENCEPHALOMYELITIS (Acute disseminated encephalomyelitis) (seriousness criteria death and medically significant). The reported cause of death was Acute disseminated encephalomyelitis. It is unknown if an autopsy was performed.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered ACUTE DISSEMINATED ENCEPHALOMYELITIS (Acute disseminated encephalomyelitis) to be related.    No concomitant and treatment medications were reported.  Company Comment This Literature Non study case report, concerns a 81-year-old male patient with no medical history reported, who experienced the unexpected serious fatal (Medically significant, Death) event of Acute Disseminated Encephalomyelitis unknown days after the first dose of mRNA-1273 vaccine administration. The event had a fatal outcome. The reported cause of death was Acute disseminated encephalomyelitis. It is unknown if an autopsy was performed. Very limited information was available in the report. No details of symptoms, clinical course, risk factors, labs, diagnostic procedures and treatment details were provided. The reporter considered the event to be related to mRNA-1273 vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per regulatory authority's report.   This case was linked to MOD-2022-537972, MOD-2022-537973 (Patient Link).; Sender's Comments: This Literature Non study case report, concerns a 81-year-old male patient with no medical history reported, who experienced the unexpected serious fatal (Medically significant, Death) event of Acute Disseminated Encephalomyelitis unknown days after the first dose of mRNA-1273 vaccine administration. The event had a fatal outcome. The reported cause of death was Acute disseminated encephalomyelitis. It is unknown if an autopsy was performed. Very limited information was available in the report. No details of symptoms, clinical course, risk factors, labs, diagnostic procedures and treatment details were provided. The reporter considered the event to be related to mRNA-1273 vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per regulatory authority's report.; Reported Cause(s) of Death: Acute disseminated encephalomyelitis