chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Off label dosing (vaccine given to underage patient); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Off label dosing (vaccine given to underage patient)) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Off label dosing (vaccine given to underage patient)). At the time of the report, OFF LABEL USE (Off label dosing (vaccine given to underage patient)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drugs were reported.  No Treatment medications were reported.
From initial information received on 10/06/03, from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a female patient (age and date of birth not reported) received Fluzone SV '2003-'2004 USP, Lot number U1260AA, administered intra-muscularly (site of administration not reported) on 10/03/03. One day later, the patient developed redness, edema, and itching at the injection site, as well as fever, aching, joint pain and joint swelling. The patient's recovery status was not reported. The reporter of this case is the same reporter of cases 200302253, 200302255, 200302257 and 200302258.
sick for 3 days; This is a spontaneous report from a contactable consumer. This consumer reported similar event for two patients. This is the second of two reports. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date 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 reporter stated that the doctor himself was sick for 3 days on an unspecified date. The doctor looked like he was completely recovered, the doctor made it sound like it was a while back. Outcome of the event was reported as unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046013 same reporter/ product, different patient / event
This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 04-DEC-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # K026385, expiration date 15-DEC-2016 (dose and route of administration were not provided). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Developed low grade fever, of 99.5 that still persists; Sore arm, nothing major; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm, nothing major) and PYREXIA (Developed low grade fever, of 99.5 that still persists) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-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 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm, nothing major). On 01-Mar-2021, the patient experienced PYREXIA (Developed low grade fever, of 99.5 that still persists). At the time of the report, PAIN IN EXTREMITY (Sore arm, nothing major) outcome was unknown and PYREXIA (Developed low grade fever, of 99.5 that still persists) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 99.5 (High) Fever.         No relevant concomitant medications were reported.   No treatment information was provided.
pt recvd vax on 21JUL93 w/no previous reactions; 23JUL pt had inc fussy; 24JUL had ax temp of 103 which dec w/APAP; 25JUL inc temp; pt became irritable, crying episodes lasting 40 mins @ times did this 4x; also rash pt taken to MD:
No symptoms with first vaccine. Extremely mild nausea with the second, however also a stomach ache & cramping that has persisted 5 days after second vaccine.
severe pain in my shot shoulder,cannot use it..  my back and groin area was so painfull I couldnt even walk. I WENT TO 4 DIFFERENT doctors and they all had no idea or knew what to tell me . they could only tell me its aging, Bull ship!
2/14/2022-Presents to weakness and SOB. Covid + test. Recently treated for bronchitis Jan 2022 with amox.  2L NC 95% sat. Afebrile. CXR: Mod right pleural effusion. Hgb 7.1 dropped to 6.5 1 unit PRBC. Admit acute decompensated HF with preserved EF in setting of severe aortic stenosis Covid 19 pneumonia.  2/15/2022- Remdesivir, Decadron and azithromycin started. Ferritin 12.5 iron supplements started. Troponinemia (downtrending) s/t demand ischemia  Trop:0.053,0.059 and 0.069. 2/17/2022-AKI worsening, BUN was 71 and 1.4 (baseline creatnine 0.7-1) remdesivir d/c low creatnine clearance.  2/19/2022-AKI worsening with diuresis. Lasix held. Placed on Bipap 16/6 45%. CXR:Worsening bilateral infiltrates   2/19/2022-  ABG: 7.154/85.6/73/30.1/95. Need for TAVR held due to acuity.  2/21/2022-Started baricitinib, aztreonam and Vanco continue decadron. 2/21/2022-Sating WDL on Bipap 45%. expiratory wheeze and rhonci noted through night r lung. 2/22/2022-Continues on Bipap, BP range -110/60-118/71  sattng 95% HR range 110-150 a fib. WBC-21.3. TPN started. DNR/DNI on file. Creatnine of 1.3, BUN 105 EGFR 41. Platelets decrease to 50 from 60. ABG: 7.34/60.8/88/33/98 on bipap 2/24/2022- Amiodarone dtt running @ 16.67 ml~/hr HR 60-80's. Continues in Bipap tolerates short period of HFNC. Palliative following family wishes to continue aggressive care.  3/1/2022- WBC-9.4. Platelets 100. BUN 82. Went into sinus brady due to worsening hypoxia  leading to asystole. DNR/DNI. Time of death 1941.
Lot was recalled by Pfizer over stability issues and Pfizer said it was only stable until 9/30/22 even though the expiration date was well after. This vaccine was given on 10/9/2022 and that is the reason for this report
Report A0384624A describes the occurrence of mercury poisoning in 24 month old male who received hepatitis B vaccine recombinant (Engerix B). This report was received as a result of litigation proceedings and has not been confirmed by a physician or other healthcare professional. The subject was born a perfectly normal, healthy boy whose Apgar scores at birth were well within normal range. Developmentally, neurologically and socially, the subject achieved every developmental milestone anticipated of all normally developing children until the age of 24 months. The subject received injections of Engerix B on 2/12/98 (lot ENG2513A2), 3/9/98 (lot ENG2588A2), and 7/7/98 (lot ENG2587A2). The subject also received diphtheria and tetanus toxoids and pertussis and pertussis vaccine and combination diphtheria and tetanus toxoids and pertussis vaccine absorbed/haemophilus influenzae type b conjugate vaccine. The attorney alleged that at approximately 24 months of age, the subject was neurologically devastated by the accumulation of Mercury in his body, having been exposed via IM vaccinations, and suddnely regressed developmentally, losing milestones of neurological development previous achieved, specifically including but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior and the loss of language skills, motor skills, and affect. Information received on 10/22/02 did not specify the outcome of these events. This report of mercury poisoning and developmental regression is considered medically serious.
Chills started 8 hours after vaccination. Lasted 1 day. Muscle aches started 8 hours after vaccination. Lasted 2 days. Weakness started 8 hours after vaccination. Lasted 2 days. Nausea started 14 hours after vaccination. Lasted 20 minutes. Fever started 10  hours after vaccination. Lasted several hours.
Both ear lobes developed varicella-like rash approximately five days after second varicella vaccination administered.  Varicella symptoms lasted for five days. Photographs available for attachment.
Low grade temp x 2 days. 102 or less. Very irritable & clingy. Didn't sleep restfully. Cried alot like he was in pain. Didn't act like himself, spacey & out of it.
05/07/2021 phone message.  16:41: Spoke with pts mother who states pt did not have a restful night last night and today just wants to sleep and not taking formula well. She states he ate a couple ounces this morning (he normally has a 5oz bottle every 3-4 hours) - he has only had a couple ounces today and wants to sleep. She denies any fever, runny nose, cough. She states he seems to be spitting up what she is feeding him. Patient Admitted on 05/08/2021 for intussusception
This spontaneous report has been received from a Registered Nurse refers to an infant patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-SEP-2017, the patient received an improperly stored dose of RECOMBIVAX HB (lot # M031574, expiration date: 11-NOV-2018; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion occurred at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. Sender's Comments: US-009507513-1710USA004063.
Information has been received from a physician concerning a 15 year old female patient who on 22-APR-2008 was vaccinated with the first dose of GARDASIL (lot# not reported). On 08-MAY-2008 the patient developed a seizure. The patient then received the second dose of GARDASIL (lot# not reported) on 25-JUN-2008 and then was given the third dose of GARDASIL (lot# not reported) on 13-OCT-2009. The physician reported that the patient did not have any experiences after receiving the other doses, but the patient believed they had a seizure because of GARDASIL. At the time of this report, the patient's outcome was unknown. Additional information has been received from the physician concerning the patient who on 22-APR-2008 was vaccinated with first dose of GARDASIL (lot# 660387/1967U). The patient then received the second dose of GARDASIL (lot# 660553/0070X) on 25-JUN-2008 and then was given the third dose of GARDASIL (lot# 660612/0229X) on 13-OCT-2009. The physician reported that the patient did not receive any concomitant vaccinations when she received the GARDASIL vaccinations. The patient's grandmother called the physician on 08-APR-2010 and reported that the patient was experiencing a seizure about once a month. The patient was seeing a neurologist. The physician did not consider the seizures to be disabling or life-threatening and the patient was not hospitalized. Upon internal review, seizure was considered to be an important medical event. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 05-JAN-2016 the patient was vaccinated with improperly stored GARDASIL 9 (lot # L017407, exp date: 15-AUG-2017). The product was stored in temperature of 50.2 F degrees for 1 hour and 10 minutes. The temperature excursion was recorded by a data logger. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided No treatment information provided   Reporter did not allow further contact
Redness on skin, with some itchiness.  The areas of skin are not stationary, in that they became or lost their redness depending on the time of day.  Beginning on Sunday 12/19, the condition was ongoing as of the report.  The itchiness seems to improve temporarily with antihistamines (e.g. Zyrtec, Claritin, Benadryl).  As of today, I was prescribed Prednisone.  This is an unusual  reaction for me.  Although the doctors were not able to identify the cause, I thought I'd report it just in case.
syncope  vomitting low blood pressure pain on fingers (both hands) even after 3 days tiredness
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant information was reported. It was reported that, approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information was reported. This case contains information for the 54th out of 77 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
10/15/2003 @ 16:40: Patient in clinic crying continuosly with increased swelling, tenderness and redness to left thigh.  MD ordered Motrin 2 cc per mouth and apply ice pack to left thigh- done.
Rash x 2 days. Location abdomen, back, face no fever per mom. Per mother states child received immunizations on Thursday 10-22-09 and broke out in rash Friday. See PA 10-29-09. P: RTC Monday 10-26-09 for F/U with MD.
Patient given HPV on 7/31/2012, returned to the office on 8/6/2012 with hives. Treated for the hives.
Rash/hives on arms, trunk, legs and face Self treating with antihistamines as of 4/11/21
Low grade fever for several days and headache that lasted about two weeks. Patient took Tylenol that helped mildly. Doc prescribed low dose steroid pack that helped on 6/24/21
Immediate allergic reaction consisting of lots of sneezing, runny nose and mucus, tight coughing, complaining of stomach discomfort and crying
40 minutes after receiving required H1N1, employee c/o itching and little shortness of breath.
This spontaneous report as received from a other medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 injection (lot# reported as L034335, expiration date 18-MAY-2017) for prophylaxis (strength, dose and route were unknown). On unknown dates, the following temperature excursions were registered: between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 20 minutes and between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 10 minutes. There were no previous temperature excursions. Digital Data Logger was involved. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA008578: US-009507513-1701USA008577: US-009507513-1701USA008576: US-009507513-1701USA008575: US-009507513-1701USA002579.
I received the J&J vaccine after 1 PM, on Tuesday, May 4th. Around 9PM that night (last night) I started experiencing chills and a dull, aching pain focused in my testicles, groin and lower abdomen.
After 10 days of receive vaccination appeared redness in the injection site about 2 inches in diameter
suffering from recurrent zoster reactivation / SUSPECTED VACCINATION FAILURE / breakthrough shingles episodes; suffering from recurrent zoster reactivation since; It has been a living torment.; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix and an unknown time after starting famciclovir, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and feeling bad. The patient was treated with famciclovir. On an unknown date, the outcome of the vaccination failure, herpes zoster and feeling bad were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and feeling bad to be related to Shingrix.  Additional details were provided as follows: The reporter (patient) was a family physician, reported via a webform. The age at vaccination was not reported. The patient received Shingrix vaccine over 2 years ago and since suffering from recurrent zoster reactivation. The patient stated that he was not interested in a lawsuit. The patient stated that he was just hoping there was a scientist there that could potentially stop what was happening. The patient wanted to know that had the adjuvant caused an inflammatory response that had led to this and was there some sort of treatment to reverse this.   The patient stated that it had been a living torment and he hope someone could help. The patient seen specialists and was on high doses of famciclovir on an ongoing basis just to keep it at bay, with breakthrough shingles episodes despite medication. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. This case had been linked with US2020249597 (wife case), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020249597:same reporter (wife case)
Case number PHEH2014US025374, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 73 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the right deltoid on 29 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
14Sep92 presented /w cough-dx cold,19Sep92 presented /w sxs for 8 days of coughing/w barking cough-dx bronchitis.20Sep92 presented @ ER /w inc coughing /w periods of cyanosis.Cult-pos Bordetella Pertussis.
Patient presented with four days of intermittent chest pain. Pain described as midline that worsens with eating, drinking, or lying down. Seen twice at hospital, found to have leukocytosis on 6/16/2021 and elevated troponins 6/17/2021. Transferred to hospital for ongoing monitoring.
1/2 hr. after shot administration developed severe pain going from shoulder of shot administered in through neck and into head. Neck pain continued while terrible headache started. Both lasted approx 2 hrs. then subsided. I feared a stroke.
I received my vaccine on a Tuesday morning, and five days later on Sunday morning I woke up with very swollen checks--my head looked like a pumpkin.  When my girlfriend saw me in the afternoon, she said, "I'm taking you to the emergency room!"  But, I told her that I had no fever and no other symptoms, so we should wait.  The swelling was bad enough that my jaws ached and my cheeks felt like they were going to burst, but if I didn't chew any food, the swelling would subside slightly, and my jaws would stop aching.   I read online that people with botox who get the vaccine can have facial swelling and a 24 hour course of benadryl will knock down the swelling.  I have never had botox injections, but I took some benadryl for two days, which made me feel really tired.  I ate only soup and yogurt, so that I didn't have to chew any food.   I don't know if the benadryl had any effect, but over about 5 days, the swelling subsided, then I could eat again without causing my jaws to swell up.
Patient reports left arm nerve pain from shoulder to index finger since shot given 10/2/12 (5 weeks) sx: tingling & numbness down (L) arm to index finger slight pain at time of vaccination.
Achalasia.    Developed symptoms mistaken for GERD/acid reflux over twelve months after the vaccine was administered in Sept 2021.   First noticed in January 2022 and the frequency / intensity increased over 2022.  In November 2022 started regurgitating regularly, became ~100x/day.    No other symptoms,    Weight of 5'10" athletic 50 year old male declined from 165 pounds to 135 pounds.    Periodic severe dehydration.   GI specialists misdiagnosed as GERD.   Performed endoscopy, barium esophagram, catscan and ultimately manometry tests which confirmed achalasia.    Surgery - Lathrosopic Heller Myotomoy with Dor Fundiplication performed in April 2023.   Early indications are successful treatment.