chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial repot received from a consumer on 21 Dec 2009: This patient with a medical history of brain tumor, which was removed and rendered damage to her pituitary gland, received Fluvirin (H1N1 Influenza virus vaccine), (lot no # 102044P1) 0.5ml, IM on 03 Dec 2009. The patient experienced a sharp pain on her right abdomen that persistently grew worse on 17 Dec 2009. The patient's blood pressure dropped to 82/42 (units unspecified) on 18 Dec 2009. She was advised to go to emergency room and there the patient was found to have a large amount of fluid in her abdomen (size of a sauce jar). It was reported that, the attending physician had never seen anything like this before and said that it could be either due to viral infection or possibly linked to the vaccination. the outcome of the events is subsiding but not completely resolved.
I82.431 ACUTE DVT OF RIGHT POPLITEAL VEIN 1/27/2022 ASYMPTOMATIC HIV INFECTION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/27/2022 ASYMPTOMATIC HIV INFECTION
Tested positive for COVID.  Headache, coughing, chills, very sore throat and fatigue/low mood that lasted 2 months   Under Item 17 in this survey, I wanted to enter that I received a FLU Shot, but since I do not know any specifics on the type and I don't remember which arm I got the FLU shot  in, I could not fill in this section .....so I did deleted all info on my flu shot.
Lump on the left side of her neck; A spontaneous report was received from a consumer concerning a 23-year-old, female patient,  who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a lump on the left side of her neck.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 18 Dec 2021,  approximately 3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly in the left arm shoulder deltoid for prophylaxis of COVID-19 infection.     She noticed a lump a day or 2 after she received vaccine on 18 Jan 2021 on the left side of her neck. Treatment for the events were not included.     Action taken with mRNA-1273 in response to the events was not reported.     The outcome for the event  lump on the left side of her neck was unknown.
Information has been received from a health professional concerning a 60 yr old male with no known history or allergies who was vaccinated with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot650329/0747P). Subsequently, the pt experienced a large local site reaction. Unspecified medical attention was sought and the client has since recovered. There was no product quality complaint involved. Additional information has been requested.
PT'S SPOUSE STATED THAT THE NEXT DAY THE PATIENT'S FACE BECAME SWOLLEN AND RED; HE ALSO HAD DIFFICULTY URINATING. HE WAS TAKEN TO THE ER AND TREATED. HE NOW HAS A CATHETER IN PLACE.
Headache, runny nose, congestion, cough, right ear plugged She's been running a low-grade fever. Her right ear is really sore and is going down into her jaw. she has pressure in her forehead when she bends over. starting on 10/3/21
Patient received MENACTRA and BEXSERO at 3 pm on 4-5-17. Woke up on morning of 4-6-17 covered in hives. Went to nurse practitioner on 4-10-17 and was given steroids. Nurse called Health Dept. to report reaction and to seek guidance on whether to advise patient to get second dose of BEXSERO or not.
58 y/o male presented for his second pfizer dose. Reports no medical history but stated that he had some abdominal pain earlier and had his last meal of half egg sandwich around 12pm. He reports that he was told 1 year ago by his PCP that he had borderline diabetes. Reports that he usually passes out when he gets blood drawn. Pt reported that he felt dizzy about 5 minutes after injection at about 1:46pm that he felt lightheaded and was about to pass out when the observation staff transferred the patient to the bed stretcher. On examination, patient was alert & oriented X 3, and sweaty. Initial vital signs at 1:46pm were BP 117/67, HR 71, Temp 97, O2 sat 100%, fingerstick was 138. Repeat Vitals at 2:09pm were BP 108/83, HR 64, Temp 96.9, O2 sat 97%. Pt was escorted off the premises in stable condition at 2:09pm
On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-May-2020 and the estimated date of delivery was 07-Feb-2021. On 12-Jan-2021, the patient experienced PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 12-Jan-2021, PREGNANCY (pregnant) 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.   No relevant concomitant medications were provided by the reporter. It was reported that at that the time of this report the patient was 36 weeks and 2 days pregnant. Treatment information is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Internal review conducted on 20-JUL-2021, resulted in updates to the pregnancy details.
Mom reported redness and swelling at (R) upper arm injection site on 4/16/11 pm. Noted redness and swelling continued with discomfort and increased temp over next two days. Child brought to ER on 4/18/11 pm. Dx infection and Rx BACTRIM PO.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history and drug reactions or allergies was provided. On 10-JUL-2018, the patient was vaccinated with a dose of improperly stored VARIVAX lot # N031004, expiration date 03-NOV-2019 (exact dose, route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 37 minutes. Previous temperature excursion included storage of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 15 minutes two times and once for 1 hour. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA002917: US-009507513-1807USA003518.
I experienced anaphylaxis-throat closing, tachycardia, audible wheezing, stridor, feelings of impending doom. I administered my epi-pen and was taken to the emergency room for further observation and treatment. I received IV Solumedrol and Versed.
2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes; 2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes) and PRODUCT STORAGE ERROR (2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes) 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 13-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes) and PRODUCT STORAGE ERROR (2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes) and PRODUCT STORAGE ERROR (2 patients received doses that went up to 54 degrees Fahrenheit for 105 minutes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
57 YO M C/O POSS ALLERGIC REACTION TO COVID 19 VACCINE. PT RECIEVED VACCINE 8 MINUTES BEFORE WE CONTACTED HIM IN THE OBSERVATION AREA. PT C/O ANUMB TONGUE GOING INTO THE THROAT WITH A RED RASH ACROSS UPPER CHEST WITH REDNESS GOING UP HIS NECK THAT HIS WIFE STATES IS NOT NORMAL FORHIM. PT DENIES DIFFICULTY SWALLOWING BUT STATES TONGUE FEELS LARGER THAN NORMAL. DENIES SOB, CHANGE TO VOICE, DIFFICULTY SWALLOWING, OR OTHERSENSATIONS OF SWELLING. ALSO DENIES NAUSEA. FOUND PT IN PASSENGER SEAT OF CAR A/O X4 IN NO OBV DISTRESS,. HEENT - PERRL, NO JVD, SPEAKS IN CLEAR VOICE IN FULL SENTENCES, NO STRIDOR TOASUSCULTATION OF TRACHEA, RED RASH BILAT ACROSS NECK THAT WIFE STATES IS NOT NORM - PT SAYS IT IS NORM TO SOME DEGREE BUT NOT NORMALLY THISRED. NO SIGNS OF ANGIOEDEMA OR OTHER ABNORMALITIES. CX - LS = CLEAR BILAT ALL, REDNESS/RASHY LOOKING PATCH ACROSS UPPER CHEST. EXTREM - PWD,GOOD PMS X4, MOVES ALL WITH PURPOSE. R/O MILD VACCINE REACTION/ALLERGIC REACTIONEXAM, VS, O2 SAT, ER VIA AMBULANCE
17 and a half years patient received first dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half years patient received first dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half years patient received first dose). On 04-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half years patient received first dose) 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.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow-up received on 31 Mar 2021 included the outcome of event Inappropriate age at vaccine administration was resolved on 4-Mar-2021; Sender's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # 027A21A  with no associated AEs.
while injecting, Typhim vi syringes came apart and the first injection the medicine ran down the patient arm; while injecting Typhim vi syringes came apart; Initial information received on 29-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2019SA121013 (case for pharmacist).  This case involves a 57 years old male patient who received a 0.5ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] prefilled syringes lot N1K81, Box for the 2 syringes Lot: N1K811M, expiration date: 19-Oct-2019 via unknown route in the left arm on 25-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of exposure via skin contact and syringe issue. Reporter had 2 Typhim VI syringes that were pressurized and while giving the injections to the patient the syringe came apart from the syringe. The first injection the medicine ran down the patient's arm and the second injection the medicine shot in reporter's lap. She tried a third typhim VI and she was able to give the dose. The first 2 injections were given in the L arm 2 inches away. The third injection was given in the right arm. The patient didn't receive any other vaccines that day.  At the time of reporting, no adverse event was reported.  List of documents held by sender: none.
She had fatigue and warm red area that was spreading down arm. Treated wtih doxycycline and Nystating/triamcin cream.
So, fatigue the first and second day, and arm sore for about 4 days, and headache on the second day. Just in general, I was feeling sick and that stopped after the 3rd day. The cold started a week after, and I'm still coughing.
Local inflammation dermis, nontender, no pallor, no loss of motion, no inguinal LA.
1JUL92 mom phoned on 26JUN92 pt had fever of 104, shaking, high pitched scream & was delirious; mom called ER; episode lasted 2 hrs; no induration @ inject site; pt was not seen by MD; Disc future DTP & Td -adv to contact PP;
After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 82-year-old, Black or African American, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 82-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Out of specification product use.
Upset stomach and fever with both doses. Diagnosed with myocarditis in March 2022
Woke up with burning sensation under her skin and fingernails-lasted 30 minutes then began with muscle aches and chills lasting until 9am or so. Was extremely exhausted at that point and felt weak and tired and slept a lot for the next two days.  Took 5 days to fully recuperate.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from Other and refers to an 1-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #W001518, expiration date: 13-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
The patient diagnosed with COVID-19; Patient diagnosed with COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Apr2021 09:30 (Lot number: ER8731) at the age of 62 years as dose 2, single and administered in arm left, administration date 21Mar2021 09:00 (Lot number: ER8727) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Parkinson's" (unspecified if ongoing), notes: other medical history: Parkinson's; "Known allergies: Pineapple" (unspecified if ongoing), notes: Known allergies: Pineapple. Concomitant medication(s) included: SINEMET; XANAX; BACLOFEN; CLONAZEPAM. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "The patient diagnosed with COVID-19"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Patient diagnosed with COVID-19". Therapeutic measures were not taken as a result of suspected covid-19.  Clinical course: No other vaccine in four weeks. The patient had Covid prior vaccination. Patient had no Covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200313386 Same patient and drug, different event separated in time
Painful injection site, nausea, vomiting, fever, chills, body aches
1ST DOSE MODERNA 01/26/2021 LOT #071220A ; 2ND DOSE PFIZER 2/22/2021 LOT #EN6198
Severe redness, pulsating burning pain. Rash extending under (R) breast, under (R) arm to back (middle) extending up 1/2 on back. Lesions still active as of 2/4/13.
pt recvd vax 17AUG94 @ 12noon & was a little whiny & crabby; grandma was holding pt & pt cried a little then became limp, eyes rolled upward a little pt was pale & then bluish;
Episode of apparent apnea with color change on day of vaccination. No other episodes. No other reason for episode.  5/15/06 9 pages to include ED and DC summary-admitted for ALTE (apparent life threatening event due to apnea) admitted 5/3-5/5/06-final DX ALTE-no apnea or desats or temp elevation during hospital stay.Prior to apnea event decreased appetite reported.
I obtained an unauthorized third dose of Moderna after having received my second Pfizer dose on February 24th.  I hope I don't get arrested for this or get the pharmacy in trouble (I lied to them about being unvaccinated because I'm petrified of this virus.  I'm 74 and had been fully vaxxed 6 1/2 months earlier)   Most of the Moderna side effects were the same as with the second Pfizer dose I had received ? arm soreness, headache, fever, chills, fatigue, muscle/joint pain, all beginning 7-8 hours after vaccination.  However, along with those issues, with Moderna I experienced urgency to urinate every hour, which lasted for the duration of all the other side effects.  The Moderna side effects lasted the same length of time as the second Pfizer dose ? starting the first evening, going through the whole of the following day and ending the morning of the third day.  After receiving Moderna on Wednesday late morning, all side effects were gone Friday morning, including the urinary urgency.
Case completed primary Covid series in October 2021, then was hospitalized for Covid in April 2022. Hospitalized. Case was admitted with hypoxia and mild congestion, was treated with Paxlovid and Dexamethosone, and weaned off oxygen within 2 days of admission. Was discharged with no oxygen supplementation needed.
June 9, 2004 @ approx. 9:15 am patient recieved Dtap #5, IPV #4, MMR #2, Hgb- 11.6, Mom called office at 5:00 pm stating his right arm is swollen,erythema the size of a med. apple. no other symptoms. She was told to watch for signs of infection and symptomatic care.
lower back pain, bilateral leg pain, fever, vomiting, diarrhea, chills, headache,- started 9-21-21. 9-22-21 no fever but still has back pain, bilateral leg pain and headache.
flu symptoms; This case was reported by a physician via sales rep and described the occurrence of flu symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms was unknown.   It was unknown if the reporter considered the flu symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported via request that the patient had Shingrix vaccine and experienced flu symptoms. The reporter consented to follow up. Other details were not provided.  It was unknown if the reporter filed an adverse event based on physician's request.
A employee at our practice that was in charge of covid vaccine here never entered covid vaccine's into the system. When  I went to enter all vaccine's into the system I noticed this lot number states it expired 5/2022 but the card that comes in the package of vaccine states used by date is 09/30/2022. When I contacted Hospital pharmacy I was told that the expiration date is extended 12 months from manufacture date. I was also informed there is a website to check expiration dates. I put the lot number in it states 8/31/2022. Management at hospital pharmacy contacted pfizer and they confirmed that this vaccine is expired.
did get shingles after those shots/ Suspected Vaccination Failure; get shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: did get shingles after those shots/ Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: get shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient friend via interactive digital media. The reporter reported that, one can still get shingles with the vaccine but it is usually a very milder case. The reporter had three friends who did get shingles after those shots. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting This case had been linked with US2023AMR038926, US2023AMR038934 reported by same reporter. ; Sender's Comments:  US-GSK-US2023AMR038926:Same reporter US-GSK-US2023AMR038934:Same Reporter
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 06-NOV-2013, the patient was inoculated with ZOSTAVAX at a pharmacy (Dosage, route of administration, Lot number and expiration date not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. Instead, the patient contracted a persistent strain of herpes zoster, or shingles. On or about 28-MAY-2015, the patient was treated by a physician for the onset of a burning rash, which was diagnosed as shingles. The female patient was prescribed valacyclovir (VALTREX) and gabapentin for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a consumer concerning his 11 year old son with a head cold who, on 12/30/99, post vax, experienced fever and arm soreness. On the morning of 12/31/99, the pt's fever was 101.7F. The reporter noted that the pt, along with his siser are both experiencing head colds and he is unsure as to whether or not the pt's experiences are related to the vaccine or the cold. Additional information has been requested.