chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the patient's mother, a health professional via a company representative, and refers to a 13 year old female patient.  No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL or with a dose of GARDASIL 9 for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported), it could not be confirmed if the product was GARDASIL or GARDASIL 9. It was reported that the patient fainted (syncope) after receiving GARDASIL or GARDASIL 9, on an unknown date. The patient did seek medical attention, but it was unknown if the patient required treatment, no intervention to prevent serious criteria or hospitalization was need. The outcome of syncope was reported as resolved. The causality assessment between syncope and GARDASIL or GARDASIL 9 was not reported.
Child was immunized 1/10/03. Mother called office 5/10/04 days child is covered with chicken pox. Immunization did not work.
Fever elevated to 104F, arm hurts, 11/9/05 was to apply ice if continues. To come to office to be checked.
The patient said he was feeling lightheaded few minutes after receiving the vaccine.  He then fainted and was out for a couple of seconds.  He came back to conscious within a few seconds.  We put cold water paper towel on him and waited with him until he felt comfortable sitting up on a chair.  The patient called his sibling to pick him up from the pharmacy.  He walked out on his own and was feeling fine when he left.
Continuing  pain and weakness radiating down to elbow. I am unaware of which particular seasonal flu shot I received.
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data). Patient acknowledged recommendation but not interested in revaccination at this time.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. HCP administer expired vaccine to 450 patients, after the manufacture date of expiration. Dose administered after 30-day Use By Date or after manufacturer date of expiry. There were 102 doses. It was unknown that when the vial was initially stored in refrigerator. The vial did not undergo any temperature excursion. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant follow up information received on 08-Jun-2022. Reporter address was updated.
This spontaneous case reported by a consumer, describes the occurrence of diarrhea, dyspnea (shortness of breath), ageusia (loss of taste for one week), product dose omission issue (has not received the second dose today, May 13, 2021; day 94 post first dose) and nausea in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 17, 2021, patient experienced diarrhea, dyspnea (shortness of breath), ageusia (loss of taste for one week) and nausea. On an unknown date, patient experienced product dose omission issue (has not received the second dose today, May 13, 2021; day 94 post first dose). On Feb 20, 2021, dyspnea  (shortness of breath) resolved. On Feb 24, 2021, ageusia (loss of taste for one week) resolved. On Mar 3, 2021, diarrhea and nausea resolved. At the time of the report, product dose omission issue (has not received the second dose today, May 13, 2021; day 94 post first dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medication information and treatment information not provided.
Patient received both Flu and COVID BiValent Vaccine. After the administration of the COVID vaccine the patient c/o dizziness upon standing, and asked to "sit in the chair" grabbed the chair to sit but fell to the ground before being able to sit. Patient fell on his bottom first, then laid back and hit his head on the ground. Pt became diaphoretic, pupils were dilated 8mm, patient was asked if he was familiar with location, and passed out x3 with 5 seconds in between unaware with location. Patient became alert and oriented to self and location after the 3rd episode of passing out. Vital signs were taken and read: BP: 142/82, HR: 48, O2: 96%. Patient was assisted onto the gurney and transported to Acute Care from the Library.
Thursday evening  8:00 PM  6 Hour migraine 10/10 pain Friday: General feeling unwell Saturday 6:00 PM  sudden severe onset Nausea/ Diarrhea for 3 hours Sunday : General feeling of unease/disoriented Monday: No symptoms  Missed work Saturday and Sunday
pt recv vax & PPD test;On returning for the reading of the PPD test pt remarked to the reported that pt had redness @ the inj site & flu-like sx. No additional information was provided from correspondence returned to Aventis Pasteur Inc. on 2-May-2000. This case is closed.
Patient became ill with strep pneumo bacteremia/meningitis after completing 3 doses of PCV7.
Started out as possible eczema, blisters throughout groin and perineal area, nodes in groin were very swollen and tender, also had flu-like symptoms. Patient was seen in the Emergency Department,  and treated. Patient mentioned she was provided medication, but felt worse after starting the treatment. Patient did not disclose any further details to this reporter.
Patients father recalled a Varicella vaccine on 12/20/10. Broke out in a rash (60 spots) beginning of January. Patient presents with varicella looking rash on 1-18-11. Dr. felt that this should be reported.
45 min after H1N1 injection given, difficulty breathing, hoarse vocie, only able to whisper, thingling in knees, fingers and toes.  feels faint, but does not pass out.  feet feel cold.  symptoms resolved with dose of benadryl and predinsone.  reoccur once daily on Friday, Saturday, Monday and Tuesday.  gets better after takes one dose of benadryl.  taking 5 day course of prednisone.  no other reaction to any other IZ or meds. seen twice in ED (Friday and Saturday) once in pedi clinic on 3/15/10. every day the symptoms are shorter.  lasted 1 1/2hr Friday, by Tuesday on lasting 1/2 hour.  hoarseness and whispery voice goes away with dose of Benadryl.
10 minutes after adminstration, patient stood next to the consult window waiting for his papers to be signed by me. He became light headed and fell to the ground hitting his face. His face sustained a bit of blood from the fall. His mom was with him the whole time to assist him. He regained consciousness. I asked him if he had anything to eat that morning or was hydrated, he replied no. I gave him water & crackers and he was improving. Medics were called and checked on him. He was released from them a bit after.
Extreme pain, extreme itching, burning, tenderness, sensitivity on left side of vaginal area and left buttock
Approximately 45 minutes after receiving the shot I started experiencing some mild tingling/burning in my right shoulder (at the injection site). Shortly afterwards, I also noticed swelling and numbness in my hands and face. The swelling in my hands increased to the point where my ring finger on my left hand began throbbing. The ring is already tight due to weight gain, but I became concerned that I may need to cut the ring off. Throbbing plateaued and continued for about an hour then subsided. Swelling and numbness also plateaued and subsided, though those took longer (about 2 days). Overall, it felt a bit like the time I discovered that I was allergic to shrimp/lobster/crab but it did not progress to the same level (no trouble breathing with this episode).
Received the vaccine at 3 am on March 8 2021. Symptoms began at 10am. Severe flu like symptoms (9 out of 10 on a pain scale, 10 being extremely painful): body aches and pains and low fever. Took both acetaminophen and ibuprofen to counteract the pains (did not help much). These symptoms lasted through March 9, 2021. Today is March 10, 2021 and my symptoms are feeling moderately faint and lethargic.
In May 2021 I woke up one day at 4:45AM with my left arm being stiff and in pain. That pain kept going all the way up. The pain started at a 3 or 4 and then it went up to a 7 or 8. I had chills fever, and headaches. I couldn't move my left side of my body and couldn't get up. I wasn't having a heart attack. I started going to clinic every week because of the pain I was having. On June 9th the doctors gave me shots and pills because I was constantly in pain. My shins were hurting very badly. The doctors kept prescribing me different pain medicines and narcotics. I had went to another country on May 5th on May 11th I had experienced really bad pain, but the pills I had didn't work. I had a panic and thought I was dying because of the pain. My legs were in horrible pain, and I couldn't get out of bed for about a week or two. I had started to get little pain on my shins since yesterday. Now I have just a little burning sensation. It's not as bad as it used to be. Sometimes I can't go to work because of the pain. I have nodules in my brain and cervix. I had pain in my back and doctors said I have sciatica, so I was given medicine for it.
Numbness/tingling to fingers, burning sensation in palm of hand in arm injection was given, redness, swelling and pain at injection site, nausea, fatigue, light sensitivity/soreness to L eye with tingling to area near eye, headache.
Information has been received from a certified medical assistant (C.M.A.) concerning a female patient age 11-12 years old who "in the last 5 months" (in 2007) was vaccinated with GARDASIL vaccine (yeast). Subsequently "in the last 5 months" (in 2007) the patient passed out within in a moment of being vaccinated. Medical attention was sought, in the office. She was treated with cool compresses and rest and her blood pressure was monitored. Subsequently, the patient recovered. She will continue with the vaccination series as scheduled. This is one of four total reports received from the same source. One of the girls received the third dose of GARDASIL vaccine (yeast) and hepatitis A virus vaccine inactivated (HAVRIX). The other girls were receiving the first dose of GARDASIL vaccine (yeast). The reporter did not specify which of the four patients was receiving the third dose. Additional information has been requested.
1/7 left work at noon, body aches, fever, night sweats, felt like covid all over again.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced severe stinging. The patient received a dose on an unspecified date. The patient experienced severe stinging. Outcome was unknown. No additional information was available at the time of this report. The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided.
Information has been received from a physician concerning an 18 year old female who on 04-JAN-2008 was vaccinated with her third dose of 0.5 ml of GARDASIL (Lot #659055/1522U) intramuscularly. There was no concomitant medication. Subsequently the patient developed myalgia. The patient received the vaccine in the right deltoid and has developed the myalgia on the entire left side of her body. The patient received her first dose of GARDASIL on 21-JUN-2007 and her dose on 06-AUG-2007. The patient's outcome was not reported. No further information is available. Additional information has been received.
PATIENT HAD PFIZER COVID-19 VACCINE   Dose 1 date: 03/22/2021,  Dose 2 date: 04/12/2021, AND TESTED POSITIVE TO COVID 9/1/2021
Became very violent, aggressive and he wasn't really himself; Twitching; Slow movement; Jerking; Sometimes he closed his eyes and he couldn''t open; He is been doing more like own instruction the only thing he did differently after the vaccine; allowed to go to the school but not catching anything; allowed to go to the school but not catching anything; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number not reported, Expiration date unknown), via an unspecified route of administration on 12Aug2021 as Dose 1, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Aug2021, patient experienced twitching, slow movement, jerking (Jerkiness), and sometimes he closed his eyes and couldn't open it. On 15Aug2021, 3 days after vaccination, patient became very violent and aggressive. He wasn't really himself and was taken to the Emergency room and discharged the following day. It was reported that, patient was still not really back to baseline and had been out since the beginning of the school year. He was doing more like own instruction, the only thing he did differently after the vaccine. Patient was allowed to go to the school but was not catching anything. The outcome of all the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Pt reports experiencing intermittent non-exertional chest pain approximately 2 weeks after receiving his vaccine dose.  He was seen in the ED and diagnosed with pericarditis following evaluation that showed diffused ST elevation with PR depression on EKG.
Awoke at 3 am with severe chills, diaphoresis, nausea, vomiting, diarrhea and headache. Syncope episode within that hour. Worsening full body joint and muscular pain which became severe by 8am lasting until around 7pm. Able at this time to tolerate 400 mg ibuprofen without vomiting and gain control of pain level. Continued, more mild headache, body ache, fatigue, presyncope and diaphoresis lasting until following day.
Patient stated that when she woke up on second day after shot (3/9/19), she could barely stand up due to disorientation and confusion and later in the day her vision was still blurry. Symptoms resolved over the next 2 to 3 days.
Weakness, Dizziness, server headache, chest pain, Blood pressure went down to 90/52 . I'm going to see primary care physician Monday.
had covid; had covid; everything hurt; This is a spontaneous report from a contactable other HCP and a consumer or other non HCP. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on unspecified date as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis. Concomitant medication included tofacitinib citrate (XELJANZ XR), via oral from Feb2020 to unknown date at 11mg daily for rheumatoid arthritis. The patient reported in Sep2021, she had covid, and was hospitalized for 2 days. Patient stated she was fully vaccinated. She missed 3 weeks of XELJANZ per MD instructions. She stated "everything hurt" in 2021 but was not able to differentiate between covid or rheumatoid arthritis related. She stated she is fine now, no specific date provided on improvement. MD aware. The outcome of events was recovered in 2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events Drug ineffective and Covid-19 and suspected drug cannot be excluded.
RECIEVED VACCINATIONS ON 8-14-08, ON 8-18-08 CAME TO OFFICE WITH C/O BEING NAUSEATED, DIZZY, ITCHING AT INJECTION SITES. R>L BIL DELTOID SWELLING, REDNESS, TENDER FROM SHOULDER TO ELBOW.  REDNESS AND SWELLING, SIZE OF SOFTBALL, 5" DIAMETER.  INSTRUCTED MOM TO GIVE OTC TYLENOL/MOTRIN, BENADRYL ON 8-15-08.  ON 8-18-08 WAS GIVEN MEDROL DOSE PAK AND LORATIDINE 10MG DLY.
RASH  BILATERAL SHOULDERS, WELPS, EYES WERE RED, RASH TO CHWST AND BACK,  ANGIOEDEMA, "FELT LIKE HER BRAIN WAS ON FIRE" PRESSURE IN HER HEAD X 40MINS. BENEDRYL CREAM TO RASH AREA , TYLENOL 100MG, SKELAXIN 800MG. RASH GONE BY MORNING
He noticed a sore arm on the following day.  He then noticed irritability for several weeks, but does not have it now.  He had a lack of concentration for more than a week that lasted 2-3 weeks.  Diarrhea 9 days after the vaccine that lasted for about a week.  General tiredness for about 2 weeks.  2 weeks and 2 days after vaccine had high BP, and it's better today at his APT.  Had occasional heart racing while doing some light snow shoveling 3 weeks after the vaccine, and it went away after that.  Chills off and on for about 10 days after to about 22 days after.  Also had loss of appetite about 2 weeks after the vaccine that lasted several days.  He also had a couple of days really poor sleep, irregular and several days that he had night mares 2-3 weeks after the vaccine.  A couple of weeks after the vaccine did not just feel very good, like he had the flu.  He also has had itching on the top of his feet and ankles that did not start until after the vaccine, and still has depending on what socks he's wearing.   He also had a swollen right ear that was real sore and had to go to the doctor to get the swelling down using some ear drops.
Product administration interrupted; Product unavailable due to pandemic; Did not receive his 2nd dose between day 25 and 35; Fever of 102; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted), PRODUCT AVAILABILITY ISSUE (Product unavailable due to pandemic), PRODUCT DOSE OMISSION ISSUE (Did not receive his 2nd dose between day 25 and 35), FATIGUE (Fatigue) and PYREXIA (Fever of 102) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2020.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced PYREXIA (Fever of 102) and NAUSEA (Nausea). On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted), PRODUCT AVAILABILITY ISSUE (Product unavailable due to pandemic) and PRODUCT DOSE OMISSION ISSUE (Did not receive his 2nd dose between day 25 and 35). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted), PRODUCT AVAILABILITY ISSUE (Product unavailable due to pandemic), PRODUCT DOSE OMISSION ISSUE (Did not receive his 2nd dose between day 25 and 35) and PYREXIA (Fever of 102) had resolved and FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 102 (High) 102.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No relevant concomitant medications were reported.  No treatment information was reported.
This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown ages and genders. Medical history and current conditions were not reported. On an unknown dates over unspecified 7 month period, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot number L024118, expiration date 26-MAR-2017, and lot number L027732, expiration date 23-FEB-2017. Dose and route of administration were not provided. No other suspect or concomitant medications were reported. As reported, temperature: uncertain, surmising worst case 51 F and 7 months; digital data logger was involved. Previous: uncertain. No adverse effects were reported. This is one of four reports received from the same reporter. Additional information has been requested.
Hospital Course:  The patient is a 74 year old gentleman with an extensive medical history including but not limited to metastatic right upper lung cancer to the adrenal gland and sacrum started on immunotherapy (Nivo/ipi) on 3/9/2023 (follows with Dr.  oncology) who was admitted for acute hypoxemic respiratory failure (88 on room air).   Noted to be COVID 19 positive.   Admitted -- >started on decadron, RDV.   Also with worsening renal function since 3/20 (creat 1.10 on 3/6/2023)-started immunotherapy 3/9/2023.   First for the hypoxemic respiratory failure with + COVID, the patient was treated with decadron from 3/21 to 3/25/2023.  He also received 2 doses of RDV (stopped -see below paragraph about renal failure) CXR revealed a right basilar opacity.   The patient had a normal BNP Of 56 on admit so less concern for fluid overload.   D-dimer on admit >4, but with worsening kidney function, CTA Chest not pursued.  The d-dimer is non specific and likely elevated in setting of cancer.  Patient also with no leg pain.  The patient's SOB Subjectively improved and objectively, the patient was on 3/25 (day of discharge) 96% on room air.  However, with exertion, his O2 sat did drop to 88.  As such, I ordered home O2 for the patient and it was delivered 3/25.   An alternative explanation to for the hypoxemic respiratory failure, is possible concomitant bacterial PNA.  A serum procalcitonin was elevated at 0.96 on 3/23 (result came back 3.25) and with basilar opacity present, I did add augmentin 875/125 x 5 days to cover for possible bacterial PNA.   As for the renal failure, the patient's creatinine rose to 3.41 on 3/23.  I spoke with Dr nephrology who recommended sodium bicarb pills and bicarb gtt as patient had associated metabolic acidosis.   I did a renal ultrasound which was negative for hydronephrosis.  I stopped RDV on 3/23 as RDV can cause creatinine elevation.   Fena 3/23 only 0.8% suggesting prerenal disease.  With bicarb hydration 3/23-3/25, serum creatinine normalized to normal at 1.30 on 3/25. Losartan was held during admission course.  I will have patient recheck his serum creatinine on 4/1 (which is when his isolation date for COVID ends).  Immunotherapy nephritis is a possibility but no way to know unless kidney biopsy done.   I will have Dr oncology follow up to see if she will continue with immunotherapy.
Increase in heaviness of menstrual bleeding and passing blood clots the size of or larger than a golf ball, soaking through a super tampon within less than an hour.  Days of period increased by 5 days.