chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case reference number 2000004518-1, is a spontaneous report from a registered nurse referring to a 33 year old female. Allergies are unspecified. The patient smokes 1/2 pack of cigarettes daily. She had a positive PPD result in 01/08/97, after a negative PPD result. The patient refused to take the recommended Isoniazid. On 7/25/96, 08/21/96, and 02/19/97, the patient received her first, second and third doses of Hepatitis B for Prophylaxis of Hepatitis B. In December 1999, she reported to her former employer that she had developed asthma, headaches, memory loss, trembling, muscle weakness, diminished effectiveness of immune system, depression, weight loss, blurred vision, fever, dizziness, and chronic fatigue. The most recent information, received on 02/15/2000, reports the condition of the patient as unknown. The follow-up states that the vaccinee then alledgely developed irregular menstrual bleeding.Irregular bowel movements and fatugue persisted She sought medical attention on June 1999. The physician obtained hair and urine samples which reportedly were positive for "unusually high amount of mercury." The vaccinee underwent chelation therapy with DMPS. However, she developed severe fatigue, vomiting, diarrhea, and severe cramping as a result of DMPS therapy, and it is discontinued. The vaccinee alleges that all the events she experienced following receipt of her thrid dose of Engerix-B are the result of mercury toxicity. She further alleges that Engerix-B is the source of the mercury. The most recent info, received on 12/13/2000, reports the condition of the pt as unknown.
8 patients received the adjuvant solution; 8 patients received the adjuvant solution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 14th September 2021, the patient received Shingrix. On 14th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was an office manager. The reporter reported that the patient could receive just the adjuvant solution of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not remember which of the patient got the full dose. The reporter did not consent to follow-up.  This was 1 of 9 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209467:Same reporter. US-GLAXOSMITHKLINE-US2021209458:same reporter US-GLAXOSMITHKLINE-US2021209462:Same reporter. US-GLAXOSMITHKLINE-US2021209463:Same reporter. US-GLAXOSMITHKLINE-US2021209483:Same reporter. US-GLAXOSMITHKLINE-US2021209482:Same reporter. US-GLAXOSMITHKLINE-US2021209470:Same reporter. US-GLAXOSMITHKLINE-US2021209478:Same reporter.
Sinus issue; A spontaneous report (United States) was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sinus issue/sinusitis.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Sinus issue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sinus issue, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
itching, site warm to the touch, minor swelling and redness at the site. Rec hydrocortisone cream, cool compresses, apap/ibuprofen/benadryl if she can tolerate same. Monitor for infection. Seek medical attention if it worsens or persists.   5/8-patient stated itching and warm to touch area lessened. reporting scheduling telemed appointment with PCP for 5-10-21.
Fever bad muscle pain day 2. Insomnia weakness headache day 4 chest pain omiting day 6
Day one, feeling very cold, chills, trembling,  achy joints, headache. After the chills passed low grade fever for the rest of the night. Buzzing in my ears, headache. Day two, buzzing in my ears and headache passes, fever leaves. Start feeling discomfort in the middle of my back and middle of my chest, later became nauseous.  The discomfort in my chest/ribs lasted about 9hrs. Both days very tired, little stamina.
Swelling from shoulder to mid arm, redness and warm for 48 hours. Eyes were hurting for 2 days, diarrhea and tiredness for 1 day. Symptoms started to improve after 48 hours of administration. Patient.
Shot was given high up on shoulder. Very painful. Elbow, arm & shoulder started hurting & still is as of 11-14-11.
The patient experienced extreme shoulder pain after receiving her vaccine.  She said that it is a pain scale score 10.  She could not lift her left arm at all.
Mother report pt upper L deltoid bruising on 7/22/15, post administration of DTaP vaccine at site. Redness, swelling noted in office (7/23/15). Pt treated for dx: cellulitis. tx: Septra oral antibiotic x 7 days.
4 hours after shot I was in Atrial Fibrillation  I waited until Friday hoping they would go away
Day two following inoculation, slight full feeling in left ear. Went away sometime during the day. Day three following inoculation, vertigo like symptoms appeared, 1-10 seconds in duration. Continued in various numbers of episodes per day for approximately 14 days. Treated with Meclizine 25mg tablet 1x on Thursday March 11 around 1pm, which caused fatigue. On Friday March 12, pcp was notified, advised to take Benadryl 1/2 dose, only took one dose due to fatigue. Neither medication had a noticeable affect.
Injection given 8/12/16 pt returned 8/17 with large hot rash covering exterior area of bicep. Patient has an apt with MD in afternoon will follow up - FLUZONE HD give RA same day.
No side effects or adverse events reported; Caller stated they accidently administered MMR-II to a 6 month; it was given intramuscularly instead of subcutaneously; This spontaneous report was received from a nurse practitioner and refers to a 6-month-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 08-SEP-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter (1 dose), lot #U022983 rHA, expiration date: 22-JUL-2023, administered intramuscularly (Product administered to patient of inappropriate age, Incorrect route of product administration) for prophylaxis (strength was not provided). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).
temperature excursion for IPOL as fridge left opened a little too long, Max/low temperature reached: 48.8F for a Duration of 40mins with no reported adverse event; After excursion vaccine was administered to a patient with no reported adverse event; Initial information received on 15-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 5 years old female patient and reporter reported temperature excursion for poliomyelitis vaccine (inactivated) IPV (VERO) [IPOL] as frdge left opened a little too long, max/low temperature reached: 48.8f for a duration of 40mins with no reported adverse event and after excursion vaccine was administered to a patient with no reported adverse event.                                                                                                           0 The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine live (OKA/MERCK) (Varivax [Varicella zoster vaccine live (OKA/MERCK)]) for Prophylactic vaccination.  On 13-Jun-2023, the patient received a Standard dose 1 of punctured poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection at a dose of 0.5 ml total (lot V1A024M, expiry date- 17-FEB-2024) via intramuscular route in unknown administration site for Immunization.  Caller reported temperature excursion for poliomyelitis vaccine (inactivated) IPV (VERO) as fridge left opened a little too long, max/low temperature reached: 48.8f for a duration of 40mins with no reported adverse event (product storage error) (unknown latency) and after excursion vaccine was administered on 13-Jun-2023 to a patient with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Human error was involved, and caller is asking how to proceed.  Action taken was not applicable  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Narrative:  74yo male pt with PAST MEDICAL HISTORY: htn colon cancer s/p colon resection COPD/asthma s/p trauma to left calf from being kicked in calf hx of bilateral DVTs and PE - on coumadin - thinks after long surgery for colon cancer HLD - intolerant to statins - muscle cramps CVA Pt died at home per spouse, cause of death unknown. No notes in medical chart leading up to pt's death. Pt had received 2 covid vaccines on 2/14/21 & 3/14/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Shortness of breath, fatigue, jaw pain within 2-3 weeks of receiving 2nd dose of pfizer vaccine
Fever 103, vomiting, pain and swelling at injection site 11 hrs post vaccination.  Fever and vomiting for 26 hours.  Treated with Motrin/Tylenol, fluids, warm wash cloth to site.
Hospitalization for severe hyponatremia, with confusion and inability to speak which we thought was due to colonoscopy prep, only to find out 2 days later when we brought her home that the colonoscopy prep was never taken
1 week after receiving simultaneous Menactra, Inactivated Polio and Hep A, the patient developed positional dizziness followed by progressive lower extremity weakness and in-coordination.  He has poor tandem walking and a borderline Rhomberg test Over an additional 10 days his motor weakness has become a primary complaint
Developed red, papular rash, one day post vax. No reaction after 1st set of vaccines.
18 hr p/vax pt devel t104, crying-APAP was given only p/pt devel fever; pt was brought to the ofc 48 hr p/vax; t102.3, alert, active, sl nasal congestion no other sx; PE nl;
Systemic: Fainting / Unresponsive-Mild, Systemic: passed out for less than 1 minute immediately after shot given-Mild, Additional Details: passed out immediately after shot given for less than 1 minute, after coming to, had her lay on floor with legs up, blood pressue and pulse normal 111/88 , 70bp, was okay. had her stay over 30 minutes for obeservation, her dad with her
Right and left upper arm body part only, with immediate rash after injecting Kinrix and Hepatitis A in Right Arm. Nausea and small vomit with saliva only occurred after ten minutes of all vaccine administration. Break between vaccines given and rash decreased. Child in sitting position to avoid falls.  Promptly evaluated by nurse practitioner, no wheezing or swelling noted. Child talkative and stated feeling better after a few minutes. Observation completed for fifteen minutes. No other reactions noted. Educated mother on signs and symptoms of any other possible reaction.
Sore throat; Headache; Felt out of sorts/ feeling unwell; Bizarre feeling/felt really bad; wondering if being on Stelera made the symptoms from the COVID Vaccine worse; extreme/ severe fatigue; lightheaded; soreness around injection/Sore arm; felt run down; chills; This is a spontaneous report from a contactable nurse (patient). This 36-years-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date: 31Mar2021), via unspecified route at left arm on 21Dec2020 14:00 at single dose for COVID-19 immunization; she also started to receive ustekinumab (STELERA injection), via subcutaneous from 2017 (last injection on 04Nov2020) at unspecified dose every 12 weeks for psoriasis. Medical history was none. Concomitant medications were not reported. No additional vaccines administered on same date of Pfizer vaccine. Historical vaccine included influenza vaccine on Nov2020 for immunization, which was 5 weeks prior to COVID vaccine. Vaccination facility type was hospital. At night of vaccination on 21Dec2020, patient felt run down, thought she had chills. She did not have fever. She woke up next day 22Dec2020 with sore arm/ soreness around injection, was otherwise fine. Day 2, 3, and 4 post vaccine was sick (23Dec2020). She had a sore throat, headache, and extreme/ severe fatigue on 23Dec2020. She was not feeling well/ felt out of sorts on 23Dec2020. She expected to wake up feeling unwell. On 23Dec2020 and 24Dec2020 she felt really bad. Could have been in bed all day. She still did not have fever. She was lightheaded and had a bizarre feeling on 23Dec2020. She woke up 26Dec2020 and felt completely fine. Patient was wondering if being on ustekinumab made the symptoms from the COVID Vaccine worse. Action taken for ustekinumab was unknown. Outcome of events was recovered on 26Dec2020.
Patient reported fever, chills, a painful arm the on 8/13. On 8/14 his blood pressure dropped to 90s/60s (normal BP range 120-130s/90s). On 8/15 he reported a higher than normal blood pressure.
Approx 40 minutes after the injection my face became tingly - cheeks, nose, around my mouth, and chin.  It continued to tingle and became numb.  (Felt similar to having Novocain for a dental procedure.  By morning my cheeks and nose felt normal but the numbness/tingly feeling around my mouth and chin lasted about 20 hours. I contacted the care line and she was not initially familiar with this side effect.  She did some research while I was on the line and explained that there have been some reactions of numbness.  She said it was not an emergency and if it persisted beyond 24 hours I should seek medical attention.
Systemic: Confusion-Medium, Systemic: Dizziness/Lightheadedness-Medium, Systemic: Fainting/Unresponsive-Medium, Systemic: Flushed/Sweating-Medium, Systemic: Headache-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium.
This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling injection site in a child subject of unspecified gender who was vaccinated with KINRIX, (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of KINRIX (unknown, unknown arm). At an unspecified time after vaccination with KINRIX, the subject experienced swelling injection site and limb swelling. The healthcare professional reported that two children were vaccinated with KINRIX and both children developed limb swelling at the injection site (see case id A0891227A for details on the other child's case). The reporter was not aware if the limb swelling was on the same area as the injection. On child was injected in the arm and the other in the thigh. No other adverse events were reported. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with KINRIX.
Information has been received from a registered nurse concerning a female who was vaccinated on an unspecified date with a first dose of Gardasil. Subsequently the patient fainted. The patient fully recovered without complication. The patient was vaccinated on an unspecified date with a second dose of Gardasil. Subsequently the patient developed a migraine headache. The patient contacted the office. The patient fully recovered without complication. Additional information has been requested.
Pt's mother reported a rash to the health dept and personal physician that covered the baby's diapered area only and some crankiness, after the 2nd dose of immunization which was given on 4/10/01. The rash did not occur until 1-2 days, post vax. At the same time, DTAP, Comvax and IPV were all given to pt. Pt's PMD recommended that we continue immunizations but split them up and give 1 or 2 at a time. We continued to give immunizations as recommended by physician, giving only 1 at a time and had no reactions until after infant received Act-Hib. Mother reported pt had diarrhea all week before getting immunization, thinking it was due to teething. She also reported that reactions started with a mild fever on 8/16/01 PM. By 8/17/01, she noticed a small red rash on one of his knees and the immunization site was red and warm. On 8/18/01, the rash had spread to his cheeks and forehead near his eyebrow area. He also started throwing up, was feverish (unknown how high), and continued to have diarrhea. At this point, she decided to take him to the ER, which labs were drawn and dehydration was dx'd from the diarrhea. He was given IV, 1 liter of fluid, and discharged to home. It appears to me that hospitalization occurred because of the hydration that had already started before immunization was given, but other symptoms may have exacerbated it.
concerning problems after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (concerning problems after the second shot) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (concerning problems after the second shot). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Vaccination adverse reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (concerning problems after the second shot) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient took 1000 mg of Tylenol 8 hours after the 2nd dose of his Moderna COVID-19 vaccine. He then took another 1000 mg of Acetaminophen 6 hours after the first Acetaminophen dose.
This spontaneous report as received from a consumer refers to her sister's 5 month old female infant. On 01-MAR-2013 the patient was accidentally vaccinated with GARDASIL (lot number not provided) by an unspecified healthcare professional. It was unspecified if the patient had sought medical attention. Additional information is not expected.
4/6/2021 Around 5 pm I began experiencing fatigue, which lasted for one week.   4/6/2021 Around 7 pm, I had a temperature of 100, which quickly escalated to 103 by 8:30 pm. I took two Tylenol around 7:30 pm, however my temperature remained at 103. Around 11 pm, I took two ibuprofen. Finally, around 3 am, my fever broke. My temperature returned to normal by 8 am on 4/7/2021.   4/6/2021 I experienced a racing heartbeat from 7:00 pm until midday on 4/7/2021.   4/6/2021 I experienced a headache beginning at 8:00 pm. I still have a mild headache as I write this, on 4/14/2021.
Pt Diagnosed with COVID-19 on 12/5/2021.  Pt had been vaccinated and did receive booster on 12/2/2021.  78 yr old male admitted to HCF on 01/06/2022 from another local Hospital.   Pt had a past medical history of Chronic steroid use, osteoarthritis, Parkinson's disease and atrial fibrillation.  The patient originally presented to the Hospital with Acute Respiratory failure secondary to COVID 19.  The patient's symptoms first started one week prior to admission.  The patient was previously vaccinated and received the COVID booster.  The pt was unable to get remdesivir due to decreased GFR.  The pt was started on Decadron.  The patient also developed acute kidney injury upon admission.  The pt was hypoxic upon admission to the Hospital and was placed on BiPAP but later required intubation and mechanical ventilation.  The pt did start on remdesivir on December 6, 2021.  The pt was unable to wean off of the vent and underwent a tracheotomy as well as a PEG tube placement.  Pt was made a DNR while at the Hospital.  On December 24, 2021 the patient was found to have a pneumothorax and had a chest tube placed.  The patient was also found to have a Right lower DVT.  On admission to this facility the pt was unresponsive and did not respond to sternal rub. On admission to this facility it was noted that the patients prognosis overall was poor given his neurologic status.   On 1/12/2022 family met with the physician and family wanted to start comfort cares.  Pt expired on 1/12/2022 at 1647.
chills started about 8 hrs after 2nd dose injection; waking up with body aches, headache and continued chills - going from chilled to warm. No fever yet.
blood pressure abnormal; Chills; bad body aches; stiffness; lymph node swelling; dose 1: 08Mar2021, dose 2: 22Mar2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Mar2021 13:00 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; XIGDUO. Vaccination history included: Bnt162b2 (dose 1, single via Intramuscular in left arm at, 13:00), administration date: 08Mar2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 22Mar2021 23:30, outcome "not recovered", described as "Chills"; PAIN (non-serious) with onset 22Mar2021 23:30, outcome "not recovered", described as "bad body aches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 22Mar2021 23:30, outcome "not recovered", described as "stiffness"; LYMPHADENOPATHY (non-serious) with onset 22Mar2021 23:30, outcome "not recovered", described as "lymph node swelling"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Mar2021 13:00, outcome "unknown", described as "dose 1: 08Mar2021, dose 2: 22Mar2021"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "blood pressure abnormal". Therapeutic measures were not taken as a result of chills, pain, musculoskeletal stiffness, lymphadenopathy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.