chrisvoncsefalvay/vaers-outcomes huggingface dataset:
general body ache; fever 100.5 degrees; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (general body ache) and PYREXIA (fever 100.5 degrees) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PAIN (general body ache) and PYREXIA (fever 100.5 degrees). At the time of the report, PAIN (general body ache) and PYREXIA (fever 100.5 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 100.5 (High) 100.5 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-100625 (Patient Link).
an extra Ipol dose was given to a two month old, Pediarix was ordered and it contains Ipol of unknown amount and then the patient was given 0.5 ml of Ipol/ No AE; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from a other health care professional via consumer via Medical information number: 00797661.  This case involves a two-month-old female patient who received an extra Ipol dose, DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] was ordered and it contains Ipol of unknown amount and then the patient was given 0.5 mls of IPV (VERO) [IPOL] (extra dose administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HIB VACCINE CONJ (TET TOX) (ACT-HIB) for prophylactic vaccination respectively.  On 04-Oct-2021, the patient received a 0.5 ml first dose of suspect IPV (VERO) lot number: T1D482M, expiry date 25-Jul-2022, frequency: once, strength: standard via intramuscular route in the left thigh (left leg) for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur lot number and expiry date not reported via an unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error due to extra dose administered (latency: same day).   At the time of reporting, no adverse event was reported.  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.
The patient was vaccinated during pregnancy.  Pregnancy was uncomplicated.  However the patient developed severe growth restriction with oligohydramnios.  The baby was delivered emergently via C-section.  Baby died 3 days later.  Diagnosis is a rare form of liver aloe immune disease.   the baby was diagnosed with gestational aloe immune liver disease.  Delivery and autopsy and workup was done.
a left throat soreness; his left eyelash follicles that had a burning and painful sensation; it was sensitive to the touch but no rash or itchiness; side effects; headache; the rear quadrant behind his left ear was where he was experiencing the shocks; a burning sensation in his left ear; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (a burning sensation in his left ear), OROPHARYNGEAL PAIN (a left throat soreness), ELECTRIC SHOCK SENSATION (the rear quadrant behind his left ear was where he was experiencing the shocks), BURNING SENSATION (his left eyelash follicles that had a burning and painful sensation) and PARAESTHESIA (it was sensitive to the touch but no rash or itchiness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced EAR DISCOMFORT (a burning sensation in his left ear), ELECTRIC SHOCK SENSATION (the rear quadrant behind his left ear was where he was experiencing the shocks), PARAESTHESIA (it was sensitive to the touch but no rash or itchiness), VACCINATION COMPLICATION (side effects) and HEADACHE (headache). On 04-Mar-2021 at 4:00 PM, the patient experienced BURNING SENSATION (his left eyelash follicles that had a burning and painful sensation). On 04-Mar-2021 at 7:00 PM, the patient experienced OROPHARYNGEAL PAIN (a left throat soreness). On 04-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, EAR DISCOMFORT (a burning sensation in his left ear), OROPHARYNGEAL PAIN (a left throat soreness), ELECTRIC SHOCK SENSATION (the rear quadrant behind his left ear was where he was experiencing the shocks), BURNING SENSATION (his left eyelash follicles that had a burning and painful sensation), PARAESTHESIA (it was sensitive to the touch but no rash or itchiness) and VACCINATION COMPLICATION (side effects) outcome was unknown.        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.   Patient treatment information include Tylenol and Motrin. He was prescribed Valtrex.
PFIZER COVID VACCINE BOOSTER GIVEN 11/21/21, LOT # FJ160; 5/19/2022 pt to ED with c/o SOB, weakness, fatigue, productive cough this morning with blood noted; poor oral intake; taking Levaquin x 1 wk per PCP for pneumonia with improvement; O2 saturation in ED 72% on RA; AHRF; admitted; O2 supplementation; ABX; A Fib with RVR and drop in EF to <15%; cardiology consulted; 5/30/22 pt tested positive for COVID; given steroids; worsening renal and respiratory status; before pt could go to hospice, pt passed away in the hospital
Covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid 19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     There was no information about previous COVID-19 vaccination doses.     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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid 19). At the time of the report, COVID-19 (Covid 19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The dosage text was reported as unknown.  The patient's mother reported that the patient and other people that she had heard of have received the Moderna Covid-19 vaccine and then caught Covid-19. They had a milder case of Covid-19. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734586, US-MODERNATX, INC.-MOD-2003-734594 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734586:Patient's case US-MODERNATX, INC.-MOD-2003-734594:Patient's husband case
Mother states (R) arm swelled & hot to touch. Eyes & face also had swelling. Pt c/o problems with vision due to swelling. Taken to hospital ER where pt was given TYLENOL & instructed to do BENADRYL at home. No testing or other meds were done. Pt remained afebrile & total recovery after 3 days.
Headache, Myalgia, Fever & NauseaVomiting Narrative: Fever, body ache, chills, fatigue, headache, Nausea
This case was reported by a healthcare professional and described the occurrence of injection site warmth in a subject of unspecified age and gender who was vaccinated with Boostrix (GlaxoSmithKline). On an unspecified date the subject received 1st dose of Boostrix (unknown, right arm). At an unspecified time after vaccination with Boostrix, the subject experienced injection site warmth, injection site redness and injection site reaction. At the time of reporting the injection site warmth, injection site redness and injection site reaction were resolved. The healthcare professional considered the events were probably related to vaccination with Boostrix. A total of four subjects were reported to have had an injection site reaction for the other three cases see A0911825A, A0911827A and A0911828A
Had a allergic reaction about 10 minutes after vaccination. Was taken to the ER for a work up.  Gave Benadryl. Had throat tightness, and skin blotchiness.  After I left the hospital. Slept the rest of the evening. Woke up at 3 am with nausea., vomiting, headache, dizziness, fatigue, joint pain, and fever. (100.6 was the highest)  The symptoms lasted about 2 days, and the fatigue lingered until yesterday. Today I am feeling better but my arm is tender, swelled, and itchy.  I have a rash on my arm.  The body aches were very painful.
Reports redness and swelling the size of a quarter. Denies soreness. Occurred approximately 48 hours after the immunization. No treatment used by patient.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with GARDASIL (lot#, expiration date, route and anatomical location unspecified). The registered nurse reported that GARDASIL was not use for the entire HPV vaccination series, due to they ordered the wrong vaccine CERVARIX, from vaccine for children. So some patients received one or two doses of GARDASIL and then, absorbed CERVARIX was used to complete the series. No adverse effects reported. The outcome of patients was unknown. Additional information is not expected.
Shortly after patient received vaccination she states she "didn't feel right". When pharmacy staff checked on her she was seated with her head down on her arms at a table and she said she felt like she had passed out. She continued to state she didn't feel quite right. Her feet were elevated and she was given a paper bag to breathe into. She didn't have any trouble breathing and no rash was visible on the body or around the injection site. She was offered a snack but refused and soon family arrived. Family provided water and crackers and her blood pressure/pulse was taken. Both were low with BP about 84/60 and pulse around 40 BPM. When asked how her BP normally runs she stated it is normally low, but not that low. All of this occurred over the course of an hour or so and after about an hour she stated she felt well enough to walk to her car and be taken home to lie down.
Fever, lethargy. Later developed vomiting and went into heart failure. Preliminary diagnosis of Acute myocarditis.
Received Influenza vaccine at 6:55 pm. 10/26/04 and began vomiting again within 15 minutes of receiving vaccine while still at clinic. Seen and evaluated by doctor that evening 10/26.  Discharged home with parents. Continued to vomit x 2 on 10/27 and has vomited x 3 on 10/28/2004 at time of filing report. Still vomiting as of 10/28/2004.  Follow up on 11/12/04 states: "Note mother had egg allergy but child has never had eggs. Vomiting started in 15 minutes post vaccination and persisted 72 hours. Prescribed clear fluids, small amounts."
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Shingrix (batch number PK9BY, expiry date 19th March 2021) for prophylaxis. On 4th October 2018, the patient received Shingrix (subcutaneous) .5 ml. On 4th October 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 7th October 2018, the patient experienced injection site erythema, injection site itching, extensive swelling of vaccinated limb and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site itching, extensive swelling of vaccinated limb and injection site warmth were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema, injection site itching, extensive swelling of vaccinated limb and injection site warmth to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix subcutaneously, which led to inappropriate route of vaccination. Three days after receiving Shingrix, the patient complained that the site of injection was red, swollen, hot to the touch and itching. The patient said that the site of injection was raised 5 inches around it.
Emesis and increased nausea, hallucinations, and delusions along with restlessness.  Resident is on health care and may be r/t change in condition of heart failure .
Shortly after DTAP vaccine his left upper arm began to swell. It got bright red,swollen, hot to touch and had a rash. He was administered Qdryl(corn free antihistamine)3 times a day for 3 days. It was also treated with Elacon steroid cream for 3 days. He did not have any signs of anaphylaxis. This redness,hotness and swelling with rash lasted 3 days. He had a temperature of 99.6 Doctors office was notified several times. They did not wish to see him unless he had a real fever or anaphylaxis. They said this was a "normal reaction"
Muscle tics; Spasms in left eye and left point finger; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the left arm on 01Apr2021 at 14:15 (at the age of 32-year-old), as a single dose for COVID-19 immunisation. Medical history included seizures. The patient did not have any allergies to food, medications, or other products. Concomitant medications included progesterone cream (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and oenothera biennis oil (PRIMROSE) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 14:30, the patient experienced muscle tics, spasms in left eye and left pointer finger. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events muscle tick/spasms in left eye and spasms left pointer finger was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
It is documented pt given FLUZONE peds lot # ut5897NA. Balancing inventory identified that the dose was pulled from U5913BA.
No adverse effect; the patient was inadvertently administered Gardasil 9, that was improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-OCT-2019, the patient was inadvertently vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # S005524 (reported as 5000024) and expiration date 29-SEP-2021 (exact dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. The temperature was 30.07F for 35 minutes. Previous temperature excursion was 77F for 30 minutes. Digital data logger was involved.
Right deltoid noted with 3 inch diameter area of redness and mild swelling around injection site. Area warm to touch. Instructed mother to apply cold/ ice pack to area (20 min on + 20 min off next 48 hours while child awake). RTC if no improvement after 48 hours.
Pt recvd vax & began to have virus or cold -like sx & then devel urticaria;
pt recvd vax & 9 days p/vax exp Bell's Palsy-rt side of face/forehead; treatment steroids;
Bruise that expanded down the length of arm. Raised and hard bump, 5 weeks later just a small round bruise about 3 inch diameter. Pt says shes fine now.
vertigo; headache; tinnitus loud; extreme fatigue; hand tremor; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 18Oct2021 15:45 (Lot number: ew0168) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Addison's disease" (unspecified if ongoing); "inflammatory disorder" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing), notes: Reaction: Rash; "Have had tinnitus for decades" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX; MYCOPHENOLATE; HYOSCYAMINE; BUPROPION. Vaccination history included: Bnt162b2 (Dose Number: 1, Brand: Pfizer ew 0177, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Event started: 21Sep2021), administration date: 20Sep2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "vertigo", "headache", "tinnitus loud", "extreme fatigue", "hand tremor", "slight disorientation", "memory problems".  The following information was reported: VERTIGO (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "vertigo"; HEADACHE (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "headache"; TINNITUS (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "tinnitus loud"; FATIGUE (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "extreme fatigue"; TREMOR (non-serious) with onset 18Oct2021, outcome "recovered with sequelae", described as "hand tremor". The events "vertigo", "headache", "tinnitus loud", "extreme fatigue" and "hand tremor" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, headache, tinnitus, fatigue, tremor.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
moderate pain at injection site; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The physician self reported the case was himself. The age at vaccination was not reported. The patient was approximately 59 years of age. The patient experienced moderate pain at injection site. For tolerance of 2nd dose, refer case US2021AMR206649, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206649:same reporter
Fever, chills, migraine, hot flashes, slurred speech all night after receiving dose. Next morning deep, painful cough.
Caller's father didn't receive 2nd dose on time; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller's father didn't receive 2nd dose on time) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller's father didn't receive 2nd dose on time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller's father didn't receive 2nd dose on time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, after receiving the first dose of mRNA-1273, patient underwent Brain surgery. Concomitant medication and treatment medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-Jun-2021 contains no new information.
Something occurred in the syringe that not the 0.5 mL entered her arm and part spilt out; Something occurred in the syringe that not the 0.5 mL entered her arm and part spilt out; A spontaneous/solicited report was received from a consumer concerning herself, a 76 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that  something occurred in the syringe so that the 0.5 mL did not enter her arm and part spilt out/device connection issue and underdose.  The patient's medical history included breast cancer and cholesterol (not further specified). Products known to have been used by the patient, within two weeks prior to the event, included medicine for blood pressure (not further specified), vitamins, atorvastatin calcium and nebivolol hydrochloride.  On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, during administration, the patient reported that something occurred in the syringe so that the 0.5 mL did not enter her arm and part spilt out. No treatment information was provided.   The second dose of mRNA-1273 was scheduled for 18 Feb 2021. Action taken with mRNA-1273 in response to the events was not reported.  The events, something occurred in the syringe so that the 0.5 mL did not enter her arm and part spilt out, were considered resolved on 22 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered, and underdose for mRNA-1273, lot # 026L20A with no associated AEs.