chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like illness; broke out; chills; shaking; fever; sweats; Initial information regarding an unsolicited valid non-serious case was received from Pfizer (non-licensed partner) (Control No: 2021233809) in the form of courtesy via a consumer or non-healthcare professional and transmitted on 10-Mar-2021.   This case involves female patient (age not reported) who experienced broke out (rash), flu like illness (influenza like illness), chills, shaking (tremor) and fever (pyrexia) and sweats (hyperhidrosis), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  In 2016, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination (reported as high dose flu shot but trade was not reported).  In 2016, the patient developed a non-serious broke out (rash), flu like illness/ flu type stuff (influenza like illness), chills, shaking (tremor) and fever (pyrexia) and sweats (hyperhidrosis) and I couldn't get warm within 5-hours following the administration of INFLUENZA VACCINE.  This case report's flu like illness after over 65 year flu shot which lasted the entire nigh. Caller reports that patient looked at the ingredients and the only common thing is the sodium and she want to know, could that have something to do with the reaction she had Caller reports, Since then she have taken the regular flu shot without a problem, and her doctor told her don't take the over 65 flu shot. reporter asks for guidance on getting the coronavirus disease of 2019 (COVID) vaccine. Patient was afraid if she is going to experience an adverse event from the COVID vaccine like she did with the flu vaccine. Reporter says that patient was scheduled to get her COVID vaccine in that afternoon and the reason that she is calling because previous reaction to flu shot. She tried to look up the ingredients of new COVID vaccine versus the ingredients in the flu vaccine and the only thing that the two have in common that she can see is the sodium. She is wondering if that would have anything to do with what she experienced. She is afraid that she is going to experience an adverse event from the COVID vaccine like she did with the flu vaccine. Caller declined to complete a safety report at this time and asked to be transferred for her question to be answered. She says she has to call if she is going to be late to receive her vaccination and she doesn't want to mess it up for her receiving her vaccine. Caller declined to complete a safety report and unable to obtain further information needed for report including lot number, expiry date for previously received flu shot and supplemental form. Investigation assessment: not provided  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all the events.  There will be no information available on the batch number for this case.
Service member accidently received second dose of Pfizer vaccine 1 week before scheduled second dose.  Members CDC card was misread as the patient receiving His first dose of Pfizer 8/02/21. Patient received the vaccination and was placed in observation for 30 minute total. Patient reported he felt fine after 30 minute observation period.  He was told to follow up with a medical provider should he experience any changes in health status.
Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 29-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy from January 2017 to 04-Oct-2017. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 08-Feb-2021 to an unknown date for an unknown indication.    On 09-Feb-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 21-Dec-2020 and the estimated date of delivery was 27-Sep-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Pregnancy test: positive (Positive) positive.     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 treatment information was provided.  No concomitant medication was provided.
she inadvertently gave Infanrix instead of Tdap; 7 year old twin siblings; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 7-year-old female patient who received DTPa (Infanrix) (batch number 7p9nj, expiry date 02-NOV-2024) for prophylaxis.   Previously administered products included DTPA-HBV-IPV (1st dose received on 30-JUL-2016) and DTAP + HIB + IPV (2nd dose received on 23-NOV-2016).   On 18-OCT-2023, the patient received Infanrix. On 18-OCT-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: she inadvertently gave Infanrix instead of Tdap) and inappropriate age at vaccine administration (Verbatim: 7 year old twin siblings). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2023 Registered nurse reported that she inadvertently gave Infanrix instead of Tdap to two 7 year old twin siblings yesterday as part of catch-up, which led to wrong vaccine administered and inappropriate age at vaccine administration. Registered nurse states their records only show patient received 2 doses of DTaP but the mother of twins said the patient received a 3rd dose as well as her twin sister The reporter consented to follow up. Did not clarify brand name of previous doses. This case had been linked with US2023145259, reported by the same reporter for 2nd patient.; Sender's Comments:  US-GSK-US2023145259:Same reporter, 2nd patient
This spontaneous report as received from a registered nurse refers to a female patient on her 20's. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number not provided). On an unknown date the patient's mother called into a TV show to report her daughter experienced early menopause after administration of GARDASIL. The patient's outcome was unknown. The causal relationship was not provided. The mother stated her other experienced the same event (MARRS 1312USA010376). Additional information has been requested.
0.5mL Moderna instead of 0.25mL  Moderna was administered as a booster dose. Pt tolerated procedure well and left in stable condition.
Muscle pain-mild from hour 8 to hour 15 Nausea- all morning- mild  Chills- from hour 8 to hour 20 Fever- up to 100.8 until alleve taken at hour 19 Extreme fatigue- noticed from hour 8 through hour 24 Headache- from hour 3 until hour 24; decreased with alleve but not completely gone Palor- until hour 24
Hives on face, Facial swelling, facial redness, face felt like burning,  shortness of breath
Depression, rash, and skin itch, lower back and back pain and others. Per 60 day follow up patient has not recovered has depression. All my records are at the VA.
Grand Mal seizure; Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 28Apr2021 at 14:00 (lot number: EW0158) at single dose for COVID-19 immunization. The relevant medical history included epilepsy, childhood leukemia and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19), all from unspecified date. Concomitant medications included lamotrigine (LAMICTAL ODT). The patient experienced Grand Mal seizure and heart palpitations on 29Apr2021 at 18:00. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
Sent: 3/4/2021   7:55 AM Subject: Non-Urgent Medical Question                    For a full week now, I have been battling diarrhea and a very hyperactive stomach and intestines. Provider prescribed some bentyl Sunday to ease my cramping. At early onset I had some nausea too. I'm wondering if I don't need some blood work, whatever you think and maybe recheck my TSH too. Dr. already ordered a UA with culture which were both negative. That was done because of back pain over left kidney a couple of weeks ago. Diagnosis: Theo. My intestines have never been right since my surgery, but this gassiness and hyperactivity is much more extreme. I tried Metamucil and it blew my guts up even worse. I know I'm due for a CT scan. I see Dr. March 22. I'm trying to hold off until then because I want to discuss with him why I prefer to have all scans at specific facility. I just wanted to get your advice since it's been a week now. I did get my second Moderna vaccine on February 15 and  Fulvestrant injections on Feb. 22. My issues started on Feb. 25. Oddly, right now as I'm typing this, my gut is much calmer. Yesterday was my worst day with diarrhea.  3/13/21 ER for back pain - transferred to second hospital - remains admitted there as of 3/16/21 History of Present Illness:  Patient is a 68-year-old female with known metastatic ovarian cancer under active treatment since 2004, currently on fulvestrant after a massive debulking surgery by Dr. last July (2020).  Patient presented to outlying emergency room with flank pain & transferred here with severe bilateral hydronephrosis on imaging.  Patient had severe left flank pain about 2 weeks ago. Treated with tylenol, motrin, and heat and pain eventually dissipated. Then Tuesday and Wednesday pt did a lot of yard work and lifting. Thursday patient woke up with excruciating right flank pain.  Nothing has made it better.  Patient has tried ice, heat, tramadol Tylenol, Motrin, steroids and pain persists.  Additionally patient having nausea and vomiting.  She has started to have burning with urination.  Pain is excruciating stabbing.  Radiates to the groin.  Patient has also started running fevers today.  She feels pretty miserable.   Also patient notes difficulty with her bowels since her last surgery.  Prior to surgery she took Linzess every day.  Since surgery it has been suggested she does not need this medication.  Patient does note little to no notice when her bowels decide to move.  Severe significant gas.  Other times patient feels quite constipated.   UA suggests possible infection with positive nitrites, 1+ leukocyte esterase and 3+ blood.  WBC 2.1, Cr 1.0, K 3.0 CT scan with multiple abnormalities, but most notably severe bilateral hydronephrosis without obvious obstructing lesion.  Multiple scattered nodular densities concerning for metastatic disease.    Patient transferred for higher level of care and urology consultation.
Following injection within 5 min face and fingers became numb. Developed nausea and confusion, minor difficulty breathing. 24 hours later injection site red, hot no swelling, remains painful.
Shingles on left side of neck & left ear lobe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jun2022 as dose 3 (booster), single (Lot number: FP7135) at the age of 54 years, in left arm for covid-19 immunisation. Patient was not pregnant at time of vaccination. The patient's relevant medical history included: "Sulfites Allergy" (unspecified if ongoing), notes: Known allergies: sulfites. Concomitant medication(s) included: FISH OIL [EICOSAPENTAENOIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]. Other medication details reported as might have taken EPA/DHA fish oil, vitamin B12. DK. Vaccination history included: BNT162b2 (lot number: FT1614, dose number 2, vaccine location Left arm), administration date: 28Jan2022, when the patient was 54-year-old, for COVID-19 immunization; BNT162b2 (lot number 33130BA, dose number 1, vaccine location Left arm), administration date: 07Jan2022, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 22Oct2022, outcome "recovered" (2022), described as "Shingles on left side of neck & left ear lobe". The event "shingles on left side of neck & left ear lobe" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of herpes zoster.  Additional information: Treatment included antibiotics & then antivirals with antibiotics. If other vaccine in four weeks reported as no.
Friday July 8th I woke and noticed I was coughing more than normal. I have a regular cough due to my prescription, lisinopril. I had just got back from a cruise. I took a COVID-19 test at 1:00pm on Friday and it was positive. I took a second home test and it also positive. Very rapidly, I noticed I had more coughing, sneezing, nasal congestion, body aches, headache and I ran a fever of 101. This all happened by midnight. I had trouble sleeping. Friday and Saturday were the worst. I self medicated with TYLENOL and SUDAFED PM. I had terrible sinus pressure. I had trouble sleeping again. Sunday I felt slightly better, but still uncomfortable. By Sunday night I felt much better. Oxygen levels have been normal and my fever broke. I woke up today, Monday, and I feel almost back to normal.
Guillain Barre diagnosed 7/26/12. Received Pneumonia vaccine 7/13/12.
Full Body aches, nausea, headache, rash at injection site. Patient stated he stayed in bed for 2 days and used 1 Aleve 220mg tablet for pain on the second day. Patient reported symptoms were resolving today 9/28/2018, however still had some body aches. All AEs have been known with this vaccine, however they seemed more pronounced than normal in this patient. Advised patient to continue to monitor symptoms and use OTC pain medications for body aches. Directed patient to be seen by doctor if any new symptoms arise or current symptoms become worse.
Maxillary facial swelling starting approximately 20 hours after second dose of vaccine.  Persistent for 3 days without involvement of airway.
Varivax was ordered by MD/ZOSTAVAX given by error. Both meds side by side on freezer shelf. Merck contacted, observe child. Child was without any side effects after 24 hours.  Mother reporting some headache but improving with time and red area at injection site and also improving with time.
Terrible pain in my neck,neck pain; Injured myself lifting something; This spontaneous case was reported by a nurse and describes the occurrence of NECK PAIN (Terrible pain in my neck,neck pain) and INJURY (Injured myself lifting something) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Fibromyalgia and Cervical spine degeneration. Concomitant products included DULOXETINE, PREGABALIN (LYRICA), AMFETAMINE SULFATE (AMPHETAMINE SALTS), ATENOLOL, FLUTICASONE and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced NECK PAIN (Terrible pain in my neck,neck pain) and INJURY (Injured myself lifting something). At the time of the report, NECK PAIN (Terrible pain in my neck,neck pain) had not resolved and INJURY (Injured myself lifting something) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has comorbidities that were diagnosed years prior receiving any Moderna COVID-19 vaccination,about 8 years prior. No treatment medications were reported.  Reporter stated that patient went to the chiropractor and she  tried heat and ice.   This case was linked to MOD-2021-416978 (Patient Link).
A non-serious spontaneous report of oral administration of FLUMIST and inadvertent oral administration to 7 month old was received from a health professional concerning a seven-month-old female. On 12-Sep-2011, the patient received FLUMIST orally. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Dec 17th, my throat felt scratchy, 45 minutes later I was wheezing.
States experienced itchy hands/feet, general itchiness starting Sunday PM.  States also experienced indigestion/heartburn, tiredness (not extreme) and soreness in the clavicle area on both sides of body.  Took Claritin and sx have resolved by Monday
Narrative:  COVID infection following completion of COVID vaccine series: 01/07/2021 COVID vaccine dose #1 02/04/2021 COVID vaccine dose #2 07/02/2021 Pt presented to ED c/o 1-day hx of myalgias, chills, productive cough, and low-grade fever 07/02/2021 COVID positive based on plasma sample test. Pt admitted to hospital due to hypoxia. 07/03/2021 Pt placed on 4L NC due to desaturating to 84%. SPO2 improved to 96%. 07/03/2021 Pt received albuterol SVN 2.5mg/3ml. Pt not on supplemental oxygen. 07/04/2021 Pt reported continued nonproductive cough and dyspnea with exertion. Denied chest pain and was afebrile. O2sat was 89-93%. Pulse ox alarms occurred overnight resulting in pt being placed on 4L NC. 07/04/2021 Pt started remdesivir (course will complete on 07/09/2021). Pt continued on IV steroids, Symbicort, Combivent, and Mucinex. 07/06/2021 Pt reported feeling better. Breathing improving with minimal productive cough per MD attending note. Pt currently afebrile with no chills, N/V. 07/06/2021 Slow steroid taper initiated 07/06/2021 PAP equipment setup with CPAP 10 and full face mask 07/09/2021 Discharged from hospital 07/10/2021 Pt reports being back to baseline 07/27/2021 Pt returns to ED with c/o bilateral leg edema, SOB at rest and with physical activity, continues COVID positive, discharged with rx for furosemide
Presented with weakness, decreased appetite; Covid-19 + ED; admitted with Covid PNA; TX steroids, remdesivir, Vitamin C, Zinc, nebs, supplemental O2. Patient was admitted to the medical floor and ID consult requested from Dr. He was continued on IV Decadron and IV remdesivir. Developed confusion episodes likely from underlying dementia or Covid-19 encephalopathy. His symptoms gradually improved and discharged to home in stable condition with PO steroids.
Fever increasing throughout the day.  Currently 102.8 degrees.  Taking Tylenol.  No energy to move, chills, muscle aches, arm pain.
Shortness of breath! Felt like I was going to pass out ! Raised my blood pressure to 189 /90 ! I could have a major anxiety attack ! Felt like my heart was going to explode. Then I was hot and cold numb then not
blood clot in my left eye, swelling of the eye and under the eye.  headaches at the base of my skull so bad nothing helped.  Joint pain so bad I couldn't walk for 2 days.
I had an annual mammogram on February 12, 2023. I was tested further and diagnosed with cancer, female infiltrating ductal carcinoma in my left breast. I had a biopsy and I have surgery to remove on March 30, 2023.
After administration of the vaccine in my left shoulder, I experienced discomfort in my arm. This discomfort continued to worsen and become painful as days progressed. The pain begin to generate from my shoulder down my upper arm. I lost many nights of sleep and have been unable to perform many activities. It is affecting my quality of life, and is still very painful 7 months later. After failed results with Ibuprofen and Aleve (and/or generic versions), my PCP prescribed Prednisone. Prednisone did not provide any relief. My PCP then ordered an MRI of the left shoulder. The results of this MRI indicated partial thickness rotator cuff tear with impingement. I am now being referred to an Orthopedic specialist for further evaluation and treatment.
This is a spontaneous report from a contactable other hcp (nurse). A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FC3181, Expiry: unknown), via an unspecified route of administration, administered in Arm Right on 10Aug2021 17:00 (at the age of 14-year-old) as dose 2, 0.3 ml, single for covid-19 immunisation. Medical history included cellulitis staphylococcal from an unknown date and unknown if ongoing No adversity, cardiac disorder from an unknown date and unknown if ongoing taking precautions,patient grandmother, neoplasm malignant from an unknown date and unknown if ongoing Four times,taking precautions,patient grandmother, asthma from an unknown date and unknown if ongoing taking precautions,patient grandmother. No concomitant medications. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FA7484, Expiry: unknown), via an unspecified route of administration, administered in Arm Right on 20Jul2021 (at the age of 14-year-old) as dose 1, single for covid-19 immunisation. On 11Aug2021, the patient experienced swelling and stiffness in arm, legs feeling weak and wobbly. The reporter stated that This morning when he woke up he started hollering that he felt like he was burning up inside he told her that his legs felt weak and wobbly. She checked his temperature and he had no temperature. She told him to crawl back in bed. The events did not result in emergency room or physician office visit. The reporter seriousness for swelling and stiffness in arm was non serious. No relevant tests were done. The outcome of the events was unknown.
Patient seen in ER with pulmonary embolism , (L) lower extremity blood clot
4/7/21 @ approximately 7:00am- I felt a burning sensation on the left side of my chest and upper back.  Went on for most of the morning then subsided. Did NOT have trouble breathing.  4/6/21 @ approximately 4 pm - Low grade fever (highest temp was 100.6) headache, fatigue. Still have these symptoms today 4/8/21
Pt devel warmth & erythema @ inject site p/recvd DT/OPV/TB tine test; The area involved was larger than a quarter in size;
reported today that she had a reaction to first vaccine of hives all over trunk and arms within 48 hours of receiving vaccine. She discussed this with her doctor at that time, and they decided for her to receive the second shot. On the second shot paperwork there is no indication of previous reaction, so reaction was not discussed with or brought to the attention of pharmacist prior to second vaccination. Patient reported today that after second vaccine she had even worse reaction of hives and ended up hospitalized because they are internal as well including inside her throat, nose, and ears. Patient is currently being treated with prednisone and cyclosporine and seeing an ID specialist.