chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Headache; Sore Right Arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and PAIN IN EXTREMITY (Sore Right Arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PAIN IN EXTREMITY (Sore Right Arm). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and PAIN IN EXTREMITY (Sore Right Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medications was provided.
pt diagnosed positive for COVID, received monoclonal antibodies and afterwards became hypoxic, transferred to ED and admitted to hospital; hx of CAD, OSA, COPD; O2 @15 L via NC; pt found in room with O2 off her face; coded a total of 3 x; after the last code, family made her a DNR; pt's condition worsened and she died in the hospital; COVID pneumonia
Administered only the liquid component; Administered only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number Amxa656a, expiry date unknown) for prophylaxis.   On 13th June 2022, the patient received Menveo. On 13th June 2022, unknown after receiving Menveo, 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 Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comment: Office manager reported that yesterday (day before reporting) a patient administered only the liquid component of Menveo. The reporter consented to follow-up via postal mail. Additional supportive information: The patient received only the liquid component of Menveo, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The lot number Amxa656a was provided, but GlaxoSmithKline could not find a match. This may need to be clarified.
This spontaneous report as received from a physician refers to a patient of unknown age. No information provided regarding medical history and concurrent conditions. On an unknown date of December-2013 (reported as 5 months ago) the patient was vaccinated with ZOSTAVAX lot # J003360, expire date 21-JUN-2014, (route, frequency, dose number not reported). No concomitant medication reported. It was reported that the physician administered the ZOSTAVAX that reached 77 F for 30 minutes. No PQC. The ZOSTAVAX was not supported by this temperature and time frame. No adverse effect reported. Additional information has been requested.
Patient reports an onset of itching and rash 7 days after the administration of the first dose. Patient is now treated with OTC oral antihistamine and triamcinolone BID.
The patient has a 3cm dark red area noted to her posterior right upper arm surrounded by a 7 inch long x 2.5 inch wide area of erythema.
On 02/23/02 above minor complained of pain at injection site. an area 3cm in diameter was red, indurated and tender to touch. Area warm to touch.
Suspected Vaccination Failure; it was shingles; I found a spot on my forehead; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and spot-like rash. On an unknown date, the outcome of the vaccination failure, shingles and spot-like rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and spot-like rash to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. Few years after receiving Shingles vaccine, the patient found a spot on his/her forehead.  The patient went to the doctor and found it was shingles.  The patient stated that, he/she was lucky he/she had been vaccinated. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
I had a slight fever; some chills; a slight overall achiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2020AMR070624.).   On 22nd April 2020, the patient received the 2nd dose of Shingrix. In April 2020, 24 hrs after receiving Shingrix, the patient experienced fever, chills and general body pain. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient could be 66 years or 67 years old at the time of vaccination. The patient received Shingrix and had a slight fever for about an hour 24 hour after the vaccine and also felt some chills and a slight overall achiness. The reporter wanted to know could that have been a vaccine response even though she did not have that reaction from the first one.
Information has been received from a registered nurse (RN) concerning a 10-month-old infant who on 12-APR-2006, was vaccinated PO with the 1st dose of ROTATEQ. Unspecified medical attention was sought, but no adverse events were reported. Additional info has been requested.
Pt noted increased weakness and has had increased falls since receiving the booster.  tolerated 1st and 2nd doses well.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 03Aug2021 (Lot number: EW0169) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Diabetic" (unspecified if ongoing), notes: Verbatim: Diabetic; "Verbatim: Cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol; "Verbatim: Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: INSULIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "Sore arm". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: He took insulin and also a pill for diabetes, blood pressure, for cholesterol. It was reported that reporter (Wife) also experienced sore arm after the first shot. Reporter stated, "The only thing we had was sore arm for a day and half and nothing else but with the second dose this went with his blood sugar." My husband I received our second dose of the vaccine, yesterday and just my husband is diabetic (Intent: Medical history). Second Shot was on 24Aug2021.  Follow-up attempts are completed. No further information is expected.
THE PATIENT FILLED OUT THE FORM SAID THAT IT WAS HER FIRST SHOT.   I TALKED HER WHEN I RANG HER OUT VERIFIED AGAIN IT WAS HER FIRST SHOT AND DISCUSSED POSSIBLE SIDE EFFECTS.   WE GAVE HER THE SHOT THEN I WENT TO RECORD THE SHOT AND REALIZED THAT SHE HAD GOTTEN A FULL COURSE OF PFIZER THAT STARTED IN DECEMBER OF 2020.  I THEN TALKED TO HER ABOUT HOW IT SHOWED HER COMPLETED DOSES OF PFIZER AND SHE HAD TOLD ME SHE HADN'T RECEIVED ANY DOSES YET.  SHE SAID THAT IT WAS HER PROBLEM AND NOT MINE.  BUT I SAID NO IT WAS MY PROBLEM TOO BECAUSE NOW I HAVE TO CALL MY MANAGER AND THEN SHE WALKED AWAY.  I THEN TRIED TO CALL THE PHONE NUMBER LISTED AND IT WAS NOT HER NUMBER.
Pt. rec'd first vaccine on 01/11/2021. Returned for 2nd dose on 02/05/2021. Pt. reported swelling of face, eyes, lips and tongue, and hives.  Did not receive 2nd shot. Referred to allergist for f/u.
Patient experienced dizziness, numbness  and fainted two days after vaccine. Complained of not being able to hear prior to fainting. Also experienced nausea and swelling in the arm. Also felt occasional numbness in leg 1/28 ( 3 days after).
The patient lost consciousness a few minutes after receiving the shot while walking back to his seat for monitoring. He came too after just a minute and we gave him a ice pack. His blood pressure was normal and his pulse was also within range. Patient was very warm to the touch.
Information has been received from the authors in a published literature article, title as above, regarding 7 (also reported as 24% of 28 patients) adolescent or young adult parents of unknown age (between 13 to 26 years) and gender with perinatally acquired human immunodeficiency virus (PAH). On an unknown date, the patients were vaccinated with a dose of MMR II (Manufacturer unknown) (Lot number, expiration date, strength, dose and frequency were not provided). Concomitant medication was not reported. On an unknown date, despite appropriate prior vaccination, the patient experienced measles non-immunity which was defined as IgG titers < 120 miU by plaque reduction neutralization (PRN) assay and < 0.70 IU by measles enzyme immunoassay (EIA) (vaccination failure and seroconversion test negative). The outcome of vaccination failure and Seroconversion test negative was unknown at the time of the report. The reporter considered vaccination failure and Seroconversion test negative to be related to MMR II (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experienced. This is one of several reports from the same source (MARRS# 1601USA010845, 1601USA010937, 1601USA010936). Additional information has been requested.
Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. Subsequently the patient experienced food poisoning. It was reported that the patient was one week later for her second dose because she was recovering from food poisoning. No symptoms or problems were noted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Developed E Multiforme rash on face, trunk & extremities. Fever to 105.7. Got shots on Wed. 10/27/99. Rash started 6 days later on Tues. 11/2/99. Was, also, on Amoxicillin during that time.
Information has been received from a registered nurse (the patient's wife) referring to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (strength was reported as 19400PFU, dose and route were unknown). The patient's concomitant medication was not reported. On an unknown date about two years later, the patient got a small case of the shingles. The outcome of the event was unknown. The reporter considered the event to be not related to ZOSTAVAX. This is one of two reports received from the same reporter. Additional information has been requested.
I got up the next morning and notice white spots on right side of forehead, eyelid and over brow. It also feels like scalp and puse bumps are on my scalp.  After about 4 days, it began to heal and scab up.
pt recv vax 1MAY95 & 1JUL96 pt exp failure to seroconvert based on lab values;
The pt experienced a fever of 102, fussiness, high pitch screeching cry, vomiting, crying lasted for 3 hours.
Hypertension Crisis 232/147 6/22/21-6/25/21, went to the ED on 6/22/21 , ativan and aspirin. Symptoms resolved and BP returned to normal 118/76.
sore arm; Tired; Left jaw feels tight, stiff and hard to open; Tender to touch; Both lymph nodes on back of her head have swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Left jaw feels tight, stiff and hard to open), LYMPH NODE PAIN (Tender to touch), LYMPHADENOPATHY (Both lymph nodes on back of her head have swollen), PAIN IN EXTREMITY (sore arm) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Herniated disc (herniated disc in neck). Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Both lymph nodes on back of her head have swollen). On 12-Apr-2021, the patient experienced JOINT STIFFNESS (Left jaw feels tight, stiff and hard to open) and LYMPH NODE PAIN (Tender to touch). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (Tired). At the time of the report, JOINT STIFFNESS (Left jaw feels tight, stiff and hard to open), LYMPH NODE PAIN (Tender to touch), LYMPHADENOPATHY (Both lymph nodes on back of her head have swollen), PAIN IN EXTREMITY (sore arm) and FATIGUE (Tired) outcome was unknown.            Additional concomitant medication included a steroid (unspecified).  On 12APR2021, lymph nodes on back of her head became more swollen.   Treatment medication information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-075078 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075078:Link to Dose 1 case
Whole body aches, dizziness, nausea from the pain Took Advil, laid in bed, slept for almost 24 hours.
Patient presented to the ED on 4/6/21 with Atrial fibrillation with RVR. Patient presented to the ED on 4/11/21 and was subsequently admitted with Atrial flutter with rapid ventricular response.
Diarrhea: Sever stomach pains began around 5:00 am, 18 hours after receiving my second dose of the Moderna vaccine. The diarrhea lasted for roughly an hour, and then the stomach pains subsided.  I also experienced difficulty sleeping prior to the diarrhea. My heart rate was elevated, and I couldn?t stay asleep.  I was also achey the entire day after my vaccination, but there were no other serious side effects.
The following month, my period was a week late. I am always regular. In August, I started noticing that my hair has been falling out in clumps. I haven?t had Covid (that I?m aware of). I had blood work taken to check my thyroid and vitamin levels. Those all came back normal. My hair is still falling out, but my cycle has pretty much returned to normal after 3 irregular months.
Pt vaccinated with DTP developed persistent inconsolably crying over 24 hr period, temp 102.R.
Erythema and itching around injection site; one hour later flushing and hives, then headache, 3 hours after injection developed wheezing, diarrhea, increased respiratory secretions; two days later still have significant erythema and induration inferior to injection site.
Fever; Aches; Joint pain; Headache; Nausea; Chills; Injection site pain up to shoulder; Weakness; Tired; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 17:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, GERD (gastroesophageal reflux disease), HBP (high blood pressure), penicillin allergy and COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and pantoprazole sodium sesquihydrate (PANTOPRAZ); all taken from an unknow date for unknown indications. The patient previously took meloxicam and experienced a drug allergy. Prior to the vaccination, the patient was 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 COVID-19 vaccination. On 09Apr2021 at 12:30, the patient experienced fever, aches, joint pain, headache, nausea, chills, injection site pain up to shoulder, weakness, tired and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, aches, joint pain, nausea, injection site pain up to shoulder, weakness, tired, diarrhea was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Within about an hour receiving the booster my right wrist swelled up. The injection caused an inflammatory response. By about 3:00 p.m. my vision became challenging. I don't know the best way to describe it other than "off." My eyes became watery and I didn't want to drive a car because I could tell my vision was "off." I seemed to feel ok while laying down. By that evening around 6 p.m. felt like I had a hangover without the nausea. I can only describe the feeling as "wonky." It was an effort to move around. I didn't do anything that I didn't have to do. These symptoms continued daily. On Tuesday I noticed that my brain became affected. It was scary. My son came home from school. He was petting our 4 year old dog and I petting our 8 year old cat and I said "don't we have the best puppies?" I mean nothing that crazy has ever come out of my mouth. Then I walked with my daughter. We crossed a street and I was looking to my right to look for cars and I said to her "always look left at this intersection." and she's like mom that is right. It continues with these examples...one night I made tater tots and I called them hash browns 3 times even after my family corrected me. These are not things that happen. Never have I ever made so many brain disconnection mistakes. By Thursday I made an appointment to see my primary care physician. I saw him today and he asked me to report these symptoms on this website. My brain as of yesterday January 24th seems much improved. I feel 80% less wonky but my vision still feels affected.
tested positive for para influenza 4; headache; fever; body aches; chills; Sore throat; coke and congestion; administration_date=16/Aug/2021, dose_number=1/ other_vaccine_same_date_vaccine_date=16/Aug/2021,other_vaccine_same_date_dose_number=2,; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 (Lot number: FC4182) at the age of 26 years as dose 2, single and administered in arm right, administration date 16Aug2021 12:45 (Lot number: RC3180) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 16Aug2021, outcome "not recovered", described as "administration_date=16/Aug/2021, dose_number=1/ other_vaccine_same_date_vaccine_date=16/Aug/2021,other_vaccine_same_date_dose_number=2,"; HEADACHE (non-serious) with onset 11Sep2021 02:00, outcome "not recovered", described as "headache"; PYREXIA (non-serious) with onset 11Sep2021 02:00, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 11Sep2021 02:00, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 11Sep2021 02:00, outcome "not recovered", described as "chills"; OROPHARYNGEAL PAIN (non-serious) with onset 11Sep2021 02:00, outcome "not recovered", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 11Sep2021 02:00, outcome "not recovered", described as "coke and congestion"; RUBULAVIRUS TEST POSITIVE (non-serious), outcome "not recovered", described as "tested positive for para influenza 4". The events "administration_date=16/aug/2021, dose_number=1/ other_vaccine_same_date_vaccine_date=16/aug/2021,other_vaccine_same_date_dose_number=2,", "headache", "fever", "body aches", "chills", "sore throat", "coke and congestion" and "tested positive for para influenza 4" were evaluated at the 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 headache, pyrexia, pain, chills, oropharyngeal pain, nasal congestion, rubulavirus test positive.  Additional information: No known allergies. The most recent COVID-19 vaccine was administered at Pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient received Antibiotics as treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has been tested for COVID-19. Adverse event required a visit to Emergency Room/Physician Office/department or urgent care/Doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.
pt c/o sweating, feeling lightheaded, 20-25 min p/vax;resp 18 nl, BP 140/80, P80;pt sweating profusely, cool towel applied to forehead, pt lay down on sofa, Vs retaken & same as above 911 called & pt taken to ER to be seen by MD;
DTAP # 5 was given left deltoid on Oct. 29, 2002. On Nov. 1, the child was seen by the doctor because of severe swelling of her upper arm. It was noted severe swelling, redness from his shoulder to his elbow, afebrile, mobility, WNL, c/o slight discomfort to the touch. Antihistimine prescribed.
Pt recv vax on 3/6/99; post vax pt exp sick w/ queasy, vax site swollen,sore,tender, body aches, no energy
This spontaneous report was received from a patient of unknown age and gender, reporting on themself. The patient's concurrent conditions included diabetes; pertinent medical history, drug reactions and allergies were not reported. On unknown dates, the patient was vaccinated with ten doses of VARIVAX injection (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies included NOVOLOG and LANTUS. The patient was receiving one dose of VARIVAX every month. The patient stated, that with every dose of VARIVAX, they needed less and less insulin. According to the patient, it cured their diabetes and "made the patient beautiful". No further information was provided. Product quality complaint (PQC) was not involved. Additional information is not expected, as there was no contact details.
Inadvertently administered MMRV and should have given MMR and VAR single antigen. This was because client had a history of seizures.
Had soreness and joint pain after the first injection (1/13/21).  She received her second vaccine yesterday, 2/10/21 (1pm CST).  At 11pm, last night began feeling rapid change in body temperature.  Severe joint pain and headache.  Currently reporting prickly skin feeling, throughout her entire body (2/11/21  - 11am CST.