chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose hot red spot on arm; 2nd dose baseball size sore spot; 2nd dose red hot spot on arm; A spontaneous report  was received from a Healthcare Professional concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hot spot on arm, red spot on arm  and baseball size sore spot on arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unspecified date, the patient received their first of two planned doses of mRNA-1273 (unknown batch number) for prophylaxis of COVID-19 infection. The adverse events reported to the first dose included swelling in arm and red arm.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (unknown batch number) for prophylaxis of COVID-19 infection. The adverse events reported to the second dose included hot spot on arm, red spot on arm  and baseball size sore spot on arm. The patient reported to have taken medications Advil and Tylenol prior to second dose of vaccination. Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 3 Feb 2021, the outcome of events hot spot on arm, red spot on arm  and baseball size sore spot on arm were not reported.
On Novemer 13 came down with chills. The following day had chills, cough, congestion and tested with at home antigen test and was positive.
Left upper arm erythematous around Varivax site. No warmth or swelling. Approx 6cm in circumference
Reaction at Injection Site - Dark Brown color patch size almost  6" long * 3" wide
Pt presented to clinic with hives/itching on entire body, torso, and extremities, was treated with Dexamethasone IM and improvement was seen after a few hours. She states rash began the evening before. She was unable to take PO Benadryl due to working.
pt recv vax 20MAR96 & 7APR96 pt exp 3 papillary lesions (one rt upper arm, one on abd, one on buttock) & fever of 101;
Fever, up to 101.0 Tired Headache Achy Sore at injection site Took Extra Strength Tylenol gelcap 500 mg, dose 2 6 hours apart
On 12 Oct 2006, two days after receiving FluMist therapy, a 42 year old female nurse patient experienced, feeling sick, fever like symptoms, thick mucous, congestion, diarrhea, stomach pain, joint pain and teeth pain. The sick feeling, fever like symptoms, diarrhea and stomach pain resolved on 16 Oct 2006. On 16 Oct 2006, six days after receiving Flumist therapy, the patient experienced coughing and bronchitis. The congestion began to manifest itself at night as well. These events persisted for two weeks. On 09 Nov 2006, the patient was seen by her primary care physician and described the events. No X rays, cultures or labs were taken. The patient was placed on Ketek and Medrol dose pak  therapy. The events of joint pain, teeth pain, coughing, thick mucous, congestion at night and bronchitis resolved on 16 Nov 2006. The patient indicated that she was able to breathe freely and that her lungs were clear. On 25 Nov 2006, 46 days after receiving FluMist therapy, the patient experienced abdominal pain, which progressed to blood diarrhea. A computed tomography scan on 25 Nov 2006 showed an enlarged right, colon, but a mal closure could not be ruled out. On 30 Nov 2006, 51 days after receiving FluMist therapy, the patient was hospitalized for bloody diarrhea. The initial clinical impression was clostridium difficile. The patient was treated with Dilaudid, hydration therapy and clear liquids. The patient indicated that she received no antibiotic therapy while hospitalized. She was discharged on 03 Dec 2006. The events of abdominal pain, blood diarrhea and bacterial colitis were resolved at that time. The patient indicated that the events of abdominal pain, bloody diarrhea and bacterial colitis were most likely due to Ketek therapy. No reporter causality as it related to FluMist therapy was provided.
Muscle weakness. High Fever (102) Chills Nauseous severe Stomach Pains Generally unwell Sore arm
Arm soreness starting approximately 4 hours after injection until approximately 72 hours after injection.  Mild injection site itching for the same period of time.
Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours, Extreme fatigue-5 days, Chills-8 hours, Fever-3 days (reducing in severity each day), arm pain in shot area- mild and continuous for 6 days.
Started feeling achy with head congestion. Husband had just tested positive 2 days before. Took a Home COVID-19 test and it was positive. Called doctor and was prescribed Paxlovid. Currently taking it.
Tested positive on 27May; Tested positive on 27May; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 03Dec2020; VYTORIN, start date: 03Dec2020, stop date: 13May2022. Past drug history included: Levaquin, reaction(s): "Knonwn allergies: Levaquin"; Macrobid, reaction(s): "Knonwn allergies: macrobid"; Benicar, reaction(s): "Knonwn allergies: benicar". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "Tested positive on 27May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) positive, notes: Tested positive on 27May, two days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses: Anti viral details product: COVID 19 Treatment, brand: Pfizer, treatment start date: 19May2022, treatment stop date: 25May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SHOULDER HURTING SO BAD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown ) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced shoulder hurting so bad. The action taken with covid-19 vaccine  was not applicable. The outcome of shoulder hurting so bad was not reported. This report was non-serious.
5mL syringes were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/2021. Diluent drawn up and injected into the vaccine vial was 1.6mL (rather than 1.3mL). Diluent was measured on the 5mL syringes incorrectly (counting each mark as 0.1mL rather than 0.2mL). This resulted in the vial being mixed with 0.3mL extra diluent. Vial had a bonus dose (so 11 doses total). Patient given a vaccine dose at 90% of the correct concentration. Error has been reported to Pfizer. Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this. No adverse effects to patients have been reported.
2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; 2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; This is spontaneous report from a contactable Other Healthcare Professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: unknown, via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included Symptomatic PVC's, Tachycardia, Bradycardia, CVA (Cerebrovascular accident) in 2018, Asthma, adhesive allergy, rhythm. Concomitant medication included flecainide, metoprolol for rhythm, spironolactone. The patient previously took hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and experienced drug allergy; received the first dose of BNT162B2 on 16Dec2020 03:00 PM in Left arm for COVID-19 immunisation, and experienced Hypertensive Emergency (BP 219/114) with no previous blood pressure issues, radiating chest pain, left arm pain, and jaw pain on 22Dec2020, admitted to the hospital. The patient received the 2nd vaccine dose administered on 08Jan2021, with a new increase of blood pressure. The patient underwent lab tests and procedures which included blood pressure measurement: new increase of blood pressure on an unspecified date; blood pressure 219/114 on 22Dec2020; Curative-SARS-Cov-2 Assay RT-PCR: negative on 01Jan2021. The outcome of the event was not recovered.  Information on the Lot/Batch number has been requested.
No adverse signs or symptoms at this point 8/6/07. Given Zoatavax rather than Varicella by accident.
Approx 6cmx8cm reddened area of L thigh. Injection site- warm to touch, redness/swelling has increased over last 2 days. Redness started 11/30/06 a couple hours after injection. No hardness or lump noted. Instructed to apply warm pack every 10 hours and monitor for redness or hardening or pain. Return to clinic if any question. Probable local reaction.
Admit 8/1/2021 From facility.  tested positive for COVID  7/28/2021 at facility. Day of admit 02 sat 81% and facility called daughter to notify pt. was going to be taken to the ER.  For EMS patient's oxygen dropped as low as 57% and patient was lethargic, and patient arrives to the ER non-rebreather.  On my examination patient is oriented x1 and further history is limited due to altered mental status.  The onset was 4  days ago.  The course/duration of symptoms is worsening.  The character of symptoms is COVID 19, hypoxia. Transferred to hospice 8/2/2021 and expired 8/4/2021.
pt recvd vax 7SEP94 & 24hrs later, facial swelling & disseminated rash over body;no fever;MD visit 19SEP-sx persisting;23SEP MD visit-itching, sl facial swelling & rash; rx solumedrol/Pred;
Adverse event began on 11/14/2020, after shot received on 11/12/2020, a red spot appeared appeared on upper left back followed with itch at approximately around 09:30AM. Later in the day more red spots with itch appeared under breast area of left side on 11/15/2020. Patient became aware of spots after awakening in the morning at approximately 09:30AM. Patient is feeling "slow" since afternoon of 11/16/2020. Patient had follow-up appointment with PCP on 11/16/2020 at 04:30PM and was prescribed Famciclovir 500mg 3x times a day for case of shingles diagnosis.
Small, irregular hives became apparent on the patient's mid-torso on the evening of November 20th, 2009.  By November 22nd, 2009, they had sparsely spread to all points on her torso, neck, and arms.  Following spread, they darkened and began to itch.  Several evolved into sores.  On November 26th, 2009, they are still apparent.
Broken or cracked back; Terrible sandpaper taste in mouth; Bones was thinning out; Sore arm from COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL FRACTURE (Broken or cracked back) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Sore arm from COVID-19 vaccine). On an unknown date, the patient experienced SPINAL FRACTURE (Broken or cracked back) (seriousness criterion medically significant), DYSGEUSIA (Terrible sandpaper taste in mouth) and OSTEOPOROSIS (Bones was thinning out). At the time of the report, SPINAL FRACTURE (Broken or cracked back), DYSGEUSIA (Terrible sandpaper taste in mouth), OSTEOPOROSIS (Bones was thinning out) and VACCINATION SITE PAIN (Sore arm from COVID-19 vaccine) outcome was unknown.            It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  No concomitant product reported by reporter. No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 55-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Spinal fracture, after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 55-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Spinal fracture, after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Injection area became very sore, joint aches, skin aches, ran a fever, chills/shivering uncontrollably, very tired (slept the whole next day only waking to alternate Tylenol and Ibuprofen.  Now that is it a day later, no fever, no chilling, but whole body is sore, not achy like when I had the fever.
Injection site red, macular, warm, and swollen "to the size of a baseball."
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe, Additional Details: Patient stated fever, nausea, chills the day after getting Fluzone HD vaccine. Counseled patient these reactions are not uncommon but if symptoms worsen or do not resolve after a couple of more days, to reach out to provider.
Some flu symptoms; heavy; taste at the back of her throat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration on an unspecified date in Dec2020 at a single dose for Covid-19 immunisation; and naproxen (NAPROSYN) via an unspecified route of administration on an unspecified date in Dec2020 at 2 dosage forms (DF) to prevent symptoms you could get with the vaccine. The patient's medical history and concomitant medications were not reported.  The patient reported that she received her first vaccine last night but two hours before, she took two naproxen to try to prevent the symptoms she heard you could get with the vaccine. She did feel some flu symptoms and heavy and a taste at the back of her throat. She was concerned that the naproxen may have had a negative effect on the vaccine. She wanted to know if there were any information. Outcome of the events were unknown.  Information on the batch/lot number has been requested.
11/21/15 (morning) - hard to sleep on. Hot to the touch. Painful around sight. 11/22/15 (morning) - at 12:50 am noticed spot was red. The red spot was the size of a tennis ball (circumference) - at 8 a.m. spot has gotten a little wide and more painful.
Sat 4 PM - fever 102 degrees - 103 degrees F (10-18-08). LAIV given to patient (10-17-08). Sleepy - lethargic (per Dad) not seen in clinic or triaged by clinic staff.
At 10:35am patient received  Pfizer vaccination , Patient ambulated to the chair and at approximately 10:40 am patient was sitting in chair appearance  pale, diaphoretic, with complaints  of dizziness , Patient remain Alert and oriented x 3 no loss of consciousness . Patient stated  he have  history of known needle phobia . Denies any past medical history. Patient also stated  did not receive adequate breakfast or sleep. Water was given and also candy  to increase blood sugar. Patient blood sugar and color improved after  10 minutes  and also stated to feel back to his normal .  Patient able to stand and walk on his own . EMS arrived on scene at 1050 am. Patient RMA.  Vital signs  97.4 , 98, 74,112/74.
This spontaneous report was received from a nurse refers to a 4 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-OCT-2018, the patient was inadvertently vaccinated with GARDASIL 9 for prophylaxis. No adverse effects were reported.
patient received an expired dose/ received a dose on 14Oct2021 of a vial that had expired on 13Oct2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose/ received a dose on 14Oct2021 of a vial that had expired on 13Oct2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose/ received a dose on 14Oct2021 of a vial that had expired on 13Oct2021). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose/ received a dose on 14Oct2021 of a vial that had expired on 13Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
Pt inadvertantly given Moderna as 2nd dose. Pt required Pfizer.
Erythema (L) thigh 5 x 7 cm. Slightly edematous and firm on palpation. No d/c, no fever. Plan cephalexin TID for 7 days topic cortisone cream and ice prn redness/swelling.
SORE INJECTION SITE 5 HOURS AFTER VACCINE EXTREMELY SORE AND SWOLLEN INJECTION SITE   8 HOURS AFTER VACCINE (NOT ABLE TO SLEEP) TREMORS, SPASMS AND SHAKING 8 HOURS AFTER VACCINE - ESPECIALLY ON ARMS AND LEGS - NOT RELIEVED BY ADDING BLANKETS OR BATHROBE  - SOME RELIEF AFTER TAKING 2 TYLENOL TABLETS TREMORS, ETC. CEASED BY NEXT MORNING (11/15/23) INJECTION SITE STILL EXTREMELY SORE AND SWOLLEN FOR NEXT 2 DAYS (11/15-16/23) UNABLE TO USE COMPUTER OR PERFORM HOUSEHOLD TASKS FOR 1-2 DAYS
Arm -aim for 2 days (Arm-pain for 2 days); This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received meningococcal group b Rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm -aim for 2 days (Arm-pain for 2 days)".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A report was received from a health care professional on 11/18/02 concerning a 24 year old female vaccinee who experienced itching all over the body and a rash on the face 1 day after receiving Fluvirin on 11/15/02. The vaccinee was reported to be recovering after treatment with diphenhydramine. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP200200793, PJP200200792 and PJP200200795.
this client is unhoused and came to us for a flu vaccine stating she had received all of her COVID shots as well as a pneumonia shot, but not this year's flu shot. After it was administered, our registrar was inputting data and noticed that this client was already in the system, having received her flu shot in October of 2021.
Pt complained of right arm numbness, paresthesia to II digit, symptoms are slowly improving.
pt recv vax 11AUG98 & 5min post vax pt exp dizzy & was placed supine, w/legs in air;vital signs remained stable & was given orange juice;approx 1/2hr later pt recovered & was discharged from the dept;
This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No drug reactions or allergies were reported. On 01-AUG-2017 the patient was vaccinated with a dose of VARIVAX (dosing details were not reported) for prophylaxis instead of ZOSTAVAX. No adverse effects were reported. No product quality complaint was involved.
J96.00 ACUTE RESPIRATORY FAILURE 5/26/2022 ATHEROSCLEROSIS OF AORTA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/21/2022 ATHEROSCLEROSIS OF AORTA R09.02 HYPOXIA 5/24/2022 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 5/26/2022 ATHEROSCLEROSIS OF AORTA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/21/2022 ATHEROSCLEROSIS OF AORTA R09.02 HYPOXIA 5/24/2022 ATHEROSCLEROSIS OF AORTA
An unspecified number of patients were administered improperly stored  RECOMBIVAX HB and MMR II.; No Additional adverse events; This non-valid spontaneous report was received from a medical assistant, and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, and previous drug allergies or reactions were not reported.    On an unspecified date, the patient's were vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) (Lot number R030809; expiration date 24-OCT-2020) (dose, frequency and route were not provided) and hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (thimerosal free) (Lot number R012001; expiration date 06-NOV-2020) (dose, frequency and route were not provided) for prophylaxis. The vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).    The vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) underwent a temperature excursion of below 2 (-15.2) degree Celsius (°C) for a period of 5 minutes; and later above 9 (14.9) °C for a period of 1 hour and 50 minutes. The vaccine hepatitis b vaccine (recombinant) (RECOMBIVAX HB) underwent a temperature excursion of above 9 (12.7) °C for a period of 5 minutes; and later above 9 (9.5) °C for a period of 1 hour and 45 minutes. The medical assistant reported that the patient did not experience any adverse event.  This report is non-valid due to lack of patients' identifiers.