chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after I got my vaccine, I started to have pain in my right  arm (opposite arm of vaccine). It kept getting more intense every day, and I developed a rash  on my right arm, right shoulder, and right side of my chest. It started to scab over in parts. I saw my nurse practitioner on 1/19/21 who said it was most likely shingles, and prescribed anti viral and nerve pain meds.
2/5/21 started having aches/chills at 11:30 a.m.  Took temp that read 99 and throughout day went to 101.   2/6/21 had temp of 99 all day with chills/aches still present but not as bad.   2/7/21, temp normal but very tired.   2/8/21 feel good!
I experienced headaches, prolong and abdominal cramping and fatigue.  My symptoms are mild and I had a virtual call with my PCP and told me to take OTC Tylenol or Advil and to monitor my symptoms.  I continue with slight headaches that come and go.
Approximately 2 to 3 days after receiving my initial Anthrax vaccine I became nauseaus and began having diarrhea and stomach pains. This continued for at least 4 days. I then received my second Anthrax injection and the day after I again began to have nausea, diarrhea, and stomach pains. I contacted the medical facility where the vaccine was administered. I was given a brief check up and blood was drawn. I continue to experience stomach pains, bloating and I have not had a solid bowel movement since receiving my second Anthrax shot.
nurse accidentally gave Fluzone Quadrivalent to a patient, that expired on 30Jun2019, no AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a 17 months old male patient who received 0.25 ml dose of expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Prefilled syringe, lot UT6259LA, Exp. Date 30-Jun-2019) via intramuscular route in the left thigh on 17-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HIB VACCINE CONJ (OMPC) (PEDVAXHIB) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  It was reported that a nurse accidentally gave Fluzone Quadrivalent to a patient, that expired on 30-Jun-2019.  The patient did not experience any adverse event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  List of documents held by sender: none.
w/in 24 hrs p/immun, pt exp inject site rxn which included swelling, tenderness & hot to the touch; tx APAP & ice packs;
Second shot rash; This is a spontaneous report from a contactable consumer(patient). A 78-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201; Expiration Date: Jun2021), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, Expiration Date: May2021), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation and experienced some pain around the shot area. The patient experienced second shot rash on 12Feb2021. The outcome of the event was recovered on Feb2021.  No follow up attempts are possible. No further information is expected.
Case number PHHY2015US044076 is an initial literature report received on 03 Apr 2015. The author presented the case of an elderly patient who experienced flu after seasonal influenza vaccination. This report refers to a 73 year old male patient. His current conditions included lymphoma and prostate cancer. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that on an unspecified date he had fever, muscle aches, sore throat and fatigue for a day. He was brought the emergency department with a change in mental status and fall. It was reported that the flu vaccine was administered one month prior to his hospitalization. His body temperature was 99.5 degree Fahrenheit and rest of the physical examination was unremarkable. Laboratory data demonstrated a normal basic metabolic panel (BMP), mild elevation in white blood cell (WBC), elevation of liver enzymes (Aspartate aminotransferase (AST): 300 and Alanine aminotransferase (ALT): 100). His creatinine kinase (CK) was 3000 and continued to rise to as high as 12000 which were thought to be out of proportion to the duration of fall (30 minutes). Influenza A subtype H3 was positive, Mycoplasma IgM antibody was positive and polymerase chain reaction (PCR) was negative on an unknown date. His electroencephalogram (EEG) and chest radiograph were remarkable. He had aggressive intravenous fluids and was treated with azithromycin and TAMIFLU. His renal function stayed stable and patient improved remarkable within 3 days. His CK did trend down. The causality of the event was not reported. The author concluded the article stating that due to drifted influenza A (H3N2) viruses, CDC recommended influenza vaccine would protect against non-drifted circulating vaccine viruses and also it offers cross protection. The author also stated that prescribing neuraminidase inhibitor antiviral medications for treatment and chemoprophylaxis as an adjuvant to vaccination improved outcomes.
pt recv vax; rash, sore throat, lt ear pain, otitis med, arthralgia;tx w/ keftab, augmentin, APAP, Ibuprofen and Rocephin;hosp w/ mastoiditis responding to IV ATBs;
Injection site soreness for 6 days. Mental and physical lethargy for 7 days with a mild headache and odd taste in throat for the first couple. Workout reduction of capability of 20% slowly edging back up to 95% on day 6.
Information has been received from a nurse referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On an unknown date the patient was vaccinated with a dose of improperly stored (Merck) PROQUAD (lot # K009891, expiration date 11-JAN-2106, dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
BELL'S PALSY EXACERBATED; TINGLING IN PALMS OF HANDS; HOT IN PALMS; PAIN IN BETWEEN SHOULDER BLADES; EXTREME WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included bells palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination on right arm. 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 19-MAR-2021, the patient stated that she experienced extreme weakness and pain in between shoulder blades within 48 hours of vaccination and ambulance took her to the emergency room where she got tested for stroke but confirmed bell's palsy diagnosis. She has bell's palsy seven years ago and it was reported that vaccine seemed to exacerbated the condition. Patient also experienced tingling and hotness in palms of hands within 48 hours of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme weakness, and had not recovered from bell's palsy exacerbated, pain in between shoulder blades, tingling in palms of hands, and hotness in palms of hands. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 23/Mar/2021. Upon review, the following information was amended: Age group updated as unknown, Reporter causality updated as possible, narrative updated.; Sender's Comments: V1: Version created to amend age group, reporter causality and narrative. This updated information does not alter the causality of previously reported event.  20210345589-Covid-19 vaccine ad26.cov2.s-Bell's palsy exacerbated. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Raised and itchy rash on left leg, above and the interior side of knee. Area of rash was approximately 4 x 3 inches. Visited with primary care doctor on 09/27/2016; she advised over the counter antihistamine and topical cortisone cream. Said to outline rash area with a pen/marker and watch for growth or more adverse reactions. If any, return to doctor for more follow-up. Rash lessened over next week.
Sore arm; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VOMITING (Vomiting) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   This case was linked to MOD21-038723 (E2B Linked Report).; Sender's Comments:  MOD21-038723:Crosslinked to MOD21-038723, Same Reporter
Patient reports onset of fatigue, headache swelling of lips, anxiety, and elevated temp - approx 6 hrs after receiving vaccine.
MRI showed myocitis, has numbness in 3rd, 4th, and 5th fingers on left hand, pain, hot inflammation at the injection site severe pain in elbow, said it was given too high
I was in the car and all the sudden everything started to spin. I just thought I didn't eat enough at first, because it went away in about an hour. A couple of weeks later I had another episode where everything started to spin. It went away in about 20 minutes. Then I had another episode while driving and I had to pull over. I went ahead and went to the movies and I was wobbly when I was walking in. I thought it was because I didn't eat enough, so I bought some candy. Then, this past episode (the big one) was in March. I was on the phone and everything started to spin and I became nauseous. I went to bed thinking it would be gone in the morning, and it was not. I had to stay home from work because there was no way I could drive. I went to the Dr. and he diagnosed me with BPPV. He prescribed me Meclizine. I am still dealing with this at this time.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 14-FEB-2009 the patient was vaccinated by a physician with ZOSTAVAX, 1 DF, (route and lot# unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles that had significant involvement on her scalp. The patient has been prescribed valacyclovir and codeine for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
no adverse event; patient was accidently administered an expired dose of MMR II; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On 11-OCT-2022, the patient was vaccinated with expired product measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #T025927, expiration date: 30-JUL-2022, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered).Product had no prior temperature excursions. No further information provided. No additional adverse event reported. No product quality complaint reported.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Medium, Systemic: Pityriasis rosea-Severe
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) on 24-OCT-2008. The patient was in the office on 06-AUG-2012 for the second dose of GARDASIL (lot #, dose and route not reported). No adverse symptoms were reported. Additional information has been requested.
Pt had vaccines 1/9 afternoon, woke in the middle of the night/early AM 1/10 with shaking chills, severe pain, and nausea. Given VICODIN and ZOFRAN for symptoms. Still with severe pain/headache on 1/12/15.
No adverse effect reported; A toddler patient was administered a dose of improperly stored VARIVAX; Information has been received from a nurse regarding a 12-months-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 19-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection as prophylaxis (lot number S021924 with expiration date in 15-JUL-2021) which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (lot number: R032162 with expiration date: 22-JUL-2021) (route of administration, strength and anatomical location not reported) (incorrect product storage).  The varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F (24.3 F) for multiple time frames. There was no previous temperature excursion and the call was because of a data logger.  No adverse effects reported.
Approx 21/2 hrs after flu vac C/O feeling shaky, pale, sweaty, VS 140/97 HR 120-130 - EE sent home by manager - states symptoms resolved after 45 min. Seen by this Nurse today (98.4, 110/74 HR 100 10-19-2017) denied any complaints today "I feel fine" R-16.
This spontaneous report was received from a medical assistant refers to a 15 year old female patient. No medical history was reported. On an unknown date in 2009, the patient was vaccinated with dose 1 of GARDASIL (lot#, expiry, route, dose not reported). On 07-JUL-2013, the patient was at the physician's office to receive her second dose of GARDASIL (lot#, expiry, route, dose not reported). No adverse effects reported. No concomitant medications were reported. Additional information has been requested.
Case PHEH2016US023447 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 60 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was determined to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
Pt complained of swelling/ecchymosis from axilla over past antecubital.  No edema/ecchymosis bicep noted deltoid muscle.  Pt states 5 days prior he heard something pop in left deltoid but had no injury until after tetanus shot.
pt devel prolonged high pitch, screaming type cry over a 3hr period; This lasted for several days; There was no temp or other effects;
Blisters on back 3 days post Hep 1 (10/13) & 2 (11/19). Blisters scabbed on day 5. Itched.
Fever PAINFUL ARM, SWEOLLEN NODES IN LEFT AXILLA AND BEHIND EARS Narrative:
severe joint pain; severe muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (severe joint pain), MYALGIA (severe muscle pain) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A, 030L20A and 017F21A) for COVID-19 vaccination.     The patient's past medical history included Clotting disorder (Clotting concerns). Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]), ETHINYLESTRADIOL, NORGESTIMATE (TRINESSA), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ESCITALOPRAM OXALATE (LEXAPRO), ASPIRIN [ACETYLSALICYLIC ACID] and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (severe joint pain), MYALGIA (severe muscle pain) and HEADACHE (headache). At the time of the report, ARTHRALGIA (severe joint pain), MYALGIA (severe muscle pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by the reporter. It was reported that patient sometimes takes daily aspirin because had a history with cloting concerns   This case was linked to MOD-2021-366416, MOD-2021-366431 (Patient Link).
Left arm and hand paralyzed at first. Now not back to normal. I have had OT and some PT. It has been 8 months.
Bell's palsy. Watery left eye, facial paralysis on left side of face. Numbness   Treatment - one week of steroids and antivirals. Eye cream
Sudden total body pain & weakness, severe chills.  Headache, joint pain. Started 8 hours after injection & continued through the night getting slightly better by 7am but still experiencing headache & joint pain.
Chest tightness, needs to cough, but could not do so. Vitals WNL. History of asthma, and smoker.
8 days after vaccine-January 17th. I woke up with redness at injection site felt warm to touch & itching. The area was approximately 3?x3?in diameter. The following morning the redness had spread and continued to spread throughout the day. I saw my physician- he suspects cellulitis. He prescribed Keflex and methylprednisolone. I am scheduled to return to his office in 3 days to re-evaluate. I have had a severe headache off and on  Since Saturday January 16th.
Arms were so sore; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 1 day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported that the patient rolled over the morning after receiving vaccine, the patient's arm was sore. This case is one of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252425:same reporter US-GLAXOSMITHKLINE-US2020AMR252429:same reporter US-GLAXOSMITHKLINE-US2020AMR252430:same reporter
Rash not at he site of injection but on the same arm by the elbow three to four days after receiving vaccine
Estimated due date: 03/05/2021 All I had really was exhaustion and I had to go lay down. I probably took an hour nap and it felt better.  I still felt sluggish but a little better. There is no way I could have worked that day the way I was feeling.
Two days later she tested positive for covid; fever; really bad headaches; light sensitivity; sore throat; runny nose; muscle soreness; This is a spontaneous report received from a contactable consumer (patient).   A 33-year-old female patient received first dose of BNT162B2(BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 18Mar2021(at the age of 33-year-old) as a SINGLE DOSE for COVID-19 vaccination. Patient medical history and concomitant medications were not reported. Patient had some muscle soreness at the time but thought she had just worked out too much. Two days later she tested positive for COVID and experienced side effects such as fever, really bad headache, light sensitivity, sore throat and runny nose.    No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Swelling / puffiness of right eye -12/30 Rash on the upper abdomen-12/31 Itching of throat-12/31 Tightness in throat-13/31 Facial swelling -12/31
Since my second dose on May 1st, my menstrual cycle has been completed off. One month it last a week longer,  another month it started a week early, another month it started a week late, another month 8 days late. Hasn?t been consistent since.
Pt woke up at night with severe stomachache. He did not self-treat himself and went back to sleep. He was ok in the morning. We are observing for further effects.
Vaccinated 12 days ago with MMR.  Had some arm soreness which has resolved.  Then on Saturday 8 days after vaccine - he developed subjective fever and chills.  Fatigued.  Eye pain, but no tearing or injection.  These have since resolved.  Yesterday, on Monday (day 10) noticed a rash first on his face and chest that is mildly itchy like dry skin can be.  No longer febrile or with eye pain.  Mildly sore throat, no cough or congestion.  Denies abdominal pain. Supportive care - nsaid, rest, moisturize dry skin.