chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th August 2018, 1 days after receiving SHINGRIX, the patient experienced pain, diarrhea, fever and influenza-like symptoms. On an unknown date, the outcome of the pain, diarrhea and fever were recovered/resolved and the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the pain, diarrhea, fever and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The reporter was the wife of the patient. Her husband was vaccinated the day after she was. He had the same symptoms (flu like symptoms, aches and fever) as she but also had diarrhea. This case has been linked with US2018141957, reported by the same reporter.
pulled a muscle in her back/ strained her back; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on Tuesday 19Jan2021, at 66-year-old. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. She stated that on 20Jan2021, Wednesday, she pulled a muscle in her back. She had strained her back and it had nothing to do with the vaccine. On Thursday, 21Jan2021, she went to the doctor and received a ketorolac tromethamine (TORADOL) injection and a triamcinolone acetonide (KENALOG) (steroid) injection to help with her back. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Suspected vaccination failure/Got the shot, 6 months later got shingles; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shot and six months later he/she got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Today afternoon/evening I started to get sore and have a headache (which is normal from what I hear.) I could only sleep a couple hours Tuesday night into Wednesday morning because I kept tossing and turning. When I woke up Wednesday morning (4-21-21) around 6:00 am, I couldn't move as I normally could and when I tried to walk I found it very painful. The whole area between my knees and my shoulders were completely numb yet it felt as if it were on fire. I slept most of the morning and a little in the afternoon as it was very painful to move, talk, laugh, etc... Finally in the late afternoon (3:00-4:00ish) the numbness wore off but the burning sensation persisted. I felt progressively better throughout Thursday (4-22-21) and about the same time in the afternoon (3:00-4:00ish) the burning wore off as well. That evening I felt perfectly normal except for the typical achiness that tends to occur with  vaccines. Today (Friday 4-23-21) I feel rested and back to my normal self.
9/14/21: Patient arrived at the ER due to  shortness of breath and cough. The patient tested positive for COVID-19 on 08/23/202.  At that time she was managed with symptomatic therapy including albuterol inhaler.  After testing COVID negative on 09/08/2021, she was getting symptomatically better.  But since last 4 days she has worsening of cough and SOB.  Shortness of breath is present even at rest, previously orthopnea/ PND absent. She complains of productive cough, associated with loss of appetite and pedal edema. Per patient, her nurse noted that her bp was 152/93 and oxygen saturation of 79%. She had televisit where she complained of home BP 170s-190s and oxygen sat was 79-85 % at room air. Patient received first dose Moderna vaccine on 1/08/2021 Lot # 011J20A and the second dose on 2/11/2021 Lot # 029K20A
that had been improperly stored; No additional adverse event; This spontaneous report was received from a medical assistant, referring to a male patient of unknown age.   No information regarding the patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant therapies was provided.  On 03-MAR-2020, the patient was inadvertently administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (route of administration, vaccination scheme and anatomical site of vaccination, were not reported); lot number S006050, expiration date 12-DEC-2020, as prophylaxis.  The administered dose of the vaccine experienced a temperature excursion 50.7 degrees Fahrenheit (F) for 25 minutes, as recorded by a data logger. Previous temperature excursions was reported as no, however previous dates temperatures and time intervals were provided. There was no adverse effect reported.
Initially syncope and falls.  She was subsequently diagnosed with congestive heart failure and atrial fibrillation, later had blood clots in her lungs, COPD and oxygen treatment
Patient c/o swelling of throat and hands, and itching of throat. Patient had clammy skin. Vital Signs within normal limits. Blood pressure 130/90. RR 20. Patient stated a feeling of impending doom. 50mg Benadryl given IM. Continued to monitor patient. Patient began to feel better. Significant Other came to pick patient up, take her home, and monitor. Patient stable. Informed patient if symptoms worsen to notify EMS
Pt. developed faint itchy rash of upper chest and upper arms, no respiratory symptoms, no C/O throat closing, etc.
24 hours after receiving the 2nd dose of the Pfizer COVID vaccine, I developed debilitating joint pain.  I have continued to have multiple health issues over the last two and a half years related to this.  I was initially diagnosed with an inflammatory reaction to the COVID vaccine and was put on several rounds of steroids.  I have undergone multiple tests and appointments at a Clinic over the last two years and was recently diagnosed with Mixed Connective Tissue Disease, and am now having pulmonary issues.  I was 100% healthy prior to receiving the vaccine.  I have submitted this form multiple times with no response.
I began to have ringing in my ears, symptoms of Tinnitus approximately 9 hours after I received the 2nd vaccination on 05/06/21. I did not get this condition/symptom on my first vaccination of 04/14/21. The ringing in my ear (more prominent in my right ear) has continued non-stop since receiving my second vaccination. I am concerned about this adverse effect  and whether this condition will be temporary.
In July of 2021 I was experiencing left leg swelling. I had some pain and discomfort at the back of my thigh. I got a cramp in my left cramp and then I noticed some swelling. I suspected DVT and I got a D-Dimer test and it was elevated. I went to the ER and they confirmed multiple clots in my left leg by Ultrasound. I was prescribed some Eliquis, and the problem seems to have subsided.
Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs; Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received BNT162B2 for COVID-19 immunization on 31Mar2021 (Lot unknown=True, Lot unknown reason=Unable to locate or read the details, Administration date=31Mar2021, Administration time=02:00 PM, Dose number=1, Vaccine location=Left arm, No reaction.) On 24Apr2021, Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs. The patient did not receive treatment for the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
He has been feeling bad for about one week. States his shortness of breath has progressively gotten worse. He also complains of difficulty swallowing. He has been unable to eat for about two weeks. He says that water just runs out of his mouth when he takes a sip.  General Appearance:    Appears thin.  Head:    Normocephalic, atraumatic Eyes:    PERRL, conjunctiva/corneas clear, EOM's intact, sclera anicteric      Ears:    TMs not observed Nose:   Patent without discharge Throat:   No erythema or exudate Neck:   Supple, without thyromegaly or masses.  Trachea is midline. Back:     Straight, no CVA tenderness Lungs:     Decreased breath sounds  Chest wall:    No tenderness Heart:    Regular rate and rhythm, S1 and S2 normal, no murmur, rub   or gallop Abdomen:     Soft, non-tender, non-distended, bowel sounds active all four quadrants, no masses, no organomegaly         Extremities:   Extremities normal, atraumatic, no cyanosis or edema Pulses:   2+ and symmetric all extremities Skin:   Warm, dry, no rashes or lesions Lymph nodes:   No adenopathy in the neck, axilla, or groin Neurologic:  No focal deficits.  CNII-XII intact.  Speech is fluent.  Conversation is coherent.  Admitted to hospital, started on nasal O2 at 4lpm.  MEDICATIONS GIVEN IN THE ER Medications Ampicillin/Sulbactam 3 gm/100 mL in NS (has no administration in time range) Azithromycin 500 mg/250 mL in D5W (has no administration in time range) fluconazole (DIFLUCAN) tablet 200 mg (has no administration in time range) iohexol (OMNIPAQUE) 300 MG/ML injection 60 mL (60 mLs Intravenous Given 10/12/21 1414)
IPOL exposed to temperature of 39.2 degrees F to 0.5 degrees F and back to 39.4 degrees F within 6 minutes, no AE; Initial information was received on 22-Sep-2020 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a patient (with an unknown demographics) who received POLIOMYELITIS VACCINE (INACTIVATED) (IPV) (VERO) [IPOL] (lot R1B251M, Expiry date 13-Mar-2021) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date, that had a cold chain deviation and temperature went to 39.2 degrees Fahrenheit to 0.5 degrees Fahrenheit and back to 39.4 degrees Fahrenheit within 6 minutes, cause of the excursion was unknown (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  This was an actual medication error case due to product storage error temperature too low.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Received MMR on 03/05/2002 and began having joint pain, headaches, and low grade fevers through 03/14/2002-03/18/2002. On 03/19/2002, got up with rash on legs, trunk, arms, and all over the body.
Had shot at 10:30 am; developed a cough, sob; wheezing and hoarseness. He took Claritin 10mg and Robitussin cough syrup. Was better by 5:00 pm. Reaction started at 5:00 pm - 8:00 pm
Started to have swelling in the face and lips and throat . Contacted the facility and recommended I go to the ER
Information has been received from a nurse practitioner concerning a 12-month-old white male with no allergies or medical history who on 03-Feb-2004 at 11:00 am was vaccinated SC in the right anterior thigh with a first dose of varicella virus vaccine live (lot #647246/0899N). Concomitant vaccination on the same day given in a different site included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no illness at the time of vaccination. On 17-Feb-2004, the patient's mother noted a quarter sized lump at the injection site. The patient also developed a low grade fever and some vomiting. The symptoms have since been reported to be resolving. Unspecified medical attention was sought and a prescription drug was not required. A product quality complaint was not involved. Follow-up information was received from the nurse practitioner who indicated that on 15-Feb-2004 at 7:00 am. there was a right thigh "bump" at the injection site the size of a 25 cent piece. There were no extending streaks and it was noted to be red. The patient had a low-grade temperature less than 100.5 on 15-Feb-2004 and 17-Feb-2004. The patient vomited one to two times on 16-Feb-2004. He was noted to be on topical nystatin for diaper rash-yeast candidiasis. "Resolving 17-Feb-2004." No diagnostic laboratory tests were performed. The patient was noted to have recovered on 18-Feb-2004. It was also reported that the patient had no adverse events following prior vaccination. No further information is expected. Follow-up information was received on 16-Mar-2004 which pertained to events that occurred 12 days following vaccination with varicella virus vaccine live. This information contained the following adverse experience: diaper rash-yeast candidiasis (15-Feb-2004).
pt recv vax 5JUN98 called w s/s 8JUN98 dizzy, fingertips swollen, sl fever, gums, oral mucosa sore;pt opted for no tx, didn't come back to MD:
After the vaccine it felt like I had a really bad cold with congestion. I had a fever, and I was tired. That lasted for 1 day. When I caught covid recently I had a fever, night sweats, chills, shortness of breath, and a dry cough. It kept me out of work for 10 days. I called my doctor and was prescribed Benzonatate, for my cough, and an inhaler. Over the past week I've tested negative for covid, but I still have a dry cough.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 9:10 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 52.62  Concomitant products were not provided.  On 28-Feb-2021, Excursion time was 9 AM, temperature was 27, total doses given for the day was 152, On 28-Feb-2021, Excursion time was 1 PM, temperature was 26. Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.   On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 PM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Injection site pain, elevated heart rate (15% at injection + 18 hours), joint soreness (predominately in hands and elbows - injection + 18 hours).   Symptoms do not require any medical intervention.
This spontaneous report was received from a physician referring to a 5 month old patient of unknown gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On an unknown date, the patient was inadvertently vaccinated with a dose of GARDASIL 9, for prophylaxis (exact dose, route of administration, anatomical location, lot number and expiration date were not reported). The physician specified that, no adverse effects were reported
On 3/23/02, per telephone call to mother, she states her daughter was paralyzed from the waist down and could not walk in 11/00. Daughter is receiving physical therapy now and has numbness on her right side, leg and back problems, feet swelling and diabetes stage 2. Per Progress Notes: Immunization card states: 1/11/02 vaccine deferred until parent brings OK from physician for shots. Appt on 1/17/02. Parent reports child possible dx with Guillain-Barre' but not definite. Had weakness from waist down for approx. 2 weeks. Hospitalized. Slight numbness remains in lower right leg. Mother in on 3/26/02 and requests copy of immunization record and it was provided. Record shows child had immunizations on 7/12/01. Hep-b 2nd dose and Varicella 1st dose. Called the hospital and talked with RN and she read the record to me: The pt was admitted to the hospital on 11/22/01 with dx of weakness in legs. On 11/21/01, the pt complained of numb legs, muscle cramps. One month prior to this incident, the pt had a viral upper respiratory infection. She complained of difficulty voiding on the 21st. Denies headache. Also complained of back pain and has a history of trauma to back during a fight with a schoolmate. Do not know when MRI was done but was mentioned in the history. The pt required catheterization while in the hospital for urinary retention. Also received physical therapy and discharged on 11/29/01. "Condition improved". Discharge dx: lower extremity weakness, urinary retention, suspect viral etiology and UTI. The pt weighs 240lbs at 13 years of age. Per call to parent; she states her daughter was dx'd with Guillain-Barre' but the doctor changed her dx to Transverse Myelitis. The mother states that her daughter is disabled because "she got a double dose of Hep-B". Says "I got no information about that" and she is unaware that her daughter received varicella. She states "they never told me that. They said she didn't". "They" means the Health Dept. She states she has a medical friend who "told me that may cases of this (paralysis) are in this county and it is full of people who had reactions from too much Hep-B". When asked about the "reaction" her daughter had, she states in November she became completely paralyzed. Now she is trying to get her on disability because of the pt's long term results; continued numbness of right leg, had back problems, her feet swell, has diabetes stage 2 and remains on physical therapy. Daughter is still in school. She states her daughter will never have any more vaccines (she has a "medical excuse"). She had an angry and defensive tone during interview. I attempted to placate her during calls; obviously not interested in other facts. A follow up report received 5/7/2002 adds: Diagnosed with transverse mylitis, NIDDM and bladder retention.
This spontaneous report as received from a other health professional and refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with inproperly stored VAQTA lot # N012324 for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 4 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA002041: US-009507513-1708USA002612:
1 d. after received Influenza vaccine and MENACTRA, pt developed nausea/HA/chills. HA persisted for 1 week, "mild" and "nagging". seen 11/20/08. Discussed possibility of non-vaccine related causes. F/u planned. HA not resolved yet.