chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalization: admitted 8/19/22, discharged 8/21/22. Presentation to the ED: Presented with generalized weakness, increased confusion, diarrhea.  COVID-19 + date: 8/19/22. Treatment: Receiving doxycycline for right lower extremity cellulitis. Did not receive remdesivir therapy or steroid therapy.  Discharge to: Home or Self Care.
Rash covering entire body- hot to the touch, felt as if skin was burning High Blood pressure Major Headache Fever greater than 102 Extreme body/joint aches
Pain at the base of skull. It went to her forehead and pain in temples, stomach cramps, nausea. Has not eaten anything. Felt better this morning.
The patient got vaccinated with Moderna and tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The patient got vaccinated with Moderna and tested positive for COVID-19) in a 58-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (The patient got vaccinated with Moderna and tested positive for COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (The patient got vaccinated with Moderna and tested positive for COVID-19) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided.  Given that the Moderna product was not reported as a co-suspect product and there is no other attribution to the Moderna product in this report from the other manufacturer, the Moderna product is not considered to be a suspect product in this report. (Both in case notes and I narrative supplement add).  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.
This spontaneous report as received from a nurse refers to a 12 year old female patient. No information regarding pertinent medical history or drug reactions/allergies was provided.  On 07-AUG-2014 the patient ws vaccinated with her first dose of GARDASIL (dose, route not reported, lot#J011272, expiration date 21-APR-2016) and on 19-AUG-2014 the patient was vaccinated with her second does of GARDASIL (dose, route not reported, lot# J010668, expiration date 29-APR-2016). No concomitant medications were provided.  The nurse reported that the patient received second dose of GARDASIL only 2 weeks after her first dose. The patient's mom called the office and reported that on 19-AUG-2014 patient did not feel well and complained of fatigue after receiving the second dose of GARDASIL. No treatment was given for the adverse events. No lab diagnostics studies were performed. The patient had sought medical attention by calling office. Outcome of "patient did not feel well and complained of fatigue" was reported as not recovered. Additional information has been requested.
Over three months from the date of my second vaccination and my right arm is still extremely painful.  It's difficult to lift my arm to the side without incurring severe pain.
Pt recv vax on 3/24/99; on same day pt exp red rash from rt shoulder to elbow then swollen &tense; dx=cellulitis; tx=Cefzil, ice compress
low grade fever, tongue felt swollen, delirious, could not walk, nerve pain throughout body (especially hands, down legs, feet), speech was slurred, fast heart rate,
Post vax, the pt complained of feeling jittery, lightheaded, and had an itchy red rash on both wrists and slightly up both arms.
24hr p/vax h/a, cough, gen aches, fever, +sputum prod, sore throat;
Blotches on her right arm just above her wrist; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 14:15 (Lot number: EN6204, Expiration Date: Jun2021) at the age of 78 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Allergy to bee venom" (unspecified if ongoing), notes: Verbatim: Allergy to bee venom; "Sulfa allergy" (unspecified if ongoing), notes: Verbatim: Sulfa allergy; "Diabetes type II" (ongoing), notes: maybe 30 years ago; "Overweight" (ongoing), notes: Overweight but does not think she is at obese point. There were no concomitant medications. Past drug history included: Ampicillin, reaction(s): "Ampicillin allergy", notes: Verbatim: Ampicillin allergy; Carbamazepine, reaction(s): "Carbamazepine allergy", notes: Verbatim: Carbamazepine allergy; Lamotrigine, reaction(s): "Lamotrigine allergy", notes: Verbatim: Lamotrigine allergy; Lisinopril, reaction(s): "Lisinopril allergy", notes: Verbatim: Lisinopril allergy; Phenytoin, reaction(s): "Phenytoin allergy", notes: Verbatim: Phenytoin allergy; Sulfadiazine, reaction(s): "Sulfadiazine allergy", notes: Verbatim: Sulfadiazine allergy. Vaccination history included: Bnt162b2 (Dose 1, 0.3mL injection, Lot number: EN6201, Anatomical location: upper right hand arm , Administration time: around 13:20), administration date: 19Feb2021, when the patient was 78 years old, for Covid-19 immunization. The following information was reported: RASH MACULAR (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Blotches on her right arm just above her wrist". The event "blotches on her right arm just above her wrist" was evaluated at the physician office visit. Additional information: No additional vaccines administered on same date of the Pfizer Suspect. No any other vaccinations administered within four weeks prior to the first administration date of the suspect vaccine. The blotches don't hurt, don't itch and it does not look like a rash. By chance patient had a regular appointment with her primary care doctor, it was her first visit with this doctor actually, and not specific to this event; and she asked the doctor what are these things, the blotches. They appeared within 40 hours of the second dose of the Pfizer-BioNTech COVID-19 Vaccine, then reported that in the morning on the day of onset they weren't there and then before the afternoon they were there. The doctor said well they're age spots. Patient asked the doctor do age spots appear in a matter of 20 minutes and the doctor said oh no, they don't. Patient also mentioned she just had her second Pfizer-BioNTech COVID-19 Vaccine shot and the doctor told patient if they get worse go to the emergency room. Patient reported the blotches are not a clump per se, but about 6 what look like fresh age marks like what people get with aging; but she has never seen age marks just appear suddenly like that.  No follow-up attempts are possible. No further information is expected.
Numbness in left hand and foot; left side of body was heavy and stiff; pain at bottom of left foot when walking. Side effects lasted about a month. Not currently experiencing side effects.
Patient Received Combo vaccine of Dtap & IPV (Quadracel) and called our office the next day to report a fever of 102.1'F. Gave tepid Bath & Tylenol, Fever down to 99'F. Mom states he vomited that night but no longer having any sx.
Urticarial facial rash on 12/11/17 at about 4 pm. Patient given BENADRYL, rash returned 4 hours later. Patient taken to ER given BENADRYL and Prednisolone. Rash. Last knew rash was 12/10/17 at 10 pm. Pt seen and examined in office, recommended ZYRTEC and continue Prednisolone for a total of 5 days.
Pain in my next, Lung when i breath hard, runny nose ,fever and body ache.
Follow-up information was received regarding patient details, product details, event details, concomitant therapy, treatment and medical history. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 6-month-old female patient who experienced urticarial rash all over body with no breathing difficulty. The patient received the first dose on 12-May-2010. The patient also received the third dose of ROTATEQ (Merck) and the third dose of PENTACEL (Aventis-Pasteur) on 12-May-2010. The patient experienced urticarial rash all over body with no breathing difficulty on 12-May-2010. BENADRYL cream was applied. The patient has fully recovered. No additional information was available at the time of this report.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site warmth (1st dose received on 28th June 2018, refer case US2018219446). On 28th November 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 28th November 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site warmth, injection site erythema, intramuscular formulation administered by other route and vaccine administered at inappropriate site. On 3rd December 2018, the patient experienced injection site itching. On an unknown date, the patient experienced fever, nausea and headache. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, nausea, injection site itching and headache were recovered/resolved and the outcome of the injection site warmth and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site warmth, fever, nausea, injection site itching, injection site erythema and headache to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX subcutaneously in the back of his right arm, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site. The patient began feeling warmth at the injection site, two hours after receiving the vaccine but this started to spread. The patient noticed that from the injection site down to almost his elbow began to swell and it stretched the shirt he was wearing and there was redness and swelling in a tear drop shape. The patient felt that he had a fever, headache, and he was nauseous. On 2nd December 2018, the patient notes that the symptoms were worst on Sunday. The patient reported that yesterday, on 3rd December 2018, 5 days after vaccination patient began to experience itching at the injection site, there was heat at the injection site, and it was still red. The other symptoms had resolved. The reporter consented to follow up. The reporter gave permission for his physician to be contacted. Unable to obtain additional information. The caller hung up because he could not get an answer as to whether he would need to get another vaccination since the second one was administered subcutaneously.
Moderna COVID-19 Vaccine EUA. Adverse side effect; diarrhea.
The pt was given the varicella vaccine on 12/16/1996. Developed varicella on 3/13/00.
(R) facial pain, pustules - blisters scabs - into (R) ear. (1) VALTREX (2) CIPRODEX Otic suspension (3) sulfamethoxazole.
Mild Soreness at injection site after first shot; Drowsy after first shot; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsy after first shot) and VACCINATION SITE PAIN (Mild Soreness at injection site after first shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04120A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced SOMNOLENCE (Drowsy after first shot). On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild Soreness at injection site after first shot). At the time of the report, SOMNOLENCE (Drowsy after first shot) and VACCINATION SITE PAIN (Mild Soreness at injection site after first shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient does not take concomitant medications.  No treatment details were reported.   This case was linked to MOD-2021-410130, MOD-2021-410132 (Patient Link).
sight impairment/did not see very well/unable to read during report; injection site pain; tiredness; muscle pain; feeling unwell; frequent urination every 15 minutes; signs of severe allergic reaction including dizziness, weakness and sight impairment; signs of severe allergic reaction including dizziness, weakness and sight impairment; signs of severe allergic reaction including dizziness, weakness and sight impairment; This is a spontaneous report from two contactable consumers. A 95-year-old male patient received 1st dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine ), via an unspecified route of administration in upper right arm on 16Jan2021 11:00 at single dose for vaccination. Medical history included diabetes from 1950 (also reported as 1991) and ongoing. There were no concomitant medications. The patient experienced not in very good shape/terrible reactions on 16Jan2021 12:00. Requested information regarding events relative to the product. Further clarified this event as to include injection site pain; tiredness; muscle pain; feeling unwell; frequent urination every 15 minutes; signs of severe allergic reaction including dizziness, weakness and sight impairment. Patient clarified that all of these events had onset of about 12:00pm-1 hour after Pfizer BioNTech COVID-19 Vaccine administered (16Jan2021 12:00) and had for the most part remained the same since onset, but for sight impairment was on 18Jan2021. The patient did not see very well; caller had to read some of the information provided in this report from forms that patient was unable to read during report. The muscle pain was marginal. The weakness was the same or worse. He wanted a pain reliver or pill. Patient did not plan to get the second dose due to adverse events. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No emergency room/physician office visit. Family medical history relevant to the events was none. The outcome of injection site pain was recovered on 18Jan2021, tiredness, feeling unwell, dizziness was not recovered, muscle pain, frequent urination every 15 minutes was recovering, severe allergic reaction, weakness, sight impairment was unknown.  Information on the lot/batch number has been requested.
injection site warm to the touch; rash at the site; slight fever; tenderness at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warm to the touch), VACCINATION SITE RASH (rash at the site), PYREXIA (slight fever) and VACCINATION SITE PAIN (tenderness at the site) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson&Johnson. Past adverse reactions to the above products included No adverse event with Johnson&Johnson.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site warm to the touch), VACCINATION SITE RASH (rash at the site), PYREXIA (slight fever) and VACCINATION SITE PAIN (tenderness at the site). At the time of the report, VACCINATION SITE WARMTH (injection site warm to the touch), VACCINATION SITE RASH (rash at the site), PYREXIA (slight fever) and VACCINATION SITE PAIN (tenderness at the site) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
This patient developed a severe local injection site reaction that eventually formed a hard mass. The patient was seen in the emergency room Monday morning following the injection and was treated there with corticosteroids and antihistamines. The patient was successfully treated in the ER and did not require admission to the hospital for further observation.
Large lump in armpit (same arm as injection). Approximately half the size of a baseball. Soreness in that swollen area.
patient received covid moderna bivalent booster and flucelvax vaccinations in left deltoid 1 inch apart at 1051am; approximately 5 minutes later at 1056am patient was diaphoretic, pale, hot, and vomiting. Called 911- first responder firefighters were here within a few minutes. BP 100/75, P77, O2 Sat  100%, EMS arrived shortly after. Patient signed a waiver refusing transportation via ambulance to the hospital and went home instead.
PATIENT WAS GIVEN AN EXPIRED DOSE.  THE VACCINE VIAL WAS 1ST PUNCTURED AT 10 AM ON 2/17/22  WHICH IS GOOD FOR 12 HOURS. DOSE WAS GIVEN AT 24 HOURS AFTER 1ST PUNCTURE ON 2/18/22.
Flublock Quadrivalent was administered to a 12 years old female patient/no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case was linked to 2019SA279962 (same reporter).  This case involves a 12 years old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant therapy.   On 04-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1929 via intramuscular route in the left deltoid.   It was of actual medication error case due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate age).  It was unknown whether any adverse event was noted or not.  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.
she has a bad headache; chill; fever; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, in the left arm (unable to confirm if given in the muscle) on 15Mar2021 (at the age of A 63-years-old) as dose 1, single for covid-19 immunisation. Time the vaccination was given: 16:15-16:30. Vaccination facility type was clinic and not a military facility. Medical history included asthma (diagnosed 10 years ago), bronchitis chronic both from an unknown date and unknown if ongoing. Respiratory problems added on to problems of wearing mask 10-12 hours a day. It had made her asthma worse. This was diagnosed 10 years ago with Chronic Bronchitis. Family medical history was none. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) 3 times a day since wearing mask. She takes 2 puffs in morning and 2 at night and Proair in the middle of the day. No further details provided. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Additional vaccines administered on same date of the Pfizer suspect was none. Prior Vaccinations (within 4 weeks) was none. Adverse event following prior vaccination was none. On 17Mar2021 at 21:00, the patient experienced she had a bad headache. The patient experienced chill, fever, nausea and dizziness on 17Mar2021 at 15:00. Caller stated she received the first dose of the Pfizer covid vaccine on Monday and experienced bad reaction yesterday (last night), she became dizzy, nauseous, had fever and chills and a headache.; they went away but now she had a bad headache. Caller wanted to know was it safe for her to go back to work. It wall started around 3pm yesterday. First, she got dizziness and then got nauseous. She ate something and got nauseous after she ate and then got dizzy. All she had left is bad headache. The headache started 6 hours after the dizziness. She did not feel a thing when she got the injection, so she was unable to confirm if it was given in the muscle. No ER or physician office required. She was afraid to get out of bed when she got Dizzy because she lives by herself and stayed in bed. She rested in between chills. Was super cold and could not get warm. There was no prescriber. Caller stated she does not have a particular doctor yet but goes to this medical practice. Caller wanted to know if it is safe for her to get the second dose. No Relevant test reported. Outcome of the event headache was not recovered and all other events was recovering.  No follow-up attempts are possible. No further information is expected.
Began having heartburn 3 days after second vaccine. Intermittent, about 3 episodes per week that occurs in the middle of the night, wakes up from sleep
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-MAR-2014, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-AUG-2016, the patient was treated by a nurse practitioner for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. She was prescribed valacyclovir and pregabalin for management of her painful symptoms and chronic pain. On or about 15-AUG-2016, she sought subsequent treatment from a nurse practitioner for another blistering vesicular outbreak, which was diagnosed as severe herpes zoster. She was prescribed pregabalin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.