chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 week post Inconsolable, constant crying, fatigue, not eating, complete behavior change for the worst.
pt recv vax 20FEB98 & 25FEB98 pt reported eye not reacting w/the other, lt eye muscle not moving w/other eye, its (the eye motion  is) slower;pt seen by ophthalmologist who referred to a neuro ophthalmologist;
Caregiver was vaccinated and observed for the required 15 minutes.  Caregiver left the building and went to drive home.  Caregiver stated, "on my way home I did not feel right - so I came back."  Caregiver was shaky and slightly confused.  Caregiver was immediately taken to the ED across the parking lot by wheelchair and the ED department was notified that Caregiver was on his way, accompanied by Registered Nurse.
This spontaneous report as received from a nurse refers to a 19 year old female patient with drug reactions/allergies of shellfish. No concomitant medications and pertinent medical history were reported. On 29-OCT-2013 the patient was vaccinated with the first dose of VARIVAX, (lot# J006572, Exp date 07-JUN-2015), injections, subcutaneous in the left arm (strength and indication not reported). On 11-NOV-2013, the patient developed headache and fatigue. She developed a red, raised and sore lesion at the injections site and 2 other itchy lesions on her right arm and 1 itchy lesion on her left arm. The lesions were red raised and less than 5 mm in diameter. They were not vesicular. No lab diagnostic studies were performed. The patient had seen in office. Claritin and hydrocortisone cream were given to treat the adverse events. At the time of reporting, the outcome of the events was not recovered. Additional information has been requested.
Tipe of allergies; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Tipe of allergies) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Tipe of allergies). At the time of the report, HYPERSENSITIVITY (Tipe of allergies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
hive-like rash 20min p/vax;treated w/PO DPH in office;
I ovulated/conceived on 02/09/2021 and miscarried on 02/28/2021. I had the pregnancy laboratory- confirmed, and supportive hormone levels were normal. The first positive test was taken 02/23/2021, at 4 weeks.
"Breaking out in bumps all over his body, is in the nurses office @ school.  Some are fluid filled.  does not have PCP.  Instructed to go to PCP.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sorer arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Platelet disorder.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MYALGIA (sorer arm). At the time of the report, MYALGIA (sorer arm) outcome was unknown.            Concomitant medication includes chemotherapy pill.   Treatment information was not provided.   This case was linked to MOD-2021-294214, MOD-2021-294231 (Patient Link).
Received MMR, Flu #1, PREVNAR at about 930AM 10-18-13. Had been fussy for about 1 day before drooling, tongue in mouth. Given TYLENOL 3/4 tsp about 6P.M. 10/18/13. Around 10P.M. mom heard a cry, went to child bedroom and she was having a seizure, drooling, eyes rolled back and tonic clonic arm and leg movement. Taken to ER.
had sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (had sore arm) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had sore arm). At the time of the report, PAIN IN EXTREMITY (had sore arm) outcome was unknown.            Concomitant medication was not reported. It was reported that patient had sore arm with the previous doses of Moderna vaccine and nothing else. Treatment medications was not reported.   Reporter did not allow further contact
Associated symptoms include fatigue, weakness, Left arm redness, pain, itching. Treatment of Prednisone dose pack, Zyrtec for itching, referral to Ashtma and immunology return to clinic for worsening or unresolved symptoms.
urticaria of face & trunk w/in 45min of 2nd inj;no wheezing;
37 hours after vaccination I had excruciating pain in my back - lower right side. I could barely walk without experiencing pain that made me keel over. I used IcyHot with Lidocaine on the spot throughout the day. I took Aleve pain reliever, and iced the location also. Pain is very slowly subsiding. Still sore now (72 hours after vaccination) but am able to do daily functions.
I woke up with a very sore throat. I couldn't work. I felt bad but no temperature. On 11/26/ 2021 I felt feverish and took an at home COVID test which came out as negative. I slept most of that day. Saturday I was running a temperature all the way through the following Wednesday.  I have been home for a week and a half out of work. Today was my first day back. I had a temperature of 99.6 to 100.5 degrees. I felt congested, stuffy, and my nose would run. I wouldn't have a headache I would just felt bed. I went to Urgent Care on 11/29/2021. They ran test and said they though it was a sinus infection or an ear infection. They also said I was coughing like I had bronchitis. I was prescribed Cefdinir 300mg 2xday. I still have a lot of mucus and feel a little tired but for the most part I am fine.
No adverse event; A first dose of Moderna Covid-19 vaccine was given on 21-Apr-2023 from a booster dose vial with a pink cap yellow border.; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (A first dose of Moderna Covid-19 vaccine was given on 21-Apr-2023 from a booster dose vial with a pink cap yellow border.) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Influenza vaccine on 21-Apr-2022. Past adverse reactions to the above products included No adverse event with Influenza vaccine.    On 21-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (A first dose of Moderna Covid-19 vaccine was given on 21-Apr-2023 from a booster dose vial with a pink cap yellow border.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A first dose of Moderna Covid-19 vaccine was given on 21-Apr-2023 from a booster dose vial with a pink cap yellow border.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A first dose of Moderna Covid-19 vaccine was given on 21-Apr-2023 from a booster dose vial with a pink cap yellow border.).    No concomitant information was reported. It was reported that no other adverse reactions reported . No treatment information was provided.
LOW DIASTOLIC PRESSURE OF 40; LIGHT HEADED; SWEATING; This spontaneous report received from a patient concerned a 26 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced low diastolic pressure of 40, light headed and sweating.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low diastolic pressure of 40, and had not recovered from light headed, and sweating. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420610-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood pressure diastolic low. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Pt was found by daughter 3/14/2021 weak, unable to stand and with swollen legs. Pt was taken to ER where she was found to have left leg DVT despite being on Eliquis 5 mg bid which she confirmed she was taken as prescribed
The patient is a 53 yo previously healthy male who experienced GBS temporally associated with receipt of Pfizer BioNTech COVID vaccine (lot # EW0162 )13 APR 2021. He denies any illness symptoms such as fever, malaise, cough, URI symptoms, n/v/d in the preceding month. He denies any immediate reaction suggestive of IgE mediated event. He reports his initial only side effect was local site tenderness. Approximately 11 days after receipt he had been playing basketball with his kids during the. day and he noted unusual fatigue that evening, pain in his shoulders/neck, took ibuprofen and went to be early. In the morning (Day 14), his right leg slipped and he fell when standing after getting out of bed. He took a few steps and discovered he had no balance and fell again. Family brought him to ER. He was evaluated but no definitive diagnosis and discharged home. He reports on 29 APR 21 (day 16) he was brushing his teeth and couldn't retain water in his mouth. He noted facial drooping, his speech was affected and he returned to ER. ER eval was inconclusive but he was admitted for further evaluation. after multiple tests including LP he was diagnosed with atypical GBS. He received IVIG and was transferred to hospital. He states he improved dramatically after a few days. He was transferred back to hospital and then to rehab for one week and then discharged home. He reports currently he estimates strength at about 60%. He is continuing to improve but fatigues easily. . ER note 27 APR documents c/o body aches x2 days, cough, weakness, HA, perioral numbness and sinus pressure. Also states family member had URI symptoms. Diagnostics included ECG (1st degree block), CXR, CT head, CBC, Chem, LFT, Trop and COVID-19 which were are WNL. A UA showed 2+ ketones. Dx was viral syndrome or possible side effects from COVID vaccine and discharged home, but placed on isolation due to concern for COVID because of symptoms. ER note  c/o oral and extremity paresthesias for this date. Triage diagnosis was vaccine reaction. ER note documents c/o facial droop, eye lid droop, left arm weakness. Neuro exam documents facial droop, unable to lift left arm above head. Diagnostics included plain films left femur and hip, ECG, CT/CTA head, MRI brain, MR venography were normal. Neuro consult did not think was CVA but he was admitted for further eval. Symptoms continued to progress to include increased weakness, DTR 1+ throughout, difficulty managing excretions. LP 01 MAY 2021 was positive for protein and neg for oligoclonal bands, or evidence of infection. He was diagnosed with atypical GBS, started on IVIG, and transferred to hospital. He was transferred back 06 MAY after completing IVIG and then transferred for rehab therapy x1 week followed by discharge home.
Information was received on 14-JUL-2017 from a nurse who reported that an unknown number of patients, names and other demographics unknown, received an unknown number of doses of VARIVAX (lot# M023383, expiration 11-MAY-2018) and PROQUAD (see MARRS# 1707USA002693) following a temperature excursion of -4.5C for two hours and two minutes. No adverse effects were reported in any patients. No other information is available. There was no previous temperature excursion. Call was because of a data logger. This is one of two reports from the same reporter. Additional information has been requested.
an expired component of ActHIB (diluent) was inadvertently administered to a 2 month old male patient/No AE; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a two months old male patient who was inadvertently administered with an expired component of ACT-HIB (diluent) 0.5 ml second dose of vaccine HAEMOPHILUS TYPE B (HIB) VACCINE  [ACT-HIB] (Diluent (liquid) Lot : UI918AAA, expiry Date: 27-Oct-2019; Act-HIB (powder) Lot : UI918AAA, expiry date: 05-Dec-2019; Carton Lot :UI918AAA, expiry Date: 05-Dec-2019) via intramuscular route in the right thigh on 08-Nov-2019.(Reporter reports that the diluent expired prior to the expiration date listed on the carton. Carton expiration date reflected the expiration of the Act-HIB (powder) vial - as reported).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired product administered.  AE symptoms: None 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.
Patient called Health Department on 3/16/21 at 10:37 am and reported that approximately 40 minutes before call she became extremely dizzy.  She has no history of dizziness and no history of health problems.  Reports she does take Fosamax on Saturday and normally feels some nausea with that.  She did take the Fosamax on 3/13/21.  She questioned if this was a normal reaction and said it was severe enough that she did not feel she could walk to the office on the college campus.  I recommended she call her doctor and if she continued to feel severe dizziness go to Emergency Room.  I called her back at 4:54 pm on 3/16/21 and she reported she did go to the Emergency Room and they did a CT Scan and also some other tests but she could not remember everything.  She said her blood pressure was elevated while in the Emergency Room.  Was discharged and has a follow up appointment with her normal provider.   Client called on 3/18/21 at 4:46 pm and said the dizziness continued and she was started on a steroid and meclizine by her provider.
Nausea, vomiting once, low grade fever (100.0-100.2 deg), chills Given 2 Tylenol 500 mg each to bring down fever. Pt not allowed aspirin with other meds.
Patient received the Pfizer COVID booster and then the high dose senior flu shot. After getting the flu vaccine, the patient looked off but insisted that he was fine. After taking a few steps out the vaccination room, he collapsed. Patient was offered water and EMS was contacted. EMS offered to take him to the ER but patient refused. Pharmacy staffed called and left message at 1500 to check on the status of the patient.
local rxn that cleared;pt reports lesions in mouth & diff breathing;pt stated site red & raised the same size as a golf ball;29OCT96 exp swollen itchy tongue w/non blister like bumps on it, very painful;lip & rt eye swollen;allerg rxn;
Client vaccinated in his home by mobile vaccine team on 1/12/23.  On 1/13/23 client developed nausea and low grade fever (99.8 orally). Client had some dizziness on 1/13/23 and nausea with minimal movement. 1/15/23 partner of client noted increased confusion- client could not recall who partner was, had increased difficulty with expressing himself, flushed, temp 99.8. Continued to have intermittent increased confusion from 1/13/23 to 1/19/23. On 1/19/23 home health nurse came to house, noted confusion, and advised ER visit. Client taken to ER on 1/19/23 for evaluation and released to home same day.
I had a fever that lasted 2 days. I went to my physician?s office where a rapid test was done and came back negative. Many other tests were done, and it concluded I had rocky mountain spotted fever without the spots. I was given doxycycline for 10 days. After the fever went away, I felt better the second day.
I had inflamed sinuses, body aches, & fever around 100.6. I had mucus also. I took a test for COVID-19 around noon, and it was positive. I treated my symptoms with lots of liquids and some zinc. I took some cough suppressants to clear up my head. The nurse practitioner prescribed PAXLOVID, and I started taking it the same day. The fever went away, and I noticed some relief. I was much better after the 5-day treatment. I continued to have fatigue, so I was not 100%. After the full 10 days I was back to myself.
Few days after receiving 2nd dose of Moderna, patient reports arm swollen, overall sick feeling, coughing, chest pain, lost her voice, balloon head, coughing up bloody mucous. Patient did state she had the first vaccination on 8/10/21 then on 9/ 11/21 she got COVID and received antibody treatment at the hospital on 9/14/21. She has been to ER and immediate care but was discharged from both with no official diagnosis.
I started experiencing a rash on my face roughly about 1 week after receiving my 4th dose. Rash spread to my limbs (fingertips to arms and ankle to my legs). Eventually I was prescribed a short course  of steroids' and ELIDEL (cream). This lasted for 6 weeks and is now under control.
Patient was admitted to the hospital for COVID-19 symptoms and was treated with typical COVID medications. Patient discharged to home
Initial and follow-up information has been received from a mother concerning her 18 year old daughter with no medical history reported, wasp stings allergy and pecans allergy who "about 6 months ago" in approximately April 2008, was vaccinated with a dose of GARDASIL,  0.5 ml. Concomitant therapy included ethinyl estradiol/norgesstimate (ORTHO TRI-CYCLEN). After receiving each of her three GARDASIL shots, the patient experienced pain and redness at the injection site. Also, after the third shot the patient experienced pain throughout her entire body, swelling and numbness that started on her left sided and has also moved to her right side. The patient has difficulty walking. The physician prescribed diphenhydramine hydrochloride (BENADRYL) and ibuprofen (ADVIL). On an unspecified date, a blood work was performed (results not provided). In follow-up information the mother reported that her daughter was experiencing difficulty breathing, pains in her lower back, constant diarrhea, swollen stomach and recently she started to have numbness and tingling on her hands and bottom of the feet and toes. On 16-OCT-2008, patient was given mixed steroids shot for any allergic reaction due to GARDASIL and then she experienced elevated blood pressure. On 18-OCT-2008, patient experienced pain from her heart down to her hand and she was shaky and weak as well. Later, physician did an eletrocardiogram (EKG), but the results were normal. He gave her pain shot. On 20-OCT-2008, she was prescribed ibuprofen (manufacturer unknown) 600 mg, but that did not help her. On 23-OCT-2008, she was given an "ultra monitor" for heart (result not reported) and will be doing another echocardiogram soon. Caller also mentioned that patient will be seeing a rheumatologist on 04-NOV-2008 and neurologist on 31-OCT-2008. On 27-OCT-2008, the patient developed an itchy rash between her left fingers and was using antibiotic ointment to treat it. At the timer of the report, physician prescribed her cyclobenzaprine hydrochloride (FLEXERIL) for muscle relaxation, but it makes her very tired. Finally, physician stated that if she does not improve from all these medications physician will hospitalize her. At the time of the report, the patient was recovering. Additional information has been requested.
about 6min p/vax pt felt very dizzy;BP dropped from 105/75 to 65/40;given adrenalin inj w/recovery;
Patient received pediatric 5-11 Pfizer COVID-19 dose (0.2 ml) instead of 12+ Pfizer COVID-19 dose. This was patient's first dose of COVID-19 vaccine.
Redness/swelling at inj. site. Mother reports fever at HS. Resolved 10/9/10.
Fatigue; swelling, below vaccine site; redness, below vaccine site; Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th October 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 11th October 2022, the patient experienced fatigue, swelling and erythema. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved and the outcome of the swelling and erythema were recovering/resolving.   It was unknown if the reporter considered the injection site pain, fatigue, swelling and erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter was a patient. The patient received Shingrix vaccine and on that evening patient experienced soreness at the injection site that had resolved. The patient reported that on 11th October 2022 1 day after received Shingrix vaccine the patient experienced fatigue that had resolved and patient experienced swelling and redness below the vaccination site but not at the injection site. The patient stated that the redness and swelling was still present, but she stated that it was appears to be getting better. The patient did not want to give any further demographics and did not had any further information about the vaccine  itself. The reporter did not consent to follow up. Additional supportive information: The outcome of swelling and redness captured as recovering as per narrative.