chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling very tired; Feeling achy / Pain; Headache; Fever; Numbness of my arm; Weakness throughout my body; Stomachache; nightmare; This case was reported by a consumer and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On 26th August 2019 12:00, the patient received the 1st dose of Shingrix. On an unknown date, the patient received TETANUS VACCINE at an unknown dose. In August 2019, 15 hrs 33 min after receiving Shingrix and unknown after receiving TETANUS VACCINE, the patient experienced headache, fever, numbness of upper extremities, weakness generalized, stomach pain and nightmare. On 26th August 2019, the patient experienced tiredness and pain. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the tiredness, pain, headache, fever, numbness of upper extremities, weakness generalized, stomach pain and nightmare were unknown.   It was unknown if the reporter considered the tiredness, pain, headache, fever, numbness of upper extremities, weakness generalized, stomach pain and nightmare to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter just wanted to report the horrible experience had with vaccination.  The patient's physician told to the patient that the patient would experience some swelling at the site, might be some chills.  The patient received Shingrix at about noon time and started feeling very tired and achy that evening. The patient went to sleep. On 27th August 2019 at 3:33 am, the patient woke up living the worst nightmare of life. The pain, the headache, fever, numbness of my arm, weakness throughout body and stomachache.  The patient spent two days out of work, in bed recovering with Motrin. The patient reported that its first shingles vaccination and my last. The reporter was not informed of returning for a second part of the shot and was also given a tetanus vaccination and asked could that have compounded the reactions. The reporter was just curious why the side effects were so severe. It was unknown if the reporter considered the tiredness, pain, headache, fever, numbness of upper extremities, weakness generalized, stomach pain and nightmare to be related to tetanus vaccine.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The pertinent medical history and concomitant medications was not reproted. On 29-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX that was improperly stored. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Started to get a rash Wednesday evening, rash continued to get worse on chest/stomach/back throughout Thursday despite taking Benadryl.
Approximately 3-4 days following the vaccination I broke out in a rash on both arms. It lasted about 3 days and the itching was controlled with cortisone. Approximately one week after the vaccination I contracted a yeast infection.  It resolved with over the counter meds one week later. The site of the injection was a bit  sore for two weeks.
Vaccine received on a.m. same afternoon, 8/30, complained of "sore arm" - Took ADVIL 8/31 am - redness of arm 3-4" below IM site. 8/31 P.M. area was swollen, more red & hot to touch. 9/1 - arm same as 8/31 P.M. Improved on 9/2 less red, 9/3 better and on 9/4 no redness remained.
Moderna Booster Dose 0.25ml given in L deltoid however the patient was here for FLU- NOT COVID-19 vaccine. The patient already received Pfizer x 3- last booster on 9/30/2021.  An additional dose was received which was a medication error, no S/S of adverse effects or event as of Friday 10/22 or Monday 10/25.
Fever 102.7; Chills; Sweats; Fatigue; Nausea; Headache; Body aches; from the booster- 3rd shot; from the booster- 3rd shot; This is a spontaneous report from a contactable consumer(patient). A 39-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Right on 24Sep2021 11:00 (At the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. No relevant past drug history, known allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 and dose 2 via an unspecified route of administration (At the age of 39-year-old) as single dose for COVID-19 immunisation and the patient previously received FLU vaccine via an unspecified route of administration, administered in Arm Left on 23Sep2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Sep2021 23:00 the patient experienced fever 102.7, chills, sweats, fatigue, nausea, headache, body aches, from the booster- 3rd shot. The patient underwent lab tests and procedures which included body temperature: 102.7 on 24Sep2021. The outcome of the event from the booster- 3rd shot was unknown and outcome of other events was not recovered,  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 17-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not reported) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Patient complained of swollen underarm, redness and pain. Recommended patient BENADRYL and to go see urgent care. We have tried to contact patient to find out MD and outcome, but no answer several times.
Severe chest pain starting 3 days after the vaccine. Elevated troponin requiring admission for post-vaccine myocarditis.
Large rash at injection site, with fever, muscle pain - 11 days after vaccine Dose 1
A report has been received from a health professional concerning a child, male patient,. The patient's medical history and concomitant medication were not reported. The patient had been receiving nasal FLUMIST QUADRIVALENT. The health professional reported that she overheard at her son's school bus the person stated her child received the entire dose of FLUMIST QUADRIVALENT in one nostril. The outcome of the event of patient received entire dose of FLUMIST QUADRIVALENT in one nostril was unknown. The report was considered to be non-serious.
Chest pains (left side only), Shortness of breath, Increasing worse over 3-4 days. Went to the ER because I thought I was having a heart attack.
Fever and chills and headache  Most importantly is having extreme swaying and  Mood swings.  Fatigue  Similar to serotonin syndrome
patient reports flair up of shingles pain, had shingles a year ago. no open sores but feeling the pain around her waist area
Initial report was received on 19 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of DAPTACEL received on the following dates: 15 October 2007, 23 January 2008, 01 April 2008 and 18 February 2009 (lot numbers, route and sites of administration not reported). The subject developed a cough and cold-like symptoms on 17 August 2012, approximately 42 months after the last dose. On 21 August 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 27 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 05 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Immunization 6/16. Started 6/19 with irritability and fever and eating. Temperature 102.4 fever 6/20 and 6/21. Seen 6/21 and diagnosed with otitis media. Prescribed Amoxicillin.
No adverse event; patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial).    No concomitant medications was provided by the reporter.  Vaccination dates reported was between 22-Jul-2022 and 28-Jul-2022.  The patient was administered vaccine with a volume of 0.25 ml (25 mcg) instead of 0.5 ml (50 mcg). Unknown if patient experienced any symptoms after getting the vaccine.  No treatment medications was provided by the reporter.
Time: 14-16 hours Severe body aches, chills, fever of 100.9, intense headache, nausea, dizziness, continuous sweating
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 02-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Patient is a 57-year-old female with a history of ADHD, on Adderall, who presented to the ED complaining of rash starting 2 days prior to presentation.  It started on her nose and shifted to her bilateral malar area and then went to her left ear and, on the day of presentation, spread to her left arm.  It is non-itchy, nonpainful.  She denies any open wounds, shortness of breath, wheezing, dysphagia.  She took the Moderna COVID-19 vaccine 1st dose on March 24, 2021.  She did have prior elevated ANA value and was undergoing investigation for autoimmune disease.  There is no formal diagnosis yet.  She also states that she has been taking care of her grand baby who seems to have had a viral illness with diarrhea.  She herself denies fever, but does complain of a cough.  The baby tested negative for COVID-19.  Patient, initially, presented to Centra Care and had been taking Bactrim, Bactroban and Medrol Dosepak with no relief. Patient's rash nearly completely resolved after IV benadryl, solumedrol, and Pepcid in the hospital. She initially had hyperkalemia, likely due to Bactrim, that resolved after kayexalate.
fatigue mild headache  shortness of breath chills low grade fever  diagnosed with   ACUTE PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONATE   had two hospital doctors  two hematologist two pa-c  specialist all suspect pfizer shot .  taking  eloquis for 90 days
Twenty minutes after the shot (on 1/23) patient noticed a maculopapular rash on both arms, very hot to the touch with very mild pruritus. Later that night she experienced chills. The next day (1/24) she was light-headed and the rash was still hot to the touch. Today (1/25), she noticed it spread to her legs but no pruritus or heat in this location. The rash on her arms today (1/25) is not as hot to the touch, but still warm. She has applied OTC hydrocortisone cream to her arms twice on 1/24.
chills, fatigue, rash. red induration at injection site, rash Narrative:  took ibuprofen for AE
Tinnitus in right ear.. Audio Hearing Test. Seen By ENT. MRI scan of brain.  Told to go home and learn to live with it.  Almost 10 months later no improvement. Suffering with it everyday.
Documentation completed at the site of the event on 05/26/2021 by MA.  0854:  Pt stated that she felt "dizzy" and "clammy".  Pt closely monitored and given ice packs.  BP 150/70, P 62, O2 sat 100%.   0950:  BP 110/60, P 58; O2 sat 100%.  No syncope. Pt still feeling dizzy.  Pt sts her wife will pick her up, supervisor advised.   Pt laid down, feet elevated for 10 minutes.  Pt states that after laying down she is feeling better.  Color has returned to face, vitals were WNL.   1030:  Pt went home, wife picked her up, she did not drive.  notifed APRN of the event on 05/26/2021 at 1015.    APRN- telephone call on 05/26/2021 @ 1211:  Called pt at her home.  Pt sts she was laying down, still feeling tired/weak but denies syncope or other neurologic signs/symptoms.   PLAN:  Encouraged pt to push PO fluids with electrolytes and explained rationale.  To go to ER if syncope or any other neurologic changes.  Pt understood and agrees.  APRN- telephone call on 05/26/2021 @ 1526.  Pt states she is feeling much better, weakness has subsided.  Pt has been drinking a lot of fluids.  Reports tenderness to injection site. PLAN:   Continue to push PO fluids.  May use compresses to arm PRN pain.  May take tylenol/advil PRN arm pain.  Told pt incident will be reported to VAERS.  To call the  office if any questions.  Pt understood and agrees.
Note that this was my booster shot. I am still having MUCH  more hip and knee joint pain than normal with my arthritis on the 6th day after my shot.. Additionally, I am having muscle pain in my leg. I did not have these side effects after the first two shots.
Within 15-30 minutes of receiving the vaccine, patient reported tongue numbness on left side of tongue. The nurse advised her to take benadryl which she did and then the numbness went away. About 8 days post vaccination, patient reported a rash around the injection site area of her arm as well as ear canal itchiness on the left side. She has been taking allertec as advised by her doctor. The rash as subsided somewhat but the ear itchiness is still present. She said that it flares up off and on.
Beginning about a week after my first injection, I started feeling absolutely exhausted and having daily headaches and have lost my balance and feel dizzy. It started out intermittent for about a week but has been daily for almost two weeks. I often need to catch myself to keep from falling.  I am scheduled to receive my second shot on the 23rd of April but am going to reschedule, and wait an additional two weeks to see if I feel any better. I am a very healthy 74 year old, was still doing my own yard work in summer and snow shoveling/roof raking in the winter.  Walking my dog regularly. I now have a neighbor walking my dog most days as I can only manage taking him out when he needs to go out .  I'm very concerned about getting the second shot as the first has changed my physical health and well-being so drastically.
I had some fever going on and went to see my Doctor they took my temp and my fever wouldn't come down. I had fatigue, headache. I went in and got an antibodies test and it came back that I had them before I got the vaccine. Recurring flu kind of thing, dizziness. Ongoing gastroenterology related issues from having colon cancer. I was diagnosed with IBSD.
I was out of for part of it. An hour later, when I went home - I felt sweaty; my wife said I went blank and started convulsions and I had trouble breathing. I remember a police officer assisting me and me being in the ambulance and that's all remember. I went to the hospital - they gave me Nitroglycerin. They said that caused my blood to speed up and pulled me out the reaction I was having at the time. I had an EKG, CT Scan, Blood Panel - said it wasn't my heart. It was something reacting to my lungs that caused me to go into distress. I had soreness in my lungs, problems with my breathing and coughing after that. They said it was something with my lungs that had been caused by a reaction to the shot- they hadn't seen anything like this before. Doctor said he didn't know what course of action to take so I was sent home without any treatment. I had a follow up visit with my family doctor. I have lung soreness and coughing - I get that more often when I have season changes or cold (extreme heat or cold in weather) - get flare up in my right lung - which is where a lot of the pain and inflammation that had come from my reaction the shot. I have never had that before. I have had a chest x-ray but they haven't been able to determine what caused it. I have tried to get a third vaccine, but have been rejected 7 times because no one wants to take responsibility for administering that to me since I had the reaction I did with the second. Had had COVID in December 2020 - and I had a chest xray at that time because I had issues with my right lung. But that had healed. They had seen that on a second chest x-ray, but with the second vaccine this is where I had issues again.
A month after my second Covid vaccine, I had severe vertigo and vomiting. I went to urgent care and  was prescribed anti-nausea and anti-dizziness medications. The doctor assumed it was inner ear issue, so I went to an ENT specialist. By then, the vertigo was gone.   On Dec. 27th, 2021, I got my booster (Pfizer FL3197) at a pharmacy. A month later, which  is present time, the dizziness started again. I have learned how to close my eyes and "ground" my head into my pillow to make the spinning stop. I haven't vomited, so the reaction seems less severe than last time.
Weak immune Response; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (Weak immune Response) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included METHOTREXATE and ETANERCEPT (ENBREL) for Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (Weak immune Response). At the time of the report, IMMUNE SYSTEM DISORDER (Weak immune Response) outcome was unknown.            Treatment information was not provided.
Patient fainted at  pharmacy  approximately 7 minutes after receiving vaccine. Went  to Emergency Room by ambulance.  On follow up phone call patient stated he is doing fine. He received iv fluids at Emergency Room.
Burst brain aneurism with sudden intense headache, weakness, sweating.  Thought it was worst migraine ever.  Went to emergency room 2 days later and learned of anerurism.  Had major head surgery to clip aneurism at Hospital, and remained hospitalized   almost 2 weeks.   Had in home physical therapy, occupational therapy, and nurse for 1 month.  No disabilities.
Case previously recorded as MA2009-3974. Initial case report received from a pharmacist, via Novartis Medical Communications on 10 NOV 2009. A 9 month-old male patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 10204P1, expiration date 28 FEB 2009) i.m. on NOV 2009. No adverse event was reported. MedCom reference no.: NA09-007885.
Patient presented with bilateral lower extremity pitting edema. Hospitalized for lower leg elevation and compresses. All labs within normal limits. Edema resolved with elevation. Patient discharged on hospital day 3.
Varivax was administered at physician office 11 days after MMR was administered at Health Dept. Mother informed the ordering provider that MMR was administered at Health dept on 5/17/21 during the Well Check physical exam on 5/28/21. Nursing staff arrived into patient room to administer 2 vaccines (DTaP-IPV & Varivax) on 5/28/21. Mother verbally informed staff nurse that MMR was given in the past few weeks. Nurse verbally acknowledged that the MMR date was noted in the patient chart & proceeded to administered Quadracel & Varivax as was ordered by physician.  Mom is aware that MMR & Varivax are both 'live' virus vaccines & called to question the validity of the most recent Varivax administration on 5/28/21 since it was not more than 30 days apart from the MMR on 5/17/21.
This spontaneous report was received from a registered nurse, via a company representative, referring to a female patient of unknown age. The adverse event was reported to the nurse by a physician because it was one of the physician's patients. The patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (Lot number, expiration date, dose and route of administration were not reported) at a hospital. Concomitant medication was not reported. On an unknown date, the patient experienced left lower extremity paralysis problems. the outcome of monoplegia was reported as recovered (on an unknown date) in a 6 month timeframe. The causality of monoplegia was unknown. Upon internal review, monoplegia was considered medically significant. Additional information has been requested.