chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was sick as hell/was sick all day the next day; temp which was 102-104 for hours; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX VACCINE (received 1st dose in March 2022 and experienced sickness, refer case US2022AMR118367) and Shingles vaccine (had the old shingles shot years ago).   On 7th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced sickness and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness and fever were recovered/resolved.   It was unknown if the reporter considered the sickness and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR118367   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the old shingles shot years ago and now had the shingrix 2 shot deal. This past Sunday, the patient got the 2nd dose and the patient was sick as hell and a temperature which was 102 to 104 degree Fahrenheit for hours and was sick all day the next day of course the patient called the doctor who gave some great advice. If the patient had known it would have made him/her so sick that the patient  wouldn't had taken the 2nd shot. The patient know this has happened to quite a lot of people so the patient wonder.  The patient was asking what had changed in the vaccine that it makes a person that ill. Just shouldn't be that bad. Additional supportive information: This case has been linked with the case US2022AMR118373, reported by same reporter. Follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR118367:Fist dose case/Same reporter US-GSK-US2022AMR118373:Hearsay case
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 17-JUL-2015 the patient was inadvertently vaccinated with a dose of improperly stored (Merck) PROQUAD (lot # L007228, expired date 03-SEP-2016, dose and route were unknown). No concomitant medication was reported. No adverse effects were reported. Additional information is not expected since the reporter refused to be contacted.
Narrative: Symptoms: Palpitations & Syncope Treatment: EPINEPHRINE 1 MG ONCE ,EPINEPHRINE 1 MG ONCE ,SODIUM BICARBONATE 50 ML ONCE
Patient had a fever of 103.7 F, drowsiness, and general achiness.
Post vax, the patient developed chicken pox. Unspecified medical attention was sought. Two other patients had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
Very lightheaded since 10am on September 10th 2021. Could barely focus. Feeling as if ill.
A physician reported that a 17 month old male received Acel-Imune and IPV (PMC France) vaccines on 3/1/00. He subsequently, developed a fever of 104F. He also developed redness, swelling and warmth at the site of Acel-Imune; the injection site reaction looked "like a cellulitis". The child was treated symptomatically and was reportedly recovering as of 3/6/00. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Acel-Imune, lot 467011.
Received tetanus vaccine on 9/16/06. On 9/18/06, I (patient) woke up with extreme pain - felt like I had been hit by a car.  Muscle aches through out arms, upper back.  Almost with flu like symptons.  The extreme aches lasted 6 days.  The aches still continue today 10/4/06, though not as extreme - Left arm where shot was given, difficult to lift arm above head or across chest.  Sleeping is extrememly uncomfortable.    Revisited the clinic where shot was given on 10/3/06.  The doctor states that I probably have serum poisoning, symptoms should go away within two weeks.
It has been 13 day's since I received my 2nd covid shot.  I have had a constant headache since I received the shot.  The headache started 12 hours after vaccination.  On a scale of 1-10 at times it stay's about a 5, uncomfortable, irritating, throbbing but tolerable.  At other times it is so severe I have to lay down for an hour or longer.  The pressure is throbbing throughout my head, makes my eyes sore, loss of appetite, soreness in face.   I reported this to my doctors office and to the clinic I received the shot.  I am still awaiting an appointment with my primary care doctor to address the constant headaches.
Following morning: patient was almost incoherent, had a temperature of 105.1, and terrible pains in his legs. Tylenol was finally able to reduce the fever, but the next day it rose to 102,  and the following day also to 102, still having pains in his legs. On day 4, his oxygen level dropped to 80 (he did have congestive heart failure exactly one year ago, but it was corrected in ten days and his oxygen level had been perfect until the vaccine). We are now on day 6 and his oxygen is slowing improving after increasing Lasix. His body had an awful shock with this vaccine which medical people feel contributed to him almost sinking to congestive heart failure again. Even with all his medications he presents as a healthy individual usually.
TONGUE SWELLED UP FELT TINGLY THROAT FELT MORE SWOLLEN FELT THAT 30 MINUTES AFTER INJECTION TOOK 2 BENADRYL AT 4 PM WENT TO ER GIVEN BENADRYL, SOLUMEDROL AND PEPCID SENT HOME 2 HOURS LATER WITH STEROID PRESCRIPTION.
slight soreness in the left arm; tired; really strong chemical state in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (really strong chemical state in the mouth), PAIN IN EXTREMITY (slight soreness in the left arm) and FATIGUE (tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (really strong chemical state in the mouth). On an unknown date, the patient experienced PAIN IN EXTREMITY (slight soreness in the left arm) and FATIGUE (tired). The patient was treated with MACROGOL 3350 (MIRALAX) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (really strong chemical state in the mouth), PAIN IN EXTREMITY (slight soreness in the left arm) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taking other unknown medication.  2 to 3 minutes after receiving the first dose, the patient had the reaction. MiraLax made her nauseous because of the polyethylene glycol.
On the 10th day after receiving the 1st dose of the Moderna vaccine, a red, swollen hot whelp appeared at the injection site.  I am reporting this on day 4 after taking 4 doses of Benadryl and applying Hydrocortisone many times.  The site measures 6 inches by 5 inches. I am seeking medical advice from my PCP later today.
This spontaneous report as received from office manager refers to an 18 year old patient. On an known date the 18 year old patient was vaccianted with an adult dose of RECOMBIVAX HB), injection, 10 microgram/ml. No adverse effect reported. Additional information has been requested.
Has taken Flu vax in the past with no problems. Pain at injection site has never gone away, 2-3 months later pain began to radiate to ankles, hands. Sometimes because of pain, it is hard to sleep at night and make movements. Has been at doctor and specialist and both agreed that there might have been some nerve damage. Last saw primary care doctor 1-2 weeks ago who recommended oxycode for pain.
Information has been received from a physician concerning a female who was vaccinated intramuscularly with the third 0.5 ml dose of Gardasil. It was reported that the patient had experienced injection site pain for 1-2 days. At the time of the report, it was unknown if the patient recovered. The physician also reported a patient that received the third dose of Gardasil and complained of general body aches, nausea and vomiting and reportedly the patient was pregnant, (WAES #0710USA02438).
My periods have been very heavy 1-2 days then barely anything however symptoms leading up to my period and during my period are much much worse than they used to be including an additional sum of dizziness that I never used to have. I have had very bad lower back pain, extreme cramps effecting my life and work abilities during those days.  I also had a large swollen lump and bruising after my shot and the bruising didn?t disappear from sight for about 4 weeks.
D#1 (9/11/23)  - fever/shaking chills, pain at injection site; fever lasted about 24hours; pain at injection site lasted 2-3days. D#4 (9/15/23) - I woke up with my L upper arm (lateral and spreading lower than at the injection site) with  pain and swelling.  Also a red, itchy rash developed in this same area. The area is hot to touch. No other symptoms of fever or chills
Localized reaction to influenza vaccine, left arm with swelling and pain. Seen 3 days after the shot. Pain and swelling of left arm is decreasing. One dose of Prednisolone given in office with follow up with 3 days.
Immediately my sweat, urine, and all bodily odor has sweet foul smell. Covid vaccine given 1/26/22 and as of today 5/9/22 I still have strange bodily odor that won't go away. Never have I smelled this way.
Patient called back and said her left arm feels numb. she is able to move it and has no swelling yet but it feels numb. no fever or difficulty breathing.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (strength, dose and route were unknown) lot # M043310, expiration date 24-APR-2018 for prophylaxis which had a temperature excursion of 10.6°F for 2 hours that was detected by a data logger. The vaccine had no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Fever began 8 hours after vaccine of 100.2.  Body aches. Site of injection is hard and sore almost 48 hours later, and fever is still present. Using Tylenol to treat.
I started having bad headaches about two weeks after taking dose 1. Then after the second shot, the headache started getting better but I still feel exhausted and tired all the time. I have no energy and I sit down and fall asleep and someone has to wake me and that's not normal. I go to see a cardiologists on 7/06/2021.
1) Fever up to 102.2 x 3 days. 2) Excessive crying/fussiness x 3 days. 3) Large knot (quarter sized) at injection site.
Case number PHEH2013US023177 is an initial spontaneous report received from a consumer on 24 Oct 2013. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on unknown date. On an unknown date, she experienced allergic reaction to the flu vaccine. The event outcome was not reported. She was further vaccinated with FLUVIRIN (batch number: 1308201) on an unspecified date and experienced welts and itching around the vaccination site (see related case: PHEH2013US022593).
Localized area of redness and induration about 3cm. diameter at injection site for MMRV posterior aspect of left arm with no tenderness at time of exam
Muscle pain mainly in the legs. Body cut (chills), no temperature. Tiredness in general. This lasted all day. The next day without problems.
Had vaccine and a couple of hours later was very sore at the injection site, and then was very sore the following day and then continued to a lesser extent until 3/11/21.  On 3/6/21 she woke up and had chills, extreme fatigue, no appetite, was kind of wobbly and she slept almost 24 hours.  It was an effort to chew.  Then that evening there was a very faint rash slightly over her shoulder of the same arm, it was not oval, kind of more irregular shaped and was not really itchy.  Then on 3/8/21 for about 1/4" to 1/2" there was a faint pink circle around the injection site and the rest of the rash had traveled down the arm to about 1/2 the size it was before and the underside of the arm/armpit was sore.  She could not tell if there were swollen glands or not.  The very faint rash went until the 9th.  The chills went through until 3/12/21, but the rest of the symptoms were much less, but the fatigue went until about the 12th. There was runny nose and congestion that started on 3/9, and went to 3/15/21, and the chills then restarted again on 3/15/21.  She also had a scratchy throat from 3/12 - 3/15/21.  She could barely function the first 3 days, just pretty much slept all the time the first week.
Febrile seizure approx 14 hours after 4 mo immunization given (PENTACEL, PREVENAR and ROTATEQ) mom states she gave TYLENOL twice and Ibuprofen once last at 9pm, occurred 1 1/2-2 hr later found in bed convulsing and vomited, turned blue. Taken to ER by ambulance.
Patient had a fall at extended care facility, patient had worsening cognitive function. CT reveals  subdural hematoma
rash, itching, swelling of the eyelids, cough, wheezing starting w/in 20 mins of inject & inc; P112, 140, 112;
Time of injection there was stinging and burning. The day after it was worse, hot, burning, stinging, sore, itchy, has a raised welp, huge red circle that got bigger
15 hours after injection (3AM) felt mild congestion in lungs and nose.  Heard that lying on stomach was preferred.  Did that, and woke up at 6AM; was fine.  No other symptoms.
Five months after receiving his 5th Anthrax injection, the patient had a seizure during which he stopped breathing and had to be taken to the hospital by paramedics. The patient is currently being followed by MD at the VA and a neurologist.
In early November I had symptoms of tightness in my chest like congestion and feeling fatigued. It lasted for about 10 days. After the first 5 days I had a telemedicine visit. They listed as plank pain that waxes and wanes and does not radiate. Associated symptoms include fever and weakness. Prescribed bedrest with no relief. I had sinus pain and sore throat.
Narrative: CONTINUES WITH DIARRHEA ON 1/28/2021 Symptoms: Diarrhea
they administered FLUZONE HD to employees that were not 65 and older with no reported adverse event; Related cases: US-SA-2022SA364394, US-SA-2022SA365006, US-SA-2022SA366945, US-SA-2022SA365883.  Initial information received on 31-Aug-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 30 years old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] long with other employees that were not 65 and older with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 30-Aug-2022, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE  (lot UJN04AA, 30-Jun-2023) via intramuscular route in the deltoid NOS as Immunization.  On 30-Aug-2022 the patient developed a non-serious "they administered fluzone hd to employees that were not 65 and older with no reported adverse event" (product administered to patient of inappropriate age) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  it was reported that Nurse reports that yesterday, they held an Employee Health Clinic and administered flu vaccines. She states that there was a "communication error" between staff, complicated by a failure to perform "triple checks". This resulted in 5 employees receiving FLUZONE HIGH-DOSE. No other vaccines were administered. QUADRIVALENT vaccine, though they were < 65 years-old.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.; Sender's Comments:  US-SA-2022SA364394:01257338 US-SA-2022SA365006:01258901 US-SA-2022SA366945:01258919 US-SA-2022SA365883:01258924
No events. Vaccine was administered before 6 mo old (3 days before turning 6 months).
Pt experienced redness and swelling at the site of injection. It spread from his shoulder down to his elbow. He also mentioned it being very sore.
Swollen lymphnode and tenderness on left side above collarbone. Dull headache.
lumpy "patches" and itchiness; lumpy "patches" and itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (lumpy "patches" and itchiness) and VACCINATION SITE PRURITUS (lumpy "patches" and itchiness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN), CARVEDILOL, APIXABAN (ELIQUIS), LEVOTHYROXINE, MONTELUKAST, ESOMEPRAZOLE, SERTRALINE and SIMVASTATIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE INDURATION (lumpy "patches" and itchiness) and VACCINATION SITE PRURITUS (lumpy "patches" and itchiness). At the time of the report, VACCINATION SITE INDURATION (lumpy "patches" and itchiness) had not resolved and VACCINATION SITE PRURITUS (lumpy "patches" and itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was scheduled to receive the second dose on 09-Apr-2021. Treatment drug included diphenhydramine"the little pink ones".
Per tele conversation with patient, she stated the following: her arm became very sore and she could hardly lift it up - approx 1:30 PM. About 7:30 PM post dinner she didn't feel well and was weak and decided to go to bed - felt "tippy" due to weakness. She soon felt very cold - added 2 down blankets to her bed, and took 2 Advil. She states she shivered and shoot all night long, her skin hurt to touch and she had a very bad headache behind her yes. Her body was achy and she did not sleep much during the night. She woke about 9:30 AM - no longer shaking continued to feel weak and achy. She stayed home from work and napped. At 2:30 PM when PHN spoke with her: H/A, shaking, body aches, skin sensitivity all gone but she feels run down, her arm soreness is gone as well. She did not take her temperature but thinks she had a fever during the night. She took 6 aspirin over a 24 hr period to help alleviate her symptoms. PHN advised she phone her physician for  his evaluation and recommendations.  10/28/13 Per tele call with pt - feels back to normal.
Fever; Aches; Chills; Headache; Injection site pain; This is a spontaneous report received from a contactable health care professional, the patient. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via unspecified route of administration on the left arm on 17Mar2021 at 01:30PM (at the age of 49-year-old) as single dose for COVID-19 immunisation. The past drug included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via unspecified route of administration on the left arm on 25Feb2021 at 01:30PM as single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient not had any allergies to medications, food or other products. Concomitant medications were not reported. On 18Mar2021 at 12:00AM, the patient experienced fever, aches, chills, fever, headache, injection site pain (vaccination site pain). The events were treated with tylenol (MANUFACTURER UNKNOWN). The clinical outcome of the events aches, chills, fever, headache, injection site pain (vaccination site pain) was recovering at the time of this report.    No follow up attempts are possible, information about lot number cannot be obtained.
1 week onset of heart failure episode and hospitalization 2 week accelerated gout episode requiring emergency room treatment 1.5 months blistering and peeling of skin requiring over counter anti biotic ointment 1.5 months severe itching arms, legs, and body treated with aloe and cortizone cream
Date and time of vaccination: (list both if they received both shots):  02/02/21 1100, 02/23/21 1200 Date and time adverse event started: 02/05/21  1100 SOB AFTER FIRST SHOT ,FATIGUE , WAS  ADMITTED TO  HOSPITAL FOR 7 DAYS , RELEASED AND THEN RETURNED TO THE HOSPITAL ,  SENT BACK TO ,  SAW THE DOCTOR 24TH  OF MARCH , DOCTOR ADVISED WATER REDUCTION AND THE PATIENT HAD DEVELOPED CHF , PATIENT PAST  ON THE 29TH
18 hours after booster, I woke to vacillation between extreme hot flashes (sweat through shirt, hair wet). This was followed by achy chills most of the following day, and ringing in ears that worsened  with hot flash. I had baseball-size swelling in left armpit (hot-to-touch, hard and extremely painful). Injection size also extremely hot, red and painful. Severe joint pain, especially in hands, knees, ankles and feet. Given prednisone step down pack day after injection. Loud ringing in ears still present 4 days post injection. Armpit lump still present (tender). Joint pain still present but tolerable with Advil 600mg every 5 hours. Injection site still hard, hot and sore (now also very itchy). Hot flashes also remain. No reduction in intensity but occur less frequently.
apnea, hypotensive episode occurring 4hr-5hr p/vax given;
injection dates: 12/30/2020,  1/21/2021, 11/3/21   Seen in hospital consultation last month for acute stroke syndrome. Presented with confusion and expressive aphasia at work. Imaging found large wedge shaped infarct in the left frontal lob. CTA with clot in the M2/M3 branch. Known h/o MTHFR coagulopathy. Numerous pulmonary embolism despite anticoagulation and antithrombotic therapy. She evidently was not medication complaint at the time of this event. Imaging also appreciated an old infarct in the right cerebellum. Other risk factors of obesity w/ metabolic syndrome. Discharged to home with outpatient therapy services and is off work during a period of recovery and f/u appointments. Still having trouble with expressive aphasia
Several hours after receiving the vaccine c/o numbness form neck to feet lasting couple of seconds,superficial chest pain lasting few seconds and a feeling of coldness and weakness
This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medications were not reported. The reporter stated, that 5 doses of improperly stored PNEUMOVAX23 lot # L013428, expiration date: 03-FEB-2017 (dose, route of administration and anatomical location were not provided) were administered to multiple unspecified patients on multiple unspecified dates. There were no adverse effects reported. Additional information has been requested.