chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7/8/02 Mom of patient called health department stating child ran fever 7/7/02 101 degrees. This morning woke up with 12 spots; red, looks like water blisters--trunk, starting on arms.
A non-serious spontaneous report of FLUMIST given to a nine-month old was received from a certified medical assistant in a physician's office concerning a nine-month-old male.  The patient's medical history and concomitant medications were not reported.  On 29-Oct-2008, the patient received FLUMIST vaccine, which is only approved for patients ages 24 months to 39 years of age.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-212 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.57 hours). Last temperature recorded -16. On 10-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route of administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Covid symptoms started on 08/14/2022; tested positive on 08/15/2022. I started running a fever of 100.5 and I went to urgent care. I also had congestion in my head. Symptoms lasted through that Saturday 08/20/2022. I checked to see if I was still positive a week later and I was but didn't feel sick at all. I went for an infusion.
Patient described shivering, shaking, cols, hard to talk, and muscle pain like she was getting hit with a stun gun. She covered up with blankets and felt better when she woke up a few hours later.
My daughter had a very bad reaction and could of died from this Pfizer COVID-19 vaccine; My daughter had a very bad reaction and could of died from this Pfizer COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRIEF RESOLVED UNEXPLAINED EVENT (life threatening), ADVERSE EVENT FOLLOWING IMMUNISATION (life threatening), outcome "unknown" and all described as "My daughter had a very bad reaction and could of died from this Pfizer COVID-19 vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea started 1-2 hrs after vaccine   12 hrs after vaccine fever then 24 hrs shoulder pain chills fever 32 hrs after vaccine fever chills vomiting blood  shortness of breath weakness
Experienced extreme post vaccine symptoms.  Within 12 - 36 hours post vaccine:  chills, fever (103), nausea, extreme headache, vertigo, arm pain, extreme muscle aches, fatigue / weakness,   2- 3 days after vaccine: fever reduced (101.8) , chills subsided, nausea reduced, headache moderate, still weak.  4 - 5 days after vaccine headache still moderate and positional (hurts to move head), sinus pressure and ear pain started, intense itching at injection site began, fever blisters in mouth breakout, eczema breakout on scalp, heightened sense of taste (salty and strong tastes seem more intense).  Symptoms are reducing over time.
Redness around injection site extending couple/few inches from injection site - patient stated itching since injection.
After my first dose I was so tired for about 4 days. I just could not wake up at all. After my second dose I was extremely sick, felt like the flu but way worse, I had a headache for ten days & started getting pains in my stomach. I went to the e.r. a couple times. I had swelling in my chest, my lymph nodes stayed swollen, still about 8 months later there is swelling but it just keeps getting worse. I have swelling & lumps in my neck, legs, arms, hands, feet, back, face, ears, nose. It hurts so bad, I got a ct scan i have cyst on my left kidney, i have a cyst on my left ovary, I have elevated liver enzymes.  We have not figured out what it all is. It seems to be some kind of autoimmune disease or something. I am going to specialists a skin & a gastrointestinal with in the next 2 weeks. Hopefully somebody does something about this soon. I was healthy before I got this shot. I have 4 kids that I can not care for properly. I have to have people help me. Oh & I also have a rash on my cheeks & bridge of my nose. There is a lot more. I need to talk to somebody about this. Oh. I have not pooped since I got the vaccination unless I have used laxatives
Pain in both thighs, altered sensation both lower legs, and slight numbness/tingling both feet lasting 2 days
significant pain in the right shoulder, possibly bursitis; difficulty moving shoulder; treatment so far includes resting shoulder and OTC pain reliever
Painful arm from trapezius/shoulder down to elbow.  Has lasted almost two weeks with no improvement so far.  No loss of range in motion but constant pain and burning all day.
Severe Swelling at injection site; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 22Feb2021 as dose 1, single (at the age of 51-years-old) for COVID-19 immunisation. Medical history included COVID-19 (prior to vaccination) from an unknown date and unknown if ongoing. Patient had no other vaccine in four weeks. Patient had no concomitant medications/other medications in two weeks. On 23Feb2021, patient experienced severe swelling at injection site. Patient received no treatment for the event. Patient had not been tested for COVID-19, post vaccination. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Daily recurring rashes that manifest as red patches, red lines, hives, and dermatographia (any slight scratch, pressure on the skin, or increase in physical activity past casual activity results in a rash forming and lasting for over an hour). Rashes appear at random, though often at parallel points on the body, around the entire body with varying degrees of severity. Rashes worsen during the night. Rashes manifest on face underneath the eyes, on jaw, and as small red lines that appear at random on the forehead.
fever; chills; body aches; Injection site soreness on her arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date, refer linked case US2019153956).   On 19th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 19th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 21st August 2019, the patient experienced fever, chills and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, injection site pain and general body pain to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on right arm. The patient experienced body aches. 2 days after receiving Shingrix, the patient experienced fever, chills and injection site soreness on her arm. The patient stated that all had resolved at this time of report except for the soreness at injection site. The reporter consented to follow up. The consumer did not had vaccine information for this adverse event. The consumer consented to healthcare professional follow up.
Patient seen 5/7/16 for annual physical exam PREVNAR 13 administered. Patient seen on 5/10/16 for pain, tenderness, swelling, redness and warmth at injection site. Localized rash and decreased ROM (L) deltoid/shoulder.
The next evening after receiving flu shot, the underside of patient's left arm became tender to the touch and upon movement of the arm.
Did not receive 2nd dose as scheduled; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose as scheduled) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery on 14-Apr-2021.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose as scheduled). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive 2nd dose as scheduled) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       . Patient missed second shot of vaccine as in the interim he had triple bypass surgery. No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Induration, bruising and tenderness, swelling at injection site.  Size of an egg. Lasted until 12/30/15.  Benadryl cream helped with symptoms.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown dates (reported as since 01-DEC-2014), unspecified patients were vaccinated with RECOMBIVAX HB (lot number, dose, frequency and route unspecified) that was exposed to a supported temperature excursion on 01-DEC-2014. No adverse effect have been reported. The outcome of the events was unknown. The causality of the events with RECOMBIVAX HB was not reporter. This is one of the several reports from the same reporter. Additional information has been requested.
red at injection site; hard at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 25-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA147, expiry date 31st May 2020) for prophylaxis.   On 9th August 2019, the patient received the 1st dose of Menveo. In August 2019, less than a week after receiving Menveo, the patient experienced injection site erythema and injection site induration. On an unknown date, the outcome of the injection site erythema and injection site induration were unknown.   It was unknown if the reporter considered the injection site erythema and injection site induration to be related to Menveo.  Additional details were provided as follows: The office manager reported that the patient returned at the time of reporting after receiving a Menveo vaccination. The patient left arm was red and hard at injection site.  The reporter consented to follow up.
Severe headaches; Fatigue; Sleepy; Weak; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headaches), FATIGUE (Fatigue), SOMNOLENCE (Sleepy), ASTHENIA (Weak) and LETHARGY (Lethargic) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced HEADACHE (Severe headaches), FATIGUE (Fatigue), SOMNOLENCE (Sleepy), ASTHENIA (Weak) and LETHARGY (Lethargic). At the time of the report, HEADACHE (Severe headaches), FATIGUE (Fatigue), SOMNOLENCE (Sleepy), ASTHENIA (Weak) and LETHARGY (Lethargic) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was provided as acetaminophen and ibuprofen.   Reporter did not allow further contact
Extra dose administered; has received 3 doses of Menveo (1st - 23May2019, 2nd - 04Feb2020, 3rd - 28Jul2020).; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose received on 23rd May 2019). Concurrent medical conditions included sickle-cell anemia.   On 28th July 2020, the patient received the 3rd dose of Menveo. On 4th February 2020, the patient received the 2nd dose of Menveo. On 4th February 2020, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced extra dose administered. On 28th July 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: The patient received 3 doses of Menveo, which led to extra dose administered. No symptoms reported. The health care professional did not provide the lot and expiry for each dose. The consent to follow-up was granted. This case had been linked with US2021082162, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021082162:same reporter
Narrative: Headache, fever, arm pain, body aches, chills, fatigue, loss of appetite, night sweats
Approximately 10 minutes after receiving his second dose of Pfizer Pediatric COVID-19 Vaccine, pt patient began to experience emesis. Patient complained of stomach discomfort. Skin is warm, pale, and dry. Episode of emesis stopped after approximately five minutes. V/S stable. Pt's mother spoke to medical consult on scene and was directed to follow up with primary care provider. Pt left vaccination clinic with mother.
Patient came to drive through mass clinic on 4/11/2021 and was inadvertently given the Johnson and Johnson vaccine, patient was too young at age of administration.  PHN whom administered the vaccination was informed of the error when the vaccination was being entered into the database site.
Employee called ~30 minutes after receiving fluzone to report that she felt itchy all over and face felt hot. Upon examination of employee, this RN observed no blotching or rash despite employee's need to scratch. Her face appeared flush. Her breathing was WNL without distress. Benadryl 25mg PO was administered immediately and EE remained under observation for 30 minutes with improvement of symptoms. At that time she drove home and stopped at her Allergist's office, who treated her with Prednisone taper, Zyrtec & Xopenex inhaler. The next day 10/21/08 she went home from work early not feeling well with respiratory complaints. On 10/22/08, while at work, she felt SOB. Dr. went to her desk to examine her. VSS, 130/92, 76. O2 mask applied. BS clear, no stridor. BP lowered to 130/80. Upon consultation with her Allergist, EE sent to local ER.
Later in the evening once home, the Eee took Benadryl for initial rash presentation on L arms (vaccination site). Took tylenol next AM for chills, body aches. hives spread to chest. Took more tylenol for itchy, burning sensation. On 12/24 Thursday she noticed new SOB, 101.7F, hives all over the body, Went to a local ED and got solumedrol, famotidine, benadryl, tylenol, IVF. DC'ed from ED on prednisone, benadryl. Had h/o COVID 4/2020.
Day after vaccine 11/12/21, body aches (Bad), Fever 11/15/21 Faint feeling, cold like symptoms 11/16/21 Heart Palpitations, and upper respiratory infection
From time vaccine given through sleep normal expected muscle soreness; About 0700 03/03/07 woke up in more pain than when I went to sleep. At work at 0800 neck began going stiff and left arm growing more painful as I tried to work out soreness. By 0900I could not move my head in any direction or way to the left because pain severe. By 0930 neck more stiff and painful aswell as arm so sensitive that when my shirt brushed up against my arm it stung as though I had been hit while at same time the inside of my left arm felt as it was being broken in small pieces from the wrist up through the humorus. If I tried to move my head it felt like a stake being shoved up from my shoulder through my neck to the left side of my head and ear. On 03/03/07 I went back to the facility and a doctor told me it was because I slept wrong from being uncomfortable from the vaccines. I was given Flexaril and Toradol. Told I could go back to work on Monday.
Hives, red welt, pain and itchiness at site of injection one week after. Redness has increased over njhbt
He states he had Pfizer one and two but no booster and recently got the booster, and he has a sore throat side effect from Covid; He states he had Pfizer one and two but no booster and recently got the booster, and he has a sore throat side effect from Covid; pills are extra big can't swallow with sore throat.; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "problem swallowing pills my whole life" (unspecified if ongoing), notes: problem swallowing pills my whole life; "rash" (unspecified if ongoing), notes: weak and didn't feel good and got a rash after chewing antibiotic pill; "weak and didn't feel good" (unspecified if ongoing), notes: weak and didn't feel good and got a rash after chewing antibiotic pill. Patient states that one time he took antibiotics and chewed the pill then was weak and didn't feel good and got a rash because it came on too quick it was supposed to be time released. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He states he had Pfizer one and two but no booster and recently got the booster, and he has a sore throat side effect from Covid"; DYSPHAGIA (non-serious), outcome "unknown", described as "pills are extra big can't swallow with sore throat."; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". Therapeutic measures were taken as a result of dysphagia, oropharyngeal pain. Patient states he had Pfizer one and two but no booster and recently got the booster, and he had a sore throat side effect from Covid so can't swallow pills and was not going to take them if he can't swallow them. patient states he had a problem swallowing pills his whole life and from the virus he had a sore throat it hurts and pills were extra big can't swallow with sore throat. He was prescribed Paxlovid and had a problem with swallowing pills because it was too big. He chewed the first three doses but then read the package warning that says do not crush or chew and he took no more.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 35 year old female patient with rheumatoid arthritis and with no drug reactions/allergies who on 15-JUL-2010 (also reported as 14-JUL-2010 in date therapy started field) was vaccinated IM with a dose of PNEUMOVAX 23. Concomitant therapies included: methotrexate (manufacturer unknown) and prednisone (manufacturer unknown). She had since developed a 1-2 inch welt at the injection site that was red and sore. They mentioned "it looked like cellulitis". The patient sought medical attention by office visit. There was no lab diagnostic test performed. The patient was given KEFLEX. At the time of report the patient's status was recovering. Additional information has been requested.
On 5/7, she developed fatigue, chills, palpitations. She felt unwell and presented to the ED on  5/12.
A 45-year-old female patient had inadvertently received a left deltoid, intramuscular injection of Daptacel, (product not recommended for use in this group), lot number C2630AA, on 08 September 2006. This product was administered instead of Adacel.  The following day, the patient experienced muscle spasms.  No testing or examination by a physician was required. the patient took nonsteroidal anti-inflammatory medications as needed.  The patient recovered from the event within 96 hours.  The reporter in this case is the same as the reporter in cases 2006-02409, 2006-03043, 2006-03044, 2006-03045, 2006-03046, 2006-03047, 2006-03049, 2006-03050, and 2006-03051.
Primary side effect is a headache which is still present 13 days after injection.  It occasionally subsides but returns.  Chills, for the first three days and again on the 9th day.
COVID-19; Vaccination site erythema; left arm stayed swollen; left arm stayed itchy; A spontaneous report was received from a consumer concerning herself, a 70 year old  white female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, COVID-19 , Vaccination site erythema, swollen left arm, and  left arm stayed itchy.  The patient's medical history included mild high blood pressure and allergy to statins and Ambien.  The patient was on concomitant medications but refused to report and list them.  On 06 Jan 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient experienced severe left arm reaction after the vaccination that stayed red, swollen and itchy for one week. Next day, on 07 Jan 2021, the patient was also diagnosed with Covid-19.  Laboratory details included COVID-19 positive on 07 Jan 2021.   No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not reported.    The events, Vaccination site erythema, swollen left arm, and left arm stayed itchy were considered resolved on 13 Jan 2021; while the event Covid-19 was considered resolved on 17 Jan 2021.