chrisvoncsefalvay/vaers-outcomes huggingface dataset:
high fever (>101), chills, shivering, headache, soreness at injection site, night sweats, heart palpations.
Woke up on 4/4 with a golf ball sized, raised welt at the injection site. It was hot and very red. The next day, it was even larger, by 4/7, it had completely gone away.  Everyone thinks I should also mention that I was admitted to the hospital with chest pain, high BP/Pulse on 3/31, they did a D-Dimer on me and it was elevated, suggesting a clot has formed and is in the process of breaking down. I had a CT of my chest and no PE was found, but I had thickening of my left lobar pulmonary artery wall, further supporting the suggestion of a possible blood clot. After an echo stress test, I was discharged the next day on HTN meds. I was experiencing chest discomfort prior to my vaccine, but again, EVERYONE is telling me I need to report this, so I am. :)
59 years old patient who was accidentally administered a high dose flu shot instead of a normal flu shot, with no reported adverse event; 59 years old patient who was accidentally administered a high dose flu shot instead of a normal flu shot, with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 59 years old female patient who was accidentally administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] instead of a normal flu shot (INFLUENZA VACCINE), with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 13-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose of 0.5 ml (lot UT7743CA, expiry date: 30-Jun-2023) via intramuscular route in the left arm for immunisation.  On 13-Oct-2022, 59 years old patient administered high dose flu shot instead of a normal flu shot, with no reported adverse event (product administered to patient of inappropriate age, wrong product administered, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
today dose is the third (3 dose); This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 94-year-old female patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 23rd August 2021, the patient received the 3rd dose of Shingrix. On 23rd August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter called to report that, a female patient who did not record getting 2 dose of Shingrix, went to get the supposed 2 dose but got home and realized she had had the second dose, so today dose was the third (3 dose). The reporter consented to follow up.
Mild Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild Fever) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Leg cramps (Mild leg cramps that flared up every once in a blue moon).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Mild Fever) and CHILLS (Chills). On 10-Apr-2021, PYREXIA (Mild Fever) and CHILLS (Chills) had resolved.            Concomitant information was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-410043, MOD-2021-410072 (Patient Link).
Narcolepsy risk due to residual chicken orexin receptor protein in the vaccine DSU; This is a spontaneous case, initially received from other non-health professional on 07-Nov-2019, concerning a patient, of an unspecified age and gender.   The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose, anatomical location, route of administration, batch number and expiration date: not provided] for an unknown indication.  On an unspecified date, the patient experienced narcolepsy risk due to residual chicken orexin receptor protein in the vaccine DSU.  At the time of initial reporting, the outcome for the event of narcolepsy was not reported.  The case was assessed as serious. The reporter did not provide causality assessment to Fluad (TIV).  Company comment: The patient experienced narcolepsy (reported as narcolepsy risk due to residual chicken orexin receptor protein in the vaccine DSU) after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced narcolepsy (reported as narcolepsy risk due to residual chicken orexin receptor protein in the vaccine DSU) after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Patient was given pediatric 5-11 yr dose. patient should have received 12 yr + dose.
Narrative: Per 7/29 MD note: "67 year old MALE veteran with: progressive decline including fever. Pt initially seen 3 days ago. Exposed to COVID through daughter, initially presented w/ diarrhea. Now w/ increasing SOB, DOE associated w/ fever as hight as 102. Took NSAIDS w/ decrease 100. Notes increasing weakness. No productive cough. No CP or LE edema. Uses CPAP at night, otherwise no o2 or MDI's used. No personal recent travel. No prev h/o PNA. No h/o lung ca. Admits to heavy alcohol use. No recent N/V or abdominal pain."
This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Low blood pressure, normally is 110/60 and reached  80/50), HEART RATE INCREASED (Heart rate is normally 70 and reached 165), GAIT INABILITY (Could can hardly walk), FEELING COLD (Freezing to death) and PAIN (Aching all over,everything hurt.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high and Cholesterol.Concomitant products included ENALAPRIL for Blood pressure high, ATORVASTATIN for Cholesterol, ERGOCALCIFEROL (VITAMIN D2), ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (Low blood pressure, normally is 110/60 and reached  80/50), HEART RATE INCREASED (Heart rate is normally 70 and reached 165), GAIT INABILITY (Could can hardly walk), FEELING COLD (Freezing to death), PAIN (Aching all over,everything hurt.), MIGRAINE (Horrible horrible migraine headache), ILLNESS (So sick) and BEDRIDDEN (In bed for 4 days). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOTENSION (Low blood pressure, normally is 110/60 and reached  80/50), HEART RATE INCREASED (Heart rate is normally 70 and reached 165), GAIT INABILITY (Could can hardly walk), FEELING COLD (Freezing to death), PAIN (Aching all over,everything hurt.), MIGRAINE (Horrible horrible migraine headache) and ILLNESS (So sick) outcome was unknown and BEDRIDDEN (In bed for 4 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Blood pressure measurement: 80/50 (Low) normally is 110/60 and reached 80/50.On an unknown date, Heart rate: 165 (High) normally 70 and reached 165.After the second dose the patient had the events.This case was linked to MOD-2022-453520, MOD-2022-453540 (Patient Link).
The day after the vax, I started getting chills, fever and a headache.  The next morning I couldn't get out of bed and had a sore arm.  I had chills and body aches. I had a tele-health visit w/ my dr the next day.  He advised me to drink plenty of liquids and to take Tylenol.  I experienced these symptoms for 3 days before I could return to work.
Mid-day on Saturday October 1st I noticed that my son began to stutter not thinking much into it and just thinking that he got excited. About one week later his caregivers at daycare/school, Grandparents, Aunts, and Uncle noticed it. Patient also at this point started to get very aggravated with himself and say "I can't talk Mommy". It progressively got worse I then contacted his pediatrician and they told me that it was normal for him to stutter like this at his age. I disagreed with this because I feel that he should have progressed rather than regressed, they then told me that I could make an appointment for an evaluation. I made the appointment with his doctor and I was given a referral to a speech pathologist. I made the appointment and they recommended a Neurologist. I've made an appointment with a Neurologist but required a referral. I contacted his pediatrician and it took them days to get back to me regarding this. They finally contacted me and I was able to schedule him the appointment, 12/12/16. They are suggesting an MRI and told me to report this incident and to see Speech Pathologist to evaluate if this is permanent or treatable. I am to have my son follow up with neurologist after testing and they will be in contact with us.
No Adverse Event; HCP (nurse) called to report TE for VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 05/11/2023 but she was not made aware until today (06/26/2023).  The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with; This spontaneous report was received from a nurse refers to a 4-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUN-2023, the patient was vaccinated with dose of improper storage varicella virus vaccine live (oka/merck)(VARIVAX) lot # W031813, expiration date: 05-OCT-2024, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.  On 11-MAY-2023, administered dose of vaccine was exposed to the temperature excursion of 10.8 degrees Fahrenheit for 8 hours and 23 minutes, with a supported temperature excursion stability elevation (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
In 1995 got Typhoid - injection and soon after starting not feeling well- headache and feeling short of breath, with progressive worsening of headache, photophobia, and noted to be pale and diaphoretic, very short of breath, possible LOC (about 6 hours later). Called 911 and woke up in ED, got shots of 7 and also got full resus including cardioversion. Patient denies any unusual activity, travel, exposures at that time. Reports he was in school, not out in field. Patient was hospitalized overnite, and told that 2 others had similar reactions to his. Patient has since received oral version of typhoid 1995, and tolerated with no symptoms that he can recall. Symptoms: Dyspnea (shortness of breath), diaphoresis, Pallor, Headache (onset within hour of vaccine receipt and worsened over period of about 6-8 hours), and Syncope. 9/18/07 Received medical records which reveal patient experienced HA & SOB which worsened & developed photophobia, pallor & diaphoresis after receiveing injectable typhoid vax.  Possible LOC & taken to ER, resuscitation & cardioversion.  Admitted overnight in 1995.  Received oral typhoid vax in 1995 w/o any noted problems.  Seen in Allergy clinic 8/2007 when told had to have typhoid vax prior to deployment for Oct/2007.  Tx w/oral typhoid vax while in clinic & then monitored for 2 hours w/o any AE.  Sent home w/epi pen.  Returned to clinic for 2nd & 3rd dose at clinic & to be monitored.  Developed a HA after 2nd dose otherwise well tolerated.
This is some time later - obviously - since this Vaccine is new I wanted you to know about possible symptoms that may or may not be related, but after speaking with multiple people thought you should know or look into it. I have had odd neuropathy symptoms and pulsing and throbbing in my entire body, including my feet and knees, that eventually moved to my chest. At first I thought i injured myself running, but symptoms began to move on both sides of my body. Its hard to put pressure on my feet. I saw my cardiologist who took me off my BP medicine as this could be a symptom from the med, but I am still experiencing symptoms. After volunteering at an event I spoke with 2 other women who also had the Moderna shot and were experiencing similar symptoms. I continuously feel like I am getting sick, and like I am getting the chills. I am exhausted and sleeping all the time. Its very interesting that 2 other people had the same symptoms with no other previous issues. My cardiologist referred me to a rheumatologist and so did the other gals I spoke with.
The tinnitus is what I saw the doctor for. The noise I am not supposed to hear I am hearing now. I have to learn to live with it. At times it makes it very hard to concentrate. I noticed the tinnitus within a month of the 1st dose. It became very strong after 2 months. Now it has been over a year.
01/18/22 presents to ED for "general fatigue and weakness". PMHx of "metastatic left breast cancer s/p Mastectomy,Chemo and RT(Onc, Dr),R mediport, GERD and neuropathy"
ADMINISTRATION ERROR! PATIENT WENT TO GET SHINGLES VAX  BUT WAS GIVEN FOURTH DOSE OF PFIZER VAX. PATIENT STILL HASN'T GOTTEN SHINGLES VAX.
Mom stated that when he woke up that he complained of it aching and itching at injection site. She looked and it was red, swollen, and warm to touch.
Patient reports a fever occurred the evening of her first dose.  Three days after a rash at the injection site along with a rash and blisters appeared on her arms, ears, hands, and face.  They have since resolved.
First Dose: couldn''t sleep, nauseous, chills; First Dose: couldn''t sleep, nauseous, chills; First Dose: couldn''t sleep, nauseous, chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 14Jan2021 (Lot number: EL1284) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "he has a form of cancer" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM; LOSARTAN; HYDROCHLOROTHIAZIDE; ESCITALOPRAM; LEVOTHYROXINE SODIUM; ASPRIN. The following information was reported: INSOMNIA (non-serious), NAUSEA (non-serious), CHILLS (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "First Dose: couldn''t sleep, nauseous, chills". Additional information: The patient stated that with the first dose he had a little reaction where he could not sleep, was nauseous, and had chills. The patient did not receive any other vaccine within 4 weeks. The patient did not had specific relevant test for thromboembolic events with thrombocytopenia. No follow-up attempts are possible. No further information is expected.
Rec'd a 1st dose of Engerix-B on the day of inject experienced localized itching & edema. Several days later general hives. Tx oral antihistamine (unspecified). Condition cleared.
Broke out in a full body rash, made another appointment and doctor said rash was not related to the vaccine and prescribed antibiotics. Speech regression, hyper sensitivity, sensitive to lights and sound. He started eating paint chips.
Within seconds of receiving the first dose of the Moderna Covid-19 vaccine, I began to experience a rapid heartbeat (tachycardia) and immediate  fecal urgency.  I experienced a rapid heartbeat for 3-5 minutes followed by what can be described as a "hot flash." Both symptoms (rapid heartbeat/hot flash) subsided within 10 minutes of receiving the vaccine.  I asked the personnel in the observation room to use the bathroom facilities, but was told the accommodation of this request was really not possible -  since there were only two (2) people monitoring about 50 people in the observation room who had received vaccines.  My using the restroom facilities would have required one of the medical professionals to leave the observation room to accompany me to the restroom. Once my observation period ended, I proceed to the bathroom and emptied my bowels.  The entirety of these symptoms abated after I was able to use the restroom facilities.
Case number PHEH2015US026953, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 55 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 05 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Patient reports headaches begain right after the second dose of pfizer vaccine and 2 weeks or less after thist time the headached have increased and he has missed work - at this time headaches are constant; relates a short term memory loss since receiving the second dose also; has been following up with primary care physician since the symptoms started. Hospitalization at  from 7/26 to 7/28. He had an outpatient MRI of the brain for persistent headaches that showed acute/subacute infarct involving genu and posterior limb of right  internal capsule as well as adjacent anterior aspect of the thalamus. Patient was started on ASA and atorvastatin for stroke prevention. He was evaluated by neurology and was recommended for outpatient follow up for management of his chronic headaches. He was instructed to discontinue sumatriptan and start taking topiramate 50 mg qAM and 100 mg qhs for 7 days, then start taking topiramate 50 mg BID. He was also instructed to start taking benadryl 25 mg qd, gabapentin 100 mg TID, and compazine 10 mg qd. He has follow up scheduled with neurology on August 10  and August 28 with  neurology. He feels that his new medications help to take the edge off his headache pain but do not completely resolve the pain. He also adds that he has only been taking topamax 50 mg in the morning and has not been taking an evening dose.   ESR and CRP were only minimally elevated. ANA was negative. Lyme panel was ordered and is pending.   Of note, patient was diagnosed with Bell's palsy resulting in left facial droop on June 12, 2021. He had a negative head CT at that time. He was treated with prednisone and  his symptoms resolved after a week.
Flu vaccination 10/1/15 with "severe" pain for 3-4 days after injection, then pain went away. Then on approximately 10/12/15 - the pain came back along with some muscle weakness, then went away, and is now back on approximately 10/21. Has pain when palpating and when lifting arm above head, and across body. No redness or swelling at site.
On 6/21/01, right leg with 3cm X 3cm red and warm with swelling. Apply cool compresses and use Tylenol; recheck on 6/25/01, rash, fussy, decreased activity, diarrhea, decreased appetite. Possible reaction to Prevnar. Fine papular, blanching and erythematous. Treatment with fluids, Tylenol and Benadryl for 3 days per MD.
This spontaneous report was received from a nurse practitioner regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2016 the patient was vaccinated with improperly stored ZOSTAVAX lot # M020071/ expiration date-18-JUL-2017 for prophylaxis (incorrect product storage). No adverse event was reported. Temperature excursion of -5C, Time frame of 75 days as of 11-NOV-2016. There was no previous temperature excursion and call was not because of the data logger. The outcome of the event was unknown. No product quality complaint was involved. Follow up information received from the nurse prescriber on 09-DEC-2016. The nurse prescriber reported that, on 22-SEP-2016, the patient was administered with improperly stored ZOSTAVAX, 0.65 ml, subcutaneously, lot # M020071/ expiration date-18-JUL-2017. The vaccine was exposed to a temperature range of -14.3 degree Centigrade up to a maximum of -7.22 degree Centigrade for a time frame of 14 days (336 hours) prior to the administration. The remaining vials of the vaccine in stock were not administered to a patients were exposed to a time frame of 90 days (2160 hours). It had no previous excursions. Additional information has been requested. Patient initials, vaccine information, event date and narrative updated. Sender's Comments: MERCK 1611USA006614:Mfr number.
10:00 AM unable to feel feet or legs, not able to walk because of this. Neck hurt, headache, temp 102.5 degrees, not able to feel arms. Went to ER given IV fluids, monitored over several hours, ate food & improved. Able to walk out of ER. Slept a lot the next 2 days per mom (stepmom).
Trembling, shaking, chills, inability to talk, extreme joint and muscle pain. Fell asleep at 11:30pm or so. Then woke up at 3am with a fever, high heart rate, pains, terrible headache, and chest pain
Terrible pain in the lymph nodes on the left side of the neck. Terrible pain in the lymph nodes in the groin area. Acid Reflex in the middle of the night for 7 nights.none
Patient insisted that they had only had 1 shingrix shot before and they wanted a second dose.  Patient had records of two doses previously and patient was given a third shingrix shot. Patient still insists that they only had 1 shot previously, though the records contradict them. They possible were given 3 doses. Patient not having any adverse reaction as of 10/12/21. Spoke to them this morning. Shot given on 10/10/21