chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/7/22 I received the flu vaccine and COVID booster; Immediately following I experienced extreme fatigue and body aches for approximately 72 hours which then temporarily improved. By 11/17/22, the fatigue and body aches had returned 11/19/22 ? tingling started in my feet 11/20/22 ? the tingling started in my hands and continued in my feet as well as soreness throughout my body, pain in hands and wrists consistent with carpal tunnel 11/22/22 ? evaluated and cleared by endocrinologist (symptoms were not related to thyroid or sugar) 11/28/22 ? pain throughout entire body tingling persisted, consulted with neurologist who referred me for a full neuro eval 11/30/22 ? full neuro eval 12/1/22 ? Electromyography (EMG) study confirmed reduced response of my muscles when the nerves were stimulated; a lumbar puncture confirmed Guillain-Barre Syndrome (GBS) diagnosis via elevated protein levels; admitted to hospital, started IV IG infusions  12/4/22 ? completed infusions  Tingling and pain persists to this day although are improved from their worst point in December. Continuing to follow up with neurologist for management of symptoms and to determine if further treatment is needed. Taking medication prescribed by neuro to manage neuropathy and pain.
soreness and redness at the injection site; soreness and redness at the injection site; hives that broke out on the back of her head and lower wrists; rashes that occurred on both arms and around the back and torso; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2020, 2 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema, hives and rash. The patient was treated with benadryl (nos) (Benadryl) and medication unknown (Other Medications). On an unknown date, the outcome of the injection site pain, injection site erythema, hives and rash were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, hives and rash to be related to Shingrix.  Additional details were reported as follows: The vaccine was given on the upper left deltoid at the local pharmacy. The patient experienced soreness and redness at the injection site, hives that broke out on the back of her head and lower wrists, and rashes that occurred on both arms and around the back and torso.  She states these adverse events occurred two to three days after getting the shot and resolved since taking Benadryl and other medications.  Her doctor was not aware of these adverse events. The reporter consented to follow-up.
Joint/bone pain in shoulders, lower back (extreme), knees, hips, wrists, ankles, fingers and toes
COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000206735
Pt received Twinrix2 on 1/6/05. Received phone call from pt on 01/12/05; client states he had been having migraine headaches since 1/8/05 or for the last five days. Has been self medication with OTC remedies. Recommended client see his family doctor for evaluation. Received Twinrix 1 on 12/9/04 with no ill effects.
Diarrhea vomit started 24 hr after injection and continue x 3 days
Narrative: Admission Date: Aug 13,2021 Discharge Date: Aug 17,2021 Primary Diagnosis during Admission/Treatment: COVID Pneumonia 82yoM with past medical history of COPD on 2L O2 by NC, non-operative gallstones complicated by recurrent pancreatitis, CKD, HFpEF, AFIB (not on anticoagulation), pulmonary HTN (group II/III), prolonged QTc, hypothyroidism, HTN, HLD, and gout who presents with SOB x 1 day. Notably, patient was admitted in July 2021 for gallstone pancreatitis, and managed non-operatively. On August 13, 2021 he presented with complaints of progressive shortness of breath from baseline 2L O2 requirement. Patient woke up in the morning with increased SOB and was found by EMS to be satting 89% on home 2L O2. He had occasional desaturations while in ED to mid-80s. Patient denies having sick contacts, has "no idea" where he could have come into contact with the virus. Has been fully vaccinated on 1/22/2021 and 2/10/2021 with the Pfizer vaccine. Denies subjective fever, chills, myalgias, CP, palpitations, NVDC, dysuria, productive cough, rashes. In the ED, patient was afebrile, with variable pulse from 70s to 150s, labile BP from 140-70s systolic, and satting high 70s to low 90s on home 2L O2. Labs were significant for anemia to 9, AST slightly elevated to 43, Cr 2.99 (labile creatinine, baseline close to 3), VBG WNL. CXR significant for "Interval increase of hazy bilateral lower lung parenchymal opacities that could represent infection, atelectasis, and/or aspiration." COVID rapid test confirmed + COVID infection. He was given Albuterol neb in ED and was admitted for further mgmt of COVID PNA. During the admission, the patient desaturated requiring 2L by NC with any movement or coughing spell. O2 requirement remained elevated at 3L by NC beyond baseline 2L NC. Pt was placed on Dexamethasone 6mg daily from 8/13-8/22. During hospitalization, the patient was continued on home Spiriva, Albuterol, Budesonide/Formoterol MDIs. Remdesivir was deferred in the setting of chronic kidney disease and Therapeutic AC with enoxaparin was given 1mg/kg twice daily as able to for CrCl>30. He recovered and was discharged on 08/17/2021.
When administering rotavirus vaccine, child appeared to gag for a second.  He then became pale and still, but still awake and alert and was not breathing.  He did not change color nor appear in distress at any time.  He slowly fell asleep, then started crying weakly and gradually recovered fully over approx. 5-10 minutes.
2 days after the first vaccine, I had vaginal bleeding. I already had my period the week before the vaccine. I went to my primary doctor and all vaginal exam, including papsmear were normal. 2 days after the 2nd dose I started to have spotting again. This is different spotting I had experience prior to start of my menstrual period.  Yesterday, 10/4/21, I noticed in the morning that my upper right arm was stiff and the injection site was tender. Everytime I move my right arm, the injection site hurts. The day of the 2nd dose, I also had mild fever and right arm severe pain and muscle pain/aches/sore. My right arm continues to be painful and feeling stiff where the injection site is. I am afraid of paralysis from the vaccine.
I had a round bruise form where I had the injection. The bruise was still visible when I received my second dose.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. A 15 year-old female patient received bnt162b2 (BNT162B2), administration date 30Jun2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset Aug2021, outcome "unknown", described as "she has been experiencing a left frontal lobe migraine". Additional information: For the last 3 days she had been experiencing a left frontal lobe migraine that she described as her skull cracking open or being broke. Follow-up attempts are completed. No further information is expected.
difficulty breathing Narrative:  Patient got first dose of moderna vaccine on 2/5/21 with no reported adverse effects. Patient got second dose on 3/5/21. Patient developed a fever, confusion, difficulty breathing, and weakness for which he presented to a emergency department on 3/6/21. Patient wad evaluated and given Tylenol then discharged home.
Two weeks after injection of 2nd dose of Pfizer vaccine, syptoms of my eczema became extreme. This was a reaction to some foods that aggravate my eczema and some foods that haven't been a problem.  Nearly my whole body was extremely itchy, so that it felt like my skin was on fire. I used the lotion my dermatologist proscribed and that helped some. After four weeks or so, the symptoms ended and I can now eat these foods (example: almonds, tomatoes, green beans) with no reaction. There is no other reason that I can think of for this reaction, except the covid injection. I have reported this to my doctor.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history and current conditions were not reported. On an unknown darte the patient was vaccinated with ZOSTAVAX (unknown strength, dose and frequency) (lot # and expiry date not provided). Other co-suspects and concomitant medicaiton was not reported. The pharmacist reported that every time he prepare and administre ZOSTAVAX to a patient, he experienced tingling of lips. The pharmacist states the lip tingling resolves within 30 minutes without requiring medical treatment. The pharmacist also reported that he wears gloves while preparing and administering the ZOSTAVAX. Cancer and overdose was not reported. The outcome of the event was reported as recovered. Additional information has been requested.
Information has been received from a physician concerning a 17 year old white female (weight 125#, height 62") who on 23-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot #658558/1061U), IM. On 18-OCT-2007, the patient was vaccinated with the second dose of GARDASIL (Lot #658488/1264U), IM in the left arm. On 26-FEB-2008, the patient was vaccinated with the third dose of GARDASIL (Lot #659182/1757U), IM in the left arm. Concomitant medication was not reported. The physician reported that the patient experienced an increased outbreak of vulvar venereal warts after each injection. It was noted that at the time of vaccinations the patient had no warts and had no prior treatment for warts. The outcome and causality of the events were not reported. Additional information has been requested.
pt felt nausea, passed out & hit head; awoke feeling that could not move hands for a few seconds; sustained cut to head; slept intermittantly for next 36 hrs w/lightheadedness; seen by MD 5 days post head trauma; MD felt not re to vax;
On day 8 my right arm at injection site started to develop a large red rash. The rash is itchy and also has raised some; Day 9 the rash has enlarged and a bit more swollen; The rash is now 4 inches long by 1 inch wide.
patient called today, 4/1/2022, complaining of increased sleepiness after vaccine.  woke up with extreme fatigue the following morning and called into work this lasted approximately 2 days.   patient went on to get dose 2nd Moderna vaccine on 08/30/2021.   About 3-4 months ago (Nov-Dec 2021), the patient noticed was sleeping longer and longer, very sleepy, and required at least 2 hours additional sleep at night.  no other symptoms.   At this time, he realized this had been occurring since receiving first dose of Moderna vaccine.  Normal sleep pattern was go to bed 10-11pm and woke spontaneously around 4am.  since initial vaccination, patient reports requiring increased sleepiness primarily at bedtime, occasionally noticed some sleepiness during the day feeling sleepy but not very often.  now needs more sleep, going to be 8-9pm and wakes approximately 5-6am.  This is bothersome to the patient.  approximately 2-3 days ago(03/30/22) patient stopped at Wendys and got lunch, sat in parking at a local grocery store to eat, and states he fell asleep while he was still eating(almost done with meal).  States he also fell asleep while driving a couple of months ago.  Instructed to have serious conversation with PCP.   states he will discuss with Dr.   This happened in the middle of the day.  Has no hx of sleep disorder and no history of increased sleep issues in the past.   Strongly advised to follow up with PCP.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19 on date of administration.Also patient did not call in to complain of adverse event. This is administration error without adverse event.
Pt was given vaccine and 20 minutes later pt was complianing of headache, nausea and dizziness. Two RN's were assessing pt. Pt blood pressure was 210/110. Pt has a history of hypertension. Pt was previously hospitalized due to a hypertensive crisis. Due to pt's history, and BP, EMS was called. EMS assessed pt, pt refused transfer to hospital.
Pt recvd 3 doses of Engerix-B 7SEP90, 7OCT90, & 7MAR91 & it was determined that pt was a non responder;
TWO LITTLE BLISTERS ON LOWER LIP; TINGLING SENSATION ON LOWER LIP; MILD DIARRHEA; PAIN ON THE INJECTION SITE LEFT ARM; TIREDNESS; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight was 190 pounds, and height was 195.58 centimeters. The patient's pre-existing medical conditions included the patient at the time of reporting was not pregnant .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced pain on the injection site left arm. On 26-JUN-2021, the subject experienced tiredness. On 27-JUN-2021, the subject experienced mild diarrhea. On 10-JUL-2021, the subject experienced tingling sensation on lower lip. On 13-JUL-2021, the subject experienced two little blisters on lower lip. The patient visited to the Doctor/healthcare professional office for the blisters in lower lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild diarrhea on 27-JUN-2021, tingling sensation on lower lip on 11-JUL-2021, pain on the injection site left arm on 29-JUN-2021, and tiredness on 26-JUN-2021, and had not recovered from two little blisters on lower lip. This report was non-serious.
Uncontrollable chills and shaking from jaws to entire body lasting about 45 minutes--7 hours after receiving hi-dose flu shot--very scary. Couldn't stop it and thought I was going to die--but it was transient.
A report was received from a health care professional on 12/12/03 concerning a 3 year old vaccinee of unknown sex who inadvertently received Fluvirin on an unknown date. On an unknown date the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
3/26/21: patient presented and was admitted through ED for Shortness of breath for past 3 days.  Patient also complains of worsening lower extremity edema. Stated being non adherent to Lasix which was prescribed for lower extremity edema. Patient was last admitted in May 2020 for COPD exacerbation. She left facility Against medical advice.   Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine.
Maculo-papular erythematous rash extensor surfaces arm and leg, arthralgias, malaise.
Days 1 to 3: Slight pain and tenderness at injection site with Day 2 being the worse.  Day 4: Slight irritation started on surface of outside left ankle.   Day 5: Outside left ankle became more sore and rash was noticed while taking shower that night.  Skin surface in that area became very dry associated with small scabs.  Day 6: Outside left ankle not sore anymore and just dry skin surface remaining. Day 7: No complaints.
I got the Shot at my local Pharmacy. on 11/3/2020.   It was my second shot.  The injection sight started hurting around 9 pm.  I  put ice on it a couple of times.  The pain woke me up several time throughout the night.  I felt my arm, it was warm and felt rough.  I got up and looked in the mirror.   There were two spots.  One was red circle around the side of my arm and underneath in the injection sight was very dark skin and several blisters.  They seemed to be in a row.  That was in the morning of 11/4/2020..  I went to the Pharmacy around noon on 11/4/2020 and had the Pharmacist look at it.  It was pretty sore.  He was very shocked and said he would call the company that made the vaccine.  At that time I was not in any pain.   He called me about 2pm on 11/4/2020 and told me that the company said it was a rare reaction.  I took Ibuprophen for swelling later on that day.  When I was sleeping on 11/5/2020, I woke up several times with pain.  When I got up in the morning of of 11/6/2020 I noticed that a few blisters had gotten bigger,  the dark circle was hot and it was painful.  I called my Dr.  and they saw at 10:40 .  Two nurses and two Drs. saw my sight from the injection.  They were not sure how to treat it but came to the conclusion to treat it as a bacterial infection with Bactrim.    I continuue to be in pain and the spot it always felt.  It is very warm and my arm to my elbow is a little red and also warm.
Fever to T max 105.3, tachycardia to HR 135, altered mental status (lethargic, nonsensical speech)
This case was reported by a pharmacist via sales rep and described the occurrence of sweating in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sweating, fever and nausea. On an unknown date, the outcome of the sweating, fever and nausea were unknown. It was unknown if the reporter considered the sweating, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was not reported to anyone previously. The age at vaccination was not reported. The call was taken by vaccines inside the sales department. The reporter did not have further details.
mom called to report area of redness & fever @ site of inject rt DTP leg-red area fifty cent also running fever <101;
Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 48-year-old female. Neither medical history nor concomitant medications were reported. On 09-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, 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. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
headache, body aches, cough, congestion, nausea. starting 12/27/21
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 27-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017) (strength, dose number, anatomical location and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacy technician refers to a 2 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Patient in the afternoon on 12/11/21 developed sore, tender raised area 4cm by 6cm in the left supraclavicular area.  It "felt fluid filled".  The day before had bodyaches, headache and temperature 99.2.  Those symptoms resolved.
This case was reported by a healthcare professional and described the occurrence of cough in a 55 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Previous and /or concurrent vaccination included hepatitis A vaccine (Havrix); GlaxoSmithKline given on 4, January 2007. concomitant medications were not provided. On 4, January 2007 the subject received and unspecified dose of Fluarix (.5 ml, unknown, left arm). On 6, January 2007  2 days after vaccination with Fluarix, the subject experienced cough, watery eyes, sneezing, rhinitis, arm soreness and fatigue. She received no specific treatment for these events. The subject reported that she experiences cough watery eyes, sneezing, rhinitis, soreness in arm, and fatigue once or twice a year, even without vaccination. On 8, January 2006 the events were resolved. Follow-up received on 01, February 2007: The events resolved on 19, January 2007. The reporting healthcare professional considered the events were possibly related to vaccination with Fluarix.