chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A week after the Moderna shot, I developed an inflammation in the left shoulder (joint and muscles).  It went away after a few weeks and then returned in May, with the addition of inflammation in the right hip (joint and muscles) .  In June, I developed an inflammation in the left hip (joint and muscles).  In September,  the inflammation in the left hip began to recede.  By November, the inflammation in the right hip and left shoulder was receding.  As of today (March 21, 2022), the inflammation in both hips is gone and is almost gone from my left shoulder.  In early March, I developed an inflammation in the ring finger of my left hand (which may have nothing to do with the vaccine).  In the fall of 2021, Dr. did a stress test to see if my pulse rate would react to a simple exercise.  My pulse was normal.  After marching in place for one minute, my pulse increased to almost 100.  I was not sweating, exhausted, breathing hard or other exercise conditions.  She suspects that I am experiencing an inflammation of the endothelial cells in the circulation system which is preventing normal oxygen perfusion to the muscles in my left arm and both legs.  I am largely better now except for an inflammation in my left hand three weeks ago which may or may not be related.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jan2022 at 12:00 as dose 1, single (Lot number: EL3247), in left arm, on 08Feb2021 at 12:00 as dose 2, single (Lot number: EL9269), in left arm, on 12Oct2021 at 17:00 as dose 3 (booster), single (Lot number: PF2585), in left arm and on 05May2022 at 15:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient treated with Paxlovid (anti-viral) for COVID-19 treatment from 21Nov2022 to 26Nov2022.
Dose administered from a vial that was greater than 12 hours post puncture at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was greater than 12 hours post puncture at room temperature) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was greater than 12 hours post puncture at room temperature). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was greater than 12 hours post puncture at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Th e reporter stated that the patient experienced no side effects after the vaccination.   This case was linked to MOD21-152960, MOD21-152979, MOD21-152980, MOD-2021-354372, MOD-2021-354517 (Patient Link).
4th day after I got the Vaccine I developed a dark red rash down both my arms and across my chest. Went away within 2 days.  2 and a half weeks after the vaccine shot I started to notice that my skin was turning yellow and I was feeling very sick. I went for bloodwork on April 23rd and my liver enzymes were raised into the 1200's. Later that night they were in the 1600's.  I was admitted into the hospital that night and was released 1 week later with the liver enzymes im the 1200's. Back in March my Liver enzymes were slightly raised at 59 but 4 weeks later I had an acute attack that raised them into the 1200's.  I have had a Liver Biopsy, heart echo, Tee procedure, cardiac Mri.  And blood tests for Hepititas, and any other kind of disease or infection.  Everything came negative. I have Autoimmune Hepititas now and never had an issue before this with my Liver. I was being asked what I did different in those 4 weeks and there was nothing but the vaccine. My Liver enzymes are still raised very high and I have to take medication.
No additional AE; temperature excursion for VARlVAX; This spontaneous report was received from a registered nurse (conflicting information as the reporter's title was reported as medical assitant) referring to a 5-year-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 10-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot number U015682, expiration date 18-MAY-2023 (dose and route of administration not provided) for prophylaxis. No adverse event was reported.         The vaccine experienced a temeprature excursion on 07-SEP-2021 of 4 degrees Celsius (°C) for 20 minutes and on 09-SEP-2021 for the same temperature and duration. The vaccine experienced a previous temeprature excursion of 4°C for 7 hours and 30 minutes; Sender's Comments:  US-009507513-2109USA005628:
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Diluent used was correct type/strength, but not the diluent that came with the Pfizer vaccine.  Diluent was 0.9% NaCl normal saline but came in a single use bottle, not intended for use with injections. No adverse effect found to date with patient.
Hot to touch and golf ball sized red circle at injection site.  Has not sought treatment or taken anything for it.
8 days post vaccination developing a large area of erythema local to the site of vaccination, posterior right upper arm. Systemic symptoms: body aches, swollen lymph nodes, axillary pain, pain at site of erythema, mild itching and tenderness at site of erythema. Afebrile on exam. Area of erythema 10cmX14 cm, tender to palpation and warm. Previous marked outline showed increase of size 3cm in 3 hours. Submandibular and cervical lymphadenopathy. Given this delayed reaction, there were concerns for cellulitis vs injection site reaction and side effect of vaccine. It was a Friday and given the presentation paired with limited follow-up availability due to the clinic being closed on weekend, and systemic systems, elected to treat for cellulitis. Follow-up on 1/12/2021 showed resolution of systemic systems along with lymphadenopathy and erythema. Now with more data available it would appear this was delayed vaccine reaction and not cellulitis.
expired doses of FLUZONE HIGH-DOSE QUADRIVALENT given with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 65 years old male patient to whom expired doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Sep-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength and lot number not reported; expiry date: 30-Jun-2022) via intramuscular route in unknown administration site for prophylactic vaccination.  On 13-Sep-2022, (latency: same day) the patient had expired doses of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE given with no reported adverse event (expired product administered).  Action taken was 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.
pt recvd vax; arm sore, redness,hives like red "wheelds";mom did not call until 22mar95;
This spontaneous report as received from a pharmacy technician concerning a currently 3 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Systemic: throat dryness-Mild, Additional Details: took benadryl and throat dryness resolved
Covid arm 9 pm  Chills 3 am 12 hours following shot  Diarrhea 8 am 17 hours following shot Fever greater that 101 3 pm 24 hours following shot
hives; allergies; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and HYPERSENSITIVITY (allergies) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives) and HYPERSENSITIVITY (allergies). At the time of the report, URTICARIA (hives) and HYPERSENSITIVITY (allergies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD21-169582 (Patient Link).
Stomach pain, chest pain, itching.  Swelling of lips, throat and body.
Really sore arm; Cold chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Really sore arm) and CHILLS (Cold chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00A21A) for COVID-19 vaccination.     The patient's past medical history was not reported .  Concomitant products included RIVAROXABAN (XARELTO), IRON, VITAMIN D3, MONTELUKAST SODIUM (SINGULAIR), DULOXETINE HYDROCHLORIDE (CYMBALTA), TOPIRAMATE (TOPAMAX), BACLOFEN, TRAZODONE, PREGABALIN (LYRICA), CEFALEXIN (CEPHALEXINE), OMEPRAZOLE, DICLOFENAC (VOLTAREN [DICLOFENAC]) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Really sore arm) and CHILLS (Cold chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Really sore arm) and CHILLS (Cold chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Extreme headaches persisting for over a week, piercing and throbbing headaches at temples throughout the day, called my doctor but only heard back from doctor through exchange, who said to take Tylenol and it?s probably nothing. I did not take Tylenol as I wanted to see if and  when it would be better. Eventually lessened after persistent headaches for over a week. Slowly got to be less and less, but am still having headaches off and on, whereas I am not the headachy type of person.  lightheadedness, feeling dizzy and light in head, strong for about a week then slowed down but also still getting it from time to time. No treatment done.  very sore arm. Was expected, but figured I should mention it while mentioning the other things
Administered 1st shot in Hepatitis B series, employee had an immediate vasovagal reaction. Was sitting on a therapy bench, and assisted into the laying down position. No injury sustained. Medical team response requested immediately. Monitored Heart rate, blood pressure, pulse ox, blood glucose immediately after incident and continued to monitor for 1 hour. Recovered fully.
Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: Pt felt a burning sensation right away and stated that their heart was racing. I checked BP several times and the range was between 130-158 / 70-90. Pt went to urgent care & MD monitored until BP & HR was normal. They are unsure if this was vaccine related or nerves.  Pt was instructed to rest at home today & is feeling better but noted that she felt itchy when she first woke up this AM but it has since passed.
Irritable, child would not eat, could not sleep comfortably, swelling at injection site of left leg, fever climbing to 102.7 despite MOTRIN/TYLENOL given. ER visit. This lasted 3 days.
Pt noted some itching at site of injection about an hour after receiving vaccine. Itched until about 8:00 pm 10/03/2001. Pt called back to state (10/04/2001, 4:00 pm) that the arm was red, hard, swollen, tender, and warm. No elevation of temperature noted. Much improved by 3 days.
Low grade temp., red prickly, itchy rash on head & scalp behind ears. Child fussy. Started w/ these s/s at 3pm 10/26/11.
Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced MYALGIA (Body ache) and HEADACHE (Headache). At the time of the report, MYALGIA (Body ache) and HEADACHE (Headache) outcome was unknown.            Concomitant medication was not reported. Treatment medication was not reported.
24 hours after PPV23 given left upper arm near axilla, started to swell and red lumps appeared on upper left deltoid. Decreased ROM of left shoulder.
Rec'd flu shot in left upper arm on 2/20/14 - pain in arm - waited 6 wks to be seen in ER Nov 2013 - given prednisone and naproxen (arm painful and inflamed) started seeing Employee Health Dr in Dec 2013 - started PT therapy 12/31/13 - severe pain in left shoulder down through elbow and stiffness/limited mobility.
Dizziness FLUSHED, HOT, DIPHURETIC, REDNESS, HEAVINESS IN STOMACH Narrative: RESOLVED IN 30 MINUTES
The following is verbatim from the article: BACKGROUND: Influenza-associated pediatric deaths became a notifiable condition in 2004. METHODS: We analyzed deaths in children aged less than 18 years with laboratory-confirmed influenza virus infection reported to the Centers for Disease Control and Prevention during the 2010-2011 to 2015-2016 influenza seasons. Data were collected with a standard case report form that included demographics, medical conditions, and clinical diagnoses. RESULTS: Overall, 675 deaths were reported. The median age was 6 years (interquartile range: 2-12). The average annual incidence was 0.15 per 100 000 children (95% confidence interval: 0.14-0.16) and was highest among children aged less than 6 months (incidence: 0.66; 95% confidence interval: 0.53-0.82), followed by children aged 6-23 months (incidence: 0.33; 95% confidence interval: 0.27-0.39). Only 31% (n = 149 of 477) of children aged 6 months had received any influenza vaccination. Overall, 65% (n = 410 of 628) of children died within 7 days after symptom onset. Half of the children (n = 327 of 654) had no preexisting medical conditions. Compared with children with preexisting medical conditions, children with none were younger (median: 5 vs 8 years old), less vaccinated (27% vs 36%), more likely to die before hospital admission (77% vs 48%), and had a shorter illness duration (4 vs 7 days; P less than .05 for all).CONCLUSIONS: Each year, influenza-associated pediatric deaths are reported. Young children have the highest death rates, especially infants aged less than 6 months. Increasing vaccination among children, pregnant women, and caregivers of infants may reduce influenza associated pediatric deaths. This case involves a two patients (age reported as less than seven months) who were partially vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient died due to influenza. The patients were less than 7 months of age and therefore did not have time for full vaccination before death. The median time from symptom onset to death was 5 days (IQR: 2-11 days). Relevant lab investigations and corrective treatment were not reported. It was not reported if the autopsy was performed or not. List of documents held by sender: none. Sender's Comments: This literature article describes two patients (less than 7 months of age, other details unknown) who died in association with Influenza infection. These patients were partially immunized with Influenza vaccine (unknown manufacturer). It is not a case of vaccination failure as complete immunization schedule was not followed. Time to onset, type and serotype of influenza infection are not reported. Based upon the reported information, the role of vaccine cannot be assessed. Reported Cause(s) of Death: Influenza.
Large rash on left arm, swelling, area is hot to the touch and very itchy.
Pt s/p Pneumovax vaccine 8/27/08 now with cellulitis (L) deltoid.
one of the worst headache of my life that lasted almost the entire day / terrible headache; a low grade fever; body aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Mar2021 10:15 (Lot number: ER8730) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "stents in heart" (unspecified if ongoing); "Aorta Blocked", start date: Sep2000 (unspecified if ongoing), notes: Angioplasty with 2 stunts; "Arthritis" (unspecified if ongoing). Family history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: DICLOFENAC taken for arthritis (ongoing); ATORVASTATIN CALCIUM taken for blood cholesterol increased (ongoing). Vaccination history included: Bnt162b2 (product=COVID 19,, lot number=EN6198,, administration time=10:15 AM, Dose number=1, vaccine location=Left arm, Route of administration: Intramuscular), administration date: 02Mar2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 23Mar2021 04:00, outcome "recovered" (24Mar2021), described as "one of the worst headache of my life that lasted almost the entire day / terrible headache"; PYREXIA (non-serious) with onset 23Mar2021 04:00, outcome "recovered" (24Mar2021), described as "a low grade fever"; PAIN (non-serious) with onset 23Mar2021 04:00, outcome "recovered" (24Mar2021), described as "body aches"; CHILLS (non-serious) with onset 23Mar2021 04:00, outcome "recovered" (24Mar2021), described as "chills". Therapeutic measures were not taken as a result of headache, pyrexia, pain, chills.  Additional information: medications the patient received within 2 weeks of vaccination was Lipitor. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient's Mother died age 77 of heart disease and Father died age 89 of heart disease. No known allergies. On 28Sep2021 I received the Pfizer Booster. Here is the data on that Vaccine - Pfizer 301458A.  No follow-up attempts are possible. No further information is expected.
Child was given Td to Rt arm-Hep B to L arm. Was fine till walking across nurse rom wher ehe staggered and fell. Caught by RN. Noted to seizure x 2-eyes to back of head. Neck flexed back, arms jerking x 10 sec and then x 20-30 sec with seizure longest one duskiness noted to lips. Squad arrive within 15 mins. Bld sugar by then in low 70's. BP 90/50 and 110/60. Pulse 80. Apple juice given. Ambulance.
NO reaction reported. Vaccines were inadvertently administered due to human error. Shot record was pre-stamped for vaccines that had been administered exactly 1 year prior to current visit (08/12/14). Nurse saw the dates and thought it was 08/12/15, and accidentally administered Tdap, Varicella, MCV4, and Hepatitis A. Patient also received HPV9, which was the intended vaccine. After administration, mother of patient asked about the number of shots, and that is when the error was realized. Mother asked about possible adverse reactions. Nurse advised her to monitor her daughter for any changes, and to inform the Health Dept. if any occurrence should happen. Patient did not show any signs of reaction, but report is being made in an abundance of caution.
pt recv vax 22OCT97 & 24OCT97 c/o itching & swelling lt arm;hives distal to inj site;
Shot was administered at my pharmacy, not at the Dr. office. Next day reactions that continue today are as follows: Headache, body ache, joint pain, nausea, diarrhea, dizziness, fatigue, shortness of breath, congestion, shortness of breath.
Left arm redness, swelling, warmth. Patient received Tdap and MENACTRA on 2/14/18 (LD) after speaking with guardian and informed of no past history of reactions to vaccines. School nurse called next day 2/15/18 due to 3x2" redness w/upper arm swelling-family took to see MD and antibiotics started. F/U on 2/16/18 and 2/20/18-swelling resolved of Left arm. Right arm fine.