chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after some hours her breast started to hurt (same side of vaccination); she can't raise arm; arm swelling; the arm is very painful; headache; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (after some hours her breast started to hurt (same side of vaccination)), VACCINATION SITE MOVEMENT IMPAIRMENT (she can't raise arm), VACCINATION SITE SWELLING (arm swelling), VACCINATION SITE PAIN (the arm is very painful) and HEADACHE (headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022H20A) for COVID-19 vaccination.     Concomitant products included NABUMETONE (RELAFEN) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced BREAST PAIN (after some hours her breast started to hurt (same side of vaccination)), VACCINATION SITE MOVEMENT IMPAIRMENT (she can't raise arm), VACCINATION SITE SWELLING (arm swelling), VACCINATION SITE PAIN (the arm is very painful) and HEADACHE (headache). At the time of the report, BREAST PAIN (after some hours her breast started to hurt (same side of vaccination)), VACCINATION SITE MOVEMENT IMPAIRMENT (she can't raise arm), VACCINATION SITE SWELLING (arm swelling), VACCINATION SITE PAIN (the arm is very painful) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the second dose was scheduled for 03-Mar-2021.
Patient under age 65 administered Fluzone HD in error with no reported adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 28 years old female patient who was under age 65 administered fluzone hd in error with no reported adverse event ,while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2022, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJN04AA and expiration date:30-Jun-2023 at a dose of 0.7ml  via intramuscular route in the deltoid nos for immunization.  On 30-Aug-2022(latency: same day) , the patient was under age 65 administered fluzone hd in error with no reported adverse event (product administered to patient of inappropriate age) following the administration.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event .   Outcome: Unknown  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 guidelines. 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 devel cellulitis in arm where pt was immunized on 7DEC; swelling, double the size of arm w/in 24 hrs of inject; also has fever of 102 which has not resolved as of 9DEc;
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 08-JAN-2015, the patient was vaccinated with improperly stored VAQTA (strength: 25/0 (unit  unspecified), lot # K005323 with expiration date of 10-FEB-2017; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Had an immediate outbreak after 1st shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine a couple of weeks ago and had an immediate outbreak of Shingles. The patient asked was that normal. Additional supportive information: The follow-up would not possible, as no contact, details were available.
patient who had the original 1st dose on Oct2022 and is now looking for a place for her 2nd dose,Is the patient able to go to a place where she can get the monovalent vaccine for her 2nd dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (patient who had the original 1st dose on Oct2022 and is now looking for a place for her 2nd dose,Is the patient able to go to a place where she can get the monovalent vaccine for her 2nd dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   No Medical History information was reported.    In October 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (patient who had the original 1st dose on Oct2022 and is now looking for a place for her 2nd dose,Is the patient able to go to a place where she can get the monovalent vaccine for her 2nd dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (patient who had the original 1st dose on Oct2022 and is now looking for a place for her 2nd dose,Is the patient able to go to a place where she can get the monovalent vaccine for her 2nd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (patient who had the original 1st dose on Oct2022 and is now looking for a place for her 2nd dose,Is the patient able to go to a place where she can get the monovalent vaccine for her 2nd dose).    No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Heart Flutters; Eyes puffy; Eyes dry itchy rash; Itchiness; Hives; A spontaneous report from was received from a  Consumer concerning a 50 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and puffiness and a dry itchy rash around her eyes, itchiness on various parts of her body and only develops hives on area she scratches, heart flutters 3-4 times since the injection that only lasts seconds.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date Jan-2021, The patient experienced puffiness and a dry itchy rash around her eyes, itchiness on various parts of her body and only develops hives on area she scratches, heart flutters 3-4 times since the injection that only lasts seconds.  Laboratory details was not provided.  The patient was taking diphenhydramine HCL as treatment medication.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events puffiness and a dry itchy rash around her eyes, itchiness on various parts of her body and only develops hives on area she scratches, heart flutters 3-4 times since the injection that only lasts seconds was resolved.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the start date of the reported events, a causal relationship between the events and mRNA-1273 vaccine cannot be excluded.
fever, chest pain, elevated troponin, and EKG changes consistent with myocarditis.
Soreness, swelling, redness, and itching at injection sight from hour 8 to 72 post injection.   Headache, fatigue, muscle aches, chills, nausea from hour 9 to 33 post injection.   Vomiting hour 21.   Severe headache and fatigue continuing from hour 33 to 57.   (Side of injection) Swollen lymph node, pain and tenderness, from hour 41 to present hour 72.   Fatigue until 72 hours.   Weird dreams since day of injection.
By morning following vaccine (each time) had fever, chills, cough, body aches-lasted approximately 10 days.
had 2 shots, 7 months apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 25-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had 2 shingles vaccinations, 7 months apart. The patient know that 2 to 6 months was recommended and asked that he/she need another shot. Additional supportive information: The patient received 2nd dose of shingles vaccine later than recommended interval, which led to lengthening of vaccine schedule. The follow-up could not be possible as no contact details were available.
Hives, eye swelling approximately 15 minutes after vaccines. BENADRYL PO given upon return to clinic.
Fever to at least 102 (as recorded in ER) even after dose of Tylenol given. Patient with seizure episode (Staring episode, limp, unresponsive) for about 6-10 minutes.
I received the first dose of Moderna on 8/3/21.  Near October 1, 2021, I began to feel fatigue, thirst and feeling of dehydration followed increased urination. On October 5, 2021,  I discussed with my wife how I was having difficulty sleeping from getting up to urinate so frequently and had weighted that morning and had lost approximately 20 pounds. I went a scheduled doctor appointment and lab work revealed my glucose over 600 and hemoglobin A1C  >12. I was referred to the ED, given fluids and and more in-depth lab work where I was diagnosed as Type 1 diabetic at 38 years old after having years of normal labs at my yearly wellness checks.  I am now insulin dependent.
Patient was vaccinated on 12/6.  He was admitted to ER on 12/7 with respiratory distress, hypoxia and tachypnea.   Coded on 12/19 and after 29 min was declared deceased.
Information has been received from a licensed practical nurse concerning an approximately 10 year old patient who on 10-OCT-2003 was vaccinated with a dose of VARIVAX (Merck).  On approximately 16-NOV-2007 the patient developed more than 100 lesions.  At the time of the report, the patients' outcome was unknown.  This is one of several reports received from the same source.  No further information is available.
left arm red and swollen and warm to touch on 5/19/04. Child not fussy, no temp, mother noticed gradual swelling and redness starting on 5/18/04. F/u call on 5/21/04 - mother states swelling is almost gone and redness is gone, child's activities not impaired.
I developed the symptoms of lower back pain and nausea. I went to the ER and got an IV with pain medicine and anti-nausea medicine. A CT scan was performed, and it was confirmed that I had a kidney stone, which is what I had suspected. A few days later, I went to a hospital, and my urologist performed a lithotripsy, because the stone was too big to pass. A stent was put in, which was in for two weeks. After the stent was removed, I was doing much better. I had another kidney stone as of 4/7/2023, but it is so small that my doctors hope I will be able to pass it.
1st dose: Itching all over body and then COVID arm Benadryl and ice helped eventually went away  2nd dose: Itching all over Then underneath arm opposite side of injection long line of dark bruising  from near armpit to elbow also small bruise near arm pit crease front.   Still ongoing not sure if should be checked out
Employee states he had severe pain at injection site in left deltoid and pain with raising his arm shortly after Flu shot administered.  He did not report s/s for 2 weeks at which time s/s improved but remained painful.  At 4 weeks Ee still complains of pain in deltoid and pain with raising arm.  No swelling, redness, hematoma seen or palpated.
. I am however on chemotherapy for stage 4 non small cell carcinoma of the lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: ?. The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: SMALL CELL LUNG CANCER (medically significant), outcome "unknown", described as ". I am however on chemotherapy for stage 4 non small cell carcinoma of the lungs". Additional information: Patient took the 4 Pfizer covid vaccines. He was eligible for the 5th bivalent vaccine. He was however on chemotherapy for stage 4 non small cell carcinoma of the lungs, and was trying to find literature as to whether this 5th dose is recommended. Event seriousness was reported as non serious by the reporter.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3-1/2 year old erroneously received Quadracel with no reported adverse event; Initial information received on 19-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 3-1/2 years old and unknown gender patient who received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On 19-Dec-2022, the patient received unknown dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (lot number, strength and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination.  On 19-Dec-2022, (same day) the patient developed a non-serious event "3-1/2 year old erroneously received quadracel with no reported adverse event (product administered to patient of inappropriate age) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine.  It is unknown if there were lab data/results available.   Action taken: not applicable.  Outcome: Unknown   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 guidelines. 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.
Day 1  40min in... intense, in-tense....fiery, pain radiates from-injection. Up neck, across shoulders and down back. In.tense. Fiery. Pain. Just over 1hr very intense bone ache. Not muscle. Bone. Ache.  Stop for lunch and find extreme bone ache across collarbone. Intense pain. Like i thought I broke collarbone.  On walking in, to order lunch, dizzy and blurred vision. Had to sit awhile to dissipate.  1.5 hrs in Finish eating and spend time breathing thru pain.  Vision clear, on my way back to work. Intense pain continues adding,  now, itchy across shoulders.  Through afternoon increased fatigue and itch. Little better at 4hrs. Day 2 utter fatigue. Want to. S.l.e.e.p.  Pain now replaces the burn. Every. Where; ache. Ache. Ache. Day3 fatigue on waking. Pain is now in all joints. Knees hips excruciating. Manage 3hrs household tasks before the fatigue sets in to stop.  Awake but still pain in joints.  Not ache; pain. Hard to move. Spend afternoon cooking and resting. Soooo exhausted. Day 4-2wks arm still sore and swollen and warm to touch. cannot bear weight in left arm. Cannot use arm to drive.  swelling down day 15 still cannot bear weight in left arm. pain continues along pathway of injected drug. burn sensation. now day 17 still cannot bear weight in left arm. If I do I get sudden weakness in arm and pain in back of shoulder.
Pt received Pneumonia vaccine to left deltoid on 8/13/14, and the next evening he developed firmness at the site of the injection, redness, warmth, soreness, aching all over (flu-like symptoms), chills, nausea. The site was so tense, pt states it had ridges on skin. S/S were worse at 6-7 pm yesterday. Pt took TYLENOL, with some relief of aching. Myalgia, Rash and Nausea Vomiting. Treatment: Acetaminophen.
Patient with severe COPD and respiratory failure on home O2, currently undergoing evaluation for potential lung transplantation. Patient reports feeling "fine" and got his vaccine 4/1. On 4/2 in the evening he developed feeling of malaise and fatigue, fever, and by 4/3 he noted cough productive of brown sputum, and dyspnea which became progressively severe. Presented then to the ED 4/3 where he appeared to be in respiratory distress and was treated with BiPAP, albuterol/atrovent nebs, solumedrol, then prednisone, antibiotics (levaquin in ED, then doxycycline after admission), hypertonic saline . Remains admitted, still on higher O2 requirements than baseline.
my back and arm is sore; my back and arm is sore; haven't been out of bed much / feel really bad; having trouble breathing; been awake alot of the night; sore joints /I felt like my knee caps were going to break; feeling heaviness in the back of my neck like a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (my back and arm is sore), PAIN IN EXTREMITY (my back and arm is sore), VACCINATION COMPLICATION (haven't been out of bed much / feel really bad), DYSPNOEA (having trouble breathing) and INSOMNIA (been awake alot of the night) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart failure in September 2020. Concurrent medical conditions included COPD and Difficulty breathing. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (my back and arm is sore), PAIN IN EXTREMITY (my back and arm is sore), VACCINATION COMPLICATION (haven't been out of bed much / feel really bad), DYSPNOEA (having trouble breathing), INSOMNIA (been awake alot of the night), ARTHRALGIA (sore joints /I felt like my knee caps were going to break) and HEADACHE (feeling heaviness in the back of my neck like a slight headache). At the time of the report, BACK PAIN (my back and arm is sore), PAIN IN EXTREMITY (my back and arm is sore), VACCINATION COMPLICATION (haven't been out of bed much / feel really bad), DYSPNOEA (having trouble breathing), INSOMNIA (been awake alot of the night), ARTHRALGIA (sore joints /I felt like my knee caps were going to break) and HEADACHE (feeling heaviness in the back of my neck like a slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
This spontaneous report was received from a physician assistant via Pfizer, Inc (manufacturer report  # 2017325014) referring to a female patient of unknown age with rheumatoid arthritis. The physician assistant reported that the patient who was on immunosuppressive therapy with tofacitinib citrate (XELJANZ) and methotrexate (METHOTREXATE) for rheumatoid arthritis was administered a dose of ZOSTAVAX (dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis on an unknown date which was obtained on her own without consulting with the healthcare professional. The healthcare professional decided to discontinue citrate (XELJANZ) for lack of efficacy during the same visit when the healthcare professional learned about the patient's administration with ZOSTAVAX. No additional information provided. Additional information has been requested.
10/22/18 9:37 AM started itching all over. 10/22/18 12:25 PM started experiencing confusion, aphasia that is still on going to date of today. Started developing headaches 10/28/18.
Fever/chills/fatigue/dizziness starting approximately 16 hours after first dose. Symptoms lasted approximately 24 hours after onset.   Treated with ibuprofen to lower temperature.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 04-DEC-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 144, 31 and R; 48, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Report A0370834A describes "arthritis type symptoms" in a 27 year old female vaccinee who received Lyme Disease vaccine recombinant OspA. This report was received form the vaccinee and has not been verified by a physician or other health care professional. There was no relevant medical history reported. Concurrent medications were not specified. The vaccinee did not remember having adverse experiences following receipt of prior immunizations. The dates of the first two injections of LYMErix were not recalled. The third injection was administered "some time in 1999." At an unspecified time post immunization, the vaccinee experienced "arthritis type symptoms" and fatigue. The vaccinee reported that no medical attention was needed. The info received on 06/05/2002 reports the events as ongoing. The adverse event of "arthritis type symptoms" does not meet serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.