chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Moderna Bivalent COVID-19 vaccine with a pink cap instead of the Blue Cap; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Bivalent COVID-19 vaccine with a pink cap instead of the Blue Cap) and NO ADVERSE EVENT (No adverse event) in an 18-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In May 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna Bivalent COVID-19 vaccine with a pink cap instead of the Blue Cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna Bivalent COVID-19 vaccine with a pink cap instead of the Blue Cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna Bivalent COVID-19 vaccine with a pink cap instead of the Blue Cap).    Concomitant medication not reported.  Treatment medication not reported.
C/O pain within shoulder joint above the injection site and restricted range of motion, beginning that evening and persisting about 1 week. Saw her again 9/25 and 10/23. Problem resolved soon after she reported it to me on 8/20/09. Stated she's going to go back to her previous plan to take all shots in left arm so she can't feel it.
Injection site was painful; Injection site was swollen; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received on an unknown date).   On 5th September 2019, the patient received the 1st dose of Shingrix. On 5th September 2019, the dose was an unknown dose. On 5th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination experienced  injection site pain and injection site swelling. On 12th November 2019 the patient received the 2nd dose and it sprayed all over her arm.  On an unknown date this year, the Health care professional received an unknown flu vaccine and it sprayed all over her arm. The patient consented to follow up.
sick; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.   This case involves female patient (age unspecified) who was sick (illness), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency, non-serious) following the administration of INFLUENZA VACCINE. She reported that she will never take other shot and she never had flu either.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case
Patient said that she experienced loss of memory and severe diarrhea after receiving her second dose of Shingrix. She said she does not remember anything after getting her vaccination except that it was more painful than her first dose and that her husband found her after coming home from church the next day. She stated that the following Tuesday she was still not feeling like her normal self (slow, sluggish, in a fog)
Expired Boostrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775yf, expiry date 22-APR-2023) for prophylaxis.   On 02-MAY-2023, the patient received Boostrix. On 02-MAY-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired Boostrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. On the day of reporting, the patient received Boostrix that had expired, which led to expired vaccine used.
Loss of balance. Loss of reflexes and strength in legs and hands. Pain and generalized weakness.
always sick; Initial information received on 24-Jan-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who was always sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.Lot number cannot be requested.  On an unknown date the patient developed a non-serious event "always sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE..  It was reported" I took flu shots for years and was always sick; I stopped 18 years ago and have never been healthier."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (always sick).  At time of reporting, the outcome was Unknown for the event always sick.
left arm and leg felt tired; arm bleed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (arm bleed) and MUSCULAR WEAKNESS (left arm and leg felt tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by reporter.     On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (arm bleed). On 20-Apr-2021, the patient experienced MUSCULAR WEAKNESS (left arm and leg felt tired). On 08-Apr-2021, VACCINATION SITE HAEMORRHAGE (arm bleed) outcome was unknown. On 20-Apr-2021, MUSCULAR WEAKNESS (left arm and leg felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information provided about any concomitant and treatment medications.
On 12/14, developed a rash all over body.  Very itchy, resulting in waking up from itchiness and inability to go ablout day due to intensity. Few but scattered hives. No other changes to environment but recent covid booster.  Developed stiffness and pain in multiple hand joints, difficulty moving hands such that driving was difficult and unable to fasten a button  Unable to be still due to intensity of itching.    Saw PCP on 12/15, she  stated urticaria and dermatographia, prescribed:  medrol dose pack, famotidine, zyrtec BID, benadryl, singulair. Symptoms improved but persisted and continue to date of this report.  Saw the doctor with ASAP Allergy mid-January, she performed lab testing and changed up meds. She did not think it was from the vaccine as "I think that would have been gone by now."  Symptoms are gradually improving with time, but still occur daily.  Immediately after booster, had a wide, horizontal  rash on arm for 2 days, approximately 2-3  inches below injection site.     After first covid shot on the same arm, had possible undiagnosed covid arm, as I did not seek any medical treatment:  reddened, slightly inflamed, hot to touch area approximately size of my palm, starting  3-4 days after shot, diminishing after several days, then returned for a couple of weeks.  Second shot was to right arm and no cutaneous effects.
Pt received incorrect dose of 10 mg instread of the 25 mg dose.  Pt was monitored for 15 minutes and there was no adverse reation seen with pt.
Arm sore at injection site first evening. Later that night started not feeling well, had really bad headache, severe body aches particularly muscles and joints, felt sick to stomach, felt very fatigued and stayed in bed several days. No fever.
Patient broke out in a rash starting on the immunization arm and spreading across chest. Rash/hives spread across chest and down left arm. Patient still has hives, however they have decreased in number and severity over the last 6 days. Patient did not feel severe and did not seek medical attention. Patient picked up over the counter Benadryl today to help with the itching from the remaining hives.
Patient arrived to post vaccine are after receiving the first dose of the COVID Pfizer vaccine. Upon entering the post vaccine are she reported a headache, vitals taken and noted to be hypertensive. While monitoring, a diffuse rash across the chest developed. She denied difficulty breathing, no swelling or redness of the lips tongue or throat noted. 911 called for emergency evaluation/transport. Upon EMS arrival rash was notably improved, blood pressure remained elevated, last set of vitals: 205/94, heart rate, 80, O2 100%. Patient was transported via EMS to the hospital for evaluation.
diarrhea worsened 2 hours after receiving the vaccine; Ringing in my ear; was already having a flare; Hearing loss was already there and the vaccine actually exacerbated the situation; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6201, first dose) solution for injection intramuscular in the right arm on 24Feb2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing irritable bowel syndrome from Mar2020 and acid reflux (esophageal). Concomitant medication included ongoing lansoprazole (PREVACID) for acid reflux (esophageal) from Nov2020. The patient stated his diarrhea worsened 2 hours after receiving the vaccine (24Feb2021 at 19:00) and had diarrhea again around 10 pm. The patient stated hearing loss was already there and the vaccine actually exacerbated the situation in 2021. The patient also experienced ringing in my ear in 2021. The patient's nurse, primary care doctor, and gastroenterologist stated it was okay to receive the vaccine as the patient was in the middle of a flare up with his IBS (inflammatory bowel syndrome) in 2021. Treatment for the event hearing loss exacerbated included unspecified steroids and has been working. The outcome of the events diarrhea worsened and ringing in my ear was unknown. The outcome of the events hearing loss exacerbated and having a flare was recovering.
Information has been received from a physician concerning a 9 year old male who was vaccinated with 2 doses of VARIVAX (Merck) on separate, unspecified occasions, contacted chickenpox on an unspecified date in the last 30 days. It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
local arm soreness for over 1wk;heat/ice/APAP or advil;
Patient is now displaying severe schizophrenia episodes of wanting to slit people's throats where before the shot he had none
No adverse events. This was an administration error.  Patient was due for DTaP and IPV, however, patient was given Kinrix (DTaP-IPV combination), which is for age 4 years old.
Patient was accidently given Moderna Covid 19 vaccine for 2nd dose instead of Pfizer Vaccine.   RN, director of facility in which patient resides, was notified on 09/01/2021 of error. No adverse effects have been noted since incident.
Student administered vaccine without meeting age requirement. Phone call to mother confirmed he was administered J&J Vaccine, mother reports no adverse effects noted.
The patient is 94 F with history of HTN, CHF (HFpEF), DM2, CAD with stent who presented with complaints of left sided chest pressure and shortness of breath. +Trop admitted for possible NSTEMI. Seen by cardiology who recommends medical management for Type 2 MI. Patient also incidentally found to be COVID + on 2/1 swab. Family exposure.  She is asymptomatic (receiving RDV while IP, does not need stay for this medication in the hospital in particular). Possible DC with Paxlovid after risk benefit d/w family. Will have 24 hours heparin gtt. Started on Imdur. Cards feel DAPT not needed, can continue her prior Plavix only.               Possible DC on 2/3 after oncoming HBS evaluates the patient.                Isolation will end on 2/11 based on swab given patient asymptomatic
After injection with Moderna COVID 19 vaccination Lot 009C21A in LA via IM, the patient states tingling and redness in arms and hands. The patient is diaphoretic.
Headache (mild); Sore throat (mild); Fatigue (moderate); Injection site soreness (mild); Muscle aches (moderate); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Lot number: EL3247, Expiration Date: May2021) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache (mild)"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat (mild)"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue (moderate)"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site soreness (mild)"; MYALGIA (non-serious), outcome "unknown", described as "Muscle aches (moderate)".  No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Sep2022 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Severe Headache on 13Sep2023. This is the second time the patient had taken paxlovid. The first time was Apr2023 with the same side effect although at the time it was unknown if it was a Covid symptom or paxlovid symptom. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
about 5min p/vax pt was sitting in chair w/eyes rolling back & upper & lower extremities twitching, pale-911 called sx lasted about 30-60seconds;BP 70/50, AP 76 irreg, resp 16;BP 110/60;
ALL OVER BODY ACHES; JOINT PAIN; FATIGUE; 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 is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced all over body aches, joint pain, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the joint pain, all over body aches and fatigue was not reported. This report was non-serious.
Swelling of lips & finger w/urticarial lesion in a 23mo old; Seen on 4th day, swelling down, some lesions still evident;
Severe headache and bodyache followed by fever of 102.3 the following day after the shot. Also swelling at the injection site. The night of the second and third day profuse sweating and diarrhea. The diarrhea could have been due to not being able to take fluids. One more thing loss of apitite and sense of surroundings set in on the second day. Theses symptoms lasted for approximately one week with the fever tapering of a little each day. 12/22/09 DC summary and medical records received for DOS 05/09/08-05/31/08.Pt. initially presented to chemical dependency unit, referred by employer. Received pneumococcal vaccination while detoxing and developed fever and slightly elevated white count for several days which resolved. Also c/o tenderness in right arm near vaccination site, which also resolved. Pt. left AMA insisting all problems were related to vaccine. Readmitted next day to complete detox program. Became disruptive and failed to comply with program and left AMA, without option of readmission. DC DX: Opioid dependence; history of polysubstance dependence with current marijuana abuse; nicotine dependence; rule out mood disorder; rule out anxiety disorder; resolved acute withdrawal syndrome; possible pneumococcal vaccination reaction, resolved.
Fever, chills, body aches, tiredness for 24 hours starting from 8pm 4/5/21 to 8 pm 4/6/21
I had my first shot on Feb 26th and 4 days later I failed an ECHO STRESS TEST.  This led to me having a heart catharization and an MRI of my heart where myocarditis was found.
RLQ pain, vomiting, nausea, fever, COVIED +, appendicitis
Next day, patient's arm became red and warm to the touch a few inches below the vaccinations. Arm was not painful and fever not established. Patient had insisted both vaccinations given in right arm. Immunizing pharmacist agreed. Patient went to a walk-in clinic on the day following the immunization who said it was most likely a local site reaction but will treat with a methylprednisone 6 day pack and cephalexin to treat possible cellulitis.
sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sinus pressure and Cough (The patient had sinus pressure and slight cough a few days before vaccination.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
patient states she could not get out of bed the following ,morning after shot, could not walk upstairs, excruciating pain in arm of injection, red extreemly red underneath arm
Pt recvd 3 doses of Hep B (recomb) vax in MAY89 & pt exp arthralgia; @ time of report sx persisted;
10-6-14 Pt called and reported pain in shoulder and neck. Started 6 hrs after receiving Tday on 9/23/14. Unable to use arm R/T pain. Denise any redness, swelling, fever. Encourage dto contact primary care doctor.
Pt came to nurse 10 min after receiving 2nd TWINRIX vaccine with hives over bilateral arms & abdomen.
This spontaneous report as received from a pharmacist refers to a approximately 64 year old female patient. On 04-SEP-2014, the patient was vaccinated with expired dose ZOSTAVAX (lot # J011211, expiry date: 31-JUL-2014) 0.65 ml, subcutaneous in the left upper arm. No adverse effects reported. No product quality complaint. No further details provided. Outcome of the event was unknown. Additional information has been requested.
Pt developed light pink rash around injection site and scattered to left forearm. Rash improved in 10 minutes after benadryl 25 mg. Followed up with parent two days later and there were no further issues or symptoms related to vaccine.
Red rash at the injection site; Red rash at the injection site; Chills; Flu like symptoms; Fatigue; Fever; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number X2X35, expiry date unknown) for prophylaxis.   On 15th April 2022, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 15th April 2022, less than a day after receiving Shingrix, the patient experienced chills. On 16th April 2022, the patient experienced injection site rash, injection site erythema, influenza-like symptoms, fatigue, fever and muscle pain. On an unknown date, the outcome of the injection site rash, injection site erythema, chills, influenza-like symptoms, fatigue, fever and muscle pain were recovered/resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema, chills, influenza-like symptoms, fatigue, fever and muscle pain to be related to Shingrix.     Additional Information: GSK receipt date: 19-Apr-2022 Reporter's comment: The case was reported patient's wife. She reported that her husband received his second Shingrix dose on Friday afternoon, into his left arm.  On same day of vaccination, in evening he began to had chills.  On Saturday morning (one day after receiving vaccination), he had developed flu-like symptoms including fatigue, fever, and muscle aches, as well as a red rash at the injection site that spread 6 to 8 inches in diameter.  The reporter reported that the patient's reactions were lasted about 3 days and were now resolved. Expiration date of the vaccine administered was unknown. The reporter declined to give consent to contact patient's health care professional. Did not consent to follow-up.
Muscle problems and went to the ER. And they found troponin in the blood  which damages the cardiac muscle