chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Dose 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 16-month-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 17-JUL-2023, the patient received Infanrix. On 17-JUL-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Dose 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: 19-JUL-2023 Clinical Manager states an expired dose of Infanrix was administered to a patient, which led to expired vaccine used. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up via postal.
Patient became dizzy and short of breath. fell against wall and had a small laceration on elbow.
Significant difference in his crohns where he had been well controlled for all these years; Liver is enlarged, again; Feel nausea pretty regularly after the second vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Significant difference in his crohns where he had been well controlled for all these years) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Smoker (stopped smoking) and Liver enlargement. Concurrent medical conditions included Crohn's (Since 25-30 years).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (Significant difference in his crohns where he had been well controlled for all these years) (seriousness criterion medically significant), HEPATOMEGALY (Liver is enlarged, again) and NAUSEA (Feel nausea pretty regularly after the second vaccine). At the time of the report, CROHN'S DISEASE (Significant difference in his crohns where he had been well controlled for all these years), HEPATOMEGALY (Liver is enlarged, again) and NAUSEA (Feel nausea pretty regularly after the second vaccine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: abnormal (abnormal) Liver is enlarged.         Concomitant medications was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-138883 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
During her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated; During her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated; She felt better shortly after 5 minutes but then her husband noted some redness in skin color in her legs and on her abdomen.; Upon arrival to bay, HR 180-190; This is a spontaneous report from a non-contactable other health care professional. A 70-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration (at the age of 70-years), on 24Mar2021 as dose 2, single for COVID-19 immunization and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8727), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included dementia Alzheimer's type, Patient husband stated supraventricular tachy-cardia usually in high 200's or low 300's if it comes on, heart rate in the 150s at times from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date, the patient experienced during her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated, she felt better shortly after 5 minutes but then her husband noted some redness in skin color in her legs and on her abdomen, upon arrival to bay, hr 180-190. The treatment was received for the events with water and Trendelenburg position. The patient underwent lab tests and procedures which included heart rate increased: 180-190, heart rate increased: hr in the 150s at times HR in the 150s at times , supraventricular tachycardia: usually in high 200's or low 300's if it comes Usually in high 200's or low 300's if it comes on all on an unspecified date. Usually resolves on its own with elevation of feet above patient head per patient husband. Patient husband was main caregiver. He was not worried about it but wanted to know what her pressures were doing. Differential Diagnosis: Red flag symptoms. Follow up response to treatment: fair. Patient discharge. The clinical outcome of the events during her 15 minute waiting period after the injection, the patient began to experience a change in her cough and felt nauseated, she felt better shortly after 5 minutes but then her husband noted some redness in skin color in her legs and on her abdomen, upon arrival to bay, hr 180-190 was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Extensive local reaction w induration, edema, erythema and pain extending up arm to shoulder and thorax. Pt was admitted to a hospital 30 hrs after vaccination for possible cellulitis.
A non-serious, spontaneous report of full dose of FLUMIST in one nostril was received from a consumer, concerning a nine year-old patient. The pharmacist administering the dose placed all 0.2 ml into one nostril, disregarding the diver clip on the sprayer device. 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.
Approximately 30 hours after I received the shot, I began getting sharp pains at the top of my inner thighs near the groin area.  By the next day, it was very difficult to walk. By Friday, three days after the shot, I could barely take a step or two to walk. Intense pain. Went to the ER Friday at 2:00 pm
Ongoing vertigo, severe headaches, shingles, rashes on arms, high fevers,  chest pain and pressure (on going),   Did experience loss of taste and smell 7 months later.
shortness of breath; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (shortness of breath) and FATIGUE (fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METHOTREXATE, ALLOPURINOL, FOLIC ACID, GABAPENTIN, IBUPROFEN, MAGNESIUM, IPRATROPIUM BROMIDE (ATROVENT), ALBUTEROL [SALBUTAMOL], METFORMIN, METOPROLOL, VITAMIN D [VITAMIN D NOS] and IRON for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (shortness of breath) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include steroid cream and immunomodulator methotrexate. No treatment medication details was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient experienced autonomic  and peripheral neuropathy resulting in weakness and significant dizziness with drop of blood pressure.  Slow improvement over time with moderate lower extremity weakness resulting at the present time.  She is no longer on midodrine
Stomach was hurting; Joint pain; Muscle pain; Fever about 100Degrees; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Stomach was hurting), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever about 100Degrees) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced ABDOMINAL PAIN (Stomach was hurting), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever about 100Degrees), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Feb-2021, ABDOMINAL PAIN (Stomach was hurting), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever about 100Degrees), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment  for the event includes Tylenol.
Visiting brother in hospital and began feeling hot. Mom says nurse checked temp and was 104 deg F. No treatment. Doing fine now.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Batch/Lot number: unknown), on 13Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "Lichen sclerosis" (unspecified if ongoing), notes: Lichen sclerosis; "Glaucoma" (unspecified if ongoing); "uterine cancer" (unspecified if ongoing); "Melanoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 Treatment: Paxlovid start date 08Jun2022 stop date 12Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received 1st dose of Pfizer COVID Vaccine on 02-18-2021 and on 03-11-2021 patient received in error Moderna COVID Vaccine as 2nd dose.
15 minutes after receiving vaccination, pt reported it feels like "my throat is closing up", left sioded neck, arm, and chest pressure, and nausea. Pt does report she has had chest pressure intermittently for past 2 weeks but throat closing feeling began after vaccination. Pt received aspirin 324 mg po x1, diphenhydramine 25 mg IV x1, famotidine 20 mg IV x1, Solu-Medrol 125 mg IV x1, morphine 2 mg IV x1, and nitroglycerin 0.4 mg SL x1.  Following treatment, pt reports she is free of chest pain and throat symptoms have improved.
1303- Pfizer 1st dose covid vaccine given IM right deltoid.  1306- patient had a syncopal event while sitting upright in chair with mother seated next to him.  He did lean on to mother but he remained in the chair. The event lasted approx. 30 seconds then patient woke up and requested water.  Mother states that the patient has had similar vasovagal events of "passing out" when blood drawn and injections given in the past.  Patient was monitored in the room for approximately 25 min and he left ambulatory with mother in no acute distress.
Patient noted onset of pain in left upper arm near/at site of flu vaccination several hours after vaccine administered.
muscle aches; fatigue; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28Apr2021 (Lot number: EP6955) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, lot number:EP6955), administration date: 07Apr2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: MYALGIA (non-serious) with onset 25Aug2021, outcome "recovered" (2021), described as "muscle aches"; FATIGUE (non-serious) with onset 25Aug2021, outcome "recovered" (2021), described as "fatigue"; HEADACHE (non-serious) with onset 25Aug2021, outcome "recovered" (2021), described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, fatigue, headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19.   No follow-up attempts are possible. No further information is expected.
After 2 month vaccines extreme night fussiness only x2 weeks. No other symptoms (same given at 4 mo except no HBV). After 4 month vaccines, same extreme night fussiness has occurred.
I started getting rashes in September 2021, but starting in December 2021 the rashes would flare up a lot more worse. I would get flare up of rashes on parts of my body that would stay for a couple of weeks and then go way for a couple weeks and then come back. Most of my flare ups was above my waist including my back, arms, chest, stomach, and face. The rashes would be red, and sometimes they would be raised like hives, be itching, or burning. I went to the doctor on May 18, 2022. They ran some test. I don't have a flare up right now. The last flare up I had was the beginning of May 2022 so far.
injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site pain). At the time of the report, INJECTION SITE PAIN (injection site pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided. Treatment information was not provided.   Reporter did not allow further contact
rash or bruise on his left leg; Bruise on his left leg; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash or bruise on his left leg) and CONTUSION (Bruise on his left leg) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced RASH (rash or bruise on his left leg) and CONTUSION (Bruise on his left leg). At the time of the report, RASH (rash or bruise on his left leg) and CONTUSION (Bruise on his left leg) outcome was unknown. Rash or bruise on left leg about 4cm in diameter, not red in color or itchy.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: inconclusive (Inconclusive) waiting for result.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       He consulted a physician assistant on 01-APR-2021, she was thinking that was not related to vaccine. No concomitant medication details was reported. No treatment medication details was reported.
7 minutes into my waiting period after vaccine administration I experienced my throat closing up I was gasping for breath I couldn?t swallow. The pharmacist gave me an epi pen and called 911. I went to the emergency room.
exacerbation of lupus. patient previously well controlled, days after vaccination developed symptoms of  bullous lupus and vasculitic ulcers,  still worsening despite increased immunosuppression.  currently hospitalized for further workup/treatment
Pain swelling at injection site, extreme fatigue, I mean extreme! Mild fever, migraine headache, arm pain, neck pain, back pain. Sick overall feeling, one week and not getting better.
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 60 years old female who was accidentally vaccinated with a dose of FLUZONE HIGH DOSE (lot UJ000AB, expiration date 28-MAR-2019) via intramuscular route in the right deltoid on 14-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration and overdose. No side effects have been reported at that time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
severe swelling in the leg from knee to hip; Initial information received on 11-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves patient (unknown demographic) who experienced severe swelling in the leg from knee to hip (swelling), while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ162AB and expiry date: not reported) (Suspension for injection) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious severe swelling in the leg from knee to hip (swelling) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.
About 48 hours after this booster of SHINGRIX (the prime was received about 2 months ago), I noticed by left arm had red splotches below the injection site that felt like bruising. A few hours later, I found a round lump near my left collar bone. It was approximately half an inch in diameter, red, and warm and tender to the touch. I took an ibuprofen. Over the next 3 days, it gradually reduced in size and became less tender, but is not yet completely gone.
COVID-19 bivalent booster vaccine use for COVID-19 under Emergency Use Authorization (EUA): Patient received Pneumovax and COVID booster in the same arm on 5/5/23; Presented to ED 5/7/23 for headache and pain/redness at injection site; patient developed hypotension, requiring a short course of vasopressors; patient also developed hypothermia; admitted for suspected myositis
intermittent numbness/pain on injection arm.  started after the first vaccine 12/15/06, increased in intensity and frequency after 2nd injection 2/27/07.
Three days post vax, the pt developed Bell's palsy. A doctor visit was required, and she was treated with prednisone tapering from 08/16/2000 and 08/28/2000. As of 08/22/2000, the outcome of the event is ongoing.
A non-serious spontaneous report of administration of expired FLUMIST was received from a registered nurse concerning a 15-year-old male. Neither medical history nor concomitant medications were reported. On 22-Dec-2008, two siblings, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of 16-Dec-2008. 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) customer not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication error that occurred shortly after the product expired. Additional information was received on 09-Mar-2009 that no delayed adverse events resulted from this error.
Right eye affected with blurry vision, flashing lights to the right peripheral side with floaters that started on the night of the second dose of Pfizer on 09/20/21 at approx 9pm.  Over the past several weeks right has progressively got worse as far as irritation to light and increase in blurry vision. The flashing lights with floaters remain in the peripheral to the right eye.
Patient was brought into clinic by his mother for the covid vaccination.  Patient and family are planning to go on a vacation  and need to be vaccinated.  Nurse mixed 1.3mls of diluent with covid vaccine and gave 0.2mls to patient in the right deltoid.   No adverse reactions were noted from parent and patient is scheduled to receive the pediatric dose of 0.2mls for next immunization.