chrisvoncsefalvay/vaers-outcomes huggingface dataset:
error resulting in administration of expired vaccine; Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2021-395451, MOD-2021-395366, MOD-2021-395445, MOD-2021-395489, MOD-2021-395550, MOD-2021-395452, MOD-2021-395490, MOD-2021-395485, MOD-2021-395486 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Patient details added
I developed an itchy, red rash approx. 3' x 5" on right arm around the injection site 2 days after the injection. There were no other discernable effects and the rash lasted about 1 week.
Reported to ER at MC 2/10 with shortness of breath and chills and patient attributed his symptoms to the second vaccination. Lab work in ER revealed WBC of 3.8 and platelet count of 122(baseline usually around 100), Total Bili 3.1. EKG NSR with prolonged ST interval. Chest xray mild left basilar infiltrate - admitted to acute care as observation with diagnosis of pancytopenia. Started on Rocephin for Pneumonia, IV fluids for hydration, accuchecks
This 6 month 7 day old male presents for follow-up of the following problem(s): Seen in ER ? Seizure. Fussy all night. At 6:00 am his upper body was jerking. No leg jerking, eyes rolled up and fixed. Upper body only, mom estimates 5 minutes. Fever 100 rectal in ER. Good appetite today. He had been sleeping on a pillow when this happened. Child is brought in today by mother. He was on mothers lap and his eyes were deviated to left side and his chest and arms were moving, arms were above head jerking. He had normal color. He was not responding. His legs were rigid not moving. He felt stiff.. It lasted over 5 min. Mother called for father. It stopped just before EMS came. When seizure stopped he was alert and responsive. I reviewed records and labs from ER.
She had heart palpitations and still continues to get heart palpitations; She had a terrible reaction with the second shot/had a bad reaction; She had an overabundance of hair fall out; Feeling really bad/felt like she was going to die; has not been good since that shot; She felt like she had a locked jaw; She had not been that sick since when she had been sick with chicken pox; Pressure-like headaches that she never had before; She went to bed and could not move for like 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (She had heart palpitations and still continues to get heart palpitations), VACCINATION COMPLICATION (She had a terrible reaction with the second shot/had a bad reaction), ALOPECIA (She had an overabundance of hair fall out), FEELING ABNORMAL (Feeling really bad/felt like she was going to die) and MALAISE (has not been good since that shot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chickenpox (Patient had been sick with chicken pox.) and Sickness (Patient had been sick with chicken pox.).   On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (She had heart palpitations and still continues to get heart palpitations), VACCINATION COMPLICATION (She had a terrible reaction with the second shot/had a bad reaction), ALOPECIA (She had an overabundance of hair fall out), FEELING ABNORMAL (Feeling really bad/felt like she was going to die), MALAISE (has not been good since that shot), TRISMUS (She felt like she had a locked jaw), ILLNESS (She had not been that sick since when she had been sick with chicken pox), BEDRIDDEN (She went to bed and could not move for like 3 days) and HEADACHE (Pressure-like headaches that she never had before). At the time of the report, PALPITATIONS (She had heart palpitations and still continues to get heart palpitations) had not resolved, VACCINATION COMPLICATION (She had a terrible reaction with the second shot/had a bad reaction), ALOPECIA (She had an overabundance of hair fall out), FEELING ABNORMAL (Feeling really bad/felt like she was going to die), MALAISE (has not been good since that shot), TRISMUS (She felt like she had a locked jaw), ILLNESS (She had not been that sick since when she had been sick with chicken pox) and HEADACHE (Pressure-like headaches that she never had before) outcome was unknown and BEDRIDDEN (She went to bed and could not move for like 3 days) had resolved.            Concomitant information was not provided.   It was reported that the patient took her second shot around 23-Aug-2021. Patient had the second shot on Saturday around 9 A.M and she started feeling really bad at 8 P.M that night.  Treatment information was not provided.
My friend's daughter/ got the vaccine / has Polycystic Ovarian Syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of polycystic ovarian syndrome in a 19-year-old female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine. On an unknown date, 7 years after receiving HPV vaccine, the patient experienced polycystic ovarian syndrome. On an unknown date, the outcome of the polycystic ovarian syndrome was not recovered/not resolved.   It was unknown if the reporter considered the polycystic ovarian syndrome to be related to HPV vaccine.  Additional information was provided as follows: The patient received HPV vaccine and experienced polycystic ovarian syndrome. The reporter mentioned that, HPV vaccine had been used to sterilize the girls and she wished, she could have known this 7 years ago. The case is linked with the case number- US2020AMR247399, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR247399:same reporter
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 75-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 20th May 2019) for prophylaxis. The patient's past medical history included mastectomy (one on left breast 30 years ago and one on right breast 12 years ago), breast cancer (previous diagnosis on both sides) and breast implant user (one silicone and one saline breast implant). Previously administered products included PREVENAR (received previously) and flu shot (in fall 2017). Concurrent medical conditions included hypertension. Concomitant products included Calcitonin Nasal Spray, hydrochlorothiazide, nifedipine, raloxifene, TOPROL, trospium and PLAQUENIL. On 6th May 2018, the patient received the 1st dose of SHINGRIX. On 6th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain. On 9th May 2018, the patient experienced extensive swelling of vaccinated limb. In May 2018, the patient experienced lymphedema. On an unknown date, the outcome of the extensive swelling of vaccinated limb was not recovered/not resolved and the outcome of the pain was recovered/resolved and the outcome of the lymphedema was unknown. The reporter considered the extensive swelling of vaccinated limb, pain and lymphedema to be probably related to SHINGRIX. Additional details were reported as follows: At 10:00 AM, the patient received SHINGRIX in left arm. On Wednesday or Thursday, the patient developed what she believed was lymphedema. Her arm was swollen from her shoulder to her wrist. She claimed that she put on a long sleeve top and it felt tight on her arm and then she noticed that her left arm was 1.5 times larger than her right arm. She was referred to a physical therapist for treatment. She also reported that the first day she felt achy during the day and it hurt to roll over at night but by the next afternoon, everything was fine. She had a CAT scan done after she experienced swelling and it showed no abnormalities and her silicone and saline implants were in place and fine. She had the CAT scan to rule out a cancer recurrence.
In less than 24 hours, started experience gastrointestinal issues - diarrhea and gas. It was pretty severe for the first week. And still, 3 weeks later, it has not gone away.  Other symptom was extreme fatigue, which started less than 24 hours later. And feeling exhausted after just going up a flight of stairs. And sleepy during the day. The worst of it was the first week, but still experiencing it 3 weeks later.
felt little tired after first dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Jan2021 as single dose for COVID-19 immunisation. Medical history included crohn's disease. she is partial immunosuppressed has crohn's disease takes prednisone "budesonide targeted prednisone. The patient's concomitant medications were not reported. Patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Jan2021 as single dose for COVID-19 immunisation. The patient stated that she felt little tired after first dose on unknown date in 2021. Outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Patient was inadvertently given Pentacel vaccine at age 5 years 3 months. Patient suffered no side effects as of this reporting.
Severe flu like symptoms after second vaccine in Spring; fever of 103. Joint aches.   With booster 12-15-2021, (third)-hypothermia, dizziness, diarrhea, Joint pain and ache.
Woke up with a tooth bothering; Sensitivity on the front sensitivity to the front tooth the cheeck feeling like cold; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL PARAESTHESIA (Sensitivity on the front sensitivity to the front tooth the cheeck feeling like cold) and TOOTHACHE (Woke up with a tooth bothering) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DENTAL PARAESTHESIA (Sensitivity on the front sensitivity to the front tooth the cheeck feeling like cold). On 03-Mar-2021, the patient experienced TOOTHACHE (Woke up with a tooth bothering). At the time of the report, DENTAL PARAESTHESIA (Sensitivity on the front sensitivity to the front tooth the cheeck feeling like cold) and TOOTHACHE (Woke up with a tooth bothering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received included No New Information
This subject is a 2 month old male, who was admitted to the hospital due to near miss SIDS while enrolled in a Phase IV P3T08 study. The subject received one dose of study vaccine; the last dose prior to the event was given on 1/28/03. The subject became apneic and turned blue, shortly after immunization and was admitted to the hospital the same day. The subject required bag valve ventilation for several minutes to keep saturations within the normal range. 911 was called to the vaccination clinic. When the paramedics arrived, the subject was active and breathing on his own, but had three additional apneic spells requiring stimulation or short-term bagging until resolution. It is not known whether bradycardia accompanied his apneic spells. He did have some perioral cyanosis associated with him and cyanosis of mucous membranes. He did appear to be somewhat pale after resolution of all episodes. It was noted that the subject was developing a few red blotches on extremities and chest. Epinephrine was given prior to transport. He was transferred to the emergency room where he was evaluated and later admitted to the hospital ICU for observation. Upon arrival at the emergency room, oxygen saturation was 85, increased to 100% quickly on 100% blow-by oxygen and after 20 to 30 minutes, he was more than 95% on room air. The subject recovered and was discharged from the hospital two days later. The subject continued in the trial. The event of near miss SIDS was reported by the investigator as possibly related to the study vaccine. The next series of vaccinatinos was given on 4/2/03, including Daptacel, Poliomyelitis vaccine inactivated, HIB vaccine, Hepatitis B, and Prevnar. The subject tolerated this series. A 15-day follow up report received 8/12/2003 adds: D/C summary has been requested by Medical Affairs. From additional info received on 07/31/2003, it was reported that the subject was seen for well child exam at 2 months on 02/07/2003. After vaccinations, the child was inconsolable with periods of lethargy and apnea. An entire ER workup was done, with the results of negative CT and negative blood work (Cerebral Spinal Flud WBC 30, but RBCs 1860. The subject did not have any further episodes of this type while observed in the hospital for 3 days. The pt's vaccine reaction was likely secondary to pertussis. A pediatric infectious disease specialist was consulted, no report of this type of reaction with acellular pertussis, but it has happened with whole cell pertussis. Recommended that subject receive no further pertussis vaccines. On 04/02/2003, the pt had a four-month visit and was given IPOL, DT, Prevnar, Hib and Hepatitis B, but no pertussis. The pt was observed for 30 minutes with no reaction. The AvP Medical Monitor evaluation is that the reaction was likely anaphylaxis, which is serious, expected and related.
Patient complained of fever, chills, headache, myalgias, fatigue, nausea, diarrhea and arthralgias from 3/10-3/15.  He also complains of deep depression lasting from time of vaccination through 4/14/2021.
pemphigus; This spontaneous report from a contactable pharmacist reporting same event under the same suspect product for 6 patients. This is one of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pemphigus on an unspecified date with outcome of unknown. It was reported that while consulting her (reporter) dermatologist, she was informed that there are 6 patients who had pemphigus after receiving COVID vaccine.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021615653 Same reporter/drug/event, different patient
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 78-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9263), on 17Feb2021 as dose 2, single (Lot number: EL9264), on 17Sep2021 as dose 3 (booster), single (Lot number: FC3184) and on 12Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "DIABETES" (unspecified if ongoing); "HIGH BLOOD PRESSURE" (unspecified if ongoing); "HIGH CHOLESTEROL" (unspecified if ongoing); "GERD" (unspecified if ongoing); "REFLUX" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; METOPROLOL; NORVASC; PRILOSEC [OMEPRAZOLE MAGNESIUM]. Past drug history included: Neosporin eye drops, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19; COVID 19 Treatment Paxlovid from 01Aug2022 to 06Aug2022.
Called approx. 11:25 am today-had been in garage not doing anything yet, flet " woozy, like drunk" went back in house and sat down, it went away in a couple minutes. No shortness of breath.Arm sore, no redness,drainage or swelling. Encourged patient to seek immed. medical attention if it occurs again. Go to ER
drug interaction; COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS; acute hypoxemic respiratory failure; septic shock; This is a literature report for the following literature source(s):  A 69-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM); tofacitinib citrate (TOFACITINIB CITRATE); folinic acid (FOLINIC ACID), (Batch/Lot number: unknown). The patient's relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (first dose), for Covid-19 immunization. The following information was reported: DRUG INTERACTION (death, hospitalization, medically significant), outcome "fatal"; COVID-19 PNEUMONIA (death, hospitalization, medically significant), outcome "fatal", described as "COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS"; SEPTIC SHOCK (death, medically significant), outcome "fatal"; RESPIRATORY FAILURE (hospitalization), outcome "recovered", described as "acute hypoxemic respiratory failure". The patient underwent the following laboratory tests and procedures: Chest X-ray: diffuse patchy opacities; Oxygen saturation: 75 %, notes: on room air; SARS-CoV-2 test: positive. The action taken for methotrexate sodium and tofacitinib citrate was unknown. Therapeutic measures were taken as a result of drug interaction, covid-19 pneumonia, septic shock, respiratory failure. The patient date of death was unknown. Reported cause of death: "COVID-19 PNEUMONIA", "Septic shock". It was not reported if an autopsy was performed.; Sender's Comments: Based on the temporal relation, the association between the events of drug interaction, COVID-19 pneumonia, septic shock and respiratory failure and the suspect products cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: COVID-19 PNEUMONIA; Septic shock
Cough; Fever; mild swelling at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (Cough), VACCINATION SITE SWELLING (mild swelling at the injection site) and PYREXIA (Fever) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Jan-2021, the patient experienced VACCINATION SITE SWELLING (mild swelling at the injection site). On 14-Jan-2021, the patient experienced COUGH (Cough) and PYREXIA (Fever). At the time of the report, COUGH (Cough), VACCINATION SITE SWELLING (mild swelling at the injection site) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, COVID-19 (positive-negative): positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   No concomitant medications were provided.  No treatment information provided
No adverse effect; Patient was inadvertently administered a dose of VARIVAX, that was expired; This spontaneous report as received from an office manager refers to a patient of unknown demographics. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. The patient's concomitant therapy included sterile diluent (DILUENT MRK INJ).  On 08-AUG-2019, the patient was inadvertently vaccinated with a dose of expired varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were not reported) (lot # M021317, expiry date: 07-AUG-2019) for prophylaxis (expired product administered). No adverse effects were reported. No product quality complaint was involved.  Lot number [M021317] is an invalid lot number for varicella virus vaccine live (oka/merck).
Pfizer 3/15/21 EN6200  1st shot; Pfizer 4/5/21 EP7534 1nd shot. 4/7/21 started breaking in hives. Took otc benaas didryl & used hydrocortisone cream; 4/8/21  6:30 am  still have hives & face was badly swollen. Called Dr. Office, they instructed me to go the ER.  Dr. at ER said this was not related to Covid.  I have ate or did any different.  Prescribed me Prednisone 50 mg 1 daily.  Taking benadryl as directed & using hydrocortisone cream on rash-hives.
an 8 year old patient received Infanrix on 8/21/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 21-AUG-2023, the patient received Infanrix. On 21-AUG-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: an 8 year old patient received Infanrix on 8/21/2023).The outcome of the inappropriate age at vaccine administration 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: 12-SEP-2023 The reporter stated that an 8 year old patient received Infanrix, which led to inappropriate age at vaccine administration. The patient had not received any vaccines in the past. The reporter consented to follow up via postal. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not feel comfortable providing initials of the patient.