chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immunocompromised patient received booster dose, instead of third dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose, instead of third dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006d21a, 038a21a and 006m20a) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Flu shot (Sanofi Pasteur high dose Flu shot was given intramuscularly (Lot: UJ74AA)) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Rheumatoid arthritis.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose, instead of third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose, instead of third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no known allergies.  The patient took unknown medication for rheumatoid arthritis.  No treatment information was provided by the reporter.
Pt received another dose by mistake- she already had the dose needed for this Flu  21/22 Season- the MA who gave the vaccine did not realize that pt had already received the vaccine in the fall of 2021 which is in the same season as the one  she gave on 2-1-22 MA notified the Provider of the mistake and Dr  advised that the pt is at  NO Risk but to let us know if she has any issues. The MA contacted the pt and then she spoke with me the Vaccine coordinator and we filed an incident report within our Employer. as of right now the pt  has not had any adverse reaction , but wanted to file the report just in case .
Information has been received from a registered nurse concerning a male who on 15-MAR-2007 was vaccinated with a dose of Zostavax (lot # 656413/1477F). Eight hours after vaccination, the patient broke out with a blistering rash on her neck. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Fever of 100 degrees or above (even with Motrin).  Body aches, severe.  Neck pain.  Flu-like symptoms for 2-3 days.
Patient noted loud Tinnitus. Immediately after getting covid vaccine within 10-15 minutes unrelenting since. Saw specialist post vaccine and not good treatment available
Information has been received from a nurse concerning a 26 year old female who on 04-DEC_2007 was vaccinated with the first dose of Gardasil. On approximately 04-JAN-2008 the patient experienced extreme pain on the deltoid area. As of 04-JAN-2007, the patient was recovering from extreme pain on the deltoid area. No further information is available.
Stroke due to a blood clot on the left side of my brain; had a dizzy spell; felt very tired; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke due to a blood clot on the left side of my brain) in a 71-year-old female patient who COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose (Intramuscular) at an unspecified dose. On 05-Mar-2021, the patient experienced DIZZINESS (had a dizzy spell) and FATIGUE (felt very tired). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke due to a blood clot on the left side of my brain) (seriousness criteria medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke due to a blood clot on the left side of my brain), DIZZINESS (had a dizzy spell) and FATIGUE (felt very tired) outcome was unknown.               No concomitant medications were reported. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.
Pt recvd MMR/HIB/OPV (did not receive DTP because MOM desired to wait); That evening eyes rolled back in head, glassy look in eye, knot on rt leg, t101R w/APAP; Called MD; MD said rxn to HIB shot;
Pt reported  tonsils feeling numb and mouth feeling swollen. Pt had unlabored respirations and reported no  difficulty swallowing. Pt was also diaphoretic. Pt reported allergies to ciprofloxacin and history of asthma. Pt given water and able to swallow water. Pt's vitals were: BP 140/92 mmHg, HR 70 bpm, and SpO2 98%. Pt offered diphenhydramine. Pt given oral diphenhydramine 25 mg//10 ml (2 doses). Pt advised to wait for further observation. Pt reassessed at 1023. Vitals were  132/74 mmHg, HR 78 bpm, and SpO2 98%. Pt reported her earlier symptoms resolved and reported feeling sleepy. At approx. 1024, pt left facility  to husband with unlabored respirations and steady gait.
itchy, red, hives and pain at injection site and generalized muscle soreness, especially left arm
pt recvd vax; hip & leg pain;pt had been referred to rheumatologist; tx w/ pain meds;
Pt has been having ongoing body aches since the night she received the vaccine. She has been taking ibp. which has helped.
Sore arm; blister in nose, lip and mouth; blister in nose, lip and mouth; blister in nose, lip and mouth; sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (Age: 64; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; BLISTER (non-serious), ORAL MUCOSAL BLISTERING (non-serious), LIP BLISTER (non-serious), outcome "unknown" and all described as "blister in nose, lip and mouth"; ILLNESS (non-serious), outcome "unknown", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tinnitus / congestion developed in left ear at the night of November 5. Congestion in left ear resolved on November 8. Tinnitus diminished over time and mostly resolved by November 10 (date of report).
never had a bad reaction, some disconfort for a day or two; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer (patient) and transmitted to Sanofi on 20-Oct-2020.  This case was linked to case 2020SA297164, 2020SA297294, 2020SA297232, 2020SA297338, 2020SA297344, 2020SA297203, 2020SA297183, 2020SA297189, 2020SA297215, 2020SA297197, 2020SA297198, 2020SA297259, 2020SA297264, 2020SA297224, 2020SA297275, 2020SA297193, 2020SA297278, 2020SA297301, 2020SA295993, 2020SA290234, 2020SA273251, 2020SA285105, 2020SA289150 and 2020SA297164.  This case involved a patient of unknown demographics who never had a bad reaction but some discomfort for a day or two (Discomfort), while patient received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, 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 and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was reported that the patient never had a bad reaction but on an unknown date the patient developed a non-serious discomfort for a day or two (discomfort), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was discomfort.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Patient fainted after injection, possible  seizure ( she had rapid eye movement)  lasted approximately 1 minute.  Patient woke up saying she was ok then fainted again lasted approximately 2 minutes .    After she woke up she wanted and received ice pack behind her neck .     We asked her to stay 30 minutes for observation.   She stated she was fine after the 30 minutes.
Redness, swelling, hardening and pain at injection site since yesterday referred by school nurse. Evaluated by Public Health Nurse Practitioner, local reaction advised to give pain relief medication as needed, use cold compress.
Was feeling fine for about 8 hours afterward. Then developed chills, myalgias and a headache. At around 3am (14 hours after) developed a fever 100.9. Took Tylenol and Motrin. Felt a bit better. Symptoms returned around 12pm, checked temp - 101.5. Took more Tylenol and Motrin.
MIGRAINE; FEVER; 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 not reported, batch number: Unknown) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 18-AUG-2021, the patient experienced migraine. On 18-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, and fever. This report was non-serious.
redness down arm, urticarial, warm to touch started 2 days after injection, resolved with loratadine and recurred 3 weeks later
no immediate rxn, no adverse rxn @ site, no acute distress resident found w/no BP, no pulse initiated CPR;
PATIENT REPORTED DIZZINESS AND CHEST TIGHTNESS 5 MINUTES AFTER RECEIVING VACCINE. GAVE PATIENT WATER AND MONITORED. TOOK PATIENTS BLOOD PRESSURE AND HEART RATE. BP 161/107 HR 48 BPM. PATIENT REPORTED DIZZINESS WAS GETTING WORSE. CALLED 911
Patient received her second dose two weeks after her first dose instead of at the 28 day mark.
On days 2 and 3 general feeling of unwellness; Fatigue; Irritability; Arm was sore after 12 hours up until day 4; Just muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 12:45 as a single dose (at the age of 37-years-old) for COVID-19 immunisation. The patient medical history included asthma, allergies, ADHD. The patient also reported allergies to animals, molds, yeast, beef, and other food sensitivities. Concomitant medications reported as Advair (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), buspar (MANUFACTURER UNKNOWN), atomoxetine (MANUFACTURER UNKNOWN) for an unknown indication on an unspecified date. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 04:00, the patient experienced arm was sore after 12 hours up until day 4, just muscle pain. On days 2 and 3, general feeling of unwellness, fatigue, and irritability. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the arm was sore, just muscle pain, general feeling of unwellness, fatigue and irritability was recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
I received the vaccine in pharmacy midday on 4/8/2022. i was fine besides tired. four days later i started getting pains when i needed to urinate. went on for about a week and called doc . did U.T.I. and was negative did cats can for kidney stone and was negative. It was a lot of pain in kidney and back pain. Lasted for about 2 weeks.
Patient stated that they had a bad headache 45 minutes after getting and had fever and chills.
I experienced a breakthrough case of COVID-19 with sore throat, fatigue, vertigo, nausea and chills.
RASH ON ARM AND RIGHT WRIST; BUMP ON WRIST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced rash on arm and right wrist. On MAR-2021, the subject experienced bump on wrist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on arm and right wrist and bump on wrist was not reported. This report was non-serious.
Had MMR and Varivax on 5/11/04. On 5/13/04 developed fever and had generalized seizure lasting one minute. On 5/14/04 had unstable gait and was admitted to hospital.  Nurse follow up on 06/18/04 states: "Add: lips turned blue, irritability, emesis, drowsy, eyes rolled back,"
Night sweats; Wheezing; Sick every since the vaccine; Upper respiratory infection; Rash; Redness at injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), WHEEZING (Wheezing), ILLNESS (Sick every since the vaccine), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) and RASH (Rash) in a 58-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.     No Medical History information was reported.    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 NIGHT SWEATS (Night sweats), WHEEZING (Wheezing), ILLNESS (Sick every since the vaccine), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), RASH (Rash), VACCINATION SITE ERYTHEMA (Redness at injection site) and PYREXIA (Fever). At the time of the report, NIGHT SWEATS (Night sweats), WHEEZING (Wheezing), ILLNESS (Sick every since the vaccine), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), RASH (Rash), VACCINATION SITE ERYTHEMA (Redness at injection site) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
On the same day following vax, the pt experienced dizziness and stomachache. The following day, the pt woke up with bumps on his rib cage and stomach. The bumps had spread to his thigh and armpit at the time of this report. While at school, on 04/09, the nurse observed that the pt was pale and noted that he had vomited three times. He also experienced a severe headache that same day and it was stated that he really gets headaches. It was reported that the pt has had chickenpox in the past. Additionally, he has had tetanus shots before and never developed any symptoms from the shots. Additional information has been requested.
No side effects from the vaccines, other than her arm being sore; Nerve pain near and above the injection site, on her left arm, left elbow, and fingers of left hand and left side of her face.; Tightness on the left arm near the secondary red area; Left arm is still warm; Vaccine was out of the refrigerator for 12-13 hours before given to the caller; Vaccine was out of the refrigerator for 12-13 hours before given to the caller; Vaccine was out of the refrigerator for 12-13 hours before given to the caller; red spot at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101625221 (Pfizer).  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 11:00 (Lot number: FJ1611) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 17Nov2021. Vaccination history included: Shingrix (first dose of the Shingrix Vaccine), administration date: 22Sep2021; Bnt162b2 (Dose:1, Batch/Lot No:EW0169, Anatomical location: Left arm), administration date: 15Apr2021, when the patient was 63 years old, for Covid-19 immunization; Bnt162b2 (Dose:2, Batch/Lot No:EW0169, Anatomical location: Left arm), administration date: 06May2021, when the patient was 63 years old, for Covid-19 immunization.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT STORAGE ERROR (non-serious), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) all with onset 17Nov2021, outcome "unknown" and all described as "Vaccine was out of the refrigerator for 12-13 hours before given to the caller"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "No side effects from the vaccines, other than her arm being sore"; FEELING HOT (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Left arm is still warm"; NEURALGIA (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Nerve pain near and above the injection site, on her left arm, left elbow, and fingers of left hand and left side of her face."; INJECTION SITE ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "red spot at the injection site"; SKIN TIGHTNESS (non-serious) with onset 19Nov2021, outcome "unknown", described as "Tightness on the left arm near the secondary red area". The event "vaccine was out of the refrigerator for 12-13 hours before given to the caller" was evaluated at the emergency room visit.  No follow-up attempts are possible. No further information is expected.
Headache; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for 02 patients. This is 2nd of 02 reports.   A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Jan2021 (Lot number was not reported) as single dose for COVID-19 immunisation. He received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Jan2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  On an unspecified date, patient experienced headache.  Consumer was not reporting any issue with Pfizer product. Patient did not admit to hospital due to the event. There were no other products that were taken together with those indicated above. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021017655 Same drug/AE, different patient
REDNESS, SWELLING, HEAT AT INJECTION SITE. 4 INCH ACROSS IN THE RED AREA AND RAISED. IMMUNIZATION WAS GIVEN ON FRIDAY 12/9/2011 AND BY SUNDAY EVENING YOU COULD SEE THE SWELLING THROUGH HER PANTS. SHE WAS NOT FEBRILE. VERY LARGE KNOT BEHIMD INJECTION SITE.
From initial information received on 24May04 from a physician regarding an adverse event. It was reported that a 50 year old female pt received a TET TOX Booster USP vaccination at a travel clinic (manufacturer, lot number and route of administration not reported) sometime during the summer of 2003. Two to three months following vaccination, the pt experienced muscle weakness and weight loss. The pt had previously experienced the muscle weakness, muscle wasting and weight loss following a tetanus vaccination (lot number, manufacturer, and route of administration not reported) over ten years ago and she had been diagnosed with post pneumonia paralytic syndrome. The physician stated that she is not sure if the events are related to the vaccination. The pt was not hospitalized, but her symptoms were ongoing at the time of this report.
a consumer received an incomplete dose of the ordered Pentacel described as the liquid Dtap-IPV portion was given but the ActHib portion was not given/No AE; Initial information was received on 12-Dec-2019 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 4 month old male patient who received only the liquid Dtap-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], but the ActHib portion was not given.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 06-Dec-2019, the patient received second 0.5 mL dose of the liquid Dtap-IPV portion of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UI992AAA via intramuscular route in the right thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  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 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.
Vaccine on December 30th @ 8:30 am. Fine all day until 1:00am next morning 12/31 it woke me up with fever, bad body aches hurt to touch me, left arm I couldn't move painful, nausea and bad headache this went on for 2 days(12/31 & 01/01).  Next 2 days (1/02 & 1/03) was recovering with just soreness, anxiety and headache(Migraine Med help), tired and shortness of breath9inhaler0. Was like having Covied again.
Nausea, stomach cramps, fatigue, hot/cold, feeling "floaty" - feeling a little better today (10/17/2015) but still not 100%.