chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 17 year old female patient. In 2010, the patient was vaccinated with the first dose of GARDASIL (lot #, dose and route not reported). On 21-AUG-2013, the patient was vaccinated with the second dose of GARDASIL (lot #, dose and route not reported). No adverse effects were reported). It was unspecified if the patient sought medical attention. Additional information is not expected.
Small pinple to side of injection site.  Progressed into non-raised red rash on arms, trunk and Left side of face.  Went to PCP given Steriod injection X1 and po meds.  Immediately improved and rash gone before finished 7 day course of steriods po.
THE VACCINE WAS NOT RECONSTITUED WITH 1.3 ML OF DILUENT, IT WAS GIVEN DIRECTY  0.2 ML FROM THE ORANGE CAP VIAL WITH NO DILUTION  I informed the mom and she said that her daughter didn't get any side effect yet
Received the second dose 51 days after the first dose; Pain on injection site; Fatigue; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received the second dose 51 days after the first dose), INJECTION SITE PAIN (Pain on injection site), FATIGUE (Fatigue) and VOMITING (Vomiting) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received the second dose 51 days after the first dose), INJECTION SITE PAIN (Pain on injection site), FATIGUE (Fatigue) and VOMITING (Vomiting). On 30-Jun-2021, INCORRECT DOSE ADMINISTERED (Received the second dose 51 days after the first dose) had resolved. At the time of the report, INJECTION SITE PAIN (Pain on injection site), FATIGUE (Fatigue) and VOMITING (Vomiting) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.    This case was linked to MOD-2021-244648 (Patient Link).
This spontaneous report was received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly stored VARIVAX subcutaneously, lot # L010148, expiration date: 24-MAR-2017 (strength and dose were not provided) for prophylaxis. No adverse event was reported. This is one of two reports received from the same reporter. Follow up information has been received on 12-DEC-2016 that all telephone attempts to obtain follow-up information had been unsuccessful. Additional information is not expected as no further information was available. Sender's Comments: US-009507513-1610USA011591: MERCK 1611USA000114:Mfr number.
This spontaneous report concerning a 12 years old patient of an unknown gender was received from a nurse. The patient's concurrent conditions and medical history were not reported. On 22-JUL-2016, the patient was inadvertently vaccinated with a dose of 1 ml of VAQTA lot # L031196, expiration date 05-FEB-2017, (strength and route were not provided)(accidental overdose). There were no concomitant medications and adverse events reported. No product quality complain was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Left arm edematous and erythematous shoulder to elbow. Benadryl 12.5mg PO given at 1400 on 6/14/07.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Other medical history: Diabetes; "gout" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "CKD 3" (unspecified if ongoing), notes: Other medical history: CKD 3; "cancer" (unspecified if ongoing), notes: Other medical history: cancer; "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after BNT162B2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Headache, Myalgia, Fever, CHILLS, FEVER ( 102.3), BODY ACHES, HA AND SORE THROAT Narrative:  Other Relevant History:
No additional AE; Medical assistant called to report T/E and reported one vaccine had been administered of PROQUAD; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 08-SEP-2023, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live rHA(PROQUAD) injection (lot #W036939, expiration date 19-MAY-2024, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On unknown dates, the measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live rHA(PROQUAD) suffered from a temperature excursion of 6 degrees Fahrenheit (F) up to 14 F for 12 hours 20 minutes and 14 F up to 46 F for 13 hours 45 minutes and 47 F to 77 F for 4 hours. No previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) (No adverse event).
Greater than 35 days since patient's first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since patient's first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since patient's first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since patient's first dose) had resolved.            Concomitant medication was not provided Treatment information was not reported  Patient had an appointment for her second dose on 13 Aug 2021, but did not receive the second dose.   Reporter did not allow further contact
A 48 year old female with a history of schizophrenia report feeling dizziness in the observation area. Paramedic take the vitals sings at 4:26pm  BP: 110/80 mmhg, HR: 73, SO2 97%, dextrose; 87. Then patient star to feel nauseas We give to the patient water and candy. at 4:36pm paramedic take her dextrose was 96.
Information has been received from a consumer concerning her "7 1/2 year old" son with asthma, allergy diary, egg allergy and allergy to anything with soy, who on 28-APR-2010 was vaccinated with a dose of VARIVAX (Merck) (manufacturer unknown). There was no concomitant medication. It was reported that on 04-MAY-2010 the patient developed a low grade fever and blotchiness all over his skin. There were no laboratory diagnostic tests performed. The patient did not seek medical attention. The vaccine was not reintroduced. At the time of the report the patient had not recovered. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 63 year old patient with medical history of hypertension and chickenpox. On 09-MAR-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose not reported) (lot # H013017, exp. date 09-OCT-2013) subcutaneous in the left arm. The patient's concomitant medication and past drug history was unknown. In March 2013 the patient developed redness, swelling the "size of a golfball" in the left armpit and slightly into this chest area. His relevant laboratory data was unknown. At of 13-MAR-2013 it was unknown if the patient would continue therapy with ZOSTAVAX. The patient continued to experience swelling under his arm, however it has improved. Outcome for redness was unknown. Relationship between redness, swelling the "size of a golfball" in his left armpit and slightly into his chest area and therapy with ZOSTAVAX was unknown. Additional information has been requested.
Chills, Fever, Dizziness, Headaches, Weakness, Short of breath, nausea for 72 hours.  Fourth day broke out in blisters numerous places - chest, both arms, back of head, between fingers;  saw Urgent Care April 30 and was given Prednisone which is helping.
temperature of the refrigerator reached 50 degrees Fahrenheit due to leaving the door ajar; Initial information received on 21-Apr-2022 regarding an unsolicited valid  non-serious case received from a health care professional.  This case is related to 2022SA145411, 2022SA143935.   This case involves Adult patient of unknown demographics who had storage error when temperature of the refrigerator reached 50 degrees Fahrenheit due to leaving the door ajar with no reported adverse event involving the vaccines diphtheria vaccine toxoid, hepatitis b vaccine RHBSAG (yeast), HIB vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid [Vaxelis], diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] and IPV (vero) [Ipol].  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 IPV (VERO) suspension for injection (strength, frequency was unknown, lot T1E871M and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, vaccines diphtheria-2/tetanus/5 AC pertussis vaccine (Batch number: U7276AA, Expiry date: 21-Jan-2024), diphtheria vaccine toxoid, hepatitis b vaccine RHBSAG (yeast), HIB vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero) tetanus vaccine toxoid (Batch number: C5808AA, Expiry date: 14-Jan-2024), IPV (vero) (Batch number: T1E871M, Expiry date: 10-Oct-2022) to be given for immunization were exposed to a temperature of 50 degrees Fahrenheit due to leaving the refrigerator door ajar with no reported adverse event (product storage error). It was not aware by caller as to how long the excursion lasted and was trying to find the information.  Further, it was reported that patient had received IPOL and having an adverse reaction.  Action taken: Not applicable.  It was not reported if any corrective measurements were taken for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  Additional information was received on 29-Apr-2022 from other health care professional: Case was update from non-valid to valid as number of patient was added, age group was added, clinical course updated, text amended accordingly.; Sender's Comments:  US-SA-2022SA145411:Related case ID (IPOL-open) US-SA-2022SA143935:Related case ID (VAXELIS)
Flushing, Diaphoresis, Dizziness  10:07 AM Vital Signs: BP 208/100 HR 89 Resp 16 O2sat 94%  Skin Signs: Diaphoretic  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Initial treatment: Moved to triage area, offer cot to lay down on, patient refused. Wanted to sit  10:15 AM Vital Signs: BP 184/92 HR 79 Resp 24 O2sat 97%  Skin Signs: Warm and dry  Circulation: Cap refill 2 sec Respiratory: Breath sound clear bilaterally  10:30 AM  Vital Signs: BP 168/94 HR 73 Resp 16 O2sat 97%  Skin Signs: Warm and dry  Circulation: 3 sec  Respiratory: Breath sound clear bilaterally  2nd vitals - Denies being flush, BP improved, HR/O2 improved, Ax3  1st vitals - Flush, diaphoretic, raised BP, increased resp, dizzy 3rd vitals - vitals WNL, patient verbalized a history of hypertension, stated she did not take blood pressure medication this morning, patient verbalizes she will take her prescribed BP meds following her return home. Advised to contact PCP Dr. for any concerns. Left in stable condition.  Home by self
multiple sclerosis; dizzy on and off; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (multiple sclerosis) in a 74-year-old female 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.     Concomitant products included LEVOTHYROXINE, METOPROLOL and AMLODIPINE for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (multiple sclerosis) (seriousness criterion medically significant), DIZZINESS (dizzy on and off) and PAIN IN EXTREMITY (sore arm). The patient was treated with PSEUDOEPHEDRINE at a dose of 2 pills of 3 mg. At the time of the report, MULTIPLE SCLEROSIS (multiple sclerosis), DIZZINESS (dizzy on and off) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding pt's who experienced swelling at the injection site. Relevant medical history was not provided. Indication for Prevnar was immunization. Concomitant medications were not reported. On 27Apr04, a physician's office revealed that in the past 2 months their pt's have reported more adverse events of swelling at the injection site after injections of Prevnar. The reporter was unable to specify the number of pt's who experienced injection site swelling. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
Shortness of breath, "tightness in throat" Mother gave Benadryl 50 mg as soon as symptoms started, Advised to repeat Benadryl if symptoms persist.
Patient reported this to pharmacist (vaccine administer) on 11/6/15 at approx. 3:42pm. The day after receiving his vaccine, he had to go to the urgent care because he could not move his arm. He stated the problems (pain and movement issues) radiated to the shoulder. Doctor treated him with steroids. He currently still has problems with the arm and is seeking physical therapy.
mom states pt w/o fever @ 9AM was sleeping slept w/mom 12noon felt cool-12:30 awake whimpel warm to touch while giving APAP had sz jerking to one side family call ER-pt taken to hosp then transferred to another hosp;
I have always had regular cycles. I had a period that started 06/24 and lasted 20 days, spotted for 2 days, and then the period lasted for another 10 days. I had 8 days without bleeding and then I started another period for 21 days. I am at the point of spotting at this time so hopefully it will stop again soon. I went to the GYN and they did a pelvic ultrasound which did not reveal any problems. I also had blood drawn and a pelvic exam that did not reveal any problems either. The day I received my vaccine, I had a sore arm. The day after, I felt dehydrated, I had horrible pelvic pains, had muscle aches, joint pain, felt fatigued and I almost fainted.
Information has been received from a physician an approximately 66 year old female who on an unspecified date was vaccinated at the health department with PNEUMOVAX 23 (lot # not reported). On the same date, the patient was also vaccinated with influenza virus vaccine (unspecified). Subsequently, on an unspecified date the patient experienced tender, large, erythematous, raised area below the injection site. The physician reported that the are is getting worse and that the patient is not allowing her to even touch the are as it is so painful. The patient also experienced flu-like symptoms. The patient sought unspecified medical attention. No further information was available.
Swollen lymph node in my left armpit. About the size of a boiled egg.
Patient was found unresponsive and brought to the ER in asystole.  Patient was deceased.  No reported reactions to vaccines, but with timing of vaccines and death, PCP wanted VAERS filed.
felt sick; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick) and FATIGUE (tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 025A21A) for COVID-19 vaccination.     Concomitant products included LATANOPROST and DORZOLAMIDE for Glaucoma, GABAPENTIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-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 ILLNESS (felt sick) and FATIGUE (tired). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (felt sick) and FATIGUE (tired) outcome was unknown.     This case was linked to MOD-2021-408614, MOD-2021-408622 (Patient Link).
From initial information received on 01/16/04 and additional information received on 01/18/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 17 year old female patient received he first dose of Menomune A/C/Y/W-135, lot number UE471AA, administered subcutaneously on 01/07/04. The site of administration was not reported. The following day on 01/08/04, the patient developed a sore throat and gastrointestinal upset. The next day , the patient still had a sore throat and also developed a fever, headache, body aches and chills. She was seen by the physician on 01/10/04 and continued to have body aches, as well as malaise ( onset date not reported) and a temperature of 101.5 degrees Fahrenheit. Upon examination, her pulse was 100 and her pharynx was negative. At 8:00 PM that evening, the reporter contacted the patient's mother by phone and was advised that the patient's fever had decreased. It was not reported whether the patient recovered from these events. From additional information received on 11/08/04 from the initial reporter, the patient's address and telephone number were provided. Vaccine administrators name was also provided. It is unknown whether the patient recovered from the events.
This spontaneous report was received from a healthcare worker refers to 4 patients of unknown ages and genders. Concurrent conditions and medical history were not reported. On 01-SEP-2015, the patients were vaccinated with a dose, which were exposed to temperatures outside of the recommended range of GARDASIL lot # K010215, expiration date on 05-MAY-2017 (strength, dose #,  dose, anatomical location and route of administration were not informed). There was not a product quality complain (PQC) involved. No adverse experience was reported. Additional information has been requested.
patient given 0.5 ml instead of .25 ml as a booster. Patient has chronic conditions but not immune compromized.
Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine however did develop symptoms within one minute of completing a run. Developed b/l hand swelling and tingling, diffuse hives and itching, tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids, Benadryl and IV steroids. This is similar to previous reactions I have had to running previously. Symptoms resolved within one hour after treatment in ED.
Resting heart rate jumped up to 120-140 and remained there for approximately 16 hours, despite using meditation and breathing techniques to keep it as low as possible. Had similar difficulties during early long COVID days. Other symptoms included full-body nerve pain and shaking violently. I considered seeking medical assistance but opted to stay home and wait it out optimistically. I increased my typical gabapentin dose by 100mg at 11 pm and continued taking Tylenol. I also attempted to calm my vagus nerve by dunking my face in ice water. Symptoms quit rather suddenly the following early afternoon. Resting heart rate dropped back to mid 60s around the same time as all my other typical flu-like symptoms resolved as well.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced PYREXIA (Fever). On 06-Dec-2021, PYREXIA (Fever) had resolved.            No concomitant medications were provided. No treatment medications were provided.  Patient stated that after first 2 shots she had no side effects.   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Contains no new information.