chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received Pediarix and Engerix B at the same time.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-month-old male patient who received HBV (Engerix B) (batch number 95D74, expiry date 28-FEB-2025) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 09-NOV-2023, the patient received Engerix B and Pediarix. On 09-NOV-2023, an unknown time after receiving Engerix B and Pediarix, the patient experienced overdose (Verbatim: patient received Pediarix and Engerix B at the same time.). The outcome of the overdose 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: 09-NOV-2023 Nurse reported that on 09 November 2023 a patient received Pediarix and Engerix B at the same time which led to overdose for hepatitis b antigen.  The reporter did not consent to follow-up.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent condition were reported. On unknown dates the multiple unspecified patients were vaccinated with either 1 or 2 doses of GARDASIL (strength, frequency, route, lot# and expiration date unknown) and completed their HPV series with GARDASIL 9 (strength, frequency, route, lot#, expiration date) (interchange of vaccine products) (wrong drug administered).  No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 (dose, route and lot# were not reported). Concomitant therapies included VAQTA. On an unknown date, the patient experienced injection site rash and rash throughout their body. The patient sought medical attention by an office visit and was treated with BENADRYL (dosage unknown). On an unknown date, after treatment with BENADRYL the events was resolved. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Got the shot at 12pm by 2pm felt weak, achy, started to get a fever of 99.9, extremely tired. Took Tylenol by 1:30-? was throwing up and fever continued to spike to 102.4 and vomiting started. Pounding headache. Could not get fever to break and freezing.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis (Previously exeperienced with rheumatoid arthritis). Concomitant products included tofacitinib citrate (Xeljanz). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX a week ago. Two days post vaccination her face and chest became red. The patient referred to the physician. No further information were provided.
1 day old pt recv vax & w/in 2hr post vax on the way home in the car pt devel sz;
Rcvd call from employer today to report c/o numbness & tingling in (L) arm. Within 1 1/2 hours after receiving shot went to local ED. ED states nerve was hit. C/o (L) arm & shoulder swollen today.
Menstrual bleeding began approx. 1 week after the first shot, not in line with my normal cycle. I bled for two weeks and it stopped. I received the second shot and began bleeding a few days later, and it HAS NOT STOPPED. It has been over two months straight of this, with no end in sight.
nauseous; This is a spontaneous report from a non-contactable consumer or other non health care professional (wife reported for her husband). An unspecified age male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 24Jan2021 as 1ST DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had experienced nauseous 1 week after receiving the 1st dose of vaccine. Patient wife scheduled to receive the 2nd dose on 13Feb2021, which was 1 day earlier than the recommended 3-week-interval so she wants to know if this was acceptable. Reporter assessed the event as non-serious. The outcome of the event was unknown.   No follow-up attempts are possible. information about lot/batch number cannot be obtained.
pt recvd vax 10JUL95 & JUL95 pt exp a gen varicella-like rash consisting of approx 10 to 15 lesions;No further details were provided;
This spontaneous report as received from a pharmacist refers to a 58 years old female patient with hypertension, hypothyroid and drug allergy to penicillin. The patient was vaccinated with, 0.5 PNEUMOVAX 23 (lot # reported as 1947AA;exp 20-OCT-2013) intramuscular in left arm on 10-OCT-2012. No other co-suspects were reported. Concomitant medications included ergocalciferol, naproxen, VENTOLIN inhaler, levothyroxine sodium and omeprazole. The pharmacist reported client not had possible cellulitis. The injection site of left arm was black and swollen. Client was seen by her physician and treatment was sulfamethoxazole, BACTRIM. The patient had sought another medical attention by came into pharmacy yesterday (11-OCT-2012). Pharmacist stated they would be contacting client today (12-OCT-2012) to follow up with her. The outcome was reported as not recovered. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a health professional concerning a 1 year old female, with no medical history and no allergies, who on 13-JUL-2005 was vaccinated with a subcutaneous first dose of varicella virus vaccine live (Lot# 650226/1109P). Concomitant therapy included amoxicillin/clavulanate potassium (AUGMENTIN). On 26-JUL-2005 the patient had a breakthrough case. It was reported that the patient was recovering. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
the patient developed symptoms 3 days later which included body aches, headache, cough, runny nose. pt is seeking her pcp for further testing/workup.
I had a reaction when they gave me the injection of both companies; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (I had a reaction when they gave me the injection of both companies) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Comirnaty (Dose 2) and Comirnaty (Dose 1). Past adverse reactions to the above products included Vaccination adverse reaction with Comirnaty and Comirnaty.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I had a reaction when they gave me the injection of both companies). At the time of the report, IMMUNISATION REACTION (I had a reaction when they gave me the injection of both companies) outcome was unknown.            No concomitant medication was reported. The patient had the first 2 shots of Pfizer vaccine and switched to Moderna for the booster. Patient had a reaction when patient got injection of both companies. No treatment information was provided.
Patient came in to get the covid vaccine. She came with her mother and no one verified her age. She received the Moderna vaccine and mother was notified of incident.
Pt began having blurry vision, felt like her tongue was tingling, sweats, itching at injection site, and sensation went to her back and down her right leg.
Severe neck and arm pain on side of injection left. Went to ER for treatment on Sat. 10/25/2014 because severe arm and neck pain continued, steroid dose pack given.
"Covid Arm" experienced about 5 days after the vaccination.  Itchy, red sore on/near injection site.  Redness/itchiness is persistent.
Tightness in chest; shortness of breath; headache; sore arm; This is a spontaneous report from a contactable consumer. This consumer(patient) reported for herself that a 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at the age of 58-years, via an unspecified route of administration in left arm on 03Apr2021 09:15 AM at single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy, asthma, hypothyroidism. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol; bupropion hydrochloride (WELLBUTRIN); desvenlafaxine succinate (PRISTIQ); loratadine and synth (as reported). The patient historically received first single dose of BNT162B2 (lot number: EN6199) via an unspecified route of administration in left arm on 06Mar2021 09:30 AM for COVID-19 immunization. The patient previously took Compazine and experienced allergy to it. On 03Apr2021 22:00 (10:00 PM), the patient experienced tightness in chest, shortness of breath, headache, sore arm. The events resulted in emergency room/department or urgent care. Patient received nebulizer treatment for the adverse events. Outcome of the events were not recovered. Since the vaccination, the patient been has not tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
viral rash on my trunk, chest, on my back and at my wrist; Much more red; This spontaneous case was reported by a consumer and describes the occurrence of RASH (viral rash on my trunk, chest, on my back and at my wrist) and RASH ERYTHEMATOUS (Much more red) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism since an unknown date and Colitis since an unknown date. Concomitant products included LEVOTHYROXINE and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced RASH (viral rash on my trunk, chest, on my back and at my wrist) and RASH ERYTHEMATOUS (Much more red). On 23-Jan-2021, RASH (viral rash on my trunk, chest, on my back and at my wrist) and RASH ERYTHEMATOUS (Much more red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 25-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (viral rash on my trunk, chest, on my back and at my wrist) and RASH ERYTHEMATOUS (Much more red) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism since an unknown date and Colitis since an unknown date. Concomitant products included LEVOTHYROXINE and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced RASH (viral rash on my trunk, chest, on my back and at my wrist) and RASH ERYTHEMATOUS (Much more red). On 23-Jan-2021, RASH (viral rash on my trunk, chest, on my back and at my wrist) and RASH ERYTHEMATOUS (Much more red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Treatment information for the event was provided.; 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 started to shake and stated to mom legs felt numb. Per parent she asked what did she mean and patient stated tingling. The Patient stopped talking and per parent was staring. Mom call pediatrician office and was intructed to call 911.  EMS (ambulance came) per mom and patient was talking. They took vital signs and patient stated she was ok now. Taken to Emergency room. Once at hospital patient states felt better and wanted to leave. Mom left and they came into pediatrician office today for follow up.
Large rash and swelling in arm where vaccine was injected. Took one Tylenol and one generic Benadryl for pain and itching.
Within 8 hrs, sinus congestion. Within 12 hrs, fever and chills, nausea.
Lymph nodes in neck blown up to where it is swollen to his temple; Feel punky; Headache; This is a spontaneous report from a contactable Consumer. This male Consumer (patient) reported that: A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 at 16:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that he received Pfizer COVID-19 Vaccine second dose yesterday at 4PM Pacific coast time. Was feeling great when he got up. Started to feel punky, had a headache, and those kinds of things. Then his left lymph nodes in his neck had blown up to the point where it is swollen to his temple. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Full body rash with mild itching.  Started on the back of my neck and has slowly spread down my body, reaching my feet today, 4/7/21.  No rash on my chest or stomach.
2 hours after receiving vaccines, developed fever, abd. pain, dizziness, and diarrhea lasting 4 days.  5th day felt better but stomach hurt, no diarrhea. Lost nine pounds. Sent to ED received saline bolus.  Dizziness and abd. pain relieved, discharged to home.  Alleges to have had similar symptoms though milder when given dose of HPV one year prior (unreported).
Patient came in to store 1/2/15 stating that we hit a nerve when getting flu shot and she has nerve damage. States that she had x-rays and blood work done. Brought in prescription for nerve pain medication.
presents with fever and shortness of breath, found to have COVID-19 infection    patient received his 3rd vaccine on 10/6/2021
I began to feel more extreme pain in my knee, ankle, shoulder, and neck. In course of getting treatment for prior back pain, I received a cortisone shot and the pain in my knee, ankle, shoulder, and neck increased.  At present pain is rated as being sometimes, and sometimes ranging up to 7.  Pain has been steady and getting worse in neck and shoulders.
Dose was not drawn up in syringe and nothing was administered though patient received the IM injection
Less than 24 hours after administration. Pt w/rt arm redness, swelling which eventually got to be size of "small cucumber". No rash, (+) myalgias, nausea.
Headache, Myalgia, Fever, Localized itching, fatigue Narrative:  Other Relevant History:
CHILLS; ACHING BODY; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced aching body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and aching body was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
On 3/13/2023, I felt groin and hip pain. I went to the doctor. They weren't sure whether I had a bladder infection, a kidney problem, or a skeletal issue. Since then, they have ruled out bladder infection and kidney ailment. I am now due to undergo an X-ray on my hip in the near future. I underwent a urine test, blood test, and ultrasound on 3/23/2023, and no infections were detected. At the time of this writing, I feel fine, except I have pain in the right hip. I'm no longer having groin pain, though.
Headache; Fatigue; The patient received BNT162B2 and was lactating; The patient received BNT162B2 and was lactating; This is a spontaneous report from a contactable healthcare professional reporting for herself and her baby. This is the maternal report.  A 35-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EH9899) intramuscular, on 16Dec2020 at 10:00, in right arm, for COVID-19 immunisation. No other vaccine was given within 4 weeks before. The patient was breastfeeding. Allergies to medications, food, or other products: no. The patient had no COVID before vaccination. Concomitant medications included ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS), vitamin D and calcium. The patient was lactating and on 17Dec2020 her baby seemed to have had an upset stomach, she had trouble sleeping and spit up a few times which was abnormal for her. On 17Dec2020 the patient experienced headache and fatigue which both resolved with lasting effects on an unspecified date in Dec2020. Treatment included paracetamol (TYLENOL). Since the vaccine she had had a headache daily. The events required physician office visit. COVID was not tested after vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020511585 baby case
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. The patient's past medical history included: blood clots. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced shingles. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000216681.
patient describes filly very dizzy and woozy. He says he has not eaten and is not hydrated.
Pt was given Moderna vaccine on 5/5/2021 and 6/2/2021. Pt came into the hospital for L&D on 6/18/2020, tested per protocol for COVID upon admission, test was positive.  Pt was asymptomatic for COVID.  Pt delivered by C-Section on 6/19/2020., with baby weighing 7lbs 3.7oz, or 3280g.
Pain in upper arms (deltoids), pain in LE (quads); intermittent blurry/double vision; headaches; muscle weakness; extreme fatigue; night sweats; feeling inflamed; dizziness; RUQ pain; SOB; intermittent tachycardia, palpitations; facial numbness; irregular period; joint pain; itching; brain fog; anxiety
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EP6955), in right arm and on 06Apr2021 as dose 2, single (Lot number: ER8727) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 18Dec2021 as dose 3 (booster), single (Lot number: 032H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Appendectomy" (unspecified if ongoing); "Cesarean section" (unspecified if ongoing); "Ramsay Hunt syndrome" (unspecified if ongoing); "cholecystectomy" (unspecified if ongoing); "known allergies: Possible shellfish allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not received any other medication in 2 weeks of vaccine. Antiviral details included COVID 19 Treatment, Brand was Paxlovid started on  22Jul2022 to 26Jul2022 (Lot number: Gd8819). It was reported as rebound symptoms 2 days after completing Paxlovid including fatigue, sore throat, congestion, body aches, headache.
This spontaneous report was received from a nurse practitioner concerning a 20 year old male patient who on 20-JUL-2011 was vaccinated intramuscularly with the first dose of GARDASIL (dose and lot # not provided), on 14-SEP-2012 was vaccinated intramuscularly with the second dose of GARDASIL (dose and lot # not provided) and on 17-JUL-2012 was vaccinated intramuscularly with the third dose of GARDASIL (dose and lot # not provided). No other co-suspects were reported. No concomitant medications were reported. There were no adverse symptoms after the first and second dose of GARDASIL. On 18-JUL-2012, the patient went to the office complaining of swollen axillary glands, pain, aching and fever. The patient was advised to rest and take ibuprofen. On 20-JUL-2012, the patient called the office to report he was not improved. On 23-JUL-2012, the patient returned to the office complaining of joint aching, "cold sweats" and loss of hand strength. At the time of the report, the patient had not recovered from the events. The relatedness for joint aching, loss of hand strength, cold sweats, fever, pain, aching and swollen axillary glands was unknown for GARDASIL. The reporting nurse considered joint aching, loss of hand strength, cold sweats, fever, pain, aching and swollen axillary glands to be disabling. Additional information has been requested.