chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician's assistant concerning a 13 year old female with no known drug allergies who on 08-AUG-2007 was vaccinated IM in the left deltoid with the second vaccination of Gardasil (Lot # 655620/0171U).  The date of the patient's first vaccination was not reported.  It was reported that the patient was not instructed to wait the minimum 15 minutes post vaccination and left the office with her family.  As she walked to the car she reported that she felt dizzy.  She then fell and hit the occipital area of her head.  Paramedics were called and the patient was transported to the ER.  A head CT scan was performed which was normal.  The event was diagnosed as a syncopal episode.  At the time of the report it was unknown if the patient had recovered from the event.  Additional information has been requested.
went deaf in right ear; This case was reported by a consumer via interactive digital media and described the occurrence of deafness unilateral in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced deafness unilateral (serious criteria GSK medically significant). On an unknown date, the outcome of the deafness unilateral was unknown.   It was unknown if the reporter considered the deafness unilateral to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got the Shingles vaccine and went deaf in right ear. The patient stated that he/she would rather get shingles than go deaf in one of ears. The follow-up would not possible as no contact details were available.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 69-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th April 2018, 2 days after receiving SHINGRIX, the patient experienced erythema of extremities and itching both hands. In April 2018, the patient experienced rash tongue and patchy rash. On an unknown date, the outcome of the erythema of extremities, itching both hands, rash tongue and patchy rash were unknown. The reporter considered the erythema of extremities, itching both hands, rash tongue and patchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness on her left hand and itchiness two days after receiving the SHINGRIX vaccine. Less than a week, after vaccination, the patient also had a patchy rash all over her tongue and also on her upper neck. The patchy rash was more pronounced on the left side. The patient experienced redness at the injection site and it spread from there. No additional details were provided as she had not seen the patient since the symptoms occurred. The caller states that one of her colleagues had seen the redness and patchy rash on the patient.
Myarm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th August 2021, the patient received Shingles vaccine. On 18th August 2021, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.  It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient stated that got the shingles vaccine and arm hurt from that shot. The follow-up would not possible as no contact details were available.
THICKENING OF THROAT, SWELLING OF LIPS, ITCHINESS OF EYES, CHILLS, NO FEVER, MUSCLE ACHES. TREATED WITH BENADRYL WHICH IMPROVED SYMPTOMS, STILL ITCHY NEXT DAY WITH ACHES BUT IMPROVING.
sweating; head felt like the worst hangover; pulsating aura around periphery; Couldn't move; keeps lifting to the right-hand side; Hearing and vision affected; Hearing and vision affected; Fatigued; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), HANGOVER (head felt like the worst hangover), AURA (pulsating aura around periphery), HYPOKINESIA (Couldn't move) and LIMB DISCOMFORT (keeps lifting to the right-hand side) in a female patient of an unknown age 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating), HANGOVER (head felt like the worst hangover), AURA (pulsating aura around periphery), HYPOKINESIA (Couldn't move), LIMB DISCOMFORT (keeps lifting to the right-hand side), HYPOACUSIS (Hearing and vision affected), VISUAL IMPAIRMENT (Hearing and vision affected), FATIGUE (Fatigued), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, HYPERHIDROSIS (sweating), HANGOVER (head felt like the worst hangover), AURA (pulsating aura around periphery), HYPOKINESIA (Couldn't move), LIMB DISCOMFORT (keeps lifting to the right-hand side), HYPOACUSIS (Hearing and vision affected), VISUAL IMPAIRMENT (Hearing and vision affected), FATIGUE (Fatigued), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant products were not reported by the reporter. No treatment information was provided by reporter.
On 08/02/2023 I injected my Patient, varicella in the deltoid instead of subcutaneously.
UPSET STOMACH ON AND OFF; SLIGHT SINUS HEADACHE; SOME PRESSURE IN SINUS CAVITY; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced upset stomach on and off. On 05-MAY-2021, the subject experienced slight sinus headache. On 05-MAY-2021, the subject experienced some pressure in sinus cavity. On 05-MAY-2021, the subject experienced chills. On 05-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.1 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills on MAY-2021, and the outcome of upset stomach on and off, fever, slight sinus headache and some pressure in sinus cavity was not reported. This report was non-serious.
Within 24hr swelling and redness at site size 9cm x 5cm-red, edematous, warm to touch.
gel like substance under bandaid at injection sight; bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (gel like substance under bandaid at injection sight) and VACCINATION SITE HAEMORRHAGE (bleeding) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (gel like substance under bandaid at injection sight) and VACCINATION SITE HAEMORRHAGE (bleeding). At the time of the report, VACCINATION SITE DISCHARGE (gel like substance under bandaid at injection sight) and VACCINATION SITE HAEMORRHAGE (bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 immunisation.     The patient's past medical history included Pregnancy (Premature rupture of embyro, twins 32 weeks live pre-term birth) from February 2008 to 02-Nov-2008. Concurrent medical conditions included Asthma since July 1995 and Allergy to antibiotic (Cephalosporin, melons, squash, pumpkin, cucumber and kiwi). Concomitant products included CETIRIZINE HYDROCHLORIDE (CITIRIZINE [CETIRIZINE HYDROCHLORIDE]) for Asthma, MAGNESIUM and CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) for Headache, DOXYLAMINE SUCCINATE (UNISOM 2).    On 01-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 24-Jan-2021 and the estimated date of delivery was 31-Oct-2021. On 01-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 01-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Pregnancy test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug provided.
ERYTHEMA APPROX. 4 CM IN SIZE TO LEFT SHOULDER AT INJECTION SITE. PRESCRIPTION FOR KEFLEX 250MG\5ML-1 TSP BID X 7DAYS(70ML) GIVEN.
Headache, Myalgia, Stiff neck, Pain shooting down left side of face, Pressure behind left eye, Right arm swelling  Narrative:
Temp 100°, body aches, nausea, headache, extreme fatigue.  Started within 24 of injection. Feels like covid round 2 The body aches and nausea are horrid.  Will call my doctor tomorrow.
Through quality checks it was discovered that the patient likely did not receive a full dose. Patient was notified that it is recommended that they are re-vaccinated.
Increased left eye watering, inability to smile on left, noticed more facial asymmetry by the next morning- Bell's Palsy.
tingling and numbness in Right hand (5 min) sweating and anxiety felt foggy 20 min.
Diagnosed as shingles illness by Dr.. Rash on right side of face & scalp. Medications prescribed: Methylpred 4 mg Dosepak, & Valacyclovir 1gram, 21 tabs. Course: 12 days.
Subsequent to receiving Prevnar, DTaP, ActHIB and IPV, the pt screamed for 40 minutes. The reported indicated that the pt received the third dose of DTaP, ActHIB and IPV and did not have a reaction. The physician indicated that Prevnar was withheld. This is one of two pts from this facility who experienced screaming following vax administration. A copy of this report has been forwarded to Aventis Pasteur.
Patient was fine until sometime in the morning hours, approx. 12 hours after receiving vaccine. Began with a fever of 100.7, nausea, leg pain/joint pain. Patient took Motrin but fever rose to 102.5, continued with nausea, and leg pain. This lasted two full days.
Information has been received from a medical assistant concerning a 78 year old female who on 29-OCT-2007 was vaccinated with PNEUMOVAX 23 (Lot #655500/1005F). On 30-OCT-2007 the patient experienced injection site pain, redness, swelling, warmth and a blister. As of 31-OCT-2007, the patient had not recovered. Additional information has been requested.
Raised, warm, red area on arm at the injection site that continued to spread for at least the next 24 hours. The area covered the majority of her upper arm, approximately 3 in wide by 4 in long. Adverse event started soon after injection. The patient saw her doctor 24 hours after vaccination who prescribed Clindamycin 300 mg for 10 days, triamcinolone 0.1% cream, ranitidine 300 mg , and loratadine 10 mg.
Pain in arm; Tightness in arm; Tingling to left arm; This is a spontaneous report received from a contactable pharmacist for patient. A 26-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via intramuscular route on left arm on 27Feb2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications were not reported. The patient did not receive other vaccine within four weeks prior to COVID-19 vaccine. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient was tested for COVID-19. On 27Feb2021 at 10:05, the patient experienced tingling of left arm with no complaints of dizziness or light headedness and the vital signs were normal. The patient drank water and orange juice with improvement to tingling noted at 10:17. At 10:22, the patient still complained of pain or tightness or tingling in arm. The event did not result in doctor or other healthcare professional office/clinic visit. It was reported that, the patient left at 10:34 and was stable and was advised to follow up with primary care physician (PCP) if symptoms persist. Therapeutic measure was taken as result of events and included the treatment with TYLENOL 325 mg. The clinical outcome of the events tingling to left arm, pain in arm and tightness in arm were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician refers to a patient of unknown age. On 13-MAR-2013 the patient was vaccinated with GARDASIL dose 3 (lot no not provided). Route of administration was not reported. On 13-MAR-2013 the patient was administered dose 3, which was received late. Dose 1 and 2 were administered sometime in 2011. No symptoms were reported. The outcome of dose 3 was received late and no adverse event is unknown. Additional information has been requested.
Death Narrative:  Patient received his first dose of the Moderna COVID-19 vaccination on 3/4/2021. He presented to facility 03/05/2021 for shortness of breath. He was originally treated for COPD exacerbation and COVID-19 was ruled out by negative testing. He was then found to have blood cultures positive for E. Faecalis. He was treated with broad spectrum antibiotics. His lack of improvement in respiratory status was the cause of discharge to hospice after which he died on 3/30/2021.
Pt returns on 3/6/2002 to complete travel immunization ;menomune and Typhim (pt going to Ethiopia X 2 months. Per pt's dad, pt developed rashes 2 days after receiving the vaccines On exam, rashes noted on her forehead and trunk per dad @ no time did she have any respiratory distress. Pt did not have to take any medications for this conditions
pt recvd vax & w/in 30mins p/vax exp a raised red neck rash which progressed to entire trunk by 1APR95;itching & h/a were also exp;7APR95 asthma was out of control;tx cortisone IM & Pred;24-36 hrs p/cortisone & pred started s/s subsided;
ADACEL vaccine administered to an employee who had previously received it on 9/15/2010.
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program Pfizer First Connect. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the first of 20 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and tested positive for the virus (COVID-19) on an unspecified date.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.,Linked Report(s) : US-PFIZER INC-2021042231 same reporter, same drug/event, different patient;US-PFIZER INC-2021042229 same reporter, same drug/event, different patient;US-PFIZER INC-2021042217 same reporter, same drug/event, different patient;US-PFIZER INC-2021042222 same reporter, same drug/event, different patient;US-PFIZER INC-2021042224 same reporter, same drug/event, different patient;US-PFIZER INC-2021042225 same reporter, same drug/event, different patient;US-PFIZER INC-2021042230 same reporter, same drug/event, different patient;US-PFIZER INC-2021042220 same reporter, same drug/event, different patient;US-PFIZER INC-2021042218 same reporter, same drug/event, different patient;US-PFIZER INC-2021042234 same reporter, same drug/event, different patient;US-PFIZER INC-2021042233 same reporter, same drug/event, different patient;US-PFIZER INC-2021042221 same reporter, same drug/event, different patient;US-PFIZER INC-2021042219 same reporter, same drug/event, different patient;US-PFIZER INC-2021042223 same reporter, same drug/event, different patient;US-PFIZER INC-2021042228 same reporter, same drug/event, different patient;US-PFIZER INC-2021042226 same reporter, same drug/event, different patient;US-PFIZER INC-2021042216 same reporter, same drug/event, different patient;US-PFIZER INC-2021042232 same reporter, same drug/event, different patient;US-PFIZER INC-2021042227 same reporter, same drug/event, different patient
Patient was given Pfizer bivalent dose for the first dose in the series rather than the monovalent dose. No known adverse events.
The day of receiving the vaccine I had a very sore arm where the shot was administered.  Fatigue level increased.  Approximately 24 hours after receiving the shot I had increase fatigue, headache, Muscle pain and weakness and chills.  48 hours after the vaccine I felt relieved of all of the symptoms and felt normal.
Tachycardia,fever,malaise,fatiuge,headache,congestion, inflamed thyroid
Immune Response to vaccine injection with forearm/arm redness/swelling/itching; treated with 3 days of around the clock dosing of Benadryl, along with cold pack application
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to the emergency department two days after receiving second dose of vaccine with persistent nausea and vomiting. Symptoms started the evening of the day the vaccine was administered. Vital signs within normal ranges. Patient observed in emergency department, adminstered intravenous fluids, diphenhydramine, and ondansetron which improved symptoms, and discharged to home stable.
Blisters formed around injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number h379C) for prophylaxis.   On 13-NOV-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 14-NOV-2023, 1 days after receiving Shingrix, the patient experienced injection site blisters (Verbatim: Blisters formed around injection site). The outcome of the injection site blisters was not resolved.   It was unknown if the reporter considered the injection site blisters to be related to Shingrix.     It was unknown if the company considered the injection site blisters to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-Nov-2023 The reporter reported that the patient received Shingrix vaccine and experienced blisters around her injections site. The reporter did consent to follow up.
pt recvd 3 doses of Engerix-B & did not convert to HBSAB;
This spontaneous report as received from a nurse refers to a 4 year old female patient. On 28-FEB-2014, the patient was vaccinated with a expired dose of PROQUAD (merck) (lot# reported as H015639, expiry date 23-FEB-2014) injection, 0.5 ml, subcutaneous. No adverse effect was reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
rash on right leg, itching on body all over, scratchy throat, dizziness, SOB, hives, nausea, stiffiness in right wrist, also pain and redness and swelling at the injection site for 8 days
This case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult male patient who received BOOSTRIX (batch number 949LJ, expiry date 21st February 2017). This case was associated with a product complaint. On an unknown date, the patient received BOOSTRIX .4 ml. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced underdose and product complaint. On an unknown date, the outcome of the underdose and product complaint were unknown. Additional information received: Reporter stated that they pulled a dose from the single-dose BOOSTRIX vial but each time there were only 0.4mL instead of 0.5mL. They administered 0.4mL to 3 patients. Nurse also reported that the vials only gave 0.4 ml rather than 0.5 ml per dose. For 3 vials, a 3cc hash marked syringe, 5/8ths inch 25 gauge needle was used. The other vial had a 1 ml syringe used, and still showed 0.4 ml. The practice is used to using prefilled syringes. There are no leaks or cracks in the vials and the packaging is dry. The reporter did not wish to use the remaining of 6 vials due to low fill. Product return is from reporter. A credit memo was requested as replacement.
Within 20 hours of receiving the Pfizer-BioNTech COVID-19 Vaccine EUA, I began experiencing the following symptoms: extreme fatigue headaches swelling, pain, and redness at injection site body aches  joint soreness  All these symptoms are continuing at 42 hours post vaccination.
Severe pain in liver after Hepatitis A vaccine and Flu shot and Pneumonia shot, all given to me at the same time, when I Have Hepatitis C, sharp stabbing pain in upper right side of my chest, below my rib cage. Rapid heart rate also.
6/6-fever (102 temporal) and headache, these resolved, followed later by chest pain, went to medical center and evaluated, negative troponins. 6/7-chest pain began again, returned to medical center,  found to have elevated troponin of 3.19.   6/8 at 1am-Transferred to another medical center PICU where he had sensation of numbness in left arm, a squeezing  sensation of left arm, and severe chest pain.  EKG showing ST elevation and troponin of 3.75.  Given dose of 30mg Toradol and pain resolved.  Started on Motrin q6h, trending troponins. In the morning pain much improved, but still with pain on deep inspiration relieved with leaning forward.  Repeat EKG shows diffuse ST elevation, consistent with presumptive diagnosis of myopericarditis. Repeat troponin at 9am of 9.3, BNP of 197.  Echo done wnl.  Scheduled for cardiac MRI with contrast per cardiology recommendation to r/o myocardial edema. Viral panel sent to r/o viral etiology despite no prior symptoms.