chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 65 year old female patient with allergies to penicillin-unknown type and no pertinent medical history;. On 30-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # and route not reported) at a local pharmacy. On 08-MAY-2013, the patient developed redness at the injection site. The patient called the office to report the adverse symptoms to the nurse and described the area as "2 inches of redness around the site of injection". The patient sought medical attention by calling the office. No treatment was given. No lab diagnostics studies were performed. The outcome of redness at the injection site was reported as not recovered/resolved. Additional information is not expected.
Information has been received from a 74 year old male with a history of shingles in JAN-2005 and an allergic reaction to tetracycline (he breaks out in a rash) who on 25-OCT-2007 was vaccinated with a "single dose" of ZOSTAVAX.  Concomitant therapy included influenza virus vaccine (unspecified) administered on 25-OCT-2007 and 11 other prescription medications "therapy unspecified".  On approximately 27-OCT-2007 a "couple of days after shot" (also reported as "sometime during the second week in NOV-2007") the patient reported feeling lethargic, tired and the back of his head itched really bad.  The itch started in his scalp and then went all the way down his back.  "He did not have any type of outbreak or rash in either area".  The patient stated that he went to the physician and they said he has post herpetic neuralgia.  No diagnostic labs were performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
ARM RASH:        started after receiving injection of influenza and pneumonia in same arm, noticed some swelling and redness, that has progressively worsened, itches, having a hard time sleeping due to pain and itching.        no fever, no chills.        admits to pain and discomfort, making it difficult to sleep. Treatment: Start Keflex Capsule, 500 MG, 1 capsule, Orally, every 12 hrs, 7 days, 14 Capsule, Refills 0 Start Vistaril Capsule, 25 MG, 1-2 capsule as needed, Orally, every 8 hrs, 3 days, 24, Refills 0
Bad headache; dizziness; Nausea; Chills; tightness in chest/fast heartbeat; tightness in chest/fast heartbeat; Sore at injection site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 29-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EL3247), dose 2 via an unknown route of administration in left arm on 11Feb2021 at 10:30 (at the age of 29-years-old) as single dose for COVID-19 immunisation at workplace clinic. The patient's medical history included fatigue, chronic rhinitis/sinus congestion, brain fog and skin rash. She was allergic to sulfonamides. Concomitant medications included valaciclovir hydrochloride (VALTREX); ethinylestradiol, norethisterone acetate (JUNEL); ergocalciferol (VIT D); polycarbophil calcium (FIBER); fluticasone propionate (FLONASE); azelastine (AZELASTIN); all were taken for an unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EL3247), dose 1 via an unknown route of administration in left arm on 21Jan2021 (at the age of 29-years-old) as single dose for COVID-19 immunisation. On 11Feb2021 at 19:30, the patient experienced sore at injection site 10 hrs post vaccination, chills started at about 12 hrs post vaccination (gone by AM), tightness in chest/fast heartbeat at about 12 hrs post vaccination (gone by AM), bad headache starting about 20 hrs post vaccination, would not go away took an advil about 24 hrs post vaccination which significantly helped, some dizziness and nausea 20-28 hrs post dose. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment received for the adverse event. The patient underwent lab test and procedure which included Heart rate and it was fast. The outcome of the events chills started at about 12 hrs post vaccination (gone by AM), tightness in chest/fast heartbeat at about 12 hrs post vaccination (gone by AM) was recovered on 12Feb2021, while the outcome of the remaining events was recovering.  Follow-up attempts completed. No further information expected.
vomiting; rash all over my arm; very fast heart beat; Headache; dizzy; Joint pain; Nausea; Fever; difficulty breathing; very tired; left arm started to hurt; arm swelled; hard; High blood pressure highest 108; chills; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard) and HEADACHE (Headache) in a 79-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 medically reported history provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METOPROLOL SUCCINATE (TOPROL XL), SPIRONOLACTONE and CLONIDINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard), CHILLS (chills), MYALGIA (Muscle pain), PYREXIA (Fever), DYSPNOEA (difficulty breathing) and HYPERTENSION (High blood pressure highest 108). On 21-Jan-2021, the patient experienced HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and DIZZINESS (dizzy). On an unknown date, the patient experienced VOMITING (vomiting), VACCINATION SITE RASH (rash all over my arm) and HEART RATE INCREASED (very fast heart beat). At the time of the report, FATIGUE (very tired), VACCINATION SITE PAIN (left arm started to hurt), VACCINATION SITE SWELLING (arm swelled), VACCINATION SITE INDURATION (hard), HEADACHE (Headache), CHILLS (chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea), PYREXIA (Fever), DYSPNOEA (difficulty breathing), DIZZINESS (dizzy), HYPERTENSION (High blood pressure highest 108), VOMITING (vomiting), VACCINATION SITE RASH (rash all over my arm) and HEART RATE INCREASED (very fast heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications include NONE..   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: An additional document received 15 Apr 2021 included only reporter details updated.
Pt received a flu shot on 9/19/13 and since then reports having shooting pain that occurs every time she lifts her arm. Pain radiate a little, but not past elbow. Pain does not go away when using ALEVE or hot/cold packs.
I have had the shot and I still have the shingles/suspected vaccination failure; I have had the shot and I still have the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have had the shot and I still have the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have had the shot and I still have the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-JUL-2023 The case was received from the patient interactive digital media. The patient had the shot and still had the shingles (at the time of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
P/receiving Td, pt exp extreme malaise, h/a, induration @ inject site, joint aches, fever & chills; Fatigue & severe malaise persisted for approx 3 days, according to reporter;
Administered FLUMIST about 1522 on 9/6/11 - next day realized pt needed second VZV - later learned that MMR and VZV should wait a month after other live vaccine. The package insert does not state this for FLUMIST. This is also missing on VZV insert but is on MMR insert. Need to change FLUMIST and VZV inserts.
Information has been received from a Registered Nurse (R.N.) concerning a 16 year old female with a history of asthma and amoxicillin allergy who on 16-FEB-2009 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (lot # 661766/0652X).  There was no concomitant medication.  On 16-FEB-2009 the patient experienced the onset of vomiting, headache, abdominal and back pain a few hours after receiving the vaccine.  The patient's mother called the office on 17-FEB-2009 and was suggested to give the patient MOTRIN and fluid replacement.  At the time of reporting the patient was recovering.  Additional information has been requested.
I received my 1st  Covid injection on 6/29/2021. On 07/03/2021 I went to the emergency room with a horrible migraine. I hadn?t been to the emergency room in many years for a migraine. Ever since then my migraines have been out of control  and they can last up to a week.
sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (received on an unknown date and was sick, refer case US2021AMR198761).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination not reported. The patient reported that, he/she was very sick after these Shingles shots.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR198761:same reporter
T 2 -3 1 - 3 inch band of vesicles, no pain, lasted less than 4 weeks.
This spontaneous report as received from a registered nurse refers to a female patient of unknown. The patient's medical history and current conditions were not specified. The patient had no drug allergies/reactions.  The nurse reported that the patient received the first dose of M-M-R II on 14-OCT-1997 and the second dose on 13-AUG-2001 (lot number not reported). On 08-AUG-2014 the patient was vaccinated with M-M-R II, dose 3. Other suspect therapies included 3 dose series of RECOMBIVAX HB (reported as "unspecified hepatitis B vaccine, manufacturer unspecified), but RECOMBIVAX could not be ruled out. Concomitant therapies included fluticasone, ethinyl estradiol, ferrous fumarate, GENERESS FE and clindamycin. On 05-AUG-2014 the patient had titers drawn and the rubella titer was negative. Reporter stated that the patient also showed negative for hepatitis titers. The reporter stated that she thought some "people just don't' respond". The outcome of the events was unknown. No intervention was provided-there was no hospitalization, no significant disability and no life threatening experiences. No product quality complaint was involved. Causality was not provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Flu shot given on 11/12/02 at 11:15. Pt returned at 11:25 complaining of throat being tight, a burning feeling in ears and neck and dizzy. Chlorpheniramine 8mg was given. Vital signs were stable. Pt states "I feel better" and returned to work in this bldg at 11:37.
Patient received the vaccine and started walking around the store to wait for the 15 mins required, He report feeling light headed and was sweating so he came back. I sat him down and gave him water and orange juice to drink. Within 10 mins he stated he was fine and his BP was 100/48 before he left.
This spontaneous report as received from a pharmacist refers to a 79 years old female patient with no medical history and no drug allergies. The patient was vaccinated with ZOSTAVAX (Lot# unspecified) on an unspecified date in MAY-2012. No other co-suspects were reported. Concomitant medications included VESICARE, lorazepam, amlodipine, hydrochlorothiazide, potassium chloride (manufacture unknown) and LIPITOR. The pharmacist stated the patient's "whole arm was one massive bruise" after she received ZOSTAVAX. The pharmacist mentioned the bruising resolved, but the patient was in the pharmacy on 10-AUG-2012, stating that she had now (date unspecified) developed "hormonal type side effects and hot flashes that last 20 minutes at a time, as well as itchy breast nipples." No treatment information was reported. The outcome was reported as not recovered for hormonal type side effects, hot flashes and itchy breast nipples. The patient had sought medical attention via office visiting. Additional information has been requested.
back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Back pain (Occasional Back Pain).   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced BACK PAIN (back pain). At the time of the report, BACK PAIN (back pain) had resolved.            No concomitant medications were provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-147408 (Linked Report). This case was linked to MOD-2021-147408 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Live follow up received on 16-May-2021; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-147408:Dose 2
Patient suffered a ischemic stroke to the thalmus part of the brain and lost motor functions on the left side of her body.  Patient was rushed to hospital and given numerous tests to dicipher a cause for the event.  All tests came back negative as to what could have caused the event.  Patient is young and healthy otherwise.  Patient was given blood thinners and monitored for 3 days and her symptoms improved rapidly.  She was released after 3 days.
CHILLS; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 08:00 a.m. for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-MAR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills. This report was non-serious.
Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an eight-year-old male patient who received third dose of vaccine DAPTACEL (Suspension for injection) (batch number, expiry date, route and site of administration were not reported) on an unknown date as child was "missing those vaccines" referring to DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, and states they used DAPTACEL for his catch-up series. The patient's past medical history and concomitant medication were not provided. It was a case of actual medication error due to inappropriate schedule of vaccine administered as 8 year old child was "missing those vaccines" referring to DTaP, and states they used DAPTACEL for his catch-up series. Caller states this child was 8.5 years old when he received his third dose of DAPTACEL, and will need his fourth dose in 6 months, when he's 9 years old. It was unknown if adverse event was received or not. 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.
Patient was monitored for 30 minutes without complaint.  Patient returned approximately 45 minutes after vaccine complaining of lips and mouth tingling that transitioned to numbness. Patient received 25mg of Benadryl PO approximately 50 minutes after vaccine. 30 minutes after Benadryl patient continued to complain of lip numbness and tingling on both palms. Patient was transferred to ED for further examination/treatment.
low grade fever,then unilateral posterior & anterior cervical lymph nodes on inj site side;no other sx;
INR inc; pt increased; pt has been maintained on Coumadin dose for 5 mos w/no change; recvd flu vax 1 wk prior;
AFTER ADMINISTRATION OF IMMUNIZATION, PATIENT APPLIED PRESSURE WITH COTTONBALL TO SITE OF INJECTION WHERE THERE WAS SOME SLIGHT BLEEDING.  HE TOLD ME THAT HE "SOMETIMES GETS ANEMIC".  WITHIN A MINUTE HIS EYES ROLLED BACK IN HIS HEAD AND HE TOOK A DEEP, GASPING TYPE BREATH AND THEN PASSED OUT.  HE WAS PASSED OUT FOR LESS THAN A MINUTE WHEN HE CAME BACK TO HIS SENSES HE APPEARED OKAY AFTER DRINKING SOME WATER AND RELAXING IN PLACE FOR A WHILE.  HE THEN SAID THAT THIS HAPPENS TO HIM "ABOUT HALF THE TIME."
Pt's mother states pt developed rash on both arms one week after vaccination. Pt has excoriations and skins on bilateral arms.
pt devel red splotches over face,head,& abd;immed upon receiving vax;this lasted for 10mins w/no other untoward sx;
Child received vaccine (Prevnar) at 9:00am on 10/12/2005. Spiked a fever of 102.6 1-2 hours afterwards. No other reactions.
Chest pains, left upper side.  Overnight emergency room stay.  Monitor BP and heart.  Sent to heart specialist for testing - all okay.  Sent to Gastroenterology Specialist.  Diagnosed with GERD.
STIFF NECK, BODY ACHES, SORE THROAT, SWEATY, FEVERISH, HEAD ACHE, ETC.
Had localized red hard lump at injection site that was extremely hot to the touch. Called Pediatrician, and spoke w/ nurse who said he was having local reaction and to put ice on it and give ibuprofen. Within 24hrs of this occurring, patient broke out in horrible hives on his entire body. Had to be taken to Urgent Care and attending Dr. said his throat was closing and administered a steroid shot and Benadryl. Prescription was written for steroids and Benadryl for 10 days. It took a full 10 days for patient to stop breaking out in hives. It was like the toxin from the vaccine had to work it's way through his entire body. He complained of sore muscles during this time as well.
received their 1st dose of the COMIRNATY vaccine dated 11Aug2021 and was inadvertently administered with with the Moderna vaccine today for her 2nd dose; This is a spontaneous report from a contactable Nurse. A 30-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution injection, Lot number: FC3181 and Expiration date: 31Oct2021), via an intramuscular route of administration, administered in left deltoid on 11Aug2021 (at the age of 30-year-old), DOSE 1, 0.3 ML SINGLE for covid-19 immunisation and received the second dose of covid-19 vaccine mRNA (mRNA 1273; MODERNA COVID-19 VACCINE; Batch/Lot number: 027C21A and Expiration date: 26Oct2021), via an intramuscular route of administration, administered in right deltoid on 03Sep2021 (at the age of 30-year-old), as DOSE 2, 0.5 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter confirmed she was calling regarding the Pfizer COVID vaccine. The reporter had a question. She stated her facility was doing injections, and they had a patient who had received their first Pfizer COVID vaccine on 11Aug2021. The patient came in today 03Sep2021 for the second dose and however, instead of receiving Pfizer, the patient inadvertently administered with Moderna. The reporter was calling to see what the side effects were and if they needed to repeat the patient's second dose. There was no Investigation Assessment provided. This report was not related to a study or programme.  The lot number for BNT162B2 was not provided and will be requested during follow up.  Follow-up (03Sep2021): This is a follow-up spontaneous report from a contactable Nurse. This Nurse reported for a patient included: added the dose, route of administration, anatomical location of vaccination, lot number and expiration date for both COMIRNATY and MODERNA vaccine  No further details were provided or obtained.
Broke out in hives all over my body on the 10th day? progressed quickly and the bottom of my left foot became pins and needles? feeling. No other allergies or eating anything different or changing detergents or perfumes/lotions
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 07-AUG-2012 the patient was vaccinated intramuscularly (IM) with a dose of VAQTA (reported lot# 0271AE, exp. date 20-NOV-2014), that had been stored under refrigeration in a plastic syringe for 28 hours. It was unknown if the patient sought medical attention. No known adverse effects. Additional information has been requested.
Within 4 hours, fatigue, exhaustion, chills, night sweats, mild nausea, significant, all-over muscle pain. Rest and sleep mostly resolved fatigue. Persistent muscle pain and malaise the next morning.  Injection site hurt more than any other vaccination site, ever. Last year had NO side-effects from flu shot.
Patient received monovalent dose of pfizer after 4/18 when the FDA stopped use of this vaccine.    They have returned on 5/24/23 for BIVALENT dose
Expired hep B vaccine given by mistake, vaccine expired 4/10/06. Vaccine given 4/14/06. As per advice repeat Hep B vaccine ASAP. Pt is scheduled 4/18/06 for Hep B vax.
I started with a cough. I went to the ENT and she took some drainage and it was an infection, pseudomonas. I started taking antibiotics for that. I still have pseudomonas and I am taking more antibiotics. I went to the ER because I had fever and my chest was hurting, I had 2 covid tests and they were both negative.  They did a chest x-ray, EKG, blood work- they were all negative, except the chest x-ray which said I had pneumonia.