chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness at injection site; warmth at injection site; pain at injection site; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported an adverse event to the caller (GlaxoSmithKline field employee) on behalf of his father (the patient).  The patient developed pain, redness, and warmth at the injection site. The patient consented to follow up. The caller did not provide the reporter's address at the time of the call and did not have any additional information regarding the patient or the event.
Pt. is 4 months old and a Kinrix was administered instead of  Pediarix.  Pt. has not adverse s/s at this time.
Within 5 minutes of receiving vaccine, pt turned pale and began gasping for air she then had a 15-30 second seizure. She was taken to ER via ambulance. Unable to reach parents by phone on 8/3/12 for f/u.
I am pregnancy (due date 08Oct2021) and got booster shot last week; got booster shot last week; got booster shot last week; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Sep2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. Second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. After first and second dose, I am pregnant (due date 08Oct2021) and got my 2 initial COVID doses. On Sep2021 the patient experienced pregnancy (due date 08oct2021) and got booster shot last week, got booster shot last week (off label use), got booster shot last week (immunisation). The mother reported she became pregnant while taking bnt162b2. The mother was due to deliver on 08Oct2021.It was reported that I am pregnant (due date 08Oct2021) and got my 2 initial COVID doses January/February and my booster shot last week. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a health professional concerning 4-6 month old patients who were vaccinated with 2 ml oral dose of ROTATEQ. It was not indicated if only one dose was given, or it the full three week regimen was completed. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/10/2006. Information has been received from a health professional concerning 4-6 month old patients who were vaccinated with 2 ml oral doses of ROTATEQ. It was not indicated if only one dose was given, or if the full three week regimen was completed. Follow-up information indicated that no patients were actually involved in the previously reported experience. Therefore, WAES# 0609USA08405 is being deleted from our files on ROTATEQ. Additional information is not expected.
Cold chills, severe shaking, muscle aches,  This lasted thru the night.  No signs the next day.
patient was supposed to be getting the new updated bivalent booster and ended up receiving the monovalent
Information has been received from an LPN for the Pregnancy Registry for HPV vaccine concerning a 24 year old female with attention deficit/hyperactivity disorder, who on 07-AUG-2008 was vaccinated with the first dose of GARDASIL (lot# 0250X). On 11-SEP-2008, the patient found out she was pregnant and on 26-SEP-2008, she confirmed that she was 10 weeks pregnant with a ultrasound performed that showed intrauterine pregnancy. The patient's LMP was approximately on 18-JUL-2008 and EDD 24-APR-2009. She subsequently took prenatal vitamins for pregnancy health and vitamin B for nausea. This was her first pregnancy. No further information is available.
318 patients received dose from vials beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  Date of refrigeration was 07-May-2021.
patient received 3rd dose of Moderna on 9/27/21 - dose #1 was given 3/25/2021 - dose #2 was given 04/20/2021 - patient is not immune compromised so did not qualify for an additional dose
Seen in emergency department on 2/01/03 and 02/02/03. high fever, lethargic, ataxia. Transferred to hospital 2/02/03. Discharged 2/2/03. Discharge diagnosis: Probable post-varicella cerebellar ataxia. Rx: IV Fluids.
I began to have bowel changes.  I would have regular bowel movements, about once a week I would have severe pain and diarrhea.  This went on for about 4 weeks.  I began bleeding from my colon on August 14th.  I went to the ER and was admitted to the hospital and was released yesterday.  The diagnosis was Ischemic Colitis.
No adverse event; given an expired vaccine; given the monovalent vaccine as booster dose; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given an expired vaccine), WRONG PRODUCT ADMINISTERED (given the monovalent vaccine as booster dose) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (batch no: EW0183) on 22-Aug-2021 and Pfizer (batch no: EW0191) on 12-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 25-Nov-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given an expired vaccine) and WRONG PRODUCT ADMINISTERED (given the monovalent vaccine as booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given an expired vaccine), WRONG PRODUCT ADMINISTERED (given the monovalent vaccine as booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given an expired vaccine) and WRONG PRODUCT ADMINISTERED (given the monovalent vaccine as booster dose).    No concomitant medication were reported.  Medical assistant reports that a co-worker accidentally administered an expired vaccine to the patient. Monovalent vaccine of Individual vials. Vial size was 5.5ml. The vial was initially stored in the refrigerator on 15-Nov-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-681150 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681150:Same reporter
Began having arthritis-type pain in my hands around 6 hours after vaccine. The pain persisted for 5 months, sometimes so badly that I couldn't use my hands at all. I tested positive for an autoimmune disease on bloodwork done at the PCP's office. However, after a couple months, before seeing the rheumatologist, the symptoms slowly faded away.  I had no known autoimmune symptoms before receiving the vaccine, and the symptoms began that same day.  I only experienced mild hand pain, occasionally, since August.  I am going to the rheumatologist in February to follow up and I'll see if I still test positive on my ANA panel.  I do not know if it is permanent, or possibly around before the vaccine.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 02-DEC-2014, the patient was inoculated with ZOSTAVAX, (lot# and route unknown), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician, at a surgical/medical healthcare facility, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Extremely sore day after escalating to pain/numbness within 3 days. Bruised-still bruised on 19 Nov when picture was taken. As of 1 Dec 2017 still constant ache, with numbness down to forefinger/thumb area. Has stabilized at a lower grade ache and numbness (similar to as when you arm is awaking from being asleep).
C/O AT INJECTION SITE AND NEIGHBORING AREAS SORENESS, WARMTH, RED BLOTCHINESS, SWELLING. PT TOOK 2 BENADRYLS. NO RESULTS. NOTICES SPREAD TO NEARBY AREAS AT 8PM. STARTED FROM POINT OF INJECTION SITE T 3 MORE AREAS MEASURING ABOUT 1.5 TO 2 INCHES IN DIAMETER. CAME TO PHARMACY SUNDAY WITH EFFECTS UNCHANGED.
This spontaneous report as received from a Licensed Practical Nurse refers to an 18 year old male patient. The patient was a non-smoker. On 08-NOV-1998 (lot # 05571), 14-DEC-1998 (lot # 0650E) and on 09-SEP-1999, the patient was vaccinated with first, second and third doses of RECOMBIVAX (route: intramuscular) respectively (inappropriate schedule of vaccine administration). On 26-JUL-2017, the patient's anti Hbs titer was negative. On 27-JUL-2017, the patient has received the booster dose of RECOMBIVAX (lot # N0006321). The outcome and causality of the event were unknown. This is one of the two reports received from the same reporter.
Patient received Pfizer pediatric COVID-19 vaccine instead of Pfizer adolescent/adult dose as indicated for patient's age (12).  Poison control was contacted, and I, the vaccinator, was instructed not revaccinate with the Pfizer adult dose since patient had no other underlying conditions.  I was instructed to vaccine with adolescent/adult Pfizer dose for second dose.
Started with headache, aches in joints and muscles, stomach pain.  Slept most of the day Wednesday and by Wednesday evening was feeling a little better.  No appetite.
Please note that the administration of the 2nd vaccine was given at the pharmacy location being reported. We do not have detailed information regarding the vaccine series 1.   An intern used the incorrect size needle to administer the Covid vaccine to the patients listed on this report. The needle size used was a 5/8 inch needle, when the correct size that should have been used was a 1 inch needle. The correct dose was given to all patients. Based on CDC recommendations, there is no need to revaccinate any patient that was administered the dose in the wrong location; in this case the vaccine was given SubQ rather than intramuscular, based on the length of the needle. All patients were notified of this error and were given advise on what to expect. All patients were informed that no harm was done, the vaccine was still effective, and no additional dose is required based on CDC guidelines. As a result of these errors, reeducation was given to the pharmacy student, and the area within the pharmacy that contains all vaccination related supplied were relabeled to make it more clear for everyone administering vaccines.
flu; nitial information received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a Consumer/Non-health-care professional.  This case involves an unknown age and unknown gender patient who had flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of influenza vaccine.  Reportedly, Got my flue shot but got the flue anyway.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Pt received her influenza vaccine & TDAP Vaccine 8/28/18 (her first time getting influenza vaccine). No recent illnesses. Developed neck, upper back, bilat arm discomfort on 9/12/18 progressing to both legs with bilateral arm weakness and numbness in hands to the point that she was no longer steady on her feet. Tingling started in her feet and progressed up her legs. Pt with mild swallowing difficulty. IVIG 40g x3 doses started 9/15/18. Patient was discharged to Rehab hospital, but required readmission for plasmapheresis treatments 9/23/18.
A few days after booster shot at the end of October, I fainted after becoming very short of breath. When I fainted, I fractured my L5 vertebra from the fall. It took me about 90 seconds to come back to consciousness. 4 days later, I went to the hospital to have an X-ray done on me and diagnosed the fracture. Tested for cardiac echo with bubble study, and CTs and MRIs of brain, and they all came back negative. Decided it was a vasovagal response. 2 weeks of heart monitoring with Z-pack, but nothing come from that. Still having back pain, and a bit restricted in my exercise options. I have not had a fainting spell since then.
Moderna COVID-19 vaccine was administered to patients past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.
About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I was taken to the ED where I was given non drowsy antihistamine and observed. At home I experienced severe fatigue, muscle aches and chills. At about 30 hours the symptoms went away
Arm extremely sore, Hot to touch, headache, achy. Next day  10/24/19, I felt like I was hit by a truck!   Fast/rapid heartbeats  Mfr - Glaxosmith Klein
Nausea, site swollen, red, stiff neck, dull headache, swollen up to collarbone.
Pt recvd 2 series of Engerix-B & is a nonresponder;
I received 5th Pfizer COVID vaccine on 12/30/2022. That night began violent vomiting. diarrhea and Global severe migraine on both sides of my head. On 12/31/2022 I sought Emergency care and was told I most likely had a reaction to the vaccine. I was treated with IV fluids, and medications for headache and nausea and vomiting. I am still nauseated and having loose stools and now I have developed additional symptoms of intermittent fine hand tremors, constant headache and lightheadedness.
Chills, fogginess, fever, headache, body ache. Sore arm
I believe it was allergy related; therefore, the temperature in the area was in the 70s and 50s at night. I woke up with a really swore throat which persists for a couple of days and moved down into my mouth. I called the doctor via telehealth and he prescribed an antibiotic and Claritin from the local drug store and I begin to feeling better after 36 hours (took it on Monday night and started to feel better on Wednesday morning).
No adverse events occurred. This Moderna COVID-19 booster vaccine was administered at the correct dosage; however, it administered prior to the 6 months time frame. Patient received two Pfizer doses on 5/28/2021 and 6/18/2021. Nurse administering the COVID vaccines was not aware that booster doses needed to be administered 6 months or longer after the 2nd dose of a COVID vaccine. Patient informed of this error and no adverse effects reported.
New onset of visual migraines without headache. First incident was 7 days after dose #1. Subsequent incidents 2- 10 after dose #2, last noted on 5/14/2021.
I experienced headache, pains at the back of my neck, Tommy pains, and dizziness.  All lasted for 24 hours. Tommy pains subsided first, about 14 hours.  I took tylenol ( over the counter) twice,  and felt better. I did contact my primary doctor' s office. I was scheduled for a visit. I was unable to keep the appointment because I was  feeling so dizzy that I slept the whole day. The next day, I called the doctor's to let them know I was feeling okay, again. I
pt recvd 3 doses of Engerix-B & was a nonresponder;
Throat swelling; Trouble swallowing and breathing; Fever; Redness in my eyes, especially on the side of the injection; Redness around injection site. Treated with Benadryl.
patient received PedVaxHIB (Merck product) instead of the intended vaccine, MENACTRA with no adverse event; Initial information regarding an unsolicited valid non-serious case from a nurse via Agency (Reference number- 00689735) and transmitted to Sanofi on 20-Jul-2021.  This case involves a 16-year old female patient received HIB VACCINE CONJ (OMPC) (PEDVAXHIB) (merck product) (lot number: S023646 and expiration date: 31-Mar-2022) at first dose of 0.5 ml via intramuscular route in the right deltoid instead of the intended vaccine, MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: unknown and expiration date: unknown) (wrong product administered) for prophylactic vaccination on 19-Jul-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  It was an actual medication error case due to wrong vaccine administered (latency: same day).  It was reported, "The caller would like to know if it's okay to give the MENACTRA today? The nurse has the patient coming in today. I checked the SRDs and PI and did not see any warnings or precautions about giving Menactra with other vaccines but the nurse wanted to escalate to double check."  At the time of reporting, the patient experienced no adverse 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.
I received the third in the series of the Hep B vaccination on 12/10/15. This was required for nursing school. On the morning of 12/15, I was not feeling well, but went for my usual morning run. After that I worked from 7 am - noon and during that time developed fever of 101F with severe muscle aches, chills, and nausea. I took a final exam from 1 - 3 pm, then went home to try and sleep it off because I had another exam scheduled for 12/16. I took something for the fever and it didn't go away. Took an ibuprofen before bed which relieved some of the pain, and went to bed at 2000, but then woke around midnight with the worst stomach pain I have ever felt. It was burning across my abdomen and I was nauseated, sweaty, and clammy all at the same time. I thought if I could get to the bathroom to get an antacid it would help. I could not get to the bathroom and laid on the floor for an hour until the pain traveled to the center of my chest with shortness of breath and pressure in the center of the chest. I called for my husband and he got me an antacid which did nothing. He called 911 and I was taken to hospital with very low blood pressure. My bloodwork showed elevated bilirubin, I had low potassium, and a CT scan showed acute appendicitis. On 12/16 they removed the appendix, but my bloodwork got worse. I was anemic, had very low platelets, and very low WBC count. The bilirubin normalized, but the other liver enzymes increased 6 times normal values. My potassium remained low. The appendix was inflamed in the middle, but fine on either side - not a "typical" appendicitis attack. I still had low potassium, and then developed liver pain. I got out of the hospital on 12/18, but still have pain and have to follow up with many doctors regarding this. The doctor mentioned "autoimmune" as a possibility and that is scary to me because before this I was totally healthy.