chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 62-year-old female patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2020). On 1st February 2018, the patient received SHINGRIX .5 ml. On 1st February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema (serious criteria other). The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site erythema was unknown. The reporter considered the injection site erythema to be almost certainly related to SHINGRIX. Additional details were reported as follows: The healthcare professional stated they have administered SHINGRIX to their first patient the day before reporting and on the day of reporting the patient called to state she had quarter size red area at the injection site. The reporter advised the patient to monitor the area and call MD if worsened. The reporter called to ask if this was a usual reaction or was there anything else recommended to do.
Sore and tight in left arm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old adult male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: UNKNLOWN), via an unspecified route of administration in the left arm on 07Mar2021 at 14:45 (at the age of 31 years old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included fluticasone(ARNUITY ELLIPTA) for unknown indication from unknown date. The patient did not have known allergies to medications, food, or other products. 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. On 09Mar2021, the patient experienced sore and tight in left arm (where injection was received) on the underneath side of the arm, spanning from bottom of armpit to elbow. No heat or swelling, just a dull and uncomfortable sensation. The patient underwent lab tests and procedures, which included COVID-19 Virus test on unknown date and resulted negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported event. The clinical outcome of pain in arm was recovering.   Information about lot number cannot be obtained. No further information is expected.
Next morning significant all over body ache, significant chills, etc. felt like I had a severe flu.  Temperature normal.  It just sucked, but not unexpected.  Severe first day, was 'useless'.  Abated over next few days.
09/06/2023: RN administered 0.5 ML Moderna Bivalent COVID-19 Vaccine to patient during scheduled Nurse Visit today @ 2:08 PM. Patient is 5Y 9M old and per CDC Guidelines should have received 0.25 ML dose of Moderna Bivalent COVID-19. Dr. notified of error. Medical Manager notified of error.   Attempted to contact patient's Mother to inform her of administration dosage error. No answer. Unable to leave message as voicemail not set up. Will attempt to contact Mother again at later time.  09/07/2023 09:21:13 AM >  Spoke to patient's mother. Informed her of COVID-19 Bivalent dosage error. Asked mother if patient experiencing any side effects from vaccination. Mother reports that the only thing patient complained of was that his arm was sore where he received his vaccination. Mother denies patient having any redness, swelling, or rash to injection sites. Mother denies patient having any other side effects from vaccination.  Mother states that patient went to school today. Reviewed with mother that patient could experience increased general side effects of COVID vaccination as a result of higher dose administered including: soreness, redness & swelling at injection site, muscle/joint pain, headache, fever, nausea, vomiting, rash, loss of appetite. Reviewed signs & symptoms of severe allergic reaction with mother. Advised mother to contact Clinic if patient experiences any concerning side effects. Reviewed emergency precautions with mother and advised if patient experiences any emergent symptoms or severe allergic response to go to ER immediately for evaluation. No further questions or concerns.
THE SYRINGE WAS DEFECTIVE; 0.1 ML OF VACCINE WAS GIVEN DUE TO DEFECTIVE SYRINGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .1 ml, administered on 29-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAY-2021, the subject experienced 0.1 ml of vaccine was given due to defective syringe. On an unspecified date, the subject experienced the syringe was defective. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 0.1 ml of vaccine was given due to defective syringe and the syringe was defective was not reported. This report was non-serious.
Five months of impaired vision (4/23/21 to present) as doctors didn't recognize my eye inflammation - including a torn cornea --was a side effect of the vaccine. The clincher was was my third shot (booster) on 8/27/21. Five days later, I was back at the doctors office getting yet another prescription for eye inflammation. My symptoms match those in the new study. I checked "disability/permanent damage" below because I still have blurry vision now, despite glasses and even though cornea healed.
Information has been received from a physician concerning a 33 year old female pregnant (17 weeks) patient with a history of VARICELLA at age of 11.  On an unknown date, the patient's son was vaccinated at age of 7 months with VARIVAX (Oka/Merck).  The physician reported that 19-OCT-2008 the patient developed a generalized rash involving her abdomen (bilateral), neck and hands.  No rash on face or scalp.  It was reported that there was never a ZOZTERIFORM distribution, so if it was ZOSTER, it was generalized and began that way.  It was reported that the patient had been seen by 4 dermatologists and the leading clinical diagnosis by them was ZOSTER.  The physician felt that the patient's rash was not typical of VARICELLA, mainly because of the odd distribution.  The patient's rash was not typical of VARICELLA, mainly because of the odd distribution.  The patient's lesions were not typical either.  The physician thought it was a rickesttsial infection.  A culture of HSV was performed and the result was negative.  Several biopsies were made and they didn't seem to be characteristic of anything.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated wit the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  Follow-up information was received with reported that there was odd looking "scabs" on the patient.  The sample was inadequate.  Follow up information was received through the VARICELLA ZOSTER Virus (VZV) identification program.  On 31-OCT-2008 a sample was collected for PCR but was INADEQUATE and no strain was identified.  On 14-NOV-2008, the patient was seen by other physician and all lesions was resolving.  The physician diagnosed Mucha-Habermann disease, a parapsoriasis of unknown cause.  The physician requested a biopsy that showed giant cells, not multinucleated.  The physician did not think this is a disease of pregnancy.  This is one of 2 reports from the same source.  Additional information has been requested.
hives; This case was reported by a consumer and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. Age group was captured as adult as per product indication. The reporter reported that are hives after Shingrix normal. Due to insufficient information hives was consider as event.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
gave an expired tenivac dose staff misread the expiration date as it was expired on 24jun2023 with no reported adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 26-years-old male patient who was given an expired diphtheria-2/ tetanus-5 adsorbed toxoids no preservative adult [Tenivac] dose as the staff misread the expiration date as it was expired on 24jun2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Sep-2023, the patient received 0.5 mL expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, suspension for injection (strength: standard) (batch number: unknown; expiry date: 24-Jun-2023) via intramuscular route in the left arm for Immunization as the staff misread the expiration date with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt was fine after 15 minute wait in pharmacy and left. she purchased front store item and seemed dizzy. pt was given water and stayed in store 15 minutes more. pharm tech escorted her to her car. Tech told her to wait before leaving and provide her with gatorade and crackers. 10 minutes later pt was fine and wanted to leave. Tech had her walk around her car to prove she was stable. pt left. 45 minutes later we were called by urgent care stating the pt had fallen asleep driving, but
Expired vaccine received; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 3:17 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine received). On 24-Sep-2021 at 3:17 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications provided. Patient has never tested positive or been diagnosed with COVID-19.  The patient did not have any adverse events and did not require any medical attention after getting the dose. No problems reported from patient.
p/recv vax pt exp soreness in shoulder w/bruising; soreness in medial aspect of elbow but now almost gone, remain w/bruising & 2'' yellowing are around lt arm
Patient was initially presented on 12/12/2021 with a chief complaint of worsening shortness of breath after diagnosed to have COVID-19 infection on 12/9 prior to coming to the hospital.  Patient also reported low-grade fever and has been using nebulizer breathing treatment with some relief of the shortness of breath.   Upon evaluation in the ED BP was 115/55, heart rate 107 respiratory rate 20 for temperature 99.3° and SpO2 92% in room air.  Patient noted to be in atrial fibrillation an EKG confirmed.  Lab work abnormal for elevated ferritin of 632, LDH 259, elevated CRP of 7.34 and D-dimer of 855. Procalcitonin and troponin are unremarkable.  No evidence of leukocytosis and creatinine was 1.0.  Chest x-ray reported prominent vascular hila and prominence of bronchovascular and interstitial markings with ill-defined patchy parenchymal opacities in bilateral mid and lower lung fields concerning for patchy airspace disease.     Patient was subsequently admitted for further evaluation and treatment for acute respiratory distress with atrial fibrillation with RVR and COVID-19 pneumonia.  Patient was placed on oxygen via nasal cannula. Patient completed Remdesivir and 5 days of Decadron therapy. Home oxygen evaluation revealed patient would require continuous oxygen.  Patient remained stable and was discharged at stable condition
Red mark appearing at site of injection 12 days after vaccine, slightly itchy, 1.5inches wide, 1 inch long.
Patient reported to PCP office with erythematous raised papules, some crusting, on right side of chest PCP diagnosed as shingles. PCP recommended cool/wet compress and caladry lotion to help with the itching.
a few weeks afterreceiving vaccines, I started feeling tired, noticed in february, became so bad pain in my hips, knees somedays i just lounged around not even leaving. it became  my home. I couldn't sleep thru the night due to the pain in  my hips, became increasingly hard to navigate  the stairs in my home.  It became less severe approximately in May ,helped by pain medication. At times I seem to have spasms in my hips , bone pain also.
After the first shot, August 18, 2016 she started to notice something randomly but after the second shot on August 29, 2017 she noticed that weird something was happening more often.  A few months after the shot, pt started to tell me something weird keeps happening to me.   She said her friend had noticed something weird happens to her too.  I still hadn't seen anything.  I tried to have her explain to me what was happening but  she couldn't.   It happened more frequently in the mornings.  Then on the day before Thanksgiving 2018 (over a year and a half after she was telling me something weird was happening) I saw it happened.  Pt had a seizure right in front of me.   It was a small seizure and from then we saw them often.   Doctors said she had absent seizures and started her on meds.   Within a few weeks they turned into Grand Mal Seizures.  Pt could not attend school from that Thanksgiving.   She was a very active child involved in sports and after school activities and her whole life stopped.   One of the seizures was so bad the Ambulance had to bring her to Hospital.   The meds have not cured her situation yet.  We are continually working on finding a way to stop the seizures and for  to go back to her normal life.   She took a sleeping test and it showed 29 mini seizures in 1 1/2 day period.   This is a child that NEVER had any problems until the HPV shot was given.
While getting child dress after shots, mother  noticed red rash on forehead top head.   patient was seen by physician and was   watched in office  for.  20min.  at that   time  Rash had almost disappeared.   no breathing issues. 10.-28-21  checked on Pt. No Problems.
Information has been received from a RN concerning a pt (age and sex not reported) who on an unspecified date was vaccinated with hep A virus vaccine inactivated (lot651877/0705R). In Feb 2006, the pt experienced severe headaches and was vomiting within a few hours of receiving their first dose of hep A virus vaccine. The pt sought unspecified medical attention. Subsequently, the pt recovered from severe headaches and vomiting. Follow up information was received from the RN. The pt was a nine yr old female student with no illness at the time of vaccination and no preexisting allergies, birth defects or medical conditions, and no history of adverse event following prior vaccinations. On 07Feb06 at 10:30AM, the pt was vaccinated with her first dose of hep A virus vaccine inactivated (lot651877/0706R), IM in left arm. The pt had a headache and one episode of vomiting on the evening of vaccine given (onset time 8:00PM). No headache or vomiting after going to sleep that night. On 08Feb06, the pt recovered. She attended school the next day following the vaccination. No further information is expected.
Initial solicited report received from a consumer (online market research respondent) in the study on 09 September 2015. The subject (gender and age were not reported) received a dose of Influenza vaccine (manufacturer unknown) on an unspecified date (site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject reported that it was taken before and the subject did not like the reaction. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Severe muscle aches and chills, headache, and joint pain starting a six hours from injection, peaking at 13 hours after injection. Symptoms subsided by 24 hours after injection.
Patient described flu like symptoms (fever, aches and pains), patient also stated he has only slept about 4 hours a night since he has received vaccine. Patient states that he is still have these symptoms and he has had an adverse event from vaccine and wants to know who will compensate him for his bills and pain and suffering.
Breakthrough case admission after 2 vaccines Pfizer 3/29/21 Lot# EN6200;  Pfizer 4/26/21 Lot# Ew0164
This spontaneous report as received from a pharmacist refers to a 24 year old female patient. Medical history and current conditions were not reported. On an unknown date, the patient who was supposed to received (Oka/Merck) VARIVAX was inadvertently given ZOSTAVAX Vial 19400 PFU via an unknown route (dose was  not reported). Concomitant medications were not reported. No adverse effect was reported. Product quality complaint was not reported. Additional information has been requested.
No symptoms being reported from patient/ family; inadvertently received dose of Gardasil 9 in error as Prevnar 13 was ordered; This spontaneous report was received from a health professional (medical assistant) referring to a 4 month old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/ allergies were not reported. Concomitant therapies included diphtheria toxoid, hib conj vaccine (tet toxoid), pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) and rotavirus g1 p1 vaccine live (89-12) (ROTARIX). On 28-OCT-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) once, lot number 1614898 and expiry date 15-NOV-2021, (strength, route of administration and anatomical location were not reported) for prophylaxis in error, as PREVANAR 13 was ordered (wrong product administered). The reporter confirmed that it was a human error and not product confusion. No adverse events were reported. No product quality complaint (PQC) was reported.
Body aches, headache, chills and sore throat since pt got J&J vaccine on 11Apr2021. Took some tylenol this morning without relief. Patient is a 35 year old female who presents to ED with body aches, headache, chills, palpitations for 3 days. She received the J&J vaccine on 11 April. She denies any fevers, no cough, no chest pain.  She denies any vomiting, has been eating and drinking well. Some loose stools. No other sick contacts. She has a history of chronic sinusitis.
Fever, headache, stuffy nose, nauseous, sore left ear when swallowing, diarrhea, sore breasts, started my period after finishing my regular cycle a week prior, aches, sore ankles from Monday May 24th 7pm-today Thursday May 27th. I do not have fever, diarrhea,  sore ear, aches, or a stuffy nose today as of roughly 3:30 am this morning.
Information has been received from a physician concerning an 18 year old female with a history of nephrotic syndrome who on 11-JAN-2007, 16-MAR-2007 and 02-AUG-2007, was vaccinated intramuscularly with the first, second and third 0.5 ml doses, respectively, of GARDASIL (Lot # of the first dose 654702/0011U, Lot # of the second dose 656049/0187U). Concomitant therapy included LOESTRIN 24 PE and KENALOG. "2 months after the third dose", on approximately 02-OCT-2007, the patient experienced an exacerbation of nephrotic syndrome. The outcome of the patient was not reported. The patient did not seek medical attention. Additional information has been requested.
The next day, post vax, got cold, then teeth chattering chills; fever went up to 103F Saturday evening. I slept Sunday and my arm had turned very red from my elbow to my shoulder. It became extremely sensitive to touch. Finally on Monday, I got up at noon and went to see my doctor. Took about 4-5 to start recovering.
Severe vertigo since about 6 days after vaccine with accompanying tinnitus that is maddening. Vertigo intensity is subsiding, though still occurs. Tinnitus feels like it's getting worse. I did have a fever ranging from 100- 101 for about 18 hours after vaccine, with headache, lightheadedness (the latter which also occurred immediately after  vaccine)
PFIZER VACCINE ADMINISTERED AFTER DOSE EXPIRATION. MIXED DOSE EXPIRED 8/30/21 AT 9:30 PM BUT WAS ADMINISTRED 8/31/21 AT 10:42 AM.
Syncopal episode several minutes after flu shot in arm. Pt helped to floor by RN and mom. Juice given. Syncopal episode lasted seconds.
2 days after 2nd injection, taken to hosp by ambulance. Extremel weak and dizzy, Hemoglobin had crashed to 7.2 and Iron below normal range. Admiited to hosp was given 3 blood transfusions and 5 bags of iron. In hosp for 4 days. Rectal bleeding
Patient reported to feeling weak and ill two days following vaccinations. She said she had a headache and couldn't get out of bed. Also she said that she got red, patchy areas on her arm below the site of administration and reported some swelling as well. This is patient's second shot and she said that during her first shot she didn't experience any of these side effects.
He suffered a seizure. Shaking (entire body) Labored Breathing, Not responding. Called 911.  Taken to Emergency Room.