chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very sore arm). At the time of the report, PAIN IN EXTREMITY (very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
This spontaneous report was received from a pharmacy intern regarding 3 patients of unknown demographics. There was no information about concurrent condition and historical medication. On one of the following dates 14-MAY-2016, 28-MAY-2016 and 26-JUN-2016 the patients were vaccinated with improperly stored VARIVAX lot # L024255/ expiration date-01-JUL-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
NO ADVERSE EVENT - GIVEN OUTSIDE OF SCOPE.    Patient registered for vaccine under DOB making her 18 years of age and eligible for the Moderna vaccine.  However, when filing paper eligibility attestation form, pharmacist noticed a different DOB.  Patient confirmed her DOB and her age of 17.  Parent and primary care provider were informed of the error.   Patient intends to return for her second shot where she will be 18 years of age.
patient that received 2 FLUZONE QIV NP injections within 2 weeks with no reported adverse event; Initial information received on 01-Nov-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 55 years old male patient who received 2 Influenza Quadrival A-B Vaccine [Fluzone Qiv] injections within 2 weeks with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Covid-19 Vaccine (Covid-19 Vaccine) for Prophylactic vaccination.  On an unknown date, the patient received 0.5 ml total (1X) of suspect Influenza Quadrival A-B Vaccine Suspension for injection (with an unknown strength, expiry date and lot number) via unknown route in unknown administration site for immunisation.  On an unknown date, the patient received 2 Influenza Quadrival A-B Vaccine injections within 2 weeks with no reported adverse event (extra dose administered) (latency: same day).  It was reported, Caller sated she needs to inform her manager so is asking if we can reach back out to her today. Caller is asking for recommendations regarding a patient that received 2 Fluzone QIV NP injections within 2 weeks. She stated when she went to administer the shot today, the orders were in the computer for it, but after it had been given, the orders were changed to the Covid vaccine. The patient did not speak up until after the shot as well that he had already received the flu shot last week. The provider stated the patient was fine, and the patient still wants to receive the Covid vaccine, but the nurse is requesting guidance or recommendations regarding the situation. Asking if there are any AEs the patient or provider needs to be aware of. Caller stated that when we call back it will go to a call center. The nurse clarified that when he received the extra dose of the flu shot, after it was realized he actually wanted the Covid vaccine, he did receive the Covid vaccine that day also.  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.
Patient had complaints following her flu injection of severe left shoulder pain present for a month prior to seeking treatment.  Unable to lift her arm without significant pain.  Affected daily activities.  Went to see an orthopedic who diagnosed her with Lt subacromial bursitis with secondary rotator cuff dysfunction secondary to post flu vaccine reaction and likely high placement. She was given a steroid injection with significant pain improvement.
Pt reports feeling dizzy, states she did not eat. Denies reactions to past vaccines. Patient frank coffee. Patient was monitored, given water, denies needing to go to hospital. Vital signs monitored. 108/86 BP, 18 RR, O2 Sat 98%, HR 77.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition and medical history of the patient was not provided. Concomitant medication included properly stored sterile diluent (manufacturer unknown). On 18-JUL-2017, the patient was administered a dose of improperly stored VARIVAX (lot # N001528, expired date 13-JAN-2019; dose and route were not provided) for prophylaxis. The vaccine was exposure to temperature excursion (range of 6 Fahrenheit degrees to 14 Fahrenheit degrees) for 12 hours. There was no previous temperature excursion. The dose of VARIVAX was reconstituted with properly stored sterile diluent (lot and expiration date not reported). Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA009098: US-009507513-1707USA008903: US-009507513-1707USA009099: US-009507513-1707USA009100: US-009507513-1707USA009101.
This spontaneous report as received from a pharmacist refers to two female patients of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX. Concomitant medications were unspecified. On an unknown date the patients experienced swelling and redness around injection site after receiving ZOSTAVAX. The outcome of swelling and redness around injection site was reported as recovered. The causality was not reported. The patient sought medical attention (spoke to pharmacist). Additional information has been requested.
Myalgias - immediate in arm, then spread to rest of body of the next day. Weakness also. Joint pain, chills.
received the first dose / in August 2020/ had not received dose two of Shingrix; This case was reported by a physician and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2020). Concomitant products included TOZINAMERAN (PFIZER COVID-19 VACCINE (BNT162B2)).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. A patient roughly in his late sixties, received the first dose of Shingrix. In this patient, COVID vaccination was prioritized, the last dose of Pfizer´s vaccine was administered a week before this report.  The patient had not received the 2nd dose of Shingrix, which led to incomplete course of vaccination  No further information reported. Reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018069003:same reporter
Several seconds after administering vaccination, patient became limp and fell forward onto this nurse. Patient was sat back up but fell forward again. No response from patient when being spoken to. Patient was laid back onto exam table when she became very stiff and began to twitch for approximately 10 seconds. When episode was complete, patient stated she had no recollection of what had happened. Dr. made aware of what had happened before examining the patient and giving the all clear for her to leave after the 15 minute window was up.
This spontaneous report was received from an unspecified healthcare worker, who was also the patient's mother, via company representative and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, reported as "several years ago", the patient was vaccinated with VARIVAX injection for vaccination (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown dates, reported as "since then", the patient had experienced seizures. It was stated that the patient was seen by an unspecified neurologist, however, it was unknown if any treatment was provided for the event, as well as, if the neurologist's visits started prior or after vaccination with VARIVAX. At the reporting time, the patient had not recovered from the seizures and the reporter did not assess the causal relationship between therapy with VARIVAX and the event. Upon internal review, seizure was determined to be a medically significant event.
Onset of headache, nausea & vomiting after eating fruit & drinking hot tea. Laid down when nausea came on, and immediately vomited. By the next day I noted the arm was very sore, with a tennis-ball-size red inflammation around area of shot. For two days I remained in bed, taking only liquids, chicken broth & juice. Sinus headaches came on during night, for which I took aspirin, then Aleve. On April 24 in the evening I took first solid food, and took a Benadryl capsule.
A few minutes after pt given flu shot came back to pharmacy saying "somebody help me" asked her if she was having difficulty breathing stated no and passed out. Pt came to a few minutes later. EMS was called and took her to hospital. Called to ck on pt and was fine. Stated this happen sometime when nervous.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-JUL-2015, the patient was suppose to receive a dose of (Oka/Merck) PROQUAD, (dose, route of administration, injection site, lot number and expiration date were not reported) but instead was vaccinated with a dose of M-M-R II (dose, route of administration, injection site, lot number and expiration date were not reported). No symptoms were reported. Additional information has been requested.
Began experiencing fatigue and brain fog within 6 hours of receiving the vaccine. 16 hours after receiving the vaccine, began to experience chills and had a fever (not measured). Took acetaminophen. 24 hours after receiving the vaccine, measured a fever of 99.8 C. Took ibuprofen. 36 hours after receiving the vaccine, still had a temp of 98.9 C. 52 hours after receiving the vaccine, currently experiencing ?COVID arm? (redness at injection site, swelling, painful to touch, small bumps appearing).
soreness on arm; weakness; nausea; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (soreness on arm), ASTHENIA (weakness) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness on arm), ASTHENIA (weakness) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (soreness on arm), ASTHENIA (weakness) and NAUSEA (nausea) outcome was unknown. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment medication provided.
Nauseated, nose felt numb for a few minutes - she thinks it's due to neomycin in vaccine?  She had same vaccine last year.
Sore nose and stuffiness followed by extreme fatigue, achiness and headaches.  Axtually, the headaches started 10/20/2010.
Fever of a 104 degrees Fahrenheit / Intense fever for 24 hours, side effects lasted 48 hours; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever of a 104 degrees Fahrenheit / Intense fever for 24 hours, side effects lasted 48 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever of a 104 degrees Fahrenheit / Intense fever for 24 hours, side effects lasted 48 hours). At the time of the report, CHILLS (Chills) and PYREXIA (Fever of a 104 degrees Fahrenheit / Intense fever for 24 hours, side effects lasted 48 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 degrees Fahrenheit.         Concomitant medications was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Information has been received from a health professional concerning a 7 year old male pt who on 26-JAN-1998 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approximately 23-APR-2004, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that "there was no single report of adverse reaction following varicella vaccination". The reporter indicated that 49 other patients developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, and WAES0405USA00619). No additional information is expected.
Patient received two doses of varicella on the same day. On 8/5/21, mother was contacted and states that after vaccination the patient has fever and could not stand being touched at the site of injection. From 8/4/21-8/5/21 the mother reports that no rash has appeared, but that patient has been looking sad and feeling hot. Mother used OTC pain/fever medications to help.
After receiving Influenza vaccine employee developed swelling and redness at injection site.  Then developed hives, headache, inner ear itching, elevated BP and heart rate. She went to the Emergency Department that night.  Her symptoms were resolved the next day when contacted except for some grogginess.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a physician and described the occurrence of vaccine exposure during pregnancy in a 31-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   Concurrent medications included Iron salt (Iron), Vitamin D, Prenatal vitamins and Docusate sodium (Colace).   On 24 August 2011 at 09:30 the subject received a dose of Boostrix (details unknown), and experienced vaccine exposure during pregnancy.  The subject received the vaccine during her 32nd week of pregnancy.  The estimated delivery date was 16 October 2011.  Date of last menstrual period was not provided.   Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
Rigors, low grade temp (99.7), body aches, headache, and nausea.   From approximately 0100 , fever broke about noon.
Left upper arm red & warm. Circumference measures 2 cm larger than unaffected arm. Redness extends 15 cm up from anti cubital. He received the shot on 3/25/13 at 315pm. States it began to throb last evening. Reported at 1100 on 3/26/13 with symptoms. Given BENADRYL 50 mg IM.
Patient's arm was red and inflamed near injection site. She described pain and discomfort. Recommended ice and acetaminophen.
Staff worker reported shortness of Breath/Labored breathing, lightheadedness/dizziness after approximately 7 minutes of receiving vaccine. Patient received Epipen injection and paramedics were called to transport her to hospital.
Pt with wheezing, coughing, tongue swelling and shortness of breath immediately after receiving second covid vaccine. Seen in holding bay and oxygen noted to be 97-99. Audible wheezing, tripoding, throat itching, mucosal swelling (tongue throat). Albuterol given x 4 Given epi injection 0913. EMS arrival 0919 and given neb albuterol and taken to ER.     bp 138/78, HR 80's, o2 sats remained high 90s
Approximately 2-3 hours after injection I developed swelling in my throat difficulty breathing with wheezing and tightness in chest. Swollen and red eyes, chills, headache and rash on my back. Fever of 99 prior to going to the ER. I received a breathing treatment and oral prednisone along with TYLENOL. Started breathing better and sent home with prescription for oral prednisone and a albuterol inhaler.
administered the Moderna Covid-19 vaccine which was beyond the 6 month expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine which was beyond the 6 month expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2022 at 1:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine which was beyond the 6 month expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine which was beyond the 6 month expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.  It was the patient's booster dose. Manufacturing date of Moderna Covid-19 vaccine  was reported as 24-Aug-2021
Painful, right upper eyelid swelling which has lasted 6 1/2 months, continuing to the present time.
Employee very anxious about vaccines in general. Pt started having tingling down left arm, tingling underleft arm, down left side of rib cage then down left leg. At same time tingling and facial numbness. HR-96. Pt states she is ok. We decided to take her to the ER via W/C and was given Benedryl. No other problems.
Information has been received from a nurse in a hospital via a registered pharmacist concerning a 63 year old male with codeine allergy who was vaccinated with Pneumovax 23.  Subsequently the patient experienced hives.  The nurse wanted to know if she should vaccinate the patient with influenza vaccine if the patient had hives in the past after received Pneumovax 23.  Unspecified medical attention was sought.  No further information is available.
Information has been received from a certified medical assistant concerning a 22 year old female with a history of removal of condylomas/genital warts, and a family history of breast cancer, who on 02-APR-2008 was vaccinated IM in the left upper quadrant of the thigh with a dose of GARDASIL (Lot# 659437/1266U). Concomitant therapy included PROVERA. On 04-APR-2008 the patient felt ill, feverish and achy. On 05-APR-2008 the patient developed a rash and swollen joints which were painful. The patient went to the emergency room and it was suspected that the patient had chicken pox, which was later ruled out. At this time the patient was not admitted to the hospital. On 09-APR-2008 the patient was admitted to the hospital for possible inflammatory arthritis, possible lupus, or possible rheumatoid arthritis. The patient experienced nausea, vomiting, and a rash with myalgia and arthralgias. Other symptoms included swelling and aches in her joints, elevated liver enzymes, fever, malaise, body aches, a rash over her trunk, arms, and legs, and an immediate weight gain of 20 pounds. It was unknown when the weight gain actually started. Rheumatoid studies were conducted. The patient's phosphatase level was 283 and her Creatinine reactive protein test was high. The patient's electrolytes, glucose, and abdominal ultrasound were normal and the blood culture was negative for infection. The patient was treated with intravenous fluid, intravenous pain medications, SOLU-MEDROL and MOTRIN. The patient was admitted to the hospital for three days and discharged with a diagnosis of a possible reaction to the vaccination. It was reported that there was a 75% resolution of acute symptoms with the use of SOLU-MEDROL and MOTRIN. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Redness and swelling of upper arm with 4cm indurated area. Treated with Benadryl, cool compresses, and Augmentin.
Systemic: left hand swelling resolved after 30 minutes-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: left hand swelling resolved after 30 minutes
Patient developed fever and chickenpox rash within 48 hours of receiving vaccination. Patient was sent to hospital and was diagnosed with chickenpox. The patient is being follow up by his physician.
This case was reported by a lawyer and described the occurrence of shortness of breath in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unknown time after vaccination with Lymerix, the subject experienced shortness of breath, fatigue, general malaise, rash, rheumatological symptoms, neurological impairment, cognitive impairment and autoimmune disease. The subject died. The cause of death was not reported. It was unknown whether an autopsy was performed. This information was received via a statement of injuries.