chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gets the first Shingrix/ in 2019 /waits until 2021 to ask for the 2nd; . This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019.).   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 for this report. The age group was not reported but was captured as adult as per vaccine indication. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist asked for the 2nd Shingrix shot do they need to start the 2 dose series over again or should they just get the 2nd shot after 2 years had passed and not worry about it anymore. The reporter consent to follow up.
Information has been received from a practice manager concerning a patient who was vaccinated with a third dose of VAQTA instead of the flu vaccine. It was reported the pediatric patient was difficult to control before vaccination and was accidentally vaccinated with VAQTA instead of the flu vaccination when the nurse was trying to restrain him.  The child was previously vaccinated with VAQTA in 2003 and 2004. There were no symptoms noted. A product quality complaint was not involved. Additional information has been requested.
Pt recvd vax about 1PM; By 5PM, had high fever & high pitched scream x 12 hrs; screaming on & off x 12 hrs; same duration-fever;
Patient experienced redness and hives 15 min. after receiving injection. Denies any swelling of lips or tongue. Patients vitals were taken BP 110/60,  Temp 97.3,  O2 98%,  P 70 Patient's sister gave her Benadryl 25mg. p.o.  15 min later patient returned to class. No hives or  redness was present.
Flare of rheumatoid arthritis in hands and elbows; Muscle pain/muscle hurted in arm; Hand pain; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from company manufacture number (21K-163-4140354-00).   A 67-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on Mar2021 (Batch/Lot number was not reported) as dose 1, single, dose 2 intramuscular on Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation, age at vaccination was 66 years; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date at Citrate Free for moderate to severe rheumatoid arthritis.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced flare of rheumatoid arthritis in hands and elbows, muscle pain/muscle hurted in arm, hand pain. Clinical course: Solicited report by a consumer of an elderly male with events of non-serious Muscle pain/muscle hurted in arms, flare of rheumatoid arthritis in hands and elbows and hand pain with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced Muscle pain/muscle hurted in arms, flare of rheumatoid arthritis in hands and elbows and hand pain. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Mar2021, he received first dose COVID-19 Vaccine manufactured by Pfizer. In Mar2021, Received second dose COVID-19 Vaccine manufactured by Pfizer. Causality for HUMIRA (adalimumab) The reporter's causality for the events of Muscle pain/muscle hurted in arms with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of flare of rheumatoid arthritis in hands and elbows and hand pain was not provided. The action taken in response to the events for adalimumab was unknown. The outcome of event rheumatoid arthritis in hands and elbows was not recovered, of other events was unknown. Causality between Pfizer Biontech Covid-19 Vaccine (Tozinameran) and events flare of rheumatoid arthritis in hands and elbows, muscle pain/muscle hurted in arm, hand pain as per reporter was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Rheumatoid arthritis, Myalgia, Pain in extremity and the suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt has had a headache, right eye blurriness, difficulty with deep breathing, and loss of taste since getting the vaccine.  No meds were given prior to being seen by me on 12/1/21.  I advised giving tylenol/motrin for pain if needed.  I contacted Peds ID to discuss the case and referred to Ophthalmology and Neurology.
Narrative:  Patient called primary care to report he developed a rash and itching 3-4 hours after first dose of Pfizer COVID-19 vaccine at outside facility (pharmacy). Rash was not painful. He was advised to report to an emergency department for evaluation of the reaction, but patient was not concerned and stated he would go if his condition worsened.
Lymphatic pain and swelling. Initially swelling in lymph node of arm of injection, then moved to head and neck lymph nodes. Swelling is intermittent, and unpredictable. When lymph node hurts, covid symptoms of nausea, fatigue, brain fog, headache, muscle/body aches appear. When swelling goes down, symptoms disappear. Pain in lymph node is severe at times.   Have used NSAIDS and ice packs on swelling. Initially this mitigated symptoms significantly. On day 6 and 7 after vaccine, medication and ice did not mitigate swelling or symptoms for the majority of the day and night. Today is day 8 and have had less frequent and less severe symptoms. When lymph node is not swollen, I have no symptoms besides some muscle soreness that is remedied by a muscle rub.
patient with soreness and scarred patch that looks like leather at the injection site; patient with soreness and scarred patch that looks like leather at the injection site; scarred patch; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-AUG-2022, the patient received the 2nd dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced injection site pain (Verbatim: patient with soreness and scarred patch that looks like leather at the injection site), skin scarring (Verbatim: patient with soreness and scarred patch that looks like leather at the injection site) and patchy rash (Verbatim: scarred patch). The outcome of the injection site pain was not resolved and the outcome of the skin scarring and patchy rash were unknown.   It was unknown if the reporter considered the injection site pain, skin scarring and patchy rash to be related to Shingrix.     It was unknown if the company considered the injection site pain, skin scarring and patchy rash to be related to Shingrix.   Additional Information: GSK receipt date:02-AUG-2023 The pharmacist called to get instructions how to care for patient with soreness and scarred patch that looks like leather at the injection site. The patch was about 1.5cm x 1cm oval-shaped. The patch began to appear about 1 month after receiving her 2nd Shingrix injection. The call was transferred call to Medical Information department after gathering Adverse Event details. The reporter consented to follow up.
Information has been received from a physician concerning a 73 year old female who on 05-SEP-2006 was vaccinated SC in the right arm  with a dose of ZOSTAVAX (Lot# 652965/0622F). Subsequently the patient developed paresthesia. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information was received from the physician. This 73 year old female with sulfonamide allergy, latex allergy, irritable bowel, migraine, shoulder pain, osteoporosis, diverticulosis, back pain, cholesterol high, hypertension, hiatus hernia, oesophageal reflux and caffeine and a history of hysterectomy, colonoscopy and cholecystectomy was vaccinated SC in the right arm on 05-SEP-2006 with a dose of ZOSTAVAX (Oka/Merck) (Lot# 652965/0622F). Concomitant therapy included RESTASIS, NORVASC, FLONASE, calcium (unspecified) (+) vitamin D (unspecified), aspirin, ESTRACE and glucosamine. It was noted that the patient was seen for a scheduled follow-up visit on 26-JUL-2007. At that time she indicated that she had lower back and hip pain, she also had stiffness in those areas. It was noted that her back pain was severe and "began when she was on the floor". The pain increased with sitting in a chair but would go away with laying. The patient's hip pain began in the left hip and then the right hip was bothering her. It was also noted that she had burning pain of her back that began after vaccination. The pain shot across both scapulae then gravitated to the upper back area. This was not associated with a prolonged rash but an initial rash. At the time of the office visit there were no rashes. The patient also had hot flashes that would come and go. The patient was prescribed PRAVACHOL and alendronate sodium (MSD). The patient was also scheduled to have an MRI of the thoracic and lumbar spines. On an unspecified date the patient recovered. Additional information has been requested.
Elevated heart rate-resolved quickly; flushing feeling; potential throat swelling (felt like lump in throat), no airway compromise.
Patient developed a fever. This am he vomited x1 and had a near syncopal event.
My cheeks have  been swollen for a week as are my eye lids. I hope  it goes away.I had chills,sweats,headache and fatigue with both shots. I was in bed for a day after the second shot. none, spoke with a Dr. in my PCP office who recommended I contact you.
Patient received vaccine around 1230 and was sitting in chair by father. started to feel odd, dad went to get a bottle of water, at 1235 patient fell forward out of chair and landed on arms, chest, and face. pharmacy staff saw patient fall and rushed out to assist him, patient came back to consciousness within seconds. he had a red mark on side of face and was disoriented. he was given bottle of water and started to feel better immediately. Emergency services was called as soon as he fell, patient was able to rest against chair and then moved up into the chair upon his request. he began to have some ringing and pressure in the back of his head but it subsided shortly after. Emergency services arrived and took over the scene, patient was A&O x3, then patient was monitored and vital were collected. patient elected to travel to the ER with parent rather than emergency services.
Pt received Pfizer 57-117 vaccine in error. No noted adverse side effects.
Mother brought child back to the office on Nov 18, 2011. Mother states child got gastroenteritis viral because of the flu shot. Child got diarrhea on Nov 17, 2011.
The patient is a 89 y male with past medical history of atrial flutter, type 2 diabetes mellitus, chronic obstructive pulmonary disease and macular degeneration  who was admitted on 11/16/2021 because of complaints of fall.  Patient apparently got up to use the restroom and stumbled and fell and hit a dresser. He also reported generalized weakness couple of days prior to admission.  Workup in the ED showed COVID-19 positive.  Labs showed elevated CRP, D-dimer but normal ferritin and negative procalcitonin.  Chest x-ray did not show any acute pathology.  Patient reported left flank pain secondary to hitting the drawer, CT abdomen pelvis did not show any acute pathology.  Patient had spiking fever during hospital stay.He later became hypoxic requiring 2 to 4 L and was started on Decadron. Patient improved and was weaned off O2. Patient however was very weak and therapies recommended post acute. Hospital stay was extended due to facilities requiring 10 day isolation which patient finished here. Arrangements were made for patient to go to nursing facility.
vaccinated at Hospital on 1/12/2021.  According to patients father she developed stomach pains, constant vomiting, sweating which started at  approx. 4am. She arrived at Medical center at approx. 7:20 stating she had been vomiting since 4am.  Attempted PO fluids while in ED. Uncontrolled nausea persisted despite medication. Admitted to Hospital for observation for uncontrolled nausea. IV fluids given
Patient called and spoke to RPH on 09-25-19 about a red, hard, hot-to-the-touch welt that appeared on her arm following her vaccine on 09-24-2019. She was told to take ibuprofen and apply a cold compress to the area. If the reaction did not resolve, she should contact her provider. RPH spoke with the patient on 09-29-19 and she stated that the ice and ibuprofen appeared to work and the reaction had alleviated. She did not contact her md about the reaction.
The pt experienced erythema at injection site. The pt also experienced warmth and tenderness to the touch.
My parents live with my family of four. My father was exposed to COVID when he was in the hospital from 1/19-1/21 getting his hip replaced.  My mother and wife lost their sense of smell on Sunday 1/24. They got rapid and differential PCR tests on Tuesday 2/2. The rapid test came back positive for both of them. I served as primary care provider for all four of them during their illness.  I started to experience mild symptoms on 2/13. Symptoms included: reduction in sense of taste and smell (could not smell cinnamon or taste spicy foods), headaches, runny nose, waves of nausea.   I went to an medical center on 2/16 to receive the Rapid, PCR, and flu differential tests. My Rapid test came back negative but my PCR test came back positive on 2/17.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # J006358, expiry 23-MAY-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on n12-APR-2014 and the (Oka/Merck) VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated (Oka/Merck) VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
headache.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021 at 8:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HEADACHE (headache.). At the time of the report, HEADACHE (headache.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant product is not provided. Treatment is not provided.
Received vaccine at 3:00. Around 5:30 noted blisters on tongue, mouth, states felt like the blisters were going down her throat. At bedtime noted improvement; took Benadryl. No respiratory distress by AM: blisters resolved. Also noted constipation.
Felt bad that night. Next morning I woke with 103 temp, confused, extreme weakness,  passing out. Extremely low blood pressure. Went by ambulance to hospital for a 4 day ICU and hospital stay.  My diagnosis was determined to be Addison Crisis due to the 2nd moderna covid vaccine.
Patient fainted about 5 minutes after getting vaccine.  He gained consciousness right away.  He complained of heart palpitations, sweating, hand tingling, and nausea.
Severe right arm pain initially, about 8 hours post infection. Body aches, profound fatigue, chills and dizziness starting 10 hours post injection and persist entire next day.
neither she nor her husband could wake up their son for school; Her son was not coherent this morning; This is a spontaneous report from a contactable consumer (parent) or other non hcp.  A 15-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EW0171, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 21May2021 16:00 (at the age of 15-Years-old) as dose 1 single for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines Administered on Same Date of the Pfizer Suspect. AE not resulted in visit to emergency room or physician office. No AE following prior vaccinations. No family history relevant to AE provided. The patient experienced neither she nor her husband could wake up their son for school and her son was not coherent this morning on 25May2021. Caller stated her 15-year-old son received the first dose of Pfizer's COVID vaccine on Friday, 21May2021 with no symptoms, fever, or discoloration. Caller stated, my son has been sleeping for the last 13 hours (he slept at midnight). This morning we could not wake him up for school for 3 hours. patient mother said her son had no symptoms after receiving his first COVID-19 Vaccine, but on 25May2021, neither she nor her husband could wake up their son for school. She said her son was just getting up now after 1:00PM. She said both she and her husband tried to wake their son up over a couple hours, and it was impossible to wake up their son. she wanted to know if what her son experienced was related to the COVID-19 Vaccine, and if there were any other symptoms she should watch for. she said she and her husband tried waking their son by taking down their son's blankets and shaking him. She said her son was not coherent this morning. She said neither she nor her husband were that concerned that their son was in danger because their son was breathing fine and had no fever. Caller was advised she would be transferred for further assistance. Reported her son had some diagnostic testing coming up on Thursday (27May2021) for ADHD, or anything else with that. she felt that her son's ADHD testing was more adolescent related. No further details provided. Reported her son woke up after 1:00PM and came out of his room to ask to use his phone, and then he went back into his room. No relevant tests were reported. The outcome of the reported events were recovered.  Follow-up (26Jul2021) No follow-up attempts are possible. No further information is expected
Pain and reduced range of motion in arm that received injection.; Pain and reduced range of motion in arm that received injection; body ache; fatigue; joint pain; fever; naseau; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included allergic to coconut. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 14:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021 at 09:00, the patient experienced pain and reduced range of motion in arm that received injection, body aches, fatigue, joint pain, fever, nausea. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain and reduced range of motion in arm that received injection, body aches, fatigue, joint pain, fever, nausea were not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. On 12-AUG-2015, the nurse reported that the patient possibly received a dose of improperly stored VARIVAX (dose, frequency and route were unknown), lot# L008272, expiration date 11-MAR-2017. No concomitant medication was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.
Big red circle on the upper leg by the inguinal area with rash and  itchiness
A Medical Assistant administered the Moderna Covid Vaccine (Lot #003C21A, Expiration Date 10-17-2021) after the 12 hours that was supposed to be administered. The vial was always at the refrigerator, but it was used after the recommended time. The Moderna Covid Vaccine vial was originally at a temperature of -3.2 degrees Fahrenheit. On 8-5-2021 the vial was placed on the refrigerator at a temperature approximately of 41.0 degrees Fahrenheit, and the vial was at that temperature for 24 hrs, when the vaccine was administered. The vial was opened on 8-5-2021 at 9:20 am, and by protocol, the open vial was not supposed to be used after 3:20 pm of the same day. On 8-6-2021, the same vial was used by the Medical Assistant, to vaccinate the patients She thought that the vial was already prepared for the day and the expiration time was 3:20 pm, but she didn't notice that the vial was from the day before (8-5-2021). The vaccination protocol was followed, the patient was observed after vaccination, and the patient didn?t have an adverse reaction. This incident was reported to the Director and the Vaccine Coordinator. Dr. recommended to call the patient that received the vaccine to inform the incident. The patient also will be called for three days to evaluate his health condition. Called the Moderna Medical Staff and report the event with a Case #MOD21127564. The Medical Staff recommendations will be presented the next 7 days.  The MA called the patient to explain the situation about the use of the vaccine after the time recommended. She communicated with the patient on 8-6-2021, patient understood the explanation and will wait for her call the next three days to evaluate any health complaint. The patient was called today, and he informed that he feels well.