chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist via a company representative referring got a 55 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, lot #, expiration date and route not reported). On an unknown date, the patient experienced tenderness and swelling at the injection site after administration of ZOSTAVAX. The patient sought medical attention. It was unknown if treatment was given for the events. The outcome of the events was unknown. The causality between ZOSTAVAX and the events was not provided. This is one of two reports received from the same reporter. Additional information is not expected as no consent to contact the physician.
Fever, headache, malaise. To be seen at medical clinic. T 100. Rest overnight. Home from school Friday, back to normal. Mom informed fever occurs at about 5% rate.
Pt received Td. & hep B, mom dropped daughter off at school, within 20-30 minutes arms were red, swollen, and rashy with hives, reported to mom. Referred to physician for f/u. Dr. visit, hives distributed over body, Rx for antihistamine, stop hep B series. Today hives gone back to school.
Information has been received from a physician and a registered nurse concerning a 77 year old female with impaired fasting glucose and cholesterol high and a history of chickenpox as a child who on 15-JAN-2008 was vaccinated in the right upper arm with a 0. 65 ml (also reported 0.5 ml) dose of ZOSTAVAX (Oka/Merck) (Lot# 658867/1413U). Concomitant therapy included ACTONEL, CRESTOR, aspirin, calcium (unspecified) and vitamins (unspecified). On 12-JUN-2008 the patient experienced Shingles. The rash was vesicular with 30 lesions under her right breast to axilla. The pain was quantified as 4 as a scale from 0 (least) to 10 (most). The patient's temperature was normal. The patient did not has exposure to chickenpox or herpes zoster recently. The patient was recovering from  Shingles. 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 with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. The sample of the lesions was collected on 23-JUN-2008. The sample was taken from a vesicular lesion. The specimen was inadequate, negative for B-Globin and no strain was identified. Additional information has been requested.
Rapid pounding heart, heart palpitations, heart skipping beats. I have never had these symptoms. These symptoms did not accrue until after my Moderna first vaccine I will not be getting my second Moderna vaccination.
C/O feeling lightheaded.  Encouraged to stay for longer Observation & agreed. BP 158/75, Pulse 97,  O2 sat 100% on RA. Up in chair with feet elevated & drinking soda. Symptoms resolved prior to  D/C. Encouraged to follow-up with ER, Urgent Care, or Primary Doctor. Verbalized understanding. Awake, alert, & oriented.
Rapid heart rate 128, b/p 135/91, nausea, diarrhea, severe body and muscles aches, fever 102.6, heart palpitations
It was reported that a pt (3 of 4) complained of redness and rash 3-4 inches in diameter after receiving the 98-99 Fluzone.
NUMBNESS AND TINGLING OF HANDS AND LIGHTHEADACHE, HX OF ANXIETY, PASSED DURING FIRST COVID VACCINE, SYMPTOMS RESOLVED, REFUSED TRANSPORT TO HOSPITAL
4 inch rash; swollen lymph nodes in her arm pit; shoulder is hot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (shoulder is hot), RASH (4 inch rash) and LYMPHADENOPATHY (swollen lymph nodes in her arm pit) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (shoulder is hot) and LYMPHADENOPATHY (swollen lymph nodes in her arm pit). On 16-Apr-2021, the patient experienced RASH (4 inch rash). At the time of the report, MUSCULOSKELETAL DISCOMFORT (shoulder is hot), RASH (4 inch rash) and LYMPHADENOPATHY (swollen lymph nodes in her arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: TCR document was attached.
tested positive for COVID by PCR; tested positive for COVID by PCR with cold/flu like symptoms; This is a spontaneous report from a contactable nurse (patient herself).   A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on unknown date for COVID-19 immunisation. Patient was vaccinated with the first dose of BNT162B2 on an unknown date. The patient started having cold/flu like symptoms on 22Feb2021 and tested positive for COVID by PCR on 23Feb2021. She did not become complacent. She was an RN and continued to wear 2 masks at a minimum. Have not seen her family since Aug2020. she literally works and come home. she did not take public transport.  She questioned if you are doing any studies on post vaccine, symptomatic, positive cases. She would be willing and interested in participating. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile and a strong temporal relationship, there is reasonable possibility of causal association between the events Covid 19 and the suspect drug BNT162B2.
This literature report (initial receipt: 13-Nov-2012) concerns a 47-year-old male patient, who had no significant past medical history. On an unknown date the patient received a flu shot (manufacturer, brand name and batch number were not provided). On an unknown date, the patient experienced symptoms 12 days after receiving the flu shot. The patient presented to clinic 2 days after awakening with pain (left shoulder, posterior aspect of upper left arm, medial aspect of left forearm), numbness (over left 5th finger and posterior lateral aspect of left arm), and muscle weakness (left arm and left hand). He also described shooting pain down his left arm with any movement of the left shoulder most prominently with arm abduction. He reported similar symptoms of shooting pain with palpation of the anterior aspect of his left shoulder. The patient was without any known trauma or preexisting pathological conditions to his neck, shoulder, or arms. The only significant recent event was receiving a flu shot 12 days prior to the start of his symptoms. Physical examination revealed no cervical spinal tenderness. Motor testing revealed weakness in his left biceps, left deltoid, and with external shoulder rotation on the left. Adson's sign was positive on the left. Neural tension stretch testing was positive on the left when specifically stretching the median nerve. The patient was prescribed a prednisone taper and pain medication (ULTRACET). Subsequent MRI (magnetic resonance imaging) scan was significant for findings consistent with a brachial plexus injury (likely Parsonage-Turner Syndrome) considering the patient's symptoms, history, and physical examination findings.
Mother was notified by NP and was advised of vaccine given, reactions and need for Hib vaccine.
Delay in menstrual cycle. Due 4/5/2021. As of 4/12/2021 still has not occured. Typical PMS symptoms and negative pregnancy test
This spontaneous  report was received from a nurse refers to unspecified number of unspecified patients of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unspecified dates in 2016 (reported as starting on or after 09-FEB-2016), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L013203, expiry date: 28-JAN-2017). Nurse reported that the vaccine underwent temperature excursion at 22.7 and -1.2 degree Celsius for 10 hours 8 minutes and 37 hours 6 minutes, respectively. No adverse effects were reported. This is one of the five reports received from the same reporter. Additional information has been requested.
pt reported unknown flushing on 10/16/2019 -- she had no other symptoms but noticed around 1 pm on 10/16/2019 flushing --- she did not report any other symptoms at this time and had no other changes to routine other than receiving flu vaccine on 10/11/2019
Soreness in arm; A spontaneous report was received from healthcare facility staff member, concerning a female patient who was participating in the mRNA-1273 Emergency Program and who experienced soreness in the arm.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 on an undisclosed date intramuscularly for prophylaxis of COVID-19 infection.  Patient received the Moderna vaccine on an undisclosed date as did her husband. Her husband reported that they both experienced arm soreness following vaccine administration.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event, soreness in arm, was not provided.   The outcome of the events, soreness in arm,  was not reported.  The reporter did not provide a causality assessment for the events, soreness in the arm.; Reporter's Comments: This case concerns a female of unknown age who had a nonserious expected event of pain in extremity. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M039317, expiration date 20-SEP-2018 (strength, dose, dose number and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored doses of sterile diluent (MRK). On an unspecified date, the vaccines were exposed to temperature ranges between 6° Fahrenheit (F) to 14° during a time frame of 1 hour 20 minutes. There was not previous temperature excursion, the temperature excursion was called by a data logger. Adverse effects were not reported. This is one of two reports from the same source. Sender's Comments: US-009507513-1709USA008861.
3 DIFFICULT DAYS; This spontaneous report received from a consumer via social media concerned a female patient of an unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received first and second dose of Sinovac (covid-19 vaccine inact (vero) cz02) (dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported administered for prophylactic vaccination. It was reported that the patient had no adverse events following vaccination with first and second dose of Sinovac (covid-19 vaccine inact (vero) cz02) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (third dose) (dose number in series 2) (suspension for injection, route of admin, batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced 3 difficult days (coded as adverse event nos) (dose number in series 2). It was reported that "24 hours after the (4th ag. COVID19) vaccination with Novavax: how is my Mother, how am I, We are perfect: absolutely no consequences, work and sport at 100 percent, it is like after the 1st and 2nd with Sinovac. (I still remember 3 difficult days after Janssen)". The patient additionally received fourth dose of Novavax (Nvx cov 2373) (dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported administered for prophylactic vaccination. It was reported that the patient was perfect and had no consequences, and mentioned work and sport at 100 percent following vaccination with Novavax (Nvx cov 2373) (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 3 difficult days was not reported. This report was non-serious. This case, from the same reporter is linked to 20220603569.
Patient received ZOSTAVAX on 09.11.2013 in (R) arm and 2013/2014 influenza vaccine in (L) arm. On 09.12.13, patient woke up with site reaction on (R) arm at origin of ZOSTAVAX. Red double ring around injection site and painful as well as difficulty breathing. Presents on 9.15.13 at pharmacy with arm red and swollen.
Information has been received from a RN concerning a 9 year old Caucasian male pt with no allergies and no past medical history who on 09/09/96 was vaccinated with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination.  Subsequently, the pt was exposed to chickenpox and had a "chickenpox break through".  On 09/26/03, the pt presented to the MD's office with a "3 day rash", which included an itchy and scaby lesion on the left arm, one vesicle on the left arm, one umbilicated lesion on the nose and several other scattered, crusty lesions, also described as small crusts, but no fever. Varicella was noted with an onset of 09/26/03. Lab tests were not performed. The pt was treated with Benadryl and calamine as needed. Subsequently, the pt recovered and returned to school. A product quality complaint was not involved. The reporter also mentioned a second pt who developed chickenpox post vaccination with varicella virus vaccine live (WAES # 0310USA00361).  Additional information is not expected.
No adverse event; Moderna bivalent shots past the beyond use date/Dose administered after 30-day Use By; The vial was initially stored in the refrigerator on 27Ju12023 and administration of vaccine was on 28Aug2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna bivalent shots past the beyond use date/Dose administered after 30-day Use By), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27Ju12023 and administration of vaccine was on 28Aug2023.) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7646C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Aug-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Aug-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna bivalent shots past the beyond use date/Dose administered after 30-day Use By) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27Ju12023 and administration of vaccine was on 28Aug2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna bivalent shots past the beyond use date/Dose administered after 30-day Use By), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27Ju12023 and administration of vaccine was on 28Aug2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna bivalent shots past the beyond use date/Dose administered after 30-day Use By) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27Ju12023 and administration of vaccine was on 28Aug2023.).    No concomitant medication was reported. Suspect product dosage text was reported as unknown. The 2.5 ml vial didn't undergo any temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-738719 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738719:same reporter (Patient 1)
No pain, redness or swelling at injection site immediately after.  Today at 1 week 1 hour after vaccine experienced itchiness. Then a small bump, no rash but warm to the touch.
Fatigue; LEG TINGLING; LOW GRADE FEVER; SORE ARM; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue), PARAESTHESIA (LEG TINGLING), PYREXIA (LOW GRADE FEVER) and PAIN IN EXTREMITY (SORE ARM) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), PARAESTHESIA (LEG TINGLING), PYREXIA (LOW GRADE FEVER) and PAIN IN EXTREMITY (SORE ARM). At the time of the report, FATIGUE (Fatigue), PARAESTHESIA (LEG TINGLING), PYREXIA (LOW GRADE FEVER) and PAIN IN EXTREMITY (SORE ARM) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  No treatment medication information was reported.  The Reference number reported.
7:30pm 3/14: feeling feverish/flu like 9:15pm: chills starting  10:30pm/ massive chills and body aches. Migraine starting   12:00am 3/15: cold sweats, migraine, nausea, dizziness  3:00am: racing heart beat, cold sweats, migraine, nausea, dizziness  7:00am: lethargy, body aches, headache, chills  10:00am: mild headache, body aches, lethargy  2:00pm: lethargy, shaky, very mild headache 7:00pm: extreme fatigue, shaky. Nausea  7:00am 3/16: massive muscle fatigue, shaky, racing heart 1:30pm: tried to shower, loss of muscle control, very shaky, hard to breathe, body and mind slow
Redness on thumb; Swelling of thumb; Swollen Face; Swollen Nose; Swollen Tongue; Dry Mouth; Dry Eyes; Blurred Vision; Mark on Face; Flushing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swollen Face), SWELLING (Swollen Nose), SWOLLEN TONGUE (Swollen Tongue), DRY MOUTH (Dry Mouth) and DRY EYE (Dry Eyes) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholecystectomy, Appendectomy and Vagotomy. Concurrent medical conditions included Penicillin allergy, Latex allergy and Food allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SWELLING FACE (Swollen Face), SWELLING (Swollen Nose), SWOLLEN TONGUE (Swollen Tongue), DRY MOUTH (Dry Mouth), DRY EYE (Dry Eyes), VISION BLURRED (Blurred Vision), RASH (Mark on Face) and FLUSHING (Flushing). On 04-Mar-2021, the patient experienced ERYTHEMA (Redness on thumb) and PERIPHERAL SWELLING (Swelling of thumb). At the time of the report, SWELLING FACE (Swollen Face), SWELLING (Swollen Nose), SWOLLEN TONGUE (Swollen Tongue), DRY MOUTH (Dry Mouth), DRY EYE (Dry Eyes), VISION BLURRED (Blurred Vision), RASH (Mark on Face), FLUSHING (Flushing), ERYTHEMA (Redness on thumb) and PERIPHERAL SWELLING (Swelling of thumb) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pharmacist adminstered to 1st dose moderna vaccine to a patient under the age of 18. No adverse reactions reported yet. Will notify patient/parent
Pt developed hive/red itchy rash on left arm (raised) no SOB.  Temp increased vitals: 131/70, 87,18, 100% Pt given benadryl 25mg PO @1949. Pt stable and released from the vaccination site
Adverse reaction from  Booster Dose: Started Dec 15 with itching all over (no rash initially), By mid-Jan was getting tiny red itchy raised dots primarily on legs, scratching lead to bleeding and as that rash healed, left brown spots.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Basal cell" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received paxlovid treatment (start date: 31Mar2023 and stop date: 04Apr2023). Other medication in 2weeks: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Significant localized redness 4cm x 5cm and swelling starting just a few hours after the vaccination. As of 9 days post vaccine when he came to have the site evaluated, the localized reaction is still present with mildly swollen firm leathery textured skin 4cm X 5cm to the injection site of the left deltoid, but no evidence of pain or distress. No other systemic symptoms noted. Left arm function remains fully intact.
Case number PHEH2013US021636 is an initial spontaneous report received from a health care professional (laboratory technician) on 15 OCT 2013, with a follow-up received on 13 NOV 2013. This report refers to a 72-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2013/2014 (batch number 1309001, expiry date: APR 2014) intramuscularly at a dose of 0.5 ml on 07 OCT 2013. It was reported that the vaccine he received was stored in room temperature for up to 24 hours. It was reported that the patient had no adverse event following the maladministration.   Follow-up was received on 13 NOV 2013: Information that patient had no adverse reaction was updated.
Fever, malaise, papular diffuse rash. Rx with TYLENOL.