chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that there was a confusion between expiration date printed in the carton and expiration date when the QR code was scanned. The product did not undergo any temperature excursion.  Patient did not experience any adverse event. Date the vial was initially stored in the refrigerator on 03-Nov-2021.   This case was linked to MOD-2022-491837 (Patient Link).
Patient returned to the pharmacy about 15-20 minutes after receiving vaccination. She described she was feeling like she was experiencing dizziness, light headedness, nausea. After about 45 minutes, patient still felt weak, but she had no trouble swallowing or breathing. Patient also stated that she had recently cut back on carbs and sugars over the last few days.
Local nerve injury/significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work; At the time of vaccination he experienced discomfort in left deltoid which was the injection site; Cannot lift his arm greater than 45 degrees; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; This is a spontaneous report from a contactable pharmacist.  A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular n deltoid left on 09Jan2021 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  At the time of vaccination he experienced discomfort in left deltoid which was the injection site, cannot lift his arm greater than 45 degrees, local nerve injury, systemic fatigue ,myalgia and other arthralgia for 24-36 hours, developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work or task, all in Jan2021 with outcome of unknown.  He called the employee health on 17Jan2021 and 19Jan2021 he saw a neurosurgeon. The neurosurgeon didn't think it was a cervical spine injury rather a local nerve injury related to the injection itself and he was prescribed a steroids taper, unclear whether if it was a temporary or permanent issue. Because this was like 10 days after the vaccine and he didn't really describe how much this issue affected his ability to perform usual work or task but he was a surgeon. The outcome of the events were unknown.; Sender's Comments: Based on the compatible time association, the peripheral nerve injury is possibly related to the injection technique, not vaccine BNT162B2. 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.
4/10/2021- 102 temp by 10 pm. Aching in all joints especially ankles and wrist. 103 temp by 12am. 04/11/2021 severe headache.. light sensitivity.. fever 101-103 until 5pm. Nausea and diarrhea.  04/12/2021 temp and aching has subsided.. Major headache and nausea and diarrhea still on-going.  Taking Tylenol 325x2 every 8 hours.
On 3/18/05, student received 1st varicella vaccine.  On 3/19/05, student returned to health service with redness of right arm from elbow to deltoid, which was hot and painful.  Area was treated with warm soaks and hydrocortisone cream and resolved.  Student was given 2nd dose of Varivax (Merck,lot # 0284P, SC, LA) on 04/18/05.  Student was given 50 mg of Benadryl prior to 2nd dose and developed approximately 1 cm of erythema around site the day after being vaccinated.
Hives on both arms, chest, and left side (ribs), tightness and itchy throat
Light pressure in her chest cough  You can take a cough medication like MucinexDM that has guaifenesin and dextromethorphan to help with chest congestion and cough. You can also use a decongestant. Be sure that your are staying well hydrated. Tylenol/motrin alternating for fevers or pain as needed. Humidification can also help.
Positive for COVID-19; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for COVID-19) in a 96-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029k20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced COVID-19 (Positive for COVID-19). At the time of the report, COVID-19 (Positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2020, SARS-CoV-2 test: positive (Positive) Received Bamlanivimab on 11/19/2020.. On 25-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On 01-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   No relevant concomitant medications were reported.  No treatment information was provided.
Patient large redded area, warm to touch 8-12-08. No fever, pain, just itches badly Suggested Benadryleream. Will see her Friday 8-15-08.
Patient had "orange" size redness & swelling of right deltoid area. no exudate no fever
4-24 hours post: achey, mild joint pain, mild nausea, fatigue, injection site soreness that only lasted 2 days 6 days post - current (day 7 post): new tenderness at injection site, soreness in armpit like lymph nodes swollen, 3 hives upper arm, fatigue
MOderately severe deltoid pain at and around injection site requiring Tylenol with Codeine and severely limiting range of motion. Moderate injection site swelling lasting 3 days.
SWOLLEN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. 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 subject experienced swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swollen was not reported. This report was non-serious.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L033690, expiration date 14-JUN-2018; lot # L038502, expiration date 16-AUG-2018; lot # M010440, expiration date 09-DEC-2018, lot # reported as M001811, expiration date 04-NOV-2018 (dose 0.5 ml, route of administration was not reported). None of the patients reported adverse effects. Administered doses of the vaccine experienced a temperature excursion of 32.4 degrees Fahrenheit for 3 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a 24 year old female patient, for the Pregnancy Registry for GARDASIL.  The patient with no drug allergy and no other medical history, on 02-APR-2008, was vaccinated with the first dose of GARDASIL.  On 06-JUN-2008, the patient received the second dose of GARDASIL.  There was no other concomitant medication.  On 17-JUN-2008 the patient went to the physician's office because her period is already late.  The blood test was implemented and the result showed that she was pregnant and experienced ectopic pregnancy (estimated due date of 17-FEB-2009).  On the night of 17-JUN-2008 the patient experienced bleeding and was brought to the hospital and was admitted for 1 day.  Subsequently, the patient ended up having a surgery because of the ectopic pregnancy.  At the time of this report, the patient is recovering.  The patient sought medical attention.  Additional information has been requested.
Tested covid-19 positive 2 months after second dose.; Tested covid-19 positive 2 months after second dose.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10 year-old patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested covid-19 positive 2 months after second dose.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: Experienced headache and flu symptoms  The lot number for bnt162b2 was not provided and will be requested during follow up.
Cellulitis  pt was treated with antibiotics...fever chills swelling at injection site...pt also had kidney infection at time of cellulitis.
Patient came to pharmacy 72 hours after administration, injection site is hot, swollen, red, and formed a knot on arm. Patient says it started about 12 hours after injection.
About 1 hour after receiving vaccine, became extremely hot, red and had a rash from head to toe that looked like a blotchy sunburn. These symptoms lasted for 2 days. Did take OTC benadryl.
PATIENT RECEIVED VACCINE BEFORE THE AGE OF ELIGIBILITY AT THE TIME OF VACCINATION
Pt arms swollen w/redness and warm to touch. Treated w/PO OTC Benadryl, Tylenol and Motrin.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 04/16/2021 and 05/14/2021. They were brought to Emergency Department via ambulance on 03/06/2022 after "having some kind of episode while driving." It was determined the individual had suffered a V-fib cardiac arrest. The individual was hospitalized and found to be having many complications and medical conditions including: COVID-19 pneumonia, acute respiratory distress syndrome, hypoxia, acute combined systolic and diastolic heart failure, A-Fib, and Hypertension. The individual was transferred to a different hospital (Hospital) on 03/12/2022 to continue care. While hospitalized, the individual's condition did not improve. They were found to have developed hypoxic encephalopathy, speculated to possibly be related to the COVID-19 infection or to alcohol withdrawal. Fevers began on 03/21/2022 and blood culture grew staph epidermidis. On 03/27, the individual self-extubated and the family declined to have the individual intubated again. They were transferred to Hospice House on 03/28/2022  to continue comfort care. They died later on the same day, on 03/28/2022.
Flu like symptoms every time. Folded bowel movement. Very hard for him to breath.
On October 30, 2009 I received a telephone call from client's father, who states client had a reaction to the H1N1 nasal mist received on October 24, 2009 at a clinic. Father states that client received the nasal mist at 3 p.m. At 6 p.m. client became extremely tired, slouched over and had an axillary temperature of 100.1. Parents gave child 5 ml of TYLENOL and child went to sleep. At 7:30 p.m. child's temperature was 101.5 axillary. The parents called pediatrician at 8 p.m. Dr ordered parents to give 10 ml MOTRIN. After ingesting MOTRIN the child had dark green diarrhea. The child went to sleep at 10 p.m. and seemed better. On October 28, 2009 the child developed a red raised rash on the inside of his thighs and his "butt cheeks"; the top of the rash was whitish in color and became very itchy causing the child to scratch the area. The rash progressed to his lower back and the top of his chest, under the nipple line. Parents applied 1% hydrocortisone cream to the rash area on October 29. On Friday October 30 the rash was evident only on the "butt cheeks", the anterior top of both thighs an in the right crotch. I instructed the parent to call the pediatrician and have him evaluate the rash. Father said they would call today and make an appointment. I called the father on November 2 to follow up re: pediatrician visit. The father stated that the doctor did not think this was a reaction to the H1N1 flu mist but instead diagnosed it as either Impetigo or a Staph infection. The child was placed on antibiotics and is doing much better. I informed the father that I would be doing a VAERS report in spite of the pediatrician diagnosis. The father was agreeable to this.
Information has been received from a medical assistant and a nurse practitioner concerning an 11 year old female with no relevant medical history reported who on 08-FEB-2007 was vaccinated intramuscularly in the right deltoid wit a 0.5 ml dose of Gardasil (lot 654702/0011U). Concomitant therapy included METADATE. On approximately 18-FEB-2007 or 19-FEB-2007, the patient developed upper right arm pain. The patient was seen on 21-FEB-2007 and 02-MAR-2007 for the upper arm pain. The pain occurred on the whole outer portion of the upper arm. The patient has no fever. Office notes indicated that "normal flexion of the elbow without problems with bilateral strength. Normal anterior and posterior rotation of shoulder. Normal internal and external rotation of shoulder. Active abduction of only 90 degrees, stopping due to pain. Able to rotate full 180 degrees with passive range but crying due to tears. Diagnosis was arm pain without reduction of strength, secondary to HPV injection. "The patient was treated with ibuprofen 350mg every 6 hours for 4 to 5 days. The nurse practitioner reported that she assumed the patient recovered from the arm pain because the patient did not return for a follow-up visit scheduled on 08-MAR-2007. The nurse practitioner considered the patient's upper arm pain an other important medical event as the patient's pain lasted longer that the indicated time frame of 48 hours for this experience. Additional information has been requested.
Felt warm and hot post vax administration. Developed body aches and chills. Developed progressive bilateral leg weakness that made her unable to walk on 05/05/2000. She has improved but has not recovered.60 day follow-up dated 10/04/00 provided no additional data.
Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a headache about one hour after. Took 1000 mg of Tylenol; and I was feeling okay. Just arm was sore. Not extremely sore. 8 pm at night - started shaking; knees were knocking together; severe chills; and it took a few minutes to recognize what was happening - took temp. 99.4; took another 1000mg tylenol; went to bathroom and without notice -  puked; woke up an hour after going to bed with worsened chills; 10:30 pm - temp 102.4; too early to take more Tylenol and so took pharmacy's version of Nyquil. Slept through the night after Nyquil but woke up with chills continuing - temp 103. 8 at 4:30 am; and then sat at side of bed and took tylenol 1000 mg  and got up to go to bathroom and couldn't walk forward and felt my arm hurt really really bad; couldn't walk forward; I leaned against the wall and bounced against the next wall and kept walking and grabbed a bedroom doorknob and got into the bathroom and fell on toilet and then crawled to couch because I couldn't walk straight. Stayed on a couch for two hours and then it was gone. Fever and chills continued that whole day on 24th. Didn't eat/had no appetite. Christmas day -no fever. Felt shaky though - like I'd been super sick. No appetite still. Felt woozy and shaky inside (felt shaky inside) and that lasted for several days.  Appetite still remains poor. 02 stats were low through all of it - four liters (up two liters than normal.  Contacted: a pulmonologist - Dr. and she helped with O2 questions.
Headache, Arthralgia, Chills Narrative:  Other Relevant History:
Itchiness around the waist , head and arm; Hives; Rash around the waist; Pain at the injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness around the waist , head and arm), URTICARIA (Hives), RASH (Rash around the waist), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchiness around the waist , head and arm), URTICARIA (Hives), RASH (Rash around the waist), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, PRURITUS (Itchiness around the waist , head and arm), URTICARIA (Hives), RASH (Rash around the waist), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided. Patient received the 1st dose of Moderna COVID-19 vaccine on February 23rd , 2021. Reports rash and itchiness around the waist , head and arm, pain and redness at injection site and hives.
Hospitalization for Sepsis due to colitis (tested COVID positive) on dates 6/18/2023-6/21/2023. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Day one, fever,  (101.8), chills, extremely hot when fever broke including hour of profuse sweating, total loss of bladder, if I was vertical the urine came out headache, unable to walk without assistance, felt like I was not going to live.  Day two fever gone, still need walker to walk, very weak.  Day three loss of kidneys, unable to urinate for approximately 14 hours still very weak.  Day 4 mouth filled with blisters.  Feeling sick for two weeks like I had the flu.
This spontaneous report as received from a physician assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX. On an unknown date the patient experienced chest pain. No treatment was given. On an unknown date chest pain resolved. No other details were provided. Additional information is not expected.
There were no adverse events, patient received two doses of the flu vaccine in the same season. He received the standard dose of 9/6/22 and the high dose on 10/17/22. The patient requested a flu vaccine from the pharmacy and the pharmacist verified that they were here to get the flu vaccine and reviewed imz history before administration.  Afterwards, the patient's wife stated that he was wanting a different vaccine. The wife then told us that the patient has  dementia and probably could not remember getting  the first dose. When reviewing  vaccine history the flu shots were separated on report and it was missed that patient had already received a dose.  Patient waiting in pharmacy for 20 minutes afterwards and did not have any adverse reactions.
confused; arm was red and sore; memory loss, could not recognize names; myalgia; a fever; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 70 years old female patient who was confused (confusional state), her arm was red and sore (inflammation) had memory loss, could not recognize (amnesia), myalgia (myalgia), a fever (pyrexia), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  The patient was in a weakened states because she has Meniers disease and has suffered from 23 bouts of severe vertigo, causing constant emesis and weight loss, for about 7 months. She recently had surgery related to that illness. She reported that today is the first day that she hasn't run a fever.   The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On 19-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left deltoid.  On 19-Sep-2019, the patient received dose of suspect VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) lot number not reported via unknown route in the left deltoid.   On an unknown date, , the patient was confused (confusional state), picked up a book to read and the words didn't make sense. She wanted to call a friend that is a nurse but couldn't remember her name. Patient had memory loss (amnesia), Several hours later following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and SHINGRIX.  On an unspecified date, her arm was red and sore (inflammation), myalgia (myalgia), a fever (pyrexia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and SHINGRIX.  Lab data was not reported.  Final diagnosis was confusional state, inflammation, amnesia, myalgia and pyrexia.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for all the events.  Information on the batch number was requested.  List of document held by sender: none.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 26-DEC 2014 the patient was vaccinated with GARDASIL, (strength, lot#, frequency, series dosage number unspecified and expiration date not reported) dose 0.5 ml, intramuscular. The product had undergone an unsupported temperature excursion. No adverse experience reported. Additional information has been requested.
Pt recv vax on 11/12/98; post vax pt exp achy, nausea, chills, sweats & fever
Needle/plunger malfunction, minimal partial dose given due to rest leaking around connection. Full dose repeated 10 minutes later. Patient tolerated injections well, no issues at injection sites.