chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A primary care physician practice submitted a report that there is poor labeling on the FLUARIX QUADRIVALENT [GlaxoSmithKline] single dose syringes and other flu injections with similar designs and from previous years. The design flaws on the syringe include: 1) No peel off label on the barrel of the syringe. 2) Cannot easily read NDC # because it is very small and on clear glass. 3). Difficulty in reading the dosing contents of syringes. The other challenging issue that is related to the administration of single dose flu shots is the change to the lot #s and NDC #s, which can be easily overlooked when giving high volumes of the vaccines (the peel off label would be helpful). These issues leads in to delays in administering the vaccines and entering info into the electronic Medical Record. What was the original intended procedure? The original intended procedure is regarding the routine administration of patient's Influenza vaccinations. The request is for the company to consider: 1) Re-designing syringe labels allowing for more contrast against syringe. 2) Increasing the type font size of the NDC (vaccination #). 3) Improve the bar scanning label on the syringe for the vaccine to allow for bar scanning using the QR Code that is on the syringe. Device Usage Problem: Device was hard to use. Other Patient Information. Ethnic Background: Not applicable. Other pertinent info: There are NO patient factors that relate to this reporting. No patient was HARMED as a result of this syringe being difficult to work with; the concern relates more to the workflow challenge of properly documenting the NDC and expiration numbers from the syringe for vaccinations.
Had varicella injection 3/11/1997 and then broke out with chicken pox on 9/3/2000. Came to office and diagnosed with chickenpox on 9/6/2000. Has chickenpox at present.
It started later that day, I have Parkinson and I started having tremors in both left and right sides and the doctor tried increasing medication and then change the medication. Once in a blue moon I would have tremors and now I have them all the time. The doctors increase my meds but the tremors don't go away. I have to see the Neurologist on a regular basic. He had to switch my medications to a new one called Rytary ER extended release x5 and Mirapex x3. Now I am pursuing deep brain stimulation with a new doctor also a Neurologist. I haven't had any test done as of yet. They are all in process with this new doctor. I just got process with him,
Mental confusion, fatigue, feverish feeling, cramping, diarrhea, nausea
Swelling and erythema around site of injection with tenderness and induration. Sought treatment in Emergency room, given antibiotics and told Dx cellulitis.
This spontaneous report as received from a nurse (also reported as medical assisstant) referring to an unspecified amount of unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. From  01-JUL-2017 until 19-SEP-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # N014371, expiration date 09-MAY-2019, subcutaneously (strength and dose were not provided) for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent(manufacturer unknown). On an unspecified date, the vaccines were exposed to temperature ranges between -9° Celcius (C) to 8°C during a time frame of 10 hours. There was previous temperature excursion from -9°C to 8°C, during a time frame of 11 hours 30 minutes. The temperature excursion was called by a data logger. Adverse effects were not reported.
Vaccine administration site and surrounding area of arm is painful for patient. States that worse when lifting but hurts all the time.
after administration, on the same day, the patient began to experience excrutiating pain down her left arm; This spontaneous report was received from a nurse and refers to a 20-year-old, non-pregnant female patient. No information regarding her pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route of administration, lot # and expiration date were not reported) for health maintenance. There was not any problems following that administration. On 30-JUL-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly, lot # 1637641, expiration date 16-FEB-2022 (strength and exact dose were not reported) for health maintenance. On 30-JUL-2019, after administration, the patient began to experience excruciating pain down her left arm. The patient went to urgent care on an unspecified date and was given steroids as a treatment which helped for a couple of days. On 09-AUG-2019, the patient was still experiencing the same amount of the pain and was going to start another round of steroids on the same day. The outcome of the event was reported as not recovered. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
We had set up appointments for Pfizer vaccines and were doing them throughout one day. The patient came in answered affirmatively when asked if he had an appointment for a covid vaccine. Pt was set at a table to fill out form and said he was coming in for his second shot. We asked for his vaccine record card but he said he didn't have it. The vaccinator went ahead and gave him a shot. While he was waiting the 15 minutes he found his record card and it stated his first dose had been a Moderna.
Pain in the arm, especially with raising the arm. Upper arm/shoulder area is warm to touch. Took ibuprofen, advised to continue ibuprofen and ice the area alternating 15 minutes on/off.
The next day I had a sore throat, and now it has developed into a cold. Sore throat, running nose, had some chills and body aches.
The vaccines were given at 10:30 AM, and the child started to cry inconsolably for 4-5 hours. During the last hour the child started to have jerking of his arms. The child was taken to the ER for evaluation. While in the ER the crying stopped, and the jerking movements decreased in frequency from every 2-3 minutes to every 5 minutes. When the crying restarted during the physician's exam the jerking movement increased. The ER physician believed that the jerking movements were seizures. The patient was given Ativan and admitted for observation. The following day the patient was seen by the neurologist and started on Phenobarbital.
diarrhea; This spontaneous report was received from a medical assistant refers to a 4 month old male patient. The patient's concurrent condition included acid reflux. Concomitant medications and drug reactions/allergies were reported as none. On 16-JUL-2019, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 milliliter one time orally for prophylaxis (also reported as "well baby check"). On 20-SEP-2019, the patient was vaccinated with second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S005874 and expiration date 31-OCT-2020, at a dose of 2 milliliter one time orally. On 21-SEP-2019 (one day later of second dose of vaccine), the patient experienced diarrhea (diarrhoea) that lasted for 12 days. The patient sought medical attention. On an unknown date in 2019, the patient's stool culture was negative for ova and parasite (O and P) and showed normal flora. No treatment was given for the event. No product quality complaint (PQC) present. The outcome of diarrhoea was reported as resolved on 02-OCT-2019.  The causality assessment was not provided by the reporter.
Fever - As High as 101.0F; Fatigue; Swollen - Near Injection Site; Red - Near Injection Site; Hot to the Touch Sensation - Near Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever - As High as 101.0F), FATIGUE (Fatigue), INJECTION SITE SWELLING (Swollen - Near Injection Site), INJECTION SITE ERYTHEMA (Red - Near Injection Site) and INJECTION SITE WARMTH (Hot to the Touch Sensation - Near Injection Site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (Fever - As High as 101.0F), FATIGUE (Fatigue), INJECTION SITE SWELLING (Swollen - Near Injection Site), INJECTION SITE ERYTHEMA (Red - Near Injection Site) and INJECTION SITE WARMTH (Hot to the Touch Sensation - Near Injection Site). On 01-Feb-2021, PYREXIA (Fever - As High as 101.0F), FATIGUE (Fatigue), INJECTION SITE SWELLING (Swollen - Near Injection Site), INJECTION SITE ERYTHEMA (Red - Near Injection Site) and INJECTION SITE WARMTH (Hot to the Touch Sensation - Near Injection Site) had resolved.        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.
Pt came to our appointment clinic on 09/17/07 for 5 y/o child received 2 vaccinations around 11:30 AM, one in each thigh. DTaP#5 was give to (L) thigh and IPV#4 to (R) thigh. Pt then presented to our walk-in clinic on 09/19/07 at 10:52 AM with complaints of "knot from shots" on (L) thigh. Received shots and parent noticed progressive erythema macula at (L) thigh site which became warm and painful to palpation. Pt was diagnosed with (L) thigh cellulitis and was started on Keflex 1 gm PO q6h x10d.(Mother of child stated pt won't swallow pills and not going to take Clindamycin.) Pt to f/u in 2 days to re-evaluate; to C if fever, increasing macules or redness at site.
At approx 5:20pm she felt scratchy, irritated throat and vocal cords while working. Went home and felt worse. Went to ER and was given oral prednisone and prescription for 5 more days of oral prednisone. She states she was in the hospital 2-2 1/2 weeks earlier and received injection to thin her blood for A-fib.
keeps on having episodes of "slight forgetfulness"; episodes of tiredness; next couple of months, she noticed she is not being herself; headache set in from morning until middle of the night; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (keeps on having episodes of "slight forgetfulness"), MYALGIA (sore arm), FATIGUE (episodes of tiredness), HEADACHE (headache set in from morning until middle of the night) and FEELING ABNORMAL (next couple of months, she noticed she is not being herself) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS], NICOTINAMIDE (VITAMIN B3) and FISH OIL (FISH OIL OMEGA 3) for an unknown indication.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced MYALGIA (sore arm). On 26-Mar-2021, the patient experienced HEADACHE (headache set in from morning until middle of the night). On an unknown date, the patient experienced MEMORY IMPAIRMENT (keeps on having episodes of "slight forgetfulness"), FATIGUE (episodes of tiredness) and FEELING ABNORMAL (next couple of months, she noticed she is not being herself). At the time of the report, MEMORY IMPAIRMENT (keeps on having episodes of "slight forgetfulness"), MYALGIA (sore arm), FATIGUE (episodes of tiredness), HEADACHE (headache set in from morning until middle of the night) and FEELING ABNORMAL (next couple of months, she noticed she is not being herself) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal. On an unknown date, Magnetic resonance imaging: normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided.   This case was linked to MOD-2021-253136 (Patient Link).
Heavy feeling in arms and legs same day of shot. 3\27\2021. Then I was sore all over on the next day. Now today3\29\2021 I have a headache and frequent loose stools and sick stomach and chills.
Pt presented to clinic with c/o blisters and itchy rash on chest - today 11/22/2021 we have a dx of probably pemphigus vulgaris - treated with keflex and prednisone initially with some improvement and then keri/kenalog lotion which we discontinued today - rash spread all over body and extremities and to oral mucosa
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), on 21Jan2021 as dose 2, single (Batch/Lot number: unknown), on 22Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: testing negative the past three days; (Jun2022) Negative, notes: testing negative the past three days; (Jun2022) Negative, notes: testing negative the past three days; (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks brand=Lyrica 75mg tid, Citalopram 40mg and Finasteride 5mg. Treatment Paxlovid, Treatment start date=19Jul2022 , Treatment stop date=24Jul2022, Indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored PROQUAD (albumin status rHA) (lot number L044056, expiration date: 02-MAY-2017 and lot number M038862, expiration date: 13-MAR-2018) (dose, route of administration and anatomical location were unknown) for prophylaxis. The vaccine experienced a temperature excursion of 6 Fahrenheit degrees (F) to 14 F for 10 minutes. Previous temperature excursion was of 6F to 14F for 10 minutes. The temperature excursions were detected by a digital data logger. The improperly stored vaccines were reconstituted with a properly stored sterile diluent (manufacturer unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter (MARRS# 1704USA006527). Additional information has been requested.; Sender's Comments: US-009507513-1704USA006527:
A patient was given the Moderna Bi-Valent booster but it was later found that the patient had not received the first two primary vaccines; No side effects reported by the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (A patient was given the Moderna Bi-Valent booster but it was later found that the patient had not received the first two primary vaccines) and NO ADVERSE EVENT (No side effects reported by the patient) in a 22-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 20-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (A patient was given the Moderna Bi-Valent booster but it was later found that the patient had not received the first two primary vaccines) and NO ADVERSE EVENT (No side effects reported by the patient). At the time of the report, WRONG PRODUCT ADMINISTERED (A patient was given the Moderna Bi-Valent booster but it was later found that the patient had not received the first two primary vaccines) and NO ADVERSE EVENT (No side effects reported by the patient) outcome was unknown.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   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 side effects reported by the patient) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A patient was given the Moderna Bi-Valent booster but it was later found that the patient had not received the first two primary vaccines).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. A patient was given the Moderna Bi-Valent booster but it was later found that the patient had not received the first two primary vaccines. It was queried which dose should they get next and how long should they wait. No side effects reported by the patient.  No concomitant or treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2023: Non-significant follow up was received: case identifiers were added.
pt recv vax 15SEP98 & on 12OCT98 pt came down w/a fever & earache;13OCT98 reported to MD w/rt sided neck swelling in addition to the above complaints;MD dx vaccine induce mumps since there is no known exposure;
broke out in rash/sores, severe itching, looks like the chicken pox, treated with Caladryl, Band-Aid spray for itching, benadryl, got 3 prescriptions from family doctor to fill.
A report has been received from a Physician concerning a 35 years old, female patient. The relevant history and concurrent diseases of patient were not reported. The concomitant medications included ascorbic acid, biotin, minerals NOS, Nicotinic acid, retinol, tocopherol, vitamin B NOS, vitamin D NOS. The patient had been receiving FLUMIST which was started on 17-Jan-2013. The physician reported that one of their pregnant patients received FLUMIST at her child's pediatrician's office which on 17-Jan-2013. The outcome of the reported event was unknown. The outcome of pregnancy was unknown. The reporter considered the event of one of our pregnant patients received FLUMIST to be non-serious. Summary of follow up information received by AstraZeneca/MedImmune on 04-Oct-2013 from Physician: Form completed date added. The coding of the event one of our pregnant patients received FLUMIST changed from drug exposure during pregnancy to vaccine exposure during pregnancy. Reporter as responsible physician added.
Muscle aches; Felt warm; nausea; Sore Injection Site; Shivers / Chills / Severe Shivering; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received on 11th March 2019, refer linked case US2019GSK045802).   On 27th August 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th August 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and shivers. On 28th August 2019, the patient experienced muscle pain, feeling of warmth and nausea. The patient was treated with paracetamol (Tylenol). On 29th August 2019, the outcome of the injection site pain, shivers, muscle pain, feeling of warmth and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site pain, shivers, muscle pain, feeling of warmth and nausea to be related to Shingrix.  Additional information received were as follows: The patient was a physician who received both doses of the Shingrix vaccine. The lot number was unknown. The patient received Shingrix on left deltoid in the evening. The patient experienced sore injection site that resolved the next morning of vaccination date. The patient experienced shivers and was treated with Tylenol every 6 hours and was fine until 11:00 am. At that time, the patient began to experience chills, muscle aches, and severe shivering which lasted approximately 45 minutes.  At 7:00 pm that evening, the patient again had chills and felt warm, but he did not take his temperature.  On 28th August 2019, the patient went to bed at 9:30 pm and woke up on 29th August 2019 with all symptoms resolved.  The reporter was unable to provide any additional details and unable to locate case number for first case. The caller stated that all symptoms had resolved, however, he still had a little soreness in his left arm. The patient also mentioned that he had experienced soreness at the injection site following previous flu shots (unknown manufacturer).  The caller did not provide any additional details. This was 1 of the 3 cases reported by same reporter.
The Jannsen COVID vaccine shot was administered at 5pm on 4/9/21. No immediate symptoms occurred. At 2:30 am on 4/10, the patient awoke with malaise. This quickly progressed to chills and flu-like symptoms. Sleep was difficult for the rest of the night and slowly transgressed into a severe headache and fatigue. Surface forehead temperature was taking in the morning on 4/10/21 and registered 100 F. The patient took an ibuprofen and felt normal by mid afternoon on 4/10. No further effects have presented as of 4/21/21
expired vaccine was administered for the second dose of the patient today 24July2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered for the second dose of the patient today 24July2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered for the second dose of the patient today 24July2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine was administered for the second dose of the patient today 24July2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Pt admitted from home with intermittent nausea, dry heaving, and central chest pressure which self resolve in 2 minutes since 2/6/21. Called 911 on 2/12/21 due to sustained episode that did not resolve. EMS treated with aspirin and nitroglycerin prior to arrival to ED. In ED patient became unresponsive and went into full cardiac arrest -CPR and ACLS care initiated. STEMI with AV conduction block. 2nd degree a-v block type II - significant bradycardia - temoprary pacemaker placed - Vfib -PEA.  Time of death 0955 on 2/12/21  Patient recieved first dose of Moderna Covid vaccine on 2/4/21