chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician referring to a 14 year old male patient. Information about patient's concurrent condition, concomitant medication and medical history was not provided. On unknown date, the patient was vaccinated with improperly stored (Temperature: 47 Fahrenheit to 77 Fahrenheit; Time frame: 40 minutes) doses of GARDASIL 9 (lot # M043731, expiration date: 22-JUN-2019; dose and route were not reported) for prophylaxis on an unspecified date after July 2017. No adverse effect reported. It was reported that there were no previous temperature excursion and there was a data logger involved. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006271:
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756526A, A0756528A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUACA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Adult Td shot was given on 6-29-06 to the Left Deltoid. One 7-3-06 client stated he saw doctor and he dx with an infection from the shot and was give Cipro and medrol.  Arm was red, swollen, warm to touch and painful reported by pt.
Initial misuse report received from a consumer on 04 December 2013.  A 8 week old child had received a 0.25 ml of FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) on 28-Jan-2021, Pfizer (Dose 2) on 18-Feb-2021 and Pfizer (Dose 3) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Date and time vial was first punctured was on 15-Jun-2022 at 9.15 AM, the vial undergo temperature excursions of plus 1.9C to plus 6.4 C for 15 mins. Storage condition at the time of the excursion was Refrigerator. Vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial on 15-Jun-2022. Visual inspection noting any vaccine state change was thawed. Proposed desired use by date was 15-Jun-2022 afternoon. No treatment medications were reported.
Had an MI on May 7th 2021.  Had EKG and blood drawn rush to cardiac cath in process having MI.  100% block LAD and one stent placed..   He had pain/indigestion in his esophogus with walking the dogs then it would go away for several weeks and did not say anything .  Then one night woke up with really bad indigestion pain took alot of Tums but never said anything during the night until next morning.
experienced sciatica and vertigo a few days post 1st Moderna vaccine dose on 5/13/2021, symptoms are still on going as of 6/8/2021. Sciatica has subsided mostly but vertigo is still very much there.
VERTIGO; ITCHING AROUND RIGHT ARM; RASH AROUND RIGHT ARM; SHARP PAIN IN RIGHT ARM; DIZZINESS; HEADACHE; This spontaneous report received from a patient concerned a 37 year old female of an unspecified race and ethnic origin. The patient's weight was 160 pounds, and height was 64 inches. The patient's past medical history included covid 19 and concurrent conditions included non-alcohol user, and non-smoker. The patient's other pre-existing medical conditions included that she had no known allergies and had no history of drug abuse or illicit drug usage. The patient was not pregnant at the time of this report. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, and expiry: unknown) dose was not reported, with frequency 1 total administered at right arm on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-FEB-2021, Laboratory data included: Covid-19 virus test which revealed that she was positive for Covid-19. On 11-APR-2021, after receiving the vaccine, the patient experienced headache. On an unspecified date in MAY-2021 (reported as about one month ago), the patient was hospitalized (date unspecified) and was diagnosed with vertigo. On an unspecified date in MAY-2021 (reported as five to six weeks post vaccination), the patient developed dizziness. On an unspecified date in JUN-2021 (reported as started approximately one week ago from the date of reporting), the patient experienced sharp pain in right arm which was very uncomfortable. On an unspecified date, the patient developed rash and itching around the area in her right arm where the vaccine was given. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching around right arm, rash around right arm, dizziness, sharp pain in right arm, vertigo and headache was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210626989-covid-19 vaccine ad26.cov2.s-Vertigo. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Soreness in both arms, both thighs; Soreness in both thighs; Began to wheeze; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2020, between 4 and 5 months after receiving Shingrix, the patient experienced pain in extremity, back pain and wheezing. The patient was treated with muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the pain in extremity, back pain and wheezing were not recovered/not resolved.   It was unknown if the reporter considered the pain in extremity, back pain and wheezing to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and he reported that about 1 month ago from the date of reporting he began to experience soreness in both arms, lower back, in both thighs and wheeze. The patient was reporting that events were getting worse.   The patient contacted their provider via telehealth and the patient was prescribed an unspecified muscle relaxant which did not improve symptoms. Reporter consented to follow up.
VACCINE 12/22 having congestion, cough, runny nose starting 12/24 and current 12/28
nausea; Headache; insomnia; This is a spontaneous report from a contactable healthcare professional. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 30Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. There were no allergies to medications, food, or other products. Concomitant medications included vitamin b complex (VITAMIN B), colecalciferol (VITAMIN D [COLECALCIFEROL]), and zinc. On 31Dec2020, the patient experienced nausea, headache and insomnia. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovering  Information about batch/lot number has been requested.
Client reported that she was "sweating" through the night, has temp. of 95.8, has "chills" and feels achy. Came to work, but went home ill about 10:15 AM.
Pt. presented in office 8/9/11, 1 day after receiving vaccines with c/o pain redness & swelling in injection site on left arm. Symptoms started that am. On examination pt had erythematous wheal with 5cm induration, that afternoon pt. had fever, increased 102 and continued next couple of days. Symptoms gradually got better over 1wk. Area of redness totalled 13 x 15 cm in area.
Extreme Fatigue, Extreme Body Aches, Fever over 101 degrees, Sweating, Chills, Extreme headache, Sensitive to Light, Loss of appetite, Extreme soreness and pain at injection site for 7 days,
A report has been received from a Health Professional concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST QUADRIVALENT 0.2 Millilitres, Total. FLUMIST QUADRIVALENT started on an unknown date. The reporter stated patient was administered expired dose which started on 13-Jan-2016. The outcome of the event of expired dose is unknown. The reporter's description of the event(s) was as follows: No pertinent medical history for any of the 3 children. The report was considered to be non-serious.
This spontaneous report was received from a registered nurse refers to a 55 year old female patient. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 05-OCT-2015 the patient was subcutaneously vaccinated with 0.5 ml of PROQUAD (Merck) in the right arm. No concomitant medications were reported. Reporting nurse stated that the patient was supposed to be vaccinated with M-M-R II and VARIVAX (Merck), but due staff error the patient was administered with PROQUAD (Merck). No adverse effects were reported at this time. Additional information is not expected as the reporter did not wish further contact.
After first shot only mild arm pain which dissipated after a few days.  After second shot mild arm pain, chills, fever for a day. However Tinnitus has been noticed (both ears). It's been almost two weeks since second shot. Tinnitus still there.
Extreme coughing about 2 hours after the shot. accompanied with a sore throat. Had watery eyes, itchy and matted. Coughing and sore throat went away in about 2 and a half hours. Rest of evening, extremely tired and had headaches. The next morning, lips were swollen. She is not not imaginer. Everything is fine now.
Chills starting at hour 6 with a faint headache. Chills only lasted 2 hours. Faint headache turned into worst headache of my life my hour 10. Called doctor they said to take one 500mg Tylenol every 6 hours. I was better after only taking one. Did not take any more. Minor soreness in arm. Small red rash at injection site that seem to appear and disappear over a 2 day time frame
sob, nausea, vomiting, tremor, tachycardia, hypoxia
Patient received Moderna COVID vaccine on 3/24/21 and 4/21/21.  On 1/14/22, patient tested positive to COVID and was admitted to our inpatient med/surg unit with uncontrolled abdominal pain, acute renal failure, and pneumonia due to COVID-19 virus. As of today (1/18/22), patient is still admitted in the med/surg unit.
Approx 15 minutes after vaccination, pt experienced lightheadedness, brief syncopal episode and blood pressure too low to palpate. Very weak peripheral pulses felt. Pt remained awake but very pale, diaphoretic and slightly cyanotic around the mouth. No rash, wheezing or shortness of breath. Due to low perfusion, pulse ox unable to read. Pt laid down in vehicle (at drive-through vaccine site), legs elevated. Epinephrine 0.3mg 1:1,000 administered IM and pt's blood pressure and peripheral circulation immediately improved. Transported by ambulance to local hospital emergency department.
Erythema - excoriation of left upper arm from distal shoulder to elbow. Given triamcinolone cream twice a day.
Developed temp of 104.8 several hrs p/receiving immun along w/screaming for a few hrs;
Patient received under diluted dose of covid 19 pfizer 5-11 vaccine. No adverse effect noted.
Vaccine kept in the refrigerator for more than 30 days; Vaccine administrated beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine kept in the refrigerator for more than 30 days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient was not immunocompromised.     On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administrated beyond 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine kept in the refrigerator for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that there was an error in documentation that occurred in their facility.  The 30 day use by expiry date of the vaccine was written inadvertently as 16-Apr-2022 and they found out that it was supposed to be 06-Apr-2022 instead of 16-Apr-2022. The patient received the third dose as booster dose of the vaccine.  No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2022-538933, MOD-2022-538899 (Patient Link).
MOTHER STATES PT HAD SIGNIFICANT GENERAL MALAISE AND JOINT PAIN STARTING HOURS AFTER ADMINISTRATION. THE NEXT DAY SHE HAD LOCALIZED SWELLING AND SIGNIFICANT SORENESS TO LT ARM.
Next day underarm red, splotch. Took BENADRYL and ice to area.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: redness of injection arm
About a day after the vaccine, (Thursday) I developed a mild headache and mild general aches . These resolved quickly. But  about Friday, my  right hand began to ache a bit. It became excruciating by Sunday.  My right elbow and my right ribs also hurt, but the joints in my right hand were on fire. I could not open, close, or flex it without severe joint pain. It was sore even to the touch especially at the joints.  The hand appeared to be a bit swollen as well. I took ibuprofen and it helped a bit. By Monday morning it was much better, but my hand still aches some.
about 1/2 to 1hr p/vax pt began w/temp had APAP p/vax;had non-stop crying about 2hr p/vax & this lasted 2 days;had a rash on face 1 day p/vax;did not want to drink;would not move;no jerking;temp was as high as 105;was OK by 17AUG96;
an asthma cough; an asthma cough; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (an asthma cough) and ASTHMA (an asthma cough) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (an asthma cough) and ASTHMA (an asthma cough). At the time of the report, COUGH (an asthma cough) and ASTHMA (an asthma cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Patient had asthma cough and wanted to know whether they can take booster.
PATIENT RECEIVED A VACCINE FROM A PUNCTURED VIAL THAT HAD BEEN REFRIGERATED FOR 48 HOURS. NO ADVERSE EVENTS HAVE BEEN.
12/10/2021 patient received 3rd dose of moderna vaccine (0.25 mL). 12/11/2021 patient experienced chest wall ache (center of chest). Area was sore to touch and was relieved by repositioning. She reported she had similar symptoms with 2nd Moderna dose. pain as a "4" in severity (on a 1-to-10 scale), dull, and aching., nausea and headache  12/15/2021 patient was found expired at home
Vaccine was administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illness at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Age of the patient was reported as 19 years 11 months.  Concomitant medication of the patient was not reported.  The patient did not experience any adverse reactions after the administration of vaccine.  No treatment information was provided by the reporter.
SUDDEN onset of OCD symptoms, sudden onset of anxiety and sudden change in mental state. Diagnosed with PANDAS.  Tested for strep & Lyme. both negative. CT scan, normal.
This spontaneous consumer report (initial receipt 16-Dec-2011) concerns a 70 old male patient, who had a medical history of arthritis, acid reflux and sulfa allergy. Concomitant medications included arthritis medication (unspecified) and acid reflux medication (unspecified). In mid Nov-2011 the patient received flu vaccine in his left arm. On the same day he also received PNEUMOVAX 23 injection in right arm. Immediately post vaccination the patient experienced adverse reaction of pain and soreness of the right arm. The right arm injection site reaction progressed to swelling, redness and the soreness continued, so much so, that he could not lift his right arm. A few weeks after the vaccination, the patient started to get a burning sensation under the right arm, in the armpit. The patient went to a doctor last Tuesday. He was diagnosed a possible shingles and prescribed an unspecified shingles medication. The patient did not have a rash or bumps under his right arm and he did not think it was shingles. In addition the patient claimed that the shingles medication was not helping. The burning sensations continued under the right armpit. He would contact his doctor for follow up. The event outcome was not recovered.
It was like shingles on right leg; Pain in the knee in right leg; Rash right leg  from the knee to ankle to feet; Sweating; Dizziness; Weakness; It was like hives on right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Rash right leg  from the knee to ankle to feet), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), ASTHENIA (Weakness) and URTICARIA (It was like hives on right leg) in a 63-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 037A21B and 046b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient has no known Allergies.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, HYDROCHLOROTHIAZIDE and LISINOPRIL for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced RASH PRURITIC (Rash right leg  from the knee to ankle to feet), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), ASTHENIA (Weakness), URTICARIA (It was like hives on right leg) and ARTHRALGIA (Pain in the knee in right leg). On an unknown date, the patient experienced HERPES ZOSTER (It was like shingles on right leg). At the time of the report, RASH PRURITIC (Rash right leg  from the knee to ankle to feet), HYPERHIDROSIS (Sweating), DIZZINESS (Dizziness), ASTHENIA (Weakness), URTICARIA (It was like hives on right leg), HERPES ZOSTER (It was like shingles on right leg) and ARTHRALGIA (Pain in the knee in right leg) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Ultrasound scan: no blood clot.         No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable