chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 17-OCT-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L042835, expiration date:19-AUG-2018, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 46 and 77 Fahrenheit degrees for 2 hours and 30 minutes. There were no previous temperature excursions reported. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000452: US-009507513-1702USA003692: US-009507513-1702USA003694: US-009507513-1702USA003695: US-009507513-1702USA003696: US-009507513-1702USA003697.
Pt seen on 2-16-2022 for Immunization services. Received Tdap vaccine at 9:15am. No problem went administration. Patient and mother was leaving the Immunization room walking down the hall to leave building. Walking through the door to the main waiting room, pt had syncope episode and slid down the wall to the floor. Nurses were called stat to waiting room. Pt found awake and alert upon arrival of nurses. She stated that this happens all the time with shots. Mom and patient declined to have ambulance come access. Pt was helped off floor and into wheelchair, monitored by Nurse Supervisor, still awake and alert x 3. She will wheeled out to car and released to mother's care.
Tingling in the left side of her neck and shoulder; Redness; Scratchy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the left side of her neck and shoulder), ERYTHEMA (Redness) and PRURITUS (Scratchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling in the left side of her neck and shoulder), ERYTHEMA (Redness) and PRURITUS (Scratchy). At the time of the report, PARAESTHESIA (Tingling in the left side of her neck and shoulder), ERYTHEMA (Redness) and PRURITUS (Scratchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient experienced redness and it was scratchy within a week.   This case was linked to MOD-2021-318618 (Patient Link).
pt recv vax 27APR96 & came to clinic 2MAY w/lt upper arm bright red & swollen from inj site to below elbow;sent to PMD who dx allerg rxn & gave rx for duricef & Medrol
Initial unsolicited case received from a consumer, who is also the patient's wife, on 16 February 2015. Another case for the patient's wife, with a similar event, is captured in case number 2015SA020526. A 58-year-old male patient received an intramuscular left deltoid injection of FLUZONE QIV (lot number not reported) on 27 September 2014. On 12 February 2015, i.e. 4.5 months post-vaccination, the patient was seen in the emergency room and tested positive for influenza type A. The event was treated with TAMIFLU and TYLENOL, and remained ongoing. Documents held by sender: None.
major pain; froze arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (froze arm) and PAIN IN EXTREMITY (major pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Patient medication history was not provided by the reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced LIMB DISCOMFORT (froze arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (major pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, LIMB DISCOMFORT (froze arm) and PAIN IN EXTREMITY (major pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.   This case was linked to MOD-2021-040665 (Patient Link).
schedule for second dose today however prior doing that she had a test for COVID-19 (Result of the test were unknown); schedule for second dose today however prior doing that she had a test for COVID-19 (Result of the test were unknown); This is a spontaneous report from a contactable consumer or other non HCP (patient) from a Pfizer-sponsored program via Regulatory Authority. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 19Aug2021 the patient was scheduled for second dose on same day however prior doing that she had a test for COVID-19 and further stated that result of the of the test were unknown. On 19Aug2021 the patient underwent lab tests and procedures which included test for COVID-19 which results was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Fever 102-103; Shortness of breath; Fatigue; Elevated HR; Swollen lymph node under the arm on the side of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 28Jan2023, outcome "unknown", described as "Elevated HR"; FATIGUE (non-serious) with onset 28Jan2023, outcome "unknown"; PYREXIA (non-serious) with onset 28Jan2023, outcome "unknown", described as "Fever 102-103"; DYSPNOEA (non-serious) with onset 28Jan2023, outcome "unknown", described as "Shortness of breath"; LYMPHADENOPATHY (non-serious) with onset 28Jan2023, outcome "unknown", described as "Swollen lymph node under the arm on the side of injection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue.  Additional information: Booster on Friday. Saturday: fever 102-103, shortness of breath, fatigue, elevated HR, swollen lymph node under the arm on the side of injection. Sunday: fatigue, taking ibuprofen every 6 hours. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: She relates having developed the following adverse effects post intial vaccination: *Nausea/headache: developed the day after vaccination, occured intermittently for 7 days after. Acetaminophen a/w alleviation of HA. NO other therapies tried or applied. She was vaccinated on a Saturday and needed to take off work the following Monday - but was able to complete all other routine activities during afterwards. *Puritic quarter sized circular rash around the injection site: developed the day after vaccination and resolved a few days ago. Now with then crescent shaped hyperpigmented area over medial side of where circular rash was. Not described as warm to touch, indurated, or a/w urticaria/hives/sloughing.
Sudden onset of dizziness, nausea, vomiting, double vision, myalgia, fatigue, headache.  Symptoms started two days following Fluzone administration. Patient presented to hospital four days following administration of vaccine.  Concern for Acute Disseminated Encephalomyelitis (ADEM)
TC 27FEb91 230pm-mom reports pt given Hib vax. Family went to dinner /p vax,pt began to vomit approx 730pm in car.Cont vomit all evening until went to sleep.Vomited X1 this AM when given bottle-went to sleep.Kept H20 down most of day...WORM
J96.00 ACUTE RESPIRATORY FAILURE 4/8/2023 ADENOCARCINOMA RIGHT LUNG, UNSPECIFIED PART R09.02 HYPOXIA 4/8/2023 ADENOCARCINOMA RIGHT LUNG, UNSPECIFIED PART J96.00 ACUTE RESPIRATORY FAILURE 4/8/2023 HYPOTHYROIDISM R09.02 HYPOXIA 4/8/2023 HYPOTHYROIDISM J96.00 ACUTE RESPIRATORY FAILURE 4/8/2023 SHORTNESS OF BREATH R09.02 HYPOXIA 4/8/2023 SHORTNESS OF BREATH J96.00 ACUTE RESPIRATORY FAILURE 4/8/2023 RIGHT FOOT DROP R09.02 HYPOXIA 4/8/2023 RIGHT FOOT DROP
Red swelling of left arm, hot to the touch, ran fever of 101.4, body aches. Received TORADOL in the right hip from Med stop on 12/14/2018. Steroid shot in right arm on 12/16/2018 from Medical Center. Also received Amox-clav 500mg. On the same day I received the Pneumonia shot, I got the Flu shot lot number EB7J7, Glaxo Smith Kline. Flu shot site was clear.
cough; runny nose; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A contactable female consumer reported similar events for herself and 1 patient. This report is for 1 of 2 patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in Aug2021 (also reported as first dose of the Pfizer covid vaccine three and a half weeks ago) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was scheduled for the second vaccine on 02Sep2021 (today) but, on an unspecified date in 2021 she was coughing with a runny nose. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The patient family was experiencing the same symptoms. Her sister already got two doses of Pfizer and had slight symptoms. Outcome for both the events were unknown.   The lot number for [BNT162B2], was not provided and would be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101151527 same product and event, different patients
A non-serious spontaneous report of "gave expired FLUMIST" was received from a nurse concerning an eight-year-old male. No medical history was reported. The FLUMIST was given on 19-Feb-2009 and had expired on 24-Dec-2008. Based on the results of the investigation, the root cause for the medications errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received on 31-Mar-2009 included Product Complaint Investigative results. Follow-up information received on 28-Apr-2009 from reporter confirming no adverse events have occurred.
Dizziness, Headache, Sedation, Fever, NauseaVomiting, sore throat Narrative:
The pt experienced fussiness, high-pitched cry, difficulty falling asleep and staying asleep, symptom started the evening of the day of the vax. The pt also had a fever of 100 - 101.
Red subcutaneous lesions (pruritic) about 1 - 3 mm in diameter occurred around both injection sites. Slightly raised areas on both cheeks (face) noted. BENADRYL ordered and the areas were gone prior to administration. Med given anyway and pt observed for 15 min prior to being released.
Shaking, throwing up, pain in the stomach started several hours after vaccine administration.  Pt went to ED and got admitted.  Ran all tests.  No other problems of significance found.  ED conclusion was that it was an adverse event secondary to vaccine administration (likely RSV Abrysvo since patient has gotten Influenza Fluzone Quad HD in the past).  Discharged within 24 hours.  Pt stated all recovered as of 9/25/2023.
Patient with PMH asthma, h/o asthma exacerbation requiring intubation and also on immunotherapy (NUCALA), which pt reportedly received today. Pt received influenza vaccine today and developed SOB approximately 10 minutes later, self-administered EPIPEN and inhaler with no symptom relief. Pt was brought to ED where emergent pharmacologic therapy (diphenhydramine, famotidine, steroids, DUONEB, magnesium sulfate) was provided but did not relieve symptoms. Pt was intubated.
Covid positive household contact.  Client is currently in Hospital waiting on a bed so he can be transfered.
CHILLS; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. 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 was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced chills. On 27-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 28-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210516323.
Received about 1/4 of the dose as vaccine leaked from needle hub during administration.  Another dose was given.
states 3 patients received doses of Comirnaty that were diluted with sterile water instead of 0.9% Sodium Chloride.; states 3 patients received doses of Comirnaty that were diluted with sterile water instead of 0.9% Sodium Chloride.; This is a spontaneous report from a contactable other HCP. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated that, she was a nurse calling from a hospital clinic. Reporter was reporting 3 doses of Comirnaty vaccine administered to patients after reconstituting with incorrect diluent. Reporter stated 3 patients received doses of Comirnaty that were diluted with sterile water instead of 0.9% Sodium Chloride. Reporter asking if Pfizer has stability information to support these doses as valid doses.  Pfizer has not tested the effects of using sterile water for injection as the diluent for the current formulation of the Pfizer-BioNTech COVID-19 Vaccine. If the vaccine that was diluted with sterile water for injection was inadvertently administered to individuals, a definitive statement on the quality and usability of the vaccine diluted in water cannot be made. The Pfizer-BioNTech COVID-19 Vaccine has not been tested with sterile water for injection as the diluent. Based on this lack of information, Pfizer is unable to definitively state if the vaccine dose is valid or invalid. Therefore, we kindly refer you to the CDC to discuss revaccination need or timing. It is not within Pfizer's remit to recommend revaccination. The clinical outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg  Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.
Patient said she had an immediate headache and later had pain in shoulder area, fever, blurred vision, elevated heart rate, and pain in feet. She treated with acetaminophen and diphenhydramine.
Acute Exacerbation of Asthma which included a 7 day hospital admission.
PATIENT REPORTS TO THE PHARMACY ON 9/29/2023, 1 MONTH AFTER HER VACCINE, THAT AT THE TIME OF THE VACCINE SHE HAD ARM TENDERNESS, AND LATER DEVELOPED DECREASED MOBILITY, SUCH THAT IT HAS BEEN DIFFICULT TO PUT ON AND REMOVE HER SHIRT ABOVE HER HEAD, IN BOTH ARMS
Arm badly swollen at injection site; tender, red, knot formed; blotchy red rash upper arm area; patient attributes reaction to the pneumococcal vaccine.
COVID Breakthrough. COVID+ on 11/4/2021 and patient is currently hospitalized with shortness of breath with no hypoxia.
FEEL DEPRESSED; SWELLING IN FACE; Neck swelling; FLARE UP/KNEES WORSE; SORE ARM/HEEL PAIN; CHILLS; Wrist pain; Vaccination site pain; Vaccine was administered through subcutaneous route of administration; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (FEEL DEPRESSED), SWELLING FACE (SWELLING IN FACE), SWELLING (Neck swelling), ARTHROPATHY (FLARE UP/KNEES WORSE) and PAIN IN EXTREMITY (SORE ARM/HEEL PAIN) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Rheumatoid arthritis and PREDNISONE for an unknown indication. Concurrent medical conditions included Ankylosing spondylitis and Rheumatoid arthritis aggravated. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 19-Mar-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient started PREDNISONE (unknown route) at an unspecified dose. On 28-Feb-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was administered through subcutaneous route of administration). On an unknown date, the patient experienced DEPRESSED MOOD (FEEL DEPRESSED), SWELLING FACE (SWELLING IN FACE), SWELLING (Neck swelling), ARTHROPATHY (FLARE UP/KNEES WORSE), PAIN IN EXTREMITY (SORE ARM/HEEL PAIN), CHILLS (CHILLS), ARTHRALGIA (Wrist pain) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, DEPRESSED MOOD (FEEL DEPRESSED), SWELLING FACE (SWELLING IN FACE), SWELLING (Neck swelling), ARTHROPATHY (FLARE UP/KNEES WORSE) and ARTHRALGIA (Wrist pain) had not resolved and PAIN IN EXTREMITY (SORE ARM/HEEL PAIN), CHILLS (CHILLS), VACCINATION SITE PAIN (Vaccination site pain) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was administered through subcutaneous route of administration) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosing remained unchanged. The reporter's causality for the event of sore arm and chills was no reasonable possibility. No concomitant medications were reported. The reporter's causality for the event makes feel depressed from swelling in face and neck, flare up/knees worse and Humira had not helped with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the events of wrist pain and heel pain was not provided. No treatment medications were reported. Reporter did not allow further contact.
swollen lymph nodes under arm on day 2 - one week later and continuing I started having spasms in my chin on the left side of face, happens a few times per hour in the same spot on the same side as the vaccine
Full body aches and pain in both the joints and muscles. Headache, fatigue,  easily out of breath. These started the day after and went away the next day. Day after injection saw blood in urine. Has not gone away.
Patient stated she had radiating pain from her arm to her neck and jaw and then down her arm.  Patient stated that she could not move her arm for 2 weeks.  She stated that she went to the doctor's office and he said that the shot was given too high.  The patient did show me a bruise on her left arm that was high on her arm, near the top of her shoulder.
stated that he was scheduled for his second vaccine and tested positive for Coronavirus the same day; stated that he was scheduled for his second vaccine and tested positive for Coronavirus the same day; This is a spontaneous report from a contactable physician. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at a single dose (first COVID vaccine) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was scheduled for the second dose on 06Jan2021 and tested positive for Coronavirus the same day. He started showing symptoms on 03Jan2021 and wanted to know, since he could not do the second Covid vaccine, because he is in quarantine and when he can get it. His quarantine ends on Friday and hopes to do it on that day. Clarified that it was 04Jan2021 that he was scheduled for the second dose and tested positive for the Coronavirus the same day and not 06Jan2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 04Jan2021. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between suspect BNT162B2 and reported event cannot be excluded.