chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received A re frozen of the vaccine; Patient received A re frozen of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received A re frozen of the vaccine) and PRODUCT STORAGE ERROR (Patient received A re frozen of the vaccine) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received A re frozen of the vaccine) and PRODUCT STORAGE ERROR (Patient received A re frozen of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received A re frozen of the vaccine) and PRODUCT STORAGE ERROR (Patient received A re frozen of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. This is a case of Expired Product Administered concerning 79-year-old patient of an unknown gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-381132 (Patient Link).; Sender's Comments: This is a case of Expired Product Administered concerning 79-year-old patient of an unknown gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Tired, headache, chills, fever- 4/28/22 Swollen arm - 4/28/22 Swollen armpit/lymph nodes left arm - 4/29/22
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 15-OCT-2015, the patient was vaccinated with a dose of improperly store (incorrect product storage) RECOMBIVAX HB, lot number L016427, expiration date 13-APR-2017, (dose, route and anatomical location were not reported). No adverse effect was reported. There was no concomitant medication reported. This is one of several reports received from the same source. Additional information has been requested.
Massive spike in blood pressure, tingling in arms and legs, random body aches, fatigue that lasted better part of 6 weeks.
temperature excursion for GARDASIL/Vaccines were administered to patients; This spontaneous report has been received from a medical assistant, referring to an 11-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 30-AUG-2021, the patient was vaccinated with an improperly stored dose of hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliters (mL) intramuscularly (IM) (anatomical site of vaccination and vaccine scheme was not provided; lot number T026323 has been verified to be valid, expiration date reported and established as 22-FEB-2023) as prophylaxis.   The vaccine experienced a temperature excursion of 47 degrees Fahrenheit during a time frame of 47 minutes (product storage error). There was no previous temperature excursion.
Concern for a possible post-vaccine MIS-C-like inflammatory reaction Symptoms at presentation included intermittent fever and hives-like rash x 5 days, conjunctivitis x 1 day, and lip erythema x 1 day.
Pt. noticed red tender area at vaccine site 24 hours after injection. Persisted for 6 days then a second similar lesion developed below the first measuring about 4 cm, which persists at day 8 (time of report). No other reaction noted.
Patient received J+J COVID vaccine by different vendor on 4/3/2021. Patient then received Pfizer dose as documented on this report by us, No adverse events reported on site.
Diarrhea started on 2/5 before breakfast and another after dinner on 2/5/21 and vomiting around 2/5/21 @1500. 2/6/21 continues with diarrrhea
CHEST PAIN; FLU LIKE SYMPTOMS; NECK PAIN; EARS HURT; This spontaneous report received from a parent concerned a 19 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the subject experienced chest pain. On 03-AUG-2021, the subject experienced flu like symptoms. On 03-AUG-2021, the subject experienced neck pain. On 03-AUG-2021, the subject experienced ears hurt. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, flu like symptoms, neck pain, and ears hurt. This report was non-serious.
I began feeling soreness at the injection site started within 12 hours of receiving the vax.  The soreness progressively became worse over the next 7-9 days and was accompanied by swelling of the muscle around the injection site (peaking at about 7 days post-injection). The discomfort at times extended down my arm, but never past my elbow.  When extending my arm outwards (e.g., when reaching for something), I would feel an unusual stiffness and moderate discomfort in my arm.  As of April 12 (13 days post-vax), the swelling is largely gone, but there is still some discomfort when extending my arm outwards.  In addition, there appear to be dry patches of skin between the injection site and my armpit.  I have not sought medical treatment for these adverse reactions to date, nor do I anticipate needing to unless the discomfort becomes more intense.
36 hours after the vaccine I experience arrhythmia/tachycardia for almost 5 minutes, my heat rate was 180-190,  I have since had 3 other similar episodes.  Tremors in left arm and numbness.  Ongoing headache.  Elevated  blood pressure.
Patient made appointment, came in, answered all questions on VAR form as her first dose. No records in our systems of any previous vaccine and verbally verified with patient prior to giving vaccine. We were notified by a family member after the fact that the patient had already received her Pfizer series earlier in the year and that patient is forgetful. Family reported three days post vaccine that patient was hospitalized
Hot flashes, extreme headaches, extreme fatigue, muscle fatigue, lasting greater than 12 hours
Lightheadedness. Malaise. Chills. Headache. Cough.  3/26/09 Received hospital medical records of 10/7-10/8/2009. FINAL DX: Percutaneous coronary intervention w/stenting Records reveal patient experienced atypical chest pains.
pt received the second dosage of the shingrix on 07/09/19.  pt started having a severe rash all over her body on 07/12/19,  Pt was advised to visit with her primary doc.  Pt went into her primary doc on 07/12 and she was given kenalog /decadron shot along with benadryl oral q 4 h .  On 07/14/19 pt called, staff rph at store, and consulted with her as the symptoms still persisted without much relief.  Upon consulting with dr's nurse, pt's primary care, they concluded that the rash was caused by a secondary reaction to the shingrix vaccine.  Currenly 07/16/19 pt has a follow up appointment at 3:30 pm .
great deal of itching, kept moving as far as locality, raised itchy sights, intense, went away after a few days, pt had also gotten 2nd shingrix shot and fluzone hd, on that same day
Left arm swollen, red, hot, rash, tender. Sore with movement. Redness approx. 4x3 inches.
Admit to hospital 8/20/08, HA, fever, nausea x 2days. HA following MENACTRA given 8/18/08 - sister also diagnosed meningitis and hospitalized 8/12/08; she also received vaccine 8/18/08  9/26/08 Reviewed hospital medical records of 8/20-8/23/2008. FINAL DX: viral meningitis, enterococcus. Records reveal patient experienced HA, photophobia, fever & nausea.  Younger sibling admitted w/same.  Tx w/IV antibiotics & antivirals.  Improved & d/c to home.
Information has been received from a nurse practitioner concerning a male who in approximately 1987, at approximately age 14, was vaccinated with MMR II. The pt received this vaccine in a foreign country. Subsequently, the pt told the nurse practitioner that he experienced a severe anaphylactic reaction. The pt did seek medical attention. Follow up info revealed that since the pt received the vaccination in a foreign country approximately 15 years ago there was no additional info available.
Patient describes symptoms as follows: Shortly after dose administration, he experienced pain going down his arm to his wrist. After that, the pain started to expand to his shoulder and up his back. As the evening progressed, he started to feel weaker and weaker. At 2 am (the morning after dose administration) he woke up with chills, muscle and joint pain, and burning skin. All of these symptoms were felt mostly in the upper body. Patient mentions that the burning skin was felt on his face and scalp. Unfortunately, the next day, the symptoms continued, but progressed to general malaise to the point that he said that he could not stay awake. This fatigue lasted all day. The adverse effects lasted about 48 hours in their entirety according to the patient. The patient has since improved and returned to baseline.
#1 dose of varicella given 7-17-19. Employee presents to clinic 7-19-19 with complaints of warmth, redness and swelling to the R. Arm at the injection site.
Pt was given vaccines at approximately 6:40pm pt waited until approximately 7:00pm to leave when he stood up he felt lightheaded and passed out. Pt came to immediately with no injury.
Patient passed away due to cardiac arrest Narrative: The patient had with PMH of CAD and multiple PCI, HFpEF, HTN. DM2, ESRD on HD, COPD and home O2 and other co-morbidities. Patient received his first dose of Pfizer vaccine on 1/21 and no adverse reaction was reported. Patient had a cardiac arrest on 2/1 and he was admitted to hospital. Patient passed away naturally on 2/1. Cause of death is not related to COVID 19 vaccination.
Breakthrough case admission after 3 vaccines Pfizer 1/27/21 Lot# EL9264;  Pfizer 2/17/21 Lot# EN6201;  Pfizer 10/1/21 Lot# FF2590
Night of vaccination I thought I was experiencing the traditional side effects of fatigue but it consistently got worse. I would blackout from time to time, nausea, hot flashes, and chills,  a hay fever. I wasn't sick prior to the vaccine and had not been around anyone with Covid. I was like this for a whole week. Since then, I found myself being more lethargic than normal. I can handle that but for the five menstrual cycles, I have felt the effects. My iron levels would drop suddenly three days before beginning my cycle.  It hits sudden and I have fallen many a time. Some while on stairs. I have to be bedridden for the first two days of my cycle. I can't walk without collapsing, vomiting, and/or my vision spins consistently. This never happened before my cycle ever.  This can continue for two days or five days.  The last time this happened was a week ago for the last cycle.
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 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: EW0151), in left arm and on 03May2021 as dose 2, single (Lot number: EW0173) at the age of 26 years, in left arm for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 07Dec2021 as dose 3 (booster), single (Lot number: 029H21B), in left arm for covid-19 immunization. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "mast cell activation syndrome" (unspecified if ongoing); "postural orthostatic tachycardia syndrome" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing); "likely autoimmune condition" (unspecified if ongoing), notes: Other medical history: likely autoimmune condition; "ADHD" (unspecified if ongoing), notes: ADHD; "OCD" (unspecified if ongoing), notes: OCD; "obstructive sleep apnea" (unspecified if ongoing); "known allergies: Pineapple" (unspecified if ongoing), notes: known allergies: Pineapple. Concomitant medication(s) included: VYEPTI, start date: 17Dec2020; BOTOX, start date: 23Aug2021; TROKENDI XR, also reported as other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive; (16May2022) Negative; (21May2022) Negative; (23May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid (start date: 11May2022, stop date: 15May2022). Clinical course was reported as, patient was tested positive for COVID on 10May2022; had symptoms started 09May2022 and started Paxlovid on 11May2022, took for 5 days (full course). She was tested negative on 16May2022, started having symptoms again on 21May2022; tested negative on 21May2022, Symptoms worsened; tested positive on 23May2022. Overall symptoms from COVID: chest pain, shortness of breath, cough, sneezing, congestion, chills, fever. Paxlovid eliminated chills and fever. Patient was not recovered from symptoms and no treatment received for symptoms.
Mild dizziness few minutes after I got the vaccine. I was advised to stay for few more minutes, vital signs checked, drank water, ate  something. Dizziness went away after 30 minutes. Severe injection  site pain the night of injection warm compresses done. Next day,  ( Jan7,2021 )woke up at 4 am with body aches especially on my lower extremities  headache, weakness  and fever reaching 102.7. Started taking Tylenol 1000 mg.   Symptoms were not relieved after 6 hours, but became more intense. Continued taking Tylenol every 6 hours round the clock until the next day, (1/8/21). Symptoms subsided but still w/ manageable headache and weakness. Symptoms subsided
Local area of injection in L deltoid reddened and warm to the touch. Child denied discomfort. Mother denies swelling.
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 38 patient's symptoms improved after Moderna vaccine; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine).    Concomitant medications were not reported.  Reporter stated she had been administering the 65+ bivalent dose to her patients who have symptoms of "long-haul COVID" (non-indicated use of vaccine) and had seen 88-90% success rate in resolving the symptoms of long-haul COVID. Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reaction reported. Treatment medications were not reported.  This case contains information for patient 29 out of 42.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Patient 29 out of 42 patients
mild nausea; Fatigue; diffuse myalgia; Arthralgia; T 37.5; Palpitations; Tingling in feet and hands; mild lightheadedness; headache; This is a spontaneous report received from a contactable other healthcare professional (patient). A 43-year-old female patient received bnt162b2 (COMINARTY, Solution for injection, Batch/Lot Number: EL3249), intramuscular, administered in arm left on 09Feb2021 12:15 as dose 1, single for covid-19 immunisation. Medical history included ongoing headache, GI discomfort from NSAIDs, possibly gluten. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks, did not experienced covid prior and post vaccination. On 09Feb2021 12:45 (after 30 min after injection), the patient experienced tingling in feet and hands, mild lightheadedness, headache, on 09Feb2021 20:15 (after 8 hrs after injection), the patient experienced palpitations, on 10Feb2021 00:15 (12 hrs after injection), the patient experienced mild nausea, fatigue, diffuse myalgia, arthralgia, temp 37.5. On 10Feb2021, the patient underwent lab tests which included body temperature: 37.5. Therapeutic measures were taken as a result of temperature 37.5 (body temperature abnormal). The clinical outcome of the tingling in feet and hands, mild lightheadedness, palpitations, mild nausea, fatigue, diffuse myalgia, arthralgia was unknown and of the headache, temp 37.5 was not recovered.
Sore everywhere. Lower stomach & groan is very sore. I can't hardly sit. Motrin is giving me some relief. I was running a fever yesterday 3-29-21. Hands are very stiff and ache.
Joint and muscle pain. My ankles and feet hurt so much that it is hard to walk. My legs are sore.  My right arm hurt all the way down. It feels better this morning.  And my right side of my neck and jaw hurt immediately after but both feel better. Although my back right shoulder muscle is tight.
Case number PHEH2011US01503 is an initial spontaneous report received from health care professional on 12 Aug 2011. This report refers to a 20 year old female patient. She was vaccinated with Menveo intramuscularly on unspecified date. But, she received only the Men CWY liquid conjugate without reconstituting it with the Men A lyophilized powder component. No adverse reaction had occurred following this drug administration error.
Woke up Sunday morning with my face swollen and fire red on the right cheek and rash on the left cheek and brow.  Right cheek hurts because of the swelling.  Took 2 Benadryl at noon.  Right cheek is burning.  Today is Monday and it is still swollen but not as red.  It hurts and got more Benadryl to take.  Took 2 at 3pm today.
pt recvd vax;immed started screaming x 6 hrs; was given rx for stronger antipyretic at next immun;
48 hrs after receiving flu shot, pt developed non-pruritic, multiple papules on chest which later spread to back, legs, groin, ears, and soles of feet, and began coalescing. Pt. states rash feels like sunburn and is tender if rubbed. Pt also c/o of painful sloughing tongue. Pt denies N/V/D or trouble swallowing. Patient states he is an RN @ ER and was seen by fellow staff-unofficially who recommended PO Benadryl and Motrin. Rash has since stopped spreading. Patient states he has hx of receiving flu shots for 11 years with only minimal malaise in the past. Seen as walk-in and given Kenalog 60mg IM. Per ID, unclear if this is a flu shot allergy. Recommended referral to Allergy Clinic for further work up. Ruled out egg allergy as patient routinely eats eggs. SkinRash, Rash, ErythemaMultiform & Sloughing. TRIAMCINOLONE 60 MG ONCE, IBUPROFEN unknown MG Unknown, DIPHENHYDRAMINE unknown MG Unknown
RIGHT ARMPIT PAIN; ARMPIT SWELLING WHICH AFFECTS HER GLANDULAR AREA; CHILLS; HEADACHE; FEVER; INJECTION SITE TENDERNESS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205821A, expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced chills. On 02-AUG-2021, the patient experienced headache. On 02-AUG-2021, the patient experienced fever. On 02-AUG-2021, the patient experienced injection site tenderness. On 04-AUG-2021, the patient experienced right armpit pain. On 04-AUG-2021, the patient experienced armpit swelling which affects her glandular area. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, fever, and injection site tenderness on 04-AUG-2021, and had not recovered from right armpit pain, and armpit swelling which affects her glandular area. This report was non-serious.
sore throat; This case was reported by a consumer via interactive digital media and described the occurrence of sore throat in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sore throat. On an unknown date, the outcome of the sore throat was unknown.   It was unknown if the reporter considered the sore throat to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter had asked that could the Shingrix shot caused a sore throat. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Patient called pharmacy today saying that she cannot get out of bed, she feels like she has the flu. No fever, no swelling, no rash. Her body is completely sore from head to toe, muscle aches everywhere and she cannot move arm. Her neck is bothering her (rigid) but she has previous history of neck pain. She was very upset. This started night that she received the shot.