chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effects reported; multiple unspecified patients were administered improperly stored M-M-R II. The M-M-R II was reconstituted with properly stored STERILE DILUENT; This non-valid spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On unknown dates since February 2020, the patients were vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA, lot # S015428, expiration date 20-MAY-2021 (dose and route of administration were not provided) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstitued with properly stored sterile diluent (lot # T001631, expiration date 11-JUN-2022).  It was reported that the doses of the product administered to the patients were not stored properly for the time frame of 1 hour in the temperature of 10.75 degrees Celsius (reported as above 9 degrees Celsius, 10.75 C) on an unknown date. There was no previous temperature excursion. Digital Data Logger was involved. No adverse effects were reported.  This is a non-valid report since it concerns unspecified patients.  As of 13-AUG-2020, all telephone attempts trying to obtain additional information has been unsuccessful.
Patient said she felt ill. became unresponsive. Would fallen if we didn't support in chair. It appeared her eyes rolled back.  Airway breathing was monitor. and fine. Called 911.  She started to come to but was extremely clammy and complained of ring in ears. she was glad EMT's checked out but declined to go to hospital with them.  We kept checking he till a friend came to pick her up.
Strange rash and spots all over body (legs, arms, thighs, chest, breasts, etc.)  Itchy and they fade out and flare-up again. When they fade they become larger, flat, and purple-like color, some rough in texture. When they flare-up they are bright red and itchy. Approximate start date: 01/27/2022 to the present. I still have them on my body.
Patient developed localized hives, on 3/24/17, around site of injection. Returned to office 3/28/17 and discussed antihistamines and going to E.D. if symptoms worsen.
Vaccine was given on second day of menstruation cycle on 4th day of mensuration when normally my cycle is finished or tapering off. I had an increase amount of bleeding with large blood clots. At the same time my birth control brand was switched to another brand so didn't know if the change in bleeding/clots was related to change in birth control or moderna vaccine. I reached out to my gyne and made her aware she stated that it was not related to the birth control as it was the same med/dosage. That more than likely was related to moderna vaccine and if the bleeding didn't stop or if it increased to seek medical attention. My cycle lasted for a total of 9 days vs 4-5 days. Clots were from day 4-9.
PATIENT REPORTED FEVER OF 103F, NUMBNESS IN FINGERS, AND SWELLING AT INJECTION SITE DAY AFTER VACCINATION. PATIENT WENT TO HOSPITAL DR SAID IT WAS MOST LIKELY FROM THE FLU VACCINATION. DR STATED HE HAD SEEN MULTIPLE PATIENTS IN DUE TO ADVERSE RXN TO FLU VACCINATION THIS YEAR.
12 year old healthy male who presents with chest pain 2 days after receiving second dose of COVID-19 vaccine (pfizer) on 6/14. Yesterday with tactile fever and headache, resolved with tylenol. This morning woke up with substernal chest pain, described as "heaviness on chest," worse with deep breaths. No SOB or difficulty breathing. Pain does not radiate. No diaphoresis. No nausea/vomiting. No lightheadedness. No fevers/chills, cough, rhinorrhea, conjunctival injection or sore throat. No rash. Normal PO. Normal UOP. Last stool yesterday, normal. No sick contacts. No recent travel.   No family hx of cardiac disease, sudden death, or coagulopathy.
Back of my right leg has a quarter size oblong shape lump it's little bit red but not warm to the touch; Back of my right leg has a quarter size oblong shape lump it's little bit red but not warm to the touch; Back of my right leg has a quarter size oblong shape lump it's little bit red but not warm to the touch, it may be a blood clot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 30Dec2020 18:30 SE for immunization. The patient's medical history and concomitant medications were not reported. Patient received the Pfizer Vaccine the day of reporting: 30Dec2020 at about 06:30 (tonight). Patient felt fine and still felt fine but when was going to rub some lotion on the back of right leg, has a quarter size oblong shaped lump (onset date not reported) which was little bit red but not warm to the touch. Patient didn't do anything to make it happen. Patient doesn't know if it may be a blood clot which was patient's question. "The blood clot something may be concerned about." Patient asked "Is this a blood clot, it could go to my heart and I could die tomorrow? So I am going to call my family doctor but thank you." The outcome of the events was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient had no pertinent medical history, no concomitant medications and no drug reactions/allergies. On 25-AUG-2008 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, the first dose, site and route of administration, lot# and expiration date were not reported. On an unknown date, after receiving the first dose of (Oka/Merck) VARIVAX, the patient developed shingles. On an unknown date the patient recovered from shingles. Relatedness between use of (Oka/Merck) VARIVAX and the event of shingles was not reported. Additional information has been requested.
shot not administered within 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shot not administered within 36 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shot not administered within 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shot not administered within 36 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
thumb numbness; thumb tingling; rash developing on the bicep, tricep, and shoulder; patch of redness on her elbow area; sore arm; pain in the pectoral area of the chest; bicep and tricep pain; shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cervical disc disease.   On 4th November 2019, the patient received the 1st dose of Shingrix. On 4th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, chest pain, muscle pain and shoulder pain. On 15th November 2019, the patient experienced numbness in fingers, tingling, rash and skin red. On an unknown date, the outcome of the pain in arm, chest pain, muscle pain, shoulder pain, numbness in fingers, tingling, rash and skin red were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chest pain, muscle pain, shoulder pain, numbness in fingers, tingling, rash and skin red to be related to Shingrix.  Additional details were provided as follows: The patient reports that she received dose of Shingrix and experienced a sore arm and soreness radiated to the bicep and tricep.  The patient is also reporting pain in the pectoral area of the chest. The patient has a history of cervical disk issues and the physician felt that the soreness was due to the cervical disks.  The patient, 4 days before the time of reporting,, reports a rash developing on the bicep, tricep, and shoulder, patch of redness and rash on her elbow area, about 4 inches down from the injection site.  The patient also reports numbness and tingling of the thumb.  This report will be cloned. The husband, patient one, is the reporter for himself and for patient 2, his wife. The follow up consent was not granted. This case has been linked with case US2019209364, reported by same reporter.
pt recvd vax; large erythematous swelling of prox outer lt arm at site 12jul94; DTP inject tender & fluctuent I&D on 22JUL94,much purosanginous drainage,culture = 0 organisms, no growth in 2 days;
Right arm swelling at injection sight. Spot was hard and swollen for 24 hrs and then decreased.
excessive sweating; This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on unspecified date, as dose 1, single for COVID-19 immunization. The patient medical history includes Type 2 diabetes. The patient concomitant medication was not reported. The patient experienced excessive sweating no fever. The outcome of the event was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient's arm immediately began to swell at the injection site.  No bleeding but area became hard and puffed straight out.  Slight discoloration developed.  An ice pack was given and patient monitored for any other signs or symptoms for 30 minutes.
Patient with seizure pulled off during vaccination and ended up receiving half dose of moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (Patient with seizure pulled off during vaccination and ended up receiving half dose of moderna vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced UNDERDOSE (Patient with seizure pulled off during vaccination and ended up receiving half dose of moderna vaccine). On 26-Feb-2021, UNDERDOSE (Patient with seizure pulled off during vaccination and ended up receiving half dose of moderna vaccine) 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.   Treatment and concomitant medications were not provided by reporter.
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During February of 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in July of 2016, the patient was treated by a physician in a physician's office for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Two types of rash big, raised hives, swelling of hands and feet, sore muscles, achy, slight fever, joints hurt, red eyes, headaches, tired within hours of vaccines. Was diagnosed with vasculitis, JRA, lupus after vaccines.
Injection was given in upper left arm.  Increasing soreness felt deep in left arm throughout that day, and next day.  Now has remained at that level and has not worsened further.  The pain is deep in the left shoulder joint and worsens upon movement.  It is difficult to find a comfortable sleeping position.  Constant aching as well.  No pain at the injection site however.
Right shoulder blade  started hurting immediately, told administer. Later felt weak, clammy, nauseated, all over dizzy/shaky. Napped fitfully, sweat profusely (sour smelling sweat), weird dreams.  After about 4 hours, woke, feeling better, but had not appetite to eat dinner. Started feeling  all of the same again around  10 pm, so went to bed. Went through the same most  of the night , woke around  7 am , feeling better, but seriously drained. Right shoulder blade still hurts.  Still pretty drained, two days later.
swelling of breast; This case was reported by a other health professional via interactive digital media and described the occurrence of breast swelling in a adult 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 breast swelling. On an unknown date, the outcome of the breast swelling was unknown.   It was unknown if the reporter considered the breast swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient experienced breast swelling after shingrix vaccine administration. The reporter wanted to know could Shingrix cause swelling of breast.
After the vaccine,  I was having dizziness, not feeling well, fatigue and severe stomach pains. I slept for a long time. About a week afterwards, my stomach was still very upset, nausea, vomiting, tingling and pain in extremities (fingers, arms, neck, shoulder) and loss of appetite.  After a week and 1/2, I decided to seek medical care and I went to the ER.  At the ER, I was given IV fluids since I was dehydrated.  They order blood work, CAT scan with contrast (positive for cyst on ovaries and gall stones). They gave me oral pain medication and oral Zofran for nausea.  I was sent home with Zofran and OTC pain medication and follow up with specialist for ovaries, gall stones and shoulder pain.   Symptoms improved over the few weeks. It took me about 2 weeks to feel better.
Profuse bleeding causing the provider to remark on it. Immediate severe bruising 2.5 inches in diameter. Throbbing and soreness immediately followed. Throbbing X 1 week. Soreness until present day. Bruising still visible until present day.
Td given to left deltoid 8/20/03. That evening a rash (pruritic) was observed on the pt's left arm. left chest, left shoulder. Also he complains of sore left neck. Clinic appointment 8/22/03. Large urticarial areas no central clearing observed left deltoid (18x14cm), left chest (5x3cm and 9x5cm), left scapula (7x6cm) left axillary (6x3cm). Rx with Benadryl.
On 2/8/00, pt had swelling, warmth and redness. Dx'd with cellulitis on 2/10/00 and given dicloxacillin.
52yr old patient with history of sensory peripheral neuropathy, HTN, pre-diabetes, and other comorbidities presented on 4/8 for annual well-visit.  MD ordered patient to receive Pfizer SARS-CoV-2 (COVID-19) Vaccine booster during visit.  CMA prepared COVID-19 Pfizer vaccine (LOT # FK9895) IM in patient's left deltoid.  Patient monitored 15minutes.  On 4/12, patient called complaining of mild swelling to right axillary post injection.  Swelling had progressed to L axillary and feels it in breast.  Pain 6/10, with bilateral axillary and breast tender and constantly sore.  Patient endorsed taking ibuprofen without relief.  Patient noted redness and itching at injection site of right arm.  Patient denied fever, numbness Patient denied fever, numbness, tingling, confusion, rash, shortness of breath.  Unclear as Immunization documentation shows booster given in Left deltoid, but patient's symptoms in right arm.  During follow up office visit on 4/12, patient positive for chills, fever, myalgias, itching, and rash and headaches.  MD instructed patient to continue ibuprofen 800mg TID, add acetaminophen 1000mg Q8H, and use cool compress 20min at a time, and diphenhydramine 25-50mg QHS PRN for swelling/itching.
Raised erythematous papules coalesced into patch. Appeared to be target in nature - to arms & neck. No oral lesions. Very pruritic. Improving with BENADRYL.
Patient received first vaccine dose on 3/10/21, waited for approximately 1 hour in Pharmacy after.  Was walking to her vehicle and became short of breath.  Patient got to her vehicle and called 911 due to severe shortness of breath.  Rescue arrived on scene at approximately 11:00am, found patient in distress and administered epinephrine, methylprednisolone, and diphenhydramine.  Patient placed on CPAP in rescue en route to ER, became unresponsive, frothing pink sputum.  Intubated by paramedics en route with iGel device.  Patient arrived to ER at 11:22am, went into cardiac arrest at 11:24am.  Patient continued to be unstable, had multiple rounds of cardiac arrest and ROSC.  Patient ultimately did not survive arrests, and pronounced dead at 2:37pm.    Medications received during course in the ER - epinephrine 1mg x18 doses, sodium bicarbonate 50mEq x4 doses, calcium chloride 1g, insulin regular 10 units x1, furosemide 80mg x1, epinephrine titrated infusion, sodium bicarbonate infusion.
This is a spontaneous report from a contactable consumer or other non-HCP. This is report 2 of 3. A female patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The caller stated she spoke to a lady who said she had an underarm lump the size of an orange. She may have been exaggerating about the size. She said she did not see it anywhere about being a known side effect. Then another lady said she also had a lump under her arm and it went down. The caller  believes Pfizer should have something put out saying it should be known especially in women. Even her doctor says its recommended for women not to have a mammogram at least 6 weeks after the vaccine. No further details provided. The lot number for the vaccine BNT162B2, not provided and will be requested during follow-up.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3183), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FA7485), for COVID-19 immunization; and had a reaction: "I had a lot of fatigue," "I'm a migraine sufferer and it threw me straight into a migraine headache." The patient reported a rash ("rash all over my body/rash popped up all over my body"), with outcome of unknown. Therapeutic measures were taken as a result of rash. Additional information: Consumer stated, they were fine after the vaccination for 24 hours. The pharmacist called and said "if you are going to have a reaction with it, would happen 24 hours after." On the first shot, patient didn't have this reaction. Instead, they had a lot of fatigue and got a migraine headache. They are a migraine sufferer. With the second shot, patient was okay initially, but yesterday a rash popped up all over their body. The rash persisted for a full 24 hours. The only thing that seems to be kind of keeping it under control is Benadryl (treatment). Follow-up attempts completed. No further information expected.
After the shot, a very sore arm with inability to lift it over 90 degrees to the side.  Increased soreness into next day (04/02/2010). Then about 6:00 PM that evening, noticed a Marble-sized ball of pain around the left clavicle, moveable up and over the clavicle and then it would slip below the clavicle, causing a sharp stabbing type pain and a "raw" feeling as any head movement or shoulder movement would drag the ball over the clavicle.  Difficult sleeping Friday night into Saturday Morning (04/03/2010).  Progressed pain and then stiffness up the left side of the neck to the jaw line.  Finally pain became too much and couldn't lie down w/o pain. Went to Urgent Care.  After eval. with Dr. and full history/exam, determined to be a reaction to the DPT Vacinnation, a swollen/inflamed lymph gland.  Was given two medications, a Vicodin (one pill only) and I believe a Restoril (sleeping pill) since my son was on second day of minimal sleep.  Released from Urgent Care @ 4:00 AM on Easter Sunday (04/04/2010)
c/o tingling in the finger, tightness of the chest which seems to be getting better.  BP: 109/73 HR: 92 Sp02: 96% room air *Seen by EMS, patient was advised to be taken to ER but she refused. Refusal form signed with EMS* Patient states she will monitor herself and go to ER if needed, reports feeling much better.
Pain back of throat, burning, red & inflamed urethra, same inner lips, white sores & bleeding a little. Prednisone prescribed. (Mucositis) Also vaginal symptoms same as above.
patient complaining of sore left arm since vaccination.  Additinally patient has rash/ hives on arms, back of legs, and stomach. Patient also complaining of itching
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 12-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a certified physician assistant for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Infantile spasms started on the 3rd day after vaccinations and progressed. Diagnosed in January 2009, being treated with medications (TOPAMAX, B6). Led to developmental delays.  4/27/09 MR received for DOS 1/6-8/2009 with D/C DX:  Seizures, likely infantile spasms. Pt presented with 6 month hx of arm jerking with central core stiffening, which have recently increased in severity and number. Parents report pt is sometimes sleepy afterwards and has been increasingly irritable lately and babbling less. Admission PE WNL. Admitted for W/u. 5/12/10 Delayed developement (receiving special ed. services). Still on seizure meds, speech delay.