chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 71-year-old female patient who received Shingrix for prophylaxis. On 26th July 2018, the patient received Shingrix. On 26th July 2018, 1 hr after receiving Shingrix, the patient experienced heart rate increased. The patient was treated with Benadry). On an unknown date, the outcome of the heart rate increased was recovered/resolved. It was unknown if the reporter considered the heart rate increased to be related to Shingrix. Additional details were provided as follows: The patient experienced a rapid heart rate. She defined this as 120 to 130 bpm. Twenty four hours later, it was still present. She contacted her pharmacist. The pharmacist advised to take a Benadryl, which the patient did. The patient reported that the Benadryl worked and her heart rate returned to normal. The patient had denied permission to contact their physician.
headache immediately after; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age who reported for herself received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 12Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history included antiphospholipid syndrome, cutaneous lupus erythematosus, systemic lupus erythematosus, sjogren's syndrome and chronic obstructive pulmonary disease (start date and ongoing status unknown for all). The patient's concomitant medications were not reported. The patient previously took immunosuppressants. Unspecified time later the patient experienced headache immediately after vaccination with outcome of unknown.    No follow-up attempts were possible. No further information was expected.
Approx. 24 hours after receiving FLUZONE in (R) thigh - pt developed 2 inch red pruritic rash around injection site.
Complained of pain when shot given. Continues to have pain in arm with pressure such that unable to sleep on side shot given. Some relief with some arthritis ointment. No redness or lumps at site of injection.
Vesicular eruption covering body and scalp=chicken pox (more than 100 lesions).
The mother states the child is crying inconsolably all night. Temp 101.5, Tylenol given but no response. Went to pediatrician in AM on 01/09/01. The MD recommended for mom to continue Tylenol and fluids. The patient did respond to the Tylenol, temp decreased by the evening of 01/09/01. Normal by AM on 01/10/01.
Pain at site injection soon after. Severe nausea & vomiting the night of. Major chills, fever, slight headache, dizziness upon rising. Then sharp shooting pain in the right leg, later also left leg, sharp pain on the left side of head,+ later right side, pressure + pain in the chest, belching, ringing in ears, pressure in head (bp normal), pain temple/forehead. Took aspirin. Pains are less today, but continue, esp after laying for a bit or sitting. Am going to continue taking aspirin for possible clots
This case was reported by a consumer via sales rep and described the occurrence of adhesive capsulitis in a 67-year-old female patient who received SHINGRIX. On 31st January 2018, the patient received the 1st dose of SHINGRIX. On 15th February 2018, 15 days after receiving SHINGRIX, the patient experienced injection site hematoma (serious criteria other: As per reporter). On an unknown date, the patient experienced adhesive capsulitis (serious criteria other: As per reporter), injection site swelling (serious criteria other: As per reporter), injection site itching (serious criteria other: As per reporter) and vaccine administered at inappropriate site. On an unknown date, the outcome of the adhesive capsulitis was not recovered/not resolved and the outcome of the injection site hematoma, injection site swelling and injection site itching were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the adhesive capsulitis, injection site hematoma, injection site swelling and injection site itching to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine in the left deltoid. Less than a month after receiving vaccination, the patient experienced frozen shoulder or adhesive capsulitis and developed swelling and itching that were specific to injection site. The injection site events resolved within several days after vaccination. The patient was required doctor's visit on 15th February 2018 due to the frozen shoulder. The health care professional also diagnosed an injection hematoma at that time. The health care professional prescribed PT for patient which she was currently undergoing. The patient required emergency room visit. The patient received the vaccine at low injection site, which led to inappropriate site of vaccination. The reporter did not feel as though SHINGRIX caused the issue but instead an inappropriately low injection site caused the issue.
Patient has numbness at injection site and scapular area. Symptoms are intermittent and are specifically in the sub scapular area. Patient reports feeling pins and needles primarily on the left side in the left arm and left leg.  Patient has numbness in arm that radiates down into fingers and leg. Patient reports numbness from shoulder to the elbow. 5 days after the vaccine,  a Telehealth doctor sent him to the ER. Patient reported that the ER drew a D-dimer test, which came back normal.  reported to ER where blood was drawn, D-dimer was drawn which was normal.  Patient also reports feeling a pressure in the left lobe of the brain and intermittent fullness in the left ear.  The patient's symptoms have never fully gone away. The symptoms remain at 50% and are intermittent. The patient never had these symptoms prior to the shot.
Arm pain days 1st few days...now gone.., armpit pain/tenderness/swollen feeling day 5(1/6/21)  after injection
Information has been received from a registered nurse concerning her approximately 11 month old son who on approximately 5/28/02 was vaccinated with a dose of MMR II. The nurse reported that her son subsequently developed a rash. At the time of this report, her son still had the rash. It was unknown if medical attention was sought. No further info is available.
Mom called 3/7/14. High fever after vaccines. 3/6/14 fever started at 9 or 10 o'clock, 103-104. Cranky fussy -cries when moved picked up in clinic. 3/7/14 fever 102.8 crying sent to hospital for labs and x-rays.
1352 - Pt reports upper lip swelling, unable to see on visual assessment,  BP-141/92, 100% on RA, T - 98.1, HR - 91, RR - 16. Given 25 mg of oral benadryl per this RN per vaccination clinic standing order.   1403 - Pt reports feeling no change from initial report but does note "some finger tingling".  92% on RA, HR - 88.  1410 - Discussed taking a 2nd 25mg dose with patient. Will hold at this time, she states "my hands normally feel puffy when this gets worse but they feel normal now". Pt reports upper lip swelling feels "puffy" but unchanged from initial report.   1418 - Pt reports upper lip swelling increased, BP - 140/85, HR - 80, RR 16, 100% on RA,  25mg of oral benadryl given.  1423 - Pt reports upper lip "puffiness" with slight improvement, new c/o upper back itchiness, no rash or hives visualized on assessment  1428 - Pt reports improvement to feeling of "puffiness", back itchiness remains the same, and pt "feels sleepy"   1438 - Pt reports resolution of upper lip swelling and says "It feels like when I came in", slight back itchiness still present  1448 - Pt reassessed 30 min post 2nd dose of benadryl, pt reports complete resolution of all symptoms, BP - 135/79, T - 98.2, RR - 14, HR - 78, 100% on RA   Discussed transportation with patient prior to providing 2nd dose of Benadryl, Pt home via private vehicle with mother (driver) and partner.  Educated patient to call nurse on call number with any further concerns or if symptoms resume.
Immediately p/ recving vax pt felt "tingling" sensation down arm to elbow then broke out in hives under arm (armpit to elbow) c/o pruritis X3 days, spoke w/ PMD, resolved p/ 3 days
pt inadvertently recv IM inj of Tetanus Toxoid Absorbed, Purogenated instead of PPD. Pt exp redness @ inj site.
Tenderness started after receiving the shot. This was similar to the first dose. The difference occurred around 9pm when the tenderness started to spread more and my left side became more sore. I went to lay down and had trouble falling asleep because of the soreness. In the morning I wanted to go to work but I felt lethargic and the soreness was felt across my body. Around noon it was not any better and I felt a little nauseous. Around 5pm I ate some food and then went back to lay down. On 02/04/2022 at 12:10 am, feeling better and the soreness is mostly in my left deltoid. I will probably go into work if they symptoms from yesterday do not return.
102.8 temp ,sweating ,body and lower back pain .sick no food. Lasting three days
Mild systemic reaction - flu symptoms. F/C/N/ fatigue and moderate local erythema / pain / swelling.
Onset of autism very gradual. Videotape of child before and after vaccination showed normal behavior prior to vaccine. Behaviors after vaccine were loss of language, echolalia, stereotypic language, flapping of arms, tantrums. Was formally diagnosed by age 3 years. Developed several allergies to soy, eggs, gluten, wheat, peanuts, dairy. Also has loose BMs.
Reportedly called in after first dose to report had a rash that sounded like hives 2 days after immunization. Very itchy. Went to urgent care but treatment unknown. Presented self at clinic on 10/30/3001 to receive other vaccinations due for but MD refused as rash present. Client reported right after second HBV slightly raised small pinpoint to converged itchy rash by outer eyes, outer aspect of thighs and entire arms.
Patient reported developing a rash near the site of injection. Rash appeared above elbow to mid-upper arm. Patient reporting vomiting and feeling dizzy the following day after being administered the vaccination.
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received through a manufactuer pregnancy registry from a 29 year old consumer who in February 2003 and March 2003 was vaccinated SC with a first and second dose of varicella virus vaccine live respectively. On 6/1/03, the patient became pregnant. The patient had blood work performed for the pregnancy and it was determined that she does not have a immunity to varicella. The patient was given immune globulin for varicella on 9/19/03 because she was exposed to varicella. At the time of the report the patient did not develop a break out of varicella. Medical attention was sought. A product quality complaint was not involved. Additional infomration was received from a receptionist in a physician's office who indicated that the patient delivered in March 2004. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 65 year old male patient with elevated blood pressure and penicillin allergy. On an unknown date, the patient was vaccinated with live ZOSTAVAX, 0.65 ml, subcutaneously (lot number not provided). Concomitant therapies included beclomethasone diproprionate, blood pressure medication, acid reflux medication and antibiotic (unspecified). On an unknown date, the patient experienced a cold sore approximately 5 days, exact date unspecified, after receiving live ZOSTAVAX. The patient was not intervened to prevent serious criteria. At the time of the report, the outcome of cold sore was unknown. The event of cold sore was unknown related to live ZOSTAVAX.
pulled a scab off and it bled; itching at the injection site; swollen; soreness at the injection site; This is a spontaneous report from a contactable consumer (patient).   A 59-years-old female (not pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 09:00 (Lot Number: EW0151) as single dose for covid-19 immunisation.  Medical history included known allergies to mold, penicillium plant, dogs, cock roaches. Concomitant medication(s) included valsartan and montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported.  The patient previously took metoclopramide hydrochloride (REGLAN) and experienced drug hypersensitivity, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6207) via an unspecified route of administration in Mar2021 09:15 AM at left arm single dose for covid-19 immunisation.  Twice since second shot patient had itching at the injection site. In inadvertently pulled a scab off and it bled the first time (a few days ago). It's itching again and feels swollen. Interestingly, soreness at the injection site is the only symptom patient have had. The first time it went away and that was it. But this is the second time since the swelling went down that patient have had itching at the injection site and this time it's swollen a little. the initial post shot swelling subsided but it has returned in the past week or so. And it didn't even bleed after the shot. Patient's band-aid came off clean the next day. Patient have not received treatment. Patient filled out this form as soon as the itching returned and realized it was the same. Events onset date reported as 03Apr2021 09:00 AM. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
ear infection; achy body; This is a spontaneous report received from a contactable consumer, the patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient stated she had an ear infection when she received her shot with an achy body and all that. The outcome of the events was unknown.  Information on batch/Lot number requested.
My symptoms were I hade a 100 fever at 8 pm and i got my shot at 430 Thursday and for the past 2 days I had a high fever and feels like I have the flu
I feel fine. I noticed yesterday that there is a fairly large red spot with slight swelling at the injection site. I don?t know how long it has been there. It was not there the first couple of days immediately following the injection and so I stopped checking. I noticed it 11 days post injection.  Otherwise everything is normal.
Patient receive immunizations 1200 after eating lunch. Hep A, Varicella, Tdap, MCV-4 and HPV-9. Immediately after receiving immunizations listed above patient complained of dizziness and nausea. Patient feet was elevated and a ice pack was applied to the back of his neck.  Patient started feeling sleepy with sinking episodes. Patient was placed in a supine trendelenburg position. 1225 Vitals 124/76 Pulse 85 Temp 98.1 Resp 16. Patient was alert, orientated to name, place and time. Skin dry and warm to touch. Resp even and unlabored. Denies SOB, chest pain, throat/lips without redness or swelling, able to move all extremities with weakness noted, lungs clear to auscultation in all lobes, skin color without paleness, no rash/hives or itching noted. Patient started with increased complaints, everything in the room appeared green, the bird in the ceiling was moving and a overall abnormal behavior with his eyes roaming the room with a fearful look and tears rolling down his eyes, patient not recovering after 30 minutes and having symptoms of anxiety/panic attack, Dr notified and agree to call "911". Mother agreed with the plan of care. 1230 BP 150/107 HR 82 Resp 16 Temp 98.0. Attempted to distract patient with the phone and he dropped the phone. He stated "My arms are weak". 1235 EMS at the bedside, transported to stretcher and sent to ER with his mother. Vitals 114/42 HR 65 Resp 16 Temp 98.0 oral. Patient was alert. Patient symptoms remain the same but visions was clear. Patient was alert, OX3 and stable at time of transfer. Instructed mother to follow-up with EMS as directed by the ER, mother verbalize good understanding and agree with the plan of care. Report given to EMS using SBAR.
No further AE; multiple improperly stored doses of MMR-II vaccines were administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies/reactions were not reported    On 09-FEB-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live albumin status recombinant Human albumin (rHA) (M-M-R II) (lot # S037503, expiration date was 20-NOV-2021, route and strength were not provided) 1 injection for prophylaxis.   Temperature excursion of this vaccine was 48.7 Fahrenheit for 1 hour and 10 minutes without any previous temperature excursion. The digital data logger was involved. No further adverse event was reported.
Presents w/ cough x 1 wk; amitted for COVID-19 pna, tx w/abx, steroids, zinc, remdesivir, & O2 therapy; weaned to RA, dc'd home
EE received 1st dose of Pfizer vaccine on 9/20/2021, at  vaccine event at . Went home feeling really tired an fatigue, had a headache and body Aches, had wired tingling on the left side of body were vaccine was administered. Woke up in middle of night feeling nausea and small amount of vomit did eat a light meal before she laid down. Report she is feeling a little better today
Case number PHEH2014US022261 is an initial spontaneous report from the consumer received on 05 NOV 2014. This report refers to a 37-year-old female patient She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 24 OCT 2014. On the same date, after vaccination she experienced a rash on her abdomen , back and on arm at the injection site. She also had loss of pigment at the injection site. The outcome of the events was unknown. The seriousness and causality of the events were not reported.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Full body itch then rash, swelling. relieved by cetirizine after 3 days.
HYPOTENSION 9/21/2022 ASTHMA, UNSPECIFIED HYPOTENSION 9/21/2022 CANCER METASTATIC TO BONE HYPOTENSION 9/21/2022 ANEMIA HYPOTENSION 9/21/2022 URINARY RETENTION HYPOTENSION 9/21/2022 NONTRAUMATIC ACUTE KIDNEY INJURY HYPOTENSION 9/21/2022 RENAL DIALYSIS DEPENDENCE HYPOTENSION 9/21/2022 BURN OF GROIN, INIT
Herpes on skin; This case was reported by a consumer via interactive digital media and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   It was unknown if the reporter considered the herpes virus infection to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had taken a dose of the shingles vaccine and a herpes had appeared on his/her skin.  The reporter wanted to know if he/she should take the antiviral. Additional Supportive Information: The follow up would not possible as no contact details were available.
TEMPERATURE (FEVER); ACHING NECK; ACHING BACK; MUSCLE SORENESS ARMS; HEADACHE; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included atrial fibrillation, and other pre-existing medical conditions included patient had no known allergies and patient reported he had not done any exercise/physical activity or weight lifting the day prior to vaccination or after vaccination. the patient reported no prior history of reaction to vaccination in the past and no previous vaccination in the past 30 days.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 13:30 to Left Arm for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, and dofetilide for atrial fibrillation. On 16-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 16-MAR-2021 21:00, the subject experienced aching neck. On 16-MAR-2021 21:00, the subject experienced aching back. On 16-MAR-2021 21:00, the subject experienced muscle soreness arms. On 17-MAR-2021, the subject experienced temperature (fever). On 17-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature (fever) on 17-MAR-2021, and was recovering from aching neck, aching back, muscle soreness arms, and headache. This report was non-serious.
pATIENT FEL DIZZY AND COLLAPSED SHORTLY AFTER VACCINATION.
Stiffness in joints of hand and feet that progressed to pain in joints. Possible Arthritis or psoriasis.
patients received doses from an expire vial; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses from an expire vial) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation since 02-Aug-2017 and Blood pressure increased since 28-Nov-2017. Concomitant products included ATORVASTATIN from 15-Mar-2021 to an unknown date and ACETYLSALICYLIC ACID (ASPRIN) from 28-Nov-2017 to an unknown date for an unknown indication.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses from an expire vial). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received doses from an expire vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No corrective treatment was provided.