chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a registered nurse concerning a 65 year old white retired female patient who on approximately Nov 09 2004 (several days ago) was vaccinated (route not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). shortly after being vaccinated, on Nov 09 2004 she developed an injection site reaction including erythema, swelling and pain, the nurse also reported that shortly after being vaccinated (date unspecified), the patient developed induration and local heat. It was reported that the patient developed pain from her elbow to her neck. the patient was treated with topical steroids and she recovered from the injection site redness, swelling and pain on an unspecified date. There was no product quality complaint involved. Additional information is not expected. It was also reported that on additional patient experienced an adverse event following administration of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P0 (WAES0412USA00290).  This is in follow-up to report (s) previously submitted on 7/29/2005.  Initial and follow up information has been received from a registered nurse concerning a 65 year old white retired female patient who on approximately 09-NOV-2004 ("several days ago") was vaccinated (route not reported) with a dose of PNEUMOVAX (lot # 648138/0009P).  "Shortly after being vaccinated", on 09-NOV-2004 she developed an injection site reaction including erythema, swelling and pain.  The nurse also reported that shortly after being vaccinated (date unspecified), the patient developed induration and local heat.  It was reported that the patient developed pain from her elbow to her neck.  The patient was treated with topical steroids and she recovered from the injection site redness, swelling and pain on an unspecified date.  Follow-up information was received from the nurse indicating that "they never heard any information about this lot, and they were never advised as to what they should do".  A lot check has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  It was also reported that one additional patient experienced and adverse event following administration of PNEUMOVAX (lot # 648139/0009P) (WAES # 0412USA00290).
He got his vaccine, he didn't feel any reaction at first. About 16 hours later when he woke up this morning, his left armpit is burning and painful, has to keep at a 75 degree angle for the last 3 hours as hoping it will go away. It feels like it is getting worse. One spot has the burning sensation with radiation from underneath his armpit into his chest area. The area is warm to touch, not red to touch. Just has the pain and burning, does look a little swollen. After the first vaccine, he was sick for 2 days and could not leave the house.
First occurred the night of vaccination, about 9 hours afterwards. Came on very suddenly and fairly strong as I was doing some physical therapy exercises. I would describe it as fairly strong vertigo.  I immediately checked to see if the EUA listed dizziness as a primary symptom, which it did not. Nor did a google search turn up any reports of dizziness or vertigo. Not moving my head helped some and I went to bed. Slept OK. Was very careful when getting up to use the toilet. By morning it was better, but still felt my equilibrium was a little off. I tried doing a test for positional vertigo to see if one ear might be the problem instead of a vaccination side effect and that was negative. By evening, I was back to normal. My biggest concern was that I was developing an inner ear problem as this was not a reported side effect. Then this morning I searched the CDC and found 96% of 302  Moderna adverse effects reported as of 2/12/2021 were for "dizziness." I am submitting this report in hopes that dizziness or vertigo  be included in the list of possible side effects. It was disconcerting to not find it mentioned as positional vertigo is a very real problem for older people.
Patient was given High Dose Influenza and not the normal for his age.   No adverse reaction noted.  Patient and Provider were notified and no concerns reported.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. The reporter was checking to see if there was an alternative schedule for GARDASIL 9 (dose and route of administration was not provided) which would be 0,1 month and 6 month (inappropriate schedule of vaccine administered). The outcome of the event was unknown. No product quality issue was involved. Additional information hs been requested.
Medical Assistant administered an un-reconstituted dose of vaccine to patient. Provider and patient were made aware of the situation. Patient was called on 8/27/2021, patient stated she is feeling fine and denies fevers, dizziness, SOB, N/V, chest pain, or any other complications. Patient only stated she had a sore arm. Patient was called again on 08/30/2021, patient stated she is feeling good with no issues. Her arm was no longer hurting or irritated.
Information has been received from a pharmacist referring to a 45 year old male patient with penicillin allergies (also reported as unknown reaction). There was no other pertinent medical history. On 25-JUN-2014, 28-JUL-2014 and 10-JAN-2015, the patient was vaccinated with the first, second and third dose of RECOMBIVAX HB respectively (strength: 10mcg/ml; dose: 1 ml; route: intramuscular; lot # of dose 1 reported as J005211, expiration date 03-FEB-2016; lot # of dose 2 unknown; lot # of dose 3 K003727, expiration date 04-FEB-2016) (inappropriate schedule of vaccine administered). There was no concomitant medication. On an unknown date of 2015, after receiving three doses of RECOMBIVAX HB, the patient was evaluated by an unspecified physician and was found to be have negative Hepatitis B antibody titers. No treatment was given for adverse event. At the time of reporting, the titers still were negative. Causality was not provided. Additional information is not expected.
Rash/blisters along mouth that spread along face and opened into sores. Also rash/blisters along waist to on back.
Passed out dizzy nausea body aches and very bad headache for 24 hrs
mild fatigue/sore arm within 2 hrs of injection that progressed significantly over next 36 hrs: Achy joints, chills, low grade fever between 99.4-100.5, headache, loss of appetite/nausea, extreme fatigue, mental fogginess. Ibruprofen and caffeine did not have effect.
10/6 0230am mouth felt funny and throat noticed lips swollen. Took 25mg BENADRYL by mouth.
This spontaneous report as received from a registered nurse refers to unspecified number of patients. On an unknown date, the patients were vaccinated with some improperly stored doses of GARDASIL (dose, route and lot # not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a healthcare worker concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (dose and route were unknown; lot # M019706 with expiration date 24-OCT-2017 and lot # reported as L036694 with expiration date 16-JUN-2017). The vaccines were exposed under temperature of 46.9 degrees Fahrenheit for 10 minutes. The previous temperature excursions were 47.2 degrees Fahrenheit for 10 minutes, 47.3 degrees Fahrenheit for 10 minutes and 46.9 degrees Fahrenheit for 10 minutes. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Chest tightness, pressure Hard to take a deep breath, felt restricted Fatigue Difficulty standing Leg weakness Dizziness
Inner ear itchy, redness in arms and neck,  took another 50 Ml of Benadryl.. day later my left leg outer thigh is numb and is still numb to date
p/vax pt devel tingling entire lt side of body to include head;12-24hr pt went on flying trip; lt ear problems began p/trip;feeling of closing, stuffiness & eventually loud ringing in lt ear x 48hr;
Patient reports left pectoral pain. Patient suspects the injection was given a little higher than it should have been. She has limited ROM of her left shoulder and is tearful during exam. Normal ROM of neck.
TESTED + FOR COVID ON         12-14-2022           AND WAS ADMITTED ON       12-7-22 FOR ACUTE ISCHEMIC STROKE AND DECEASED 12-18-22.    PRESENTED TO ER OUTSIDE WINDOW FOR TPA.   HAD LARGE VESSEL OCCLUSION PER CT OF NECK.
Expired vaccine administered. The Vaccine was mixed on 04/20/2022 unknown time. Staff unknowingly administered the vaccine expired vaccine on 4/21/2022.
19JUN95 nipples on both breast inflamed & edematous & painful; MD dx as inflamed milk ducts & put on ATB; 28JUN95 states pt is improving;
3JUL91 pt recvd DTP/OPV/HIB in morning; Exp inconsolable crying 1230PM to 3PM, inject site swollen & reddened; APAP brought temp down; No higher than 102 R; 4JUL91 t102 in AM, brought down w/APAP;
Administered Afluria Influenza Vaccine (licensed for ages 3yrs and up) to this patient (age 7 months).   Notified mother 3 hours later.  Mother reported that  patient had not exhibited any signs or symptoms of adverse reaction.
Patient developed itching, redness, swelling, and warm to touch on and around area of injection. Left arm measured approximately 5 in x 5 in, right arm measured 3.5 in x 3.5 in. Patient developed reaction on both arms, but right arm had a central clearing.
Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Myalgia; headache; anorexia; fatigue; weight loss; sweats; This is a spontaneous report from a contactable physician (patient). A 65 years old years female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9899) via an unspecified route of administration at Left arm on 22Dec2020 01:15PM at single dose for COVID-19 immunization. The patient's medical history included hypertension, body mass index (BMI) 30, hypothyroidism and Covid-19. Known allergies: penicillin, sulpha drugs, seasonal allergies. No other vaccine in four weeks. The concomitant was reported as hydrochlorothiazide, losartan potassium (HYZAAR), levothyroxine sodium (SYNTHROID), Metformin. The patient experienced pain, edema and erythema in 4 cm circumference around injection site myalgia, headache, anorexia, fatigue, weight loss, sweats, all started from 24Dec2020. No treatment received for events. The outcome of the events was recovering.
a little tired; sore arm; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (a little tired) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy. Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FATIGUE (a little tired) and PAIN IN EXTREMITY (sore arm). At the time of the report, FATIGUE (a little tired) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided
Not sure about onset, patient was not clear. Called in Monday 12/14/15 and complained of pain/numbness, and cold fingers. Suggested ibuprofen.
11AM 24 hrs p/vax had seizure; APAP given a/as ordered & pt has no fever; taken by ambulence to hosp; EEG done 1 wk later which was nl; mom instructed pt should not have Pertussis;
Began with a severe cough 02/27/21 lasting for days....possibly causing blood clots in the lungs.
The patient has a swollen, red, itchy, hard, the size of a person's hand rash located at the injection site. Patient received the flu shot and ZOSTAVAX on 11/06/17, patient started to have local reaction on Tuesday 11/07/17 night. Patient is going to the doctor to get seen to make sure no infection.
Expired Moderna dose administered to patient on 04/04/22 vaccine Exp Date: 04/03/22 with no adverse effects noted after 15 minutes observation Charge Nurse notified Vaccine Manager LPN made aware Patient made aware f/u appt with provider today for evaluation
My ears are ringing so loudly that I can barely hear the TV; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 10:45 (at 66 years old, not pregnant) single dose for covid-19 immunisation. Medical history included diabetes from an unknown date. Concomitant medications included metformin; insulin glargine (TOUJEO). The patient previously took codeine experienced Known allergies: Codeine. Patient had her first dose of BNT162B2 vaccine on 17Mar2021 11:15 at 66 years old for COVID-19 immunisation Lot number=ER2613 on left arm. Patient experienced ears are ringing so loudly that she can barely hear the TV on 08Apr2021 08:00. No Covid prior vaccination. Not Covid tested post vaccination. No other vaccine in four weeks. Treatment was received for the adverse event. The outcome of the event was not recovered. The event was reported as serious with disability criteria.
PREVNAR 13 injection on Tuesday, September 29. The injection itself hurt like heck. A few hours after the injection I developed a very sore throat and felt awful. It is now Sunday, October 4th and I still have a sore throat and feel like crap. I do not believe I have a fever. The injection site is still swollen, black and blue, hard and painful to the touch.
51 y/o male, retired, who contracted the health center due to persistent headaches and polyarthralgia onset following receipt of AVA #3 Sep 2004 during deployment out of the country. 1) Headaches were reported as frequent, on the order of 3-4 times per week, associated with nausea/photophobia, and often interfering with his functional capacity. Review of available medical records substantiated this history, indicating he received medical evaluation through both primary care and a neurologist beginning in May 2005, at which time he was diagnosed with migraines following a normal head CT and brain MRI. 2) Joint pain was reported as involving bilateral fingers and bilateral knees; denied history of trauma or overuse; joint pain was to accompanied by erythema, swelling, warmth, or joint deformity; no underlying history of rheumatoid disease; no medical evaluation of joint pain to date. Symptoms: Headache-Migraine, Joint Pain- multiple joints.
injection site swelling, redness and soreness; injection site swelling, redness and soreness; injection site swelling, redness and soreness; itchiness and hot to touch at the injection site; itchiness and hot to touch at the injection site; Redness gradually started spreding and has spread down her arm to her elbow and inside the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site swelling, redness and soreness), VACCINATION SITE ERYTHEMA (injection site swelling, redness and soreness), VACCINATION SITE PAIN (injection site swelling, redness and soreness), VACCINATION SITE PRURITUS (itchiness and hot to touch at the injection site) and VACCINATION SITE WARMTH (itchiness and hot to touch at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site swelling, redness and soreness), VACCINATION SITE ERYTHEMA (injection site swelling, redness and soreness), VACCINATION SITE PAIN (injection site swelling, redness and soreness), VACCINATION SITE PRURITUS (itchiness and hot to touch at the injection site), VACCINATION SITE WARMTH (itchiness and hot to touch at the injection site) and ERYTHEMA (Redness gradually started spreding and has spread down her arm to her elbow and inside the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Allergy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (injection site swelling, redness and soreness), VACCINATION SITE ERYTHEMA (injection site swelling, redness and soreness), VACCINATION SITE PAIN (injection site swelling, redness and soreness), VACCINATION SITE PRURITUS (itchiness and hot to touch at the injection site), VACCINATION SITE WARMTH (itchiness and hot to touch at the injection site) and ERYTHEMA (Redness gradually started spreding and has spread down her arm to her elbow and inside the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. On unspecified dates the patients received doses of improperly stored VAQTA (dose, route, lot number and expiry date were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
left arm pain, generalized body aches, chills and fatigue. Treatment included  Tylenol the next day. Outcome: Moderate improvement has continued c/o of mild fatigue and generalized body aches that does interfere with ADL's currently working.
Received MMR and Td on 4/10/08. Reports overall muscle achiness since then, mostly in her thighs.  Reported severe thigh pain on 4/15/08 that made her nauseated.  Felt as if she could "barely walk".  Was sent to ER and diagnosed with Myositis.
Pt saw MD; had rash t104 10day p/vax; MD told mom would have dx "for sure" Roseola if child hadn't had MMR;
Breakthrough case admission after 2 vaccines Pfizer 2/9/21 Lot# EL9267;  Pfizer 7/23/21 Lot# EW0179
PATIENT REPORTED A RASH BEGAN AROUND THE INJECTION SITE, THEN SPREAD TO HIS CHEST AND UPPER BODY. HE TOOK ONE DOSE OF BENADRYL. PATIENT THINKS IT MAY HAVE BEEN THE ADHESIVE ON THE BANDAGE, AS THE BANDAID IS LATEX FREE. PATIENT REPORTED THIS IS THE FIRST TIME THIS HAS HAPPENED AND HE HAS HAD THE FLU SHOT EVERY YEAR.
PATIENT WAS DESCRIBED AS HAVING SYNCOPE WITH PALE SKIN RAPID HEARTBEAT AND BP OF 147/103
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 01-MAY-2016, the patient was inadvertently vaccinated with a dose of VARIVAX, (dose route of administration, injection site, lot number and expiration date were not reported) in stead of an intended dose of ZOSTAVAX. There were no concomitant medications reported. No adverse effect was reported. Additional information has been requested.
I had an extremely severe headache beginning Tuesday mildly and escalating to severe by Thursday affecting my sleep and continuing through Saturday when it slowly abated. I don't get headaches ordinarily. It was bad enough I considered going to the hospital Sunday if it didn't improve but it was bad enough I attributed it to be more likely a brain tumor or something than related to the vaccine. I can't figure out what else it could possibly have been.
Patient came in pharmacy on February 23, 2018 wanting to know which flu immunization he received. He stated he had vision changes (can't read small print) since January 2018 and immunization was given 10/16/2017. He stated he had went to his eye dr and had his vision checked and he thinks it's possibly coming from the influenza vaccine he received.
red patch (like a sun burn) which was also dry and scaly; Swollen left arm from shoulder to elbow; Itching; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red patch (like a sun burn) which was also dry and scaly), PERIPHERAL SWELLING (Swollen left arm from shoulder to elbow), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE SWELLING (Sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 054C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, OMEPRAZOLE, METOPROLOL, LOSARTAN and ATORVASTATIN for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Sore arm). On 26-May-2021, the patient experienced ERYTHEMA (red patch (like a sun burn) which was also dry and scaly), PERIPHERAL SWELLING (Swollen left arm from shoulder to elbow) and VACCINATION SITE PRURITUS (Itching). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ERYTHEMA (red patch (like a sun burn) which was also dry and scaly), PERIPHERAL SWELLING (Swollen left arm from shoulder to elbow), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE SWELLING (Sore arm) outcome was unknown.            Other treatment information included, antihistamine cream was provided.
Discoloration of skin where vaccine given and itching at site for appox. 6 weeks after vaccination
Trouble swallowing, sensation of throat swelling approximately 45 min to 1 hour after receiving dose #2.  Pt received one dose of Benadryl 25 orally.  Symptoms improved completely.
burning feeling, red streak just above, it was blistering/diagnosed it as shingles; This is a spontaneous report from a contactable nurse (patient).  A female patient of an unspecified age (age: 76; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was asking whether she is okay to get her 2nd dose with a shingles outbreak on her back. She received the 1st dose of the Pfizer covid vaccine on 04Feb2021. On Saturday or Sunday (Feb2021), she had a burning feeling and red streak just above the flank. By Monday, it was blistering and on Tuesday, even more. Her doctor diagnosed it as shingles and prescribed medication for it. She only has a day or 2 of medication left. Her 2nd dose of the covid vaccine is due on 25Feb2021. Outcome of the event was unknown.  Information about lot/batch has been requested.
I had pain in my arm. I felt dizzy and I don't know if it is related or not.