chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a physician concerning a 65 year old female patient with a history of chicken pox as a toddler and herpes simplex in February, 1980, who was vaccinated with ZOSTAVAX, given at another facility. Concomitant therapy included alendronate sodium (MSD) and INDERAL. On 02-AUG-2008, the patient experienced shingles and in 04-AUG-2008, was seen in office. Vesicular rash over the right flank and right leg, of 1-2 weeks duration. There was no fever, no pain. On an unspecified date, the patient recovered from shingles. The patient contacted physician's office. The patient thought that she contracted shingles from her father-in-law who had shingles in July, it was also reported that there was no exposure to chickenpox or herpes zoster within the last five years. The patient was enrolled in the Varicella Zoster Virus Identification Program to Identify if VSV is present and if it is present to identify if it was associated with the wild-type VZV strain or with the OKA/MERCK vaccine VZV strain. On 04-AUG-2008, a blood sample was collected. No PCR was collected.
pt recv vax&devel a large area of cellulitis (area of rxn spread 3x the initial size) tx w/Keflex po;rxn resolved p/approx 1 wk;this is 1 of 8 patients from this site who exp the above rxn
mild seizure; sweaty; peaked and pale looked; felt clammy; fever of 100 degrees Fahrenheit; chills; achiness; not felt good at all; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (mild seizure) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VITAMIN D3 for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 17-Apr-2021, the patient experienced VACCINATION COMPLICATION (not felt good at all), PYREXIA (fever of 100 degrees Fahrenheit), CHILLS (chills) and MYALGIA (achiness). On 18-Apr-2021, the patient experienced SEIZURE (mild seizure) (seriousness criterion medically significant), HYPERHIDROSIS (sweaty), PALLOR (peaked and pale looked) and COLD SWEAT (felt clammy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, SEIZURE (mild seizure), HYPERHIDROSIS (sweaty), PALLOR (peaked and pale looked), VACCINATION COMPLICATION (not felt good at all), COLD SWEAT (felt clammy), PYREXIA (fever of 100 degrees Fahrenheit), CHILLS (chills) and MYALGIA (achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 100 degrees fahrenheit (Inconclusive) 100 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included as Tylenol. She also had orange juice and water during these episode.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This case was received from a health professional on 08 November 2007.  Seriousness Criteria: Other-Medically Significant A female patient received an injection of Fluzone (lot number not reported), and later developed immune or idiopathic thrombocytopenia purpura. The reporter felt did not provide any additional information.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 04-OCT-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L021609, expiry date 19-SEP-2016) subcutaneously (strength, dosing details, anatomical location were unknown). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
ER 5/16/13 - Febrile seizure - 103.9 fever in ER ER notes included. Over weekend after vaccines, low grade fever - fussy then temp spike on 5/16/13. Pt here for an ER recheck from last night after having a febrile seizure. Pt was eating but had felt warm to dad prior to episode. He was in high chair and father saw him shaking and not breathing. He took him outside asking neighbors to help and called 911. Pt was not choking which father thought initially and by the time the ambulance got there he had stopped seizing but breathing was shallow and he was sleeping until he was poked in ER. Fever noted in ER to be 103.9. Pt here last Friday and had PREVNAR and VARIVAX shots. Father recalls that ad ter his 9 month visit getting PREVNAR and hep B he developed a high fever and had red blisters all over face that eventually went down to chest. Patient feeling well. Onset was sudden. Has not occurred before. Date of last seizure seizure.
I was seated in a chair in the patient treatment room when the nurse with the shot came into the room.  The nurse stood next to me to prepare me for the shot, then administered the shot while still standing.  The nurse chose a location on my left arm near my shoulder, high up on the arm in the area of the deltoid muscle.  Not in the tricep muscle.  The area of the shot was swollen and hurt (pain level 4-5) for approximately 2 days, accompanied by general malaise-like symptoms.  The malaise symptoms dissipated in  approximately 4-5 days.  However, even though the shoulder pain reduced, the pain persists to this day at a level of 3-4, sometimes more when trying to raise the left arm above the shoulder level. (Next) The left shoulder pain occurs now any time I try to raise my left arm above the shoulder level by extending the arm out and away from the body.  If I bend my left arm at the elbow first, then push the left arm up above my shoulder height, there is no pain.  If the left arm hangs down next to my body there is no pain.  However, significant pain occurs when I have to pull a shirt over my head to dress and undress, when applying deodorant to the left arm, if I lean on my left elbow, of if I push with my left arm as when standing up from a chair or doing a push-up exercise.  I normally exercise in a gymnasium every other day using weights, weight resistance machines, and aerobic machines.  Now I have to use reduced weight levels due to the pain when doing some exercises.  For instance, before the shot I would use 30 pound weights for curls to exercise the biceps.  If I use 30 pounds now for curls, there is a sharp burning pain in my left bicep.  I have to go down to 20 pounds to do curls for the left arm.  Similarly, I had to reduce the weight levels significantly for bench-press type exercises and limit the movement of the weights to just a few inches from fully extended arms.  If I bend my arms completely during a bench-press type exercise, I have significant pain trying to re-extend the left arm.
pt recv vax 7JAN96 & 11JAN96 pt presented to Er w/a painful, hardened area which was warm to touch;no further details were known as of the date of this report;
Area became red swollen hard and hot plus itchy.  By 2 days after shot it had spread over entire upper arm.  ER doc prescribed hydroxine for itching and hydrocodone 325mg for pain.  As of today, 5/5/2010, redness and hardness has decreased some, but still large area affected and still hot and itchy and painful.  Only relief is with cold pack applied.
Fever started at 0230 on 8/1/17 axillary temp of 102. Mom gave Tylenol at 0230, 0800 and 1300. Mom called health department at 1500 on 8/1/17 to report that pt was having hallucinations and was seeing sheep, a net and perceived that his hands were gigantic. Advised to continue fluids, Tylenol and consider dosing with ibuprofen. RN called at 1730 and Mom reports that pt is better - fever has broken and no hallucinations at that time. On 8/2/17, RN called again and Mom reports that pt had a good night, ate breakfast and was walking around a bit. Again, no hallucinations at this time.
He couldn't breathe/ husband passed away after receiving the 2nd dose; This is a spontaneous report from a contactable consumer (wife). A 73-year-old patient (husband) received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Batch/Lot number: was not reported, Expiration date: was not reported, Age at vaccination: 73-year-old) via an unspecified route of administration on 19Apr2021 11:00 AM as dose 2, single for COVID-19 immunization. Medical history included kidney failure. Concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date for covid-19 immunization. It was reported that her husband had passed away, 21Apr2021 around 8:00AM, because he couldn't breathe even with the ventilator. She stated they both received the 2nd dose of the covid vaccine on 19Apr2021 around 11:00 am. On tuesday, the following day, around 1:00 pm, he couldn't breathe, so he went to the hospital at about 1:30 pm. They said he had to go to the big hospital downtown as they did not have dialysis and her husband had had kidney failure.  In the morning, she was told that her husband had passed away, 21Apr2021 around 8:00AM, because he couldn't breathe even with the ventilator.; Reported Cause(s) of Death: He couldn't breathe/ husband passed away after receiving the 2nd dose
hyporesponsive, extremely sleey with poor feeds, vomited a few times that started a few hours after shots waxed and waned and continued for 24-36
Wednesday 09/15/2021 1000 hours: Normal soreness as expected immediately after injection. 1500 hours: Left arm began to feel limp and heavy (weak) with pain extending from injection site distal towards elbow. 1700 hours: Previous symptoms with noticeable fatigue and muscle pain. 2200 hours: Previous symptoms with feeling of dizziness, fatigue/ general lethargy.  Thursday 09/16/2021 0200 hours: Previous symptoms with insomnia, sweating, migraine headache, joint pain.  Signs: Initial temperature of 100.4 (F). 0630 hours: Previous symptoms with additional chills.  Signs: fever increased to 101.2 (F), visible sweating (soaking wet t-shirt).  One 81 mg Aspirin taken by mouth. 1000 hours: Previous symptoms with additional nausea (no vomiting), signs: fever increased to 101.8 (F).  One Acetaminophen Regular Strength 325mg taken by mouth. 1500 hours: No change in symptoms.  Signs: fever reduced to 101.2 (F)  Friday 09/17/2021 0400 hours: No change in symptoms, signs: fever reduced further to 100.8 (F) 1100 hours: No symptoms of pain from injection site, muscle pain, sweating, migraines, joint pain, chills, nausea (all resolved).  Continued symptoms: limp/weakness of left arm, dizziness, insomnia, fatigue/ lethargy, slight headache, photosensitivity.  Signs:  None, Body temperature normal.  Saturday 09/18/2021 0630 hours: Remaining symptoms: Lethargy, fatigue, dizziness, all other symptoms resolved.  No observable signs.  At no point were my lymph nodes visibly larger or noticeably larger upon palpation.  No edema, discoloration, or warmth was noticeable at the injection site.  Vitals outside of temperature remained normal with no observable change in BP, Pulse, or oxygen saturation.  Diagnostic tools: OMRON BP MONITOR, MODEL: BP652N SANTA MEDICAL Pulse Oximeter, MODEL: SM-165 BRAUN Tympanic thermometer, MODEL: ThermoScan 5
Developed alopecia areata. Exact date of on-set is unknown with large patch of missing hair noticed in mid August. So, within 5 weeks of vaccine, serious alopecia areata had developed. Currently, applying Clobetasol propionate cream as prescribed by physician. Additional hair loss continues to occur.  10/16/07 Reviewed pcp medical records.  Received vax record which confirms dose & lot # for HPV.  No medical records beyond 6/20 included.  T/C to pcp to request same. PCP reports no visits in July or August.  11/27/07 Reviewed medical records from specialist which reveals patient exprienced baseball sized area of hair loss w/rash inside it on the occiput.  Noted to have very mild seborrheic dermatitis in other areas of scalp but not enough to produce alopecia.  Tx w/topical cream.   FINAL DX: alopecia areata.
Headache, NauseaVomiting,  pressure in nose, sinus pain  Narrative: Pt in clinic observation area at 10:50am developed nausea, headache, pressure in nose and sinus pain. At 11:00am 11:00 trembling, reporting sensation of swelling to forehead, runny nose, watery eyes, more pressure- ice pack applied. She was given cetirizine 10mg at 11:05am. 11:30 reports feeling more nauseated, trembling, headache, light headed continued. Anxious appearing. 11:50 BS check was 107. Employee feeling worse she reports. 12:00 reported finger (at accucheck site) felt numb, toes felt numb. reports feeling SOB, now with roof of moth tingling, sensation of swelling/tingling lip. Brought to ED for further evaluation via w/c in stable condition. Report off to ED provider/ triage RN. The pt reported feeling fine once she arrived in the ED. In the ED she was treated with ibuprofen for a headache.   Other Relevant History:
Case number PHEH2014US020859, is an initial spontaneous report from a nurse received on 15 Oct 2014. This report refers to a 5 months old female neonate. Her medical history and concomitant medications were not reported. She received an intramuscular dose of MENVEO (batch number: A13047) instead of pneumococcal conjugate vaccine (manufacturer and batch number: unknown) on 14 Oct 2014. No adverse event was reported following this medication error.
Really red; Radiates outward/2inch x 2inch/circular but not a perfect circle; Knot on her arm; Warm; Initial redness; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Knot on her arm), FEELING HOT (Warm), ERYTHEMA (Initial redness), ERYTHEMA (Really red) and RASH (Radiates outward/2inch x 2inch/circular but not a perfect circle) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (fosamax,reported.), Drug allergy (hydrocodone), Drug allergy (macrodontia), Drug allergy (zinc) and Drug allergy (z-Pak).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced ERYTHEMA (Initial redness). On 08-Feb-2021, the patient experienced NODULE (Knot on her arm) and FEELING HOT (Warm). On 14-Feb-2021, the patient experienced ERYTHEMA (Really red) and RASH (Radiates outward/2inch x 2inch/circular but not a perfect circle). At the time of the report, NODULE (Knot on her arm), FEELING HOT (Warm), ERYTHEMA (Initial redness), ERYTHEMA (Really red) and RASH (Radiates outward/2inch x 2inch/circular but not a perfect circle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       she had her second dose on 05-MAR-2021. Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up received and contains non-significant information. On 13-Jul-2021: Updated outcome of the events to recovered/resolved.
Fever, night sweats, chills first night starting at 11:30 woke up in the morning at 730 with migraine treated with excedrin fever of 102 at 11am with aches and chills ibuprofen taken at 4pm. Fever reduced to 100 at 9pm migraine came back. 1/31 woke up with severe migraine treated with excedrin no fever recorded all day. 1/31 5pm migraine came back with nausea and vomiting throughout night. Tylenol taken at 8pm no relief. 2/1 migraine back nausea tinnitus in both ears
Post vax, the pt experienced severe myalgia, joint pain, and swelling of the ankles and elbow.
pt recv vax & NOV96 pt exp fever up to 102, fatigue, gen weakness, rash on upper & lower extremities & serum sickness;pt hosp for 1wk;
Patient reported peripheral neuropathy in feet, toes, hands, arms - starting 10/18/12 the day after receiving Flu shot from pharmacy. She received ZOSTAVAX from pharmacy on 10/7/12.
Pain at site followed by paresthesia of arm and lip. No confirmed weakness. Abnormal nerve cond. R arm. 11/17/08 MR received for DOS 11/5-6/2008 with no specific dx.  Pt presented with c/o numbness and tingling of L sided extremities, face and lips R>L x 4 days.  Similar episode in 2001 with (-) w/u. Some dizziness and H/A.  Neuro consult PE (+) for give-way weakness on the L side and (-) sensation to pinprick and temp bilat.
Extremely itchy rash developed on arm approximately one week post-vaccination, and lasted for about 4 days before starting to diminish. As of today (1/22), some residual itchyness remains, but not as severe as during that primary time frame. Applied Maximum strength topical frequently, but little relief resulted from it. I did not seek medical treatment, but strongly considered doing so at several points to seek a prescription-strength topical. Marking below as having "recovered" - because it is now far more manageable. But it has not yet resolved 100% (maybe 90-95% resolved?).
Injection site pain, redness, warmth and swelling on 10/24/15. Pt states doesn't "feel well" and feels like she could pass out.
Within 2 weeks after receiving HPV4, child developed two areas of rash (raised: one dime size and one quarter size.  Located under L arm towards back and one left back near waist.  Parent said outside ring was raised and then inside became raised; itchy; no vesicles; no resp involvement; no lip swelling; not sick at time.  Used OTC ringworm med thinking it was that.  Didn't help but self resolved within 2 weeks.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. Patient's concurrent conditions or historical information were not reported. On an unspecified date in February 2015, unspecified number of patients were administered with six doses of GARDASIL (lot#K009202, expiration date: 17-DEC-2016), 0.5 ml, intramuscular, (frequencies and routes not reported) that were exposed to temperatures outside of the recommended range. No adverse effects reported. Follow up has been received. The nurse stated that 5 patients received doses of improperly stored GARDASIL (lot#K009202, expiration date: 17-DEC-2016). Additional information was received from the registered nurse, concerning one out of five patients, namely a 11 year old female patient. She was vaccinated with improperly stored (temperature excursion) GARDASIL (lot#K009202, expiration date: 17-DEC-2016), intramuscularly on 12-FEB-2015. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies, and concomitant therapies was provided. On an unknown date, the patient was vaccinated with M-M-R II injection, intramuscularly (dose, lot#, expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Tachycardia-Severe
Pruritic, itching rash on trunk, right arm and leg. Present for two days prior to report. SoluMedrol 125mg IM given in-office. Prednisone 10-day taper given (starting at 10 mg).
Pt called reporting that her arm was red, swollen, painful and had hard knot the size of grapefruit. Instructed pt to go see her provider to assess this and to let us know the outcome. Also called pt several times and left voice mails asking her to come in and let us see site for documentation purposes. As of this date I do not know what the outcome is.
Moderate swelling/tenderness & mild erythema at site of injection noted on 10/08/2015. Patient returned 10/12/2015.  It was noted that there was a large area of erythema & mild induration around injection site and extending to medial arm down to elbow level.
His skin where he got the shot in that left arm and a little around the shoulder skin is really sensitive to touch; The sensitivity has been keeping him awake at night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 15:00 (Lot number: EW0150) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type-2 Diabetes" (unspecified if ongoing), notes: Verbatim: Type 2 diabetes. The patient took concomitant medications. The following information was reported: HYPERAESTHESIA (non-serious), outcome "unknown", described as "His skin where he got the shot in that left arm and a little around the shoulder skin is really sensitive to touch"; INSOMNIA (non-serious), outcome "unknown", described as "The sensitivity has been keeping him awake at night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hyperaesthesia.  Additional information: The patient did not receive any additional vaccines on same date of the pfizer suspect, did not have prior vaccinations within 4 weeks and not have any family medical history relevant to event. Clinical course: it was reported that patient got the first Pfizer vaccine on 20Apr2021 and about 3 to 4 days later his skin where he got the shot in that left arm and a little around the shoulder skin was really sensitive to touch and there was not a rash or broken out, but he just couldn't stand to touch it or have anybody else touch it. The sensitivity was ongoing and has been remaining the same and he just went and talked to them and got a can of Dermaplast spray to kind of numb it, the sensitivity has been keeping him awake at night quite a bit at this point and he had to do something, and he sleeps on that left side also. Patient HCP saw him on 16Apr2021 before he got the pfizer vaccine and he had lab work, and everything done at that time, and everything was good and his A1C was down at 6.8; states he has a history of type 2 diabetes and his kidney function, and everything was really good, and he was glad to see that. His patient card has a sticker with the information on it and there is not an expiry date or NDC listed for the Pfizer Vaccine, the card also has TLC 18301 written on it. The second dose of the vaccine was scheduled for 11May2021. Patient was no sick or anything at the time of the Pfizer vaccine, he takes a blood pressure medicine that he started taking several years ago but does not know the name or dosage of the blood pressure pill.  No follow-up attempts are possible. No further information is expected.