chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a licensed practical nurse concerning a 65 yr old white retired male who on 06Feb06 at 10:00AM was vaccinated IM, into the left deltoid, with a first dose of pneumococcal 23v polysaccharide vaccine (lot 651322/1044P). On the evening of 06Feb06, the pt developed a severe local reaction. The pt's arm was red, hot, swollen and hard from the injection site to the elbow and halfway around the arm. The pt also developed chills. On approx 09Feb06, the pt was seen in office and the area was 10cm x 5cm. The pt was advised treated with ibuprofen (Advil) and ice. On approx 10Feb06, the pt recovered. The office is concerned and reluctant to administer the remaining 3 doses from this vial. The doctor would like a lot investigation. A lot check has been requested. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. Additional information is not expected.
Given IM injection 12/5/2006 in right deltoid - states injection site sore for one week duration. Began hurting again 12/15 and now having difficulty moving right arm without pain.  Has not take any OTC meds or used moist heat to area.
Fatigue; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (Fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form. On 05-Mar-2021, FATIGUE (Fatigue) and HEADACHE (headache) had resolved. Not Provided          No specific treatment information for these events was provided by the reporter      Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-Significant follow up appended to AER
A couple of days after the vaccine, back muscle (upper back, left side- the same arm of vaccination) started hurting. Since then, the pain is constantly there BUT it moves to various locations, only on the left side, sometimes in muscles, sometimes in shoulder joint and often at the site of vaccination. The pain, while it moves around, is only at one location, often in addition to the vaccination site. Thus it can be in left shoulder joint and the site. Or it could be the site and at the shoulder- neck joint. Never has the pain migrated to the right side and is confined to the left arm, shoulder, upper back area. Naturally the pain dulls upon taking a couple of Tylenol?s or Advil?s but otherwise has been there no -stop for about two weeks, shortly after the  vaccination. Avery slight swelling can be felt at the injection site.
booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.
Immediate arm soreness, tightness, dizziness, lightheaded, severe high blood pressure, shortness of breath, nauseated
11/07/21: Pt admitted to the hospital for SOB. Onset was in the morning. reports she had an ongoing cough for a couple weeks, assoc nasal congestion. She states she had COVID a month ago, but also tested positive to this visit. Pt requiring 5L O2 for 98%, 69% on room air. Given 10mg IV decadron.  11/08: Pt down to 2L with O2 sats in mid 90's. continuing empiric abx - vancomycin.  11/09: Pt tested positive for rhinovirus, continue supportive care.  11/10-11: Continue supportive care  11/12: pt discharged. continue with steroids
Feeling dizzy,nausea,shaking, fast pulse(220), light headed.  10/28/09 ER medical records received service date 10/20/09. Assessment: Acute vertigo. Consider reaction to influenza vaccine (H1N1). Patient presents with nausea and dizziness worsened by movement. Skin flushed. Headache and fatigue. Mildly orthostatic.  10/27/09 Clinic medical records received service date 10/22/09 - 10/23/09. Assessment: Vertigo. Reaction to H1N1 vaccine? Viral?  Patient c/o she became dizzy, lightheaded, after H1N1 vaccine. Follow-up visit for vertigo. Feels better.
stabbing pain in temples; I have had a headache since the vaccine; Joint Swelling in my hands and back of my neck; Stomach upset; Stabbing pain in upper thighs and legs; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 03Apr2021 at 14:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to egg, wheat and dairy products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 14:30 since the vaccine, the patient experienced headache a pressure painful headache, which was going on for 9 days, otherwise the patient reported that she never gets headache she only get one headache may be once a year so this was very concerning for her. The patient also experienced joint swelling in her hands and back of her neck, stabbing pain in her temples, upper thighs, legs, etc. The constant headache made her stomach queasy. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. The clinical outcome of the events headache, pain in temples upper thighs, legs, joint swelling in her hands and back of her neck and stomach queasy was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
4th day after the shot...I was at work got diarrhea that lasted for 5hrs; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (4th day after the shot...I was at work got diarrhea that lasted for 5hrs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (4th day after the shot...I was at work got diarrhea that lasted for 5hrs). At the time of the report, DIARRHOEA (4th day after the shot..I was at work got diarrhea that lasted for 5hrs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Migraine, Vertigo, Fatigue, Joint and Arm pain,  tingling  on right side of face, numbness, tingling from pinky and radiated throughout hand. Beta blocker for migraine pain. Physical Therapy for vertigo. Also went to chiropractor for numbness. Still have migraines and vertigo today. No vision issues.
Patient stated that she felt like she was going to die; Pain that goes from under her eyes to her abdomen; Pain that goes from under her eyes to her abdomen; Small rash the size of a quarter around injection site; Diarrhea along with nausea & vomiting; Diarrhea along with nausea & vomiting.; Diarrhea and stomach cramps; Diarrhea and stomach cramps; Heart racing; Dizzy upon standing up; Shortness of breath; Kept waking up all night; A spontaneous report was received from a consumer concerning of an unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Patient stated that she felt like she was going to die (Loss of consciousness), Diarrhea and stomach cramps (Diarrhoea), Diarrhea and stomach cramps (Abdominal pain upper), Heart racing(Palpitations), Dizzy upon standing up (Dizziness postural), Shortness of breath (Dyspnoea), Kept waking up all night (Sleep disorder), Pain that goes from under her eyes to her abdomen (Eyelid pain), Pain that goes from under her eyes to her abdomen (Abdominal pain), Small rash the size of a quarter around injection site (Vaccination site rash), Diarrhea along with nausea & vomiting (Nausea) and Diarrhea along with nausea & vomiting (Vomiting).  The patient's medical history was not provided.No relevant concomitant medications were reported.   On 20-Mar-2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Mar 2021, about 30 minutes after the shot,the patient experienced diarrhea and stomach cramps.Later that evening, the patient still had diarrhea along with nausea & vomiting. Patient tried to sleep but could feel her heart racing and was dizzy upon standing up, and shortness of breath.Kept waking up all night. Has pain that goes from under her eyes to her abdomen and small rash the size of a quarter around injection site.  On 22 Mar 2021, patient still has all the symptoms, only they seem to have intensified. Patient stated that she felt like she was going to die. The event Loss of consciousness, was medically significant. Treatment details were not reported.  No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown.  The outcome of the events diarrhea,abdominal pain upper,palpitations,Dizziness postural ,dyspnea,sleep disorder,Eyelid pain, Abdominal pain, Loss of consciousness, nausea,vomiting and vaccination site rash was not resolved at the time of the report.; Reporter's Comments: This case concerns a female patient with serious unexpected loss of consciousness and nonserious unexpected abdominal pain, abdominal pain upper, diarrhea, palpitations, dyspnea, dizziness postural, eyelid pain, sleep disorder and expected vaccination site rash, nausea, vomiting. Event onset 30 minutes after first dose mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
To preface, I'm a physician (pediatrician).  I developed a swollen, indurated, erythematous itchy area approx 3x5 cm at the site of the vaccine the evening I received the vaccine, persisted a couple days, finally resolved leaving very slight induration behind.  EIGHT days after vaccine (on Dec 31), I received my regular allergy injections (one in each arm, below site of Moderna vaccine), that evening the site of the Moderna vaccine again became indurated, swollen, itchy/painful, red (redness was more widespread than the original reaction, I have pictures if needed), this lasted for about 72 hours, again leaving a very slightly indurated area behind.  Plan to do both allergy shots in the OTHER arm this week.
pt c/o sore throat and feeling of anxiety; she sat down on a cot for about 20 minutes, offered water and she refused; 02 sat measured 99% on RA; eventually she said she felt better and left, she mentioned that she has benadryl in her car that she'll take if needed
Rash developed on forehead less than 1 hour after receiving the vaccine. The rash spread across forehead to eyelids, cheeks and lips. The rash is red and mostly fine bumps that make skin feel irritated and occasionally itch. Applying hydrocortisone twice daily gives slight to moderate relief. Rash is still present on cheeks and forehead 14 days after the vaccine. Patient intends to schedule doctor visit to address rash. Menstrual bleeding lasted 13 days, 3 days longer than normal. The bleeding was much heavier than normal and increased menstrual cramps were present  for several days.  Developed sore throat on day 5 after the vaccine. Developed stomach pain and diarrhea the second day after the vaccine, which was on and off for the next week.
Pt c/o pink, tender, warm to touch area approximately 2" below inj site. Denies fever, chills, itchiness, or resp distress this AM.
I now have chronic hives. I have changed nothing in my diet or beauty products or laundry,
Pt recv series 3 vax;  Recurrent herpetic whitlow active since 1st dose & continues to be sxmptomatic.  Herpectic like lesions in left 4th finger.  Off duty til lesions dried.  Tx w/ meds. Finger healed, returned to work.
Fever to 101.5, vomiting for 24 hours, "welts" on feet briefly.
36 hours after shot, dizziness, weakness, and high blood pressure. 12-6-05 still dizziness
22NOV94 t103-104; irritable; cried & screamed; 25NOV94 mom reported pt had episode of gasping & wheezing & took pt to see MD; MD stated TM's were dull w/rt side somewhat reddened; throat clear; heart had regular rate & rhythym; lung clear
Information has been received from a registered nurse (R.N.) concerning a breast feeding female who on an unspecified date, developed diarrhea after her child was vaccinated with the first dose of Rotateq.  The mother did not inform anyone of her diarrhea but mentioned it to the nurse when she brought the child in for the second dose of Rotateq.  The mother recovered from the diarrhea.  No adverse experience occurred with the child.  No product quality complaint was involved.  Additional information has been requested.
2:1 second degree AV block, requiring ER evaluation, temporary pacemaker, monitoring in CCU
The pt developed headaches, fatigue, swollen, sore and painful joints (especially in hands, wrists, fingers and includes shoulders, knees, feet, toes and neck). Persistent arthritis-like symptoms are worsening and impairing my ability to function normally.
Can't eat, headache, fever, total body aches.  States feels signs and symptoms have her feeling she is an "8" in discomfort on zero to 10 pain scale. Patient is seeing Open Door on Friday, 7/27/12 on a separate issue.  Will discuss.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 10-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, the VARIVAX (Merck) was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 05-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R018140  and expiry date 25-JUN-2020) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown.  This is one of several reports received from the same reporter.
Dizziness and nausea on arising the moving after receiving vaccine lasted less than 30 minutes. Patient seemed off after lying down for 30 minutes after event.
She was seen in clinic about 6 days ago.  She received her meningitis type B bexsero vaccine.  This was her booster vaccination and she did not react to last injection. Received vaccine in right leg.  The vaccine felt fine going in.  That night she had significant pain at the injection site.  And woke up with pain.  Patient states three days later she noticed redness and bruising.  Over the last 3 days redness has increased in size.  Pain is getting better.  Area has been warm to touch .  One headache on Monday none since.   Nothing else has changed.  No other symptoms other than her baseline aches/systemic complaint which are unchanged and follows with her doctors for these things.  SKIN:  She has large erythematous 20 cm x 18 cm area on her anterior right thigh.  It extends about 2 cm or so by the most medial aspect from the margins that she drew but the rest looks okay.  There is a resolving 2 inch or so area of yellow bruising around where the shot was given she says its a little sore there to touch but nothing significant.  There is no nodule or abscess or fluctuant indurated area felt.  The rest of the area is nontender.  Maybe slightly more warm than the rest of the surrounding skin but not significantly.  The area around the bruised area at the most superior lateral aspect the erythema seems like it is starting to fade in scattered areas.  I drew new margins.  Discussed whether this is an injection site reaction and/or cellulitis.  I really think a large local reaction.  Seems larger than typical and even with reading vaccine insert.  We discussed these possibilities.  Discussed obtaining blood work or not.
Chills; body aches; injection site soreness; This is a spontaneous report from a non-contactable consumer. This 35-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, Solution for injection) via an unspecified route of administration to her left arm on 04Feb2021 05:00 PM (Lot number: EL9269) as single dose for Covid-19 immunisation. Facility type vaccine: Hospital. The patient's medical history included COVID (Covid prior vaccination). Patient had known allergies Nickel (Ni). Concomitant medications were not reported. On 05Feb2021 07:00 AM, the patient experienced chills, body aches and injection site soreness. Covid was not tested post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
temp of 104.4; This case was reported by a consumer via call center representative and described the occurrence of fever in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. Next day after receiving Shingrix, the patient had a temperature of 104.4 degrees F. The patient asked if the patient would get the 2nd dose.
Pt received Influenza vaccine at 13:40 and at 15:20 had swelling of left side of upper lip. BP was 133/87 and P was 66.
Recurrence of Herpetic Keratitis; This is a literature report.  A 52-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "herpetic keratitis of the right eye" (unspecified if ongoing); "herpes simplex virus (HSV) stromal keratitis", start date: 1992, stop date: 2019. The patient's concomitant medications were not reported. Past drug history included: Prednisolone acetate, stop date: 2017, for herpetic keratitis, notes: 1% topical; Trifluridine for herpetic keratitis, notes: topical; Acyclovir for antiviral prophylaxis, notes: oral; Valacyclovir for antiviral prophylaxis, notes: oral. Vaccination history included: Bnt162b2 (DOSE 1), administration date: Mar2021, for covid-19 immunization; Zostavax varicella zoster vaccine, administration date: Mar2020, for varicella zoster. The following information was reported: HERPES OPHTHALMIC (medically significant), 24 hrs after the suspect product(s) administration, outcome "recovering", described as "Recurrence of Herpetic Keratitis". The patient underwent the following laboratory tests and procedures: Ophthalmological examination: two weeks after the initial symptoms and was found, notes: to have 20/40 visual acuity in the right eye with patchy stromal haze and confluent punctate epithelial erosions along the inferior cornea; the patient presented to our clinic and vision had, notes: declined to 20/60 with new nummular opacities at multiple stromal levels. Sector iris stromal atrophy was noted; Slit-lamp examination: depicting corneal stromal haziness, notes: and sectoral iris atrophy(right eye); Visual acuity tests: 20/40, notes: right eye; 20/60, notes: vision had declined; 20/30, notes: stabilized. Therapeutic measures were taken as a result of herpes ophthalmic. Clinical Course included for relevant history herpes simplex virus (HSV) stromal keratitis: 3-4 episodes of reactivation/year until 2010; decreased to 1 episode of reactivation every other year with last episode in 2019.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.