chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 9-month-old female with no pre-existing allergies, birth defects or medical conditions who on 05-MAR-2007 at 18:00 pm at a "well-child check-up" was vaccinated intramuscularly with a first dose of VAQTA instead of a dose of hepatitis B virus vaccine. No medical attention was sought and no diagnostic laboratory tests were performed. Subsequently, no adverse reactions were reported. No product quality complaint was involved. Additional information is not expected.
This spontaneous report as received from a physician refers to a male patient of unknown age. On 02-NOV-2010 the patient was vaccinated with the first dose of GARDASIL by an unspecified Pediatrician (intramuscular, lot#, dose and frequency unknown). On 10-JAN-2011 and on 16-MAR-2011, the patient was administered with the second and third dose of GARDASIL (lot#, dose and frequency unknown) (route: IM) respectively by an unspecified Pediatrician. The patient was given a fourth dose of GARDASIL on 21-OCT-2014. No adverse effects were reported. It was not specified the patient sought for medical attention. Additional information has been requested.
Treatment of COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: LJ5372) at the age of 67 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 14Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF8851), in right arm and on 05May2022 as dose 4 (booster), single (Lot number: FM9992), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Familial Mediterranean Fever" (unspecified if ongoing); "Prinzmetal angina" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Raynaud's syndrome" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: green tea" (unspecified if ongoing). Concomitant medication(s) included: COLCHIQUIM, start date: Nov1985. The following information was reported: COVID-19 (medically significant) with onset 28Dec2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 28Dec2022, outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2022) positive; (28Dec2022) positive; (04Jan2023) negative, notes: First negative rapid test; (06Jan2023) positive, notes: Rebound case, showing positive rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19, included Paxlovid.
Information has been received from the agency (case #2007023-2447519) via a physician concerning a 15 month old male on 10-DEC-2007 was vaccinated with COMVAX (lot # 656271/1157U) 0.5 ml. On 10-DEC-2007, five hours after being vaccinated in the evening, the patient experienced a fever. On 12-DEC-2007, the patient was assessed in the emergency room for persistent fever (102-103). A CBC and blood culture were planned. At the time of reporting, the patient had not recovered. Additional information has been requested.
Headache, Myalgia & Fever Narrative:  dose 1-DAY 2: BODY ACHE RESOLVED BY THE END OF THE DAY dose 2-"extreme" fatigue, severe headache, and low-grade fever.  Other Relevant History:
Information has been received from a infectious diseases pediatrician concerning her 5 year old daughter who, at her 5 year old check-up, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Concomitant vaccinations included a dose of influenza virus vaccine (unspecified) and a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component vaccine (+) poliovirus vaccine inactivated (ver0) (+) tetanus toxoid (Pediarix). The pediatrician reported that after receiving the dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live her daughter went into anaphylactic shock. 911 was subsequently called to the child's pediatrician's office. It was noted that the child's face swelled around an oxygen mask and head such that her ears could not be seen. The patient was treated with epinephrine. The child was rushed to a hospital via ambulance, but it was not reported if she was kept overnight. Allergy testing revealed that the child had a severe allergy to gelatin. The child was noted to be recovered as she responded well to the epinephrine. Anaphylactic shock was considered to be immediately life-threatening. Additional information has been requested.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a adult female patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: 3 patients vaccinated with vaccine that was stored at -2.56C.
pt reported devel a sore @ site of vax approx 24hr p/vax;sore was fluid filled & then ruptured w/a resulting scab;when observed by NP on 5AUG96 lesion appeared to be healing approx .5cm x 1.0cm w/central scab & mild excoriation @ borders;
Pt. developed rash on both upper arms (deltoid area) and slight erythematous on both ears. (+) mild pruritus.
Patient experienced sweating, dizziness and tingling on the mouth. She was sweating profusely and feeling hot. Pharmacist gave her Benadryl and after 20 minutes , she said she felt better . Observed the patient for few more minutes until she was okey. Patient advised to call primary care doctor if anymore reaction.
About 2 weeks after the second shot on 8/28/2021, I has very slight Tinnitus increasing every day. At the end of September, Tinnitus was moderate to severe making it difficult to sleep, concentrate at work, talk to other workers. Checking on the internet, I found an 11,000-12,000hz Tinnitus sound that matched my frequency.  Saw Dr, he took some blood tests.  Cleaned out my ears with solution, no help. Got an Appointment with ENT, was in 20 days, NO WAY! Went back to Dr. got 5 days of 50 mg Prednisone with taper, which seems to help.  Saw ENT, he was skeptical it was vaccine-related, could be a normal occurrence.  He wanted to see me again in 20 days, I said NO WAY.  I got a new ENT appt at end of Predisone treatement.
Patient went to stand after vaccine and sat back down in chair, became unresponsive to stimuli and seemed to stop breathing.  She regained consciousness with a bloody nose and feeling "shaky".  Offered water and cold cloth on neck. EMTs arrived and assessed patient. Patients vitals seemed stable and they offered she could go to hospital or not. Patient chose to go and was taken by EMTs to ER. Has a history of cardiac issues
This spontaneous report as received from a medical assistant refers to a 6 patients of unknown age. The patients medical history was not reported. On 02-JUN-2-13 and 03-JUN-2014 6 patients were vaccinated with PEDVAXHIB, (lot#: J013944, exp date: 13-AUG-2016, 0.5 milliliter (ml), intramuscular). Concomitant medications were not reported. On 02-JUN-2013 and 03-JUN-2014, 6 patients were vaccinated with improperly stored PEDVAXHIB. The PEDVAXHIB that had been improperly stored and no adverse effects was unknown. Additional information has been requested.
It started with soreness in the top of the  left shoulder  and injection site, which was to be expected. Then muscle pain and strain that starts in the inner arm traveling down the muscle to the left wrist.  Left arm cannot extend to full range with out a "pulling, or ripping " feeling. The left arm is painful to the touch, and the pain gets worse when manipulated.  No redness or obvious swelling. Just lasting pain through the entire left arm muscles.  There is no soreness on the injection site, and no longer any soreness on the shoulder.  Took Tylenol PM for three straight nights but the pain and strain is persistent and only provided a very mild temporary relief. Also tried using a cold compress that only gave minimal relief. Symptoms are still on going.
This is a 28-year-old male member who received his primary smallpox vaccination on 04/25/04. Initially, vaccination site/course went as described in briefing. Over the course of the last several months, intermittently since vaccination, developed a single "knot" under both arms. Since approximately late November 2003, has developed only under the left arm. Client states that the knot appears about every 6 weeks and lasts approximately 12-16 hours. He describes the knot as non-painful, "dime-size knot" that is smooth and round. It does not limit his arm motion. Denies fever, chills, fatigue, nausea and vomiting in association with the presence of the knot. He was seen at clinic and told that it was "a common thing".
1 week after vaccine, my right eye lid began twitching--like it would do occasionally if I spent too many hours on the computer. But unlike previous twitching which would twitch off and on for maybe an hour, this one continues to this day, 3 months since it began and it's pretty frequent, up to 20 twitches per hour sometimes. It also twitches when my eyes are closed.  Only thing different in my life/activities was that I had received the Covid vaccine.
Information has been received from a physician and his office manager concerning a 25 year old female with a history of bladder repair in July 2007 during which blood transfusions were required and breast implantation in March 2008 and no known drug allergies, who on 11-APR-2009 was vaccinated with first 0.5mL dose of GARDASIL (route not reported, lot number 0074Y). There were no other vaccines administered that date. On 13-APR-2009, the patient experienced foot rash (also reported as rash in the left leg) and nausea. The patient recovered from nausea after four days (17-APR-2009). On 21-APR-2009, the patient came into the office. During that visit only a little redness was remaining on her leg. The medical assistant considered this event as recovering since the patient was directed to her general practitioner for allergy treatment. Additional information is not expected.
after administering Janssen COVID Vaccine, patient felt light headed, rapid heart beat, sweating all over the body, cold, slouched over in chair, nausea, did not throw up, weak (could not make a strong fist), felt dehhydrated, general unwell, took about 10 to 15 minutes to get back to baseline for patient.  I sat with patient in IMZ room until felt better...I asked if wanted EMS but shook head no...later in evening I saw patient in store pulling freight....gave water at their request
Confusion/inability to complete tasks: within 20 minutes of getting my vaccine, I was unsafe to drive (drove on the wrong side of the road). Within 2 hours, I could no longer focus enough to work (I'm an engineer). It's been 6 days since my shot and I'm still confused, forgetful, unable to focus, and unsafe to drive. I forget steps during work tasks, and forget what I'm doing while I'm doing it. It's like a short term/prospective memory issue. Lack of coordination: 5 days after shot, could not navigate stairs without assistance. Could not remember ADL (did I get mail, did I eat, did I shower, day of week...) Fatigue: Slept/ rested all day for 2 days after the shot. It's now 6 days after the shot and I'm still unusually tired, needing 2-6 extra hours of rest a day. It's tiring to walk short distances, to focus/converse, to work. Sore arm: my arm was very sore for 2 days after the shot (painful at rest, worse if touched, like a bruise). By 4 days after the shot, it was not sore even if pressed/hugged. I do not have any headache.
Received Pfizer vaccines on 3/15/21, 4/5/21 SARS-CoV-2 Nucleocapsid Total Ab, S Positive  on 3/18/22. admitted to hospital on 3/17/22 w/ fever, SOB, pneumonia d/t COVID-19 Underlying advanced stage follicular lymphoma with skeletal involvement
LOSS OF WORK; FAST HEART RATE; DIZZINESS; LOSS OF APPETITE; WEAKNESS; BAD HEADACHE; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 05-AUG-2021) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUN-2021, the subject experienced fast heart rate. On 29-JUN-2021, the subject experienced dizziness. On 29-JUN-2021, the subject experienced loss of appetite. On 29-JUN-2021, the subject experienced weakness. On 29-JUN-2021, the subject experienced bad headache. On an unspecified date, the subject experienced loss of work. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fast heart rate, dizziness, weakness, bad headache, and loss of appetite, and the outcome of loss of work was not reported. This report was non-serious.
This is a spontaneous report from two contactable nurses via a Pfizer sales representative. The nurses reported similar events for 3 patients. This is the third of 3 reports. A patient of unspecified age, gender and ethnicity received the first dose of TRUMENBA (lot number M13066) via an unspecified route of administration, on unknown date, at single dose. Relevant medical history included streptococcal infection before the vaccine. Concomitant medications were not reported. On unknown date the patient experienced faint redness and swollen at sight, fever at 101 F, stomach pain, vomiting, dizzy, severe headache, severe soreness of arm and she was nauseous. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
injection site has been red, swollen, and itchy for 8 days; seems to be a dermal response - no other adverse symptoms
Nausea; arm pain; HEADACHE; MUSCLE ACHE; redness; This case was reported by a consumer and described the occurrence of nausea in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nausea (1st dose received on 21st October 2021, for tolerance refer case US2022AMR060911).   In January 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced nausea, pain in arm, headache, muscle pain and erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, pain in arm, headache, muscle pain and erythema were recovered/resolved.   It was unknown if the reporter considered the nausea, pain in arm, headache, muscle pain and erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-Apr-2022 Reporter's comments: This case was reported by the patient. She called back to present further details. The patient received the Shingrix in January 2022, she thought around the 20th of the month in left arm. She stated the side effects from the Shingrix vaccine were rough compared to other vaccines. The side effects lasted about 2.5 days.  The reporter gave consent to follow up with the healthcare professional and pharmacy. Additional Supportive Information: For toterance of 3rd dose, refer case US2022AMR060153.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR060153:same reporter US-GLAXOSMITHKLINE-US2022AMR060911:same reporter
It started first with headache, then my throat felt like someone was squeezing it. I took 2 Advil and arrived home.  I tried to lay down but my head was hurting worse then laying prone then sitting. I continued to take 2 Advil every 4 hours. At 3:00AM I woke up in bed with my chest area (above breast) having sharp pains.  The pain was also in the lower neck area close to shoulder joint. The Advil did seem to lessen the pain, but about two hours later I was very uncomfortable again.  I went and sat in recliner chair with foot rest up. The pain continued to be in the area on top of shoulder of the left arm (injection arm) going from outside of shoulder across to the lower neck region.  Then, pain also the area above breast on left side. I did notice that when I took a deep breath, the pain became sharper and more like piercing pain.  I did not have trouble breathing - just painful. 24 hours later the pain is still there and worse when laying down on bed.  The pain then seems to go up neck and also become a headache. The pain is about a scale of 8.5 out of 10. 3:00pm about 27 hours after receiving injection at doctors office, I called my physician and explained all my symptoms.  They suggest I take 2 Aleve every 12 hours and if I do not feel better with less pain tomorrow (Wednesday Nov 11th) then they want me to return to office.
By evening not feeling well. Vomited but no fever. Ate dinner later and went to bed. In AM noted red raised circles on Flu shot arm but disappeared after 3 1/2 hours became pale and nauseated, diarrhea, cold sweats, felt like she was going to pass out, laid down slept 2 hours felt fine after nap.
A week after this patient's shot, on 07/10/00, in the left arm, her left arm was very painful. The patient started to get stabbing pains in the arm; she could not move her arm. The patient had 9 weeks of physical therapy. Nothing helps. She can't sleep at night due to the pain. The patient also had a Cortizone shot, it did not help.
This spontaneous report has received from a medical assistant referring to 15 years old patient of unknown gender. No information was provided regarding the patients' medical history, concurrent conditions, drug and allergy history. Concomitant therapies included sterile diluent (MRK). On 22-SEP-2017, the patients were vaccinated with improperly stored doses VARIVAX (lot # N017396, expiration date 07-JUN-2019, dose and route was not provided) for prophylaxis. The doses of VARIVAX were exposed to a temperature excursion of 15° Fahrenheit (°F) to 46°F during a time frame of 1 hour and 23 minutes, which was detected by the data logger. There was a previous temperature excursion of 6°F to 14°F for 1 hour and 16 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA003604: US-009507513-1711USA003603: US-009507513-1711USA003605: US-009507513-1709USA011228.
Patient admitted directly from clinic with hypoxia.  Initially needed 4L O2 to maintain sats, has since improved to PRN supplemental O2 to keep oxygen to 92%, especially with activity seems to be chronic, with significant desats with activity - Completed 3 days azithro, rocephin and steroids - Discharged after several days on oral augmentin to complete course of treatment Hospital admission within 6 weeks of receiving the COVID vaccine.
Patient received his second dose of COVID vaccine on 10/29.  On 10/30 he developed substernal chest pain that was sharp and intermittent.  He also developed shortness of breath, fatigue and body aches.  Patient was admitted to the hospital for observation and started on ibuprofen and colchicine.  The cardiologist diagnosed him with myocarditis secondary to the vaccine.  Patient was seen in a follow up appointment on 11/9 where he reported significant improvement in his chest discomfort and shortness of breath.
Low blood sugar; Headache; Queasiness; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (Low blood sugar), HEADACHE (Headache) and NAUSEA (Queasiness) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced BLOOD GLUCOSE DECREASED (Low blood sugar), HEADACHE (Headache) and NAUSEA (Queasiness). At the time of the report, BLOOD GLUCOSE DECREASED (Low blood sugar), HEADACHE (Headache) and NAUSEA (Queasiness) outcome was unknown.
client complained of dizziness 3 mins after receiving vaccine. Client signaled EMTs for assistance. EMT began assessment and vitals and EMT informed PHN and PHN. Upon arrival client sitting upright in chair, alert and oriented x4. PHN continued assessment. Per client felt dizzy, blurred vision and sweaty. Vitals at 1854: blood pressure 148/96, pulse 71, oxygen 99%. Client denied chest pain, shortness of breath, headache, no swelling or flushing noted. Medical history of hypertension, per client takes medication at night. Medication Micardis for blood pressure. No known allergies. EMT gave client water. Vitals at 1900: blood pressure 149/98, pulse 72, oxygen 99%. Client stated dizziness improving and blurry vision resolved. Vitals at 1905: blood pressure 139/86, pulse 70, oxygen 98%. Vitals at 1910: blood pressure: 147/92, pulse 68, oxygen 98%. Per client normal blood pressure 130s/80s. Per client dizziness resolved. 1915 vitals: blood pressure 128/91, pulse 68, oxygen 98%. PHN advised client to follow up with provider and gave ER precautions. Last vitals at 1920: blood pressure 140/95, pulse 64, oxygen 99%. Per client all symptoms resolved, able to stand with no dizziness. Wife present with client and would drive client home. Client left facility at 1922 with steady gait.
Pain, redness, swelling, itching shoulder to elbow. Antibiotic, BENADRYL & ibuprofen prescribed 10/10 resolved.
Breakthrough case admission after 3 vaccines Moderna 4/9/21 Lot# 043B21A;  Moderna 5/19/21 Lot# 006C21A;  Moderna 11/28/21 Lot# 012H
acute urticaria started on 1/9/2021 on left upper arm and radiates down the arm. Urticaria on chest/abdomen and back. Patient c/o burning and itching sensation on left arm and abdomen and back. Patient was seen on 1/11/2021 and prescribed hydroxyzine 25mg 1 tablet three times a day
Soreness/pain in right arm at site of Pneumovax 23 injection shortly after administration.  Pt had erythema and induration at site that night that progressed to shoulder and mid forearm within the next 3-4 days, chills and felt feverish x 3-4 days.  Pt took ibuprofen q 4-6 hrs and used warm compresses.  Pt called ID fellow on 12/31 to report adverse reaction.  Pt states he is improving but has not totally recovered as of report today.
a patient who was in the pharmacy was administered a dose of PREVNAR 13 on an unspecified date 2 years ago. Patient is in the pharmacy and will be administered the PNEUMOVAX 23 vaccine on 06-JAN-2020; no adverse event; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date in 2018 (reported as 2 years ago), the patient was vaccinated with pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) for prophylaxis (dose, route, lot# and expiration date were not reported).  On 06-JAN-2020, the patient was in the pharmacy and would be vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route, lot# and expiration date were not reported) (information capable of leading to medication error). No adverse event was reported. No additional information was provided.