chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. states that after receiving the 3rd dose of Moderna 12/06/2021, started experiencing symptoms that evening of fatigue, chills, possible fever, headache, shortness of breath, loss of appetite, and joint pain. Self-treated with Home O2, lasting 48hrs. No noted Primary visit/communications.
ON 10/29, FLU AND VARICELLA ADMINISTERED, PT LEFT IN GOOD CONDITION; 0N 11/2, PT RTC WITH CELLULITIS AT VARICELLA IMMUNIZATION SITE. PT TREATED EMPIRICALLY WITH COURSE OF KEFLEX, AND MEDICALLY EXCUSED FROM SCHOOL FOR 2 DAYS.
1/6/2021-vaccine @ 1506. Within an hour, felt nausea, headache, and horrible taste. In approximately 24 hours, felt very ill.  Slept 4 hours.  Woke with over 101 temp, chills, slight cough, and previous symptoms.  By 3 am, fever up past 102 with body aches as well as the previous symptoms.  Slept 2 1/2 days.  Fever finally gone 1/10/2021. Headache finally subsided 1/13/2021. Nausea subsided 1/14/2021.  Slight cough still  lingering.   One great note, my Covid-hands seemed to have possibly cleared.  The swelling in my knuckles & palms of both hands seems to have disappeared after the vaccine!
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  There had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. Were filling out a temperature excursion assessment with the State at the time of report. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
Patient was very nervous/anxious. Fainted after HPV shot. Checks by Dr./Nurse. Recovered within 10 minutes. Told patient to stay in the room until feel better to leave.
received pneumoccal/flu vaccine 2 days prior to presentation at ED. within 12 hrs developed painful, erythematous swelling at the pneumocaccal injections site. also deveoped  headaches, myalgia, dry heaves, fever/chills
Information has been received from a registered nurse concerning her 21 year old son who on an unspecified date was vaccinated with a 0.5 ml second dose of RECOMBIVAX HB (lot # not reported). The nurse stated her son needed the RECOMBIVAX HB due to he was attending school and his titer showed he failed to seroconvert to a previously administered hepatitis B vaccine (Manufacturer unknown). No adverse events reported. the patient did not seek medical attention. Upon the time of the report, the patient's present status was unknown. Additional information has been requested.
Subsequently the pt experienced an elevated SGOT and SGPT with normal alkaline phosphatase and bilirubin. A hepatitis screen showed her to be positive for Hepatitis A. As of 10/5/00, the outcome of the events is ongoing.
Pink tinged spotting one week after vaccination for 5days. Menstrual cycle is regular. After my vaccine I?m  late on my Menstrual cycle. Took Pregnancy test results are negative.
Information has been received from a physician's assistant concerning an approximately 1 year old female patient who on 08-APR-1999 was vaccinated with the first dose of VARIVAX (Merck) (lot number not reported). On 19-OCT-1999 the patient experienced a rash which was identified as shingles. The rash started on the lower back above the buttocks and moved to the lower leg. These areas were described as blisters. The infection made the patient walking difficult and was considered to be disabling. Unspecified medical attention was sought. It was unknown if there were lab studies performed. The symptoms improved on therapy. On an unspecified date the patient recovered, but she was still experiencing flare ups of nerve pain in her lower leg (discrepant information). The physician's assistant considered the patient's events to be disabling. Additional information has been requested.
This spontaneous report as received from a pharmacist and from a patient's mother, refers to the patient of unknown age and gender. No information on patient's medical history, concurrent conditions and concomitant medications was provided. On 18-MAY-2017, the patient was vaccinated with an expired dose of GARDASIL 9, intramuscular (dose, lot# and expiry date were not provided). The reporter was informed of the expired dose by an unknown nurse approximately 30 minutes after vaccination. The patient did not experience any adverse effects. Product quality issue was not involved. Additional information is not expected as there was no consent for further contact.
Day 1 - sore arm and becoming ill by night (maybe near midnight).  Day 2  Temperature elevated 2 degrees, chills, itching Left forearm outside in mid area, tired but hard to get to sleep ; Day 3 Rash on both sides of forearm (left backside and right forearm inside near crease in arm with  raised bumps and skin very pink both above and below the crease - and areas were about an inch to 1 1/2 inches), chills continued, had to cover up and fell asleep off and on (naps are not something I do) and went to bed early, tired, very achy body.  Day 4  Although feeling better, the rash on the right inside arm near the crease is continues and lightens the pinkness a bit but other spots are appearing.  NOTE: My husband won't send in a report but he had the two VERY BAD DAYS like I did but no chills but his  rash was in small splotches and the entire length of his  one inside forearm.  I am wondering if this vaccine was not inactivated enough?  I hope the rash will eventually go away.  I knew not to scratch it.
Given  DTaP first. Cried. Hib given. Cried and stopped breathing.  No color change.  Went limp for about a minute. Recovered after he he was stimuated. Cried again.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020). On 16th May 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, limbs stiffness, injection site pain, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, limbs stiffness, injection site pain, injection site swelling and injection site itching were unknown. It was unknown if the reporter considered the injection site erythema, limbs stiffness, injection site pain, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on left deltoid. The health care professional reported that the patient developed redness, swelling, itching, pain, and stiffness below the injection site.
This spontaneous report was received from a nurse and refers to a 1 year-old male patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 29-JUN-2017, the patient was vaccinated with improperly stored first dose of VARIVAX, one unspecified dose in the right thigh (lot # M047662 with the expiration date of 02-DEC-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The patient was concomitantly vaccinated with a dose of M-M-R II and pneumococcal vaccine (unspecified). The administered dose of VARIVAX experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide. Sender's Comments: US-009507513-1706USA009938.
Pt had 2 episodes of vasovagal responses , pt passed out within 10 seconds of receiving vaccine, she recovered then passed out again 10 minutes later for a longer period, paramedics were called.  BP was initially at 90/52 with a pulse of 58.  A physician was on site and patient was not experiencing any symptoms of stroke or other issues
Persistent headaches, Advil provides zero relief. Aside from headaches, is the extreme fatigue. Right now I need to lie down 20 hours daily - I am healthy and energetic, abnormal for me to need rest during the day
Local skin reaction/rash at site of injection. No treatment indicated. Resolved in 3-5 days.
This non-serious initial spontaneous case, was received on 23-Sep-2017 from other health professional (pharmacist), concerning a 3-years-old, child (female) patient. The patient's medical history and concomitant medications were not reported. On 23-Sep-2017, the patient was administered with FLUCELVAX QIV (dose, batch number: 195213, expiry date: 31-Mar-2018, route of administration and anatomical location: not reported) which was characterized as inappropriate age at vaccination. As FLUCLEVAX QUADRIVALENT had not been established in children less than 4 years of age. The patient had no adverse event at the time of the report. No treatment medication was received. The outcome of the events was not reported. The reporter considered the events as non-serious. Non-significant follow-up received on 03-Oct-2017. The reporter states that no further information regarding adverse event was available. Non-significant case correction received 23-Sep-2017: Batch number was updated on the screen. Narrative was amended accordingly.
Received phone call from patient's aunt reporting that patient developed "watery pimples all over the body" yesterday 03/23/2016 and is concerned that it is chickenpox. No fever, no cough, no itchiness, or no malaise. Patient received VZV, Hep A, and Hep B on 03/09/2016. Patient has no allergies, no concurrent illness during vaccination day and is not taking any medication at this time. Aunt states they took patient to ER today and was diagnosed with Varicella lesions and was advised to stay away from other children. No diagnostics or medications were given in the ER. Currently, patient is well and no other injuries or ailments were sustained.
Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with drug allergies to "Quinolones" and a pertinent medical history of a spontaneous abortion (date unknown) who on 23-JUN-2011, 26-JUL-2011 and 20-DEC-2011 was vaccinated with her first, second and third dose of GARDASIL (third dose: lot number 671006/1291AA, expiration date 12-APR-2014) respectively. Concomitant therapy included omeprazole and prenatal vitamins. On 20-DEC-2011 after the patient received her third dose of GARDASIL it was determined she was pregnant. No adverse effect reported. The patient's LMP (last menstrual period) was 26-OCT-2011 and estimated delivery date was 01-AUG-2012. "Urine hCG after the vaccine was administered" and "a beta hCG was performed as well and the results have not be obtained yet". The patient had sought unspecified medical attention. At the time of the report, outcome of the event was unknown. Follow up information has been received from the registered nurse and a family nurse practitioner concerning the 24 year old female case worker above. The patient with (GERD) Gastrooesophageal reflux disease and a history of a spontaneous abortion 11 weeks from LMP (last menstrual period) (captured in WAES # 1201USA00571) on 06-OCT-2011 who on 23-JUN-2011, 26-JUL-2011 and 20-DEC-2011 was vaccinated with her first, second and third dose of GARDASIL (lot number: first dose 668229/1569Z, second dose 668229/1569Z and third dose 671006/1291AA) respectively. The patient's estimated conception date was also reported as "09-NOV-2011". Follow-up information has been received from a registered nurse and refers to a 24 years old female patient with blisters on the rear of the tongue, drug hypersensitivity, gastrooesophageal reflux disease and a history of surgery and abortion spontaneous (dates not specified). The patient has a history of 1 previous pregnancy. It was reported that the patient became pregnant with an LMP of 26-OCT-2011. Initial exposure to GARDASIL was at 0 week(s). It was reported that on 28-JUL-12 the patient delivered a female infant weighing 2862.71 gms or 6 lbs 5 ozs (infant's length was 20 inches) via cesarean delivery. The infant's APGAR scores are not available. Unspecified diagnostic tests were carried out at fourth, fifth and eighth month of pregnancy (approximately in February, March and June 2012, respectively. Outcomes unknown). Upon delivery, the infant was noted to be a normal, healthy newborn. Upon internal review, cesarean section was determined to be an other important medical event. Additional information is not expected.
Day 1 after vaccine, arm was sore, had allergy symptoms such as runny nose and headache. Continued to have sinus issues about a week and a half after. Arm felt fine after day 2.
passed out from the pain; Dry heaves; head felt swollen; my headache continued to move down to my right jaw; ever had migraines before; stomach sickness; arm hurt at the vaccination site; Chills; head was aching terribly; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out from the pain) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-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 LOSS OF CONSCIOUSNESS (passed out from the pain) (seriousness criterion medically significant), RETCHING (Dry heaves), HEAD DISCOMFORT (head felt swollen), PAIN IN JAW (my headache continued to move down to my right jaw), MIGRAINE (ever had migraines before), ABDOMINAL DISCOMFORT (stomach sickness), VACCINATION SITE PAIN (arm hurt at the vaccination site), CHILLS (Chills) and HEADACHE (head was aching terribly). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (passed out from the pain), RETCHING (Dry heaves), HEAD DISCOMFORT (head felt swollen), MIGRAINE (ever had migraines before) and VACCINATION SITE PAIN (arm hurt at the vaccination site) outcome was unknown, PAIN IN JAW (my headache continued to move down to my right jaw) and HEADACHE (head was aching terribly) had not resolved and ABDOMINAL DISCOMFORT (stomach sickness) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Inconclusive  did not showany problem. On an unknown date, Magnetic resonance imaging: inconclusive (Inconclusive) Inconclusive  did not show any problem. On an unknown date, X-ray: inconclusive (Inconclusive) X-ray confirmed there was nothing wrong in my jaw..         Patient had done blood work that did not show problems No Concomitant medication information was provided. Action taken with mRNA-1273 in response to the events was Not Applicable.  Company comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
my tongue got very swollen, my throat burned and my ears hurt.   Took benedryl and it cleared up my tongue issue in 15 minutes.  My throat and ears felt better when I woke up on the 2/28/2021
Started with sore arm, red and swollen, sore throat, head and chest congestion, body aches, then developed into coughing, runny nose, chills. I have been sick ever since I was given the Tdap. I saw Family doctor on 12/26/2012 for the symptoms, he diagnosed me with bronchitis and prescribed Levaquin and cough med.
20 hrs post 2nd Moderna injection, I experienced chills, fever and headache.  The chills/fever/headache  lasted for 12 hours.  The next day, I experienced various rash sites (NONE at the injection site, though) that seem random and change daily.  Day 1 of the rash was on the upper left thigh, scalp and palms of both hands.  Day 2 of the rash, was on the right forearm, upper abdomen and left hip.  The following day, the rash moved to the right ankle, nape of the neck and left buttocks.  The rash is very itchy, warm to the touch, and slightly raised.  I've tried soaking in epsom salts and lavender oil, ice, and antihistamine creams.  It seems to soothe the affected areas, but then crop up a new site!  I suspect that the timing is too coincidental to be anything other than a systemic reaction to the Moderna vaccine.
This spontaneous report as received from a consumer refers to a 70 years old female patient with codeine allergy and no pertinent medical history. The patient was subcutaneously vaccinated with ZOSTAVAX on 14-APR-2011 (lot# and dose were unspecified). No concomitant medications were reported. On 30-JUN-2012, the patient broke out in case of shingles on her forehead and was experiencing bumps on her head, mouth and right ear. She had pain off and on and had a rash which was beginning to crust over on her forehead. The patient went to the doctor, and subsequently the ophthalmologist and received treatment for the shingles outbreak, The treatment included valacyclovir three times a day, hydrocortisone 1%, neo-poly-dex for eye. The outcome of shingles was reported as recovering/resolving. No lab diagnostic study was performed. No additional information has been requested.
Palsy, left arm, left side of face, numbness and tingling arms and face,
PT WAS GIVEN PREVNAR VACCINE AND APROXIMATELY 5 MINUTES LATER MOM ASKED NURSE TO COME AND LOOK AT PTS LEG BECAUSE HE WAS RED AND SPLOTCHY. HAD PROVIDER COME IN AND LOOK AND HE REQUESTED BENADRLY TO BE GIVEN. VACCINE WAS ADMINISTRED IN RIGHT THIGH
Within the first few days after I got my first COVID 19 injection,  I started having ringing in my right ear.   The ringing in the ear varies in intensity but is always present. It is present as soon as I wake and continues until I fall asleep.  It is present every day.  I have only had 2 episodes of ringing in my left ear that were very brief.  I did not have these symptoms prior to my vaccine.  No prior ear trauma or exposure to continuous or extremely loud noises.  I did get my second COVID 19 vaccine as scheduled on 1/27/2021.  After that dose, the ringing was less intense, but continues daily.
Received Varivax right anterior thigh 8/14/08.  Developed redness, warmth, swelling at injection site on 8/23/08.  Exam on 8/26/08: mild erythema and subcutaneous induration right anterior thigh.  Physical signs are decreasing from peak of severity on 8/25/08.
mom reported pt had fever to 104 & irritable & crying all noc long;exam OK in clinic the following day;
pt was seen in office on 16NOV93 for fussiness & cont fever; 12NOV93 hospitalized to r/o meningitis; CSF was neg for bacteria however cell count was high 107, seg 18, L18 mono 6; CSF  protein- inc 73;
Developed red papules on lower extremities, some with white center within a few hours of injection, they were itchy, and not blanchable. Rash nearly resolved by 11/6/18.
This spontaneous report was received from the mother of a female patient of unknown age. The concurrent condition and medical history was not reported. On an unknown date, the patient was vaccinated with all the 3 doses of GARDASIL or GARDASIL 9 (the reporter was not sure which was vaccine was administered). The concomitant medication was not reported. On an unknown date the patient was accidentally vaccinated with the fourth dose of GARDASIL or GARDASIL 9 somewhere between 6 and 18 months after the third dose (extra dose administered). No adverse effects were reported. Additional information is not expected as no HCP details are available.
Fever; Aches; Tiredness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing), notes: ACE inhibitor which has managed my blood pressure for the last 3 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 immunization, reaction(s): "Tiredness", "Aches", "Fever"; Bnt162b2 (Dose: 02), for COVID-19 immunization, reaction(s): "Tiredness", "Aches", "Fever".  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Aches"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional information: the patient had an original 2 dose regimen of Pfizer vaccine and then 2 Pfizer boosters. Aside from general reactions (fever, aches and tiredness). The patient not had other symptoms.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): PFIZER INC-PV202300028832 same patient/event, different vaccine dose number;