chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 76-year-old female patient with osteoporosis, high blood pressure, chronic obstructive pulmonary disease, allergies to moxifloxacin hydrochloride (AVELOX), quinine, meloxicam and penicillin (unspecified); and history of a blood clot. On an unspecified date in November 2016, the patient was vaccinated with a dose of an unspecified pneumococcal vaccine (manufacturer unknown) (lot #, expiry date, dose and route of administration were not reported). Subsequently on 13-FEB-2017, she was vaccinated with a dose of PNEUMOVAX23 injection, intramuscularly (lot #, expiry date and dose were unspecified). Concomitant therapies were not reported. On 14-FEB-2017, the patient called the physician's office stating that she was experiencing pain, soreness, swelling, and warmth to the touch at the injection site that began a few hours after the injection was administered, approximately on 13-FEB-2017. No lab diagnostic studies were performed. The patient was given an unspecified treatment for the events. The outcome of the events was reported as not recovered at the time of this report. The investigator did not provide the causality assessment between the events and unspecified pneumococcal vaccine (manufacturer unknown), or PNEUMOVAX23. Additional information has been requested.
pt has a flare up of musculoskeletal  symptoms  after  MOderna shot   in 08/2021, since then   she is  having inflammatory response. d/w  pt ,  she contacted   her rheumatologist, increased   prednisone to 20 mg  daily. Please, report it,  Moderna was  given, third shot on 08/18/21.
itching, swelling, redness in area where shot was given ( oval 3 1/2 by 2 1/2 inches)
fever 100.4 for 36 hrs, then today 1/5 hives on administration side (arm)
rash noted approx 6hr p/vax given;resolved w/in 24hr;
The day after I got the second dose I had a blood clot form in my brain.  I developed a headache in that part of my head where the clot was located.  That headache remains to this day.  Three days after the second dose I had an MRI that showed the blood clot, described as an acute infarction, meaning it happened recently.
lymph node in the left neck and was swollen and tender; lymph node in the left neck and was swollen and tender; Peculiar throat sensation; rash on the left ear which spread to face, neck, and chest; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH (rash on the left ear which spread to face, neck, and chest), LYMPHADENOPATHY (lymph node in the left neck and was swollen and tender), LYMPH NODE PAIN (lymph node in the left neck and was swollen and tender) and OROPHARYNGEAL DISCOMFORT (Peculiar throat sensation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced RASH (rash on the left ear which spread to face, neck, and chest). On 16-Jan-2021, the patient experienced LYMPHADENOPATHY (lymph node in the left neck and was swollen and tender), LYMPH NODE PAIN (lymph node in the left neck and was swollen and tender) and OROPHARYNGEAL DISCOMFORT (Peculiar throat sensation). At the time of the report, RASH (rash on the left ear which spread to face, neck, and chest), LYMPHADENOPATHY (lymph node in the left neck and was swollen and tender), LYMPH NODE PAIN (lymph node in the left neck and was swollen and tender) and OROPHARYNGEAL DISCOMFORT (Peculiar throat sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Medications included Benadryl, Steroid, Pepcid, IV fluid,Cephalexin, Prednisone, Benadryl, and Epi- Pen. No concomitant medications were provided by reporter.
Rectal temp to 101.7. C/O fussiness, no redness or swelling.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 23-SEP-2014. Demographic details for each patient ere provided. This report referred to a 6-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the second dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 10-JAN-2014 at 3:20 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00AM). The parents of the patient were going to consult with physician, and declined to repeat the dose1. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
6 1/2" x 5 1/2" area of swelling, redness, warm to touch.
2 month old patient received a dose of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that the 2 months old patient inadvertently received a dose of Kinrix which led to inappropriate age at vaccine administration.
10/28 hands and feet swollen, few hives-itchy. 10/22, 10/24-diarrhea, vomiting. 10/27 diarrhea.
Monovalent COVID-19 Vaccine was administered as a booster shot instead of a bilavent. Patient did not have any adverse events or outcome.
Pain in left arm, hard to move, fever. Given ibuprofen & VICODIN for pain. Ordered CBC & Blood cultures.
tested positive for Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for Covid) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010m20a, 027b21a and 013F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Migraine, Anemia, Chronic pain, Fibromyalgia, Arthritis and Drug allergy (Macrobid).   On 09-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: (Positive) tested positive for Covid..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient took elderberry, prevacid, multivitamin medications within 2 weeks of vaccination with Dose 4 Pfizer booster, Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine.  It was reported that patient experienced symptoms such as oral ulcers, roof of mouth pain (feeling of rawness) and throat pain that were more extreme, she could not eat or drink anything for days because her mouth was so raw and painful inside.  On 23-SEP-2022 00:00 patient administered Dose 4 with Pfizer booster of LOT or Batch number GJ5342 on left arm  and felt like the exact same symptoms only much milder and tested negative for COVID-19 on 26-SEP-2022.  No treatment medication were reported.   This case was linked to MOD-2022-651445 (Patient Link).
This case was reported by a physician (who is also the subject) and described the occurrence of brachial plexitis in a male subject aged between 40 and 49 years old who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date in approximately 1993 the subject received unspecified dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced brachial plexitis. The subject reported that he received ENGERIX B about 20 years ago (approximately 1993) when it first came out, and that he experienced brachial plexitis after administration. The subject stated he reported it to the CDC. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the brachial plexitis was unspecified. The subject also reported experiencing events with AVODART, please see case A1051856A.
Second dose given 19 days after 1st dose; A spontaneous report  was received from a pharmacist concerning a patient (age and gender unspecified) who received second dose of Moderna's COVID-19 vaccine (mRNA-1273), 19 days after 1st dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route of administration and unknown arm, for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the second dose was given 19 days after 1st dose (inappropriate schedule of vaccine administered).  No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.  The outcome of the event second dose given 19 days after 1st dose was considered resolved.; Reporter's Comments: This report refers to a case of a consumer who received second dose for mRNA-1273 (lot # not provided) 19 days after the first dose, with no associated AEs.
Symptoms began with fever 102 F, chills, joint aches, and injection site soreness approximately 12 hours after vaccine was received. Symptoms were abated with naproxen and resolved approximately 10 hours after they started.
O2 Sat 93%. Hives, wheezing and swelling, bradycardia EPI x 2 then transported via EMS to staff and hospital ER.
Information has been received from a physician concerning a 24-28 year old female who was vaccinated with PNEUMOVAX 23. Subsequently the patient experienced vasovagal episode. The patient fainted. There was also a drop in blood pressure and around the injection site there was swelling. The patient received unspecified medical attention. The patient recovered on an unspecified date. No further information is available.
a rash on chest and back; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, a week after receiving his Covid vaccine, the patient developed a rash on chest and back. He stated he had no other changes in medications, soaps, etc. He was scheduled to get his second shot on 09Mar2021 and wanted to know if he should get the shot. Outcome of rash was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Tinnitus-Medium, Additional Details: COVID "toes"
Later that night back off knee started to hurt needed day pain has spread to include a larger area.   Noticed blisters on Friday.   Saw Dr. Monday
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red knees and elbows turned red), BLISTER (itchy Measles-like blisters), DIZZINESS (very dizzy), PRURITUS (itchy Measles-like blisters) and VACCINATION SITE PAIN (hurting at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red knees and elbows turned red), BLISTER (itchy Measles-like blisters), DIZZINESS (very dizzy), PRURITUS (itchy Measles-like blisters) and VACCINATION SITE PAIN (hurting at the injection site). At the time of the report, ERYTHEMA (red knees and elbows turned red), BLISTER (itchy Measles-like blisters), DIZZINESS (very dizzy), PRURITUS (itchy Measles-like blisters) and VACCINATION SITE PAIN (hurting at the injection site) outcome was unknown. Treatment information not provided. List of concomitant medication were not given. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: TCR received on 16-JUN-2021 contains No new information found.
high fever trembling blue around mouth staring noted by mom; brought to ER t103.8; treated for fever; seen by MD given ATB for mild ear infect;
01/03 Coughing, runny nose, slight headache, slight sore throat for ten days. 01/16 Loss of taste, partial loss of smell (ongoing). 01/05 Telehealth with PCP and was advised to take CoVid test 01/06 took test at Curative. 01/09 Test results positive. Later around the 01/15 took a rapid home test per PCP request, returned a negative result. PCP set appointment on 01/24 for follow up.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 09-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number M031568, expiration date 24-DEC-2017 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082:
On July 4th at noon I was tired, and my arm was hurting. It was getting worse by the third day. My range of movement was getting worse, and I had to call out of work due to so much pain. I had my boss call my clients because I wouldn't make it into work. I can't do much of anything in the house like housework. My husband has to help me put my clothes on and help me brush my teeth. I have been. The pain is really bad it is hard to sleep at night due to the pain. The pain lasts for a long time and there is nothing to release the pain. I cannot do this forever. I am going to try and go and see another doctor.
Minimal Side Effects After First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minimal Side Effects After First Vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION COMPLICATION (Minimal Side Effects After First Vaccine). On 16-Mar-2021, VACCINATION COMPLICATION (Minimal Side Effects After First Vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications as not reported by reporter  Treatment medications were not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-116676 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116676:
I did not have an adverse reaction to the vaccine. Within about two weeks, I developed psoriasis on my back. I have never had this before. I went to my dermatologist and began taking medication to control it. As of today, I am feeling better with no symptoms.
pt had onset of szs (non-febrile) w/in 17hrs of being vaxed;went on to have 5 more szs that day
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 657143/0380U).  Subsequently, the patient developed erythema at the injection site within one day.  The erythema was described as swollen, painful and warm from the injection site to the elbow.  The pain and swelling prevented the patient from using her arm.  Unspecified medical attention was sought.  At the time of the report, the outcome was unknown.  The physician requested a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  Additional information has been requested.
A non-serious spontaneous report of flu-like symptoms with symptoms of sore throat, runny nose, stuffy nose and feels like a head cold has been received from a consumer concerning an adult female, subsequent to FLUMIST. The patient had no prior exposure to FLUMIST in the past. Concomitant medications were not reported. The patient received FLUMIST nasally on 10-NOV-2010 for Influenza prevention. On 11-Nov-2010, Thursday night at bedtime a slight sore throat was noticed. On Friday morning, 12-NOV-2010, nose was stuffy and runny. The stuffy runny nose has continued but the sore throat had gone. The patient felt like a head cold and had to take ibuprofen to get some relief at bedtime. The events resolved within four to five days from onset. Additional information was received on 02-Jan-2011 and incorporated in the narrative: outcome at the event. Other information received was: lot no, expiry date of FLUMIST.
feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed; chest pain; chest pain, going into her back, on her left side; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, NDC number: 5926710001), intramuscular on 07Jan2021 (around 10ish in the morning) at single dose at right arm for covid-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. At the beginning of the week, patient had some vertigo but when she went in for her second vaccine, the vertigo was gone already. There were no concomitant medications. There was no adverse event following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC: 59267100002 Lot: EH9899) intramuscular on 17Dec2020 at single dose at right arm for covid-19 immunization. Patient received the second dose of the vaccine in the morning, around 10 something on 07Jan2021 at the hospital she worked at. She started feeling badly around 7:00 at night 07Jan2021 with chills, 101.6 fever, terrible muscle aches, a headache. Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed. She was having chest pain, going into her back, on her left side. When probed for the outcome of these symptoms, patient stated she had a fever, but not quite as high. She had been taking paracetamol (TYLENOL) and it was not helping. Patient provided the following product information for the paracetamol she was taking: TYLENOL, 500mg NDC: 6984270778 Lot: 9MR0454 Expiry date: Oct2021. The back pain/muscle pain was still there. She had chills but not as badly. The soreness in her arm had improved. Her arm was still sore, but not like it was yesterday. Outcome of events feeling badly, headache and chest pain was unknown, outcome of events chills, fever/ 101.6 fever, arm was so sore she couldn't even move it was recovering, outcome of events back pain/muscle pain was not recovered. The report is considered as non-serious. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. History of all previous immunization with the Pfizer vaccine considered as suspect.  No further information was provided or obtained.
3/20: Injection site was swollen and red, approx. 3x1". 3/21: PM: Rash started on trunk and cheeks. 3/22, AM: Rash darkened and spread, approx. 80% of body covered. 3/20, PM: Fever of 103.
mom states about 1-2 hrs. after child received imms. fever of 103-104 deg started lasting 4 days. Child also had vomiting and weakness and limp.