chrisvoncsefalvay/vaers-outcomes huggingface dataset:
information has been received from registered nurse concerning a 11 year old male who in approximately 2000, at the age of 5-years-old vas vaccinated with Varivax (Oka/Merck). In May 2006, the patient experienced "breakthrough varicella rash". It was reported that the patient had "more than 50 rashes on upper parts of the body including scalp, face, shoulder and back". The patient sought unspecified medical attention. On approximately 12-JUN-2006, the patient recovered from the event. It was reported that the patient had a 12 year old brother, who at the age of 5-years-old was vaccinated with Varivax (Oka/Merck) at a different place and different time and subsequently experienced "breakthrough varicella rash" (MSD, WAES#0607USA04106). Additional information has been requested.
Full body rash/Still experiencing a rash; Sore arm (first dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (first dose)) and RASH (Full body rash/Still experiencing a rash) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm (first dose)). On 06-Apr-2021, the patient experienced RASH (Full body rash/Still experiencing a rash). On 04-Mar-2021, PAIN IN EXTREMITY (Sore arm (first dose)) had resolved. At the time of the report, RASH (Full body rash/Still experiencing a rash) had not resolved.            No Concomitant medications reported.No treatment medications reported. 3 more biopsy's completed and medical info agent name was Hiral Amin   This case was linked to MOD-2021-225630 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up- Outcome of event- updated
Pt received PNEUMOVAX 0.5cc S.C into (L) deltoid. Several hours later her arm became very tender, red, swollen with pain on movement that lasted 3 days.
Pt reported pain, redness and swelling at the injection site for 3 to 4 days after vaccine administration. Pt did not take anything and symptoms resolved.
This is a spontaneous report obtained from a contactable consumer. A 65 year-old female consumer received on 03DEC2014, PREVNAR13, at 0.5 ml single, intramuscular on left arm. The consumer mentioned that she took a couple of drugs, one for pain and one to help symptoms of fibromyalgia (no further details provided). The consumer mentioned that her arm hurt on 03DEC2014 about 3 hour after shot and in the morning she could not even wash her hair and in afternoon the whole arm got stiffer. She further mentioned that when she went to bed last night she had 4 little rashes around the site. At the time of report the rash was big as her hand and she was little concerned. Investigation: none. The consumer mentioned that her arm was very sore and rash was big as her whole hand and it was hot. The patient also experienced swelling. Follow-up (23DEC2014): New information reported from the same contactable consumer includes: vaccination details, reaction data and  patient's clinical course. Follow-up (18FEB2015): Follow-up attempts completed. No further information expected.
Shaking, after waking from sleep. Mother feels gait is not normal and despite no redness, swelling or tenderness in leg.
pt came in to the pharmacy saying she had cough body aches no fever or congestion just feeling like flu like symptoms. These symptoms would come on and off for a couple days now and asked if she needs to go see a doctor she said no she will get better and not worried. She does not want to take a covid test and just want to get better on her own. She only has a little cough now. Pt got the fluzone hd on 9/25 and it is 10/12 when she reported this to us today.
Immediate spike in blood pressure and heart rate, feeling warm, very faint, lightheaded, shaky.  Nurses on site were concerned about the blood pressure and heart rate and sent me to the ER in an ambulance.  They monitored me there and I went home once I started feeling better with only slightly elevated pressure.  For about three weeks after the injection, I felt very lightheaded, nauseous, had a headache every day, felt confused and out of it.
did not feel good with the 2nd covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 2, single (Lot number: EN6198) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Hip problem" (ongoing), notes: hip problem had two prior cortisone shots and hip problem was before the Pfizer covid vaccines. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EL926), administration date: 29Jan2021, when the patient was 75-year-old, for Covid-19 Immunization, reaction(s): "Chills", "she just had felt so bad so went back to bed all day". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "did not feel good with the 2nd covid vaccine".  Additional information: Hip problem was not something that just started recently. She also got a shot of cortisone and another shot and does not know if that one was cortisone also because she went to a different doctor and they gave her a shot that appeared to be like cortisone and she went to facility the second time and they gave her a shot and she was not sure if it was cortisone or hydronic and has no name for the shot. Had no lots, expiry dates or NDC numbers for the cortisone shot or the other shot she does not know the name of and states the cortisone shot did not work.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201203569 same reporter/patient/product, different dose/AE;
A non-serious spontaneous report of I gave the patient the whole dose of FLUMIST in one nostril was received from a physician concerning a 17-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 19-Oct-2009, a physician administered the whole content of a FLUMIST dose in one nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
diarrhea; low appetite; felt achy/achiness; tired/fatigue; This is a spontaneous report from a contactable healthcare professional.  A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: Ek9231, via an unspecified route of administration, in right arm on 31Dec2020 at 17:30 (at the age of 32 years-old)  as a single dose for COVID-19 immunization.  The vaccine was administered at a hospital. Medical history includes type 1 diabetes, anxiety, and anemia. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included insulin lispro (HUMALOG), drospirenone, ethinylestradiol (GIANVI), propranolol (PROPRANOLOL), sertraline (SERTRALINE). Past drug history included an allergy to amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did take concomitant medications within 2 weeks prior to the vaccination. On 31Dec2020 and 01Jan2021, the patient was achy, tired, had diarrhea, low appetite. The clinical course was as follows: From 5 hours to about 24 hours after the vaccine she felt achy and tired. She felt fine after that. A week later (approximately 07Jan2021 at 18:00), she had diarrhea, low appetite, fatigue, and achiness. The patient was not hospitalized for the events nor received treatment. The clinical outcome of the events of achy, tired, had diarrhea, low appetite was recovering. Since the vaccination, the patient has not been tested for COVID-19.
10/19/07 Received HPV #3, itchy rash started several hours after HPV #3 at injection site. Spread all over body. Took Benadryl. Rash gone 3-4 hrs later.
Injection site is edematous, warm, erythematous at subcutaneous are of (L) arm. Pt had 2 injections place on same arm (one IM, one Sub Q). Tx: ice to area, BENADRYL.
itching and rash - no tongue swelling, sob  or throat closing stable vitals treated with benadryl 25, solumedrol 125 and pecid 20 mg IV She had gradual improvement and resolution
fallen 5 times since 2/17; has gone from using a walker to being wheelchair bound; 2nd Moderna dose packs a wallop; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FALL (fallen 5 times since 2/17), GAIT INABILITY (has gone from using a walker to being wheelchair bound) and VACCINATION COMPLICATION (2nd Moderna dose packs a wallop) in a 93-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FALL (fallen 5 times since 2/17), GAIT INABILITY (has gone from using a walker to being wheelchair bound) and VACCINATION COMPLICATION (2nd Moderna dose packs a wallop). At the time of the report, FALL (fallen 5 times since 2/17), GAIT INABILITY (has gone from using a walker to being wheelchair bound) and VACCINATION COMPLICATION (2nd Moderna dose packs a wallop) outcome was unknown.            No concomitant medications or treatment medications were reported Action taken with mRNA-1273 in response to the event was not applicable
I experienced headaches, fever, redness at the injection site, dizziness, weakness, chills, dehydration, low blood pressure, nausea and diarrhea. I went to the ER because of my symptoms, they did EKG, vital signs, lab work. I can say I am not having any of my these symptoms today.   I do not have lot # at this moment.
passed out; flu like symptoms; sudden huge pain under her sternum; hit her neck really hard and was in a lot of pain; she felt fluish and the next day pretty fluish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Hearing loss" (unspecified if ongoing), notes: she has hearing loss. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (Manufacturer unknown)), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE (Manufacturer unknown)), for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "flu like symptoms"; NECK INJURY (non-serious) with onset 2021, outcome "unknown", described as "hit her neck really hard and was in a lot of pain"; LOSS OF CONSCIOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "passed out"; FLUSHING (non-serious) with onset 2021, outcome "unknown", described as "she felt fluish and the next day pretty fluish"; BONE PAIN (non-serious) with onset 2021, outcome "unknown", described as "sudden huge pain under her sternum". The events "hit her neck really hard and was in a lot of pain" required emergency room visit.  Clinical Course: Reported as, Female consumer stated that she had the first COVID 19 booster dose a year ago and that night she self like she had flu like symptoms that were worse the next day. She was in the kitchen and got a huge pain under her sternum and passed out and hit the side of the dishwasher door with a handle sticking out and hurt her neck. She hit her neck really hard and was in a lot of pain. She went to the ER and they checked her neck to make sure it wasnt broke. She said they checked her heart at that time too. She was never diagnosed with myocardia or pericarditis but wonders if that was the issue. She mentioned this to her doctor last summer and he didn't think much of it. After reading this she is concerned about the new vaccine. She also mentioned getting COVID in August after having the vaccines. Caller stated it was hard to hear, she has hearing loss. Clarified has had hearing loss for a long time and it is not related. She signed up to get another COVID vaccine and it recently came out, she hadn't seen it until last week or 2, about myocarditis or pericarditis, an inflammation of the heart. She was now 76 years old and was 75 when she last had the vaccine in the afternoon and that night she felt fluish and the next day pretty fluish.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
unknown amount ran down a newborn patient's leg; unknown amount ran down a newborn patient's leg; unknown amount ran down; This case was reported by a pharmacist via call center representative and described the occurrence of inadvertent exposure to vaccine in a neonate patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th February 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 24th February 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced inadvertent exposure to vaccine, exposure via skin contact and accidental underdose. On an unknown date, the outcome of the inadvertent exposure to vaccine, exposure via skin contact and accidental underdose were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that an unknown amount of Engerix-B ran down a newborn patient's leg when a nurse was administering the vaccine, which led to inadvertent exposure to vaccine, exposure via skin contact and accidental underdose. The reporter did not consent to follow-up.
Swollen, fever, headache, breathing, severe pain/burning sensation. First visit to urgent care, given toradol shot. Systems not changed went to primary dr 9/30, given predisol, fever gone, arm still swollen and bruised, very bad appetite and now experiencing diarrhea and its been almost 15 days after injection. Breathing hurts in upper stomach, right under breast.
Chills and Fever 37.7 Celsius. Nausea for 8 hours beginning 10 pm. Vomiting x 1 at 3 am.
Pt. complains of itching and soreness around injection area which started the day after the injection. Has interrupted sleep due to itching and pain in upper arm. Area is red, hot, bruised, and swollen which is still present 8 days after injection. Area extends 3-5 cm beyond injection site. Itching is still present with discomfort 8 days after injection.
pt recv vax & blacked out following vax;concern was expressed w/particular lot of Hep & noted that 5 addtl pt reportedly had an adverse exp from same lot
This spontaneous report was received from a Medical Assistant referring to a 16 year old patient of unknown gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On 08-AUG-2016, the patient was vaccinated with PROQUAD. Lot #: M007965 - Expiration Date: 15-AUG-2017 (Strength, dose and route were not provided) (drug administered to patient of inappropriate age). No adverse event was reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Patient leaves a voicemail reporting that he saw doc on Friday for a "Pneumonia shot" and 2-3 inches down from the injection site his arm got a red spot, swelled and kept getting bigger, so he was seen at Urgent Care yesterday. Patient says he was started on antibiotics.
Nurse administered 0.5ML dose instead of 0.3mL dose.  At time of event, no adverse events noted.
Early Sunday morning I woke up with multiple blood clots in my mouth.  they were along the roof of my mouth in between my teeth. When I pulled them out one area started bleeding again - but it wasn't like normal blood it was very thick almost like a gel or that it was coagulating instantly.  Saturday I had just general fatigue and hot and cold flashes. By Sunday mid morning I felt fine and no additional bleeding has occurred.
feeling like she got ran over by a steam truck; blisters in mouth; Sores in the mouth.; feels like bottom lip is split open; Flared up my fibromyalgia; unable to do anything; very tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feeling like she got ran over by a steam truck), ORAL MUCOSAL BLISTERING (blisters in mouth), STOMATITIS (Sores in the mouth.), CHAPPED LIPS (feels like bottom lip is split open) and FIBROMYALGIA (Flared up my fibromyalgia) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced FEELING HOT (feeling like she got ran over by a steam truck), ORAL MUCOSAL BLISTERING (blisters in mouth), STOMATITIS (Sores in the mouth.), CHAPPED LIPS (feels like bottom lip is split open), FIBROMYALGIA (Flared up my fibromyalgia), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to do anything) and FATIGUE (very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (feeling like she got ran over by a steam truck), ORAL MUCOSAL BLISTERING (blisters in mouth), STOMATITIS (Sores in the mouth.), CHAPPED LIPS (feels like bottom lip is split open), FIBROMYALGIA (Flared up my fibromyalgia), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to do anything) and FATIGUE (very tired) outcome was unknown.            No concomitants were reported.   This case was linked to MOD-2021-154996 (Patient Link).
Headache,shivering, body aches, muscle's sore all over, nausea and upset stomach with stomach pain.  If not better by Monday 01/06/2020, I'll be contacting my Dr.
The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.; Administered vaccine after having two excursion for a total of 29 hours and 30 minutes; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine after having two excursion for a total of 29 hours and 30 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine after having two excursion for a total of 29 hours and 30 minutes). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine after having two excursion for a total of 29 hours and 30 minutes) and PRODUCT TEMPERATURE EXCURSION ISSUE (The first temperature excursion lasted for 9 hours 45 minutes/The total amount of the excursion is 29 hours 30 minutes.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was first punctured on 04-Mar-2022. The vial were not exposed to room temperature. The vial was stored only in freezer. The vial did undergo temperature excursion. The maximum 10.8 degree Fahrenheit and minimum 5.5 degree Fahrenheit were reached. The vial was not moved from freezer to refrigerator. The vial was found to be refrozen in the visual inspection. At least 1 vial was impacted. No previous excursions were seen.   This case was linked to MOD-2022-592557 (Patient Link).
1 day after given left leg LAT (DTaP/HIB) 0.5cc IM- redness and warmth noted. cm area of erythema. No induration- some swelling and red line running down leg to knee. Afebrile. Tylenol, Benadryl, Cool compress prescribed. P120 R16 Temp 98
Patient had a very large (larger than softball) sized redness around the injection site as well as a 101 degree fever the two days after receiving the immunization.
FACIAL EDEMA AND ERYTHEMA OVER NASAL AREA AND CHEECKS ONE DAY AFTER ( LESS THAN 24 HOURS). THEN THE NEXT DAY ( LESS THAN 24 HOURS ) LEGS ARE EDEMATOUS AND ERTHEMA, IMPROVED WITH BENADRYL.
HYPOTENSION 12/27/2022  &  1/12/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Rash, wheezing, lower abdominal pain, dizzy; asthmatic reaction.
Systemic: Fainting / Unresponsive-Mild, Additional Details: approximately 13 minutes after first covid dose the patient stated she was blacking out. Patient then lost consciousness for approximately 2 minutes. Patient regained conscoiusness and was breathing normally but remained unresponsive to questions. Patient was moved to bench. Blood pressure was 131/54 with a pulse of 57. Patient remianed awake but unresponsive to questions. 911 called after 5 minutes. Squad responded in approximately 5 minutes. Patient regained verbal response and recovered
After recieving vaccines child stood up out of mothers lap, fainted and fell to the floor. I picked the child up off the floor, child awake but sleepy pupils sluggish but reactive to light. child was given 8oz cup of mountain dew and a cookie. Instruct mother to stay with child and nurse in nurses office for 10 minutes. Vital signs normal pulse 75, b/p 81/47, o2sat 98% no wheezing or complaints of difficulty breathing. After staying 10mins child more awake, pupils not sluggish and able to walk with a steady gait.
I conceived twins with one cycle of IVF. Previous pregnancy- emergency c-section at 28 weeks for placental abruption in 2018.That pregnancy resulted in live birth of premature infant, prolonged NICU stay. He is healthy today; no birth defects. I am 15 weeks pregnant now, due date 9/5/21. Twin pregnancy.  I received the moderna vaccine on 3/15/21. On 3/16/21 I had low grade fever (99.6), chills, body aches as expected. Then on 3/17/21 my water broke.  Amnisure and ER exam confirmed PPROM at 15 weeks. I was admitted for observation then discharged after 24 hours. I remain on bedrest at home and the fluids have stopped leaking.   Of note,  I am a physician, and I was diagnosed with COVID about a year ago, 3/2020 with mild symptoms. Fever, severe headache, and mild shortness of breath lasted about 2 weeks. I continued to test positive for 5 more weeks before tests were negative.
pt recv vax 3AUG98 & pt was unable to see out of rt eye, exp dizziness & nausea;