chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer who is the mother of a 9 year old male pt with no relevant medical history and no allergies who on 30Sep1994 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 10Mar2004, this past Wednesday night, the pt developed chickenpox. There was no treatment required. There were no laboratory diagnostic tests performed. It was noted that the pt saw the physician at the clinic. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.  This is in follow up to report previously submitted on 05/14/2004, information has been received from a nurse practitioner concerning a 9 year old male patient with no relevant medical history and no allergies who on 10/20/1995 (previously reported as 09/30/1994) was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. The patients mother reported that on 03/10/2004, this past Wednesday night, the patient developed chickenpox. On 3/11/2004 the patient was seen at the clinic with an apparent varicella infection. There was no treatment required. There were no lab diagnostic test performed. It was noted that the patient saw a physician at the clinic. The reporter mentioned that the patient did not experience an adverse reaction to the vaccine. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is requested.
Received booster early. Patient received second dose of initial primary series on August 8, 2021. Patient should not have received booster until  February 8, 2022.
Swollen lymph nodes (left armpit) Headache Muscle pain Nausea Arm pain Joint pain On 08/12/2021 abnormal menstrual bleeding
This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. On an unknown date in 2011, the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). On 02-MAY-2012, the patient was vaccinated with dose 2, GARDASIL (lot#, expiration date and route not reported). The patient was in the office on 12-JUN-2013 (reported as today) to receive dose 3, GARDASIL. No adverse effect reported. Additional information has been requested.
Pt developed hypertensive crisis necessitating hospitalization about 2 weeks after getting the flu shot this year. Same thing happened last year!
This spontaneous report was received from a license vocational nurse and refers to an unknown number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored VAQTA (dose, route of administration, lot number and expiry date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
reddened skin @ site of shot started 40hr p/shot seen 3 days p/vax lt deltoid area course of cephalexin;
During the night after received 1st Moderna vaccine woke up feeling like her left arm was "on fire", like it had hot needles inside of it.  The next day after using ice and Benadryl the pain was gone.
Fever spiking over 103 for almost three days, night sweats and serious shakes for two nights, fever blisters all over my mouth after day 2.
Low white blood cell count: High belly Reuben: generally, wasn't feeling well low energy.
This spontaneous report as received from a registered nurse concerning unspecified number of patients of unknown age who on an unknown dates were vaccinated with doses of GARDASIL (dose, route and lot number not provided) that were exposed to 28F for an unknown period of time. No adverse symptoms were reported. Additional information has been requested.
Patient report  fever of 101.2 and chills. Treatment include Tylenol with improvement.
Given MMR SQ (R) leg, VARIVAX SQ (L) leg - developed redness & hive & swelling at MMR site within 1 minute, redness, sl swelling, no hives at VARIVAX site within 5 minutes. Given PO BENADRYL 1 minute after MMR reaction noted. Developed periocular swelling & redness about 1/2 hour after vaccines & given ORAPRED po 15 min later - local  reactions & periocular reaction resolved fully after 15-20 minutes.
This spontaneous report was received from a physician refers to a patient of age 14 (unspecified units) (unknown gender). No pertinent medical history was reported. On 11-SEP-2014, the patient was vaccinated with VARIVAX (Merck) (lot # K002920 and expiration date was 26-FEB-2016) dose 0.5 ml, subcutaneous injection. Concomitant medications was not reported. The physician reported that temperature excursions beginning 11-AUG-2014, with worst case exposure of -3.9C for 110 hours affecting VARIVAX (Merck) with lot # K002920 and expiration date 26-FEB-2016. Excursion supported for use within 3 months. No adverse effects reported. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. This is one of the several patients from the same source. Additional information has been requested.
5/12/08 RCD vacc. than pm.  Developed fever 102 degrees, severe myalgia, abd pain nausea.  Seen 5/13/08 at OV.  Still muscle pain & shakes.   No fever.  S/w pt 5/15/08 100% recovered.
On January 1st and then again on March 20th I had pretty severe heart pain. It felt as though my heart were beating too quickly (ended up being around 160-180 BPM), and felt like it was affecting my entire body.   Not sure if this was vaccine-related, but after seeing myocarditis events wanted to share in case of more data being needed.
6 hour run of AFib. I am a physician. I did not go to the hospital but had an irregularly irregular pulse with light headedness, mild shortness of breath, and after spontaneous conversion felt tired.
After first Vaccine I had itching on front and back of neck. I didn?t make a connection to vaccine. After second dose I had pain at injection sight for 6-7 days. I had itchy and swollen arm around injection sight for a week.  Day 2-3 tired, achy, feeling of coming down with a bad cold. Lasted 2 days. On 7th day after vaccine I broke out in extremely itchy hives on my throat area (externally, no issues with breathing or swallowing). Lasted a couple hours then got somewhat better. 2 days after first reaction of hives I?m still very itchy and face and neck sometimes break out in hives. I?ve been taking Benadryl and using calamine lotion to control hives.
Had FLUZONE 10/3/17. Was seen in ER for hives 10/4/17. Treated with BENADRYL and DECADRON.
I tested positive for COVID-19 at home on July 22 I had headache, sore throat, low-grade fever (99.5 was highest reading), body aches, fatigue, and dry cough. My fever and sore throat lasted two days. Dry cough and fatigue lasted about five or six days total.
On 2/14/00, the pt developed 20 skin lesions located on her neck, face, trunk, back and scalp. On 2/15/00, the pt was seen by a physician. Additional information has been requested. Follow up states patient recovered 02/22/2000.
Red skin eruptions, extremely itchy, covering wrists, elbows, forearms, stomach, nose - secreting liquid/crusty discharge. These have since healed, but have left scars. The other immediate reaction has been severe ENT allergies - every day since, from ZERO allergies before the vaccination. I am now plagued with congestion, sneezing, sore throat, headaches, extreme fatigue, foggy mind. My 'healthy' life as before is gone.
Had both doses in 2019, had shingles in 2023/ Suspected vaccination failure; Diagnosed with shingles in eye; Eye swelling shut; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and MRNA 1345 for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (shingles in right eye 2018). Concurrent medical conditions included glaucoma (glaucoma in right eye (2018)).   On 11-JUN-2019, the patient received the 2nd dose of Shingrix. On 30-MAR-2019, the patient received the 1st dose of Shingrix. In JUN-2019, the patient received MRNA 1345. On an unknown date, an unknown time after receiving Shingrix and Shingrix and an unknown time after receiving MRNA 1345, the patient experienced vaccination failure (Verbatim: Had both doses in 2019, had shingles in 2023/ Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Diagnosed with shingles in eye) (serious criteria GSK medically significant) and eye swelling (Verbatim: Eye swelling shut). The patient was treated with steroids nos (Steroid (Not Specified)). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and eye swelling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and eye swelling to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster and eye swelling to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 21-MAR-2023 On March 30 2019, the patient received 1st dose of Shingrix.. On June 11, 2019 the patient received 2nd dose of Shingrix. Around the time of dose 2 the patient volunteered for a (Moderna)  trial vaccine and was given mRNA -1345-P 301 vaccine. In February 2023 the patient visited the health care professionals with right eye swelling shut but no rash. The patient was diagnosed with shingles in the right eye. The treatment drug steroid eye drops for eye swelling which was not recovered. The patient reported the historical condition of glaucoma and shingles in the right eye on 2018. The patient did not consent to follow up. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Went to work in the Emergency department as a nurse at 08:30. While doing nothing at rest, began to have palpitations. Checked Watch and HR was 134. My resting HR is usually 50-60 BPM. I also got lightheaded and dizzy while walking after the palpitations began. I hooked myself up to a cardiac monitor in the ED and it appeared to be sinus tachycardia. I had a HR of 130-140 for 20 minutes with palpitations, nausea, and dizziness. It went away on its own after 20 minutes. For the next 8 hours at work though, anytime I walked around, my HR went back up into the 120s-130s and I felt dizzy with intermittent nausea. I drank about 4 large cups of water in that time and it didn?t help my symptoms. Eventually, the symptoms went away after going home and resting around 9pm that same day. I have never had anything like this happen to me before with a HR that high while not doing anything.
local erythema encompassing large area from should to elbow that lasted ~ 1 month, tenderness
Fever blisters on top of upper lip on the right side of her mouth. Self treated with Benadryl. Lip is swollen also.
arm hurt; latex reaction: bloody itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and RASH PRURITIC (latex reaction: bloody itchy rash) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt) and RASH PRURITIC (latex reaction: bloody itchy rash). At the time of the report, PAIN IN EXTREMITY (arm hurt) and RASH PRURITIC (latex reaction: bloody itchy rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications provided
7/29/06 aches, runny nose and headache, no fever. 7/30/06 noted a lump behind L ear with tenderness. Temp 101.4, headache and aches. 7/31/06 saw Dr at urgent care. He questioned symptoms due to MMR/virus. 8/1/06 rash over entire body also headache. No fever at this time.
This non-serious, spontaneous case, initially received from other health professional (nurse) on 08-Oct-2018, concerns a 03-year-old, male child patient. On 08-Oct-2018, the patient (less than 4 years of age) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019]. At the time of this report, no adverse events were reported. This case was linked to case 201804369 and 201804369 due to the same reporter. Follow-up report received from the reporter on 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was amended accordingly.
This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was allergic to penicillin. Concomitant medications were reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since having the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 25Mar2021 at 08:00, the patient experienced itching started in hands and progressively moved up arms. Hives on hands and arms, extreme itching. Hives moved to legs and feet with extreme itching. Hands are very red and hands are swollen. The patient received antihistamine treatment for reported events. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the reported events itching started in my hands and progressively moved up my arms, hives on hands and arms, hands are very red and hands are swollen was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
rash; This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was allergic to latex. No information regarding the patient's pertinent medical history and concomitant therapies was provided. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (dose, lot # and expiration date were not reported) for prophylaxis. On an unknown date, after receiving a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient developed rash for an unknown period of time. The patient sought medical attention by seeing an unspecified provider. The patient received prednisone as a treatment for the event. The outcome of rash and the relatedness between the rash and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not reported.
I started having a lot of pain around injection site and swelling that rose around like an allergic rash about 2 inch in diameter kind of oval shaped. Then at night I got chills, body aches and pains, I think I got a fever and symptoms kept me up for awhile. I called the pharmacy the next day and was told it was ok to take ibuprofen. I did take some because of the pain and fever. I also did not feel well so I was in bed for the whole next day. I gradually started feeling better but that took about almost a week and the raised spot allergic reaction shot site lasted more than 3 days. It took almost a week for it to go away completely and it?s when I felt better.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 4:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 4:54 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient allergies to medications, food and other products was unknown. Vaccination date was reported as 12 Feb 2022 16:54:37.The patient received booster dose. Its 30 days Expiry date vaccine went into 2 to 8 degree C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg exp. date of 04-Apr-2022.  No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
52 yo female received J&J COVID-19 vaccination on 3/10. On 3/18, she presented to the ED with chief complaint of SOB and anemia. CT confirms bilateral submassive PE seen in segmental and subsegmental lobes. Symptomatic with tachypnea, pleuritic CP, tachycardia. Patient has history of PE 3 years ago as well, and was on warfarin for 6 months. Only family history of clots is elderly grandmother with DVT's. No sudden death in family. Age-appropriate cancer screening up to date. Patient is wheelchair bound and was dehydrated 2/2 gastroenteritis which made her high risk for VTE. Less likely due to hypercoagulable disorder. At discharge, she is hemodynamically stable...Tachypnea and pleuritic chest pain resolved. Myeloproliferative neoplasm panel negative. She was started on apixaban (will finish loading doses 3/26, and continue 5mg BID indefinitely). Will be referred to hematology as outpatient for PE + anemia.
foot went number; rings of tightness on leg; Beyond 42 days for 2nd dose; slight headaches on left side of the head; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (foot went number), MUSCLE TIGHTNESS (rings of tightness on leg), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 42 days for 2nd dose) and HEADACHE (slight headaches on left side of the head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 HYPOAESTHESIA (foot went number), MUSCLE TIGHTNESS (rings of tightness on leg), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 42 days for 2nd dose) and HEADACHE (slight headaches on left side of the head). At the time of the report, HYPOAESTHESIA (foot went number), MUSCLE TIGHTNESS (rings of tightness on leg) and HEADACHE (slight headaches on left side of the head) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 42 days for 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient had got multiple MRI and was advised by doctors to wait on second dose.  No concomitant medications were reported. No treatment medications were reported.
Patient states that her arm is still sore a week later after receiving the shot.  She has no other symptoms
Day 8 after being vaccinated with the Moderna COVID-19 Vaccine EUA my arm became red, hot and swollen. My arm was also sore. the area affected was right under the injection site.
Heart started hurting 3 days ago.  Resting heart rate consistently at 75 (usually 60). Having trouble with my normal cardio exercising without feeling weak.
Pt experienced a 3 inch patch of shingles on the right trunk. Pt was treated with Zovirax. Follow-up was received which indicated the shingles was unable to be cultured due to use of Zovirax.
One week after receiving injection had blotches all over face, like "chicken pox", like "hives", itching "driving me crazy" painful-Has appointment to see the doctor tomorrow.
Td given 12-8-5 L deltoid, minor soreness 12-8, 12-9 and early 12-10-05.  Later 12-5-05 redness, swelling, temp 101 per patient.
Mom states patient had redness, pain and some swellling  to the (left) anterior mid-thigh that progressively worsened.
After having my third shot of Lymerix vaccine, I developed severe pain in my left knee, 6 weeks later it was in my right knee. It is also now located in my right hip and the top my spine in the back of my neck. PCP and orthopedic surgeon visits.
During observation, patient stated he was lightheaded. Denied any other symptoms. No SOB, no oral or facial swelling, no rash or swelling. Vitals stable- BP 100/62, pulse 62, RR 12. Ate breakfast but had not had lunch. Patient was observed for 30 minutes and given water. Symptoms resolved by end of observation period.
Patient received COVID 19 vaccination on 3/30/2021 as part of vaccination program.  Per obituary, he died at home on 5/13/2021
1. Next day tremendous headache-gradually easing 2. Sunday morning grass green pee (one insident) 3. Burning at the old shingles location (from Nov2017) 4. Weakness increasing as the days went by...to the point of almost falling off chair; severe drowsiness. pt had  to hold her head up 5. Patient felt as if she was poisoned 2 weeks later started slowly getting better but still weak.
Swelling and large red rash present from upper thigh to knee at largest. Grew for one day before starting to slowly ebb back. Was very, very hot to touch and felt hard under skin. Extremely itchy and uncomfortable. Painful as well. Could move/walk but favored other leg.  Treated with anti-itch cream and cooling cloths and ice. Swelling had gone down after 72 hours from shot and rash was still visible but not as vibrant and no heat present. Hard feeling had started to dissipate as well.
This is in follow-up to report(s) previously submitted on 7/8/2008. Information has been received from a health professional concerning a 25 year old, 130 pound female with no illnesses at time of vaccination, and no pre-existing allergies; birth defects or medical conditions, who on 09-APR-2008 was vaccinated with a partial dose of GARDASIL (lot # 655604/0052X) due to a malfunction of the pre-filled syringe. The syringe malfunctioned before the complete dose could be administered.  The patient was subsequently administered a complete dose of GARDASIL at the same office visit. No problems were reported. Patient outcome was not reported. Additional information has been requested. The SR # is 1-3040431198. No additional information is expected.
Delayed swelling, redness, itchiness at injection site. Symptoms started 8 days after vaccination.
Narrative: COVID infection following COVID vaccine series 07/03 Janssen, dose #1 09/12 pt cc: chills, cough, fatigue, fever, headache, rhinorrhea, sore throat exposure: unknown 09/17 COVID swab, result: detected 09/21 clinically resolved