chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 24-JUL-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration were not reported) subcutaneous on or about November of 2016 at a medical center, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-DEC-2016, the patient was treated at an urgent care clinic for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. On or about 08-DEC-2016, the patient was treated by a physician at a medical clinic for ongoing and worsening symptoms, and was diagnosed with post-herpetic neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
On 7/14 patient called and complained of round 1/2 golf ball sized warm spot at injection site. On 7/15, patient stopped in pharmacy and the injection site was not raised. Injection site was warm to the touch and smaller in circumference
No adverse reaction that was reported, however the Moderna vaccine was given to this 17 year old female.
less than 2 days after second Pfizer vaccine near syncope, hypoxic aND DEVELOPED SUBMASSIVE PULMONARY EMBOLISM. NO OTHER KNOWN RISK FACTORS OR ACUTE EVENTS FOR CAUSE OF Pulmonary embolism and no prior dvt/pe
Information has been received from a physician concerning a 50 year old hospitalized female with community acquired pneumonia and no allergies who on approximately 12/20/04 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included an unspecified influenza virus vaccine, antibiotics and steroids. On 12/21/04 twelve hours after vaccination, the patient developed acute respiratory distress. Twenty four hours after vaccination, the patient was placed on life support with a ventilator. It was reported that the patient has not recovered. No product quality complaint was involved. Acute respiratory distress was considered to be immediately life threatening. Additional information has been requested. Per Follow up report received on 06/14/2005:  Patient still has not recovered.
Adult dose of Hepatitis A given (1440 elu) instead of Pediatric dose of Hepatitis A (720 elu).
Same night of vaccine (3/5/21) - Intense throbbing in left eye socket escalating around 2am followed by blurred vision and a migraine that lasted for at least 3 days. Intermittent pain for the next several months.  June 4th - Severe pain behind both eyes as a result of blood clots followed by swollen & very red eyes and eye lids. Today (8/15/21) - Continued throbbing pain and swelling in left eye. Will follow up with ophthalmologist this week.
After walking for about 4 miles in my friends neighborhood my left knee became tender and swollen. The next day I went on a 3.5 mike easy hike and my left knee became very swollen and I couldn't walk on it. I was pondering going to the emergency room... Thought maybe I tore something.  I'm a former college football player and I've had all kinds of injuries. My knees have been bullet proof so far. I've never had a swollen knee. About six months ago I hyperextend my left knee and it was still a little tender. Long walks and hikes never caused any swelling just painful if it was hyper extended.  It's possible the flight was a factor but I think the shot somehow caused my knee to swell.  After the hike I was walking around again in a few days.  The strangest thing... The tenderness behind my knee that had been there for almost six months was gone and hasn't come back.  Just wanted to document this odd reaction.
Urine turned very yellow; Stool became very soft; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (Urine turned very yellow) and FAECES SOFT (Stool became very soft) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included ATORVASTATIN for Hyperlipaemia, METFORMIN and CENTRUM MEN for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced CHROMATURIA (Urine turned very yellow) and FAECES SOFT (Stool became very soft). At the time of the report, CHROMATURIA (Urine turned very yellow) and FAECES SOFT (Stool became very soft) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-MAY-2021 contains significant information - Concomitant medications added.
arm was swollen; a lot of pain /  aches; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced swelling arm and pain. The patient was treated with magnesium sulfate, potassium nos, zinc (Epson Salt Soak), methyl salicylate (Icy Hot) and non-drug therapy (Heating Pad (Nos)). On an unknown date, the outcome of the swelling arm and pain were unknown.   It was unknown if the reporter considered the swelling arm and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in her left arm and her arm was swollen and she also experienced extreme pain for 2 months and she mentioned that she had a lot of pain for a month. The patient used Epson salts bath, Icy hot and heating pads to treat the pain. Reporter mentioned that the pain was resolved but still every now and then it was aching a little bit and also stated that she would not get the 2nd dose. The reporter consented to follow up.
Week 1: Nausea, sour stomach, fatigue, headache. At night: body aches, fever, itching all over body, difficulty sleeping. Week 2: rash under arms, diarrhea, nausea, dizziness, lead legs, difficulty sleeping. Eye fatigue. Breakouts on back.
Information has been received from a physician concerning an 11 year old male who was vaccinated with a dose of varicella virus vaccine live.  The physician reported that the patient subsequently developed 50 pox-like lesions after exposure to varicella.  Unspecified medical attentions was sought.  It was also noted that the patient's sibling was also exposed to varicella, but did not contract varicella.  At the time of this report, the outcome was unknown.  Additional information has been requested.
PT. RETURN 1 HOUR AFTER IMMUNIZED REFERRING ITCHING AND RUNCHES ALL OVER THE BODY. PT. I REPORT THAT THIS HAPPENED EVERY TIME THAT HAS BEEN IMMUNIZED BUT THIS TIME THE REACTION TAKEN LONGER. ESTIMATED VITALS BP 130/90, P 120, SAT. 98%. ANTIISTAMINE (BENADRYL) WAS ADMINISTERED BY MOUTH. DR. WHO RECOMMEND TRANSFER TO THE EMERGENCY ROOM. PT. HE REFUSED.
Received Pneumonia vax on 1/26. Around 1/30 - 1/31 soreness and sensitivity started on scalp on top left side of head. Touching it feels like type of acne. Itchiness began a couple of days ago and reminded him of chickenpox when younger. Affected area has several acne-like bumps not just one. Reporting it as a possible side effect to vaccine. As of yet has not noticed any other changes/symptoms.
Headache Pain, swelling at site, Fever 2nd day Narrative:  Other Relevant History:
This spontaneous report as received from a healthcare professional concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 15-MAY-2014, the patient was vaccinated with one dose of VARIVAX (Merck) (dose, strength, lot number and expiration date were not reported) subcutaneous route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored VARIVAX (Merck), was administered on 15-MAY-2014. The reporter stated that the VARIVAX (Merck) was exposed to a temperature of 6.4F for 2 hours of 05-MAY-2014. No adverse effect reported. Additional information has been requested. These case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609).
Pt recv vax on 1/6/99; on 1/19/99 pt exp rash on torso & arms, headache, fever, fatigue, myalgia, abdominal tender; tx=Tylenol & Advil Sinus
Blurry vision; Her calves felt different/ walked about 3 miles every day but was now feeling weirdness in the calves; Brain fog; She was not going to get the next dose; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), LIMB DISCOMFORT (Her calves felt different/ walked about 3 miles every day but was now feeling weirdness in the calves), FEELING ABNORMAL (Brain fog) and INTENTIONAL DOSE OMISSION (She was not going to get the next dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Did not receive the monoclonal antibody drip treatment) in March 2021.  On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VISION BLURRED (Blurry vision), LIMB DISCOMFORT (Her calves felt different/ walked about 3 miles every day but was now feeling weirdness in the calves), FEELING ABNORMAL (Brain fog) and INTENTIONAL DOSE OMISSION (She was not going to get the next dose). At the time of the report, VISION BLURRED (Blurry vision), LIMB DISCOMFORT (Her calves felt different/ walked about 3 miles every day but was now feeling weirdness in the calves), FEELING ABNORMAL (Brain fog) and INTENTIONAL DOSE OMISSION (She was not going to get the next dose) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient had some underlying conditions.  No concomitant medications were provided. Treatment information was not provided.   This case was linked to MOD-2021-294440 (Patient Link).
client reported syncope episode 2 hrs after receiving first dose. Client states fell and hit head. Next day followed up with medical provider.
Severe hives and itching; Large areas of hive-like swelling and itching on arms, legs, hips; Large areas of hive-like swelling and itching on arms, legs, hips; This is a spontaneous report from a contactable consumer (patient reported for himself). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EWO168, expiry date not reported), via an unspecified route of administration, administered in left arm on 12May2021 12:00 (at the age of 51 years old) as second dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received the first dose of BNT162B2 for covid-19 immunization (at the age of 51 years old) on 21Apr2021 12:00 PM (lot EWO171) administered in the left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a pharmacy or drug store. Patient experienced severe hives and itching began on Saturday, 15May2021 (three days after the second dose) at 08:00 AM, which were described as large areas of hive-like swelling and itching on arms, legs, hips. They have gotten worse; Benadryl provides only short-term relief. Since the vaccination, the patient has been tested for COVID-19. As per reporter, the events were not serious by the reporter (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The events were reported as not recovered.   Follow-up attempts are completed. No further information is expected.
result of INR test change- reduce to 1.5 to 1.7; affect the thickness of blood; This spontaneous case was reported by a consumer and describes the occurrence of INTERNATIONAL NORMALISED RATIO DECREASED (result of INR test change- reduce to 1.5 to 1.7) and HYPERCOAGULATION (affect the thickness of blood) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included WARFARIN for Clot blood.   On 09-Feb-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 09-Feb-2021, the patient experienced INTERNATIONAL NORMALISED RATIO DECREASED (result of INR test change- reduce to 1.5 to 1.7) and HYPERCOAGULATION (affect the thickness of blood). At the time of the report, INTERNATIONAL NORMALISED RATIO DECREASED (result of INR test change- reduce to 1.5 to 1.7) and HYPERCOAGULATION (affect the thickness of blood) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, International normalised ratio decreased: (Low) INR values reduced to 1.5 to 1.7.   No treatment information was provided.
The vaccine side effects started 12hrs after the vaccine including a headache. I normally always get migraines, but this headache got progressively worse. I went to see my PCP and she sent me home to rest. The next day it got worse, and I was vomiting, and I couldn't sit up and I couldn't hear (I'm hearing-impaired) so I was sent to the ER. Moving my head was extremely painful. I was sent to a neurologist who confirmed I had a leak of cerebrospinal fluid that was coincidentally and "spontaneous" leak of the fluid after my vaccination. The MRI scan confirmed it and tried to find the source of the leak. Since my brain was resting on so many nerves, I was suffering from vomiting, nausea, vertigo, distorted my hearing, couldn't talk, or walk normal during that time. I was sent home from the ER that same day. I was just informed to receive bed rest by laying my head flat.
Developed noted scaly, red, lumpy rash and tender induration just inferior to the injection site on the right upper arm. Pruritic. No vesicle/blister. No discharge or crusting. Mild fatigue/malaise. No fever. Self tx'd with BENADRYL cream. Slowly improved over the last 2-3 days. No prior h/o shingles vaccination or disease.
Cervical pain, upper posterior back pain, injection site pain in the upper arms started within the first hour after injections. Then mid to lower neck pain gradually continued to worsen. Symptoms advanced with severe neck and posterior chest pain, shortness of breath, fatigue, fever like symptoms with  frequent chills, sweating, nausea, vomiting into severe anterior chest sternum pain that radiated into arms. Immediately diagnosed with myocarditis and treated
immediately after the vaccine the patient fatigued and was somnolent on day 5 after the vaccine she had a syncopal episode during dinner requiring 911
This case was reported by a consumer via call center representative and described the occurrence of chills in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 3rd December 2018, the patient received the 2nd dose of SHINGRIX. On 4th December 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, pain and influenza-like symptoms. On 10th December 2018, the patient experienced leg pain. On an unknown date, the outcome of the chills, fever and influenza-like symptoms were recovered/resolved and the outcome of the leg pain was not recovered/not resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the chills, fever, leg pain, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient received SHINGRIX in left arm. The patient reported that he experienced flu like symptoms. The flu symptoms consisted of chills, fever, and achiness. Less than a month after receiving SHINGRIX, the patient also experienced a sore arm for a few days. The patient also reported leg pain, which began about 7-10 days after the injection. Did not consent to follow up. The case was closed. The start date mentioned in the narrative as 3rd December 2019, which is future date, so we captured 3rd December 2018 as vaccine start date.
This child had a large erythema reaction to Prevnar. Erythema measures 9 cm x 5.5 cm.
A spontaneous report was received from a healthcare worker concerning a 13 month old child (gender not reported) who on 01-DEC-2014 received an expired dose of MMR II (lot number reported as H020257; expiration 08-NOV-2014). No adverse experience was observed. No additional information was provided. Additional information has been requested.
he's a little bit foggy; Vaccine breakthrough infection and COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Vaccine breakthrough infection and COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and FEELING ABNORMAL (he's a little bit foggy) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced COVID-19 (Vaccine breakthrough infection and COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced FEELING ABNORMAL (he's a little bit foggy). At the time of the report, COVID-19 (Vaccine breakthrough infection and COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and FEELING ABNORMAL (he's a little bit foggy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, SARS-CoV-2 antibody test: positive (Positive) positive. On 29-Oct-2021, SARS-CoV-2 antibody test: positive (Positive) still positive.         No treatment and concomitant medications were reported.  He tested positive on the antigen home test on 25 Oct 2021. The patient had repeat testing on 29 Oct 2021 using the same kind of test still revealed positive result.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow-up received on 01-NOV-2021 includes events added and lab data and other event related info.; Sender's Comments: This case concerns a 60-year-old male patient with no details on relevant medical history, who experienced the unexpected non serious event/ of COVID-19 after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). Additionally, Drug ineffective was captured. The event occurred approximately 7 months and 22 days after the second dose of mRNA- 1273 vaccine. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report
Fever Fatigue Headache Muscle pain Chills Joint pain Nausea Chest pain Shortness of breath Feelings of having a fast-beating, fluttering or pounding heart  Most side effects lasted 2?4 days. Muscle pain started throughout my entire body, but by the 4th day was limited to my right side ? from hip to ankle ? and continues today, 11days later. My doctor prescribed a muscle relaxer which has zero impact. I am using Diclofenac, but unsure if it helps. I am only getting 1?2 hours of sleep every 24 hour period, sometimes in only 30 minute intervals.
Arm, joints and muscles extremely very painful, very tired and sick to my stomach.  Stayed in bed for 2 days, then sat around for 3 more days.  At that point I tried to start doing things although my muscles and some joints were still a little sore.  I lasted 2 days and was back down again for a day then took it easy for 3 more days .  Not really sore now, but still a little tired.  Have been doing more and will try to go back to normal tomorrow
RIGHT LEG WITH INDENTATION IN SKIN SUSPECTED DUE TO VACCINE.  LIPOATROPHY
Allergic Reaction in Hives, underarm redness, itching, upper torso. Confined to left underarm where shot was received.
Approx 48 hours of headaches, chills, muscle aches, fatigue, low grade fever
Worried; Palpitation; Strong side effects; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), VACCINATION COMPLICATION (Strong side effects) and ANXIETY (Worried) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hearing impaired.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PALPITATIONS (Palpitation) and VACCINATION COMPLICATION (Strong side effects). On 31-Jul-2021, the patient experienced ANXIETY (Worried). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Palpitation) and VACCINATION COMPLICATION (Strong side effects) was resolving and ANXIETY (Worried) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
Patient had first dose of Moderna vaccine at another facility on 1/10/2021. Around 1/18/2021 she felt poorly, more fatigue and noted her urine was dark. By 1/22/2021 she opted to present to the ER where she was noted to have severe hepatitis (ALT 1600) but oddly a normal bilirubin. Her INR, CBC and vitals were normal. She was sent home from the ER and I saw her today 1/25/2021 in consultation for the liver enzyme issues. It is not clear that this is related to the vaccine. She may have hepatitis A or this could have been a medication/supplement induced hepatitis but due to the timing I felt it should be reported.
On 1/23/2021  Patient initially seen at clinic, she was told to watch and see. On the Second visit  the physician recommended ice and ibuprofen. Then the patient reported to hospital for a third visit and they treated for cellulitis with a rocephin injection and oral antibiotics.
Within 15 minutes of receipt of second Moderna COVID vaccine, pt experienced tingling and numbness in gums and tongue in her mouth.  This symptom has progressed to involve migratory tingling and hypesthesia in her mouth, arm , left side of face, hands and thighs. No weakness. Symptoms last minutes to hours in each area, no predictable pattern.  no weakness, seizure activity.   Vaccine was administered as part of vaccine effort