chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives/broke out in hives; trouble breathing; This case was reported by a physician via sales rep and described the occurrence of hives in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included typhoid.   On 1st May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a month after receiving Shingrix, the patient experienced hives and difficulty breathing. On an unknown date, the outcome of the hives and difficulty breathing were unknown.   It was unknown if the reporter considered the hives and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on 1st May 2019 at pharmacy,  The patient experienced broke out in hives and had trouble breathing.
2 days after the 3rd booster dose I developed significant swelling of the right axillary lymph nodes extending out to the lateral breast.  I had Moderna dose 1 & 2 in the Right Arm as well and had right axillary lymphadenopathy as well. The swelling and pain persisted for ~2 weeks. I took ibuprofen and warm compress for my axilla and breast. The swelling went down significantly after two weeks. Then 3 days later I started my menstrual cycle and the same particular area on the right lateral breast swelled and became painful again, it was warm and formed a significant lump. I contacted my physicians office who advised waiting two weeks to see if the pain/swelling/lump would go away. The pain and swelling has gone away but a lump remains in that breast. I had an office visit today for an evaluation and an ultrasound was ordered.
Patient received above listed vaccines in clinic without difficulties at approximately 2:45pm with mom and uncle present in room. Patient was sent to lobby for 10 minutes of monitoring. At 3:00pm front office staff came to nurses room stating patient had passed out and was carried to vehicle by his uncle. Nurse to patient vehicle, alert and oriented x4. vital signs stable. patient stated he began feeling weak and sick to his stomach and then passed out. Stated he now feels "normal".
Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was experiencing SOB but all blood work normal - assumed normal SOB with pregnancy.  Night/morning of 4/15 started seizures, transported to ED.  Diagnosed with massive pulmonary embolism.  Emergency C-section prerformed by Dr.  Pt. did not survive.
Was given BOOSTRIX when should have been given INFANRIX. No adverse events reported.
patient was administered a dose of Shingrix on 07Nov2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 5NC4N, expiry date 08-OCT-2023) for prophylaxis.   On 07-NOV-2023, the patient received Shingrix. On 07-NOV-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: patient was administered a dose of Shingrix on 07Nov2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date- 08-NOV-2023 The Pharmacist reported that the patient received dose of Shingrix which was already expired, which led to expired vaccine used.  At the time of reporting, repeat dose has not been administered. This was 1 of the 2 cases, reported by the same reporter for different patient. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023154980:Same reporter,2nd patient
I got a very bad headache about 7-10 days AFTER I got the vaccine, and felt generally unwell but not severely sick.
Proximal right arm pain, tenderness on palpation, no swelling, no erythema.
Patient admitted for Covid-19 PNA and acute resp failure with hypoxia.  Patient was started on Decadron and remdesivir.  Patient acutely decompensated on 01/22/2022 and was transitioned to AVAPS on 01/23/2022.  Patient required intubation and course complicated by worsening renal failure.  02/06/2022 Patient condition continue to decline and multiorgan failure worsened.  Patient required pressors and renal failure/hyperkalemia worsening despite dialysis.  Patient expired on 2/6/2022.
Cellulitis, redness, swelling, hard lump, heat, tired, headache, pain
Low grade fever 99.7°F; achy; Feels warm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever 99.7°F), PAIN (achy) and FEELING HOT (Feels warm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Low grade fever 99.7°F), PAIN (achy) and FEELING HOT (Feels warm). At the time of the report, PYREXIA (Low grade fever 99.7°F), PAIN (achy) and FEELING HOT (Feels warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 99.7 99.7.     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.
My COVID-19 symptoms started on 01/08/2023. I had a severe headache, achy, sinus drainage. I also started feeling chills so that's when I decide to check my temperature. It was 100.03. Early morning on 01/09/2023 I took a home COVID-19 test which was positive. I called my doctor right away she prescribe me with Anti-viral but because of the side affect I didn't take the medication. I took TYLENOL and then I took Ibuprofen. I also took a PCR test at pharmacy which was positive too. As of now I still have the sinus drainage. The mucus is brown and white in the middle. It is horrible. I went to my doctor's office for a follow up on 02/28/2023. I told her about the horrible mucus issue I was experiencing. She prescribe me Fluticasone (nasal spray) I took it for short time since the taste was so bad I had to stop. I still have mild headaches, and sinus drainage.
Nauseous, light headed, jaw pain, neck back pain. BP taken in his office (L) arm manually 118/82 P up 87. Glucose take by PT/meter 118 pt hx of diabetes. PCP conversation w/TL on 9/3/15, nurse believes pt was having a cardiac and/or diabetic episode.
I developed a fever at about 11:45 pm the night I received the 2nd covid vaccine. (2/1/21).  I ran a fever until about 2 am on 2/3/21. I also had a headache and intense pain in my legs and my knee and hip joints.
Red rash appeared on Saturday, May 1, after receiving shot on April 20.  Rash-red area 2-3 inches long, itchy at times.  Shot location is sore
9:00 horrible headache started, injection site pain went up into neck, lasted 13 hours, joint pain, fatigue, 101 fever, chills
Patient had syncope episode after vaccination. Last approximately 15 minutes and then with drinking water, distraction, and having a snack provided by clinic client was recovered.
Pneumococcal vaccine - Pneumovax - administered IM in left arm. Arm became 4+ edema, around to back of arm and down arm as well as very painful.
2 weeks after the injection, I developed multiple rashes that were later diagnosed as Dermatographia. I visited 1 doctor & the ER, neither of physicians knew what was going on. I visited the Dermatology clinic and Dr. immediately recognized what was happening and stated how these cases were on the rise from patients who received the booster. I am currently taking Allegra in the morning, Zyrtec at night and CeraVe for when there is an itch. Dr. said this can last for a few months to a few years.
My husband had first tested positive for covid. A few days later I had a little sore throat. It felt like a tickle in the throat. The next day on 9/10/2021 I had went in for a covid test and it came back positive. I had muscle aches, a headache, and I felt very tired. On 9/12/2021 I developed head congestion for 3 days. I had a headache that lasted for a whole week. I had also lost my taste and smell that lasted for a whole week as well. I had talked to a telehealth doctor.
Headache. Body aches.  Chest pain.  Shortness of breath.   Accelerated heartbeat.  Muscle cramps.  Pussy eyes.  Vision blurriness.
Information has been received from a physician concerning a 12 year old female patient who on unspecified date was vaccinated with a dose of GARDASIL, 0.5 ml, IM, (Lot # not provided). Physician reported that a patient fainted and her heart rate went down to 48 and her blood pressure was low. The patient had a temperature before the vaccination of 100 degrees. She came in for a sick visit. The patient had a negative strep test. The patient has sought medical attention. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Injection site pain & swelling on first & second day. Swollen & painful  left axillary lymph nodes on 3rd day.
Redness at injection site started within 1 day of vaccination. Patient then developed large amount of bruising and tenderness at the site. Patient reported this reaction to the office on 11-10-14 at 9:51 AM. Patient refused to come for office visit so we could.
Did not sleep much; Hurt all over; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Did not sleep much) and PAIN (Hurt all over) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INSOMNIA (Did not sleep much) and PAIN (Hurt all over). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Feb-2021, INSOMNIA (Did not sleep much) and PAIN (Hurt all over) had resolved.            No relevant concomitant medications were provided. The action taken for mRNA-1273 was not applicable.    This case was linked.
body and muscle aches; sore arm; fever 101F; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body and muscle aches), VACCINATION SITE PAIN (sore arm), PYREXIA (fever 101F) and CHILLS (chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (body and muscle aches), VACCINATION SITE PAIN (sore arm), PYREXIA (fever 101F) and CHILLS (chills). On 13-Feb-2021, MYALGIA (body and muscle aches), VACCINATION SITE PAIN (sore arm), PYREXIA (fever 101F) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 101 f (High) 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the second dose of improperly stored M-M-R II lot # M000768, expiration date 05-JAN-2018, for prophylaxis (route was not reported). Concomitant therapies included STERILE DILUENT lot # reported as K024994, with expiration date 12-OCT-2017. It was stated that the temperature excursion was for 67 minutes, with a temperature of 14 Celsius degrees. A digital data logger was used to control temperature. No previous temperature excursions were reported. It was also reported that the sterile diluent was properly stored. No adverse effects were reported. A product quality complaint was not involved.
Idiopathic Thrombocytopenic Purpura; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Idiopathic Thrombocytopenic Purpura) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Idiopathic Thrombocytopenic Purpura) (seriousness criteria hospitalization and medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Idiopathic Thrombocytopenic Purpura) had not resolved.            It was reported that vaccine was taken due to job requirement.   No concomitant details were provided. No treatment details were provided.  Company comment: This case concerns a 24-year-old female patient with no medical history provided who experienced serious unexpected event of Immune thrombocytopenia. Very limited information provided precluding comprehensive assessment. No information regarding patient's medical history nor concomitant medications was provided. Detailed information regarding vaccination was also not provided. Furthermore, the precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided. At the time of the report, the event was still ongoing and no further information regarding clinical course of the event nor hospitalization details was provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 24-year-old female patient with no medical history provided who experienced serious unexpected event of Immune thrombocytopenia. Very limited information provided precluding comprehensive assessment. No information regarding patient's medical history nor concomitant medications was provided. Detailed information regarding vaccination was also not provided. Furthermore, the precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided. At the time of the report, the event was still ongoing and no further information regarding clinical course of the event nor hospitalization details was provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pfizer Covid 19 vaccine treatment under Emergency Use Authorization(EUA): My menstural cycle has changed and I have started with old brown bleeding with clots 10 days prior to my normal cycle. I have never had this happen and have never had any issues with my periods. Will be seeking medical treatment on 1/27/21 with OBGYN.
Information has been received on 05-FEB-2019 from a lawyer and a male patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) on or about 09-APR-2013 at a pharmacy, as recommended for routine adult health maintenance 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. The patient was treated at a medical group for a vesicular outbreak which was diagnoses as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for prevention of shingles, 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, and pain and suffering, and other damages. Additional information has been requested.
I Immediately got a headache,  lightheaded, dizzy, throat swelling, hard to breathe. A pain under my left breast. I could taste the medicine in my throat. Very sleepy.  This Lasted several hours until I went to bed , 8:30 pm. I had chills all night. I woke up at 2:00 am, following day with excruciating right arm pain. Also had pain in left arm, head, neck, upper shoulders, legs, ankles, and feet. Also had a pain under my left breast.  All of the above symptoms I have had from 05/05/2021 thru today, 05/10/2021 when I went to seek care.  (Tired, headache, weak, chills , pain in legs, arms, head & neck, upper and lower back)
Large 3 inch diameter of redness at shot site, swelling at shot site, muscular pain in left arm and overall body pain.
Patient with history of Parkinson's disease and TBI. He was seen in the ED on 12/8/22 for weakness and cough that started the day before. In the ED, he tested positive for COVID-19 by PCR. Ultimately, he was admitted 12/8/22 - 12/11/22 for COVID-19. Initially, the patient was not on oxygen however during his admission was on 1-2L O2. He was able to be weaned off supplemental O2. Patient has received the COVID primary vaccine series and two boosters.
This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (around the injection site, a certain spot in the left arm begin aching, sporadic pain) and PAIN IN EXTREMITY (soreness in left arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 031L20A and 013L20A) for COVID-19 vaccination. The patient had never tested positive for COVID test. Concurrent medical conditions included Lactose intolerance, Sulfonamide allergy (sulfa drug) and Seasonal allergy. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In May 2022, the patient experienced VACCINATION SITE PAIN (around the injection site, a certain spot in the left arm begin aching, sporadic pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in left arm). At the time of the report, VACCINATION SITE PAIN (around the injection site, a certain spot in the left arm begin aching, sporadic pain) had not resolved and PAIN IN EXTREMITY (soreness in left arm) had resolved. No concomitant medications were provided by the reporter. It was reported that the patient completed her vaccine series and only had soreness in left arm which lasted 3 days and did not had any severe problems. However, in the month of May 2022, around the injection site, she begin experiencing a certain spot in the left arm which began aching, sporadic pain, occurring 2 to 3 times per day, lasting less than a minute, but in the past week it had been a daily occurrence. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The adverse event did not cause the patient to seek medical care. It was unknown if the patient experienced a similar event in the past. No treatment medications were provided by the reporter.
NO ADVERSE EVENT.  PATIENT RECEIVED THE SECOND DOSE OF THE VACCINE AT 14 DAYS VICE THE RECOMMENDED INTERVAL.
Woke up at 1230 am with chills, headache and mild dry cough and we too tired to get up to take my temperature and take Tylenol. I woke up again at 3:50am with chills and aches and this time got up to take my temperature- oral temp 100.9. Took Tylenol shortly after and the fever came down to 98.9. Still achy and fatigued.
chronic 10/10 head pain, dizziness, blurriness, orthostatic hypotension, bradycardia, tachycardia, overstimulation, vasodilatation, brain fog, exhaustion, pooling, hot/cold sensitivity, tinnitus.
Numbness and Tingling in hands and feet; Numbness and Tingling in hands and feet; Itching; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness and Tingling in hands and feet), PARAESTHESIA (Numbness and Tingling in hands and feet) and PRURITUS (Itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (IV Dye). Concomitant products included HYDROCHLOROTHIAZIDE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), GABAPENTIN and LETROZOLE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) UNK dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness and Tingling in hands and feet), PARAESTHESIA (Numbness and Tingling in hands and feet) and PRURITUS (Itching). At the time of the report, HYPOAESTHESIA (Numbness and Tingling in hands and feet), PARAESTHESIA (Numbness and Tingling in hands and feet) and PRURITUS (Itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment includes Benadryl.
PT STATES LEFT HAND IS STARTING TO SWELL AFTER RECIEVING MODERNA SHOT IN LET ARM
The patient claimed that she was feeling like she might faint and then shortly thereafter, appeared to have a small seizure. 911 was dialed and a series of questions were answered that they asked before they dispatched EMS. The patient sat quietly until they arrived. She seemed alert but frightened over her response. After some time, they decided to take her to the urgent care center.
Information has been received from a physician concerning an incident involving a child who was vaccinated last month (Sept 2005) with varicella virus vaccine live and developed lesions around the injection site, reported as a rash and lymphadenopathy in the groin after vaccination. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
I remained at the facility 15 minutes after the shot and felt fine.  I was driving home on the highway and my left cheek on my face felt numb, my jaw felt funny.  I became dizzy and felt like i was going to faint.  My heart rate speed up.  I pulled over on the highway and called 911.  I began to feel better after a few minutes.  They sent an ambulance who took my blood pressure and pulse and said they were normal.  The episode came on very quickly, it did not last very long, maybe 10-15 minutes.  My concern, should i have the second shot?
Started to feel chills on 3/30/2023. Felt feverish on 3/31/2023. Tested negative. Tested positive on 04/01/2023 with fever and very sore throat.
He received his first dose of Pfizer on 2-Nov-21. Per review of available records, he has been experiencing ongoing constipation (severe), as well as internal and external hemorrhoids and bloating which began several days following the COVID-19 vaccine. No prior history of this or any GI issues. He is currently undergoing specialty evaluation (GI).  Colonoscopy revealed internal hemorrhoids, but was otherwise normal. He presented to the ED the same day (1-31) for rectal pain and bleeding and underwent an I&D for a simple abscess of thrombosed hemorrhoid. Abd CT normal. Thyroid panel, CBC, CMP normal. Pending CRP and celiac panel. Currently on Linzess and Motegrity with minimal change.
5/27  I experienced headache, sore throat, and fatigue. Symptoms got worse on 5/28, I had painful swallowing, stomach cramping and diarrhea started late in the day, into 5/29. 5/29 loss of appetite along with increased fatigue.  Tested positive with At home test on 5/29. Telemedicine with doctor on 5/29, who prescribed Paxlovid. 5/30 Swollen glands in neck. 6/4 symptoms noticeably improved, stomach pain continued. Fatigue, Stomach issues, sore throat persist to present. No fever at any point.