chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 92 years old male patient. The patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown) in 2009. No other co-suspects were reported. No concomitant medications were reported. The patient was diagnosed with shingles three weeks ago (approximately on 17-OCT-2012). The patient was currently receiving unspecified medication for treatment from primary physician for shingles. The patient sought medical attention via visiting office. The outcome of event was unknown. Additional information has been requested.
Patient woke up on 4/27/21 with ecchymosis on left side of torso/axillary line, above hip, approx. 10cm x 15cm, non-tender. Denies history of injury.
At first I was real tired and had headache. I notice my arm and leg was hives. When I went to doctor my arms and legs had hives. I did not have hives on my feet and hand. I had took some Benadryl and next morning I had Claritin . It lasted for 24 hours.
WAS TOLD THAT IT WAS THE ONE AND DONE AND IT WAS THE JANSSEN VACCINE, BUT LOT # IS MODERNA:  He got the vaccine, had no reactions at all for 2 weeks.  Then on Friday, 4/23/21 he woke up early with pain in his left arm near the area of the injection and the back of his arm and to his shoulder like he was hit with a bat.  It did not move the next day and went to his PCP on Tuesday and referenced Ortho and could not find any doctor and his pain was getting worse.  He went to the ER on Wednesday, had a bad experience.  Went back on Friday 4/30/21 and nothing was done for his shoulder and needs to see somebody regarding his arm.  The arm is painful and painful to move in all directions.   They did not do anything for him in the ER, actually made it worse.   The ER said that they could not do an MRI as he needed a referral from an orthopedist for that.    They wanted to check him for his heart, and they would not listen to him.
Information has been received from a physician concerning a 15 year old female with no known allergies who on an unspecified date was vaccinated with a third dose of GARDASIL (Lot number not provided). On an unspecified date the patient received the third dose of GARDASIL and experienced syncope. The patient recovered on an unspecified date. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Patient developed fevers, chills, muscle twitches, vomiting, and dizziness one day after receiving the vaccine. 2 ED visits since the reaction
This spontaneous report as received from a pharmacist refers to a 62 years old female patient with no pertinent medical history and with no drug reactions or allergies. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (Lot # 671142/1268AA, dose not reported) on 27-JUN-2012. Concomitant medications included nonsteroidal anti-inflammatory drug (unspecified), atorvastatin, VESICARE, estradiol, ALIGN, PRILOSEC and calcium with vitamin D. On 06-AUG-2012 the patient experienced varicella like rash on her body. There was no pain or itching with rash. The patient saw a physician for medical attention. There were no lab diagnostic studies performed. No treatment was given. At the time of this report the patient had not recovered. Additional information is not expected.
heart racing; light headed; dry mouth; fingers and feet tingling with sharp pain; A spontaneous report (United States) was received from a consumer concerning a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart racing/palpitations, lightheaded/dizziness, mouth dry/dry mouth, and fingers and feet tingling with sharp pain/paraesthesia.  The patient's medical history included cancer. Concomitant medication included tamoxifen.   On 04 JAN 2021, the patient received the first of two planned doses of mRNA-1273 (batch number: unknown) intramuscularly on her right arm for prophylaxis of COVID-19 infection.  On 04 JAN 2021, the patient experienced heart racing, lightheaded, mouth dry, fingers and feet tingling with sharp pain.  Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, heart racing, lightheaded, mouth dry, fingers and feet tingling with sharp pain was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
high fever 102,  fatigue, no energy, aches in muscles in joints, nauseous
5 minutes after, I started getting  hives - on chest and stomach and back and was spreading onto my legs. One of the nurses at the site, gave me several doses of Benadryl and a Zyrtec. I was there 45 minutes - I kept getting more and more hives and my throat was getting itchy and my breathing was off a little bit. After taking the Benadryl, it started slowing down eventually and I was able to leave in 45 to fifty minutes. My primary care physician told me to take Benadryl before and after getting the second round of the vaccine. I had hives and a small rash on my chest for three days and I had to take Benadryl for those days. I t was extremely itchy. Symptoms resolved by end of day three.  There was also a slight tingling in my fingers  while I was experiencing the rash.
Initial unsolicited report received from a non-healthcare professional (patient) on 27 October 2016. This case involves a 70 years old male patient who was vaccinated with a dose of FLUZONE HD (dose, dose in series, batch number, expiry date were not reported) intramuscularly in the left arm on 26 October 2016. The patients' illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as amoxicillin and ASA allergies. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 28 October 2016, 2 days following the vaccination, the patient got up to go to the bathroom and had gastric disorder, vertigo and felt on the floor. Up the whole night the patient had sick feeling in his stomach. The patient required ER/ doctor visit. Laboratory investigations were not reported. Corrective treatment was not reported. The outcome of the events was reported as not recovered. List of documents held by sender: none.
COVID 19 Treatment; COVID 19 Treatment; Booster; Off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 at 09:45 as dose 4 (booster), single (Lot number: FJ4989) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Other medical history: Lupus; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: HYDROXYCHLOROQUINE, start date: 07Jul2019; PROPRANOLOL, start date: 01Oct2018; LEVOTHYROXINE, start date: 27Mar2021. The following information was reported: IMMUNISATION (medically significant) with onset 29Apr2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 29Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Negative; (29May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 29-JUN-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) PROQUAD (rHA, lot # R002931, expiration date 29-JUL-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# M039639, expiration date 28-MAY-2019). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.; Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.) and HEADACHE (Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   On 01-Apr-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) UNK UNK, total. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. In 2021, the patient experienced HEADACHE (Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.). On an unknown date, the patient experienced PAIN IN EXTREMITY (Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.). In 2021, PAIN IN EXTREMITY (Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.) and HEADACHE (Since Apr2021, the consumer had 2 Moderna COVID Vaccines and afterwards his arms were achy and he had a slight headache.) had resolved.            No relevant concomitant medications were reported. On 01-Apr-2021, the patient started taking DUPIXENT (DUPILUMAB) via pre-filled pen, at unknown loading dose followed by 300 mg every other week (QOW) via subcutaneous route. No treatment medication reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622308 (Patient Link).
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: pain,sswelling and itching at site-Mild, Additional Details: just swelling at njection site,,,was given too low
Discomfort at injection site. Red and swollen at site. Warm to touch at site. Monitoring redness and tracking for worsening s/s. NP started on Bactrim for cellulitis.
Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, upper back; Small bumps directly around lymph nodes with intense itching which feels like it's on the inside sometimes; This is a spontaneous report from a contactable consumer. A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 18Mar2021 12:00 as single dose for COVID-19 immunization. Medical history included SAPHO syndrome, vasculitis, gout, arthritis, carpal tunnel syndrome, hot peppers and garlic sensitivity, and seasonal rhinitis allergy, all from an unknown date. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included ibuprofen; pregabalin (LYRICA); methotrexate; omeprazole; and paracetamol (TYLENOL), all taken for an unspecified indication. The patient previously took Biaxin and Bactrim and experienced allergies. On 20Mar2021, 04:00, the patient experienced pain and itching around lymph nodes under armpits, breast area middle of chest, top of shoulder, and upper back. Onset was intense aching pain two days post injection. Small bumps directly around lymph nodes with intense itching which felt like it's on the inside sometimes was reported. It was a Monday night of 22Apr2021 at 9:55 PM and symptoms were static, not worsening not improving. No treatment was received for the events. The outcome of the events was not recovered.
high fever, chills, tremors, night sweats, dry heaves, migraine, nauseous.  began 8 am and ended 2 AM on Tuesday morning.  Then 3 days later developed bronchitis.
Covid-19 Positive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 Positive) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 Positive) (seriousness criterion hospitalization). The patient was hospitalized from 21-Apr-2021 to 25-Apr-2021 due to SARS-COV-2 TEST POSITIVE. At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was in quarantine.  Treatment information was not provided.   This case was linked to (E2B Linked Report).; Sender's Comments: Based on biological implausibility the event of COVID-19 infection causality is assessed as not applicable in relation to mRNA-1273. :Case For wife
Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX (Merck). After receiving ZOSTAVAX (Merck), the patient was diagnosed with unilateral hearing loss. The physician reported that the patient saw another physician and it was confirmed that the patient had unilateral hearing loss. At the time of this report, 17-FEB-2009, the event persisted. Upon internal review, unilateral hearing loss was considered to be an other important medical event. Additional information is not expected.
Three days post vax, the pt developed a rash from his arm to upper breast which itched.
10/2/21: Fever/chills, nausea, migraine, extreme muscle fatigue, lethargy This led to an episode of Vasovagal syncope in which the patient needed to be taken to the ED. Fluids were given (Normal saline, then Lactated ringers) and Metoclopramide for the nausea and migraine.
The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced feeling of faint and dizzy, feeling jittery, feeling cold, body aches, burning sensation on the arm, burning sensation in ears, her head was hurting, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from burning sensation on the arm, had not recovered from feeling of faint and dizzy, and the outcome of her head was hurting, headache, fever, feeling jittery, feeling cold, body aches and burning sensation in ears was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
I was experiencing Extreme fatigue so I determined I would need to take some time off work beginning on 9/1/2022. I was just too tired to work, rather than being sick.  The first week of September, I was feeling sick.  I experienced excruciating pain down the left side of my body and was diagnosed with Shingles later that week.  I experienced the symptoms until late November of 2022.  Exhaustion lingers and is not decreasing as does post hermetic neuralgia to time of reporting.   Early November I was diagnosed with Kidney Disease.  There was continuing and recurring Pelvic Pain, CT scan on 12/20, inconclusive results.  In January there was a referral to a cardiologist for a workup, clean bill of health.   Oral Surgery in February, where I got Azithromycin.  The azithromycin led to a persistent case of Candidiasis that is current to time of reporting.  Nystatin is treating the Candidiasis.
On April 3, 2021 around 5 PM stated having tingling, numbness and slight swelling in right hand.  as of 5:47 PM on 4 April the same symptoms remain unchanged.    I had the headache from mild on April 1, 2021 to severe on April 3 to where I took a Tylenol to help ease the pain.
The patient reported the symptom of a fever 24 hours after her vaccination. That was the only symptom she reported.
Pt felt nausea, dizziness, blurry vision, bone pain in arms and legs.  We gave pt some water and had her lay down for 30 minutes.  Pt felt symptoms improved and pt was feeling better
severe muscle ache and joint pain; severe muscle ache and joint pain; extreme fatigue; chest pain; Nausea; chronic pain over entire head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 21-year-old male patient received bnt162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN9581) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Chronic depression", start date: Jan2018 (ongoing); "Anxiety", start date: Jan2018 (ongoing); "OCD", start date: Jan2018 (ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM; FLUOXETINE; NORTRIPTYLINE. The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "not recovered", described as "chronic pain over entire head"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "severe muscle ache and joint pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; CHEST PAIN (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown". The events "severe muscle ache and joint pain" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300180183 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-PV202300192087 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202300400482 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Have had Diarrhea  every time after eating anything solid since the covid vaccine.   Have taken Imodium with little success. Symptoms include after eating, bloating, cramps having to run to restroom.
doesn't want to get up; fatigue; like a normal flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like a normal flu), SOMNOLENCE (doesn't want to get up) and FATIGUE (fatigue) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (like a normal flu). On an unknown date, the patient experienced SOMNOLENCE (doesn't want to get up) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (like a normal flu), SOMNOLENCE (doesn't want to get up) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  Treatment information include Antihistaminic and regular flu medicine.   Reporter did not allow further contact
Six days post-vaccine, my arm began hurting again, but more of a deep muscle pain. Over the next 2 days, there is a baseball sized knot on my arm that hurts, itches, and is hot to the touch.
My vison was a little blurry. At a routine eye exam, they found a branch retinal artery occlusion in both eyes. I was referred to a retina specialist. I had surgery to cauterize 9 or 10 areas in my right eyes that were bleeding. With the branch retinal artery occlusion in my left eye I had vision loss and bleeding as well. The left eye was not severe enough to warrant surgery. I have new bleeds that I will see a doctor for. I went to the retinal specialist on Tues. I have followed up with a neurologist, hematologist, cardiologist. I have had over $3000 worth of blood work. Everything came back normal except for MTHFR positive and HLAB27 was also positive (heterozygous) I was told yesterday that I will eventually go blind although the timeline is uncertain. I can no longer drive at night.
This spontaneous report was received from a licensed practical nurse via a company representative regarding a adolescent patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VARIVAX (lot#, expiry, route and dose not reported). No concomitant medications were reported. On an unknown date, the patient contracted physician documented shingles. The company representative noted a second dose of VARIVAX had not been administered. No treatment information was reported. The outcome of shingles was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.