chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 16 year old female student with no pertinent medical history who on 16-Jan-2007, at 14:45, was vaccinated, into the left deltoid, with a first dose of Gardasil (lot #655619/1427F) concomitantly with a first dose of Havrix (lot AHAVB143BA) in the left arm and a first dose of Menactra (lot U1968AA) into the right deltoid. On 16-Jan-2007, at 14:45, while sittings on table, the patient complained of severe pain in the left arm. As the patient was complaining, she fell forward, and the licensed practical nurse laid her down. The patient's eyes were fixed staring at the ceiling and her body started jerking wildly and thrashing. The patient went from jerking and trashing to "jumping up and asking what happened." The patient was guided back to the table and her body started jerking and thrashing with her eyes fixed on the ceiling and non-reactive. Subsequently, the patient came to diaphoretic. In January 2007, the patient recovered. No further information is available.
Rash - started 2 hours after receiving Hep B vaccination combined with malaise and fever.
blurred vision in left eye; sore arm; This case was reported by a consumer via call center representative and described the occurrence of blurred vision in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced blurred vision and pain in arm. On an unknown date, the outcome of the blurred vision was recovering/resolving and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the blurred vision and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced sore arm for about one week and that resolved.  The caller reported that she experienced blurred vision in her left eye and has been seen by ophthalmologist and another eye specialist. The caller reported that blurry vision has improved some but still present and wears corrective lens glasses. The reporter consented to follow up.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 25th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In January 2019, 12 hrs after receiving SHINGRIX, the patient experienced joint pain, muscle pain, sinus headache, sinus congestion and influenza like illness. On an unknown date, the patient experienced pain in arm, erythema of extremities, decreased appetite and woozy. On an unknown date, the outcome of the joint pain, muscle pain, sinus headache, sinus congestion, pain in arm, erythema of extremities, decreased appetite and woozy were recovered/resolved and the outcome of the influenza like illness was unknown. It was unknown if the reporter considered the joint pain, muscle pain, sinus headache, sinus congestion, pain in arm, erythema of extremities, influenza like illness, decreased appetite and woozy to be related to SHINGRIX. Additional details were provided as follows: The reports stated that she did not had any problems after the 1st dose of SHINGRIX. After the 2nd dose of SHINGRIX in left arm, she felt like she had the flu. About 12 hours after the dose she had severe muscle and joint pain and a bad sinus headache, like all of her sinuses were stuffed. She did not want to eat, and stayed in bed for about 24 hours because she felt woozy when she got up. The symptoms resolved after about 24 hours. Her arm was also very sore and red for about 3 days. The reporter gave consent to follow up.
Four weeks after receiving the Shigrix vaccine, I started developing red pimples on my left hand and arm. A few days later, I developed large red bumps on my left neck. Large red rashes similar to those of urticaria spread over my left arm while more red dots, some filled with clear fluid like in chickenpox, continued to appear on the lower part of my left face, my back, around my navel and in my groin. Most of them were on the left side. By June 20, the rashes were covering most of my left arm and my left back. Some of the rashes were straight lines, others were similar to acute urticaria. Since I was by then on a business trip, I saw a pharmacist who thought I had hives and prescribed an antihistamine medication and a non-prescription ointment. Things did not improve, so I saw a doctor who diagnosed a giant urticaria and prescribed Desloratadine and Betamethasone cream. They had little effect but the rashes started to improve around June 27.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided. On 14-AUG-2018, the patient was vaccinated with one improperly stored dose of ROTATEQ orally, lot # N029669, expiration date: 02-SEP-2019 for prophylaxis. The administered dose of ROTATEQ was exposed to the temperature between 9 degree Celsius to 25 degree Celsius (9.3 degree Celsius) for 15 minutes. Previous temperature excursion was between 2 degree Celsius to 8 degree Celsius (1.8 degree Celsius) for 10 minutes. Digital data logger was involved. No adverse effects were reported.
01/18/22 presents to ED for "abdominal pain, vomiting, and diarrhea". PMHx of "HTN, T2DM, BPH, GERD, CAD, prior CVA"
Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer and Cancer surgery (Cancer removed from his hand and face) on 09-Dec-2020.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-409903, MOD-2021-409906 (Patient Link).
11-11-09 - fever, body aches, nausea, fever reported at 100.9 oral. 11-12-09 - fever gone, left upper arm swollen.
Pain post injection; This is a spontaneous report from a contactable healthcare professional via a Pfizer-sales representative.  A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain post injection on an unspecified date. Outcome of the event was unknown.     No follow-up attempts are possible. No further information is expected.
Beginning early April 22, increasing post-nasal drip with throat irritation resulting in mild cough.  Managed with Loratadine and Fluticasone along with OTC cough drops.  These symptoms continued through April 26 and started becoming more persistent around April 27.  On April 28, I added an OTC sinus rinse to my treatment (twice a day).  The afternoon of April 29 I started getting some periods of sinus pressure and a runny nose.  Over the next couple of days the sinus pressure and runny nose increased to consistently present throughout the day.  The evening of April 30, I started taking a nasal decongestant.  On April 30 and May 1, I conducted an at home Covid 19 test (once each day).  Both tests were negative. The afternoon of May 1, the sinus pressure became sinus pain above and below both eyes.  On May 2, I sent a message to my doctor through their patient portal.  They advised to continue the treatments I was already on for 2 to 3 more days.  Over the next 2 to 3 days, the nasal congestion, sinus pressure and sinus pain continued.  Also, my top row of teeth began hurting (just saw my dentist about 3 weeks prior and was told all looked good).  On May 5, I made an appointment with a nurse practitioner at Family Medicine, and she diagnosed me with bacterial sinusitus and prescribed a 7 day course of Doxycycline Hyclate 100mg.  With the addition of the antibiotic, my symptoms began to improve and resolved fully over the course of the next week.
I contracted COVID-19 04/20/2022 with symptoms of shortness of breath, chest tightness, myalgia, fatigue, headache, sore throat, muted sense of smell short term, and these symptoms lasted until 5/3/2022. I was prescribed Paxlovid in a smaller standard dose due to kidney disease. I have lingering symptoms of chest tightness, and shortness of breath.
Chills; Sweating; Body Aching; Hurts to move/can not move with out pain; Sharp pains in hands and feet; Sharp pains in hands and feet; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Jul2021 13:30 (Lot number: ER8731) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 14Jul2021, outcome "recovering", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 14Jul2021, outcome "recovering", described as "Sweating"; PAIN (non-serious) with onset 14Jul2021, outcome "recovering", described as "Body Aching"; PAIN (non-serious) with onset 14Jul2021, outcome "recovering", described as "Hurts to move/can not move with out pain"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 14Jul2021, outcome "recovering" and all described as "Sharp pains in hands and feet". Therapeutic measures were not taken as a result of chills, hyperhidrosis, pain, pain, pain in extremity, pain in extremity.  No follow-up attempts are possible. No further information is expected.  Facility type vaccine: Pharmacy or Drug Store. Patient did not received other vaccine in four weeks. It was unknown if patient had covid prior vaccination. Patient had not tested covid post vaccination. Adverse event: Chills, Sweating, Body Aching, Hurts To Move, Can Not Move With Out Pain, Sharp Pains In Hands And Feet  Follow-up attempts are completed. No further information is expected.
2 hrs after vaccine felt sweating, clammy.  Gas pains and cramps began. Loose stool once. 7 pm arm was sore and throbbing 6 of 10, injection site flushed and warm to the touch  9pm pain worsened to 8of 10. Unable to grab toothbrush with left arm sharp pain 10 of 10. Unable to sleep on left side due to pain and pressure . 6:00 am Thursday pain worse and unable to lift arm above the shoulder. Was unable to drive with left hand. All day today bad gas and abdominal cramps.by the end of the work day I was unable to hold anything in my left hand, body aches started, legs tight and achy. Frontal headache. Took Tylenol extra strength q 6 hrs, nsaid 800mg bid. And aleve, no relief
Moderna COVID-19 Vaccine EUA 3 diarrhea, treated successfully with loperamide
pt recv vax & face became bright red, pt crying;w/in seconds face became blotchy;while being exam, small pinpoint raised spots appeared w/large irregular splotches & raised bumps;rash spread over entire body w/in 5-8min;circumoral cyanosis
Immediately after receiving H1N1 immunization the patient c/o "burning of her throat and feeling funny". Pt is 9 wks pregnant. Pt placed in supine position and administered apple juice. BP 106/60 palpable, P 88 and thready, R-22 unlabored. Taken to ED via ambulance. 11/2/09 Emergency Department Records received from date of service 10/30/09. Dx:  Medication Reaction. Assessment:  9 week pregnant woman presented after getting H1N1 vaccine and immediately had some throat irritation and "burning" and became anxious and tachycardic.  There was no syncope or feeling of throat closing, no stridor or urticaria, no SOB or abd. pain.  No evidence of allergic reaction on physical exam.  Pt. discharged to home.   11/16/09 Prenatal records received. Normal prenancy. EDC 6/7/10. No further notation.
This case was reported by a consumer via patient support programs and described the occurrence of difficulty breathing in a 58-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine and an unknown time after starting VENTOLIN HFA and ADVAIR, the patient experienced difficulty breathing. The patient was treated with VENTOLIN HFA and ADVAIR. On an unknown date, the outcome of the difficulty breathing was unknown. It was unknown if the reporter considered the difficulty breathing to be related to Influenza vaccine. Additional information provided as follows: The age at vaccination not reported. The patient experienced breathing problems 2 weeks ago from the date of reporting. The reporter stated that it could be related to the weather changing or a reaction to the flu shot received. The patient also stated that he was using VENTOLIN more for breathing recovery because of congestion or trouble breathing. The reporter has agreed to have GlaxoSmithKline's Safety team follow-up with them via postal mail. This case was not associated with product complaint.
BODY ACHES, FATIGUE, INJECTION SITE PAIN, ITCHING AT INJECTION SITE Narrative:  65 yo female with PMH sleep apnea, depression, GERD called triage line on 3/24/2021 to report flu-like symptoms (fatigue, body aches, and injection pain site with her second dose of covid19 vaccine. It was noted that she also had similar symptoms to the first COVID19 VACCINE that was administered on 02/19/2021 (hence this report with the first covid19 vaccine). Pt with her first covid19 vaccine, symptoms started the day after. The only difference is with COVID19 VACCINE second dose, the itching at the injection site did not resolve.
Delayed injection site reaction. Began about one week after immunization. 9 cm of redness, swelling and irritation. Itchy and puffy.
Headache, joint pain to the degree I was unable to sleep. Symptoms started about nine hours after injection. Reaction similar to symptoms experienced when I contracted Shingles in 2008.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with M-M-R II (lot # L003855, expiration date: 05-FEB-2017; lot # L041456, expiration date: 22-OCT-2017; and lot # L010488, expiration date: 26-MAR-2017) for prophylaxis. According to the reporter, the vaccine was exposed to temperatures between 42 degrees fahrenheit (F) to 77 F for 57 hours, and between 32 F to 35 F for 166 hours. No adverse symptoms were reported. A digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA010755: US-009507513-1709USA010753: US-009507513-1709USA010754:
Diffuse itchy rash all over head/face/body. Symptoms started in left axilla night of injection. The next day itchy rash spread to face, scalp, neck. The next day rash then moved to chest, trunk, back, arms, legs, feet. OTC Benadryl and Claritin with some relief.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "osteopenia" (unspecified if ongoing); "slightly elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: VALTREX, start date: 01Feb2013; NATURES WAY COD LIVER OIL; NATURE'S WAY VITAMIN D3; VITAMIN C + ZINC; CALCIUM; NATURES WAY COZYME Q10. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Nov2022, outcome "recovered" (27Nov2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Nov2022) Positive; (27Nov2022) Negative, notes: tested negative on that day. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient developed covid on 22Nov2022. She tested positive. She was prescribed Paxlovid that day and took all doses, ending on Sunday 27Nov2022 (five full days later). She tested negative on that day. The patient had no known allergies. Other medication of patient in 2weeks was Red Bean and Yeast.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
pain in shoulder/ Pain continue to migrate to elbows, wrists; pain in hand/feet; This is a spontaneous report from a contactable consumer. This 76-Year-old male consumer reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER2613) via intramuscular route of administration on 19Mar2021 at 12:45 (at 76-year-old), as dose 2, single for COVID-19 immunization. Medical history of the patient included Heart disease-stent, Sluggish artery, Acid reflux (esophageal), Crohn's disease. The past drugs included atorvastatin that cased allergy. It was mentioned that no vaccine was received in four weeks. The patient received other medications in two weeks. The patient did not have COVID prior vaccination and was not tested for covid post vaccination. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 26Feb2021 (at 76-year-old), as dose 1, single for COVID-19 immunization and experienced pain in joints that was normal. On an unknown date in 2021 the patient experienced shoulder pain and pain continued to migrate to elbows, hands, wrists and feet. The patient received treatment with Mobic. The event resulted in physician office visit. The event outcome was unknown.
Erythema, tenderness, induration, and warmth of upper right arm, including the injection site, and fever, consistent with cellulitis.
I received the shot at 9:00am Friday March 12, 2021.  I woke at 3:08am Saturday March 13th, 2021.  I woke in a pool of sweat.  The bed sheets were actually wet.  I began throwing up, and severe diarrhea, and an intense headache.  After several hours, my right leg started to cramp for about 30 minutes.  I was sick for about 12 hours, and I could not keep any food down until 4:00pm Saturday March 13th, 2021.  It was a miserable and scary night.
missed her second shot; real bad spinal cord pain for 2 days/back was hurting; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (real bad spinal cord pain for 2 days/back was hurting) and PRODUCT DOSE OMISSION ISSUE (missed her second shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07B21A) for COVID-19 vaccination.     The Medical History was not provided by the reporter.     On 07-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 SPINAL PAIN (real bad spinal cord pain for 2 days/back was hurting). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her second shot). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 10-Apr-2021, SPINAL PAIN (real bad spinal cord pain for 2 days/back was hurting) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed her second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.
09/29/2020 Went to dermatologist; head itching.  3 weeks later, Dr. examined; bumps on back. Prescribed prednisone for rash. After medication dose, rash reappeared. 2x Biopsy; inconclusive. 'Dr. didn't accept results and wanted to pursue medication - I declined; 'I'll deal with it''.  Patient still complains of bumps and itchy head.
Had chronic urticaria from receiving anthrax vaccine while in military...2000 year. Took hydroxyzine daily from 2000- 2019 to counter severe rash. Discontinued meds in 2019. Urticaria gone. A couple weeks after Covid vaccine the chronic urticaria returned and I am now taking hydroxyzine (25mg) every 3 days to stop rash.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 11-AUG-2016, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # K006138, expiry date: 29-APR-2016 (dose not reported). No concomitant medications were reported. There were no adverse events reported. Additional information has been requested.
fully vaccinated (Pfizer, 1/8/21, 1/29/21); onset of symptoms 8/3/21
Red rash, hives generalized on body. Treatment:  Benadryl and Prednisone given in the ER.
Patient reports having "tremendous pain in my neck, spine, back, and left leg". This pain started within a few days after second Moderna shot. Started with flu-like symptoms and then pain began to get worse and worse until he could not put pressure on his left leg. He finds it difficult to walk.
Tinnitus Right ear within 30 days of second Moderna dose.  Tinnitus came and went for several months and became permanent after about 3 months.  I now have hearing loss in my right ear and permanent tinnitus.