chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received Shingles vaccine many years ago).   On 10th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th February 2020, 1 days after receiving Shingrix, the patient experienced injection site pain. On 12th February 2020, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient experienced pain at injection site after getting the dose of Shingrix vaccine. The pain started the next day after vaccination and it lasted for total of one day. She has had the original Shingles vaccine many years ago. The reporter did not consent to follow-up.  The case has been linked with the case US2020080767 reported by same reporter.
I?m filing this just in case it is related? I had minimal GI issues until less than 2 months after I received my second shot. I began experiencing issues with my bowel movements in June, a colonoscopy confirmed ulcerative proctitis in August and by November I was hospitalized with pan colitis. I have been diagnosed with the autoimmune disease ulcerative colitis and am told I will be on Remicade (an IV infusion) for the rest of my life.
numbness on left side of face  and neck temporary 15 minutes; numbness on left side of face  and neck temporary 15 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Feb2021 13:00 (Lot number: EL1284) as dose 2, single and intramuscular, administration date 13Jan2021 13:00 (Lot number: EL1284) as dose 1, single for covid-19 immunisation. Family history included: "hypertension" (ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 03Feb2021 14:00, outcome "unknown" and all described as "numbness on left side of face  and neck temporary 15 minutes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, hypoaesthesia. No follow-up attempts are possible. No further information is expected.
2nd dose outside of 42 day window; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose outside of 42 day window) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L21A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose outside of 42 day window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose outside of 42 day window) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details not provided.  Patient received First dose at 15-JAN-2021. Patient did not report pregnancy at that time. Se stated that she didn't know she was pregnant. Patient cancelled her second dose appointment due to confirmation of pregnancy. In March patient called the pharmacy to schedule her second dose because she had miscarriage(12-Mar-2021).   This case was linked to MOD-2021-047919 (Patient Link).
I started with a nasty cough, flu like symptoms, feeling achy. I went to get tested on August 2, 2021, came back negative. I later found out by Tuesday went got another COVID-19 test on August 2, 2021, feeling worse (cough, shortness of breath) contacted family physician. They gave us inhaler, steroids, Tylenol every 4 hours and antibiotics. Maybe due to my seasonal allergies took me longer to recover took 3 1/2 weeks.
pt recv vax & immed became pale lost consciousness, eyes rolled back & jerked;upon regaining consciousness pt felt like might throw up;BP 92/70 & 5min later BP 100/60;
This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. On 28-JUL-2014, the patient were vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
Felt very shaky following day; Shivering uncontrollably; Intense joint and muscle pain.; Intense joint and muscle pain.; Strong headache; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 75-years-old non-pregnant female patient received a dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: FF2590), dose 3 via an unspecified route of administration, administered in Arm Left on 14Oct2021 12:00 (at the age of 75-years-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included High blood pressure, asthma, obesity, diverticulum, atrial fibrillation and Dust mites from an unknown date and unknown if ongoing. Concomitant medications included influenza vaccine (FLU VACCINE VII) taken (Arm Right) for an unspecified indication from 07Oct2021. It was reported that she was not a pregnant at the time of vaccination. patient received flu shot prior to four weeks of vaccination. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. Patient previously received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 09Mar2021 as dose 2, single (at the age of 75-years-old) and patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL9266) for via an unspecified route of administration, administered in Arm Left on 16Feb2021 (at the age of 75-years-old) as dose 1, single for COVID-19 immunisation. On 15Oct2021, the patient woke at 3:00 a.m. and experienced intense joint and muscle pain, strong headache and by 5:00 a.m, shivering uncontrollably which lasted until 11:00 a.m. The patient Stayed in bed most of the day on 16Oct2021 felt very shaky following day. It was reported as patient not received treatment for the events. The outcome of felt very shaky following day was unknown and outcome of Intense joint and muscle pain, strong headache was recovering and shivering uncontrollably was recovered on 15Oct2021.  Follow-up attempts are completed. No further information is expected.
Information has been received from a health professional concerning a 78 year old female with allergies to Ancef, "decongestant", Talwin and Lomotil and no pertinent medical history who, "2 1/2 weeks ago", on approximately 09-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included Lescol XL, Lanoxin, Boniva, Coumadin, Bumex, enalapril malate MSD, Caltrate, vitamins (unspecified) milk of magnesia, chondroitin sulfate sodium (+) glucosamine sulfate and potassium (unspecified). "About 3-4 days ago", on approximately 23-OCT-2007 the patient began to experience hyperpathia. The patient developed pain and sensitivity in the left shoulder area, only on the left side (does not cross midline). The patient was very sensitive to any type of touch. Medical attention was sought. The following labs were performed: complete blood count, C-Reactive protein and sedimentation rate (results not provided). The patient was prescribed Lortab and Lyrica. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Information has been received from a registered nurse concerning a female patient who on 10-Apr-2002 and 16-May-2002 was vaccinated with a first and second dose of varicella virus vaccine live. On 27-May-2003 it was reported that the patient "now" has a negative titer. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Tackycardia was developed after taking the first dose of the Pfizer COVID-19 vaccine (Feb 24). About two weeks after taking the second injection, paid a visit to a cardiologist on Apr 8. Echocardiogram was performed afterwards to check for heart abnormality. Sinus tachycardia slowly resolved with time after the follow-up doctor visit on May 10. However, I wasn't able to exercise for several months because of the abnormally high heart rate (>130 beats/min) in response to medium-strength physical activities such as walking. Even six months after taking the second shot, it would take several hours for my heart rate to go back to normal level after routine exercises I used to do regularly before taking the vaccination.
Pt C/O redness, swelling, warmth, and pain at injection site. (size: 6"x5"). Pt to apply cold compresses PRN.
Patient noticed her arm had an adverse reaction 5 days after prevnar vaccine (vaccine given in left arm on 7/13/17). Reported her upper arm had a rash "the size of a dollar bill" on 7/18/17 that was not there the day before. The rash was hot to the touch, red and bumpy. According to the patient the size of the rash decreased significantly from 7/18 to 7/20 and is now about 3 inches diameter around injection site. She is comfortable monitoring it from home as it continues to improve. I advised her to call us or her doctor if she notices it worsening or if it doesn't improve. We will call and check on her tomorrow as well to make sure it is improving.
Her husband came to the pharmacy stating that his wife was waiting in the parking lot ,after her second  covid vaccine,  and wasn't feeling  well.    I went to the parking lot and she was sitting in the car.  She was lethargic, complaining of left arm pain, nausea, and weak.  She was awake and able to communicate.  I asked if she wanted me to call the ambulance and she said yes.  I placed the call and they were here in about 10 minutes.  The emt determined she should be taken to the hospital.  At this point, she was feeling better.  She stated she didn't want to go l, but in her best interest  it was determined she should be assessed at the hospital.
Atrial fibrillation with RVR now controlled. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
O2-99%, BP 139/80;  HR 74; 10:52 am BP 150/90; Nausea Pt. exit at 10:54 am.
This spontaneous report was received from a nurse concerning an unspecified number of patients. The patients' historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patients were vaccinated with an unspecified number of doses of PROQUAD subcutaneously, reported lot number R011217, expiry date 15-OCT-2019, reported lot number R011802, expiry date 21-OCT-2019, (laterality, strength were not reported) and VARIVAX reported lot number R009411, expiry date 29-MAR-2020, reported lot number R003300, expiry date 01-FEB-2020, reported lot number N035940, expiry date 18-DEC-2019 and reported lot number N034551, expiry date 05-DEC-2019 (laterality, strength, dose, route were not reported) both vaccines for prophylaxis, following a temperature excursion. The administered doses of the vaccines experienced a temperature excursion of 6 Fahrenheit (°F) to 14°F (-14 Celsius (°C) to -10°C) for 14 hours 30 minutes and of 15°F to 46°F (-9°C to 8°C) (-6.1°C) for 20 minutes, with multiple excursions, as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported. This case was considered non-valid due to lack of patient identifiers. As of 09-NOV-2018, all telephone attempts to obtain follow up information had been unsuccessful. Follow-up information has been received from the registered nurse on 08-JAN-2019, referring to a 13-month old male patient. The patient had no allergies, birth defects or medical conditions. It was reported that the patient had two brothers/sisters. On 21-SEP-2018, the patient was vaccinated with an improperly stored dose of: M-M-R II (strength and dose were not provided), lot # N025894, subcutaneously, in the left thigh, for prophylaxis; of VARIVAX (strength and dose were not provided), lot # N035940, subcutaneously, in the right thigh; of VAQTA, (strength and dose were not provided), lot number R013858 (expiration date not provided), intramuscularly, in the left thigh; as prophylaxis; and of PREVNAR 13 (strength and dose were not provided), lot # reported as W11304, intramuscularly, in the right thigh. No previous temperature excursion was reported. There was no adverse effect reported (also reported that the patient received treatment for the event and the patient was recovered). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA002757: US-009507513-1901USA002753: US-009507513-1901USA002754: US-009507513-1901USA002755: US-009507513-1901USA002764: US-009507513-1901USA002763: US-009507513-1901USA002762: US-009507513-1901USA002761: US-009507513-1809USA010598: US-009507513-1901USA002759: US-009507513-1901USA002758: US-009507513-1901USA002765: US-009507513-1901USA002756.
This spontaneous report was received from a pharmacist, concerning a 60 year old male patient. The patient's medical history was not reported. His concurrent conditions included Chronic Obstructive Pulmonary Disease (COPD). The patient's concomitant medications were reported by the pharmacist as "an extensive list". The reporter informed that on 18-DEC-2017, the patient received a dose of ZOSTAVAX administered with sterile diluent (MERCK), both subcutaneously, for prophylaxis, lot #N020852 and expiration date 31-JUL-2018 and lot #N013283 expiration date 03-OCT-2019, respectively (strength, dose and frequency were not reported). It was informed that on 19-DEC-2017, the patient developed a "COPD flair up". On the same date, the patient went to an unspecified physician and was prescribed MEDROL and Z-PACK. At the time of reporting, the outcome of COPD flair up was unknown. The causal relationship between the vaccination with ZOSTAVAX and COPD flair up, was not provided by the reporter.
She came by after a couple hours and told me that she thought her arm was swollen, it did not look too swollen. We had told her to take some MOTRIN and BENADRYL. Next day, I had talked to a member of management about patient. She told me that her shoulder had swelled up to size of tangerine and she took day off to go to Dr. I called patient later at home, she said her doctor told her that she was probably allergic to it. Told her to apply heat every hour or so and continue MOTRIN. I followed up with patient 11/19 and she said her arm was back to normal couple days later after her shot.
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375 (same reporter).  This case involves a 61 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Mild cold symptoms; 4-5 scabbing vesicles on trunk and legs.
"Softball" size- 10 cm x 11 cm- on right thigh at site of DTaP- Pruitic rash with erythema and swelling and warmth. No fever, no respiratory symptoms- local reaction only. Began Zyrtec on 3/11/04 and outlined erythema in office. Told to call if erythema spreads and to recheck on 3/15/04.
Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Additional Details: Approximately 5-10 minutes after IM adminstration of Pfizer vaccine, patient was complaining of nausea, lightheadedness, feeling of "passing out". Patient's blood pressure was 98/67 with HR 62.  I called 911 and immediately gave patient about 8 -10 ounces of water, which she sipped slowly over 10-15 minutes.  Rechecked her blood pressure, which was 102/69 until rescue arrived.
Patient request exemption to influenza and AVA vaccine. Influenza vaccine concerns: He reported being "incapacitated for 3 days" following receipt of all past influenza vaccines and was told he was a "hyper-responder". He described similar reactions following 8 influenza vaccines as being very weak with diffuse headaches (3-4/10), dull throbbing joint pain (bilateral shoulders, knees, elbows, hips), and being hot, sweating and subjective fevers (did not take temperature or seek medical care). All symptoms resolved within 3 days with no further sequelae with bed rest and TYLENOL. He advised this set of events occurred with all 8 flu vaccine (1999-2010) without increase in severity or duration. Anthrax vaccine concerns: Patient reported onset of symptoms following 3 "bad batches" of Anthrax vaccinations (AVA) in 2003. He described the following reactions: his reaction to first Anthrax vaccine given 10/9/2003 (BIOTHRAX FAV077) as an annoying "normal" diffuse headache 3-4/10 within 24 hours after vaccination that resolved with TYLENOL; AVA vaccine #2 (BIOTHRAX FAV077) was given 10/21/2003 with complaints 24-48 hours later of diffuse headache (5-6/10) and on sides of chest itching/red spots again resolving with TYLENOL and something for itching; and AVA vaccine #3 (BIOTHRAX FAV079) given 11/7/2003 with severe headache to left temporal side of head shooting into the back of his head (8-9/10) lasting for 2 days resolving with TYLENOL use. He denied any systemic reactions such as phonophobia, photophobia, nausea, vomiting, dizziness or neuro deficits with all headache episodes. He also complained of "red itchy skin" day 2 after AVA #3 vaccine lasting for 10-14 days. He denied any new detergents, deodorants, clothing, travel, food groups, medications, soaps, etc. He reported that he and several others were seen by flight surgeon with similar complaints (headache, itching). While TYLENOL provided effective headache relief, the patient stated that he required its use for about 10 days.
I woke up at 5am and when I sat up, I slumped over. I sat up again, stayed for 30 sec, went to the bathroom and when I came back, I experienced severe dizziness. For the next 4 hours, I couldn't move my head and would get a zing right up the back of my neck. When I tried to sit up again, I got really sick to my stomach. After 8 hours, I started feeling better and was able to sleep on either side, but not on my back. When I was on my back everything would start spinning again. By the afternoon of the next day, I was feeling better, but was afraid to move my head too much because I didn't want everything to start up again, so I went to the doctor. My BP was high, so he had me lay on the table. He turned my head and set it off again, so I was miserable again for the next 10 hours. After that, I felt better and was able to get up and function.
Lymph nodes under her armpit and neck are swollen; Swollen arm; Muscles being tight it could affect the nerves and be causing her pain; Shoulder is swollen and she could feel it was warmer on the left side; It was warmer on the left side; the next day, were very sore and tight/pain radiated down to her elbow and wrist; the next day, were very sore and tight/pain radiated down to her elbow and wrist; her arm started to get "stiff and sore; intense throbbing pain, from her shoulder through her back; felt very fatigued and tired, and she stayed in bed and slept the whole day; felt very fatigued and tired, and she stayed in bed and slept the whole day; Arm started to get "stiff and sore"/her arm and shoulder on the left, the next day, were very sore and tight/pain radiated down to her elbow and wrist; her left arm, where she received the vaccine, "started to get sore; Pain from her left shoulder drop back down into her back and the back of shoulder scapula; neck stiffness; This is a spontaneous report received from a contactable consumer(patient). A 47-year-old female patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 20Apr2021 at17:05 (Lot number: EW0150) into left arm as single dose for COVID-19 immunization. The patient medical history and concomitant were not reported. On 21Apr2021, the patient had experienced that her arm started to get "stiff and sore" and that is was "throbbing" and she was "exhausted. She stayed in bed for a day, went back to work cleaning houses on Thursday 22Apr2021. She reported that the pain radiates from her left shoulder, around to the scapula on her back, then down to her elbow and wrist, and feels like its "pulling" and she "feels like I need to continue to flex my wrist".  Symptoms worsen when she walks, stands, or sits, the only relief she gets is when laying on her back in bed, or in a very specific way on her left side. She reported that symptoms worsened 27Apr2021 and that she's "been in bed since Wednesday" (28Apr2021). On 30Apr2021 the patient had experienced shoulder was swollen and she could feel it was warmer on the left side. On 03May2021, the patient had experienced swollen arm, and the lymph nodes under her armpit and neck are swollen and also experienced with the muscles being tight it could affect the nerves and be causing her pain. Therapeutic measures were taken for the AE and treatment included were Ibuprofen, Acetaminophen, Massage, ice, and heat. The outcome of the events felt very fatigued and tired, and she stayed in bed and slept the whole day was recovered, on unknown date. The outcome of other events was not recovered.  No follow-up attempts are needed. No further information is expected.