chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel a bit itchy.; red bumps appearing on her legs/spread to her arms, body and back/look like a latent case of chicken pox; red bumps; red; This case was reported by a consumer via sales rep and described the occurrence of itchy rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox at the age of 5 years). Previously administered products included Shingrix (did not have this reaction with the first dose of shingrix).   On 29th January 2020, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, couple of weeks after receiving Shingrix, the patient experienced itchy rash, varicella-like rash, papular rash and red rash. On an unknown date, the outcome of the itchy rash, varicella-like rash, papular rash and red rash were unknown.   It was unknown if the reporter considered the itchy rash, varicella-like rash, papular rash and red rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by the relative of the patient. Couple of weeks later the patient noticed red bumps appearing on her legs. Assuming it might be insect bites she tried to ignore them.  It started to spread to her arms, body and back. The red bumps she said look like a latent case of chicken pox even though she had chicken pox at the age of 5 years. The bumps do not hurt or itch except the ones that are drying feel a bit itchy.
Information has been received from a physician concerning a 15 year old female patient who on an unspecified date was vaccinated with an unspecified dose of GARDASIL (lot number or expiration date not provided). In "2009" the patient had fainting when getting the vaccine. No medical attention was sought. At the time of the report, the patient was recovering. Additional information has been requested.
Could not lift right arm and pain; A ball under arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift right arm and pain) and LOCALISED INFECTION (A ball under arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift right arm and pain) and LOCALISED INFECTION (A ball under arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift right arm and pain) and LOCALISED INFECTION (A ball under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Astrazeneca COVID-19 Vaccine (Both Dose 1 and Dose 2 was from  Astrazeneca). Past adverse reactions to the above products included No adverse event with Astrazeneca COVID-19 Vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) had not resolved.      After 48 hours, patient still have fever. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter
30 minutes after Pneumovax was given in right deltoid and flu vaccine was given in forearm, she had swelling and redness in the forearm injection site. She felt all right. Ten to 12 hours later, she had dry heaves and intermittent chest pain. No shortness of breath. Did have chills. Hardness and redness at injection sites persisted as of the next day. We had given 1/2 dose of flu shot IM on advice from her allergist.
Patient suffered a anaphylactic reaction to the COVID vaccine. 15 minutes having receiving the vaccine, she began to have  Aa headache and feeling lightheaded and found it difficult to swallow. Taken to the ED where she was given prednisone, Epi Pen and benadryl.
Initially I developed dry cough, followed on subsequent days by diarrhea, generalized aches and fatigue, and finally dyspnea on exertion which became severe within 24 hours.  There was no fever, and pulse oximetry on room air was greater than 90%.
Information has been received from a medical assistant concerning a female who fainted after receiving a dose of GARDASIL sometime last year in 2008. The patient had sought medical attention, in the office. At the time of report the patient's status was unknown. This is one of several reports from the same source. No further information is available.
Sore muscles, especially legs; headache; extreme tiredness; labored breathing; runny nose.
This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-JUN-2015, the patient was vaccinated with a dose of GARDASIL lot # K011325 with expiration date: 08-APR-2017 (dose and route of administration were not reported). On 04-JUN-2015, the patient received a dose of GARDASIL 9 lot# L013429 with expiration date: 21-JUL-2017 (dose and route of administration were not reported) and on 28-MAR-2016, the patient received another dose of GARDASIL 9 lot# L037339 with expiration date: 09-FEB-2018 (dose and route of administration were not reported). There were no adverse effects reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
My daughter has had several odd and unusual health issues since having these vaccinations. She was an otherwise healthy and happy child prior to this. She has had a complete turn around in personality and numerous health issues of unknown origin. I can only attribute many of these to this vaccine.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, (Oka-Merck) PROQUAD underwent a temperature excursions. On 26-AUG-2014, the patient was vaccinated with (Oka-Merck) PROQUAD, 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report from the same source. Additional information has been requested.
General malaise starting 2 days post vaccination. Inability to stay warm. Chills. Pain medicines for fibromyalgia (hydrocodone) help for 4 hours.
Pain upon injection followed by immedate bubble-like swelling of site. Site became swollen with a diameter of approximately 1-2 inches and protruding from the body approximately 0.25 inches.
Bilateral  8 toes, except big toe is bluish red; Bilateral 8 toes, except big toe is/swollen; Bilateral 8 toes, except big toe is/burning feeling; Bilateral 8 toes, except big toe is/painful; Looks like Raynaud's phenomenon.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FH8030) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VIT B12; ADVIL. Past drug history included: Metoclopramide, reaction(s): "known allergies: Metoclopramide", notes: known allergies: Metoclopramide. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left), administration date: 03May2021, when the patient was 50 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 12Apr2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: NAIL DISCOLOURATION (non-serious) with onset Dec2021, outcome "recovering", described as "Bilateral  8 toes, except big toe is bluish red"; SWELLING (non-serious) with onset Dec2021, outcome "recovering", described as "Bilateral 8 toes, except big toe is/swollen"; BURNING SENSATION (non-serious) with onset Dec2021, outcome "recovering", described as "Bilateral 8 toes, except big toe is/burning feeling"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "recovering", described as "Bilateral 8 toes, except big toe is/painful"; RAYNAUD'S PHENOMENON (non-serious) with onset Dec2021, outcome "recovering", described as "Looks like Raynaud's phenomenon.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nail discolouration, swelling, burning sensation, pain in extremity, raynaud's phenomenon.  Additional information: It was reported that she had bilateral 8 toes, except big toe is bluish red, swollen, burning feeling and painful looks like Raynauds Phenomenon. No other vaccine in four weeks. other medications in two weeks included Vit B12, Advil as needed. No covid prior vaccination, she had covid tested post vaccination. AE treatment included Advil and Atenolol. No other medical history and no hospitalization prolonged.  No follow-up attempts are possible. No further information is expected.
This case was reported by a physician via call center representative and described the occurrence of fever in a 37-year-old male patient who received SHINGRIX. On 22nd May 2018, the patient received SHINGRIX. On 22nd May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, inappropriate age at vaccine administration and wrong vaccine administered. On 23rd May 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: On 22nd May 2018, the patient went to a pharmacy to receive the Varicella vaccine. On 29th May 2018, the patient received the Hepatitis A vaccine. The paperwork was faxed to the reporter and the reporter discovered that, on 22nd May 2018, the patient was administered a dose of SHINGRIX vaccine instead of the Varicella vaccine which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter stated that, the patient tolerated the vaccine well except that, he had a fever on the same day which resolved the following day after receiving SHINGRIX. The reporter could not see the lot number or expiry date on the paperwork which was faxed to him because, it was hard to read.
a bump appeared at the injection site that is tender to the touch; Information has been received from a female pharmacist (who is also the patient) of unknown age via a company representative referring to herself. Information about concurrent condition, concomitant medication and drug reactions/allergies was not provided.  On 17-JUN-2019, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, lot# and expiration date were not reported) for prophylaxis.   The reporter reported that on an unknown date in June 2019, an unspecified amount of time after receiving the first dose of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), a bump appeared at the injection site that is tender to the touch (Injection site mass). She also stated this has happened before with other vaccines. No treatment was given. Information about lab diagnostics/studies and medical attention was unknown by the reporter.  The outcome of the event was reported as recovering. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
first dose of vaccine in 2019, never went back for my second due to COVID; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in fall of 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient never received 2nd dose of Shingrix due to covid outbreak The parent asked, did he/she need to start over with the 2 doses regimen or should just get 2nd dose.
Stiff-Person Syndrome attack more often but on a very irregular pattern; This spontaneous case was reported by a consumer and describes the occurrence of STIFF PERSON SYNDROME (Stiff-Person Syndrome attack more often but on a very irregular pattern) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Stiff person syndrome.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced STIFF PERSON SYNDROME (Stiff-Person Syndrome attack more often but on a very irregular pattern) (seriousness criterion medically significant). At the time of the report, STIFF PERSON SYNDROME (Stiff-Person Syndrome attack more often but on a very irregular pattern) outcome was unknown.            Patient had Stiff-Person Syndrome before vaccinated it was controllable and attacks was on regular basis but after getting the first dose then the second dose it attack more often but on a very irregular pattern Concomitant product use was not provided. Treatment information was not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient reported the existence of the stiff person syndrome from already before receiving the first dose of vaccination. However, following both vaccinations, the syndrome worsened.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient reported the existence of the stiff person syndrome from already before receiving the first dose of vaccination. However, following both vaccinations, the syndrome worsened.
Accidentally given 1 mL instead of the 0.5mL dose; A spontaneous report was received from a physician concerning themselves, a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced receiving double the normal dose (1 mL instead of 0.5 mL) [Accidental overdose].    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29-Dec-2020,  the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   The patient was reported to be one of four individuals who were accidentally given 1 mL of the vaccine instead of the recommended 0.5 mL dose. The patient did not experience any adverse effects.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who accidentally received double the normal dose of mRNA-1273 vaccine during administration of their first dose.; Sender's Comments:  :Master case - linked case numbers pending
At 16:01, patient was given ProQuad and Kinrix.  At 16:03, myself (resident physician) and Dr. (attending physician) were notified that the patient was having an allergic reaction to the vaccines.  The patient developed itching of the lateral face on both sides with urticaria.  She denied shortness of breath, nausea, wheezing, vomiting, lightheadedness, or other symptoms.  She was given diphenhydramine 20 mg PO (1 mg/kg) and had no further development of symptoms and no new symptoms.  She was observed until 16:31, after which time she was allowed to go home.  The urticaria had improved at the time of discharge from the clinic but had not resolved.  Diphenhydramine prescribed for PRN use at home for itching.
Aching going from my neck to the back of my head; It's not really bad, but it's like aching; Aching going from my neck to the back of my head; It's not really bad, but it's like aching; This is a spontaneous report received from a contactable consumer (patient).   A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0185, NDC Number: Unknown, Expiry Date: Unknown), via an unspecified route of administration on 22May2021 as 1ST dose single, for COVID-19 immunization. The patient has medical history with Allergy and Heartburn from an unspecified date. Concomitant medications included Omeprazole for Heartburn and Cetirizine HCL for Allergy form an unspecified date and unknown if ongoing. Patient reported that, got the first dose of the Pfizer Covid-19 vaccine yesterday, 22May2021. This morning she got a dull ache from the neck to the back of the head on the left side, the same side that the vaccine was administered. she stated that, aching going from my neck to the back of my head; It's not really bad, but it's like aching. Patient reported that, she has bloodwork couple of months ago on an unknown date (Vitamin D deficiency). Everything was okay except for Vitamin D, so she was taking Vitamin D supplements. Patient did not receive any treatment for the event she reported that, she hasn't. she was trying not to, to see what the side effects are though. Outcome of the events were unknown.  Follow up attempts are needed. Further information has been requested.
Initial misuse report received from a healthcare professional on 19 June 2013. It was reported that one vial of ActHIB which was not reconstituted was found in the PENTACEL box, so a patient received only DTaP-IPV portion from PENTACEL vaccine. No information was provided regarding the patinet. No adverse event was reported. List of documents held by sender: none.
injection site was swollen up, big, red; chills; diarrhea; joint and muscle pain; Joint pain; arm was sore; A spontaneous report was received from a consumer concerning a 40 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  first dose on 05-01-2021 in right arm (intramuscularly).  on 5-012021 injection site was swollen up became big and red.   on 7-01-2021 patient experienced the following events which are chills, diarrhea, joint and muscle pain..  The patient's had Covid-19 on june month as medical history. No relevant concomitant medications were reported.    On 18/Jan/2021, the patient experienced events pain at her injection site for 2 days, had congestion, headache, nausea, fever, body aches and no apetite.
Started with a sore throat and slight headache within 2 hours after shot, went away within the day. Cough started by 7 pm the same night with slight asthma symptoms. Woke up at 7 am with an asthma attack. Tried treating it with my inhaler - it was ineffective. By 8:30 went to urgent care for an asthma attack. Nebulizer helped. Needed my inhaler each day for almost a week (Saturday 9.19 was last inhaler use) due to tightness in chest and difficulty breathing. Only needed to take 1 day off work but was unable to fully do physical therapy or my usual work outs during that time.   I don't know if this is related but I started having diarrhea Sunday 9.20 that is still ongoing. Went to a different dr Wed (9.22) for that an abdominal pain. Diagnosed with diverticulitis and put on antibiotics.  Will get a CT scan of abdomin on Monday. Also have a dr's appt on Saturday to check up on my asthma.
Pt. received vaccine 3-15-13, returned to Health Center 3/21/13 stating injection site remains sore to touch. States soreness has improved but persists. Injection site with mild pink color approximately 1.5 cm diameter. She worked out/exercised either the day of the vaccine or day after - she cant not remember which. No swelling or drainage of the area. She did not apply ice to the site originally, did not take pain relievers, and did not seek medical care.
Severe head ache in the sides of my head and behind my eyes.  After 24 hours the headache is still very very intense. Tylenol didn't help, neither summatriptan, my usual medicine for migraines.
After giving pt her vaccine, I had her fill out a teen questionnaire & I noticed her face expressions changed. I asked her if she was okay? She mentioned her head hurt & she was feeling nausea. I gave pt water & had her lay down & took 2 sets of BP. Pt. waited x 20 minutes. Dr okayed for them to leave.
fatigued; Very little energy; colitis; Stomach issues; My bowel movements now have a gel layer on it.; Blood in my stool; This is a spontaneous report from a contactable consumer reported for herself. This 51-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 29Apr2021 16:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. Patient was not pregnant.  Medical history included arthritis. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); levothyroxine (LEVOTHYROXINE); hydrocodone bitartrate, paracetamol (NORCO); morphine sulfate (MS CONTIN).  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 at age of 50 years old on 22Mar2021 04:45 PM in left arm for COVID-19 Immunization, and experienced fatigued/tired, fall asleep.  In 2021, after the second shot patient still had days she got very fatigued and had very little energy.  Also, suddenly had some type of colitis that she had never had.  She had to be careful on what she eat or feel sick.  She ended up with blood in stool.  She was awaiting a colonoscopy but continual had stomach issues.  Her bowel movements now have a gel layer on it. Events resulted in Emergency room/department or urgent care, and patient was hospitalized for 3 days. Treatment included a diet of just liquids and worked up to solids. The outcome of events was not recovered.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   Information on lot /batch number has been requested.