chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her face started itching; her face started swelling; her whole neck was all red; her whole neck was swollen; her face is hot; her lymph nodes in both arm swollen; headache; fever; fatigue; chills; pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), FATIGUE (fatigue), CHILLS (chills), LYMPHADENOPATHY (her lymph nodes in both arm swollen) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergy and Sinus operation. Concomitant products included LORATADINE, PREGABALIN and MONTELUKAST for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm). On 15-Feb-2021, the patient experienced FATIGUE (fatigue) and CHILLS (chills). On 16-Feb-2021, the patient experienced LYMPHADENOPATHY (her lymph nodes in both arm swollen), HEADACHE (headache) and PYREXIA (fever). On 20-Feb-2021, the patient experienced PRURITUS (her face started itching), SWELLING FACE (her face started swelling), RASH (her whole neck was all red), SWELLING (her whole neck was swollen) and FEELING HOT (her face is hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 14-Feb-2021, PAIN IN EXTREMITY (pain in the arm) had resolved. On 16-Feb-2021, CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, FATIGUE (fatigue), LYMPHADENOPATHY (her lymph nodes in both arm swollen), HEADACHE (headache), PRURITUS (her face started itching), SWELLING FACE (her face started swelling), RASH (her whole neck was all red), SWELLING (her whole neck was swollen) and FEELING HOT (her face is hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
#1 The injection site was sore, red, and hot to touch, the site then had a large lump under the surface of the skin, then it was black and blue. From start to finish from the redness to the bruising was about 3 days.   #2 Sore throat, followed by hoarseness and then ultimately loosing my voice, body aches, headache, fever and chills with the fever lasting 4 days and ranging from 99.5 to 106.1. Also have had a runny nose, followed by congestion with a course and constant productive cough.   I still have all the symptoms listed above today 02/08/2021 except the fever, chills and body aches.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadedness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Systemic: Weakness-Severe.
doses administered after temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after temperature excursion). On 13-Jun-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after temperature excursion) had resolved. Not Provided      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.   30 Patients were reported as patient identifiers in this case.  No concomitant medications were reported.  No treatment medications were reported.
My daughter received the second shot of GARDASIL, this second time it was GARDASIL 9. Immediately after receiving the shot she fainted and experience stiffness/seizure that lasted 3-5 minutes. She was taken to the ER by ambulance. After 3 hours of observation she was discharged and referred to a neurologist for further examination.
Broke out in shingles two days after injection on right side of waist and abdomen.  Much pain and nausea.  No appetite.  On day #9 today with no sign of let up, although blisters have dried up.
The patient came to the pharmacy today with a sore red arm. She said it started on 06/20/18 that evening and it became progressively worse the last couple of days. She said the site feels hot to the touch and painful. She just puts ice pack on it to relieve the pain. I told her to take some MOTRIN to alleviate some of the pain and to see her doctor.
Sore throat, low grade fever, chills, coughing, body aches, flu sxs (no appetite, tiredness, headache).
p/vax pt devel great swelling from shoulder to elbow, 1wk later pt had swelling from below the elbow to 1/2 down arm toward the wrist;pt could not move or use lt arm for 24hr & it more than doubled in size;could not get out of bed;T100.3
Both of my legs  developed an itchy red rash approx 60 hours after the vaccine.  Hives/bumps and  patchy redness  on both  both calves and thighs.  My neck also feels itchy but not severe and no hives or red itchy rash.  I took two benedryl and used an OTC anti-itch cream  tonight and will see my doctor it it persists.
Swelling, redness from site to elbow same arm. No infection noted from provider. Gave meds only- no more pnemonia shots
This spontaneous report as received from a healthcare professional refers to a patient of unknown age. On 22-OCT-2014 the patient was vaccinated with a dose of expired ZOSTAVAX, dose, route not reported, lot # J008433, expiration date 11-OCT-2014. No adverse effects reported. Additional information has been requested.
Swollen face; It was flushed; It was red; it's hard to tell if there is a rash; The texture of my face doesn't feel good, it doesn't feel smooth; This is a spontaneous report from a non-contactable consumer (patient).   A female patient of unspecified age reported herself who received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 13Mar2021 as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Mar2021, she woke up with swollen face. It was flushed and red and it was hard to tell if there was a rash, the texture of her face doesn't feel good, it doesn't feel smooth, but she doesn't care about that. Patient asking if her face swelled up could her throat close up at a later time. Asking if anyone else who has experienced this symptom had a delayed reaction where their throat closed later. The outcome of the events was reported as unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Severe pain in shoulder, unable to life arm up and in front (cannot brush hair, apply make up, etc).
Patient immediately stated that she was dizzy after receiving vaccine. BP 141/96. She stated that she has anxiety. She sat for 25 and friend drove her home. She was advised to call her primary care doctor if not feeling well and call EMS for an emergency.
This is a spontaneous report from a contactable consumer. A 44-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Oct2021 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 16Oct2021, the patient experienced left arm pain, tired, run down, achy and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events left arm pain, tired, run down, achy and chills was resolving at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.
I broke out with a rash; I felt caught in cold; feet got extremely numb and tingly; feet got extremely numb and tingly; felt like hot and cold on my feet, it felt like cold water going through; I had trouble walking; I felt really strange/ i am not feeling the greatest; Chills; I am not going to get the second shot; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported; Expiration Date: 05Aug2021; NDC number and UPC number: unknown) via an unspecified route of administration on 02Jul2021 (at the age of 63-years-old) in right arm as a single dose for covid-19 immunization. Medical history included autoimmune disorder from an unknown date and unknown if ongoing. The patient takes a lot of unspecified medication. The report was not related to a study or programme. Patient got the shot a week ago and right away shortly she got a reaction. She felt that she caught in cold, felt really strange. They checked her for an hour. When she was walking to car her feet got extremely numb and tingly then she felt like hot and cold on her feet, like cold water going through and then she had trouble walking because of it. She went to the emergency room and then they said its part of the shot. She had not felt like ever since. She experienced chills and broke out with a rash; she was not feeling the greatest and she was not a happy champer. She reported that she will not take the second shot. The patient was treated with antihistamine like Claritin. The outcome of all the events was unknown.  Information about lot/batch number has been requested.
Had weird contractures in hands; shaking chills; fever (up to 101.8); severe joint pain; muscle soreness; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular in the left arm on 14Jan2021 11:00 at a single dose for COVID-19 immunization. The patient has no medical history. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization on an unspecified date. On 14Jan2021 21:00 (reported as after the second dose), the patient developed shaking chills. Shortly after, she started developing fever (up to 101.8) and had weird contractures in hands. She also had severe joint pain. The symptoms lasted for 30 hours. She felt better the next day, just muscle soreness. Treatment was not provided in response to the events. The outcome of the events was recovering. The patient has not tested for COVID post vaccination.   Information on Lot/Batch has been requested.
Evening after receiving MMR: onset of sore throat, nasal and head congestion, joint aches: total body, duration 3 days.
Based on additional information received on 02 Nov 2018, this case considered as valid case from non case. (event updated) Initial information received on 10-Oct-2018 (initial version was non case). Follow up received from nurse on 02 Nov 2018. This case is linked to cases 2018SA284510 and 2018SA284522. This case involves infant male patient for whom vaccines were given before they were known to be inactive due to temperature stability was reported, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 02-Oct-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in the left thigh. It was an actual medication error due to incorrect product storage as vaccine were given before they were known to be inactive due to temperature stability. No adverse event were not 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. List of documents held by sender: none.
Round red rash, itchy, hard, warm to the touch, about 2 inches circumference. Over the course of 4 hours, got more itchy. Went to the doctor, they said take Benadryl. Took 1 Benadryl, itching stopped. The next day, red rash was much improved, not itchy, smaller in size. Each day got smaller.
Information has been received from a physician via a field representative referring to a 14 year old male patient. Information about medical history, concurrent condition and concomitant medication was not reported. On 27-OCT-2015 the patient was vaccinated with GARDASIL 9 (lot # L016429 with unspecified expiration date, one dose/three dose series; strength and dosage unspecified) for HPV prevention. Concomitant medication included unspecified flu vaccination. On the same day, the patient passed out after administration of vaccination but prior to exiting the office. The parent of the patient informed the physician that the patient did not have much to eat and was nervous prior to the administration of the vaccine. The patient recovered while in the office on the same ay and was able to attend school the following day. Additional information has been requested.
patient came to pharmacy 2 days later complaining about fever and night sweats. also complained about rash on right side of arm. site of injection for both vaccines was put in the system as the left arm when patient states he received one shot on each arm. so dont know which vaccine he actually got on right arm that caused reaction
Development of alopecia, leading to hair loss.  First one spot observed, then additional developed about 1 month later).
sick; Initial information received on 30-Nov-2020 regarding an unsolicited valid non-serious case from a patient.   This case involves a patient of unknown demographics who was sick (illness), while the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylaxis vaccination.   On an unknown date, (latency unknown) after the administration of suspect vaccine therapy, the patient got sick (illness) whenever got the shot.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.     There will be no information available on the batch number for this case.
Shortly after receiving my third dose of the vaccine, I started getting big bruises on my arms, legs, and hands. At first I attributed it to rough play with my grand kids. I went for my annual physical with my PCP (who has now retired) where he did a blood test and found that my platelet level was extremely low. It was 33 when the normal range is 150-400. He advised that I immediately see a hematologist. I was able to see one the next day who diagnosed me with CLL (Chronic Lymphocytic Leukemia.) I am currently under treatment for this diagnosis.
Approximately 3-4 hours after receiving the shot I had stiffness and pain in neck , shoulders, upper back and chest. Also started feeling very hot but did not show fever on thermometer. Approximately 4 1/2 hrs after shot I started having a bit of  difficulty  breathing, and my  lungs feel itchy like they do when I?m about to go into an asthma attack.   It?s now approximately 7 1/2 hrs since shot and I still feel the same.    Have taken albuteral inhaler one time when breathing started to feel difficult but the feeling in my lungs did not and still have not changed.
pt placed in walker @ home-mom noted slumped to side, eyes glassy & unresponsive for approx 2 mins, then blinked & laughed & was dazed & tired; 5mins later had a similar spell, resolved again in 2 mins
I have side effects; it was pain in the back of my head closer to the neck behind my right ear; Needle in the right arm; had the needle in the right arm, in the shoulder in the right arm; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101587242 (Pfizer).  A 71-year-old female patient received bnt162b2 (BNT162B2), administration date 28Oct2021 (Lot number: 301258A) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization, reaction(s): "No reaction on previous exposure to vaccine"; Bnt162b2 (2nd Dose), for COVID-19 immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: IMMUNISATION (non-serious) with onset 28Oct2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 15Nov2021, outcome "unknown", described as "I have side effects; it was pain in the back of my head closer to the neck behind my right ear"; PAIN IN EXTREMITY (non-serious) with onset 15Nov2021, outcome "unknown", described as "Needle in the right arm"; ARTHRALGIA (non-serious) with onset 15Nov2021, outcome "unknown", described as "had the needle in the right arm, in the shoulder in the right arm". The events "i have side effects; it was pain in the back of my head closer to the neck behind my right ear", "needle in the right arm" and "had the needle in the right arm, in the shoulder in the right arm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any prior vaccinations. Lab Test: blood work, X-ray and Urine test and that was for rheumatology (Further clarifications unknown). Treatment: Consumer stated that she went to a doctor, and he said use something cold on head that was it (Further not clarified). Vaccination facility was a food store.  Follow-up attempts are completed. No further information is expected.
7/7/06 Right deltoid very red, puffy, hard and hot to touch, reported to MD 7/7/06. Advised to cold compresses x 20 min q 2 hrs. Ibuprofen 400mg q 6 hr 7/11/06 resolved.
Day after having the shot I developed mouth sores, 1 on the right side and bottom of my tongue, and 1 on the bottom of my mouth under my tongue all on the right side, they hurt when I eat and talk mostly.   My left armpit has a tender and sore spot towards the back of my pit. Other symptom I am experiencing is flushed face mainly my upper cheeks are redder in the mornings. These 3 symptoms I have been experiencing for 3 days now. I had the shot on a Thursday and it is now Sunday.
Patient complain of left shoulder pain especially with cross arm over chest movement. 1 week of Naproxen and passive ROM exercises an ultrasound imaging if no improvement.
This spontaneous report was received from a pharmacist via a employee and refers to a female patient of unknown age. Her pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 29-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (exact dose, route of administration, lot # and expiration date were not reported) to prevent a pneumococcal disease. On 30-NOV-2016, she had a reaction. Her arm was red and swollen around the injection site. There was a treatment given for the adverse events. The patient did not seek medical attention. The outcome of the events was reported as recovering. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported.  This is one of several reports received from the same source.; Sender Comments: US-009507513-2306USA011972:
Body Aches- 400mg ibprofen taken 20 hours after vaccine Fatigue- went to bed early on following day Pain at injection site- refer to treatment for body aches.  Pain persists 45 hours later.