chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complains of having metallic taste for 3-4 days following first dose of Pfizer Covid-19 vaccine.
Client administered 2nd dose of Moderna at age 17 because 1st dose already given & as per CDC guidance, the 2nd dose can be administered.
1) 4 hours after vaccination,  Lips, cheek mouth area swollen. Hives all over body developed next day.  Went to urgent care day after vaccination for benadryl shot.  Facial swelling is gone.  However, sporadic minor hives occurring ongoing.  2)  Joint, Muscle, Jaw, Pain ongoing  3)  Numbness on side of face, hips, thigh, gluts, and legs, developed on 16th Sunday morning 6 days after vaccination.  Ongoing currently.
My left arm is pretty much useless since the 1st covid shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 24Apr2021, outcome "not recovered", described as "My left arm is pretty much useless since the 1st covid shot". The reporter left arm was pretty much useless since the 1st covid shot. The left Delta was all but wasted away in attribute. The reporter stated, the patient had vaccine dates for 24Apr and May 11th roughly patient thought.  The lot number for bnt162b2 was not provided and will be requested during follow up.
TWO COVIDS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced two covids. Treatment medications (dates unspecified) included: hydroxychloroquine and ivermectin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two covids was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000247860.
On 03/11/2001, the patient developed chickenpox that was noted to be a "really bad case of it". The patient had between 100 and 200 pox marks that are all over his body, even his mouth and throat. It was reported that the patient went to a rollerskating party and several of the children subsequently broke out with the chickenpox. It was noted on 03/15/2001 the patient was still breaking out with the chickenpox. The patient sought unspecified medical attention. Additional information has been requested.
Vaccine expired on 01-Apr-2022 and date moved to refrigeration on 04-Apr-2022; Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and date moved to refrigeration on 04-Apr-2022) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and date moved to refrigeration on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients/ 80 Patients received expired moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and date moved to refrigeration on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 04-Apr-2022.   The vial did not underwent any temperature excursion.   The pharmacist reported that he thought that the vaccine expired in June 2022 however the vaccine expired on 01-Apr-2022.   No concomitant medication were reported.   No treatment drug were reported.
was fully vaccinated against shingles 2 years ago and came down with shingles five days ago; came down with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included covid-19 (came down with covid 3 weeks before the day of reporting in August 2021). Previously administered products included COVID 19 VACCINE MODERNA (was fully vaccinated with COVID 19 VACCINE MODERNA in March 2021).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On 5th September 2021, between 1 and 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was fully vaccinated against shingles 2 years ago and came down with shingles five days before the day of reporting. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles was unknown at the time of reporting.
High fever 102 and hives. Seen at ER/ Antelope Valley Hospital . Medication: Benadryl, Motrin and Tylenol.
a 10 mo old infant recvd HIBV B on 21nov90;at time of vax there were no adverse exps;
BODY ACHE; NAUSEA; TIRED; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, nausea, tired, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from body ache, nausea, tired, fever, and headache. This report was non-serious.
This spontaneous report as received from a physician refers to an unspecified number of patients. The patients concurrent conditions and medical history were not reported. On an unspecified dates, an unspecified number of patients received an improperly stored dose of M-M-R II (dose, route of administration, lot number and expiration date were not reported). No concomitant medications were reported. No adverse effect was reported. No further details were provided. This is one of two reports received from the same reporter. Additional information has been requested.
progressively worsening symptoms of COPD; A spontaneous report was received from a consumer who was also a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced progressively worsening symptoms of chronic obstructive pulmonary disease (COPD)/COPD exacerbation.  The patient's medical history included COPD, which the patient admitted was worsening before the vaccine. Relevant concomitant medications included simvastatin, lisinopril, and allopurinol.  On 04 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 11 Feb 2021, the patient was hospitalized for progressively worsening symptoms of his COPD.    Treatment included a prednisone injection in the hospital and prednisone 60 mg orally after discharge from the hospital (date unknown) for more than a week.    Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event progressively worsening symptoms of COPD was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
This case was reported by a nurse via call center representative and described the occurrence of passed out in a 22-year-old male patient who received HAVRIX (batch number TB995, expiry date 25th October 2020). On 20th April 2018, the patient received the 1st dose of HAVRIX 1 ml. On 20th April 2018, less than a minute after receiving HAVRIX, the patient experienced passed out (serious criteria GSK medically significant), disorientation and dizziness. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the passed out, disorientation and dizziness were recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the passed out, disorientation and dizziness to be related to HAVRIX. Additional details were provided as follows: This case was associated with pharmaceutical product complaint. At 3:15 pm, the patient received HAVRIX in left deltoid. The nurse reported that the patient was scared to get the HAVRIX vaccine and within a few seconds of the vaccination, the patient felt dizzy and passed out. This lasted for a couple of seconds and then resolved. the patient was out cold and was slightly disoriented after passing out but resolved quickly. The reporter insisted that the adverse event experienced was related to the lot of the HAVRIX product and insisted that a quality assurance (QA) report be filed.
p/vax pt exp extreme muscle pain & unable to move rt arm; then devel T99.5; inj site rxn of red; itchy; streaky rash & edema from shoulder to elbow; tx APAP; DPH; & ice; then devel spider-like rash on rt arm
With the first dose about 12 hours later I experienced some numbness of my face.  The next day I had a  measles-like rash which went away in a few hours. Pain in my arm went away in 2 days.  With the second dose on the third day after the injection I developed severe itching and noticed a red spreading rash in the area of the injection, just a little below the injection site.  This is very red, sore and feels somewhat warm to the touch.  The area is about 5 inches in size and is still painful.  I have also noticed some shortness of breath but minor.   Some numbness and itching around my face.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. No treatment information was reported.   This case was linked to MOD-2021-395985.
sore arm/really sore; chills; nausea; horrible headache; whole body hurting; high temperature (100.9 was the highest; sweating; strong reaction; really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/really sore), CHILLS (chills), NAUSEA (nausea), HEADACHE (horrible headache) and PAIN (whole body hurting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031C20A and 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included TRAMADOL, ESTRADIOL, PANTOPRAZOLE, LEVOCETIRIZINE, MONTELUKAST, POTASSIUM, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm/really sore), CHILLS (chills), NAUSEA (nausea), HEADACHE (horrible headache), PAIN (whole body hurting), PYREXIA (high temperature (100.9 was the highest), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (strong reaction) and PAIN (really sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm/really sore), CHILLS (chills), NAUSEA (nausea), HEADACHE (horrible headache), PAIN (whole body hurting), PYREXIA (high temperature (100.9 was the highest), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (strong reaction) and PAIN (really sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.9 100.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-039239 (Patient Link).
Dad stated that immediately after the PENTACEL shot, child had 3 raised scratch areas. Then received PREVNAR. Developed erythema multiforme 3/24/2009 and seen 6/25/09 in office. 6/28/09 rash gone after BENADRYL.
Something triggered Myasthenia gravis; Also known as a snowflake condition; Autoimmune issue. It can affect speech, breathing, swallowing, chewing; I had a sagging face. The symptoms was like I was getting a stroke.
Extreme vertigo requiring ambulance transport and 2.5 day staying in hospital, Still suffering dizziness/imbalance through 03-01-2021 but improving. Also, experienced intermittent fatigue but improving as well.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 50 year old male. Initial information was processed with additional information received on 10-JUN-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202821A, expiry: UNKNOWN) frequency 1 total, dose was not reported, administered to right deltoid on 08-APR-2021 13:00 for prophylactic vaccination. Concomitant medications included guselkumab.  Consumer called to report that he had an antibody test for 2 types of antibodies (he did not remember the type of test) on 07-JUN-2021. His Doctor called him on 08-JUN-2021, to tell him that the test results were negative for both (coded as confirmed immunological vaccine failure). He was extremely agitated and did not want to answer questions. Patient was on Tremfya and had been for about 1 year. Patient did yell and cuss before he disconnected the call. On 07-JUN-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) negative for both.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000182258 The suspected product quality complaint has been confirmed to be not voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210616652- covid-19 vaccine ad26.cov2.s- confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
did not use the supplied 0.4% Sodium Chloride diluent that was in the box; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA186114 and 2019SA188132 (same reporter).  This case involves a 19 months old male patient who was vaccinated with a 0.5 ml dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot U1919AA and Exp. Date 04-Jun-2019) via intramuscular route in the right thigh (reported as right leg) on an unknown date of March or April 2019.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was an actual medication error case due to wrong solution used in drug reconstitution. It was reported that, Act-HIB is mixed with a sterile diluent instead of the supplied 0.4% Sodium Chloride diluent that was in the box.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Arm had been itching since the vaccination, but last last night the itching was so bad it woke me up. When I looked at it it was very red and swollen, about 2 1/2" round, very hard, and hot to the touch. It appears to be lower than the injection site, but I can't be sure. I put cortisone cream on which helped a little. I don't feel it's necessary to go to a doctor, as I'm hoping it just goes away in a few days.
For about 12 hours he itched all over.  When he got up in the morning his shoulders and ankles also ached.   When he moved around the muscle discomfort was relieved, but would come back when he was not moving his joints.    Around 10 AM, he sat in a hot tub about 45 minutes, then applied body lotion and was relieved.  Neither the itch or muscle aches returned.
Information has been received from a registered nurse concerning a 25 week old infant who was vaccinated on 10-OCT-2007 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint was involved. Additional information is not expected.
Pt passed out within 10 seconds of receiving shots. Regained consciousness with 5-10 seconds. Pt said she hadn't eaten since 9:30am. (shots given @ 2 pm approx.). Felt fine after eating some crackers, BP & pulse normal.
pt recv vax & exp an atypical febrile sz; No further details were provided;
Received 1st SHINGRIX 50 MCG 7/18/2018 about 9:30 AM. By that evening, noticed muscle aches, then chills and extreme fatigue. Then experienced extreme anorexia which lasted for 3 days. Barely able to force down water. Mild diarrhea. Metallic taste in mouth. Gradually recovered 7/21-7/23.
encephalitis/short term memory difficulty multiple lesions on mri treated with iv steroids 12/2/05 Per review of medical records the following additional symptoms were noted: distorted vision, confusion, loss of balance, falls, unusual smells, "roaring" in ears, increased urinary frequency, and weakness L leg. 12/22/05 Review of medical record indicates stroke in occipital lobe and ataxia.  Follow-up: 12/02/2005 - VERBAL REPORT FROM REPORTER: Date of admission was 11/22/05. Pt. likely to be discharged today or tomorrow. Final diagnosis is ADEM s/p influenza vaccine. Additional symptoms not mentioned on original VAERS report include left-sided weakness, gait disturbance. While in hospital the patient has exhibited intermittent sundowning. 12-2-05 Verbal report from vaccine provider: Lot # not recorded. Syncope and dizziness do not appear to be pre-existing to receipt of flu vaccine. Apparently patient had not had any previous flu vaccines.
Patient  is experiencing rash on chest, abdomen, inside of forearms and tingling feeling on feet, calves, hands, and forearms
Incorrect age group--patient received Moderna at age 16 on 3/8/21.  Second dose Moderna given 4/6/21 in accordance with CDC guidance.  No AE.
I am a 76 year old female who got a high dose flu shot on 10/15/18 and on 10/20/18 I got a very painful case of shingles. I believe that the flu shot challenged my immune system so much that it weakened it and allowed the shingles to erupt.
The injection was very painful & was given higher up on my shoulder than previous flu shots. As the vaccine was injected, the pain was very intense along with a horrible aching feeling. As the time went on, I was unable to lift my left arm above my head. As I documented in the attached form, the pain in my shoulder became progressively worse to the point of being unable to elevate my arm above my head; or to raise my arm up to put on a pullover sweater; difficulty in shampooing and combing hair; difficulty sleeping; lifting and various other tasks were very painful. 11/03/11: Appt. with Dr., an Orthopedic Surgeon X-Ray of shoulder/evaluation/treatment. 12/20/11: Follow-up appt. with Dr. (at this time, he referred me to a physical therapist). Treatment Goals: *Improve Range of Motion *Improve Strength *Decrease Swelling *Decrease Pain *Improve Endurance/Conditioning *Home Exercise Program. 12/22/11: Appt. with Dr. to document what happened with my shoulder after receiving the flu shot. 12/29/11: Bones Physical Therapy (6-weeks of treatment). 3/05/12: Bones Physical Therapy (additional 4-weeks of treatment). 3/27/12: Dr.: At this time he gave me a Cortisone Injection. 4/02/12: As of this date, I have not returned to the pre-vaccination state of health. I still have pain in my shoulder and am limited as to how I can use my arm. I am still unable to perform certain tasks that I was previously able to do. I have more detailed information if needed.