chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Has not received second shot; A spontaneous report was received from a 59-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced has not received second shot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient had not received the second shot yet.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event has not received second shot was unknown.  The reporter did not provide the assessment for the event, has not received second shot.; Reporter's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.
Legs were swollen; had swollen legs like edema; I had a rapid heart rate/Quick heart rate like my pulse, it's not that high but for me it was high it was like 112, 115 as my resting heart rate, it's just been having like heart palpitations; I had a rapid heart rate/Quick heart rate like my pulse, it's not that high but for me it was high it was like 112, 115 as my resting heart rate, it's just been having like heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, expiration date: Mar2021), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. Medical history included patient had sort of allergic reaction not to a vaccine but 'a bad reaction'. There were no concomitant medications. The patient received COVID Vaccine on 18Dec2020 and ended up on Christmas she went to take a bath that was on 24Dec2020 or 25Dec2020 and noticed that her legs were all swollen and she was not used to that at all having swollen legs. She did work on her feet but she wasn't working on her feet for that week, so she just didn't know what was causing the swelling and within the last couple of days in Dec2020 she had a quick heart rate like her pulse, it's not that high but for she it was high it was like 112, 115 as her resting heart rate, so it's just been having like heart palpitations kind of, she just wanted to report that and kind of see if other people were getting that as a symptom possibly from vaccine. She had in her past had sort of allergic reaction not to a vaccine but 'a bad reaction'. She had swollen legs like edema, so she was just hoping. And then the patient stated that she wasn't tired at the starting, so she wasn't tired the same day' (could not be clarified further). No treatment was received for all events. The outcome of the events was unknown.
Bright red itchy rash; Bright red itchy rash; Bright red itchy rash, resembling a sunburn; Other side effects: fever started Sat. night ended Tues. highest temperature 102.9; dizziness; weakness; headache; fatigue; body aches; This is a spontaneous report from a contactable consumer (patient) reported that a 53-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: fc3182), dose 1 via an unspecified route of administration, administered in Arm Left on 21Aug2021 14:45 (at the of 53 years old) as dose 1, single for covid-19 immunisation. Medical history included Ehlers Danlos and Dysautonomia, penicillin allergy. The patient Known allergy Penicillin: rash, hives. The patient previously took anaprox and experienced hypersensitivity. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Facility type vaccine: Pharmacy or Drug Store and facility country in US. Prior to vaccination patient had COVID-19. Post vaccination, the patient had not been tested for COVID-19. No treatment was received in response to the adverse events. On 21Aug2021, the patient experienced bright red itchy rash, resembling a sunburn, other side effects: fever started sat. night ended tues. highest temperature 102.9, dizziness, weakness, headache, fatigue and body aches. The patient underwent lab tests and procedures which included body temperature: 102.9 fahrenheit on an 21Aug2021. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Patient  experienced sign and symptom of Syncope 5 minutes after receiving the COVID -19 booster dose. Patient recovered immediately. I checked for any injure, non to found. I observed the patient for additional 30 munities. Patient were alert and responsive for all the questions.
Pt had immunization of varicella 3/28/05 rash appeared 4/4/05, no fevers or SOB. Dr called. could give 2mg steroids. But could effect efficacy of varicella. Decided to watch child, if worsens would administer steroids, child ok. did not worsen, child recovered. No steroids administered.
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. No Medical History information was reported.On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant information was not provided. Treatment information was not provided.This case was linked to MOD-2021-408551 (Patient Link).
5/1/2021 Drainage and weird taste in back of mouth 11:30a Slight redness left thigh warm to touch 12:30-1:15p Fatigue 12:30-current Nausea 12:30-current  Headache 3:15-current Diarrhea 4:30-current Sore arm 8p-current General malaise, especially if standing up 9:30p-current Face pressure 11:30p-11:35p  5/2/2021 Shakes 5a-7a Chest pains 8a-current, intermittently  Anal bleeding 2p, every bowel movement since, bright reed blood in toilet and on paper  Lightheaded and faint called EMS Blood pressure 155/94 3p, they suggested to follow up with my PCP in AM  Anal bleeding 5:30p Red streak R arm near injection site 6:15p-6:45p Red dots on L knee 6:15p-current (not itchy)  Started period/spotting 1st one since conceiving last year. I am 12 weeks postpartum and exclusively breastfeeding. (light brown not heavy) 9:30p (with prior two children J did not start my period until babies were about one year old and weaning from breastfeeding)
This spontaneous report was received from a physician refers to a female patient of unknown age. The patient had no pertinent medical history. It was unspecified if patient had drug reactions or allergies. on 28-MAY-2013, the patient was vaccinated with 0.5ml of third dose of VARIVAX (Merck), (lot number, expiry date was not reported and route was subcutaneous). There were no concomitant medications reported. The patient had VARIVAX (Merck), series as a kid on unspecified date. The patient had titers done for admission to a university and her varicella titer came out as equivocal about a month ago. No adverse effects were reported. The patient sought medical attention. Additional information is not expected.
1 of 8 adults vaxed from the same lot# but 3 different vials who exp an adverse event;pt felt listless (low energy level); but did not exp flu like sxs as the other 7 pts;documented viral outbreak in area also
Moderna COVID-19 Vaccine  Facial numbness around cheek area and tingling in lips and tongue within 15 mins of receiving injection.
caller stated the pt had some swelling in the right arm the day of the vax and has been really cold at night.   Three days later he developed extreme swelling in his right breast.  Caller states he looks like he has had a breast implanted.  Pt has not contacted his PCP regarding his symptoms since the swelling seems to be better today.
typical reported symptoms that mimic COVID; I went into a-fib; itchy inner arm; This is a spontaneous report from a contactable other HCP (healthcare professional/patient). A 67-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. It was reported that the patient had no known diseases or conditions. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") were reported as no. It was reported that the patient was not on any medications prior to the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EL9266) via an unspecified route of administration in the right arm on 03Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation and experienced sore arm. On 25Mar2021 at 08:45 the patient experienced I went into a-fib and itchy inner arm and on an unspecified date the patient experienced typical reported symptoms that mimic COVID. The clinical course was reported as follows "I had just sore arm after shot 1, but after shot 2 I went into a-fib. I also had the typical reported symptoms that mimic COVID and itchy inner arm." The adverse events I went into a-fib and itchy inner arm resulted in a physician office visit and the event I went into a-fib required treatment with blood thinner and calcium blocker. The patient was tested for COVID-19 post vaccination on 07Apr2021 with a nasal swab which was negative. The clinical outcomes of the events I went into a-fib and itchy inner arm were not recovered/not resolved and the clinical outcome of typical reported symptoms that mimic COVID were unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Atrial fibrillation cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Systemic: Vomiting-Mild
Intense headache within 1 hour of vaccine, followed by dizziness and severe nausea.  Tried to rest, but woke up shortly after with widespread muscle contractions, pain, and cramping.  Headache was worse.  Eyes were tearing uncontrollably.  Fever measured 105.2 by forehead reading. Started to increase fluid intake and took aspirin for fever reduction at the advice of one of my doctors.  Terrible fatigue and weakness followed.  Unable to sleep since right after vaccination.  Unable to tolerate solid food.  Unable to sit upright in bed without fever spiking. Fever remaining between 102-103 with aspirin and cool compresses. Continued muscle cramps all over body.  Headache resolving, but scalp tenderness remains. Changes in vision also.
On 4/25/00, the pt developed a chicken pox rash appearance over arms, legs, trunk and face for 2 days. Mother states mild fever.
Patient experienced redness around the area and this started to swell up after several hours of the vaccination administration. Patient stated this was very painful and seemed to enlarge through the night. Patient put ice on to help the pain. Patient came to notify pharmacist the next day right away at 9am. Blistering had formed around the area. Patient mentioned experiencing numbness in the arm with the Prevnar13 which lasted for several months after vaccination in 2018. Patient is going to speak with primary care physician on reaction.
8/31/21 before dinner time, started minor lower back pain. 9/1/21 lower back pain disappeared, but left arm started muscle pain. 9/2/21 left arm muscle pain continued and couldn't move left arm. 9/3/21 got up at 7am and felt sick after slet for 8+ hours. Had one tab Tylenol at breakfast and strated feeling weak before finishing breakfast. Laid on couch to rest and started severe cold sweating, too weak to move my body, but the brain is racing with many thoughts, including calling 911 and getting up to get a towel for the sweat. Unfortunately, I couldn't move, and then I passed out, approximately 8-9am. I got up at 9 and went to bathroom after a phone call. Had diarhea twice. I felt better around 10am.
Patient recieved SPX vaccination on 01/08/2014 after a negative pregnancy test. On 02/03/2014 patient found out that she was pregnant which was confirmed by another pregnancy test.
Patient told me she was beginning to not feel well and then fainted while sitting in the chair. She was non responsive for approx. 1 minute then woke up. I held her in the chair while she was unresponsive. After she woke up, we had her lay flat and observed her until she felt better. Dad was present at this time.
I am on day 3 and still have a 101.6 degree fever, and arm is very sore. Body aches, chills, and fatigue.
Since my vaccine, more symptoms grew as the weeks went on. I developed severe itchiness all over my body within a day and a half of the vaccine, mostly in my upper body, face, chest, arms and torso, in addition to legs, but stronger itchiness in upper portion. From the 2nd day on after the vaccine, I have experienced severe fog brain, at least 2 to 3 times a week, at times interfering with my job duties. The brain fogginess has caused me to forget my schedule, go to the wrong rooms, and confuse many things. Last week, I experienced very bad pain along my body and was not able to stand up straight. Now beginning from last Wednesday or so, I began to develop joint pain, some swollen joints, and sharp shooting pains along my joints, down my legs, arms, and fingers. I have not had any of these symptoms at all before the vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a adult female patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult and ENGERIX B adult. On an unknown date, the patient received the 1st dose of ENGERIX B adult, the 2nd dose of ENGERIX B adult and the 3rd dose of ENGERIX B adult. On an unknown date, unknown after receiving ENGERIX B adult, ENGERIX B adult and ENGERIX B adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B adult, ENGERIX B adult and ENGERIX B adult. Additional details were provided as follows: This case was not reported previously to anyone. The age at vaccination was not reported. The certified pharmacy technician reported that she was immunized for hepatitis-B with ENGERIX, years ago. The patient reported that she went through the 3 series vaccine regimen, and on time. The patient was tested and was a Therapy non-responder. No information was known about the dates or other information other than, it was years ago.
11 Doses administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 01Dec2021  No concomitant medication was reported.  No treatment medication use was reported
Around 10:45 am throat started feeling constricted and felt anxious.  Got a ride to the emergency room and arrived at 11:20am.  Angioedema (due to COVID-19 vaccine) diagnosis.  IV started and benedryl and epinephrine given.  Pulse ox diagnostic.  Released 2:35pm.  Rx:  Rest, Medrol Dosepak, Acetaminophen, Motrin and Benadryl.
Severe pain at site of injection, chills, malaise, tiredness, nausea.
Issues going on; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th November 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than 2 months after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's wife reported that the patient had issues going on after receiving 2nd dose of Shingrix. Consent to follow up was provided.
pt recv vax & a few hr later exp severe body ache, skeletal fatigue & chills; devel sl fever & swollen lymph nodes in arm & neck; there was also swelling & soreness to the touch @ the inj site; slept for almost 72 hr;
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023), PRODUCT STORAGE ERROR (Product storage error), EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 05-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a temperature excursion Dates of administration 05Jan2023), PRODUCT STORAGE ERROR (Product storage error), EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         No concomitant medication was provided. No treatment medication was provided. Date vial was initially thawed 04Jan2023 4 adult patients received doses of the vaccines affected by a  temperature excursion Dates of administration 05Jan2023. This case is for patient three of four.
Fever 101 degrees, joint aches, lasting 8 hours; rash on upper trunk lasting 3 days
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 27-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). The pharmacist reported that on 28-MAY-2013, the patient experienced swelling, rash and tenderness at the injection site. Also reported that the reaction was red, swollen and pruritic, although the patient is not experiencing pain at the site. She stated that there are two welts aside from the injection site and they look like they could be a bug bites. She stated the redness was approximately 5 inches long. At the time of the report, the patient's outcome was unknown. Additional information has been requested.