chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We brought patient into the doctors office for her 2 month visit but she had a fever that day and decided to delay her vaccination.  The next week she was still having some symptoms of an upper respiratory infection so we decided to bring her in to get checked out.  She had not been having any fevers, she was having wheezing and congestion, as well as retractions.  The doctor we saw that day said that it would be safe for her to get her immunizations even though she was still sick.  She recieved the pediarix vaccine.  The following week we noticed new severe redness, scaliness and roughness on both her cheeks.  It looks like eczema.  It is very red, rough to the touch and crusting off.  It extends from the chin line to above her eyebrow on both sides.
15 minutes after the injection I felt hit all over, even my eyeballs. I was weak and needed to sit down due to feeling pre-syncopal. After 5-10 minutes the feeling of hot went away. I still felt weak but not pre-syncopal. During the day I had to sit every 10-15 minutes due to my legs feels like they were going to buckle. This lasted for the entire day. The next day I felt better but it took 3 days to feel normal.
Based on the follow-up information received on 29 JANUARY 2015, this case is medically confirmed. Initial unsolicited report received from consumer on 17 NOVEMBER 2014. A 24-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (batch number, expiry date, dose number was not reported) in the deltoid on 18 OCTOBER 2014. On 18 OCTOBER 2014, the patient had experienced migraine, headache, generalized body aches, fatigue and a site reaction of induration 2 inches. Lab investigations were not reported and corrective treatment included self medication with EXCEDRIN, PHENERGAN, IMITREX from an unspecified date. The patient had denied to provide an information on illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects included history of migraine headache. At the time of this report, the outcome of the event was resolved on an  unspecified date. List of documents held by sender: none. Follow up information received from consumer on 29 JANUARY 2015. It was reported that no additional information to provide.
Redness, swelling, soreness - 3 x 3" patch possible breathing constricted
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Alcohol use (socially - 3 drinks per week). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 14-Feb-2021 to an unknown date for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 16-Jan-2021 and the estimated date of delivery was 23-Oct-2021. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Pregnancy test: positive (Positive) positive. On 14-Apr-2021, Glucose tolerance test: april 12, 2021: negative (within normal range) (normal) April 12, 2021: negative (within normal range).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Estimated date of conception on 30 Jan 2021 In Apr 2021, MaterniT21 PLUS Core+ESS+SCA was performed resulted in to April 12, 2021: negative screenings for chromosomal disorders (Trisomy 23, 18, 13). On 14 May 2021, AFP was performed and resulted into May 07, 2021: Screen Negative for Open Spina Bifida.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: completed Pregnancy Report Form.
Overall slight fatigue; increased body temperature; unable to lift my arm; Extreme soreness in left arm centered on injection site; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A 25-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 10:00 (at the age of 25-year-old) as single dose for COVID-19 immunisation. The patient's medical history included Childhood Pneumonia (caused slight damage to lungs, Body temperature fluctuations common due to medication). The patient's concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication. The patient previously took penicillin B for drug hypersensitivity and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Mar2021 at 10:00, the patient experienced extreme soreness in left arm centered on injection site, unable to lift my arm. On 03Mar2021 the patient experienced overall slight fatigue, increased body temperature. It was reported that light soreness began within 30 minutes after injection and increased gradually throughout the day on March 2nd 2021. Extreme soreness to the point of being unable to lift my arm the following day caused me to miss work. These symptoms regressed with rest and stretching until the evening, at which point the patient was fully functional again. The other symptoms were very light and only occurred from Wednesday March 3rd to Thursday March 4th. No further symptoms have developed since. The patient underwent lab tests and procedures which included body temperature: increased on 03Mar2021. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Patient did not receive treatment for the events. Outcome of the events fatigue, increased body temperature was recovered on 4Mar2021 and outcome of the other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
terrible body aches from her head to her toes; A spontaneous report (United States) was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event achy all over.  The patient's current condition included multiple sclerosis. No relevant concomitant medications were reported.  On an unknown date, patient received first of two planned doses of mRNA-1273 via unknown route in for prophylaxis of COVID-19 infection. On 11 Mar 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 032M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 11 Mar 2021, after taking mRNA-1273, the patient experienced the event(s) achy all over. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  On outcome of event, achy all over was reported as resolving.
9/27/16 Received mandatory flu vaccine (FLUARIX) into left deltoid - pain, erythema, induration, limitations of range of motion of left arm.
The pt experienced a 4 x 2 inch erythema area around injection site of DTaP.
Patient after receiving her vaccine and sitting in the observation area she started to feel sick and anxious. Patient pulse (70bpm) and BP (148/90) was taken. Patient was asked to remove her mask and slow down her breathing. Gave patient water and monitored her for the remainder of her observation time (15 minutes). Patient was fine within 10 minutes. Patient was anxious but not having a true reaction. Called her 30 minutes after leaving store and she was fine shopping.
SADDLE PULMONARY EMBOLISM ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS ACUTE PULMONARY EMBOLISM
ACUTE NON ST ELEVATION MI 2/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Edema extended from elbow to neck,pain. Mom gave Benadryl and Advil with some relief.
Tingling in roof of mouth, then lips, then tongue. Felt like the sensation one gets when numbing (local anesthesia) is applied. No swelling or numbness followed.  It?s 4 hours later and lips still tingling.  Have eaten dinner without problem, but the tip of tongue remained sensitive during and after I ate.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: patient pointed to the area where we gave a shot and it is the correct area to give vaccine. Pt is saying he is still in pain and cannot lift his arm very well.
Post vax, intense, generalized pruritus, lip swelling; pruritus worse over face and scalp.
NO ADVERSE EVENT; Doses were administered after the 30 day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (NO ADVERSE EVENT) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (NO ADVERSE EVENT) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD).    Concomitant product use was not provided by the reporter.  It was reported that Doses were administered after the 30-day BUD between 8 to 15-Jun-2023. 7 doses were administered, though the clinic is not open on the weekend, so no doses were administered during that weekend. All doses were given to adult patients. No reported symptoms or side effects.  Treatment information was not provided.  This case contains information about patient 4th out of 7 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729901 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729901:(Master case Patient no-1)
Patient has a red welt the size is 9.5x 6 cm. on his right thigh. Red and swollen and warm to touch
Patient became pale, dizzy, and diaphoretic after receiving vaccines.  Patient fainted.
This case was reported by a consumer via call center representative and described the occurrence of crying in a 4-month-old male patient who received KINRIX. Concomitant products included Pneumococcal vaccine, Rotavirus vaccine and TYLENOL. On 1st February 2016, the patient received KINRIX (intramuscular) .5 ml. On 1st February 2016, less than a day after receiving KINRIX, the patient experienced crying, decreased appetite, difficulty breathing, fever, drowsiness and inappropriate age at vaccine administration. On an unknown date, the outcome of the crying, difficulty breathing and fever were recovered/resolved and the outcome of the decreased appetite and drowsiness were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the crying, decreased appetite, difficulty breathing, fever and drowsiness to be related to KINRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient's birth weight was reported as 7.63 kg. The patient has 1 sibling. The patient's mother planned to follow up with the patient's physician on an unknown date.
several pt @ this site devel redness & swelling @ the inj site p/vax;pt recovered p/4-5 days;
I am having trouble breathing and feel like my lungs do not hold as much air and retain as much oxygen.; This is a spontaneous report from a contactable consumer (Other HCP, patient). A 23-year-old male patient (age at vaccination: 23 years) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on an unspecified date, as a single dose for COVID-19 immunization and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization at nursing home/senior living facility. The patient's medical history included Tourette s syndrome and sleep apnea. Concomitant medications were not reported. The patient did not have known allergies. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that he was having trouble breathing and feel like my lungs do not hold as much air and retain as much oxygen on an unspecified date. There was no hospitalization prolonged. The adverse event result in emergency room/department or urgent care. It was unknown if the patient received treatment. Outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Day after vaccination:  headache,  body aches, tired, soreness near injection site.  Two and three days (so far) after vaccination:  soreness in greater area near vaccine site, at first just further down the deltoid and into bicep, then wrapping  around tricep, into underarm area and further down inside of bicep.
One week after the vaccination rashes started on hands and feet, extremely itchy and painful to the extent that performing daily tasks became difficult. Went to urgent care which prescribed triamcinolone acetonide 0 .1 % topical cream.
No additional AE; Caller stated the vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 18-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number U022321, expiration date reported and validated as 15-JUL-2023) as prophylaxis, after a temperature excursion (product storage error).  The vaccine experienced a temperature excursion of minus (-) 14.1 degrees Celsius (C) for 12 minutes. There was no previous temperature excursion.
Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023; No adverse event; Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 35 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:master case
Red rash around injection sight that is tender and raised. Some white coloring around red area.  It is not itchy and does not hurt. its oval in shape and is about one inch in width and 2.5 inches long
Only adjuvant administered; Only adjuvant administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number FA95N, expiry date 28th July 2023) and (batch number 052JX, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: The reporter stated that a 2 antigen (powder) was left in the shingrix box and the reporter believes that 2 patient out of the 10 patients received only the adjuvant portion of the shingrix.  The reporter was planning to revaccinate all 10 of them because she was unsure who got them. The reporter did not had any information to provide on the patients. The Vaccine Administration Facility was the same as Primary Reporter The reporter give consent to follow up. This case was for 2 of 2 linked reports. Additional supportive information: The patient received only the adjuvant portion of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022152231:Same reporter
Much worse menorrhaghia this month. I?m passing ping pong ball size clots, going through super plus tampon and an overnight pad hourly to every two hours. Cycle was delayed by two weeks and had cystic acne with it which is unusual.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-FEB-2017, the patient was vaccinated with improprerly stored dose of M-M-R II recombinant human albumin (RHA) lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported.        Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved.   This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742
Mild headache and body aches, nausea, and tiredness. Left arm tenderness and pain with muscle use.
Localized muscle pain, at the site of the injection; Fever (100.9); This case was reported by a consumer via interactive digital media and described the occurrence of injection site muscle pain in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced injection site muscle pain and fever. On an unknown date, the outcome of the injection site muscle pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient had body temperature test which results 100.9 degree F. After receiving 1st dose of Shingrix, the patient experienced localized muscle pain, at the site of the injectionand fever. The reporter reported that ycan you estimate how long these side effect symptoms might last. The reporter consent to follow up.
I did not have an adverse event after receiving the vaccine. On 06/14/2022, I was diagnosed with atrial fibrillation.  I had cardioversion where they shocked my heart. I also had a cardiac ablation so now; I no longer have atrial fibrillation.
Injection site soreness and redness, fatigue, extreme muscle aches (painful to even walk), shortness of breath, headache, teeth sensitivity. Fairly similar reaction to dose #1, except not the teeth sensitivity. I am unable to enter the Vaccine info above. SHINGRIX Vial Kit NDC: 58160-0823011.