chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/18/ Felt ill, no appetite, site swollen approximately half dollar size, warm to touch, no fever or redness, shot given 4/16 evening. 4/19/13 Feeling better, still decreased appetite did take 1 BENADRYL evening before. 4/22/13 No redness, no warmth but now little bumps on arm. No other c/os, states fine.
Flu like symptoms the following day lasting 24 hours. 36 hours after 2nd Moderna dose, all adverse symptoms gone.  I also received the 3rd Moderna dose on 8/16/21 and experienced the exact symptoms as the 2nd dose. All adverse symptoms gone within 36 hours.  Adverse symptoms would not stop me from a 4th vaccine if/and when the time comes.
Reddened, warm, tender welt at varicella injection site (LA)and low grade fever per mom. Was given TYLENOL at home that evening..   measured 4/22/16 @ 1530 at 7cm x 6 cm and raised, warm, remains tender to touch. Advised to continue TYLENOL as needed, warm compresses for comfort and anti-itch cream such as CALAMINE lotion if needed. Advised to go to ER for any facial/tongue/throat swelling, difficulty breathing, etc.
Patient had reaction at injection site, redness, swelling, hot, large area (4 inches approx).
December 27th of 2021, I woke up in the middle of the night/early a.m. with heart burn or acid reflux. As mundane as that may seem, I have never in my 51 years of life experienced heartburn at all. But as of 12/27/2021, I have acid reflux disease. I have uncontrollable acid reflux every few days since that date. My doctor put me on a prescription level antacid that did not work. They did an endoscopy on my throat that revealed what they called inconsequential ulcers. They have put me on another prescription strength antacid that has also not worked.
2/9/03 has frontonasal encephalocele febrile illness + max of 102.1. Seizure that lasted 15-20 minutes coarse breath sounds and possible R middle lobe infiltrate. Step pneumoniae (+) for 6 B. The discharge summary states decreased central vision and emesis.
TDaP injection 4-22-11. Pain for the next 2 days. 04:30 am 4-25-11 noted warmth, erythema 2 x 7" around injection site. Has allergy to Thimerosal but usually able to take TD vaccine without problems in past (5-7 years ago).
Mom states walked to car and pt passed out. Returned to clinic, pt was pale, skin clammy. Pt was responsive. Cool clothes to back of neck/forehead. Within 5 minutes, skin was normal in color, lips pink. Water given. Had last eaten 4 1/2-5 hrs previously. Mom states had been outside playing most of the morning.
24hr p/vax pt had acute onset of partial complex sz-10 sec;given phenobarb;pt had a second sz characterized by rt upward gaze & head deviation;
Adolescent Tdap (Boostrix) given instead of Infant Dtap.  12/15/06 potential adverse event onset/ 0 adverse event reported. 4/24/07.
Possible late 2nd dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Possible late 2nd dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2023 The reporter reported that the patient received the first dose of Shingrix vaccine in 2019 at the pharmacy. The reporter cannot confirm if she received it.  The reporter wanted to know if patient should receive the Shingrix series both doses or just the second dose. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
the vial was initially stored in the refrigerator on 04Aug2022 and administered on 06Sep2022; No adverse Event; Dose 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 (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 04Aug2022 and administered on 06Sep2022) and NO ADVERSE EVENT (No adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 04Aug2022 and administered on 06Sep2022) and NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 04Aug2022 and administered on 06Sep2022) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (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 administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 04Aug2022 and administered on 06Sep2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Aug-2022. The facility administered the vaccination after the 30 day BUD. The vial did not  undergo any temperature excursions. No treatment medications were reported.
PATIENT C/O NECK PAIN THAT STARTED GOING DOWN  HER ARM WITH NUMBNESS AND TINGLING, THEN STARTED SHAKING VIOLENTLEY,  SYMPTOMS JUST KEPT GETTING WORSE.
Tired; achy arm sore as heck; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness and pain in arm were unknown.   It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient received first dose of Shingles vaccine and patient felt tired and experienced achy arm sore as heck. The patient asked did anyone had any side effects and if so what were symptoms. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Fibromyalgia like pain right side of body including shoulder, knee, feet, back including burning sensation mid back above waist .  Pain lasted approximately 2  1/2 days.
Redness, edema and induration at injection site left thigh, area of erythema 6 1/2 x 4 1/2 inches, induration 7 x 6 inches. Thigh measurement left 16 5/8 inches Right 14 1/2 inches. Benadryl, ice and Ibuprofen.
On 8/6/09, the patient had inconsolable crying for about 5 to 6 hours after vaccination.  She required evaluation in the emergency room.  SHe had an abdominal X ray and fluoresin place din her eyes to rule out a corneal abrasion.  Her evaluation was normal except for crying.  She was given Valium and discharged home. The next day she followed up with her primary care pediatrician in the office.
shortness of breath; This case was reported by a other health professional via call center representative and described the occurrence of shortness of breath in a 50-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shortness of breath. The patient was treated with steroids nos (Oral Steroids). On an unknown date, the outcome of the shortness of breath was unknown.   It was unknown if the reporter considered the shortness of breath to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows:  The age at the vaccination was not reported. After receiving dose of Influenza vaccine Quadrivalent unspecified season, the patient experienced shortness of breath. The patient required a course of oral steroids. The patient said was there any components of the Shingrix vaccine like the ingredients in the influenza vaccine. The patient would like to have the Shingrix vaccinations, but Iwould like to ensure receiving the vaccinations would be safe for her. The reporter consent to follow up.
allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received Shingles and experienced horrible side effects and allergic reaction. The patient could not receive second dose. Consent to follow up was not possible as no contact details were available.
Initial report received from a patient on 01 November 2007. A 73-year-old female with history of allergies to multiple medications had received a left deltoid injection of Fluzone SV 2007-2008 (lot number and route of administration unknown) on 17 October 2007. Soon after (exact date not reported), the patient experienced difficulty breathing that worsened over the next two weeks. The patient also had wheezing and a cough. On 28 October 2007, the patient went to the emergency room where results were normal for a chest x-ray, EKG, CT scan and blood work. The patient was discharged from the emergency room and was subsequently seen by her physician who ordered prednisone. At the time of the report, the patient indicated that she was still very short of breath with coughing and wheezing, but also stated that it was improving. The patient reported having the same symptoms last year after receiving a flu vaccine (unknown brand) at the same location. The patient was scheduled to follow-up with her physician on 05 November 2007. The reporter of this case is the same as for case 2007-03698, which involves difficulty breathing, cough and wheezing experienced by the same patient last year following receipt of a flu vaccine (unknown brand).
Redness, warmth, swelling, pain of R arm. Appeared consistent with cellulitis.
Headache, Myalgia, Fever, CHILLS, LEFT ARM SORE AND SWOLLEN Narrative:
Shingles; zoster related-conditions; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   On or about 06-OCT-2011, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for the long-term prevention of shingles and zoster related-conditions.   On an unknown date, the patient was treated by a family nurse practitioner for shingles and other zoster-related conditions (ill-defined disorder).  The outcome of the shingles and other zoster-related conditions (ill-defined disorder) was unknown and the casuality assessment between the aforementioned events and the vaccination with a dose of zoster vaccine live (ZOSTAVAX) was reported as related.
ongoing pain in legs, specifically in calf muscles and behind the knees.  Achy, dull pain with occasional shooting pains.  Feels like a charlie horse is about to start, or has just ended. Pain is not severe, but can sometimes prevent sleeping at night.  Pain started on day 2 after vaccine and is still present on day 9.
The caller reports she tested positive for Covid illness about a week ago, and she then passed it on to her daughter; The caller reports she tested positive for Covid illness about a week ago, and she then passed it on to her daughter; This is a spontaneous report from a contactable consumer. This consumer reported for a 53-year-old female patient (reporter's daughter).   A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and Dose 1, single on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications was not reported. The caller was a consumer who reported that she is 74-year-old female and her daughter 53-year-old had both been fully vaccinated with the Pfizer-Biontech COVID-19 vaccine. The caller reported she tested positive for Covid illness about a week ago (on an unspecified date), and she then passed it on to her daughter (on an unspecified date). She indicated that they had followed CDC recommendations that stated fully vaccinated patients can be around each other and need not wear a mask. She asked for how many people in the population who were fully vaccinated had tested positive for Covid19, the percentages, and the percent of the cases which were the new delta variant. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on an unspecified date. Outcome of the events was reported as Unknown.   No follow up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021846613 same reporter/drug/event, different patient
Pt said her arm started hurting aroung 4-5 PM on Saturday May 11th. She came into the store on Sunday May 12th when we opened at 11AM and the area on her left arm had a red, raised, swollen patch around where the vaccine had been administered. The area felt warm to the touch. She said it had not changed much since it started hurting the day before. She was recommended to take oral benadryl and use benadryl cream on the area and take Tylenol if it continued to be painful. She was also told that if it got any worse to go to the emergency room.
COVID-19, I received my 3rd dose on 01/07/2022 and my COVID symptoms started on 01/09/20222 with stuffy nose; itchy throat; cough; fever; I went to my doctor and he prescribed me prednisone and Z-PAK I took it for about a week. Am not fully recovered yet but I've noticed that after the vaccines I get tired more often. If I sit I can't even get up. I don't feel the way I use to feel. Vaccine made me more weaker than before.
I was diagnosed with pulmonary embolism on 08/27/2021. One week prior I had an upper respiratory infection. I saw the doctor and they gave me some medication. I went in again on 08/24/2021 and they gave me more medication and they thought I was having an asthmatic reaction to my respiratory infection. On 08/27/2021 I went again and they did a CT scan. It showed I had 2 blood clots in my lower left lung and that is when I was diagnosed with pulmonary embolism.
Child received VZV on 9/21/10. Parent state on 9/23/10 child had fever/starting breaking out with small blister. Continue to break out on 9/23/10. Parent states NO new blister since 9/24/10. Pt has number of crusted area on face & body. Denies any other problems. Recommended to stay out of school no additional outbreak & areas crusted over.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 14:00 as dose 2, single (Lot number: EP7534), in left arm and on 30Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FC3183) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TAMIFLU, start date: 25Apr2022, stop date: 29Apr2022. Past drug history included: Cyclobenzadrine, reaction(s): "Allergy_Cyclobenzadrine". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Follow-up (18May2022): Follow-up attempts are completed. No further information is expected.
Hives; Sunburn feeling on stomach; Rash all over body; Patient received first dose on 16 Feb 2021, she was afraid to get second shot and so did not do so; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), DYSPEPSIA (Sunburn feeling on stomach), RASH (Rash all over body) and PRODUCT DOSE OMISSION ISSUE (Patient received first dose on 16 Feb 2021, she was afraid to get second shot and so did not do so) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Sulfonamide allergy (Allergy to sulfa) and Drug allergy (Allergy to lexapro).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received first dose on 16 Feb 2021, she was afraid to get second shot and so did not do so). On an unknown date, the patient experienced URTICARIA (Hives), DYSPEPSIA (Sunburn feeling on stomach) and RASH (Rash all over body). At the time of the report, URTICARIA (Hives), DYSPEPSIA (Sunburn feeling on stomach) and RASH (Rash all over body) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient received first dose on 16 Feb 2021, she was afraid to get second shot and so did not do so) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.  HCP was contacted, caller first was advised to not get second shot and later HCP said is not sure and it might be better to receive second shot.
pt recv vax;exp n;14aug95 exp diffuse myalgias;20aug95 devel approx 30 chicken pox lesions on upper arms,chest,back & abd;cough;tx w/ Zovirax,atarax,amoxil;approx 2 wk sx resolved;
fever  (101.7 F).; chills; This is a spontaneous report from a contactable pharmacist. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 30Apr2021 at 15:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Concomitant medications received within two weeks of vaccination was not available. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via intramuscular route of administration in the left arm on 09Apr2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021, the patient underwent body temperature check and the result was 101.7 F. On 30Apr2021, the patient experienced fever (101.7 F) and chills. The fever continued the next day. The fever and chill occurred again the following night. Therapeutic measures were taken as a result of fever and chills and included treatment with ibuprofen (MANUFACTURER UNKNOWN) from an unknown date. The clinical outcome of the events of  fever and chills was recovered on an unknown date. The patient had "Not reported" allergies to medications, food, or other products. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Lab data (new date added, unit added, result update to "unknown result on 30Apr2021, 101.7 F on 01May2021"), updated narrative ("The patient had "Not reported" allergies to medications, food, or other products. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care" added and events recovery date (May2021) removed).
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037821B) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Within 3 hours of receiving the booster I had all of the symptoms of COVID.  Some of the sypmtoms have improved but my lungs are in bad shape.  I'm on Prednisone 30mg QD X 10 days, on day 5, some improvement.  I have never had this much trouble in my life with asthma.  These symptoms started after the 2nd dose of Moderna, got a bit better over the summer, and then escalated with the booster.    These symptoms are much worse than any asthma flare up.  They continue on and on.  I don't know if I will ever be OK again.  I regret  getting the vaccines and booster.  But we were all told they were safe and effective.  I don't agree.  My asthma was under control previously.
pt died at home; had a positive COVID test on 9/3/21; per death certificate, cause of death:  COVID 19 viral infection