chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first thing that was notable was that within 30-35 minutes, I felt tired to the point I didn't feel safe to drive. After that, I had chills for about two days. I had severe body aches, mostly at night, three nights in a row. I didn't leave my house. I didn't drive. I slept for 3 days and it went away. Breakthrough ,COVID-19 Case: I started feeling ill on April 13th. It started with a sore throat. I felt like I had a mild cold for three days until I lost smell and taste on Sunday, the 17th. I tested at home and it was positive. The week before I had multiple negative tests because I was going to travel. I would say I was very weak through April 20th. After that, I was able to work starting on April 21st. Although, I work and live a normal life, I have a lingering cough and I feel tired all the time.
Severe headache, body aches, rigors and fever of 103,  treated at home with oral hydration and tylenol and ibuprofen
No additional AE; Patient received their third dose of GARDASIL 9 prematurely (8 weeks early than recommended dosing interval). Received 1st dose on 27-FEB-2023, 2nd dose on 04-APR-2023, and 3rd dose 09-MAY-2023; Patient older than 45 years old (56 years old at time of administration) received GARDASIL 9; This spontaneous report was received from a registered nurse referring to a 56-year-old patient of an unknown gender and race.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 27-FEB-2023, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided) (product use issue). On 04-APR-2023, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided). On 09-MAY-2023, the patient was prematurely vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided) as it was given 8 weeks earlier than the recommended dosing interval (inappropriate schedule of product administration). No additional adverse events (no adverse event) were reported.
Information has been received from a female pharmacist with a history of chickenpox as a child who administered Zostavax (Oka/Merck) to patients in the pharmacy but she herself had never been vaccinated the zoster vaccine.  She takes carbamazepine (Tegretol) for seizures.  On approximately 20-AUG-2007 the patient developed herpes zoster of her R upper back.  She felt there was an "itch mite" in that area that that was what she thought she had.  She eventually went to her physician and was diagnosed with shingles.  No treatment was prescribed.  The lesions had resolved but the pharmacist continued to have pain in the affected area.  Subsequently, the patient recovered.  This is one of several reports received from the same source.  Additional information has been requested.
SWEATY/FELT CLAMMY; HAIR FELL OUT; ITCHING; WHEEZING; HIVES ON CHEST; BLURRY; SUPER TIRED; ACHY ALL OVER; LITTLE WONKY/BLURRY BRAIN/FELT WONKY IN THE HEAD/BLURRY/THREW UP MY BREAKFAST; FLU LIKE SYMPTOMS; SHOT SITE SORE; 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, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced shot site sore. On 08-APR-2021, the subject experienced achy all over. On 08-APR-2021, the subject experienced little wonky/blurry brain/felt wonky in the head/blurry/threw up my breakfast. On 09-APR-2021, the subject experienced super tired. On 10-APR-2021, the subject experienced blurry. On 11-APR-2021, the subject experienced itching. On 11-APR-2021, the subject experienced wheezing. On 11-APR-2021, the subject experienced hives on chest. On 12-APR-2021, the subject experienced sweaty/felt clammy. On 12-APR-2021, the subject experienced hair fell out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, shot site sore, achy all over, little wonky/blurry brain/felt wonky in the head/blurry/threw up my breakfast, super tired, itching, hives on chest, wheezing, sweaty/felt clammy, hair fell out and blurry was not reported. This report was non-serious.
Granuloma Annulare (benign skin condition) Initial RX from March to May 2022, topical steroids  Second RX from May to December 2022, tacrolimus ointment Third RX from December 2022 to current, topical pimecrolimus
Right side of face  and felt like I was in a fog- it did something to it on the very first vaccine; And then with this second vaccine - it made my lips funny - some kind of sensation -  and I felt in a fog and tired. Within an hour this happened. I had those symptoms for a few hours. I stayed  home from work for a couple of days to make sure I was okay. I have been experiencing high blood pressure symptoms - I was having a pain in my arm - and that's when I found out I had high blood pressure (about a month ago is when I found this out) - I had to see the doctor once a week to check the blood pressure - Losartan - He put me on this for the symptoms - they've changed the medicine about three different times to see what will help me and Losartan starting to help.
Case number PHEH2013US012001 is an initial spontaneous report from a nurse via sales representative on 30 May 2013, and a follow up received from the nurse on 20 Jun 2013. This report refers to a 15-year-old female patient. She had no medical history and her concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M11042) at a dose of 0.5 ml intramuscularly in her left deltoid on 02 Aug 2012. She developed swelling of left arm and went to emergency room in 03 Aug 2012. The nurse did not visualize the arm when the event occurred. The patient had recovered completely on an unspecified date. The seriousness and causality was not reported. No other information was provided. Follow up information received from the nurse on 20 Jun 2013: Update site and dose of vaccination, and outcome of event.
Mother claimed that child developed hives on and off for 2 days after receiving the H1N1 vaccine for the whole week. Mother called the doctor who told her to give child BENADRYL and it helped.
Suspected vaccination failure/had them 4 times even I had shot; I had them 4 times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.     Additional Information: GSK receipt date: 22-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had them 4 times even though, he/she had the shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sleeping; Total lethargy; Muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping), LETHARGY (Total lethargy), MYALGIA (Muscle aches) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleeping), LETHARGY (Total lethargy), MYALGIA (Muscle aches) and PYREXIA (Fever). At the time of the report, SOMNOLENCE (Sleeping), LETHARGY (Total lethargy), MYALGIA (Muscle aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2021-132792 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-132792:Crosslinked case of reporter
No additional AE reported; he received his second dose of GARDASIL 9 over 1 year after his initial first dose; This spontaneous report was received from a 37-year-old male patient, referring to himself. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 26-AUG-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis. On 07-FEB-2022 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis over 1 year after his initial first dose (inappropriate schedule of product administration). No additional adverse event reported.
Stiffness in hip.  Numbness in leg from thigh down to calf. Pain remains no matter what is done.
8 days after injection red circular mark emerged at the vaccine site and another on a different place on the shoulder. Marks were consistent with those reported in this paper: (hyperlink removed).
I have been feeling dizzy; at times felt fainting; fell on the ground on 1/7/2021 evening between 8-9pm after feeling fainting.
Information has been received from a healthcare worker (also reported as a certificated medical assistant) referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VAQTA (strength 25/0.5 (unit unknown), lot#, expiration date, dose and route were unknown). The temperature excursion for VAQTA was not supported with in-house stability data. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
closing in on esophagus; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGEAL ACHALASIA (closing in on esophagus) and PAIN (Soreness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included BENAZEPRIL, AMLODIPINE, AMITRIPTYLINE and CLORAZEPATE DIPOTASSIUM (CLORAZEPATE) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced OESOPHAGEAL ACHALASIA (closing in on esophagus) and PAIN (Soreness). At the time of the report, OESOPHAGEAL ACHALASIA (closing in on esophagus) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Calming Exercises
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 62 years old patient, who was vaccinated with FLUZONE QUADRIVALENT and where couple of drops dripped, lot number not reported via unknown route in unknown administration site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was as actual medication error case due to vaccine underdose. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Chills, nausea, headache, body ache, mildly labored breathing, loss of appetite, slight fever (no more than 100 degrees). All happened in a 24 hour period, with nausea, fever and loss of appetite lasting on and off for several days.
Initial report received from a health care professional on 30 October 2007. A five-year-old male with history of reactive airway disease and possible allergies to peanuts and amoxicillin had received a left deltoid intramuscular injection of Fluzone SV  2007-2008 (lot number U2530AA) on 27 October 2007 and within a few hours of the vaccination, he started developing soreness and swelling near the left deltoid injection site. The following day, the patient was taken to "Ready Care", as the swelling had extended to his elbow. Treatment with Septa was initiated. The patient was seen by his pediatrician on 29 October 2007 and was dose of epinephrine and was started on Benadryl. By October 2007, the swelling had extended to the patient's wrist. At the time of this report, the patient had not recovered. No additional information was provided.
Narrative: 7/1/- J&J Vaccine 7/24- COVID symptoms first appeared 7/28- positive for COVID 7/29- reports mild fever (98.3), loss of taste/smell, rhinorrhea, sore throat; caught from coworker 7/31 - sx improving, sore throat resolved 8/1 - continues to have no taste, other symptoms resolved
Angioedema of bottom lip. Started approximately 4 hours after the vaccine, worsening until 12-18 hours. Self resolved within 24 hours.
DEATH; STROKE; VACCINE WEAKENED THE HEART/HEART INFLAMED; HEARTBEATS IRREGULAR; TINY TUMORS; LOSING MEMORY SLOWLY; This spontaneous report received from a consumer via social media through company representative concerned a female of unspecified age race and ethnicity. 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 was not reported, batch number: unknown expiry : unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had tiny tumors appear, and started losing her memory slowly, and soon after had a stroke. The reporter stated that the vaccine weakened the patient's heart and the heart inflamed which led to an irregular heartbeat. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and had not recovered from tiny tumors, losing memory slowly, stroke, heartbeats irregular, and vaccine weakened the heart/heart inflamed. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20211258139, 20211263643 and 20211263721.; Sender's Comments: V0: 20211256750-covid-19 vaccine ad26.cov2.s-Death, stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Vaccine stored in the freezer, instead of the temperature range indicated on the package (2-25ºC). Vaccine administered to this patient without knowing it was stored improperly.
Noticed a large lump on my collar bone that caused pain if I reached my arm up or across my body. Lump was visable in the mirror. I had a routine prenatal appointment on 4/23/2021 so I informed my Doctor that I noticed the lump. She was not sure what it was and requested an ultrasound.    Pregnancy information - 1st pregnancy, was 25 weeks pregnant at the date of my 1st vaccine dosage.
I gave Pfizer 5 to 11 year monovalent vaccine not the Pfizer 5 to 11 year old Bivalent vaccine.
7cmx6.5 cm local rash at injection site multiple episode of vomiting same day 7/10/2021 with lethargy and decrease appetite and arm pain continuing until today 7/12/2021
Had a week of zero side effects or reactions; After a week my arm was itchy and a little bit  red. Itchiness has subsided after a day or two but the rash is horrible and getting bigger. No unusual amount of pain,  but the rash is hideous and growing.
Pt recvd 1 dose of Engerix-B & devel elevated temp which resolved p/5 days;
severe Anaphylactic reaction, was hospitalized; This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 37-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th November 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 15th November 2020, less than a day after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced anaphylactic reaction (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved.   The reporter considered the anaphylactic reaction to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by nurse for herself. The patient received the Fluarix vaccine last year and experienced a severe anaphylactic reaction to the vaccine. The patient was hospitalized for a week.   The patient stated that her doctor suspected Gentamycin as the ingredient in the Fluarix last year that might had caused the reaction, which was why she was inquiring whether gentamycin was an ingredient in the Fluarix this year. The reporter inquired if GlaxoSmithKline vaccines were egg free.  The reporter declined to permission to contact her healthcare professional. The reporter did not consent to follow-up. No additional details were provided by the reporter.
Patient states she had an infection  at the vaccine site and took 7 days of smz/tmp antibiotics to resolve the infection
Severe chills and nausea, diarrhea, exhaustion, fatigue, migraine
This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer regarding her 18 month old daughter who received doses of Prevnar and Infanrix on 11/16/00, and subsequently experienced swelling, fever, crying, autistic behavior, constipation, diarrhea, yeast overgrowth of gastrointestinal tract and food allergies. The patient's concurrent illnesses include multiple food allergies and drug hypersensitivity. Indication for Prevnar was immunization. Product was administered on 11/16/00. Dose regimen was 1 dose. Concomitant medications were not reported. On 11/16/00, the child received a fourth dose of Infanrix, along with Prevnar. That same day, she experienced swelling, high fever, and crying. Crying and fever resolved on 11/19/00. On an unspecified date in November 2000, the patient developed autistic behavior. On unspecified dates, the patient also developed constipation, diarrhea, yeast overgrowth of the gastrointestinal tract, and multiple food allergies. The child was examined at a physician's office and treated with Nystatin. In August 2001, the child was diagnosed with autism. As of 3/24/04, autism, constipation, diarrhea, yeast overgrowth and food allergies were unresolved. No additional information was available at the time of this report.
rash on both arms that started 1/19/2021, headaches. arm got really swollen for up to 41/2 inches around injection site. still have scare around my arm
Sudden headache, followed by racing pulse, feeling of fatigue, could not breathe well. The temperature of my face rose and I felt dizzy and collapsing. Cold, sweaty hands.
Pt received Covid-19 Moderna vaccine dose #1 on 1/23/21.  Dose #2 administered on 2/20/21 @ 12:43pm.  Pt presented to  on 3/9/21 w/ complaints of localized edema x1-2 days in the left lower leg.  (Symptoms started 3/7/21). Pt denied associated calf or extremity pain but reported she went shopping on Saturday and walked "alot." Pt reported she could walk on it but it "felt funny & tight" so she took an extra furosemide 40mg on 3/8/21.  Trace edema in right ankle, 3+ pitting edema left leg from knee distally, slight increased warmth, no calf tenderness, negative Homan's sign, extremity asymmetric. Pt referred for venous doppler (unilateral, left leg, left leg edema, . Findings:  acute, occlusive DVT in one of the duplicated left FV, the left popliteal vein, peroneal vein, & PTV. Superficial phlebitis and phlebothrombosis left GSV.  per, FASC, RVPI 3/9/21 @ 2:27pm. Pt sent to ED for evaluation. Pt started on Xarelto in ED, changed to Eliquis per Dr. Eliquis 5mg PO BIDx7 days, then 5mg PO BID.
Pt reported developing a rash, 1 day, post vax, and sought medical help on 10/20/99. He developed a macular-papular rash in triceps region of left arm and posterior neck. He had itching and burning with water. He was prescribed HC cream but never really resolved but it did help. Pt was also seen at that time for pain and swelling to right eyelid which he had for 7 days. Pt symptoms are not completely resolved. Recommended consulting a dermatologist. He had similar reactions with all previous shots but did not seek treatment or report them.
Erythema, edema at inject site rxn occurred 2 days p/vaccination.
Information has been received from a medical assistant concerning a 4 year old male patient with no allergies and no past medical history who on 06APR2001 was vaccinated subcutaneously in the left thigh with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 07NOV2003, the pt began to develop spots. Four days later, the pt had a total of approximately 20 to 25 spots. "Itchy" was also noted. Medical attention was not sough. Additional information has been requested.