chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After about 24 hours: muscle and joint pain;  After about 48 hours: intense muscle and joint pain back pain, fever of 101.7, shortness of breath Following day: weakness, extreme fatigue, tachypnea, shortness of breath on exertion Shortness of breath and cough persisted for several days, finally resolved day 6 post vaccine
Individual was given vaccine at 10:00 am. AT 10:40 am after receiving the vaccine individual developed itchy and reddened left forearm and stomach Individual vitals were stable. Individual went home after waiting 45 mins. with no noted distress.
Flu vaccine 10-5-12. Within 1 hr of receiving shot got achy feeling - itchy scalp. Flushed face. Erythema on extremities. Tx: Cold compresses - OTC antihistamines.
Minor client came in with mother for 2nd dose Pfizer. First dose given on 4/21/2021, as recorded in registry and on her vaccine card.   Mother signed consent, DOB was recorded on form, suggesting daughter was 16, thus eligible.  Registry advocate noted that client had a record with multiple vaccines recorded and all information correct exc. DOB.  I went to confirm w/  minor client to prevent a second registry entry, and client reaffirmed the incorrect date several times. I assured her she was not in trouble, she confirmed she was in fact 15 yr old. Mother came in to discuss, insisted the daughter was 16, then when pressed, that she recorded the wrong DOB on form in error.  She said she thought it was approved for 15 yr olds now.  I counseled parent that the EUA was granted by the agency, but the committee was still meeting to confirm protocols, and not ready to administer at the local health department.  Advised her that I will f/u re: side effects, outcomes in 24 hours.
patient has pinkish?colored erythematous patch a little below where she stated the vaccine was given and was warm to touch.
-vaccinated @ 1450 , at 1455 nausea VS BP 132/84 HR 90 O2 Sat 99% 1500 SOB, wheezing, lightheadedness throat scratchy, pale VS BP 164/84 - observation ended - transported to ED by Emergency Team received 0.3mg epinephrine IM 50mg Benadryl IM , albuterol nebulizer x 1 Discharged from ED @ 1715
Patient developed a bump similar in appearance to a pimple directly over injection site. Not itchy or bothersome and went away on it's own.
Chills; Headache; Nausea; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced chills, headache and nausea. On an unknown date, the outcome of the chills, headache and nausea were unknown.   It was unknown if the reporter considered the chills, headache and nausea to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine before going to college. The patient had side effects like chills, headache and nausea. The reporter stated, it was scary.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 19th October 2018, the patient experienced injection site pain, injection site induration and injection site erythema. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the injection site induration and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site induration, injection site erythema and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on left arm. One day after receiving SHINGRIX, the patient developed pain, redness and hardness at the injection site. The patient stated that, the redness and hardness had resolved, however the pain had not gone away and it was limiting his range of motion in his left arm. The patient had denied permission to contact their physician.
Uterine Polyps; received the first dose and the second dose of BNT162B2 on 24Feb2021; This is a spontaneous report from a contactable other HCP. A 31-year-old female other HCP (patient) reported that she received the first dose (at right arm, Lot No. EN5318) of BNT162B2 and the second dose (at left arm) of BNT162B2, both at single dose for COVID-19 immunisation on 24Feb2021 at 01:00 PM (as reported). Relevant history was unknown. Relevant concomitant drug was not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  List of any other medications the patient received within 2 weeks of vaccination: No. known_allergies: No. The patient experienced uterine polyps on 10May2021. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was hospitalized. Surgery was received as treatment. The outcome of event Uterine Polyps was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had Nasal Swab tested for COVID-19 on 03Jun2021 with negative result.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the event uterine polyps  onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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 to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
expired vaccine was administered with no reported adverse event; Initial information received on 06-Mar-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient to whom expired hib (prp/t) vaccine [Act-Hib] vaccine was administered with no reported adverse event.  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.   On 06-Mar-2023, the patient received an unknown dose of suspect hib (prp/t) vaccine (lot UJ647AAB and expiry date: 05-Mar-2023) Powder and solvent for solution for injection via unknown route in unknown administration site for prophylactic vaccination.  On 06-Mar-2023 the patient developed a non-serious event of expired vaccine was administered with no reported adverse event (expired product administered) (Latency: same day) following the administration of hib (prp/t) vaccine.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Within 10 minutes of vaccination, the patient reported feeling numb in the left arm.  It was not painful, there was not swelling or redness.  I advised patient to contact doctor if the numbness persisted for 3 days, I advised the patient to take Tylenol or ibuprofen.  I called the patient back 4 hours later and the patient's mom reported that the numbness was gone, but the arm was now itchy.  I advised the patient to seek out his PCP if the feeling was still there after 3 days.
Feels like 2nd dose didn't go in the deltoid muscle; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Feels like 2nd dose didn't go in the deltoid muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Feels like 2nd dose didn't go in the deltoid muscle). On 02-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Feels like 2nd dose didn't go in the deltoid muscle) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was provided.; Sender's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot # 029a21a with no associated AEs.
Within 5-10 minutes of vaccination, acute stomach pain; followed by itching of palms and soles of feet.  Itching spread to entire body, hives appeared on face, ears and arms within 20 minutes.  Subsequently, red blotchy rash appeared on legs and stomach.  Patient was treated with 1 3/4 tsp of benadryl.
Information received 08MAR2016 from an Investigator. In January 2009 a 34 year old female experienced a miscarriage. A 34 year old G1P0 female received dose # 5 of BIOTHRAX vaccine (anthrax vaccine adsorbed) in December 2008 at 4+5 estimated gestational age (EGA). Subject was determined to be pregnant in December 2008, 7 days after vaccination. She reported that she had a miscarriage in January 2009 at 7+0 EGA. No other information was provided regarding other vaccinations, treatments, concurrent medical conditions or medications, medical history, or relevant laboratory/diagnostic results. Sender's Comments: The event of miscarriage is considered medically significant by the sponsor and the report has been upgraded to Serious.  In the absence of adequate medical assessment of the reported events, a causality association is deemed not assessable.
Fever; A spontaneous case report was received from a consumer concerning a female patient, of unknown age, who administered Moderna's  COVID 19 Vaccine   The Patient Medical History was not provided. no relevant concomitant medications were reported.   on 18/JAN/2021, the patient experienced Fever 99.3 °F after 100 °F and then got down to 99.3 F.  Action taken with the second dose of mRNA-1273  in response to the event was not reported.  Report Source- Non-Health Professional,  Age-  ,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,Outcome- Fever - Recovered/Resolved.
9/17 & 18 fever and chills, 9/19/06 developed lesions (15 lesions oh shoulder, flank, ankle), 9/23 headache, 9/24 admitted to hosp with r/o viral meningitis, CSF neg varicella. 10/5/06 Received medical records from PCP which reveal patient seen on 9/20/06 varicella zoster virus by rapid PCR test same day was positive.  MD noted rash on arm for approx 2 days after having had vaccine approx 2 weeks prior to visit due to being recently found to be nonimmune serologically.  Hard itch lesions on back of neck & left deltoid approx 4 days prior to visit & now with lesion on right anterior chest wall & chills.  MD punctured left deltoid lesion to obtain specimen for testing. 10/5/06 Received medical records from hospital which reveal patient admitted 9/24/06-9/27/06 after developing severe frontal HA day before admit.  Continued to have significant pain, nuchal rigidity & scarring on shoulder & ankle where had previous lesions.  Started on IV antiviral med.  Final Dx: Meningitis, varicella vs enterovirus.  Patient was to continue antiviral IV upon d/c./ss Per 60 day follow up: No adverse effects. - varicella test
Information has been received from a physician concerning a 21 year old female with a allergies to yeast and glute and history of getting commonly yeast infection in ears and mouth, who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # and route no reported).  The physician reported that the patient had the first injection of GARDASIL vaccine and 5 days after she got the dose on an unspecified date, she developed a yeast infection in her mouth.  The physician reported that the patient did not make the doctor aware that she was allergic to yeast, only to gluten.  Also, the physician reported that the patient did check off on the paperwork that she drank wine.  At the time of the report, the outcome of the patient was no reported.  It was unknown if the patient sought medical attention.  Follow up information has been received from a physician concerning the 21 year old female patient, no illness at the time of vaccination who on 01-SEP-2010 approximately at 15:00 pm was vaccinated intramuscularly into the right deltoid with the first dose of GARDASIL (Lot # 666163/0664Z).  The physician reported that on 02-SEP-2010 at 09:00 am the patient complained of RIB pain, she claimed that she got tracheal-esophageal thrush and oral thrush from the vaccine, as well as sore throat.  Diflucan 150 mg was given for yeast infection.  On an unspecified date, the patient had recovered.  There were no laboratories performed.  The physician reported felt that tracheal-esophagus thrush, oral thrush and sore throat required medical intervention to prevent serious criteria.  No further information is expected.
High fever for three days post vaccine (high = 103).  under arms were sore and swollen for four days, headache for four days.  Arm at injection site swollen and hard for six days following vaccine.
Seizures, went by ambulance to er.  Stayed there for observation for an hour and was released home
Pt came to the pharmacy on March 15,2021  to show that she had a large, red, swollen area around the area on her arm where she stated she received the Shingrix vaccine 2 days prior, on March 13,2021. Her are had a red area about the size of a grapefruit on her arm, and was quite red. The patient said the area was painful and itchy.  I examined the area and discussed the possibility of adverse effects and apologized it happened to her. I explained I would submit an VAERS report., and follow up with her.  On March 16,2021 i called the patient to follow up and she said the area was slightly bigger and her daughter had taken a picture and sent it to her physician. I followed up again with patient on 3/19/21 and she said it was better and lighter pink color. She will talk to md about not getting the 2nd dose as this could be allergic response. No further follow-up needed at this time
It started with low energy and a severe sore throat. I took a home COVID-19 test and it was negative. I went to our local hospital and took one of their tests and found out that night it was positive. The next night, I still had a really bad sore throat and a fever of 100.4. I was also very fatigued. I took a five day course of the generic version of Paxlovid. By 04/25/2022 I felt better but the fatigue stuck with me for about 10 days. I was still testing positive for about nine or ten days. During the days I am able to do normal activities but at night I still get very fatigued around 9pm. Also, about a week after I started feeling back to normal, I had an really bad IBS flare up that last about 5 days.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2012, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Headache chills fever  upper respiratory cough, muscle aches,  earache, stomach ache, pain at injection site and itching
Child developed hives on face on 2/15/00. On 2/16/00 pt developed hives on face, neck, trunk, arms and legs. Pt was seen by a private MD and told to use over the counter Benadryl. Hives lasted 3 days.
One day following administration of vaccine developed pruritic, erythematous rash over upper chest, upper back, upper arms, as well as body aches, diarrhea, nausea and headache.  On days 2-4 following vaccination, myalgias, nausea, and diarrhea resolved.  Rash continued to be erythematous and pruritic. Intermittent headaches, becoming severe on day 4 with syncopal event, dysarthria, bilateral lower extremity numbness in non-dermatomal pattern, bilateral calf pain, and bilateral quadriceps & hamstring weakness resulting in inability to ambulate.
pt was administered 0.5 ml of moderna booster into right deltoid. No adverse reactions/side effects noted during observation and patient exit.
Feeling sick with the stomach; Really bad pain; pain in the stomach; Diarrhea; Vomiting; Feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Lot number: FE3590) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunization; Bnt162b2 (2nd Dose), for Covid-19 Immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "not recovered", described as "Feeling sick with the stomach"; ABDOMINAL PAIN UPPER (non-serious) with onset Nov2021, outcome "not recovered", described as "Really bad pain; pain in the stomach"; DIARRHOEA (non-serious) with onset Nov2021, outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset Nov2021, outcome "not recovered", described as "Vomiting"; MALAISE (non-serious) with onset Nov2021, outcome "not recovered", described as "Feeling sick".  Additional information: My wife went to get her booster shot (Clarified as COVID-19 Vaccine) last week on Thursday and then she started feeling sick Friday and then Friday she started feeling sick and then till today she is feeling sick with the stomach, really bad pain, diarrhea and vomiting. She got no headache, cold or nothing, it is just the pain in the stomach."  No follow-up attempts are possible. No further information is expected.
My arm was a little sore at injection site the day after. Then the second day after I woke up to my arm being a lot more tender and it had a red rash beneath the site of the injection and was slightly swollen and occasionally itched. Each day since then the rash has gotten bigger and spread further around my arm, feels feverish, the knot got bigger and is more painful to touch.
Chills, Body Aches, Fever as high as 101.6. Fever started the following day (02-26-2021) at 930am and lasted approximately 12 hours. Was down to 99.0 around 8:30pm
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A2B1) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            Treatment product was not provided. concomitant product was not provided   This case was linked to MOD-2021-073336 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR received on 24-MAY-2021.Received second dose. Patient declined further follow-up.; Sender's Comments:  MOD-2021-073336:Same reporter/different patient (husband case 1st dose)
Painful arm, body aches and chills, fatigue. Lasted about 24 hours.
Patient presented with PPROM at 32w5d (EDC 11/5/2021) on 9/15/2021 and experienced spontaneous labor.  Pregnancy previously complicated by IVF conception, hypothyroidism with normal TFTs, anxiety.   Underwent primary cesarean delivery due to arrest of descent.  Acute blood loss anemia with transfusion of PRBC, FFP.  Newborn with Apgars of 0/0/0 and severe HIE and died 9/27/2021
Headache & fever starting 6 hours after vaccine & still present at 48 hours.
Heart hurts, heart randomly starts beating really fast. Feels like theres acid in my throat. Cant sleep, laying down worsens the pain.