chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from pharmacy intern and refers to an over 26 year old patient of unknown gender. There was no information regarding patient's concomitant medications, medical history, concurrent conditions, drug reactions or allergies provided. In approximately August 2016, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot number, expiration date were not provided) dose 1, for prophylaxis. In April 2017, the patient visited pharmacy and asked to receive second dose of GARDASIL 9. It was unknown if the second dose of the vaccine was administered. No adverse event was reported. No product quality complaint was involved in this case. Additional information has been requested.
Patient was onsite at a Vaccine Clinic, open to the public and received a Pfizer shot for his 2nd dose, when the first shot given was Moderna. Patient had no adverse reactions and did not report any injury or illness. This is being reported for the deviation from process with the mixed series as outlined on the Covid 19 Vaccine Error and Deviations flyer dated from 5/18/2021 as this is still considered an administration error.
Problem with balance; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Problem with balance) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Guillain Barre syndrome (during toddler stage).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (Problem with balance). At the time of the report, BALANCE DISORDER (Problem with balance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.
Pt was seen 9/27/21 with stroke symptoms (aphasia, R facial sensory changes, visual symptoms), given TPA and diagnosed with residual facial nerve palsy.  Pt also had accute appendicitis 11/24/21. Pt continues with "brain fog", word finding difficulties, computational difficulties and myalgias.  These symptoms were worsened after the booster, Moderna, lot 05h21A given at the pharmacy on 1/3/22.
Bexsero instead of menactra; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number 4CY37, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 29th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-Aug-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received Bexsero instead of Menactra, which led to wrong vaccine administered.
Between 5:05-5:07 Patient reported blurred vision. Went out to examine the patient and patient was diaphoretic with enlarged pupils and pale. He then stated that he could not see and stopped responding to voice and touch. After approximately 1 minute patient regained consciousness and said his vision was starting to return. Approximately 5 minutes after he said his vision had returned to normal, his pupils had returned to normal size.
The patient came to the clinic to receive his second dose of Moderna. But, the patient received a booster dose of Moderna instead. Contacted the patient to come back to the clinic to receive the rest of the vaccine to make up for the second dose.
87-year-old male with a PMH significant for AFib on warfarin, HTN, HLD, GERD, vaccinated x2 with Moderna who was diagnosed with covid-19 on Monday 1/10 at PCPs office. Confirmed with PCP, got molecular test, no prescriptions as outpatient. He reports experiencing tiredness and cough, very mild SOB with activity. Today, his O2 sat at home was reportedly 90-91%, he called his PCP and was advised to come to the ER for admission. In the ER, his O2 sat on arrival was 92% on RA, O2 sat during assessment 96-97% while talking. CXR negative for cardiopulmonary disease. Lab significant for transaminases AST 337/ALT 363, CRP mildly elevated, LDH 343, INR 4.18, troponins negative. Covid AG still pending collection.  He was admitted to medical for an Infectious Disease evaluation.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 18-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and zoster-related conditions.         On an unknown date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, he was treated and hospitalized for shingles. As a direct and proximate of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EK5730) and on 09Jan2021 as dose 2, single (Lot number: EL3246) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Jul2021 as dose 3 (booster), single (Lot number: 024C21A) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT (GSK). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) positive; (02Jun2022) Negative; (09Jun2022) Positive. Therapeutic measures were taken as a result of covid-19 with Paxlovid from 26May2022 to 30May2022 for 5 days, first negative antigen test on day 9 of infection (02Jun2022). Now with nasal congestion and newly positive antigen test 7 days later (09Jun2022).; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.
Patient received vaccine at 1031. At approx 1037 she reported mild tongue numbness. She denied SOB or chest tightness. At 1041 she also developed facial numbness/warmth and continued to deny respiratory distress. Vitals at 1044 were HR 102, RR 18, BP 151/97, O2 97%. By 1102 she reported improvement of symptoms. Vitals at this time were HR 89, RR 18, BP 137/97, O2 97%. We continued monitoring patient for 1 full hour at which point she reported complete resolution of symptoms. No medication intervention was necessary.
STATES 2 HOURS AFTER INJECTIONS AND FOLLOWING LUNCH, SHE BECAME NAUSEATED AND VOMITED. THIS OCCURS FOR 2 DAYS WITH "A LITTLE" DIARRHEA. PARENT TOOK HER TO HER PCP THAT DAY. DR TOLD HER IT WAS THE HEP A THAT MADE HER SICK.
pt recv vax;tested pos for HBsAg antigen and is antibody neg;
Did have the quarter sized red ring and rash around the injection site about 3 days after vaccine. About 8 days after vaccine pt has a fine rash on both forearms, top of hands, tricep area, later sides of torso, lower back, lateral sides of thighs and quads
This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of body pain in a 28-year-old male subject who was vaccinated with TWINRIX. On 3 AUGUST 2013 the subject received 1st dose of TWINRIX (unknown, left arm). In AUGUST 2013, less than one day ("within 24 hours") after vaccination with TWINRIX, the subject experienced body pain, sensation of fever, ("feels/felt feverish") and fatigue and on 13 AUGUST 2013, 10 days after vaccination with TWINRIX, the subject experienced elevated aspartate aminotransferase (AST) and elevated alanine aminotransferase (ALT). The nurse practitioner reported that the subject experienced body aches, fatigue, and felt feverish. The subject was seen by the reporting nurse practitioner on 13 AUGUST 2013 and the events were ongoing. The nurse practitioner clarified that the subject did not actually have a fever so his feeling feverish was subjective. It was also discovered at this appointment that the subject had "elevated LFT's" (liver function tests). According to the nurse practitioner, his AST was 70 and  his ALT was 147 and the "other levels were within normal range". At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with TWINRIX.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Diarrhea-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: The patient reports that adverse effects were noticed on the night of 5/20/21 and then checked into hospital
Within 24 hours of having my 3rd shot (booster), I started have pain and soreness in my left armpit (lymph gland). The pain and soreness has decreased each day and is barely noticeable  today.  It did not impede the use of my arm nor did it spread to any other location in my body.
09/21/2010 Mild local erythema, edema, warmth to the touch, achy. No fever, hives, dyspnea, wheezing, angioedema. Advised warm/cool compresses Ibuprofen and antihistamine. Observe & follow in 24hrs if no improvement or if worsens.
On the 8th day after the injection I got a rash/redness by the site.  It was about 1 and 1/2 inches in diameter...it has slowly spread and now it is about 6 inches in length and 4 inches wide...still itching and red (not as red as in the beginning) Have been taking an antihistamine and using cortisone cream which helps the itching.  Looks like bottom of the rash has some edema  in it.
Low grade fever, chills, lower back ache, headache  Took Tylenol. Whole episode lasted less than 24 hours.
Started with itching 4-5 hours post injection. Denies hives or rash. Itching to palms, scalp, neck and waist. Takes BENADRYL at home it goes away but by morning itching returns.
Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Mild, Systemic: Vomiting-Medium
Menstrual cycle has been much heavier (soaking thru tampons and pads within 2 hours) and longer 8-14 days.  Cramping has  also intensified.
Symptoms felt the day after shot: - chills - fever - fatigue  (I felt better after 24 hours)
Rash on left thigh 403/4 inches wheal with erythema and with heat. low grade fever 99.4 TX Orapred.
Right mid arm tense, red, swelling, Tylenol and Benadryl and cold compresses.
Had violent vomiting and diahrea, chills, high fever, headache, nausea, no energy, arm hurting.  day 3 still nauseaus and very tired.
10/13/2021 COVID-19 PNEUMONIA, HYPOXIA, ACUTE KIDNEY INJURY, COAGULOPATHY; 11/05/2021 DEATH R/T COVID-19
50 cent piece size welts, redness, hot and hurts to touch. Motrin as directed and warm pack to site injection.
Arm started getting hot and itchy  9 days after injection  . Big red spot on upper arm 4 x 3 approx.
pt recv vax 3NOV95 & was exposed to chicken pox;20DEC95 pt devel fifteen to twenty generalized chicken pox lesions & presented to MD;no further details were provided;
Patient reported day after receiving vaccine she developed a flat/red/itchy rash to her right arm and across her abdomen.
1. Pain and swelling at the injection site with intense itching - (Dec 1) took back to the doctor and they treated for a staph infection with augmentin 2. (Dec 2-9) Chronic headache and fatigue and flu like symptoms - rested at home 3. (Dec. 9) Measles like rash all over body with intense itching and aches in arms and legs and sore throat - treated for reaction to medicine (augmentin) by nurse line from pediatrician. 4. (Dec. 11) Continued rash and itching and aches with sore throat - confirmed adverse reaction from doctor 5. (Dec. 12-ongoing).  Recovering from rash, chronic sore throat, nausea, pain in legs and arms, general fatigue.
an expired dose of Daptacel was inadvertently administered to patient/No AE; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a two-month-old female patient who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] inadvertently (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication received by the patient was ROTATEQ (no dosing details reported).  On 06-Feb-2020, the patient received a 0.5 mL first dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5367AA, expiry date: 30-Jan-2020] via an intramuscular route at the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  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 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.
Reaction was on left thigh where MMR/Varicella was given. It began to swell the following day (08/31/2018) around the injection site. Swelling and redness continued to spread until it enveloped the entire front of the thigh and beginning to go around the sides surrounding the injection site. Extreme swelling, redness, hot to the touch, itchy, scabbing and uncomfortable. Resembled cellulitis and an urgent care doctor did diagnose it so on 08/31/2018. Followed up with regular doctor the following day (09/01/2018) and was told it was a "localized reaction" and not an allergy. Treatment: none; Skin is still discolored and scabs have not yet healed. Swelling has decreased and the thigh is now normal size.
FATIGUE; NAUSEA; HEADACHE; FEVER; RACING HEART; WEIRD DREAMS; FEEL UNUSUAL; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-OCT-2021 for prophylactic vaccination. 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 OCT-2021, the patient experienced feel unusual. On 06-OCT-2021, the patient experienced racing heart. On 06-OCT-2021, the patient experienced weird dreams. On 06-OCT-2021, the patient experienced fatigue. On 06-OCT-2021, the patient experienced nausea. On 06-OCT-2021, the patient experienced headache. On 06-OCT-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heart, weird dreams, fatigue, headache, and fever on 13-OCT-2021, and had not recovered from nausea, and feel unusual. This report was non-serious.
Patient scheduled second dose. The store is listed only for Pfizer vaccine. Patient presented with appointment for second dose. Upon verifying the date of 1st dose, we gave Pfizer second dose. Patient needs Moderna second dose, but was given Pfizer second dose. No reaction/adverse reaction happened at the time of the incident. Patient was given CDC guidance regarding getting two different covid-19 vaccine. Patient was told that per CDC recommendation, patient is considered fully vaccinated and no further Covid-19 vaccine is required.
I was vaccinated with Moderna in the right arm. Immediately afterwards, I  felt a searing pain in my right index and middle fingers. This pain last several minutes, and has recurred several times over the last 3 days.
Patient tested positive for COVID back in December 2020. She passed away at the nursing home facility on April 1, 2021.
After vaccination, area where vaccinated started to slightly tingle. Later, I experienced swelling, redness, itchiness. Area was also warm to the touch and sore. Today, area is slightly sore and still itches occasionally.
Pt. tested positive for Covid 19 by PCR on 07/21/2021
I had pink little dot on mid-section on my back. My nurse practitioner took a look at my back and determined I had an outbreak. I was prescribe Benadryl. It slowly disappearing.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) was reported to be  1) 22-DEC-2016. [It was written next to this date "due" 22-FEB-2017.) No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
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 69-year-old male patient received BNT162b2 (BNT162B2), on 25May2022 at 20:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sinuses" (unspecified if ongoing), notes: Sinuses was taking cholesterol pills but stopped temporarily to be treatment. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". 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.  Clinical course: The patient received Paxlovid for treatment of Covid-19 from 31Aug2022 to 06Sep2022. No adverse effect, mild systems but 5 days after Paxlovid tested positive with sore throat similar to strep throat. No known allergies. No other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approx 15 outbreaks since first and second dose; Rash is itchy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced approximately 15 outbreaks of Shingles since receiving first).  In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles and itchy rash. On an unknown date, the outcome of the shingles and itchy rash were recovered/resolved.  It was unknown if the reporter considered the shingles and itchy rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient received shingrix vaccine and experienced approximately 15 outbreaks of Shingles. The patient reported that outbreak always occurs on the left side, on the upper buttocks, lower back where the waistband of the underwear lies. The patient stated that rash was itchy and had the appearance on mosquito or spider bites. The reporter consented to follow up. For second dose refer this case US2021177371,reported by the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021177371: