chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient recieved second dose of menactra at age 16 and third dose today was 4 months later, no AE; Initial information received on 26-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 year old male patient who was vaccinated with a second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and four months later patient was again vaccinated with 0.5 mL third dose of (lot U6586AA, expiry date: 14-Apr-2021, frequency once) via an intramuscular route in the right deltoid on 25-Jun-2020 for prophylactic vaccination (extra dose administered).  Medical history, medical treatment and family history were not provided. Patient recieved first dose of Menactra at the age of 11 years.  Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (HPV VACCINE VLP RL1 9V (YEAST)) for Immunisation.  It was an actual medication error case due to an extra dose administered. It was reported that the patient received Menactra today which was a third dose. He received the second at age at 16 years and third dose 25-Jun-2020 was 4 months later.  At the time of this 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.
pt. vax'd w/1st dose of hepatitis B & developed bumps on the abdomen & neck w/muscular stiffness & itching. after 2nd vax rash began itching & spread to face and rt leg.
About 7-8 weeks after the vaccine, my left breast became inflamed. I went through a series of doctors and ended up being diagnosed with granulomatous mastitis, an autoimmune disease. I belive that the vaccine triggered this disease, which I am still dealing with.
Patient reports pain and swelling on 1/24/15. On 1/25/15 patient reports itching and heat at injection site. Then he reports red raised skin reaction.
administered only the liquid component of Menveo; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 22-JUN-2023, the patient received Menveo. On 22-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered only the liquid component of Menveo) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-JUN-2023 The pharmacist reported that a patient was administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The healthcare professional was unsure if the age of the patient was 18 or 19 years.
Patient stated that he got hives around the injection site and later it spread to other parts of his body - this is now resolved Patient stated that he felt a tightness in his chest on the evening he got vaccinated and that it has persisted until now. Patient refused to go to the hospital for evaluation
Patients Mom states that after completing the COVID-19 series she has had a very irregular menstrual cycle, irregular hormone levels, and anemia. The patient has been hospitalized due to these issues
headache; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th January 2020 08:15, the patient received Shingrix. In January 2020, less than a day after receiving Shingrix, the patient experienced headache and tiredness. On an unknown date, the outcome of the headache and tiredness were unknown.   It was unknown if the reporter considered the headache and tiredness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient wanted to know whether how long mild side effects would last. The patient had a mild side effects, just headache and tiredness after vaccination. The patient received vaccine the day before reporting evening around 8:15 pm and at the time of reporting it was 6:50 pm next day. The headache was just mild to moderate but still felt very tired.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03Aug2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Oct2021 at 12:00 as dose 3(booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "(Remission) Ulcerative colitis" (unspecified if ongoing); "GAD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "asthma" (unspecified if ongoing); "migraine" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies:sulfa drugs, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound started 4-5 days after negative test/completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient received anti viral treatment (Pfizer Paxlovid) from 05Jul2022 to 09Jul2022 for COVID 19 Treatment. There was a rebound started 4-5 days after negative test/completion of Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
14 hrs of non stop vomitting after first vaccine which led to chronic nausea, and every sick occurrence leads to nausea and gallbladder removal. The chronic nausea is continuing at this time.
Patient received the 1st dose of Moderna and was observed for 15 minutes after the injection. Patient was released and states on their way home they do not know what happened but the woke up and had hit a tree. The airbags did deploy, patient had a gash around 2 inches on the right eyebrow, vital signs were blood pressure of 79/49, oxygen of 99%, and a heart rate of 49. Patient was promptly evaluated by a physician and determined to be more appropriate for the ER, patient was escorted via wheelchair to the emergency room accompanied by a nurse and the physician whom then gave report to the on call physician at Hospital.
Migraine headaches for 15 days; Sore arm; Tingling feeling into finger tips; Fatigue for one week; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm right on 13Apr2021 at 10:45 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no past drug history. 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 14Apr2021 at 07:15, the patient experienced sore arm with a tingling feeling into finger tips, fatigue for one week and migraine headaches for 15 days. Therapeutic measures were taken as a result of sore arm with a tingling feeling into finger tips, fatigue, migraine headaches and included treatment with Tylenol. The clinical outcome of the event fatigue was resolved on 21Apr2021, migraine headaches was resolved on 29Apr2021 , sore arm and tingling feeling into finger tips were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
A female patient had received an injection of ADACEL; sanofi pasteur Ltd. lot number C4008BA (route of administration not reported) in left deltoid on 10 January 2012. On an unspecified date following vaccination, the patient developed redness, swelling and pain in arm. It is unknown if the patient received any corrective treatment. No further information was available at the time of this report. The patient outcome was not reported.  Documents held by sender: none.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient lied down on floor and was unresponsive for 5-10 seconds. Pt reports this commonly happens to her after a vaccine.
Information has been received from a registered pharmacist concerning 29 year old female pt who was vaccinated with third dose of Hep B vaccine. Aspiration from the left deltoid was without blood. Upon administration of the vax, the pt jumped. After removal of needle, the injection site was bleeding moderately. A small amount of blood was noted in the tip of the syringe. The administering nurse felt that some of the vaccine could have been given intravenously. The pt's vital signs were stable and she was without complaints.
07jun90 pt vax hepta b. pt ex gen malaise and weakness similar to influenza, aching joints and muscles.
not sure if i marked the right vaccine above ..on 11/14/2016 he had flu 11v4 MDV.  Event was on 12/22/16 he went to the dr for a cough and fever that had been going on for about 1-2 weeks, dr dx him with bronchitis.
Sore arm; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 27Jan2021 at 14:30 at a single dose on right arm for COVID-19 immunisation. Medical history included polycystic ovaries (Polycystic Ovarian Syndrome) from an unknown date and unknown if ongoing. Concomitant medications included metformin, spironolactone, buspirone and ethinylestradiol, levonorgestrel (CAMRESE). The patient experienced sore arm and tiredness on 27Jan2021 at 15:00. Treatment received for the adverse event was reported as No. Outcome of the events was recovering.
Localized swelling and redness, 5" by 3" slightly tender, itchy.
Information has been received from a consumer concerning her daughter with no pertinent medical medication who was vaccinated IM with the third 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication. The reporter said that her daughter started experiencing "periods of dizziness and blackouts" a month after getting her third dose of GARDASIL. This adverse event had "persisted" and happened at least once a day. The patient had had to "come home from work a couple times" because of this adverse event. There was no adverse event after receiving the first 2 doses of GARDASIL. The patient sought unspecified medical attention. A blood test and an echocardiogram were performed and the results were unknown. At the time of the report, the patient had not recovered. The patient's sister experienced mononucleosis, dizziness, blackouts and vomiting after getting her third dose of GARDASIL (MSD, WAES# 0909USA01177). Additional information has been requested.
Discharge Provider: MD  Primary Care Physician at Discharge: MD Admission Date: 7/16/2022  Discharge Date: 07/19/2022  Headache [R51.9] Acute intractable headache, unspecified headache type [R51.9]   HOSPITAL COURSE:   Patient is a 12 y.o. male with PMHX significant for shunted hydrocephalus (Strata 1.0; last revised 2017), left temporal arachnoid cyst,  vision impairment (legally blind), and migraine headache presenting with headache and vomiting in setting of COVID infection..    Mother reports she initially started to have cold-like symptoms starting Monday (7/11/2022). Patient then started to have symptoms of headache, rhinorrhea, congestion and vomiting starting roughly two days prior to presentation. Family tested positive for COVID at home. Initially seen at ED on 7/14 with concern for headache believed likely secondary to COVID infection. Head CT without increase in ventricular size (slightly decreased); although noting acute sinusitis. No concerns for shunt malfunction. Provided IV fluids and discharged with Reglan for nausea/vomiting x2. Continued to have headaches at home with continued nausea/vomiting. Again seen at ED on 7/16 and provided migraine cocktail with Toradol, Reglan, Compazine, Benadryl and a x1 NS bolus. Continued to have headaches and nausea/vomiting despite interventions and was admitted under Neurosurgery service. Headache located in frontal area, constant, and associated with photophobia. Follows with neurology for migraines.   Inpatient was evaluated by Peds Neurology who recommended migraine regimen with Toradol, magnesium, benadryl and compazine. He developed dystonic reaction to compazine with increased tone in neck, arms, wrists, and hands, and twitching of lips. He also experienced episodes of dysconjugate gaze. PO benadryl did not help but rapidly improved after iv benadryl. Discontinued Compazine and Reglan and monitored mental status. Headache resolved, pediatric hospitalist team took over as primary team as neurosurgery had no concerns for shunt malfunction. Dystonic episodes slowly improved, did not hinder oral intake, and patient was felt to be stable for discharge. Will send home with migraine regimen per neurology in case headaches return, and benadryl for dystonia.
my arm still sore to the touch; soft lump; This is a spontaneous report from a contactable consumer. A contactable consumer (patient) reported for herself that the female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2) for covid-19 immunization. The patient experienced my arm still sore to the touch on an unspecified date with outcome of unknown, soft lump on an unspecified date with outcome of unknown. The consumer reported that "i had my 2nd vaccine on 03Mar2021. Why is my arm still sore to the touch and a soft lump."  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever- onset- 5 hours after vaccine (continued for 36 hours) Body Aches- Started 12 hours after vaccine and continued for a total of 24 hours Headache- Started 12 hours after vaccine and continued for a total of 24 hours Fatigue- started 12 hours after vaccine and continued for a total of 24 hours Nausea- Started 12 hours after vaccine and only lasted 3-4 hours
Vertigo when getting up from lying down position, rolling over in bed and getting up after sitting down.
Tired; Loss of appetite; Get hungry but eats a little then loses appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), APPETITE DISORDER (Get hungry but eats a little then loses appetite) and FATIGUE (Tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 010A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM (COZAAR), INDAPAMIDE, VITAMIN D NOS, MULTIVITAMIN & MINERAL, FLAXSEED, POTASSIUM CHLORIDE and METRONIDAZOLE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced DECREASED APPETITE (Loss of appetite) and APPETITE DISORDER (Get hungry but eats a little then loses appetite). On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired). At the time of the report, DECREASED APPETITE (Loss of appetite), APPETITE DISORDER (Get hungry but eats a little then loses appetite) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient received FLUVIRIN, PNEUMOVAX, and BOOSTRIX all on 11/4. She had never received a flu shot prior to this and was diagnosed with pertussis 18 months ago. Hours after the vaccination administration, she began to have chills, body aches, nausea, and overall poor feeling. She took Ibu and APAP q6h to help with symptoms and diphenhydramine at night. By 11/7 she was feeling better but was still feeling mild symptoms.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2006, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-DEC-2015 the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
full body pruritic rash requiring benadryl 25 mg PRN for more than 2 weeks after the vaccine. No new laundry detergents, soaps, fabric softeners, deodorant, new medications, new foods. As of today, still present but markedly improved. Nearly resolved.
Information has been received from a registered nurse concerning a 19 week female patient with no medical history or allergies reported who on 26-APR-2007 was vaccinated with Rotateq (Lot # 656191/1365F). Concomitant therapy included Comvax (LOT# 654992/0984F) given in the right leg, diphtheria toxoid (+) pertussis acellular vaccine (unspecified), poliovirus vaccine and Prevnar. On 27-APR-2007 the patient developed a papular, red, "sandpaper" like rash. The rash appeared on the left side of the body, from about 3 inches below the nipple line to the top of the left thigh. The patient sought medical attention and was treated with BENADRYL. There was no product quality complaint involved. Additional information has been requested.
Mild swelling at the site occurred about 24 hours after the vaccines. Fever (Tmax 102). Rx-supportive care, TYLENOL PM pain.
Second shot- Fever, chills, headache, redness and swelling a site of injection.
Got some bumps on my neck; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 25Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient got the second shot of Pfizer COVID and on an unspecified date patient got some bumps on neck. Patient enquired that did anything to do with the shot or not; because patient never had this before. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
itching near the injection area; red rash around band of her left arm; local reaction with arm pain, little tenderness while rubbing her left arm; Initial information received on 26-Jan-2021 regarding an unsolicited valid non-serious case received from the other health care professional (HCP) via Medical Information (Reference number- 00447170).  This case involves a 65 years old female patient who experienced itching near the injection area (injection site pruritus), red rash around band of her left arm (vaccination site rash) and local reaction with arm pain, little tenderness while rubbing her left arm (vaccination site pain), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 23-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ519AA, expiry date: 30-JUN-2021, Strength: High Dose, via intramuscular route in the left deltoid for prophylactic vaccination.  On 26-Oct-2020, the patient developed a non-serious itching near the injection area (injection site pruritus), red rash around band of her left arm (vaccination site rash) and local reaction with arm pain, little tenderness while rubbing her left arm (vaccination site pain) three months three days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Reporter can be contacted by Sanofi: Yes Potential PTC(Product Technical complaint): No, Description: Call transferred from Sanofi Pasteur customer service. HCP reports she experienced adverse reaction to FLUZONE HIGH-DOSE QUADRIVALENT. Caller also has question regarding the difference between FLUZONE QUADRIVALENT and FLUZONE HIGH-DOSE QUADRIVALENT. Additional Description of event: Caller reports local reaction with arm pain for 3 days following the injection. She reports a few days later she experienced a red rash around band of her left arm. Caller also reports some itching near the injection area for one day. Caller reports she did not feel right after administration and states she probably will not receive the high-dose formulation next influenza season. While on phone, caller states she is experiencing a little tenderness while rubbing her left arm now. She does report that office physician confirmed other patients had strange rashes on back, chest, and arms following administration of FLUZONE HIGH-DOSE QUADRIVALENT. First time product used: Yes and Still using product: No.  No laboratories details reported.  No corrective treatment receive by patient.  On 27-Oct-2020, the patient recovered from injection site pruritus.  The event outcome was reported as unknown for other events.