chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administering Bexsero instead of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 2022) 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 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: 29-Mar-2022 Reporter's Comments: Agency reported potential case of administering Bexsero instead of Menveo. Health care professional (HCP) said that the count of Bexsero and Menveo were off they realized the possible mistake. The reporter consented to follow up. Additional Supportive Information: The patient received Bexsero instead of Menveo, which led to wrong vaccine administered. This is one of four cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022056731:same reporter US-GLAXOSMITHKLINE-US2022056735:same reporter US-GLAXOSMITHKLINE-US2022056734:same reporter
This is a spontaneous case, initially received from other health professional on 28-Feb-2018, concerning a 64-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Feb-2018, while drawing the FLUCELVAX QIV (batch number: 195125 and expiry date: 30-Apr-2018), the vaccine leaked from MDV (multi dose vial) stopper's puncture hole on the patient's (administrator's) hands and patient washed her hands. The defect was discovered during use of product. The packaging was not damaged and packaging (carton, leaflet) were not appeared wet or water damaged. The 23-gauge needle and syringe size of 3 ml were used. No air was added to the vial from the syringe but when needle was extracted, vaccine sprayed out of the punctured hole. Leak was observed at the point of needle exit and no leak was observed around the edges of the stopper. This report was associated with PTC (product technical complaint) with PTC reference number: 1028299. The investigation performed, concluded that FLUCELVAX Batch 195125 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components. The most likely root cause will be attributed to improper handling by the user. It was reported that, no adverse effects were noted. The reporter assessed the events as non-serious. Follow-up received quality assurance department on 12-Apr-2018: The investigation performed, concluded that FLUCELVAX Batch 195125 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components. The most likely root cause will be attributed to improper handling by the user. Narrative was amended accordingly.
Pulmonary embolism bilaterally.  Also severe cardiomyopathy, LVEF 33%  on 12/13/21
2nd RN discovered too little vaccine in vial for the number of vaccines that had been given. A total of 2 for the morning.  It appears no diluent was added to the vial of children's Pfizer 0.2 ml
Received an Expired Dose of Heplisav-B; Initial Report Received on 28-Jul-2022  A Medical Assistant reported that a patient (age, gender, race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine).  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 28-Jul-2022, the patient received an expired dose of HEPLISAV-B (Lot #, expiration date 24-Jul-2022 and NDC # not reported) through an unknown route and site.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
My menstrual cycle started in the middle of my cycle three days after shot. I'm on BC to keep my periods regular.
First dose on 06-Nov-2020 / diagnosed with COVID-19 later December; This case was reported by a pharmacist via and described the occurrence of covid-19 in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th November 2020, the patient received the 1st dose of Shingrix. In December 2020, less than 2 months after receiving Shingrix, the patient experienced covid-19. The patient was treated with monoclonal antibody (nos) (Monoclonal Antibodies). On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and in later December 2020, the patient was diagnosed with COVID-19, which was treated with monoclonal antibodies. There was no other problem with 1st dose. The pharmacist wanted to know that could this patient receive the 2nd dose of Shingrix. No further information provided. The reporter consented to follow-up.
Client received immunizations at 9:30 AM on 11 22 10. After she ate supper (approx 9 hrs later) she had a fever of 100.2; nausea and a severe headache. Took 2 ibuprofen (200mg each) sometime during the night; still had headache this morning which is severe. Has temp 100.2. Took 800mg ibuprofen over the past hour. Nurse referred client to urgent care; Minor ER or Emerg. Room
Adverse event - Hot at injection site, extreme swelling, extreme redness, itching, blistering, hardening at injection site underneath in the lymph nodes in the arm pit. Headaches, irritable, irritation in eyes. No fever or elevation in heart rate. Some respiratory difficulty requiring the use of the rescue inhaler and a neutralizing treatment at the Urgent Care facility. However, there was not swelling in the throat area.
effected her asthma; ended up testing positive/had COVID-19 in November; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (effected her asthma), COVID-19 (ended up testing positive/had COVID-19 in November) and DRUG INEFFECTIVE (Lack of drug effect) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient went to urgent care 2-3 times) and Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), LOSARTAN, MONTELUKAST, SERTRALINE, PRAVASTATIN, ALBUTEROL [SALBUTAMOL], LEVOCETIRIZINE, PROBIOTICS NOS, MELATONIN, MIRABEGRON (MYRBETRIQ) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (ended up testing positive/had COVID-19 in November) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced ASTHMA (effected her asthma). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHMA (effected her asthma), COVID-19 (ended up testing positive/had COVID-19 in November) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In November 2021, SARS-CoV-2 test: positive (Positive) ended up testing positive.Concomitant product included Resmipat 1.25 taken 2 sprays daily, Ristela spray taken twice a day and nebulizer taken as the circumstances arises.Treatment medication included monoclonal antibodies on 23 Nov 2021 and antibiotics. Sender's Comments: This case concerns a 79-year-old female patient with relevant medical history of Asthma, who experienced the unexpected event of COVID-19, Drug Ineffective, and Asthma. The events of COVID-19 and Drug Ineffective occurred approximately 8 months after the second dose of mRNA-1273 (Moderna covid-19 vaccine); while Asthma occurred at unspecified interval. The rechallenge was not applicable as events occurred after second dose. Patient's underlying medical condition remains a confounder.The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) in not affected by this report.
Had pfizer shot in the afternoon of November 16, 2021. I had perfect hearing. 4 days later I was stone deaf. Could not hear anything. People were speaking and I could only read lips. I went to Eye and Ear Emergency center. They confirmed thru testing that I had fluid in both my inner ears. Continued to be deaf for weeks and went to Dr. ENT and he tested me for tumors, etc. He said it would take weeks but fluid should dry out. Today Dec. 28, 2021 my hearing is a little better, but I am struggling to hear people. It was frightening
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions or concomitant medications was not provided. On or about 2016, the patient was inoculated (by an unspecified person) with ZOSTAVAX for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. After receiving ZOSTAVAX, the patient was diagnosed (by an unspecified person) with postherpectic neuralgia. As a direct and proximate result of these malfunctions, 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. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events of persistent strain of herpes zoster, postherpectic neuralgia, and vaccination failure were considered to be disabling by the reporter. Additional information has been requested.
Pain in left arm centered in bicep muscle where inoculation with FLUZONE HIGH-DOSE 2016-17 serum. Experienced noticeable pain and difficulty in raising arm above shoulder, pain when using arm to lift, push or pull.
Tiredness; chills; fever; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot unknown: True, lot unknown reason: not available/provided to reporter at the time of report completion) intramuscularly at right arm on 18Jan2021 at 12:00 PM at a single dose for COVID-19 immunization. Medical history included known allergies: penicillin. Other medical history was reported as none. No other vaccine in four weeks. Other concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer) intramuscularly at right arm on 28Dec2020 at 01:00 PM at a single dose for COVID-19 immunization. Facility type vaccine was at Hospital. The patient was not pregnant. The patient experienced adverse events included tiredness, chills, fever; with start date on 19Jan2021 at 04:30 AM. No treatment received for events. The outcome of events was resolving. No COVID prior vaccination and no COVID tested post vaccination.  Information on the lot/batch number has been requested.
Case number PHHY2011US58425 is an initial spontaneous report received from a consumer on 28 Jun 2011 with a follow-up from the consumer on 11 Jul 2011. This report refers to a 21 years old female patient. She was given only the CYW-135 liquid component of MENVEO (batch number: 090701) without being reconstituted with MenA lyophilized conjugate component, intramuscularly on 11 Jun 2011. The patient was revaccinated with the correctly reconstituted MENVEO (batch number: unknown) on 29 June 2011. No other adverse reaction was reported. Follow-up received from the consumer on 11 Jul 2011: Updated information about revaccination of the patient.
About 24 hrs after vaccine, woke from nap with itchy nose and congestion.  Throughout the night, patient was progressively more pruritic. She started to sneeze often with conjunctival injection. When she woke up in the morning, she noted her face was covered in red dots. She went to school and at that time she felt feverish with associated joint pain and shortness of breath. Her face was blotchy. Due to the constellation of symptoms, she was excused from school and went to Urgent Care. At UC she had diarrhea and episode of emesis. They gave her BENADRYL with strict return precautions. Then soon after leaving, at 1400 she fainted with associated lip swelling and so went to ED. They gave epinephrine right away and a dose of prednisone. All symptoms went away, then 2 hours later all the symptoms started to return. She again had nausea and severe vomiting with shortness of breath and body aches and so another epinephrine injection was administered
COMPLETELY IMMOBILE; SWEATING; DIZZINESS; NECK PAIN; FAST HEARTBEAT; SHOULDER PAIN; CHILLS; JACKHAMMER HEADACHE; WEAKNESS IN BODYPARTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient had no allergies. 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 19-MAR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAR-2021, subject received Covid vaccine. On MAR-2021, the patient was completely immobile, experienced sweating, dizziness, neck pain, fast heartbeat, shoulder pain, chills, jackhammer headache, weakness in body parts. Treatment medications (dates unspecified) included: ibuprofen. The patient could not do normal exercise that used to do earlier, because of headache.  The patient was in bed from friday, saturday and sunday and 22 march also included in it. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient had not recovered from jackhammer headache, and the outcome of chills, sweating, dizziness, weakness in body parts, completely immobile, shoulder pain, neck pain and fast heartbeat was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210340656-COVID-19 VACCINE AD26.COV2.S-completely immobile. 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).
Received nasal FLUMIST on 10/27/10 at 930 AM. C/o headache after vaccine. Snack & watched x 15 min. Returned to class. 1005 c/o itchy eyes, flushed on face & chest. Tonsils red and enlarged. Arch of soft palate is bright strawberry red. T=99.8 BP 140/78; P 84 & reg. 1005 BENADRYL 12.5mg po - fast melts. 1010 Epi 0.3mg (1:1000) (R) deltoid. 911 called. 1020 T=100; chest & face clearing. Pinna of both ears - red & hot.
Patient had fainting episode immediately after shots were given. Fell to the floor and jerked for a few seconds. Fell to the floor and jerked for a few seconds. Came to and was pale and lethargic. Vomited one time. Mother took her to the E.R. Has Family History of seizures.
Fever to 103 w/extreme irritability & inconsolability-moderate local rxn in thigh;
vaccine  brand=Pfizer / BioNTech/vaccine  brand  other=Moderna; 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 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: Gj2524) at the age of 53 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11May2021 as dose 1, single (Lot number: 027c21a), in right arm, on 08Jun2021 as dose 2, single (Lot number: 011d21a), in right arm and on 03Jan2022 as dose 3 (booster), single (Lot number: 059h21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "diabetes type 2" (unspecified if ongoing); "pituitary tumor" (unspecified if ongoing); "PCOS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine  brand=Pfizer / BioNTech/vaccine  brand  other=Moderna".  The patient received treatment with Paxlovid from 25Feb2023 to 02Mar2023 and experienced Paxlovid rebound on 07Mar2023.
The patient  is an idd resident and while administering the shot pulled her arm away forcefully and some leaked out. I spoke with Moderna on the phone, she said that if 50 percent or more was administered that we do not need to revaccinate. All 3 people agreed that more than 50 percent was administered so we did not revaccinate per the company direction.
5/30  9y.o. male with prior history of cerebral palsy and epilepsy with focal intractable seizures presenting with fever and altered mental status.
Patient recieved extra dose of Hepatitis B vaccine. Recieved 4 doses in total series
Patient came in to clinic for Nurse visit for 2nd dose of BEXSERO, I gave HPV GARDASIL 9 also. Patient already has 3 doses of HPV. Notified Dr. of incident and advised patient another dose of HPV does not have harmful effects. Patient was informed of vaccine error. BEXSERO was the only vaccine initially that was only suppose to be given. HPV GARDASIL 9 is the extra dose). No adverse reaction 15 min after injection.
Per mom both legs were very swollen 3in in diameter.  Left leg worse, very bright red and warm to touch.  Lasted 4 days.  On 4th day continues to have minimal swelling in left leg.
Swollen lymph nodes (underarm) on side of injection; This is a spontaneous report from a contactable consumer, patient. A 30-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Lot Number: ER2613) via an unspecified route of administration, administered in the right arm on 26Mar2021 at 15:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient has no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on 05Mar2021 at 15:45 (Lot Number: EN6205; at age of 30-years-old) via an unspecified route of administration in the left arm for COVID-19 immunisation. The patient experienced swollen lymph nodes (underarm) on side of injection on 28Mar2021 at 08:00. No treatment was provided for the event. The patient had not recovered from the event, swollen lymph nodes (underarm) on side of injection.   No follow-up attempts are needed. No further information is expected.
pt recv vax 16APR97 & APR97 pt exp  n/v, fever, muscle pain @ site of inj & weakness in the rt arm;pt felt like was improving as time passed;
problems with the ear/ pressure sensation in the right ear; ringing in my ear; This is a spontaneous report received from a contactable consumer, the patient. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, the patient experienced problems with the ear/ pressure sensation in the right ear and ringing in the ear. Clinical outcome of the events problems with the ear/ pressure sensation in the right ear and ringing in the ear was unknown.  Information on the lot/batch number has been requested.  Follow-up (04Apr2021): Follow-up attempts are completed. No further information is expected.
cold sweat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 17:00 (Lot number: 30130RA) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FA7485, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 21Aug2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: COLD SWEAT (non-serious) with onset 18Sep2021, outcome "not recovered", described as "cold sweat". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of cold sweat.  Additional information:Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. Device Date was 04Oct2021. No Prior vaccinations.    No follow-up attempts are possible. No further information is expected.
After observation time completed, mother asked how the Pfizer vaccines could be added to the CDC card of the Moderna card that was given to them that day. Staff not aware patient had previously received Pfizer doses. Spoke with mother of patient on 10/18/2022 and verified that no serious side effects or reactions were seen in patient post vaccination except a fever the night of vaccinations but patient was fine the next day.
Headache, chills, fever, arm soreness, skin sensitive to touch. Feels like i have covid again  waking up this morning.
Redness, swelling and itching beginning ~1wk from injection. Tennis ball size welt.
4/30/18 received SHINGRIX vaccine and later that evening reports urticaria and rash all over body. 5/8/18 Pt. calls into medical office stating she is having an allergic reaction to the Shingles vaccine she received a week ago. Pt. states she has been using BENADRYL and taking oatmeal baths without relief of her symptoms. Pt. states a friend of hers who is a MD prescribed her lidocaine cream for itching and it seems to be helping. 5/9/18 Pt. called into medical office stating her itching and rash are getting worse and was advised to do go to UC for evaluation and treatment. Pt. seen in UC and prescribed Cetirizine HCL 10 mg for her symptoms.