chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional (nurse) and described the occurrence of intramuscular formulation administered by other route in an adult subject between 48 and 52 years of age of unknown gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2013 at 14:30 the subject received a dose of FLULAVAL (.1 dose, intradermal, unknown arm) and experienced intramuscular formulation administered by other route, wrong vaccine administered, and underdose. The FLULAVAL is indicated as a 0.5ml dose to be administered intramuscularly; however this subject received 0.1 dose "in the forearm". The nurse reported that "she accidentally gave" "a 0.1 dose of FLULAVAL as a PPD in the forearm, instead of intramuscularly." The nurse refused to provide any additional details. The nurse reported 2 other cases with FLULAVAL. See cases A1045207A and A1045210A for details on the other cases. Follow up was received from nurse on 1 November 2013. The nurse reported that this case had been reported to a Regulatory agency; however, a reference number was not provided. The nurse documented that on 7 October 2013 at 14:00 (previously 14:30), a female subject between 60-69 years old (previously an adult between 48 and 52 years of age of unknown gender) received a primary dose of FLULAVAL and experienced "marked pruritus for 10 minutes" and injection site redness (not previously reported). The nurse did not consider the events serious. The events were not life threatening, did not involve severe or permanent disability, did not involve hospitalization, did not involve congential defect, and did not jeopardize the subject or required intervention. The subject was evaluated by a physician within 15 minutes of the vaccination. On 10 October 2013, the nursing report documented that there were no adverse reactions at that date; however, the specific date of resolution was not reported. The nurse also provided follow up for the other 2 cases of A1045210A and A1045207A.
Normal symptoms: arm pain for 1 week, fatigue for 2 days Abnormal symptom: cloudy vision for 2 days (it's as if I had a film over my eyes)
got the vaccine/Suspected vaccination failure; shingles 6 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the vaccine/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles 6 times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 The case was received from the patient's parent via  interactive digital media.  The patient got the vaccine and still had gotten shingles 6 times. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Seven hours after receiving the vaccine I began having excessive PVCs.   Prior to this, I had usually had only about 0-3 per minute....and they usually weren't noticeable.    I started having them after every few regular heartbeats....possibly 10 or more per minute....and they  were noticeable.  The PVCs and headache kept me from sleeping that first night. I also had side effects like others reported...headache, fever, backache, chills, fatigue. After two  days or so they subsided.
Red rash developed on 3/7 and doubled in size by am of 3/8, injection site itchy and whole arm numb/sore down to fingertips
6/22/17 mom reported bloody stool with streak of blood x2, vomited x2 yesterday evening, refused to take bottle, seen by Dr. 6/22/17 and sent to Medical Center for U/S and evaluation-transferred to another Medical Center.
Severe joint pain & body aches,  Injection site is inflamed, hot and red, approximately 3? long and 2.5 inches wide and tender when touched. Loss of appetite, foggy mind.
So sore and painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles before).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shot and experienced soreness and painful. No further information was provided.
This spontaneous case, initially received from other health professional (nurse) on 30-Apr-2018, concerning a 04-year-old, female child patient. The patient historical condition included anaemia. The patient did not receive any concomitant medications. It was reported that, on 15-Mar-2018, the vaccine underwent temperature excursion of 34.3-degree F for 820 minutes, which was the first temperature excursion. On 18-Apr-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195244, expiry date: 30-Jun-2018 and anatomical location: not reported) which underwent temperature excursion of 34.3 degree F for 820 minutes. It was reported that, patient did not experience any adverse events after the vaccination. The reporter assessed the events as non-serious. This report was cross-linked to case 201801690 reported from the same reporter. Update 08-Jun-2018: Non-significant case correction was performed with IRD 30-Apr-2018: 'Accidental nature of the event' was removed from the case comment and case comment was corrected accordingly.
mom stated constant cry lasting 45 mins w/short intervals lasting long enough to catch breath; cry was unusual & scared mom; did not take to pvt MD; this episode started approx 6 hrs p/inject;
Patient is fully vaccinated. COVID positive on 5/6/2022. 52-year-old female patient with history of COVID in April oxygen dependent on 2 to 3 L nasal cannula presented secondary to worsening shortness of breath.  Patient states that this has been going on for approximately 1 to 2 weeks having intermittent fevers with a T-max over 102.  Patient otherwise denies any nausea, vomiting, diarrhea, chest pain.  Patient does have a history of GERD, MS, history of pulmonary emboli. CXR: Multifocal pulmonary infiltrates. Treatment: oxygen, antibiotics, Eliquis, steroids. Discharged home.
/24 ~24hrs post vaccination, pt presents to ED c/o itchiness all over x 1 day. Denies fever, chills, nausea, vomiting, CP, SOB, abdominal pain, difficulty breathing.  Denies accompanying rash. Otherwise, denies new medications, soaps/detergents/lotions, recent travel. Pt is currently menstruating (LMP start 4 days ago) and is also c/o increased vaginal bleeding since waking up this morning. States she is currently changing tampons once every hour compared to changing 3 tampons/hr during her usual menstrual periods.    Denies f/c, n/v/d, sob, cp, cough, abd pain, constipation, blood in stool, dysuria, hematuria, dizziness, HA, vision changes, dysphagia, sore throat, voice change.  Currently staying at a substance use rehab facility. Smokes 1/2PPD, denies current etoh or illicit drug use.  Pt given famotidine 20mg BID and zyrtec 10mg daily.   7/26 Pt presnets to ED again c/o same.  Diffuse rash noted all over her body. Pt was given benadryl 50mg IM, Prednisone 60mg PO and famotidine 40mg PO in the ED.  Dischared w/ Prednisone 50mg x4 days.  Pt continued to have issues with vaginal bleeding, later attributed to IUD.  NO mention of rash/itchiness at later visits.
PATIENT DEVELOPED REDDENED 3MM KNOT IN LEFT DELTOID POST VACCINATION.  NO OTHER REACTION NOTED. SCHOOL NURSE APPLIED ICE TO AREA FOR 30 MINUTES.  KNOT DECREASED TO 2MM.  NO REDNESS NOTED AT 10:20 AM.  STUDENT VERBALIZED THAT HE HAS A SORE ARM.
I have been getting all the vaccines from Pfizer and I have got sick each time; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 10Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I have been getting all the vaccines from Pfizer and I have got sick each time".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions were no provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX (lot # N031003), expiration date on 03-NOV-2019, for prophylaxis (strength, dosage, route and frequency were no provided). It was stated that the sterile diluent was properly stored. Also it was explained that the VARIVAX, was during 8 hours in a temperature of 8F, and that there were previously excursions: 41F for 62 hours, 6F to 14F for 72 hours. Data logger was positive. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA000594; US-009507513-1809USA000595; US-009507513-1809USA000596; US-009507513-1809USA000593; US-009507513-1809USA000587.
Left supra-clavicular swollen lymph node(s). Tightness at sight. Swelling is about 2 inches in diameter. There is currently no redness or pain.  Spoke to nurse. Monitoring symptom.
At ten days after receiving my vaccine my left upper arm reddened and swelled around the site of injection.  There is some pain and the site is very hot to the touch.
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age an gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patients received incorrectly stored doses of VAQTA (dose and route of administration were not reported) lot # N003194, expiration date: 28-OCT-2017. No adverse effects were reported. The vaccines were stored in 48 degrees Fahrenheit for 36 minutes. The temperature excursion was detected by a 'Digital Data Logger'. There were no previous temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009663: US-009507513-1705USA009664:
COVID following COVID vaccine series 03/19 COVID vaccine dose #1 04/08 COVID vaccine dose #2 07/01 reported start of "sinus symptoms" 07/12 presented to PCP with c/o nasal congestion, low grade fever, tiredness, diarrhea, post nasal drip, treated for lower respiratory tract infection since 07/01 07/15 reports testing positive for COVID with home kit, c/o cough, diarrhea, fatigue, fever, headache, myalgia, rhinorrhea 09/28 Influenza vaccine from non-VA pharmacy 10/3 COVID test for pre-procedure, tested POSITIVE for COVID, asymptomatic 10/04 clinical resolution for COVID d/t asymptomatic, likely persistent positive from previous infection
Patient was giving a patient their Covid booster vaccine and after completing the vaccine she was putting the syringe in the sharps container and the syringe bounced off the sharps container lip and rebounded into her thumb resulting in a needlestick injury. Patient immediately noticed that she was bleeding and we contacted the company nurse triage line for guidance on what to do.
pt recv vax; 21jul95 reports jerking spells, arm,body shook back & forth for a couple of sec;saw MD,electrolytes done;if episode cont EEG will be done;mom reports no jerking movements;
achy; skin hurts; Tired; sore arm; low grade fever; This is a spontaneous report from a contactable consumer. An 18-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), via an unspecified route of administration on the right arm on 24Mar2021 as a single dose for COVID-19 immunisation. It was reported that medical history was unknown. It was unknown if patient has received any other medication within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. It was unknown if the patient has any allergies to medications, food or other products. Prior to 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 4 weeks prior to the COVID vaccine. On 25Mar2021, the patient experienced tired, achy, sore arm, low grade fever and skin that hurts. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The clinical outcome of the events tired, achy, sore arm, low grade fever and skin hurts was recovered on an unknown date.   Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality unticked in slide 1.   No follow-up attempts are needed. No further information is expected.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "severe skin" (unspecified if ongoing); "respiratory" (unspecified if ongoing); "Medication allergies" (unspecified if ongoing); "food intolerances" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment of Paxlovid for COVID-19 from 27Apr2023 to 02May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300183864 same patient, different drug and different event;
No reaction on day of immunization (12/11/15) except standard muscle soreness at sight. Patient woke up Saturday AM feeling lethargic, "hung over" and with a rash on arm at site.
Having delayed reactions of itching at the injection site; Having delayed reactions of swelling at the injection site; Having delayed reactions of redness at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Having delayed reactions of itching at the injection site), VACCINATION SITE SWELLING (Having delayed reactions of swelling at the injection site) and VACCINATION SITE ERYTHEMA (Having delayed reactions of redness at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Having delayed reactions of itching at the injection site), VACCINATION SITE SWELLING (Having delayed reactions of swelling at the injection site) and VACCINATION SITE ERYTHEMA (Having delayed reactions of redness at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Having delayed reactions of itching at the injection site), VACCINATION SITE SWELLING (Having delayed reactions of swelling at the injection site) and VACCINATION SITE ERYTHEMA (Having delayed reactions of redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Additional information received included no new information and the reporter refused to provide further information.
About 3 minutes after receiving the vaccine, the patient reported feeling dizzy and as if she had a lump in her throat. She did not have trouble breathing or swallowing and no itchiness or rash. The patient was given Benadryl and Zyrtec. She continued to be slightly dizzy and was taken to the emergency department for monitoring. Workup in the ED was negative. The patient was discharged home.
headache; Fever; chills/uncontrolable shivering; Sweats; Hot Feeeling; Fatigue; This is a spontaneous report from a contactable consumer or other non HCP. A 44-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot Number was EW0180, Expiry date was not reported), dose 2 via intramuscular route of administration, administered in arm left on 11Jun2021 08:45 (Age at vaccination: 44-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history were not reported. Concomitant medications were reported as none. Patient had no known allergies. The patient previously received bnt162b2 (BNT162B2, solution for injection, Lot Number was EW0183,expiry date was not reported), dose 1 via an intramuscular route of administration, administered in arm left on 21May2021 (Age at vaccination: 44-years-old) 09:00 AM as dose 1, single for COVID-19 immunization. On 11Jun2021 22:45 the patient experienced headache, fever, chills/uncontrolable shivering and on 11Jun2021  the patient experienced sweats, hot feeling and fatigue. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient received no treatment for the events. The clinical outcome of the events headache, fever, chills/uncontrolable shivering was recovering, and unknown for other events.  Follow-up attempts are completed. No further information is expected.
Starting on day 13 after my first dose of the COVID vaccine I started having tinnitus bilaterally. I?ve never had any ear issues prior.  The ringing is constant. I initially did not think much of it until it got louder 2 days after my second dose of the Pfizer COVID vaccine. I got my second dose on March 12th and 48 hours later the ringing got much louder.
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. During the time period of 30-OCT-2015 through 04-NOV-2015, the patients were vaccinated with improperly stored GARDASIL (lot # K006960, expiration date 18-FEB-2017) (dose and route were not reported). No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A few minutes after receiving flu vaccine, patient felt weak and briefly passed out. Her mother fanned her and she quickly woke up. She then vomited. She was given a cold beverage which she sipped on and she rested until she felt better and well enough to leave.
After vaccine, developed subjective fever, malaise, headache, nausea and a rash over chest and neck. Symptoms mostly resolved after 48-72 hours, except for nausea which persisted longer. No specific treatment.
I got the vaccination at 12.15pm (03/28/2021) and after couple of hours, I developed headaches. I felt tired and went to bed early but I woke up at 2am (03/29/2021) with bone, muscle, and joint aches. I had chills, I couldn't sleep all night due to the pain especially in my legs (mainly bones). I used an electric blanket in the morning, which helped me with the pain a little bit. Around noon (03/29/2021), I had some blood when I peed. Then, in the evening, my kidneys started aching. I thought this was all related to urinary system, but today (03/30/2021) when I had a rush of blood coming from vagina, I think this vaccination might be causing vaginal bleeding too. I have Mirena IUD, and I don't have periods at all.
Difficult to swallow, then unable to swallow and swelling of the throat 2 minutes after vaccine. Shortness of breath then panic attack.  Hives back and buttocks.
Patient was administered Havrix that was expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16-DEC-2022) for prophylaxis.   On 25-APR-2023, the patient received Havrix. On 25-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Patient was administered Havrix that was expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-APR-2023 The operations manager reported that a patient was administered Havrix that was expired on 16-Dec-2022. The vaccine administration facility was the same as Primary Reporter. The reporter consented to follow up via email.
Client is fair skinned and freckled. Warm reddened areas 1 1/2 inches in diameter at injection site, 4 slightly raised hives anterior, directly below and below and posterior to injection site ranging in size from 1/2 inch to 1 1/2 x 2 inches. Client states site is tender, warm and uncomfortable to move. She also states that tenderness progresses across her anterior shoulder to upper anterior chest directly below clavicle of right arm where vaccine was given IM in right deltoid.  Client states warmth and readness began early evening after vaccination.  Site described above directly related to vaccination site.
About 24 hours after 2nd dose of Moderna Covid-19 vaccine Fatigue Headache
13 year old patient was given the 5-11 year old pediatric COVID Pfizer dose.  Patient did  not experience any adverse effects.  Patient's parent was notified and parent was informed the patient should receive another booster since the booster dose she received was lower than the recommended dose for her age group.