chrisvoncsefalvay/vaers-outcomes huggingface dataset:
light flu-like symptoms; achy joints; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (light flu-like symptoms), ARTHRALGIA (achy joints) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (light flu-like symptoms), ARTHRALGIA (achy joints) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (light flu-like symptoms), ARTHRALGIA (achy joints) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-392056, MOD-2021-392086 (Patient Link).
3 hours after vaccine, swollen, sore lymph nodes in neck, 4-5 hours after periods of exhaustion that would come in waves. I went to bed. The next morning, I felt extreme fatigue. I was in bed all day. About 27 hrs after vaccine (approx 6pm), I had chills. Took temp was 99.7 (my temp is always 97.6-as a baseline). Took 2 Tylenol. Took temp 30 min later was 100.6. Laid in body with 4 blankets trying to get warm. Temp lasted until Tylenol kicked in. Next day, (2 days after vaccine), left armpit lymph node sore/swollen.
Patient who is 48 who they are considering administering the vaccine to; Patient who is 48 who they are considering administering the vaccine to; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration and off label use were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the 48 year old patient received Shingrix, which led to inappropriate age at vaccine administration and off label use. The reporter was asking if shingrix could be given to people with a history of shingles, under the age of 50. The reporter consented to follow up.
1st 24 hrs p/vax pt exhibited reddness, raised area & warm to touch around inject site; 2nd 24 hrs area remained unchanged-72 hrs post vax inc in swelling & reddness & area warm to touch; fine skin rash also noted during 2nd 24 hrs;
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX (Merck) dose 2 (route, dosage and lot number unknown). The nurse practitioner reported that a patient received her scheduled 2 doses of VARIVAX in the past but stated "titers are equivocal". So, nurse practitioner noted that the patient's school is requiring another dose of VARIVAX (Merck) because the titers do not meet their requirements. The outcome of the event was unknown.  Additional information has been requested.
I felt tired, slight headache for 2-3 days, stuffy and drainage of nose, and little cough. I tested positive at home for COVID-19. Then the next day I went to the urgent care and tested positive there as well. They prescribed me cough medicine.
Patient received Pfizer as the covid-19 vaccine second dose --they received Moderna as the covid vaccine  first dose.
At approximately 8:00pm on April 28, I began to feel weak while walking through my house.  About five minutes later, I sat down, thinking that would resolve the feeling of weakness.  After approximately 30 minutes, I still felt weak, so I took my blood pressure.  The reading was 160/87 with a heart rate of 75, all of which are substantially higher than my normal readings (which I take daily since my cardiac surgery in May 2018).   I took my blood pressure again about 20 minutes later and the reading as 166/88 with an irregular heart rate of 81.  I then took an EKG reading with a Mobile device, and it indicated sinus rhythm.  I was still feeling weak at this point.  Over then next hour, the weak feeling began to resolve, and my blood pressure readings improved.  At 10:00pm the reading was 142/78 with heart rate of 67, and at 10:41 the reading was 130/77 with a heart rate of 60.  My normal systolic reading is usually in the 110-119 range and my normal heart rate in in the 50s-low 60s.  I felt well enough to go to bed, and I slept normally.  When I woke in the morning, I initially felt fine, but after brushing my teeth and walking to the kitchen, the weak feeling returned.  At 7:11 am I took my blood pressure, and the reading was 152/92 with a heart rate of 92.  Another Mobile EKG indicated sinus rhythm with Premature Ventricular Contractions.  The PVCs are not a new issue for me.  I've had them for a least a decade.  I spoke with my primary care provider at 7:30 and by that time the feeling of weakness was subsiding.  She advised me to continue to monitor my blood pressure for the next few hours and then to contact her to let her know how I was feeling and what the reading were.  The blood pressure readings were 135/82 heart rate 65 at 8:18am, 131/76 heart rate 63 at 9:42 am, and 126/83 heart rate 63 at 10:33 am.
Expired Infanrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 20-FEB-2023 Reporter's comments: The nurse reported that a patient received an expired dose of Infanrix at the time of reporting. The reporter did not consent to follow-up. Additional information declined by HCP. Additional supportive information: At the time of reporting, the patient had received an expired dose of Infanrix vaccine, which had led to expired vaccine used.
On 1/24 about half hour after shot had a medal taste in my mouth. Around 3:00 pm I had numbness around my face and left ear. My heart rate was elevated and elevated blood pressure.  Went to the ER and checked to make sure I was not having a stoke. Today 1/25/2021, I feel drained and groggy but the numbness has gone.
Patient noticed redness at injection site on 3/12/08.  Pinkish/red patch is 3 inches long and 1.5 inches wide.  The discoloration is mild and almost not noticeable.  There is no associated pain.  There is tenderness when agitated.  Patient called physician but was not seen.  Physician phoned in an antibiotic.
72 y.o. M w PMH of OSA on CPAP, chronic hypoxic resp failure on 2 L NC at night, HFpEF, COPD, morbid obesity, DMII, CKD III, factor 7 deficiency, dubin-johnson syndrome who presents after a fall down the stairs. See prior notes but he was recently hospitalized for MSSA empyema requiring thoracotomy, pleurdesis complicated by hemothorax. As he was walking down the stairs he heard a pop. He was too weak to get up. He thinks he likely bit his tongue during the fall which lead to blood in his mouth. There was question of possible hemoptysis as some of it was mixed in his sputum. In the ER CV surgery, Trauma Surgery evaluated the patient. He was placed on 3 L NC for hypoxia satting at 96%.   Hospitalized less than 90 days after booster.
Patient received second dose of Pfizer COVID-19 vaccine. Patient stated she felt dizzy, heart was racing, and feeling not well. Patient took Benadryl for the nausea and stated she felt slightly better. Patient was advised by doctor, if blood pressure increases to take Metoprolol which she took half a dose. EMT was called and patient blood pressure was elevated and they could not get blood pressure to drop. EMT advised patient to go to the emergency room and EMT escorted patient.
Four hours after receiving my "drive up" flu vaccine, I had fever, chills, dizziness, runny nose, cough, raspy throat and diahhria.  I self-medicated with Immodium, benedryl, aspirin and cough drops.  My cough developed first.  When I called the Public Health Dep't, they said cough was not related to the vaccine.  I did not call back once the other symptoms set in.  As to the manufacturer of the vaccine, I don't know it.
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 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. It was reported that the patient has no known allergies.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 22May2022, outcome "unknown", COVID-19 (medically significant) with onset 22May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive, notes: First tested positive 22May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received treatment of Paxlovid treatment for COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
when it was injected it squirted toward the right from the needle hub resulting in a partial dose of medication administered to the patient; No adverse effects were reported.; patient was administered a partial dose of GARDASIL 9 in a defective pre-filled syringe /  when it was injected it squirted toward the right from the needle hub / Medical assistant reported she could feel a crack in the vial part of the syringe.; patient was administered a partial dose of GARDASIL 9 in a defective pre-filled syringe /  when it was injected it squirted toward the right from the needle hub / Medical assistant reported she could feel a crack in the vial part of the syringe.; patient was administered a partial dose of GARDASIL 9 in a defective pre-filled syringe /  when it was injected it squirted toward the right from the needle hub / Medical assistant reported she could feel a crack in the vial part of the syringe.; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information reported about the patient's concomitant medication, pertinent medical history and drug reactions/allergies.  On 09-JUL-2019, the patient received a partial dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number R008163 and expiration date 18-NOV-2020) intramuscularly for prophylaxis, from a defective pre-filled syringe (product quality issue, syringe issue, incorrect dose administered). It was reported that the syringe looked fine and was not leaking prior to attempted administration, but when it was injected it squirted toward the right from the needle hub resulting in a partial dose of medication administered to the patient (product container issue). The medical assistant reported she "could feel a crack" in the vial part of the syringe. No adverse effects were reported.  The outcome of the product quality issue, syringe issue and the product container issue was not reported; the reporter did not provide a causality assessment between them and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
This spontaneous report as received from a nurse refers to a patient of unknown age. On 04-DEC-2013 the patient was vaccinated with MMR II lot # 1885AA and expiry date 30-NOV-2013. The patient was administered expired vaccine. This is 1 of 2 reports from same reporter. Additional information has been requested.
Daptacel was given to a patient instead of Adacel, no AE; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 11 years old female patient who was vaccinated with 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number :C5732AA  and expiration date:24-Apr-2022) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiration date were not reported) via intramuscular route in the right deltoid as prophylactic vaccination on 26-Aug-2020.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered .  No adverse event reported at the time of reporting.  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.
Administrator calling to report PROQUAD dose that was administered after its expiration date. Vaccine expired: 4/11/2022. Dose administered: 4/28/2022. No PQC. No additional information.; Information has been received from other healthcare professional regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 28-APR-2022, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (recombinant human albumin) for prophylaxis, lot number T034828 with expiration date on 11-APR-2022 (expired product administered) (strength dose, route of administration, strength and anatomical location not reported)
Red, itchy at injection site, afebrile x 2d. Use Ice et Hydrocortisone Cr. 1% prn.
Information was received from a pharmacist concerning a female pt (reported as in early 60's), with penicillin and sulfa allergies. On 21-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot # J008802, exp. 19OCT2014). The pharmacist reported that the patient developed redness around the injection site after vaccinated with ZOSTAVAX. Treatment included diphenhydramine. At the time of this report, it was reported the patient had not recovered. Additional information has been requested.
Hard red swelling at injection sight. Reddest in center then lighter at outside of an oval area that was about 8 inches long; followed by rash on forehead and itching eyes.
When presenting for vaccination the patient reported to the healthcare providers that were administering the COVID-19 booster doses of Pfizer COVID-19 vaccine that she had completed the initial vaccination series with the Pfizer-BioNTech COVID-19 vaccine more than 6 months ago.  Due to not having internet access at the site the patient's word was taken after the staff at the facility reported that the patient did not have any cognitive impairments.  After the patient received the vaccine staff at the facility found the patient?s vaccination card and determined that the patient had received one dose of Moderna COVID-19 vaccine on 12/22/2020.  Since the patient did not complete the initial series the second dose of the COVID-19 vaccine that was administered (Pfizer) will be the final in the primary series.  Patient did not report any symptoms, but this error is being reported since she received Moderna for her first dose.
Patient had a PMH of type 2 diabetes mellitus, hyperlipidemia, PTSD, tremor, COPD/coal workers pneumoconiosis, hypertension, hip/joint pain, and obesity Patient received both the Moderna COVID booster and the Quadrivalent preservative free (Afluria) influenza vaccines on 11/4/21 Received 1st dose of Moderna COVID Vaccine on 2/13/21, 2nd dose on 3/13/21, 3rd (booster) dose on 11/4/21, Primary care nurse contacted patient's residence 11/5/21 to discuss knee x-ray findings. Patient's wife informed nurse that patient had passed away the night before on 11/4/21. Cause of death or other information currently not available at time of this report.
Brain fog; Depression; Anger; Sadness; Confusion; Headache; Tiredness; Stomach pain; Body aches even my legs; Body aches even my legs; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FJ8757) via an unspecified route of administration in the right arm on 19Nov2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included quetiapine fumarate (SEROQUEL) and duloxetine (MANUFACTURER UNKNOWN); both for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. On 20Nov2021, the patient experienced brain fog, depression, anger, sadness, confusion, headache, tiredness, stomach pain and body aches even in legs. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events brain fog, depression, anger, sadness, confusion, headache, tiredness, stomach pain and body aches even in legs was resolving at the time of this report.
Pt was given moderna  vaccine from a bottle that was on day 31 in the refrigerator, moderna was notified and we received a response stating  that vaccine should stiff give excepted coverage , and should not cause any problems , but if Pt would like they can receive another dose of the vaccine. I have attempted to contact Pt and left Voice messages  for her, and have given her our call back #.
Child was identified by name and birthdate and was inadvertently given the 5-11 y/o vaccine.
Nurse gave child varicella vaccine, then MMR at 2:10 pm. He vomited immediately following MMR at 2:11pm. Mom states that child drank a full 8 oz bottle of milk followed by a full 8 oz bottle of root beer in the last 1/2 hour. Temp 97.8 pulse 120. After being cleaned child was calm and in no distress. Contacted administrator and called CDC hotline (#4018). Received approval to give other vaccine from CDC and mother. No further problems at this time.
Daughter given moderna vaccine but she is only 16; A spontaneous report was received from a consumer concerning her daughter, a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unspecified date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unspecified date, the patient was given moderna vaccine, but she was only 16.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, patient was given moderna vaccine, but she was only 16 was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Starting at about 05:00 in morning, I woke up feeling shaky and chilly. I was very achy. I had a fever. I took my temperature and it was 102 fever. I took Tylenol. (Extra Strength) I went back to sleep. I woke up about 08:00 am and I still had chills and was extremely achy and had a really bad headache. My temperature was 101.8. Then I started throwing up every 20 minutes for the whole entire day. I still had a fever. It was 102.6 at one point. I had been taking extra strength Tylenol as often as I could take it. I still had a headache was very very achy. I was throwing up constantly and couldn't get out of bed. I had my husband come home to take care of toddler. That lasted then for a full 28 hours - through the next evening. When I woke up on April 7 I had a light headache, a little achy but fever was gone. At the time of my vaccine, I was just 8 weeks pregnant. I had an ultrasound when I was seven weeks along they could hear the heartbeat. I had a miscarriage around 8 weeks and four days. It would have been about one day after the vaccine when I was having my reaction to the vaccine. I am still having bleeding from the DMC - removal - but otherwise I'm recovered.  Pregnancy history - It was my second pregnancy. Estimated due date - November 15, 2021.
Roughly 4-5 minutes following my vaccination I felt a rush of lightheadedness, tension in my neck, difficulty obtaining a deep breath, flushed and sweating. My vitals were obtained by on on-site medic HR/BP were elevated and SO2 had dropped. I was under direct supervision of a medic for roughly 45 mins, vitals were taken again half way through and had normalized but were still high in comparison to my usual. The light headed feeling and flushed feeling did not subside and I was unable to drive myself home, I had to leave my vehicle and arrange a ride from my husband. Since returning home I have battled sweats, chills, increased pain in my left shoulder, increased headache, body aches, tension in my neck and shoulders, and diarrhea. It has been 24 hours and an intense headache/neck ache still remains, some fluctuating warm/cold body temps, and diarrhea are still persisting.
6 days after vaccine after having no symptoms at all I suddenly felt nauseous about  9 p.m.  Went to the bathroom and can't remember what happened next as I passed out.  Fell hard and knocked shower out of track.  Woke up throwing up massively.  My husband ran in and helped me.  I threw up a lot and had chills.  After cleaning up, went to bed and piled on blankets.  Woke up again sometime in the 11 to midnight range and threw up once more.  Still chilled.  About 3 a.m. I woke up and removed all the blankets as I felt okay again.   I never found a place to report this in my daily reports as within 24 hours I felt normal again.  I am 100% positive this was a reaction to the vaccine.  I did not need to seek medical treatment as it passed within 6 hours or so.
Angioedema and anaphylaxis approximately 15 minutes after the vaccine was administered.  She was given IV solumedrol, benadryl, and famotidine which improved her tongue swelling.  Afterwards she was admitted to an inpatient observation unit at the hospital.  Around 9pm patient developed recurrent tongue swelling and difficulty swallowing.  0.5 mg of epi was administered.  There was some initial improvement followed by additional worsening after 5 minutes.  She was ultimately transferred to the ICU for a continuous epi infusion.