chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 35 years, in left 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: "Known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Aug2023 to 18Aug2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300283766 same patient, different drug/event;
Headache, Myalgia, Fever, stomach aches, soreness at injection site Narrative: per nursing report: "2nd dose of Moderna vaccine yesterday. [1/27] C/o headache, stomach pain, sweating last night, temp of 100.4 last night. States woke up this morning [1/28] with body-aches and right arm soreness
Swelling of entire arm, hands, face; rash on arm; complete stiffness of arm, neck and head (loss of movement) and fever.
My hyperacusis Tinnitus increased after the new Pfizer Covid vaccine. Paresthesia on the forehead is happening as well; similar to the feeling of static or a foot falling asleep. This happened within the hour after receiving the new vaccine. This did not happen with any other Covid-19 Vaccination. No new medications or routine- only the Vaccination at 3:40PM
PT STATED THAT SHE DEVELOPED A RASH ON THE RIGHT ARM/BACK. SHE WENT TO HER PHYSICIAN AND WAS TOLD THAT IT WAS A MILD CASE OF SHINGLES. NO TREATMENT, MD TOLD PT THAT IT WAS GETTING BETTER.
COVID 19 Treatment: Paxlovid; COVID 19 Treatment: Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment: Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Sep2023 to 20Sep2023.  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.
Dose 1: 5/30/2018 / Dose 2:10/31/2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult patient who received Herpes zoster (Shingrix) (batch number 5SB37, expiry date 19th June 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th May 2018).   On 31st October 2020, the patient received the 2nd dose of Shingrix. On 31st October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received 2nd dose of Shingrix later then the recommended interval, which led to lengthening of vaccination schedule. The pharmacist wanted to know if 3rd dose was needed, also the pharmacist was aware of CDC (Centers for Disease Control and Prevention) recommendations. The healthcare professional was not comfortable for giving patient information. The reporter consented to follow up.
one dose of IPOL administered post excursion with no reported adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid non-serious case via health professional. GMI number: 01193802  This case involves a 4-year-old female patient who experienced one dose of IPV (VERO) [IPOL] administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Immunization; Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP) for Immunization; and Varicella Vaccine for Immunization.  The caller reported a temperature excursion of OPENED IPOL MDV with 69F for 10 hours of unknown cause because no human error as no one was present at the time of excursion, maybe due to a storm.   On 11-Jul-2022, the patient received opened IPOL MDV at dose 1 dosage form (DF) once (lot: T1D481M, expiry date:  via intramuscular route in the left thigh for prophylactic vaccination, administered was post excursion with no reported adverse event (poor quality product administered).  It was reported that "this situation is reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard. No further information provided by the reporter."  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.    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 the guidelines. 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.
Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 minutes after receiving the 2nd COVID vaccine dose. Patient reported symptoms felt similar to times when she had exposure to cats or after exercising. She denies any previous treatments for anaphylaxis or any previous severe reactions. Vital signs at time of initial assessment were BP 147/100, pulse 80, O2 Sat 99% on room air.  Patient was observed for 50 minutes and chest tightness/arm tingling symptoms resolved. Patient did also develop a dry "tickly" cough about 60 minutes post vaccination.  Patient was administered albuterol 2 puffs via MDI and reported improvement of cough. She again reported the cough to be similar to the type of cough she had gotten when exposed to cats. No further treatment needed. Patient stable and released to go home.
Information has been received from a nurse practitioner concerning a female (age not reported) who on approximately 01 Nov 2006 was vaccinated with the first dose of HPV vaccine. On approximately 01 Nov 2006, the patient developed total body itching. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
The orange cap Pfizer vaccine for 5-11 years old was administered to an 11 year patient undiluted. The patient has been contacted and is currently experiencing now adverse effects.
The patient received his Moderna vaccine two weeks earlier than he should have. His first dose was administered on 6/3/21 and the new dose was administered 6/17/21. The patient reported that he felt tired and week the next day with some slight chills. However, this feeling resolved after 24 hours. He has not reported any other signs or symptoms since.
It was reported the patient came down with COVID-19 twice this year, the first week of MAR-2023 and the 3rd week of MAY-2023. The patient reportedly didn't get very sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (It was reported the patient came down with COVID-19 twice this year, the first week of MAR-2023 and the 3rd week of MAY-2023. The patient reportedly didn't get very sick) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Moderna COVID-19 vaccine (original formulation) as primary series). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In March 2023, the patient experienced COVID-19 (It was reported the patient came down with COVID-19 twice this year, the first week of MAR-2023 and the 3rd week of MAY-2023. The patient reportedly didn't get very sick). At the time of the report, COVID-19 (It was reported the patient came down with COVID-19 twice this year, the first week of MAR-2023 and the 3rd week of MAY-2023. The patient reportedly didn't get very sick) had resolved.            No concomitant medication was reported.  Reportedly, a patient started treatment on unreported dates with Moderna COVID-19 vaccine (original formulation) for his primary series, and 2 updated bivalent booster doses. It was reported the patient came down with COVID-19 twice this year, the first week of MAR-2023 and the 3rd week of MAY-2023. The patient reportedly didn't get very sick. His last booster dose was reported to be about 6 months prior to when he got sick in March with COVID.  No treatment information was provided.
14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, wobbly and tired, every day got a bit better, but I'm still feeling it as of today; 14 days after the vaccine I am feeling a bit better but still unusually tired. At first I was weak, wobbly and tired, every day got a bit better, but I'm still feeling it as of today; 7 days after my first Pfizer Covid vaccine I developed severe fatigue and moderate headache,14 days after the vaccine I am feeling a bit better but still unusually tired; 7 days after my first Pfizer Covid vaccine I developed severe fatigue and moderate headache; This is a spontaneous report from a contactable consumer (Patient). A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was unknown), dose 1 via an unspecified route of administration, in left arm (shoulder) on 16Jan2021 09:15 (at 45-years age) as single dose for covid-19 immunisation. Medical history was and concomitant medications were not reported. Patient was not allergic to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 06:00 7 days after first Pfizer Covid vaccine patient developed severe fatigue and moderate headache. 14 days after the vaccine he was feeling a bit better but still unusually tired. At first, he was weak, wobbly and tired, every day got a bit better, but he was still feeling it as of today. On 24Jan2021 patient underwent laboratory test that include post vaccination COVID-19 nasal swab test which results negative. The patient did not receive any treatment for the events. The event outcome was reported as resolving.  Information on the lot/batch number has been requested.  Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Cellulitis of right anterior lower leg - She was initially treated with IV ancef with excellent clinical and lab response. Decision was made to transition to oral antibiotics and discharge home with plans for close outpatient follow up. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night; Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night) and PRODUCT STORAGE ERROR (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night) and PRODUCT STORAGE ERROR (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night) and PRODUCT STORAGE ERROR (Administer doses from a vial that was punctured more than 12 hours ago and left at room temperature over-night) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Patient requested for second dose of Hepatitis-B vaccine but instead she got another dose of RSV vaccine (Arexvy) by mistake. When she complained of bruising in the injection site she found out from the pharmacy that she got RSV vaccine 2 months after getting the first dose of RSV vaccine instead of second dose of Hepatitis-B vaccine.
Pt recv vax on 5/7/99; on 5/9/99 pt exp fever (104.2); tx=Advil
Patient was vaccinated on 4/19/2022 with a beyond used date Pfizer vaccine. Pfizer clinical team was consulted and they could not confirm the viability of the beyond used date product. Patient was informed on 5-6-22 about the error and was advised to get re-vaccinated with Pfizer#1.  Patient did not report any adverse events yet.
About 8 hours after vaccine began to feel flu like symptoms. By next am had chills, sore arm, generalized aches and pains, fever 101.4 and generally felt "awful".
I became flush and felt a cold sweat come over me, I was in mid conversation with a fellow employee when he asked me a question and I was unable to answer due to a lapse in my ability to form a complete thought. I then felt the room getting dark and narrowing quickly, it was then I realized I was in the process of ?passing out?. I don't believe I passed all the way out,  although the next thing I remembers was  hearing my charge nurse, asking me a series of questions while I had my legs elevated and I was lying down on the break room couch with a blood pressure cuff on my left arm and a pulse-ox on my right index finger.  I was having trouble focusing my eye sight on one object.  My blood pressure during the event hit numbers of 210/190 but slowly subsided over the course of a couple hours. I still was dizzy when attempting to ambulate with assistance for the remainder of the day. It took a full two days for me to finally return to normal. My wife came and picked me up from work where I left my personal vehicle as well as my personal belongings secured in my locker until I was able to retrieve them on Saturday.
Patient did not receive entire dose of vaccine. Needle disconnected from the syringe, resulting in vaccine spillage.  Unable, to contact patient to re-vaccinate. Staff responsible for incident has been retrained and educated.
This spontaneous report was received from a healthcare worker refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA (Lot number, expiry date. dose and route of administration were not reported). No adverse events were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Intussusception resulting in surgical procedure and partial bowel resection. MR from pediatrician received which included hospital H&P from Oct. 16,2006 as well as a surgical pathology report dated Oct. 20, 2006.  Well baby exams at 6 days, 3 weeks, 2 and 4 months significant only for thrush and yeast rash in the diaper area. Breast fed. Vax given 10/11/06 include DTaP, Comvax, IPV, Prevnar, and Rotateq.  Bloody stools, fever, and vomiting began 10/15/2006 and infant was seen in the ER.   F/U with pediatrician 10/16/06 resulted in a direct admission to the hospital for rehydration, with an admission assessment of "Fever with bloody diarrhea and at least 5% dehydration."  Hospital MR received.  Infant had been hospitalized at a local hospital prior to admission to another hospital on 10/20/06 for surgery due to new onset of bilious emesis. (Exploratory Laparotomy and a Ladd Procedure).    Post-operatively, child became febrile on post-op day #3. Abd. X-ray negative.   Antibiotics and TPN continued. Post op day #7, CT of the abd/pevis done due to child being febrile since post-op day#3 and 90cc output from NG tube of greenish fluid. No evidence for leak or obstruction found. Improvement began 10/29/06 and the infant was discharged on 10/31/2006. No discharge diagnosis written on discharge summary. Lot number obtained for Rotateq ME0319F  exp. 1/11/2007 Per (FDA) "please add lot number to VAERS report if not yet done". Lot # added.
The next day after I felt my throat closing and was having breathing issues so I was transported to the ER where I was administered IV benedry with another antihistimine with it and monitored for a few hours and released shortly after.  Advised to continue taking the benedryl and the other antihistimine for an additional week.  I was really sick and nonfunctioning sick for about 2 weeks after and I still have respiratory issues that comes and goes periodically to date.
Has not received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In May 2021,1st dose received intramuscularly in left arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 7-Apr-2022 Reporter's comments: This case was reported by the patient. After receiving 1st dose of Shingrix, the patient was not told that she was supposed to get two doses by her healthcare professional. As of the date of reporting she had not received her second dose. The reporter did not consent to follow-up. The reporter did not give consent to contact the healthcare professional.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. VAERS details for 1st dose was provided.
I received the vaccine on 4/1/21 around 8:35 am and was 26 weeks pregnant with estimated due date of 7/5/21. Had a sore arm for a couple hours right after vaccination which did go away and didn't return. Around 3:15 pm the same day, I started to feel rundown - fatigued and slight elevated temperature. Around 2 hours later, I started feeling feverish and my temperature was around 99 degrees F. I took a tylenol which helped bring my temperature down temporarily, but around 9 pm it was a lot worse and I was feeling chills as well. I took my temperature and it was 102 degrees F. I took more tylenol and this helped bring my temperature down again. I went to bed and started feeling chills again around 3 am so I took another tylenol and when I woke up again around 8 am, I did not feel feverish anymore, but had a headache and still felt rundown and fatigued. On 4/2 (day after vaccine), I started feeling better as the day went on and fever did not return.
Extreme pain by late afternoon - could not sleep because of pain- took Tylenol.  Saw doctor on 12/15/2005, was given anti-inflammatory medicine- doctor stated immunization possibly given too high and in joint - arm fine as of today.
Immediate hot flash; Prickly heat; Rapid pulse over 110; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 02Apr2021 at 13:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease and allergy to antibiotics. Concomitant medications included levothyroxine sodium (SYNTHROID) and clonazepam (MANUFACTURER UNKNOWN). The patient previously took TAGAMET for unknown indication and experienced drug allergy. 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 02Apr2021 at 13:00, the patient had experienced immediate hot flash, prickly heat and rapid pulse over 110. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse events. The clinical outcome of the events hot flash, prickly heat and rapid pulse was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Losing sight), PAIN (Sore), PRURITUS (Severe itching) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VISUAL IMPAIRMENT (Losing sight), PAIN (Sore), PRURITUS (Severe itching) and HEADACHE (Headache). At the time of the report, VISUAL IMPAIRMENT (Losing sight), PAIN (Sore), PRURITUS (Severe itching) and HEADACHE (Headache) had not resolved. No Concomitant product use was reported. The reporter was calling on behalf of their wife who was the patient who received the second shot in Apr-2021. The patient was experiencing sore, losing sight, headache, and severe itching. The patient went to doctor and they confirmed that the reactions were caused by the vaccine. No treatment information was provided.
Large amount redness and swelling 14cm X 11cm; cellulitis of left upper arm.