chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ringing in the ears; dizziness a few minutes after the vaccine; vomiting / vomited; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient in his 30's received bnt162b2 (BNT162B2), administration date 20Apr2021 (Lot number: ER8731) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 20Apr2021, outcome "unknown", described as "Ringing in the ears"; DIZZINESS (non-serious) with onset 20Apr2021, outcome "unknown", described as "dizziness a few minutes after the vaccine  "; VOMITING (non-serious) with onset 20Apr2021, outcome "unknown", described as "vomiting / vomited". Therapeutic measures were not taken as a result of tinnitus, dizziness, vomiting. Additional information: The patient did not have any medical treatment and were just given some water. The Relatedness of drug to reactions/events Ringing in the ears and dizziness a few minutes after the vaccine with Primary Source Reporter as source of assessment and as method of assessment was related.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438548 Same reporter, drug and events; different patient.;US-PFIZER INC-2021457291 Same reporter, drug and events; different patient.;US-PFIZER INC-2021457177 Same reporter, drug and events; different patient.
The next day, another Rph noticed Moderna bivalent vaccine vials in the fridge was expired. That vail along with the whole package that was in there was thaw on 2/19/23 in the refrigerator and should be expired on 3/9/23 but it was given on 3/15/23 to one patient.  Moderna lot 016h22a manufacturer expiration at freezing is 5/2/23.    Rph reached out to Moderna to consult and got an email on 3/27/23 stating, " Use of an expired vaccine or a vaccine that has undergone a   storage excursion  that is determined to be invalid constitutes a vaccine administration error/deviation. Moderna does not provide any specific recommendations in the event of a vaccine administration error or deviation except to instruct vaccination providers to report these events to the Vaccine Adverse Event Reporting System (VAERS). Safety and efficacy data are not available to support administration of an additional dose to patients who received vaccine impacted by storage and handling errors. The management of these patients is at the discretion of the healthcare provider."  Rph got a hold of patient on 3/30/23 and she stated she is doing fine with no reaction.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Patient received the pediatric formulation of the Pfizer-BioNTech COVID-19 vaccine as a booster dose, despite being 12 years old. No adverse reactions were observed during vaccination nor during the 15 minute observation period.
35-year-old female received her first dose of the Covid-19 vaccine mRNA Moderna on August 06, 2021. On August 06, 2021, the patient complained of body aches, headaches and pain at the site of injection. Patient declined treatment to pain. On August 10, 2021, I spoke with prescriber who states that patient is doing okay, and pain related to COVID-19 vaccine has resolved.
No additional AEs were reported; 33 patients received improperly stored vaccines; This spontaneous report was received from licensed practical nurse (L.P.N.) and concerns a patient of unknown age an gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 31-MAR-2022, the patient was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB); lot number: U026217; expiration date: 02-NOV-2023 (formulation, strength, dose, dose number, frequency, route of administration were not reported) for prophylaxis (improper storage of product in use). Administered dose of vaccine experienced the temperature excursion of 34,3 degrees Fahrenheit (F) for 55 minutes. There was no adverse effect reported (no adverse event). There were no previous temperature excursions reported.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001791: US-009507513-2204USA001816:
severe pain on her right side of her shoulder; This is a spontaneous report received from the Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (Pfizer COVID-19 Vaccine, Lot number was not reported), via an unspecified route of administration on 26Feb2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced severe pain on her right side of her shoulder on an unspecified date in 2021. The outcome of the event was unknown.    No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
Pt. felt dizzy after receiving both bivalent Moderna and Flu shot. BP WNL, Felt relieved after 15 mins
Chest Tightness; Headache; Joint pain; Fever; Experienced chills; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Chest Tightness), CHILLS (Experienced chills), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Past symptoms felt similar to her past diagnosis of Covid-19).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced CHILLS (Experienced chills) and FATIGUE (Fatigue). On 06-Jan-2021, the patient experienced CHEST DISCOMFORT (Chest Tightness), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever). On 07-Jan-2021, CHILLS (Experienced chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Fever) had resolved. At the time of the report, CHEST DISCOMFORT (Chest Tightness) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
S/S reported on 11/20/08 to nurse practitioner - reported that evening of 11/13/08, his arm "felt numb tingling" down (L) arm. Afebrile. Some redness noted @ injection site and he put alcohol on it and went away. Later, he said (L) leg was crampy and numb off/on several days. No loss of strength or motor movement of (L) side. Took Goody's off/on with some relief. Only slight "tingling feeling" of (L) arm on 11/21/08.
rash and swelling in the injection site; rash and swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash and swelling in the injection site) and VACCINATION SITE SWELLING (rash and swelling in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash and swelling in the injection site) and VACCINATION SITE SWELLING (rash and swelling in the injection site). At the time of the report, VACCINATION SITE RASH (rash and swelling in the injection site) and VACCINATION SITE SWELLING (rash and swelling in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
DIARRHEA & VOMIT FOR 24 HOURS BODY ACHES & CHILLS
fever; chills; muscle aches; joint aches; Headache; fatigue; sleeplessness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), ARTHRALGIA (joint aches) and HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A. and 038A31A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin lesion. Concomitant products included STEROID ANTIBACTERIALS for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache), FATIGUE (fatigue) and INSOMNIA (sleeplessness). At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache), FATIGUE (fatigue) and INSOMNIA (sleeplessness) outcome was unknown. Not Provided          No treatment medication was taken.
Pt received vaccine on 05/28/2004 came to our clinic on 06/18/04 with c/o 24 hours of rash started on face and up to trunk and leg. No fevers/other complaints. Required Benadryl as needed for itching.
c/o flu-like sx (myalgia, h/a w/swollen, puffy area around incision site radiating to shoulder area;
This is a spontaneous report from a contactable consumer (reporting for husband) from a Pfizer sponsored program. A 73-years-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration at age of 73-years-old on 21Oct2021 in the afternoon around 3:00 to 4:00 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included parkinson's from 2011 and ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at age of 72-years-old on 10Jan2021 and second dose of bnt162b2 at age of 72-years-old on 31Jan2021 for Covid-19 immunization and both experienced no reactions. The patient experienced paralysis or loss of function in right hand on 23Oct2021. He thought that he slept on his hand funny because it was not working right. He had the head nurse at the home look at it and there was no swelling and he was in no pain. Physical therapy looked at it and they couldn't find anything but they gave him a hand brace and he keeps taking it off because it was not comfortable. So there has been no change for 2 weeks and his hand was still dead. She has been watching and it was not better. The patient underwent lab tests and procedures which included x-ray: normal in Oct2021 they found nothing abnormal. Outcome of event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Breakthrough case admission after 2 vaccines  Moderna 1/20/22 lot# 067H21A;  Moderna 2/24/22 Lot# 060H21A
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from Office Staff. This case involves a four months old male patient who received third dose of 0.5 mL vaccine QUADRACEL lot C5497AA, expiry date: 17-Jul-2020 via intramuscular route in the left thigh on 24-Oct-2018 instead of PENTACEL (batch number and expiry date not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; HIB VACCINE (HIB) for Immunisation; and PREVNAR 13 for Immunisation. It was actual medication error due to wrong vaccine administered. It was unknown whether patient experienced any adverse reaction after vaccination. 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. Documents held by sender: none.
Firm, red, hot, itchy patch of skin developed in arm about 40+ hours after injection. Patch grew larger throughout the day, 57 hours after injection it was 3 inch by 1.5 inch.
Starting approx. 12-28 hours after injection: Headache - persisting for 24+ hrs. Fever (99-100 F.) persisting for about 24 hrs. Fatigue - persisting for 24+ hrs. Muscle aches - persisting for approx. 18 hrs.
Pt recvd 3 Engerix-B vax on 29AUG89, 25SEP89, & 26FEB90; 23APR90 titer=57; 11MAR91 titer was neg;
Patient stated the next day after getting her 2nd dose of the Moderna vaccine, she started feeling pain at her injection site. Patient stated her doctor prescribed her Motrin but the pain has not subsided since it started.
Information has been received from a health professional concerning a female who on approximately 17-AUG-2007, was vaccinated with a first dose of GARDASIL. On approximately 17-AUG- 2007 the patient experienced pain in her arm. There were no obvious bruise of exterior sighting of a problem; however she was unable to lay on her arm. At the time of the reporting the pain in her perisited. Additional information has been requested.
Developed a croup-type cough for several days, was irritable and moody. Took her to the doctor at 2 weeks after vaccine. She then developed runny nose and fever 3 weeks after vaccine.  Symptoms were not improving. Administered homeopathy about a month after the vaccine, which finally relieved the symptoms.
Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-APR-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
received expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.  Nurse reported three patients were given doses from an expired vial (doses administered >12 hours post puncture).
Felt light headed after vaccine and has continued to have "dizzy spells" and vertigo up to several times a day, especially on arising.  Gives a history of "low blood pressure," but unsure of what the numbers typically are.  Has had two events of nausea and headache on other days in the past two weeks since vaccine but doesn't believe it's related to the vaccine.  States that events have gotten better over time.  Encouraged to see his PCP.
arm discomfort; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm discomfort) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included RANITIDINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (arm discomfort). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, LIMB DISCOMFORT (arm discomfort) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-018648 (E2B Linked Report).; Sender's Comments:  MOD-2021-018648:same reporter, different patient and event
The first day, I woke up and felt I had a very bad cold. I had a scratchy throat, a runny nose, and had no energy. On day two, it was pretty much the same. On day three, the symptoms weren't as bad, but I began to suspect it wasn't a cold and took a COVID-19 test. I called the doctor to talk about treatment. About day 5 or 6, my symptoms had pretty much clear. I had a headache and an occasional stuffy nose. At this point, all the symptoms are gone except for a scratchy throat and an occasional stuffy nose. My energy started to come back.
Vaccine given by approved staff to the patient before the age of 18 did not realize the age of the patient until after vaccine was given.  Patient had primary dose of Pfizer vaccine at another facility, he was given the Moderna vaccine as a booster by our facility.  Patient was observed for 20 minutes and released without any complications according to the clinical staff member.
shingles after first dose; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In January 2022, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix and experienced Shingles. The patient was about to receive second dose no later than 8th February 2022 and the reporter wanted to know when the patient should receive second shot. The reporter wanted to know how long do he need to wait to give his second shot. The reporter abandoned the chat after reporting this when tried to collect the adverse event and his demographics. Consent to follow up was not possible as no contact details were available.
Initial report was received from a consumer, who was also the patient's parent, on 16 June 2013. This reporter reported another adverse event for the same patient which was captured in case number 2013-07002. A 19-month-old female patient had received an injection of PERTUSSIS VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later had a seizure. The patient was in the ICU. No other information was available. Outcome was not reported. Documents held by sender: None.
This case was reported by a healthcare professional and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received 4th dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced an unspecified adverse event. The reporter believes that there might be a quality assurance problem that caused the adverse event. This was considered to be a product complaint. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the event s were probably related to vaccination with INFANRIX. The representative was not sure if the INFANRIX was in prefilled syringes or vials. Follow-up information from Quality Assurance was received on 23 June 2009. The INFANRIX vaccine lot AC14B088AA met the requirements of our specifications and the batch suitable for vaccination purposes. Linked cases include A0772416A and A0772419A.
expired dose of Adacel vaccine administered inadvertently; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked with 2019SA172512 (same reporter).  This case involves a male patient of an unknown age, who received an expired 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [Adacel] lot number, expiry date: 02-May-2019,  not reported route unknown in the left deltoid on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   It was an actual medication error case due to expired vaccine used.  It was not reported whether the patient had any adverse event or not.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Pt started with rash and MD and pt both thought this was allergic reaction. Started with BENADRYL but no relief. Woke up the next day and rash had spread and pt reported a fever. Arm is swollen and red. Pt reported that she called MD and MD thought this was an infection and called in KEFLEX 250 2 QID #28. Pt reported she went in to MD office this AM and MD confirmed infection. Pt reports no labwork/samples were taken. She reported pharmacist administered vaccine did clean skin with alcohol pad and put a bandage on immediately after injection.