chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited case received from a pharmacist on 13 Oct 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of ADACEL (Batch number: U5477CA Expiry date: 29 Oct 2018) intramuscularly on deltoid right and a dose of AFLURIA (Batch number: WT52706 Expiry date and route was not reported) in deltoid left on 22 Sep 2016. The patient's illness at the time of vaccination was reporter as none and preexisting physician diagnosed allergies, birth defects, medical conditions were reported as Allergies: none known. And any other vaccinations within four weeks of vaccinations were not reported.The patient's other concomitant medications were not reported. On an unknown date, following vaccination (reported as three week later), the patient continues to experience inflammation and discomfort from site radiating down to elbow (arm discomfort and vaccination site pain). The patient lab tests and corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Case number PHEH2013US026015 is an initial spontaneous report received from a pharmacist on 13 DEC 2013 and a follow up report from the physician received on 09 JAN 2014. This report refers to a 49 year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml dose of FLUVIRIN 2013/2014 (batch number: 13391P) intramuscularly on 11 DEC 2013. This FLUVIRIN pre filled syringe reached 48 F on 03 DEC 2013 at 6 PM; at 08:55 AM on 04 DEC 2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine then reached 47 F on 04 DEC 2013 at 5 PM. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in rage since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. The physician stated that they do not have any patient know with the above details.  Follow up report from the physician received on 09 JAN 2014: Physician's statement regarding the patient was updated.
Temp of 100.7; Very bad headache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Very bad headache) and PYREXIA (Temp of 100.7) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022 at 12:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022 at 4:00 PM, the patient experienced HEADACHE (Very bad headache). On an unknown date, the patient experienced PYREXIA (Temp of 100.7). At the time of the report, HEADACHE (Very bad headache) and PYREXIA (Temp of 100.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 100.7 (High) 100.7.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  No treatment medication was provided.  It was reported that temperature started during the night on an unknown date in January 2022.
Red Ring around injection, swollen, itchy, hot to touch, and wheezing. Patient took benadryl, iced and rested. Patient's PCP prescribed zpack and steroids.
8/26 in pm fever 101 degrees same night as vaccine followed by hive like morbilliform eruption (trunk), intercurrent fatigue/malaise x 7 days. No fever on eval today. Rash faded. Pharynx clear, no nodes.
dizziness, weakness, SOB, hoarseness;pt saw MD & put on keflex;
facial drooping; facial numbness; fever; chills; swollen lymph nodes; full body aches; dizziness; abdominal and side cramps; abdominal and side cramps; heavy heart beat; constipation; This is a spontaneous report from a contactable consumer. A 39-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. According to the patient, he received the first Pfizer COVID-19 vaccine shot and he was looking for guidance on getting the booster shot. He had no major health issues, however, he experienced the following side effects on an unspecified date: facial numbness/drooping, fever, chills, swollen lymph nodes, full body aches, mild dizziness, abdominal and side cramps, heavy heart beat, and constipation over the last 96 hrs. since the shot. He has not had COVID-19 and they have been isolating for the last year. He was asking for any advise. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
One week after vaccination, a red itchy rash developed on the same arm. Rash faded overnight and was totally gone after three days. 200 mg of ibuprofen taken on day one; all other meds taken during this timeframe were my normal daily meds.
Patient inadvertently received 0.5 mls of Moderna instead of 0.25 mls. It was understood she was receiving a second dose when it should have been her 3rd dose.  Patient has no side effects at this time .
Developed slightly raised red skin rash 3 inches wide and 7 inches long around the injection site left arm 12 days after received first dosage of Moderna. It is tender, sore, and warm. I've noticed it when I took off my shirt after my afternoon walk and felt my arm very warm and sore. Been using cold compressions with my wet face towel.
Fever; headache; Chills; Body ache; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever), HEADACHE (headache), CHILLS (Chills), MYALGIA (Body ache) and FATIGUE (fatigue) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L28) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 03-Feb-2021, the patient experienced PYREXIA (Fever), HEADACHE (headache), CHILLS (Chills), MYALGIA (Body ache) and FATIGUE (fatigue). At the time of the report, PYREXIA (Fever), HEADACHE (headache), CHILLS (Chills), MYALGIA (Body ache) and FATIGUE (fatigue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
This case was reported by a consumer and described the occurrence of flu like symptoms in a 45-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included multiple sclerosis. Concurrent medications included Unknown (Infusion). On 22 September 2010 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 25 September 2010, 3 days after vaccination with FLULAVAL, the subject experienced flu like symptoms, nausea, vomiting, muscle pain, low grade fever, weakness and vaccination failure. At the time of reporting the events were unresolved.
Difficulty walking; redness is present on most of the upper thigh; temperature of 100 degrees; Swelling at injection site; Redness at injection site; Warmth at injection site; area is tender to touch; This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   On 29th May 2020, the patient received Kinrix (intramuscular) .5 ml. On 30th May 2020, 1 days after receiving Kinrix and an unknown time after starting ibuprofen, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site tenderness. On 1st June 2020, the patient experienced walking difficulty, redness of legs and fever. The patient was treated with ibuprofen, benadryl (nos) (Benadryl) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, injection site tenderness, walking difficulty, redness of legs and fever were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, injection site tenderness, walking difficulty, redness of legs and fever to be related to Kinrix.  Additional details were provided as follows: On 30th May 2020 at 10AM, the patient reported the redness, swelling and warmth to touch at the injection site. The swelling was of a baseball size. On 1st June 2020, 3 days after the vaccination the patient experienced the redness had gotten worse, and the patient had and the temperature of 100 degrees F. The redness was present on most of the upper thigh now the area was tender to touch and patient had difficulty walk. The patient had been taken Ibuprofen, ice and Benadryl. This case was 2 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091774:Same reporter US-GLAXOSMITHKLINE-US2020091764:Same reporter
Experienced cold-like symptoms on June 30, 2022.  Tested positive for Covid on July 1, 2022.
Became lightheaded a few minutes after, getting up from exam table, bump head (L) on wall caught before fell, LOC, groggy 1-2 min, vital stable. 1 week later still dizzy and fatigued. By 8/6/2009 was back to normal.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 58-year-old female patient who received SHINGRIX (batch number K2ZY4, expiry date 3rd April 2021) for prophylaxis. On 11th December 2018, the patient received SHINGRIX. In December 2018, 2 days after receiving SHINGRIX, the patient experienced rash, pain localized and skin warm. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the pain localized and skin warm were unknown. It was unknown if the reporter considered the rash, pain localized and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient developed a rash 2 inches below the injection site. The rash was 1.5 inches in diameter, slightly painful, and slightly warm to the touch. The pharmacist consented to follow-up.
Very high fever (103.3) chills body aches headache frequent urination chest congestion cough swollen lymph nodes in underarms fatigue nausea
Around noon on Wed 102319, I received by Vaccination shot by my company's turnkey provider.  I noticed the pain right away however I didn't think anything of it and didn't try to look at my Arm until the next morning during my shower.  That is when I noticed a red Rash and swelling on my upper arm,  took a photo, contacted our Company nurse and she told me to see a Doctor,
Rash and swelling  surrounding injection site elbow to shoulder at peak on 2/3/2021.
received a vial that was broken when they opened it. Called to see if they can get a replacement. Has not been administered to any patients; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5019, Expiration Date: Feb2025) for immunisation, Device Lot Number: F658, Device Expiration Date: 01Jun2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "received a vial that was broken when they opened it. Called to see if they can get a replacement. Has not been administered to any patients".  Causality for "received a vial that was broken when they opened it. called to see if they can get a replacement. has not been administered to any patients" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Product Quality Group provided investigational results on 09Nov2023 for rsv vaccine prot.subunit pref 2v: Examination results: vial lot HF5019, syringe lot GY5692, expiry date syringe and vial Feb2025. Pictures were taken. The label of the vial and syringe had no defects. The blister was opened and had no defects. The vial had a normal looking not reconstituted cake. The vial was full with an attached flip-off. The vial adapter was still in its packaging. The syringe was empty. The tip of the barrel was broken off, in tip cap. The luer lock was unopened. The rubber tip cap is loose. The rubber plunger was at starting position. The plunger rod was firmly attached. Complaint is confirmed. Sample was send for further investigation.  Additional information: Reportability Determination: Based on the new information received on a broken Abrysvo syringe during a sample evaluation associated with site investigation record PR#: on 30Oct2023 has changed the reportability from Not Device Related to 30-day Reportable Malfunction. The overall reportability on the case level has changed. This is Medical Device Related. This complaint for "Received a vial that was broken when they opened it. Site Investigation pictures evaluated on 30Oct2023 showed an Abrysvo syringe with the tip of the barrel broken off" for ABRYSVO SFDPO 5X0.5ML GVL+SYR is a reportable malfunction since if it were to recur it could likely cause or contribute to death or serious injury. Abrysvo Diluent Syringe: NDC: 00069025001, Lot: GY5692, Exp: Feb2025. Caller mentioned that they received Abrysvo directly from their distributor (not from Pfizer) but it was damaged. She wants a replacement for this.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Pain from when he took the shot. It was pain shooting all over his. About time he made it to the car he stated he had a very bad headache. The pain now comes randomly.
Throat starting feeling itchy. Went to her PCP who prescribed a Medrol Dose Pack.
pt recvd vax & was acting very tired; started to shake eyes rolled back in head; pt taken to hosp then released;
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022 at 12:29 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 11-Feb-2022 at 12:29 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  A series of patients approximately 540 patients received lot 066H21A past its 30-day expiry date. Vaccines went into 2-8 c thaw state on or above 24-Dec-2021. This vaccine was administered up until its manufacturer expiry date of 04-Apr-2022.  No treatment medications were provided.
Resident received a TST Mantoux on 7/2/21 and then received COVID Vaccine 7/7/21. There was not a 4 week time frame between the two administrations.
Information has been received from a physician concerning a 37 year old female who in September 2001, was vaccinated with varicella virus vaccine live (Oka/Merck). There was no concomitant medication. Subsequently the patient failed to seroconvert after receiving first injection in September 2001 and the second injection in November 2004. As of 11-SEP-2007, the patient experienced no adverse symptoms. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # J014855, expiration date 01-APR-2016. No adverse effect were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 328, 59 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Came into the pharmacy to show the pharmacist on duty her arm.  She said it did not hurt or anything however she was concerned about the bruise on her arm at the site of the injection
extreme vertigo; unable to move head or body without vertigo worsening; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 28Feb2021 as 1st dose, single dose for covid-19 immunisation (at the age of 73-year-old). Medical history included hypertension, chronic lymphocytic leukaemia, prostate cancer, malignant melanoma and blood pressure abnormal. Concomitant medication included BP medications (unspecified) in two weeks. Patient did not receive any other vaccine in four weeks. Patient no covid prior vaccination. No covid tested post vaccination. No known allergies reported. On 28Feb2021, the patient experienced extreme vertigo and unable to move head or body without vertigo worsening. Patient did not receive any treatment for events. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
they were suppose to giving a HD, but gave a regular strength instead with no adverse event; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non healthcare professional via Media Information (under reference 00807032).  This case involves a patient (unknown age and gender) who were suppose to receive a QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), but received a regular strength of QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) instead (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect FLUZONE QUADRIVALENT (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered (same day latency).  At time of reporting, no adverse event reported.  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 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.  There will be no information available on the batch number for this case.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for three days and couldn't see any patients) 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 ILLNESS (Sick for three days and couldn't see any patients). At the time of the report, ILLNESS (Sick for three days and couldn't see any patients) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment and concomitant medication information was provided by the reporter. Reporter did not allow further contact.
2/28/07 school (nurse call to report that mother stated after vaccination on 2/26/07. Child was ill the next morning with sore throat, weak legs, sore injection site and flu like symptoms. Was not taken to Dr mother gave Tylenol and child felt better in one day. Unable to reach parent by telephone. spoke with sibling 3/2 states pt went to school
flu; Initial information received on 16-Jan-2021 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient an unknown age and gender who experienced flu (influenza), while he/she received INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) 3 to 4 weeks following the administration of INFLUENZA VACCINE.  Patient reported that's why I don't get a flu vaccine. Each time I was getting one, 3-4 weeks later I was getting a flu and not in a weak form.  It is unknown if the patient experienced any additional symptoms/ events.   Medication Details and reason for taking the medicine: Indication: Not provided.   It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information on the batch number for this case.
Injection site became swollen and itchy about 7 days after injection.  Within a day or so, began running a fever that rose as high as 102.4.  Fever lasted about 24 hours, and swelling at injection site almost totally disappeared after about 3 or 4 days.
This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. On 12-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose 1, 0.65 ml, subcutaneous, lot # not provided). On 14-JAN-2015, the patient inadvertently received second dose of ZOSTAVAX (dose, route and lot # not provided) (extra dose administered). No adverse effects reported. Additional information has been requested.
CONTINUOUS TINNITUS. MOSTLY IN RIGHT EAR. IT'S GETTING WORSE.