chrisvoncsefalvay/vaers-outcomes huggingface dataset:
passed out; heart rate drop to 25; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A 75-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (hospitalization, medically significant), outcome "unknown", described as "passed out"; HEART RATE DECREASED (hospitalization, medically significant), outcome "unknown", described as "heart rate drop to 25". The patient age 75 just got her new booster. Immediately thereafter she passed out with a heart rate drop to 25. Taken by ambulance to hospital.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a certified medical assistant (CMA) concerning a 65 year old patient who on 28-OCT-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included tetanus toxoid and influenza virus vaccine (unspecified).  Subsequently the patient experienced swelling, pain at injection site, hot skin to touch, red and warm to touch at injection site, and achiness all over.  The outcome of the events was not reported.  Follow up information has been received concerning the 65 year old male patient employed in a dental lab with coronary artery disease (CAD), diabetes mellitus, hypertension, and a history of myocardial infarction (2002) who on 28-OCT-2005 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine.  On the same day, the patient was also vaccinated in the right arm with influenza virus vaccine (unspecified), and in the left arm with tetanus toxoid.  Other concomitant therapy included pioglotazone hydrochloride (ACTOS). atorvastatin calcium (LIPITOR), aspirin, metoprolol, lisinopril, and glipizide.  On 29-OCT-2005 it was reported that the patient developed "red, hot and swollen at injection site".  The patient recovered.  Additional information is not expected.
SORE ARM; TIRED; FEVER; SLEEP EARLY; HOT AND COLD FLASHES; SWEATING; SLIGHTLY DIZZY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 11-APR-2021, the subject experienced sleep early. On 11-APR-2021, the subject experienced hot and cold flashes. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced slightly dizzy. On 11-APR-2021, the subject experienced tired. On 11-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, slightly dizzy, sleep early, hot and cold flashes, sweating, fever and sore arm was not reported. This report was non-serious.
Cluster-type rash on right upper back, including a central reddened area and blood-filled pustules surrounding it. Rash was itchy. Had appointment with NP office of Dr. on October 16, and was diagnosed with shingles. Received Rx for Valacyclovir.
Lump near collar bone on the left side/ Lymph nodes; headache; pain in upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Lump near collar bone on the left side/ Lymph nodes), HEADACHE (headache) and VACCINATION SITE PAIN (pain in upper arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-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 VACCINATION SITE LYMPHADENOPATHY (Lump near collar bone on the left side/ Lymph nodes), HEADACHE (headache) and VACCINATION SITE PAIN (pain in upper arm). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Lump near collar bone on the left side/ Lymph nodes), HEADACHE (headache) and VACCINATION SITE PAIN (pain in upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Second dose administered 14 days after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 14 days after the first shot) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 14 days after the first shot). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 14 days after the first shot) outcome was unknown.            no concomitant drugs and treatment medications were provided.
Feverish; Aches in muscles and joints; Aches in muscles and joints; Fatigue; This is a spontaneous report from a non-contactable consumer (Patient). A 33-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0186 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 25May2021, as single dose for COVID-19 immunization at hospital. The patient medical history was not reported. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0167 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 04May2021, as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 26May2021, the patient experienced feverish, aches in muscles and joints and fatigue. The events were reported as non-serious. The patient did not receive any treatment in response to adverse events. The outcome of the events was reported as resolved on an unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 13 year old female patient who was vaccinated with the third dose of GARDASIL vaccine (lot# was not available) on unspecified date and played a "vigorous volleyball" using the same arm where she received the vaccine the following day after receiving the vaccine. There was no concomitant medication. The physician reported that on 06-NOV-2008 the patient experienced "serious malaise after vaccination" and on 17-NOV-2008, the patient brought to the hospital and was admitted for a "couple of days", Lab diagnostics Studies Performed included neurological tests when the patient was in the hospital including MRI. The patient sought medical attention through the physician. At the time of report the patient was recovering. Additional information has been requested.  2/23/09 MR received for DOS 11/15-xxxx with  DX:  S1 distribution sensory neuropathy.  Lower extremity weakness and altered sensation. No D/C information available.  Pt presented with 1 wk hx of weakness and fatigue. Had local reaction to recent HPV vax 11/6/08 with fever.  Pt describes heaviness of extremities and difficulty lifting them. Low grade temp with mild intermittant H/As, numbess in foot and toes and low back pain.  Seen by outpt neurologist and found to be areflexic. Instucted to go to ER with worsening sx.  Presented for eval following an episode of dyspnea which self-resolved.  Neuro exam (+) for loss of sensation on the back and decreased in extremities. DTRs and strength WNL. Abdominal reflexes absent.  Admitting DX:  S1 sensory neuropathy.  LE weakness and altered sensation.  2/26/09 Neurology consult received dated 11/14/08 with DX: Generalized weakness with depressed ankle jerks.  S/P Vaccination.  R/O GBS despite normal NCS/EMG. PE (+) for decreased strength, depressed reflexes in upper extremities and ankles, normal sensation.  Instructed to go to ER for further progression of sx which pt did.  This is in follow-up to report (s) previously submitted on 1/16/2009. Follow up information received on 23-FEB-2009 stated that the patient with no medical history or allergies, reeived the third dose of GARDASIL vaccine (lot # 661768/0652X) into the left deltoid on 06-NOV-2008 at 10:00. The patient experienced severe fatigue, malaise and feeling of weakness. The patient was admitted on a hospital and was hospitalized foe 2 days. Laboratory diagnostic studies included unspecified laboratory procedures and a magnetic resonance image (MRI). It was also reported that per neurology Guillain Barre Syndrome was excluded. The patient gradially recovered on 26-NOV-2008. No further information is available.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information receivedon 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to cases 2023SA057733 (CLUSTER).  This case involves an adult patient of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available.   Action taken: Not applicable.   Outcome:  Unknown for both the reported events.   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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.      This case was linked to MOD-2021-405760 (Patient Link).   Reporter did not allow further contact
Redness, warmth, swelling at and above injection site and into armpit. Took TYLENOL, BENADRYL, and applied cold compress.
Patient given  0.5ml  dose of Moderna 6-11 y.  No adverse reaction from this.  Contacted Agency who in turn contacted CDC and I was told patient did not need another dose of vaccine.
FEVER, PAIN, REDNESS, SWELLING,  BODY ACHES, HEADACHE, WARMTH AT SITE
epigastric pain 4/10 with elevated blood pressure 170/72, HR 75
He presented to the emergency room at Hospital 4/16/21 with chest pain and shortness of breath. D-dimer was elevated. Bilateral pulmonary embolism diagnosed by CT 4/16/21
Patient developed petechial and purpuric rash on bilateral legs 2-3 days after first Moderna COVID shot. Then developed recurrence after the second shot. Got skin biopsy showing leukocytoclastic vasculitis.
Pt. passed out after flu shot and started snoring for approximately 2 seconds then awake monitored and watched blood pressure for 15-20 min. 1st reading 100/60 pulse 66 2nd reading 107/57 pulse 57.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
7-8 inch long 3-4 inch wide swollen, warm, itchy area, taking antihistamines and anti-inflammatories, slowly going down as of 10/1/2017.
Bumped into a door and had a red mark on the part of the body; This is a spontaneous report from a non-contactable consumer or other non hcp (patient) from Pfizer sponsored program support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11May2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on APR 2021 as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, patient experienced bumped into a door and had a red mark on the part of the body on an unspecified date. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 12/14/99, the pt experienced a bright red mark shaped like a "v" on the leg where the injection was given, and the area on the leg became red, indurated, raised circle that was very hard. On exam, the area was annular and indurated with a size of 2 1/2 cm. The v shape lesion was slightly tender on palpation. The pt also developed four erythematous papules on the back and extremities. Follow up was received from a registered nurse. The pt recovered on 12/20/99. Additional information has been requested.
Patient works nights and it was her night off.  She states that she woke up around 2:00 AM feeling tired, lethargic, lightheaded/dizzy, itching on both arms, and had broken out with a rash/elevated bumps on arms.
05/22/2022 That evening I had a headache and bad cough. Through the night, I could not sleep, started running a fever and had difficulty breathing. The next day, on 5/23/2022, I tested positive for COVID at home. I then tested positive at the Health Department. I could not stop coughing, my head felt like it was going to burst, my chest was really tight and congested, was freezing, running a fever and hurt all over. I called my doctor late that afternoon. The next day, 0n 05/24/2022, I had a tele health visit with my doctor.  She suggested that I have the monoclonal antibody therapy infusion. On 5/25/2022 I had the infusion. I feel so much better, but am still not recovered.
patient came back today concerned about the 1.5 inch bruise surrounding the bandaid from his flu shot, it was not uncomfortable and he says he was on no blood thinner or asprin like product.  The Pfizer vaccine on the left arm had no discomfort or brusing at all
Pt had extreme dizziness. PT was laid down to floor with feet elevated. Ice pack was given. EM was called and pt was transported to nearby ER
record reports pt. being readied for discharge when she c/o itching. Erythema without urticaria noted R shin, was in NAD and lungs were clear.  Oral benadryl planned, but pt. c/o difficulty breathing before receiving med.  Had emesis; lungs then noted with decreased air entry.  Continued observation, rec'd epinephrine IM, methylprednisolone and Ondansetron IV.  She responded to treatment and was discharged later that afternoon (~17:09 PM)
This spontaneous report was received from a consumer referring on her daughter, a 16 year old female patient. Medical history and concurrent conditions were not reported. In 2013 the patient was vaccinated with GARDASIL dose 1, 1 single shot. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The reporter stated that after her daughter received her first and only dosage of GARDASIL dose 1 in 2013, she had an immediate and extreme personality change. The daughter also began to have fatigue and joint/muscle pain. She has constant "sinus colds and coughing. The developed "depression, anxiety, agitation and mood swings." In addition, her menstrual cycle was also affected. She had an electrocardiogram (EKG) that indicate that her heart is "acting up" (on an unknown date). Therapy with GARDASIL was discontinued. The outcome of depression, fatigue, muscle pain, joint pain, coughing, menstrual cycle affected, mood swings, agitation, anxiety, heart acting up, sinus colds and extreme personality change was reported as not recovered/not resolved. The patient sought medical attention, she was seen by many unspecified HCPs. This is one of two reports from the same source. Additional information has been requested.
I recieved the Influenza Vaccine yesterday, November 10, 2003 @ 12:00 pm. Within the hour the site of injection was red, swollen, hot, and itching. I have had a temperature of 100-101.4 with serious nausea, and my face feels very flushed. I have taken anti-nausea med. and Tylenol. Nothing seems to help. It has been aproximately 31 hours.
Asymptomatic rash on lower legs, pain in right knee for 2 weeks then pain in right ankle.
Well child visit where child received imm. on 6-13-07. On 6-20-07 child had seizures and was transported to ER - CXR and urine (-) child sent home, 2 days later had seizure and upon to ER found acute otitis media. Treated will amoxicillin. At conclusion of antibiotic a 3rd seizure occurred. ER changed to a different antibiotic Augmentin. I have referred patient for neurology consult.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received BEXSERO (batch number 149001A, expiry date September 2016). Concomitant products included PREVENAR. On 2nd May 2016, the patient received BEXSERO .5 ml. On 2nd May 2016, immediately after receiving BEXSERO, the patient experienced injection site pain and inappropriate age at vaccine administration. On 6th May 2016, the patient experienced lymphadenopathy. On 11th May 2016, the outcome of the injection site pain and lymphadenopathy were recovered/resolved. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the injection site pain and lymphadenopathy to be related to BEXSERO. Additional details were provided as follows: The 58 years old patient received BEXSERO in left arm and PREVENAR in the right arm. This led to inappropriate age at vaccine administration. The patient experienced left arm soreness immediately after receiving BEXSERO and 4 days later she experienced swollen lymph nodes in left armpit, neck, and upper shoulder area between collarbone and neck. On 11th May 2016, the patient was feeling better and the side effects were resolved. No other side effects were reported.
Arm hurt where vaccine was given after the administration for about 2 weeks.  No pain for a day or two then shoulder pain occurred until seen 4/27/17.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from an other health professional.   This case is linked to cases 2023SA054981(CLUSTER) and 2023SA057733(CLUSTER).   This case involves an adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   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.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.