chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9PM fever (temp unk) dec energy, APAP given; 2PM, warm crying, eyes rolled back; stopped sucking, arms limp, parents tried to arouse but unable;3mins eyes rolled back didn't seem to breathe, hands & feet cold & bluish;
R anterior thigh, small erythema 1.5 X 2cm surrounding shot site; area of erythema 4.5 X 5cm extending distally from site, mild warm, non-tender, no induration, minimal swelling.
MMR given rt thigh SQ 4:30 pm shortly after began swelling and hot to touch. Having child stay in clinic for 20-30 min.
No additional AEs were reported; improperly stored vaccines; This spontaneous report was received from a licensed practical nurse referring to patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 25-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose, lot #U026217, expiration date: 02-NOV-2023 (strength, route and anatomical location were not provided), for prophylaxis (product storage error).   The administered vaccine experienced a temperature excursion in 34.3 degrees Fahrenheit for 55 minutes. There was no previous temperature excursion. No additional adverse events (AEs) were reported.   This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001791:
an expired dose of Engerix B was given to a patient / The dose given expired on 4/13/2021; This case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number CP275, expiry date 13th April 2021) for prophylaxis.   On 13th May 2021, the patient received Engerix B .5 ml. On 13th May 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter indicated that an expired dose of Engerix B was given to a patient, which led to expired vaccine used.
Adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided. No concomitant medication provided. No proper adverse event reported.   Reporter did not allow further contact
Three days after receiving TD, she developed a generalized fine, red, raised rash on neck, abd, legs, arms, feet, causing much itching, Has felt feverish at times.
1030 pt reported dizziness, pt passed out and vomitted, bp 96/66. Team Alert initiated.  Pt alert and awake when ER staff present., Declined ER visit, Husband called to drive home. AT 1100, Bp 149/81, pt home in stable condition.
7 days after completing the 3rd vaccine for Japanese Encephalitis, pt. awoke c/o chills and headache which lasted for 2 days.
G40.822 INFANTILE SPASMS 2/3/2023 EPILEPTIC SPASMS NOT INTRACTABLE WITHOUT SE
I had pain and difficulty lifting my right arm shortly after the shot and that persists, 6 weeks later. I have some weakness and lack of mobility in that arm, centered on the injection site.
This spontaneous report as received from a registered nurse (who was also an office manager) refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date in 2015 (reported as "a year ago"), the patient was vaccinated with unknown dose of GARDASIL (route, lot # and expiry date were not reported). Concomitant medications were not reported. On an unknown date in 2015, the patient complained of pain after administration of GARDASIL. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Itchy rash on the back (about half dollar size); Headache; My arm was sore; Felt sluggish; A spontaneous report was received from a 62 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, felt sluggish, arm was sore and had an Itchy rash on the back (about half dollar size).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, Tuesday evening at 6:15pm, the patient received their first of two planned doses of mRNA-1273 (lot number: 011J20A) intramuscularly for of COVID-19 infection.   On 30 Dec 2020, the patient experienced a headache, felt sluggish and her arm was sore.  On 31 Dec 2020, the patient developed a rash on her back that is about half dollar size; It was a little itchy. She stated that her arm is still slightly sore, but the other symptoms were gone.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of events, headache and felt sluggish were resolved.   The outcome of event, arm was sore is resolving.   The outcome of event, itchy rash on the back (about half dollar size), is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A female patient of an unspecified age (from 16 to 18 years old) received on 07Aug2015 TRUMENBA (lot number J28923, expiry date Jun2016) at 0.5 ml single, intramuscular, in left upper arm. No antipyretic was given prior to vaccine. No other vaccines were given on the same day or within four weeks prior to date of vaccination. Relevant medical history and concomitant medications were unknown. On 07Aug2015, the patient experienced swelling (swelling of arm pain), redness, pain, muscle aches, feeling hot touch, fever at 101 degrees F, chills and headache. Clinical outcome of the events was unknown. The events did not require an emergency room of physician visit. The reporter considered there was a reasonable possibility that the events were related to the suspect vaccine. Follow-up (25Sep2015): New information from the same contactable physician includes: vaccine lot number, expiry date, route of administration, posology, additional events 'chills' and 'headache', causality assessment.
Couple of days later after having the vaccine I started to feel severe lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 06May2021 at 14:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient did not have any allergies to medications, food, or other products. Concomitant medications included women ultra mega vitamins and levothyroxine sodium (EUTHYROX). 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 COVID vaccine. It was unknown whether any therapeutic measures were taken as a result of the reported event. On 09May2021 at 20:00, the patient experienced severe lower back pain couple of days later after having the vaccine. 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. The clinical outcome of the event lower back pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
PT REPORTED BODYACHES, FEVER, CHILLS STARTED THE DAY AFTER THE VACCINATION
p/vax pt exp hives, angioedema & abd pain;confirmed urticarial vasculitis;
pt recv vax & 1 hr later exp SOB, heart pounding, dizziness & was anxious;
Nausea within about 45 minutes after vaccine, Headache later in evening into next day with fatigue
swelling localized to R cheek, skin w/o redness, no s/s of puncture to indicate insect bite.         >NO discharge from Stenson's duct on palpation, no Anterior cervical or Posterior cervical LNs, no submental LNs noted on examination        >Oral examination was normal w/o pus or cellulitis.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 52-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number YR7AA) for prophylaxis.   On 03-JAN-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-Apr-2023 The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug. The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
seen by a dermatologist who stated that the patients rash was shingles; the rash was worse as it was creeping down his leg and spreading below his knee; 1st dose same day that was seen by the physician because of a rash in his inner thigh and knee pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cephalexin (Keflex) unknown for rash and hydrocortisone ointment for rash.   Previously administered products included Zostavax (received dose on an unknown date). Concurrent medical conditions included rash (rash in inner thigh) and knee pain.   On 10th May 2022, the patient received the 1st dose of Shingrix, Keflex at an unknown dose and frequency and hydrocortisone at an unknown dose and frequency. On 10th May 2022, unknown after receiving Shingrix and not applicable after starting Keflex, the patient experienced drug use for unapproved indication. On 11th May 2022, the patient experienced shingles and rash aggravated. The patient was treated with acyclovir. Keflex was discontinued. Hydrocortisone was discontinued. On an unknown date, the outcome of the shingles, rash aggravated and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the shingles and rash aggravated to be related to Shingrix and Keflex.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's Comments: Reporter was the wife of the patient.   The reporter stated, the patient received his first dose of Shingrix on Tuesday and the patient also was seen by the physician that day complaining of a rash in his inner thigh and knee pain.  The patient was prescribed Keflex and Hydrocortisone ointment for the rash.   The following day, on 11th May 2022, the rash was worse as it was creeping down his leg and spreading below his knee.   On 12th May 2022, Thursday, the patient was seen by a dermatologist who stated that the patients rash was shingles.   The dermatologist stopped the Keflex and Hydrocortisone cream and applied Acyclovir. Reporter did not have information regarding the specifics of the Shingrix vaccine The reporter consented to follow up. On 11th May 2022, 1 day after receiving Keflex and Hydrocortisone and Shingrix vaccine, the patient experienced rash aggravated and shingles. It was unknown if the reporter considered the rash aggravated and shingles to be related to Hydrocortisone. Additional Supportive Information: The patient received 1st dose of Shingrix, on same day that was seen by the physician because of a rash in his inner thigh and knee pain, which led to drug use for unapproved indication.
Temp 101 on 9/30/16 evening; on 10/1/16 temperature ran from 99 to  100 throughout the day; on 10/2/16 Temp 101-102 increased lethargy, altered mental status, decreased respiration with SATs 75% then atelectasis requiring emergency intubation.
Petechia, blood blisters in mouth. Ended up in critical care at hospital with 0 platelets. Diagnosed with Immune Thrombocytopenia Pupura
Patient received second dose of Pfizer Covid-19 vaccine about 1105 am.  About 1115 am patient complained of feeling lightheaded and dizzy.  Patient was given some cold water and advised to sit for about 15 minutes to see if the dizziness would pass.  About 1135 am patient complained that her lips felt a tingling sensation and her tongue felt thick.  At 1140 am patient was administered 25 mg of diphenhydramine to help with current symptoms.  Shortly after patient complained her throat felt swollen, her lips were numb and her tongue felt even more thick.  Patient was administered 1 dose of Epi-pen at 1145 am in right outer upper thigh.  Shortly before EMS arrived at 1150 am patient reported that her throat still felt swollen and that her heart was racing.  EMS arrived at 1150 am and events and medication reviewed with EMS.  EMS reviewed patient's vital signs, which were stable with a pulse ox holding at 99, and then transported her to the ambulance.
Reaction or redness of lower extremities about one hr after shot. (1st series of vacc. PEDIARIX/HIB and ROTATEQ).
Fatigue; Arm soreness; Muscle aches; General ill-feeling; Pain when moving; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration in the left arm on 09Apr2021 at 10:15 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome and penicillin allergy. Concomitant medications included escitalopram oxalate (LEXAPRO) from an unknown date for unspecified indication. 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 09Apr2021 at 10:30, the patient experienced fatigue, arm soreness and pain when moving, muscle aches and general ill feeling. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fatigue, arm soreness and pain when moving, muscle aches and general ill feeling were resolving at the time of reporting.   No follow-up attempts are possible. No further information is expected.
1 minute post vax the pt slumped over in the chair, eyes closed, non-responsive, right leg and both arms with jerky movement. After 1 minute he opened his eyes and appeared dazed. He reported nausea and headache. Student was very pale and 911 was called. The student was taken by family to MD. MD felt it was an allergic reaction and referred them to an allergist.
Foster mom reported localized rxn w/inconsolable high pitched cry for 1 1/2 hrs;
Admitted on 4/12/2021 with acute respiratory failure, bronchiectasis, possible UIP pulmonary fibrosis
No Adverse Event; injected with Expired Bivalent Moderna COVID-19 Vaccine beyond 30 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (injected with Expired Bivalent Moderna COVID-19 Vaccine beyond 30 days in the refrigerator) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2023, 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 January 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (injected with Expired Bivalent Moderna COVID-19 Vaccine beyond 30 days in the refrigerator). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (injected with Expired Bivalent Moderna COVID-19 Vaccine beyond 30 days in the refrigerator) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (injected with Expired Bivalent Moderna COVID-19 Vaccine beyond 30 days in the refrigerator).    No concomitant medicine were reported. On 08-Nov-2022 vial was initially stored in the refrigerator.  No treatment medicine were reported.
This spontaneous report as received from a nurse refers to two patients of unknown age. The patients were not pregnant. On an unknown date the two patients were vaccinated with PNEUMOVAX23 (lot# H014196; expiration unspecified) (dose, route and injection site were not reported). On an unknown date the two patients developed a red area around the injection site. The outcome of was unknown at the time of report. Action taken and causality were not provided. The patient had sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
L arm red, hot and swollen below point of PPV23 injection. Treated with MEDROL and Cephalexin monohydrate.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA267265, 2018SA267282, 2018SA267253, 2018SA267283, 2018SA267295, 2018SA267304, 2018SA267274, 2018SA267294 and 2018SA267305 (same reporter). This case involves a 56 years old female patient who was vaccinated with an expired dose of 0.5 mL vaccine FLUZONE QUADRIVALENT lot UI815AA, expiry date: 30-Jun-2018 via unknown route in the left deltoid on 17- Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expire vaccine used. It was reported that 9 doses of expired FLUZONE QUADRIVALENT single dose vials exp. date: 30-Jun-2018 given inadvertently to employees for routine vaccination with no reaction 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 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.
The pain in right arm was unbearable could not move it at all. The area was red and very warm (Hot). It could not be touched massaged. Put me in bed for several days, very sick. Gave me generalized fever, body aches. I became weak. I felt dehydrated. Had headaches. I was so sick a relative wanted to take me to the ER.
felt like he had the flu; not thinking straight; fever; headache; chills; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the flu), THINKING ABNORMAL (not thinking straight), VACCINATION SITE PAIN (soreness at the injection site), PYREXIA (fever) and HEADACHE (headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TESTOSTERONE for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 11-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he had the flu), THINKING ABNORMAL (not thinking straight), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). The patient was treated with IBUPROFEN at a dose of 500 mg. At the time of the report, INFLUENZA LIKE ILLNESS (felt like he had the flu), THINKING ABNORMAL (not thinking straight), VACCINATION SITE PAIN (soreness at the injection site), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-228293, MOD-2021-228278 (Patient Link).
This case was reported by a consumer on 11 February 2008. Seriousness criteria: Other-Medically Significant A 58-year-old female, with no medical history, received an intramuscular left deltoid injection of Fluzone (lot number U2515AA) on 31 October 2007. Immediately following vaccination, she complained of intense musculoskeletal pain in the entire left arm. The pain continued, and the patient became unable to life her arm above her head. She denied numbness, and was able to freely use her fingers. She was seen by a physician, and an x-ray of the arm was within normal limits. Treatment included exercises only; no medications had been prescribed. At the time of the report, the event remained ongoing. The reporter of this case also reported that another patient had complained of arm pain after vaccination with Fluzone; that non-serious event is captured in case number 2008-00442.
patient can't take the flu shot. They made patient had the flu; patient had 3 of them and patient got sick every time; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a patient of unknown age who can't take the flu shot. they made patient had the flu (influenza) and had 3 of them and patient got sick every time (illness), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient who can't take the flu shot. they made patient had the flu (influenza) and had 3 of them and patient got sick every time (illness), (latency: unknown) following the administration of suspect vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.