chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of vaccine post temperature excursion with no adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient for whom reporter reported administration of vaccine post temperature excursion with no adverse event while receiving vaccine IPV (VERO) [IPOL]   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation; and measles vaccine live (Enders-Edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (Wistar ra 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for Immunisation.  HCP office inquiring about the stability of vaccines after a temperature excursion and reporting adverse events for patients who received doses post excursion.  Unopened Products: DAPTACEL, TUBERSOL, ACTHIB, IPOL, VAXELIS, MENQUADFI Opened Products: TUBERSOL and IPOL Cause: Power outage. Max/Low Temperature reached: 54.3 degrees Fahrenheit Duration out of recommended range: 2 hours and 45 minutes  On 29-Sep-2022, the patient received dose 4 of suspect IPV (VERO) at a dose of 0.5 ml (milliliter) total once Suspension for injection (lot V1A022M, expiry date - 17-Feb-2024)(strength: unknown) via subcutaneous route in the left upper arm for Immunization after post temperature excursion with no adverse event (Poor quality product administered) (latency: same day).  No lab data was reported  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Received H1N1 vaccine @ school. School nurse called to gym-pt c/o "allergic reaction" EMS called 9:52. Pt tx with EPINEPHRINE, IV fluids, BENADRYL IV, O2. Improved in route to ER. No rash noted by nurse. Improved d/c home.
INJECTION SITE PAIN IN LEFT ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced injection site pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain in left arm. This report was non-serious.
pt recvd vax;site started to itch p/ 2 hrs;muscle blew up,was red;bubbly to touch about 4: in diam;inner ache & top itch w/ throbbing;arm started hurting p/ 6 hrs;heat applied;subsided a little;still bit swollen,hard & red w/ ache;
having pain with walking and when he reach to get something; he might have swelling the butt; muscle pain in back of legs; This is a spontaneous report from a contactable consumer or other non hcp (Patient) reporting himself.  A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1681), via an unspecified route of administration on 02Mar2021 (Age at vaccination: 65-years-old) as single dose for covid-19 immunization. Medical history included knee and hip replaced done 9 years ago. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Batch/lot number: EL3302) on 09Feb2021 (Age at vaccination: 65-years-old) as single dose for covid-19 immunization and experienced muscle pain in back of legs. It was reported that he got the first dose on 09Feb2021 and the next following week or week after started experiencing muscle pain in back of legs. stated then on 02Mar2021 he received the second dose and is still experiencing leg pains but it is not always it is only like if he goes for a walk outside for a couple of minutes and then all of a sudden he starts having pain in the back of his leg in the muscle area. Caller wanted to know if the muscle pain in the back of his legs is because of the vaccine. stated just so you know his wife had her vaccine at the same place but a different time and she is experiencing pain in her left leg. Upon Follow-up, dated 03Jun2021, it was reported that both legs muscle pain after a week of receiving the first dose of the Pfizer covid vaccine. patient wanted to know if knee and hip replaced done 9 years ago have anything to do with the pain he is having. His doctor stated they are finding it the pain gets intensify with/when replacement is done. patient received the second dose on 02Mar2021 and has been having pain with walking and when he reaches to get something, he was ok when sitting. He also stated that he might have swelling the butt. he got the pain shot, was taking diclofenac 75 mg and was also prescribed Flexeril but he does not take it as he does not like the make it makes him feel. Therapeutic measures were taken as a result of muscle pain in back of legs. The outcome for the events was reported as unknown at the time of this report.  No follow up attempts are possible. No further information is expected.
This spontaneous report as received from a physician, via company representative, refers to a 61 year old female patient. The reporter stated that a patient experienced a severe allergic reaction on her arm at the injection site after receiving a dose of PNEUMOVAX 23 into arm, (dose, strength, route of administration not reported), on 27-AUG-2013. The patient has not fully recovered and continues to have unspecified issues with her arm. The patient was seen 3 different times in an unspecified emergency room for symptoms related to the injection site reaction. The first emergency room visit was on 01-SEP-2012. The dates of the other two visits were unknown. Besides the emergency room visits, the patient was also seen by two unspecified healthcare providers. It was reported that the patient had an elevated white blood cell count of 19,000 (units not provided) the date of this blood test was not specified. The patient also developed vertigo which started in November 2012. Due to the several and size of the injection site reaction, the patient had an ultra sound (date unspecified) of her arm to rule out cellulitis. Cellulitis was not detected on the ultra sound. The relatedness between PNEUMOVAX 23 and events was not reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand: Pfizer; Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 19:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 56 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), on 09Apr2021 as dose 2, single (Lot number: ER8731) and on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Apr2022 as dose 4 (booster), single (Lot number: 005M21A) for covid-19 immunisation. The patient's relevant medical history included: "slightly high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN, start date: 07Nov2022 (in two weeks of vaccination). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Apr2022, outcome "unknown", described as "vaccine brand: Pfizer; Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  Clinical course: Patient had no known allergies. Patient took Paxlovid (Lot number: Unknown) for 5 straight days (Sunday to Thursday: start date was 27Nov2022 and stop date was 01Dec2022). Patient was feeling somewhat better on Wednesday, 30Nov2022, and more better on 1Dec2022. Patient felt 90% better on Friday, and that state of health stayed the same through Sunday. On Monday, 5Dec2022, He felt dramatically worse, almost as bad as he did on Sunday, 27Nov2022, but the headache was less intense. Patient was recovering from symptoms. No treatment received for symptoms.  No follow-up attempts are possible. No further information is expected.
Patient received influenza vaccine on 10/9/2017. On 10/11/2017 patient suffered a myocardial infarction and passed away.
Pt w/ syncopal episode w/ no LOC post administration-w/24hr's of Menactra #2 Men B. Seen in ER IV admin diphenhydramine Elevated CBC - repeat labs, flu, covid test done. EKG normal and ER referred to cardio & neuro
Friday approx. 4-6 hrs post imm fever 104.6 crying leg swollen red eyes blood shot called ER-Friday.. Tues saw MD Tylenol, Motrin, antihist. still running fever 102 degrees.
Patient received a dose of vaccine that may be less than completely effective due to storage conditions.   No adverse effects reported.
Site swelling ice was applied, lip swelling, epi was administered 0.5 ML left arm. Taken to Hospital by ambulance. Patient in good condition slight swelling lips only.
This is a spontaneous report from a non-contactable pharmacist, received via a sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. A 72-years-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose in the arm for immunisation. The patient medical history and concomitant medications were not reported. On unspecified date after vaccination the patient experienced bruising in the arm of injection with outcome of unknown and cough that lasted for a little while. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Drug dose administration interval too short; Bells Palsy/ Facial drooping; This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 74-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On 8th February 2019, the patient received the 2nd dose of Twinrix. On an unknown date, the patient received the 3rd dose of Twinrix. On 1st June 2019, 113 days after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the bell's palsy and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the bell's palsy to be related to Twinrix.  Additional details were provided as follows: The patient came in for third dose of Twinrix, when they noticed facial drooping. The patient received 3rd dose of Twinrix earlier than recommended interval, which led to the shortening of vaccination schedule.  The reporter reported developing Bells Palsy 4 month after receiving 2nd dose of Twinrix. The reporter consented to follow up. The reporter did not have lot number or expiration date at this location.
After 7 hours, I started to feel like I had a migraine. Then my whole body ached horribly, I had chills, a fever, difficulty breathing
EMAIL WAS RECEIVED TO DISCONTINUE PFIZER PEDIACTRIC COVID VACCINE ON 10/12/22, THIS BOOSTER WAS ADMINISTRATED ON 10/07/22, ACCORDING TO THE MANUFACTURE DATA THE VACCINE EXPIRATION DATE IS 09/30/22 BUT MANUFACTURE CONFIRMED THE VACCINE STABILITY GOOD UNTIL 10/19/22, HOWEVER THIS EVENT WERE REPORTED HERE BUT THERE WAS NO ADVERSE EFFECT OR PROBLEM REPORTED FROM THE PATIENT.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with the first, second and third dose of GARDASIL (Lot #, dose and route not reported) respectively on 05-AUG-2010, 29-SEP-2010 and 30-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was not experiencing any known symptoms. It was not known if the patient sought medical attention. Additional information has been requested.
The patient was seen for well check 24 hour after seeing cardiology everything appeared well for this patient, had vaccines, no fever, became congested and heart stopped.
Several rapid flashes of light followed by sever headache that has reduced to a dull ache for going on 4 days now. On the 2nd night 08/13/2016 at 7pm I noticed red blotches on my face. By the morning of 08/14/2016 at 6 am I had them on my stomach. I have had a runny nose for 2 days and a low grade fever of 99.3. The red blotches dont itch but they do burn and especially when I get hot or go outside in warm weather.
bleeding(spotting); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (bleeding(spotting)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Menopause (went to menopause 3years ago) in 2018.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (bleeding(spotting)) (seriousness criterion medically significant). On 10-Mar-2021, POSTMENOPAUSAL HAEMORRHAGE (bleeding(spotting)) had resolved. Not Provided          Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
67 y.o.    Admit Date:  7/30/2022   Discharge Date: 8/2/22   Principal Dx/ Final Dx: Epigastric pain   Relevant Inpt Dx: Principal Problem:   Epigastric pain Active Problems:   Essential hypertension   History of Hodgkin's disease   Type 2 diabetes mellitus without complication, without long-term current use of insulin   Adnexal mass   COVID-19 virus detected       HPI:   Hospital Course:   This 67 year old woman was admitted with upper abdominal pain.  She was seen by GI and surgery.  EGD showed hiatal hernia.  HIDA scan consistent with cholecystitis.  She had laparoscopic cholecystectomy.  At time of surgery gall bladder was gangrenous.  She is doing well and will follow up with pcp and surgery.   Imaging also showed adnexal mass.  She was seen by hospitalist ob/gyn.  Ca125 was 18.1.  This was not addressed at time of surgery due to inflamed GB and adhesions.  She will follow up with ob/gyn            Consults:   IP CONSULT TO GASTROENTEROLOGY IP CONSULT TO SOCIAL WORK IP CONSULT TO GENERAL SURGERY IP CONSULT TO OB GYN       Disposition:  home   Discharge Condition:  fair   Discharge Medications:   Current Discharge Medication List   START taking these medications   Details oxyCODONE-acetaminophen (PERCOCET) 5-325 mg per tablet Take 1 Tablet by mouth Every 6 hours as needed for Pain for up to 5 days. Qty: 20 Tablet, Refills: 0   Associated Diagnoses: Acute cholecystitis     CONTINUE these medications which have NOT CHANGED   Details ketoconazole (NIZORAL) 2 % cream Apply once a day to breast, rub in gently. Qty: 30 g, Refills: 2   Associated Diagnoses: Intertrigo   blood sugar diagnostic test strips Check glucose daily.   esomeprazole (NEXIUM) 20 mg DR capsule Take  by mouth.   Irbesartan 300 mg Tab     levothyroxine (SYNTHROID) 150 mcg tablet     metoprolol (TOPROL-XL) 50 mg     Hydrochlorothiazide (MICROZIDE) 12.5 mg capsule Take 1 Cap by mouth Daily. Qty: 90 Cap, Refills: 3   Associated Diagnoses: Essential hypertension   metFORMIN (GLUCOPHAGE) 500 mg tablet Take 1 Tab by mouth Daily. Qty: 90 Tab, Refills: 3   Associated Diagnoses: Type 2 diabetes mellitus without complication, without long-term current use of insulin     STOP taking these medications     mupirocin calcium (BACTROBAN) 2 % CREAM Comments:  Reason for Stopping:
A "halo" on the arm where the vaccine was administered; This spontaneous case was received on 22-Aug-2022 from a pharmacist via Agency (reference number: SEQW22-02391) and concerned a 70-year-old, female patient.  The patient's medical history was not reported. The patient was not taking any concomitant medications.   On 22-Aug-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 346357 and expiry date 18-May-2023.  On the same day, after receiving Fluad Quadrivalent, the patient experienced a 'halo' on the arm where the vaccine was administered. Two hours after vaccination the patient called and complained of the event. No treatment measures were performed.   At the time of initial reporting on 22-Aug-2022, the patient had not recovered from the event.   The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 70-year-old female patient experienced vaccination site discolouration (reported as a 'halo' on the arm where the vaccine was administered) after vaccination with the suspect Fluad Quadrivalent vaccine. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.; Sender's Comments: A 70-year-old female patient experienced vaccination site discolouration (reported as a 'halo' on the arm where the vaccine was administered) after vaccination with the suspect Fluad Quadrivalent vaccine. Causal role of the suspect vaccine is assessed as possibly related, due to biological and chronological plausibility.
pt recv vax & immed became pale;cried & then fainted;mom was holding pt & began pt began to shake pt then regained consciousness;c/o pain in stomach;syncope probably was 30 sec;fatigued;pt wanted to sleep;poss vasovagal rxn;5 nosebleeds
1 hr after administering, pt began experiancing hoarse voice/ loss of voice. later sx to include fever, swollen lymp nodes, chills, L ear pain.
One day post vax the pt developed a rash on the middle of her chest. 14 days (03/14/2000) later the pt experienced difficulty in moving her hands and toes. The next day (03/15/2000), she experienced difficulty moving her right knee. On 03/21/2000, the pts physician prescribed Arthrotec for joint pain because Alleve did not work. The pt was still experiencing joint pain, inflammation and itching on her chest. Additional information has been requested.
Post vax, she had a low-grade fever, no appetite, little energy and had a "dazed" look on her face. In the evening of 12/3/00, she had a fever of 104F. During this time period, (12/1/00-12/03/00) we gave her alternately, Tylenol and Motrin (children's).
Narrative: Pt received Moderna Covid vaccine #1 on 3/5/21 and #2 on 4/2/21. No notes or scanned records indicating what happened after his second vaccine. Date of death is reported as 4/26/21. Time from second vaccine to date of death is 24 days. No autopsy report available.
Facial swelling, tongue swelling, trouble breathing, hypotension began approximately 24 hours after vaccine administration. Pt was treated in emergency department.
After vaccine I noticed an immediate metal taste in my mouth, 30 minutes after vaccine I noticed a tingle feeling to my tongue and the metal taste, 45 min after vaccine I noticed my tongue was swollen, Vaccination clinic called and recommended taking diphenhydramine and go to ER if symptoms got worse.
Shingles, right eye/forehead/scalp which started the afternoon/evening of 10/5/19 and worsened over the next 2 days.  Was evaluated and diagnosed in urgent care on 10/7/19 at 0800.  Was also seen my ophthalmology at 1045 that same morning.
I got burning sensation in my hands, down my lower body, down my buttocks to my feet like my skin is burning.
rash; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and diarrhea. On an unknown date, the outcome of the rash and diarrhea were unknown.   It was unknown if the reporter considered the rash and diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced a rash and diarrhea. The patient did not provide any demographics. The reporter did not consent to follow-up.
Itching at Injection site; Swelling, and Itching at Injection site; Redness, Swelling, and Itching at Injection site; This case was reported by a consumer and described the occurrence of injection site itching in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter consented to follow up. All information was not available.
chest pain; abdominal pain; joint pain; headache; throwing up; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 01Feb2021 for COVID-19 immunisation. The patient experienced chest pain, abdominal pain, joint pain, headache and throwing up on an unspecified date after getting the second dose of the Covid19 vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.