chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details available. No additional AE reported. No PQC.; Medical assistant reports administration of VARIVAX after temperature excursion. Product experienced temperature excursion yesterday 1/11/2023 and was administered today 1/12/2023.; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age or gender.  The patient's medical history, concurrent conditions, concomitant therapies, drugs reactions or allergies were not reported.  On 12-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot #W006412, expiration date: 23-FEB-2024, administered for prophylaxis (vaccination scheme, route of administration were not provided) following a temperature excursion of -14 degree Celsius (C) up to -10C for 30 minutes (product storage error), it was stated that no previous temperature excursion occurred before. No additional adverse event reported. No PQC..
Fever, chills, cold sweats, body ache. Miserable for 24 hours. Arm hurts still 1 week later. Haven't been able to sleep in right a Side because arm is still so tender
9/25-Flu shot given by LPN at Doctor's office. Immediate pain in right shoulder joint. Pain 6/10, increased temperature to touch, nausea, constant burn, weakness of (L) arm. Having existing SX numbness, tingling.
multiple pneumonias caused by an viral interstitial infection; fatigue; Shortness of breath; back pain; pain in the left arm and hand; Initial information was received on 16-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health professional.   This case involves a 77-years-old male patient who experienced multiple pneumonias caused by a viral interstitial infection (pneumonia viral), fatigue, shortness of breath (dyspnoea), back pain and pain in the left arm and hand (pain in extremity), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 04-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE injection (lot number: UJ444AA, expiry date- 30-Jun-2021, strength: standard) via intramuscular route at an unknown administration site for prophylactic vaccination.  On 04-Sep-2020, the patient developed serious back pain, pain in the left arm and hand (pain in extremity), fatigue, shortness of breath (dyspnoea) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient was hospitalized 2 months 9 days after this event occurred. The event fatigue and dyspnoea were assessed as medically significant.  On 12-Nov-2020, the patient was admitted to the hospital where he was diagnosed with serious multiple pneumonias caused by a viral interstitial infection (pneumonia viral) 2 months 8 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.   The patient was hospitalized for all the events in the intensive care unit.  It was reported that patient was on a ventilator but after diagnosed with multiple pneumonias ventilator has since been taken off.  The caller reported that the consumer is still in the hospital.  Reporter relationship : Caregiver, Product used : Used. Still using product : No.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  The patient was not recovered from any of the event at the time of reporting.; Sender's Comments: This case concerns a 77-years-old male patient who experienced viral pneumonia, fatigue, dyspnoea, back pain and pain in extremity after vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. Further information regarding medical history, concomitant medications, previous vaccination and laboratory data ruling out predisposing etiologies were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed.
Patient under the age of 18 received the Moderna COVID Vaccine - No Adverse reactions - patient observed by Physician for 15 minutes,
Headache beginning 16 hrs after the vaccine through 24 hrs after the vaccine. It eventually went away after a second treatment of ibuprofen. Some fatigue during this same period.
Reports developing itchy, red rash on buttocks and legs. Five days after vaccine administration. Took Benadryl with moderate relief. Called office 09/17/2001 and rash was assessed by physician 09/19/2001 with no further treatment. Pt ingested raspberries on day rash appeared.
Pfizer vaccine was diluted with .8cc of diluent instead of 1.8 cc dliuent. No signs or symptoms occurred during the 15 minute waiting period.
Bell's palsy; Loss of taste; Can not close one eye, no muscle movement on one side of the face.; This is a spontaneous report from a contactable nurse.  An adult female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 05Jan2021 15:30 at single dose for COVID-19 immunization.  There were no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient experienced Half face paralysis, Bell's palsy. Loss of taste. Can not close one eye, no muscle movement on one side of the face. All on 08Jan2021 14:30 with outcome of unknown. No treatment was received.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Half face paralysis/Bell's palsy cannot be fully excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Immediately developed a fine rash across entire torso. Was not present prior to dose( had a CHSC) 11/19/2008 treatment with BENADRYL and improving. 11/24/2008 completely resolved.
double vision; body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (double vision), MYALGIA (body aches) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 025B21A) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE (LAMICTAL), OLANZAPINE (ZYPREXA), QUETIAPINE FUMARATE (SEROQUEL), METOPROLOL and MELATONIN for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced MYALGIA (body aches). 06-May-2021, the patient experienced PYREXIA (low grade fever). On 07-May-2021, the patient experienced DIPLOPIA (double vision). On 07-May-2021, DIPLOPIA (double vision), MYALGIA (body aches) and PYREXIA (low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: low (Low) Low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included Birth control pill for unknown indication. No treatment medications were provided.
Positive PAP smear after 3rd HPV (GARDASIL) vaccine. Specimen taken 5/20/08 - reports attached. Reported 6/4/08 HPV Hybrid Capture II detected. 8/11/08 - PAP smear - negative
I started getting symptoms of mild cough, tiredness, and fatigue, as well as losing voice that lasted about one week. I did have mild symptoms. I received a positive COVID-19 test on 2/15/2022. I was on a cruise ship that done the testing. I took Nyquil. My doctor also prescribed Benzonatates with a telehealth visit. The cough lingered for 3 weeks.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 77-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The date of vial initially stored in the refrigerator was unknown. Number of doses/vials were 173. No treatment information was reported   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant live follow-up: Additional reporter added.
Information has been received from a registered nurse concerning a 39 year old female patient with hypertension and depression, no known drug allergies and a history of gastric disorder who on 02-MAR-2010 was vaccinated subcutaneously with VARIVAX (Merck) (lot# 665992/1402Y). Concomitant therapy included lisinopril, omeprazole (MSD) and "DREN". On 13-MAR-2010 the patient experienced a mild varicella-like rash on her trunk area, body aches, fatigue, headache and a loss of appetite after receiving her first dose of VARIVAX (Merck). The patient sought unspecified medical attention. The results of the VZV titer was negative which were performed prior to receiving VARIVAX (Merck). On 22-MAR-2010, the patient recovered from these events. Follow-up information has been received from the registered nurse concerning a Records Clerk who on 02-MAR-2010 was vaccinated subcutaneously with a first dose of VARIVAX (Merck). On 13-MAR-2010, the patient developed generalized body rash, body aches, nausea, and itching. On an unspecified date, the patient recovered from these events. No further information is available.
A report was received from a health care professional on 10/29/02, concerning a 40 year old female vaccinee who experienced an injection site reaction 1 day after receiving fluvirin vaccine on 10/23/2002. On 10/24/02, the vaccinee developed a 8"x 6" area of redness, swelling, tenderness and itching near the injection site. The vaccinee has not yet recovered. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/13/02: A follow up report received from a health care professional indicated that the vaccinee received Fluvirin via subcutaneous injection inferior to the deltoid muscle. Symptoms of the event included induration around the injection site. The vaccinee recovered after 7 days. Ref: PJP200200614 and PJP200200619.
NP states a 4 month old received Kinrix. The patient was supposed to get a separate Dtap and IPV.; NP states a 4 month old received Kinrix. The patient was supposed to get a separate Dtap and IPV.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis.   On 26-JUL-2023, the patient received Kinrix. On 26-JUL-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: NP states a 4 month old received Kinrix. The patient was supposed to get a separate Dtap and IPV.) and inappropriate age at vaccine administration (Verbatim: NP states a 4 month old received Kinrix. The patient was supposed to get a separate Dtap and IPV.). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUL-2023 The reporter consented to follow up via postal. The Vaccine Administration Facility was the same as Primary Reporter. The reporter stated that a 4 month old received Kinrix and was supposed to get a separate Dtap and IPV, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Five days after receiving the Shingrix vaccine in my left upper arm, I noticed an inflamed lymph node in my left clavicle area.  Node remained inflamed, and on 6/3 I noticed a rash on that arm.  At the end of the day on 6/4 I noticed that my left arm was swollen significantly (enough to notice by just looking at it).  Rash persisted until late July, swollen arm and swollen lymph node persist to this day (8/20) although severity is reduced.
on 4DEC92 pt had a rxn to the vax recvd on 2DEC92; pt exp flu-like sx of fever, chills, aches & pains which was treated w/APAP had subsided;
Patient admitted for failed outpatient tx of UTI with progression of symptoms to include fevers, vomiting, pelvic pain. Was treated with bactrim and culture shows resistance to the bactrim along with several other agents. Pt discharged with 1 week cipro to complete 10 days antibiotic course. Hospital admission within 6 weeks of receiving the COVID vaccine.
5 minutes after receiving Pfizer booster, patient was checking out at front desk when she felt "weak and dizzy". Felt legs crumple like she was going to pass out. She was observed for over 1 hour and given juice and water with improvement in her dizziness/ weakness. Felt better at the time of discharge. BP was 118/84. O2 100%. pulse initially 130s, but then low 90s at time of discharge. Thought to be pre-vasovagal syncope. Pt has hx of syncope during panic attacks. EKG was sinus tachycardia with no acute abnormality.
Positive varicella-presented 6/26/02 with fever, rash, multiple erythematous based vesicular all over, itchy. Sx's resolved 1 wk.
a few hours after vaccination: slight pain in the upper arm, soreness/swelling along with redness at the injection site and fatigue. Patient reported taking Tylenol and applied ice pack to the injection site with a little relief.
Joint pain, swelling, and redness of right middle knuckle starting three to four days post vaccination. Unable to grasp and tighten fist with grip weakness. Only on that hand and that specific knuckle. Treated with Tylenol 1000 mg, ibuprofen 400 to 600 mg, and benadryl 25 mg, and zyrtec 10 mg for 3 to 4 days after symptom onset. Returned to normal function in about 10 days. After second dose of Pfizer symptoms did not really develop immediately but noticed 3 weeks after symptoms returned. The symptoms seem to come and go and do not know if they have fully resolved yet.
pt recv vax;arm devel redness, fever, swelling;on 26jul devel pox at inject site;arm is still sensitive to touch;
Swelling -> 30 1/2 inch in diameter (Lt) thigh, redness, warm to touch. Itchiness. Treatment: Recommended BENADRYL.
Pt recvd vax 14AUG91 @ 3AM on 15AUG & became irritable but was afebrile; Seen in office dx ear infect w/in 48 hrs p/immun 16AUG hospitalized 3 days w/constant cry; presented w/sx similar to viral meningitis; however sepsis work-up neg;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medication in 2 weeks. Paxlovid Treatment start date: 19Jul2022, and Treatment stop date: 23Jul2022.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unknown number of patients were vaccinated with improperly stored PROQUAD (Merck) (lot number, dose, frequency and route unspecified) (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the event was unknown. The causality of the event with PROQUAD (Merck) was not reported. This case is linked to # 1502USA004176 via same reporter link. Additional information has been requested.
First an ear ache, then ringing in my right ear and finally loss of equilibrium. Some of the equilibrium problems continue even now.
My symptoms started on 08/14/2022 at night around 7;00PM .  I had headache, runny nose, achy, fever,  and tired. I tested positive on 08/15/2022.  I did the a tele health on 08/16/2022, she prescribed me Paxlovid but I didn't take it because I am very sensitive to medication.   We discussed that if it gets worse  I will take the medication but I didn't had to.
Itching; Cramping in abdomen; Pain in hips; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 18Feb2021 at 15:20 (Batch/Lot Number: EN6200; Expiration Date: Jun2021) (at the age of 48-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm (Batch/Lot Number: EL9265; Expiration date: May2021) (at the age of 48-years-old) on 28Jan2021 at 14:45 for COVID-19 immunisation and experienced chill (recovered), pain in hips (recovering) and pain in left ear (recovered); (the patient received no treatment for the events and did not require admission to the hospital). The patient experienced cramping in abdomen pain in hips  on 18Feb2021 and itching on an unspecified date. The patient received no treatment for events cramping in abdomen and pain in hips and did not require admission to hospital. The events did not require an emergency room visit. The patient visited an online to use televisit for events pain in hips and itching on 18Feb2021. The outcome of event cramping in abdomen was recovered on an unspecified date; outcome of event pain in hips was not recovered; and outcome of event itching was unknown. The patient did not undergo any relevant tests.  No follow-up attempts are needed. No further information is expected.
Pain at sight of injection. Ongoing since injection (4 days) Fatigue - ongoing Fever - 100.8 - resolved on 3rd day Confused thinking - ongoing Body and muscle aches - resolved on 4th day
Approximately forty-five minutes after the second vaccine dose, I began wheezing. I have a history of asthma as well as medication allergies. This was deep wheezing that happens when I have an allergic reaction. In spite of using my albuterol inhaler, I continued to wheeze (moderate) throughout the night. I stayed up most of the night to monitor myself, using my inhaler every four hours. I am in a densely populated area with a lot of hospitals, so I knew I could call for an ambulance if needed and therefore chose not to go immediately. I take a daily dose of an antihistamine (Allegra 180mg). The following morning, I woke to increased wheezing. I took my antihistamine a few hours early, and within an hour, the wheezing was better, and within a couple of hours, it had decreased to the level it had been the day prior. By late that night, I was no longer wheezing.  In addition to wheezing, I got a mild headache almost immediately after the second vaccine dose was given. After the first dose, I experienced a bitter taste in my mouth. I had recently been on clindamycin, which caused a very bitter/metallic taste in my mouth. I was finished with the antibiotic 8 days before the first dose of the vaccine. I wasn't sure that the bitter taste was related to the Pfizer vaccine, but the taste had started to decrease pretty significantly in the two days before the second dose. Within a few hours after the second Pfizer dose, the bitter taste had returned to the level it was after the first dose. I still have the bitter/metallic taste in my mouth as of today (06/13/2021). I believe the other symptoms I had were normal post-vaccine side effects (malaise, aches, swollen lymph nodes, low-grade fever, additional headaches).
Patient awakened with crying and left sided jerking on 4/12/2018. She was brought to our pediatric office where seizure activity was observed and patient was taken to Hospital where she was admitted from 4/12/2018-2/14/2018. She was without fever at our office and in the Emergency Room. Pediatric Neurology was consulted. After workup was completed she was diagnosed with a seizure disorder and she was discharged on Phenobarbital and KEPPRA.
Runny nose, nasal stuffiness, sore throat, cough, lightheadedness, tiredness, headaches.
Splotchy skin (mottled skin),; migraine; fatigue; nausea; dizziness; from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in left arm on 26Mar2021 at 18:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included anaemia and vitamin-D deficiency. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), paracetamol (TYLENOL EXTRA STRENGTH), ferrous sulphate (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in left arm on 05Mar2021 at 18:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.  The patient experienced splotchy skin (mottled skin), migraines, fatigue, nausea and dizziness on 28Mar2021 at 20:00. The patient had not received any treatment for the reported events. The adverse events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of splotchy skin (mottled skin), migraines, fatigue, nausea and dizziness were not recovered at the time of this report.   No follow-up attempts needed. No further information expected.