chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tightness/tensing of her muscles; muscle cramps, spasms; nerve pain; aches in her shoulder; This is a spontaneous report received from a contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness/tensing of her muscles, muscle cramps, spasms, nerve pain, aches in her shoulder, all on an unspecified date with outcome of unknown, all events non-serious. Reported almost immediately following the injection she felt an tightness/tensing of her muscles. She reported that since that time she has experienced muscle cramps, spasms, and what she described as nerve pain, along with aches in her shoulder.  No follow-up attempts are needed. Information on lot/batch number cannot be requested.
Information has been received from a physician concerning an approximately 20 year old female who on approximately 25-FEB-2007 was vaccinated with a first dose of Gardasil. Subsequently the patient developed amenorrhea. Unspecified medical attention was sought. It was reported that the patient planned to discontinue the series of injections. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Joint pain; brain fog; This is a spontaneous report from a contactable Nurse (patient). A 54-year-old female patient (not pregnant) received BNT162B2 (Pfizer, lot number: EL0140) first dose on 29Dec2020 10:45 via intramuscular on right arm at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications in two weeks included dexlansoprazole (DEXILANT) and escitalopram oxalate (LEXAPRO). The patient had allergies to Erythromycin. No other vaccine in four weeks. Facility type vaccine was Hospital. Patient had Joint pain and Brain Fog on 31Dec2020 01:15 PM. No treatment. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the event was not recovered. The serious was reported as no.
Red rash on left arm around injectrion site. Office visit 5/18/2017 to get anti-inflammatory rx.
Case number PHEH2013US022563 is an initial spontaneous report received from a nurse on 25 OCT 2013. This report refers to a 11-year-old female child. She was vaccinated with MENVEO (batch number: X12120) intramuscularly at 0.5 ml on 19 SEP 2013. MENVEO had undergone an excursion to zero degree Celsius for 16 hours; however the vaccine was not frozen. No adverse event was reported following this administration error.
Vaccine expired on 13 Oct 2021 and placed in refrigerator on 18 Oct 2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 18 Oct 2021) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 18 Oct 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 18 Oct 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vaccine placed in refrigerator on 18 Oct 2021. Vial did not undergone temperature excursion. No any adverse event reported.  Treatment medications were not reported.
My daughter had never had a previous problem (2 of series of 3 shots). The shot was given when patient was sitting and as soon as the shot was given we were told where to check out. Within a minute of walking out of exam room patient went blind and fainted. I was close enough to catch her. The Dr and Nurse came to help and we layed patient on an exam table. Within a minute her color came back and I held a cold damp towel on her head for releif. She layed for about 10 minutes and felt good enough to leave.   I wish I had read the website and I would have insisted that she would have been laying down and monitored for 15 minutes after, as this could have been prevented. She was so anxious that this would happen again the day after that she had felt nausea again. I talked to Dr the next day and he still insist that he will not have all patients lay down while giving Gardasil injections.  Even though he knows there is a risk of fainting.
Lost taste; lost sound; Cold all the time; Initial information received on 06-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves a patient (age and gender not reported) who experienced lost taste (ageusia), lost sound (hypoacusis) and cold all the time (nasopharyngitis), while he/she received INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious lost taste (ageusia), lost sound (hypoacusis) and cold all the time (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for all the events.  Reporter assessment for the causal relationship with suspect vaccine was not reported.  There will be no information available on batch number for this case.
This spontaneous report was received from a pharmacist via a sales representative, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated, in the physician's office, with a dose of ZOSTAVAX (Administration route, lot number and expiration date were not provided). No concomitant therapies were reported. On an unknown date, the patient experienced an outbreak of shingles. The patient went to the reporter's pharmacy to ask about the event. The outcome of herpes zoster was unknown at the time of this report. The reporter did not provided a causality assessment between the event and therapy with ZOSTAVAX. Additional information has been requested.
approx 10 min after FLUVIRIN dose pt c/o heart palpitation, diaphoresis, chest pain, difficulty breathing. Called 911, had pt sit down and try to relax. EMT arrived within 5-10 min. Pt claims she felt better but EMT evaluation concluded pt needed to be transported to the hospital. EMT Reported increased BP.
09/08/2022  at 04:00PM  immediately a red circle appeared on my left arm on the injection site . It was burring. The next morning my arm was flared up. On Friday morning I had a weird headache. I went to work and I was feeling chills. I was feeling with low energy. I was craving for food and I was getting dehydrated. On Saturday I was feeling Nausea through out the day. I even had drink. My heart rate went high. I felt like so blanked out. My left arm was flaring wasn't really sure if it was a reaction or not. I wasn't feeing well and I was so thirsty I wasn't sure what happen. All of a sudden I started vomiting I felt like I lost myself. Instead of Hospital and I went home. I was all over the place. At around 1:00PM I started experiencing diarrhea. I also saw that I couldn't feel my right leg. I was blanked out. I was having stroke like symptoms.  I am a health person I've never experienced this in my life. I was taking to the hospital.  I also broke out in rash on my chest, face, neck and it was flaring. when I was in the hospital  my symptoms started getting better slowly.  I was in the hospital for 2 day. I am in a walker now. I will be getting physical therapy soon. I can't stand for long time I get dizzy.
SORE ARM; This spontaneous report received from a patient via a company representative 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, ) dose was not reported, administered on 23-MAR-2021 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 MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
pt described brief episode of eye rolling, staring "out of it lasted a few seconds; no tonic clonic sz; no post ictal state 1 episde occurred same day as shot & again 3 days later; also anorexia; t99-100; recommended EEG-parents refused;
Headache, facial drooping and numbness, ringing ears, dizziness, lightheaded. lethargy, loss of taste and smell, ears popping
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 9/12/2022 Discharge Date: 9/17/2022  PRESENTING PROBLEM: Acute hypoxemic respiratory failure (HCC)  Pneumonia due to COVID-19 virus COVID-19    HOSPITAL COURSE:  Patient is a very pleasant 71-year-old gentleman the past medical history reviewed and noted significant for moderate persistent asthma, essential hypertension and anxiety presented with shortness of breath and was found to have COVID-19 and bronchopneumonia.  Patient was also noted to have an elevated renal function with a creatinine of 1.41 and met sepsis criteria.  Patient did receive dexamethasone however after the 3rd dose of remdesivir a patient developed fluid overload and was diuresed with Lasix.  Patient continued to do well and was eventually weaned off oxygen.  His creatinine returned to normal.  His only symptom upon discharge was a residual cough.  He completed a 5 day course of ceftriaxone and azithromycin.  He was discharged with an additional 5 days of dexamethasone to complete a 10 day course.  He was encouraged to have a pulse oximeter and a blood pressure cuff to monitor his heart rate oxygen saturation and blood pressure along with primary nurse on when to return to ER.  Patient was agreeable with this plan.  Questions and concerns addressed.  Patient was discharged with the noted additional discharge instructions.  Patient was discharged in good condition to home with wife.
Swollen lymph node under arm (in armpit area), onset at 60hrs post injection, currently still swollen. Pain at injection site, onset at 24hrs, relief 72hrs post injection (no medication taken for pain)
Patient was given a HPV instead of Hep B. Mom was called 2/2/22 baby did not have any side effects. Mom called 2/3/22 baby was restless all night.
red itchy spots spread all over body forming a rash. Has spread over the course of days once I start3ed seeing the spots. Very itchy!
Pt c/o pain at the injection site. Next day c/o rush of fever, nausea and vomiting.
Information has been received from a physician concerning a 19 year old female who on 22-AUG-2007 was vaccinated by injection with the first 0.5 mL dose of Gardasil. On 22-AUG-2007, after the patient received her first dose of Gardasil experienced "anaphylactic reactions including swelling of the throat." The patient sought unspecified medical attention. Subsequently, the patient recovered from anaphylactic reactions and swelling of the throat. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. In follow-up it was reported by the physician concerning a 19 year old female with no illness at the time of vaccination and no pre-existing allergies, birth defects, or medical conditions whose reported weight was 130 pounds and whose reported height was 66 inches who on 22-AUG-2007at 3:00 p.m., was vaccinated by injection into the left arm with the first 0.5 mL dose of GARDASIL, (lot # 686094/05240). It was reported that 15 minutes after the vaccine was administered the patient had throat swelling, itching, vomiting x 1. The patient was treated for "anaphylaxis" with SOLU-MEDROL, BENADRYL and prednisone. There was no decrease in blood pressure (BP) and no changes in respiratory status. The patient recovered on 22-AUG-2007. The reporter determined the patient's anaphylactic reaction to be immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. in addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Pt reporting right facial paresthesia (decreased sensation, tingling) within 1 hour of vaccination,  extending from right temporal region to below right jawline.  Approx. 12 hours later he experienced subjective fevers / chills, headaches, diaphoresis, right-sided pain extending from neck down spine and to right knee.  A majority of symptoms resolved, but he has had ongoing decreased sensation since that time and intermittent tingling sensation.   Neurology evaluation reported concern for partial cranial nerve VII palsy.
rash and itching 10/30/2009 MD records from 10/23/2009.Dx allergic reaction  Patient with c/o's rash and itching. Tx: benadryl.
PATIENT RECEIVED 2ND DOSE TOO EARLY. 1ST DOSE WAS ADMINISTERED 0N 4/7/2021. 2ND DOSE WAS ADMINISTERED TODAY, 4/22/2021.  NO KNOWN ADVERSE REACTIONS AT THIS TIME
A few hours after receiving the 2nd COVID-19 shot I started to feel sleepy, then I was feverish all night with severe chills.  My hand was literally shaking -- I could not text!  Low grade fever of 100.2 but my normal temperature is between 96.2 to  97.4.   Symptoms lasted until 4:00PM the next afternoon.  However I continued to be sleepy until 7:30 pm that same afternoon.  In all, symptoms were severe but very short lived -- perhaps 26 hours.  Just sharing information; no need to report to my doctor.  Something is wrong with website-- NOBODY DIED -- I can't get the check mark to go away!
Adverse effect of other vaccines and biological substances, initial encounter on 2023-08-04.
When giving the dose, approximately 0.2ml leaked out of the contact between the barrel and needle (it was the luer-lock syringes supplied with the vaccine) while giving the dose in the left deltoid.  There was 0.2ml left in the vial from which the dose was drawn.  That was drawn up and administered in the R Deltoid to complete the dose.    The patient had no adverse effects.  She waited the 15 minutes with no problems.
cold sore/fever blister/ used abreva and it started spreading; This is a spontaneous report received from a contactable consumer.   A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7534 and Expiration date was not reported), via intramuscular route of administration, in arm right, on 17Mar2021 (last Wednesday) (at the age of 77 years), as a single dose for COVID-19 immunization. Patient received ABREVA (Batch/lot number: D54N) on 20Mar2021 for oral herps. The patient medical history included appendectomy (Since she was 18 when she had an appendectomy). There is no Patient History and no Investigation Assessment. Patient stated that she had the Pfizer vaccine last Wednesday and the following day (18Mar2021) she had a cold sore or fever blister. Later clarified as cold sore. On 20March2021, she used abreva and it started spreading, while getting the abreva in store, a lady she was talking to, said she got one (cold sore) after her 2nd one. Patient asked if cold sore/fever blisters were reported by others after getting the vaccine. Patient stated that she was trying to treat the cold sore and it keeps spreading. Patient stated that she has not had a cold sore since she was 18 when she had an appendectomy. Stated that the pharmacy tech mentioned that she had the second shot and could not make the connection that it was to her cold sore. Stated that it was unknown which shot she had. Patient stated that she was using Abreva and has not dried it up. Stated that it has spread from her lip down to toward her chin. Stated that it is clusters and not just one spot. Clarified that the medication stopped the itching part but it is still growing. Stated that she was using a product and it has not helped. Provided a lot of BO193113Y. At the time of this report event outcome was not recovered.   No follow-up attempts are possible. No further information is expected.
Within 30 minutes of receiving TYPHIMVI & MENACTERA client experienced feeling of "pressure" / "feeling like someone was pressing on my throat" for approx 2 hrs.  Did not seek medical attn & s/sr resolved without any intervention.
No additional AE's or PQC's were reported; improperly stored dose of Pneumovax was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 18-NOV-2021, the patient was vaccinated with first dose of improperly stored (temperature excursion occured on 04-NOV-2021) pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot# U018309, expiration date: 08-JAN-2023 (exact dose, route of administration, anatomical location were not reported) for prophylaxis. Administered dose of vaccine has been stored in the temperature of 70 Fahrenheit (F) for 16 hours. There were no previous temperature excursions reported. No adverse event was reported.
Local & systemic reaction 5x5cm erythemic area on L upper leg. Also hives everywhere about 8-10 hrs post shots. Tx with benadryl & Zyrtec. Hies resolved 6/14/01.
ulcers on fingers and toes; swelling on the fingers and toes; lungs felt heavy; ocular migraine; experienced a wheeze; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER, WHEEZING, MIGRAINE, SKIN ULCER (fingers and toes) and PERIPHERAL SWELLING (fingers and toes) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced WHEEZING (experienced a wheeze). On 11-Apr-2021, the patient experienced LUNG DISORDER (lungs felt heavy) and MIGRAINE. On 12-Apr-2021, the patient experienced SKIN ULCER (fingers and toes) and PERIPHERAL SWELLING (fingers and toes). At the time of the report, LUNG DISORDER (lungs felt heavy), WHEEZING, MIGRAINE, SKIN ULCER (fingers and toes) and PERIPHERAL SWELLING (fingers and toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Further information has been requested. US-MODERNATX, INC-MOD-2021-098214:
1st dose about 2-2.5 months ago; 2nd dose has not been given; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose about 2-2.5 months ago; 2nd dose has not been given) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose about 2-2.5 months ago; 2nd dose has not been given). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose about 2-2.5 months ago; 2nd dose has not been given) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
headache; body pain; extreme nausea/nausea; dry heaving; diarrhea/5 liquid stools that have a metal smell; severe abdominal pain and gas with a metal smell; gas; gas as well the same night with a metal smell; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaving), DIARRHOEA (diarrhea/5 liquid stools that have a metal smell), ABDOMINAL PAIN (severe abdominal pain and gas with a metal smell), FLATULENCE (gas) and PAROSMIA (gas as well the same night with a metal smell) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RETCHING (dry heaving), DIARRHOEA (diarrhea/5 liquid stools that have a metal smell), ABDOMINAL PAIN (severe abdominal pain and gas with a metal smell), FLATULENCE (gas), PAROSMIA (gas as well the same night with a metal smell) and NAUSEA (extreme nausea/nausea). On 22-Mar-2021, the patient experienced HEADACHE (headache) and MYALGIA (body pain). On 05-Mar-2021, RETCHING (dry heaving), DIARRHOEA (diarrhea/5 liquid stools that have a metal smell) and ABDOMINAL PAIN (severe abdominal pain and gas with a metal smell) had resolved. On 22-Mar-2021, HEADACHE (headache), NAUSEA (extreme nausea/nausea) and MYALGIA (body pain) had resolved. At the time of the report, FLATULENCE (gas) and PAROSMIA (gas as well the same night with a metal smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Following my first dose, when my menstrual cycle came I had blood clots the size of my palm. The blood clots were so severe that my left arm had restricted blood circulation (blue). I do not normally feel when my cycle is coming on, however, the past 3 months the cramps have been unbearable. My cycle is normally 5 days long, the past 3 months I've had 7 day cycles.
Racing heartbeat. No pain. Went to ER. Put on blood pressure medicine. Still having blood pressure issue. Latest episode was 7/8/2021.
NA Hospitalization for Acute Resp Failure with Hypoxia secondary to acute and chronic CAD
Parent's relate that from the day he received MMR, HIB and IPV, he had change in behavior. He was clingy, insecure and screaming at night. This behavior progressed and fever of 102F-104F started 9 days, post vax, and continued for 4 full days with marked irritability. He complained of "boo-boos" in his knees and wrists.