chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 11-JUL-2017 from a pharmacist who was reporting on a patient of unknown age and gender. No medical history or concomitant medication was reported, The pharmacist reported that on 10-JUL-2017, the patient received an expired dose of ZOSTAVAX (lot M015926, expired 28-JUN-2017) that was inadvertently administered to the patient. Indication was for prophylaxis. It was unknown if the sterile diluent was expired (no lot or expiration reported). No adverse effects. No further information to report. Additional information has been requested.
Date of admit was 2/22/22, Patient is an 18-year-old teenager with no PMHx who presented with 4 days of fevers, abdominal pain, diarrhea, rash, conjunctivitis, headache, myalgias, and fatigue and subsequently tested positive for COVID19. As per patient, symptoms started Saturday 2/19/22. Patient has coughing and would feel like coughing when he inhales.  CT A/P showed some groundglass opacities at lung bases. Patient states rash was in feet, legs, chest and back. Due to concern for MIS-C, he was started on steroids (received 6mg dexamethasone today) and received a dose of IVIG today. Patient endorses improvement of rash already since first presentation to hospital. Tmax in hospital 100.4, WBC 11.1, ESR 22, CRP 251, RESPAN neg, monospot neg, blood cultures so far ngtd.  Remdesivir 3 doses IVIG 1 and 2nd Asprin chewable enoxaparin
Tongue tingly lower; inside of upper and lower  lips swelled; itch on palm of hands, bottom of feet and thighs and face; This is a spontaneous report from a contactable 81-year-old female consumer reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot En5318)  single dose on 04Feb2021 at 14:30 at right arm for COVID-19 immunisation. Medical history included osteoporosis, reflux, spinal stenosis and macular degeneration, asthma, hypertension. The patient had known allergies. Concomitant drugs included Atenolol, calcium, fish oil, cyanocobalamin (B12), loratadine, tocopherol (VIT E). The patient had tongue tingly lower and inside of upper and lower lips swelled, itch on palm of hands, bottom of feet and thighs and face on 04Feb2021 at 14:30. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received steroid injection and diphenhydramine hydrochloride (BENADRYL) as treatment. The event was reported non-serious. Patient recovered from the event with lasting effects.
outbreak of weeping lesions on scalp, face & neck 1FEB95;current dx severe infantile eczema;
pt exp 1min sz & was unresponsive & shaking;adm to hosp via amb;t100.6 to 104, tonic sz, & postictal period;dx febrile sz;devel erythematous mac marble like rash;dx erythema infectiosum;pneumonia & no antibodies for measles or mumps
Had difficulties breathing; Hyperventilation; Dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had difficulties breathing), HYPERVENTILATION (Hyperventilation) and DRY MOUTH (Dry mouth) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Had difficulties breathing), HYPERVENTILATION (Hyperventilation) and DRY MOUTH (Dry mouth). At the time of the report, DYSPNOEA (Had difficulties breathing), HYPERVENTILATION (Hyperventilation) and DRY MOUTH (Dry mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported
Hives, throat swelling, hives on skin, dizziness, face is still broken out.
Information has been received from a physician concerning a 15 year old female who on 08-MAY-2008 was vaccinated with her first dose of GARDASIL (lot # unspecified). Concomitant suspect therapy included VARIVAX (lot # unspecified). Other concomitant therapy included MENACTRA and TETANUS TOXOIDS (lot#s unspecified). It was reported by physician, that the patient got really dizzy post vaccination on 08-May-2008. Physician noted that the patient came back on 12-May-2008 and still experiencing some dizziness, but has normal muscle strength. On unspecified date the neuro and glucose check were performed (results not reported). Unspecified medical attention was sought by visiting doctor's office. At the time of this report, the patient had not recovered. Per physician, the patient will not be receiving any further GARDASIL shots. No further information provided. Additional information has been requested.
This is an instance of breakthrough COVID-19 disease after which death occurred.  The individual was vaccinated with the   Pfizer product on 02/22/2020 and 03/15/2021. They became symptomatic on 11/23/2021 and tested positive on 12/04/2021. They were seen in an emergency department on 12/05/2021. They were admitted to hospital on 12/05/2021 and remained hospitalized until their death on 12/20/2021. Death Certificate details are as follow: Part I Cause of Death A: COVID 19 Pneumonia Part II Other Significant Conditions: Lymphoma, Hypogammaglobulinemia
Fever as high as 103 same day as vaccine, lasting for about 4 days. Headaches, "flu-like" symptoms, congestion & fatigue. Coughing up green colored phlegm. Taking aleve as needed. Diagnosed with bronchitis by PCP on 3/8/2021, prescribed amoxcillin. Followed up with PCP again on 3/12/2021 and was told that her chest xray and labs were "negative". Symptoms improving today.
Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild
got her period two weeks early.; She had bad menstrual cramps with that irregular period.; nausea; She has gotten her period twice since then and each time she has had very painful menstrual cramps plus some nausea./She had not had super painful; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 15-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in arm left on 13May2021 at 16:45 PM (at the age of 15-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Patient had no known allergies. The patient concomitant medications included melatonin, multivitamin (vitamins NOS) (patient received within 2 weeks of vaccination), both drugs taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was not COVID tested post vaccination. The patient experienced got her period two weeks early, she had bad menstrual cramps with that irregular period, nausea, she has gotten her period twice since then and each time she has had very painful menstrual cramps plus some nausea/she had not had super painful, all on an unspecified date in 2021. Adverse event result in doctor or other healthcare professional office/clinic visit. Reported Event: Within days of getting her first Pfizer vaccine, [Redacted] period two weeks early. She had bad menstrual cramps with that irregular period. She has gotten her period twice since then and each time she has had very painful menstrual cramps plus some nausea. She had not had super painful. The patient did not receive any treatment medication for the events. Outcome of the events was unknown. Device date was 29Jul2021.  Follow-Up (09Aug2021): Follow-up attempts are completed. No further information is expected.
VOMITING; SENSITIVITY TO HEAT; NAUSEA; LOW GRADE FEVER; NUMBNESS AT THE INJECTION SITE; ARM HURT REALLY BAD/SORE TO THE TOUCH; LEFT ARM PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's past medical history included adhd, and hypertension, and other pre-existing medical conditions included the patient have no known allergies. The patient experienced drug allergy when treated with esomeprazole magnesium for drug used for unknown indication, and drug allergy when treated with diazepam. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced numbness at the injection site. On 17-JUN-2021, the subject experienced arm hurt really bad/sore to the touch. On 17-JUN-2021, the subject experienced left arm pain at injection site. On 17-JUN-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) never got over 100F. On 18-JUN-2021, the subject experienced nausea. On 20-JUN-2021, the subject experienced vomiting. On 20-JUN-2021, the subject experienced sensitivity to heat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, numbness at the injection site, and arm hurt really bad/sore to the touch on 20-JUN-2021, sensitivity to heat, left arm pain at injection site, and nausea on 21-JUN-2021, and low grade fever on 18-JUN-2021. This report was non-serious.
On 3/17/11 pt reported sore, swollen & itching arm that started 3/16/11. Pt received HepB #1 (L) deltoid 3/15/11. MD evaluated - ordered hydroxyzine & compresses & 1 day f/u.
On 4-18-18 child was given 2 vaccines: PENTACEL and Hep A-left thigh. On 4-19-18 child developed hives, axilla and legs.
Right arm from shoulder to elbow is red, warm to the touch and swollen. Patient denies pain or itching.
Patient was awakened by swelling of tongue and throat, swelling and pain in testicular area.
Achiness and pain in left arm after TD given Tues 5/13/03. No fever, no redness, no swelling. Pain became worse Sun night 5/18/03. Saw Nurse Practioner Fri 5/23/03 because still had achiness and throbbing in left arm, but not as bad as Sunday. (Moved to new home beginning of May). Using Aleve or Advil. Did not apply cold pack until Mon 5/19/03. Was tense when vaccine was administered. Only very slight stiffness during night 5/27/03.
pt recv vax; lt arm below inject site & "almost" down to elbow about 6" is red & hot to touch; some blister near where where the bandaid was applied;
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 07-MAY-2015 the patient was vaccinated with an improperly stored dose of M-M-R II 0.5ml (rHA (recombinant human albumin), lot #J014876, expiration date 21-NOV-2015, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a 17 year old female patient who "about two months ago" (in approximately March 2010), was vaccinated with a 0.5 ml first dose of GARDASIL IM (Lot number not provided). The physician reported that when the patient came for the second dose she reported that after getting her first injection it felt like "acid being purred into her skin and she could not use her arm". On an unspecified date the patient recovered. The patient did not receive her second dose. No laboratory tests were performed. The patient sought unspecified medical attention. Additional information has been requested.
3/27/21 day after shot  Pain, tenderness & swelling at injection site, fatigue, headache, muscle pain, joint pain, chills, nausea & vomiting, fever, difficulty breathing, fast heartbeat, dizziness & weakness.  Went to emergency room. Received anti nausea meds and extra strength tylenol. Majority of symptoms dissipated after several rounds of meds and sleep.   Next day continued to experience lingering impact of headache, nausea, and fatigue.
Neck pain; Nausea; Headache; Temperature 97, temperature 98.5; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), NAUSEA (Nausea), PYREXIA (Temperature 97, temperature 98.5) and HEADACHE (Headache) 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 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced PYREXIA (Temperature 97, temperature 98.5). On 13-May-2021, the patient experienced NECK PAIN (Neck pain), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, NECK PAIN (Neck pain), NAUSEA (Nausea), PYREXIA (Temperature 97, temperature 98.5) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.5 (High) 98.5 F at 9.30 am 97 F at night..         Patient wants to know when to take Acetaminophen. Concomitant medications information was not reported. Treatment medications were not provided by the reporter.
shaking for 1 min, eyes rolled back; went stiff, then limp; cranky for about 24 hrs; no treatment other than APAP;
Contracted COVID 19. Fever over 102, headache, muscle aches, coughing, loss of taste, loss of smell, fatigue.   **I'm not sure this really qualifies as an Adverse Event. the only reason I'm submitting this form is because when the CDC called me as part of the "v-safe" program & I told them I contracted COVID-19, the representative I spoke with recommended that i log onto the VAERS website to submit a report**
3 1/2 hrs unconsolable crying about 5 hrs p/vax;
Immediately after vaccine patient started to feel clammy and dizzy. Patient then passed out while sitting upright. Mom and RN supported patient's upper body so he did not fall.  While passed out the patient's legs extended straight and head/arms made jerking motion. Pt quickly woke up within one minute of passing out. The patient asked where he was but quickly became aware of his surroundings. The patient still appeared pale. He then vomited and his legs were shaking mildly. Once the patient was stable the RN alerted doctor of the incident and asked for her to evaluate the patient. Mom stayed with patient while RN out of room. Vitals were done and the patient rested in room. Ice pack, snack and water were given to help him recover. Doctor evaluated the patient. Per doctor's judgement the patient was able to leave the office once he felt able to safely leave. The patient was able to walk out of office after about 30 minutes. His color had returned to normal in his face and he was no longer clammy when he left the office. Mom was to stay with patient to monitor him throughout the day.
HEART RACING; HEART RATE OVER 150; POURING SWEAT; SHIVERING; FREEZING COLD; WORST HEADACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient did not have medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: UNKNOWN) dose was not reported, administered on 06-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-DEC-2021, the patient experienced heart racing. On 06-DEC-2021, the patient experienced heart rate over 150. On 06-DEC-2021, the patient experienced pouring sweat. On 06-DEC-2021, the patient experienced shivering. On 06-DEC-2021, the patient experienced freezing cold. On 06-DEC-2021, the patient experienced worst headache. Laboratory data included: Heart rate (NR: not provided) over 150. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worst headache, pouring sweat, shivering, freezing cold, heart racing and heart rate over 150 was not reported. This report was non-serious.
10 cm x 5 cm leg swelling surrounding the injection site - appearing within 12 hrs of vaccination. Erythema also present. No tenderness to palpation.
This spontaneous report was received from a registered nurse referring to a 4 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. On 13-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # M040558, expiration date on 03-OCT-2018, for prophylaxis (strength and route were not reported). Concomitantly, the vaccine was reconstituted with a properly stored sterile diluent (MERCK). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513 1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1712USA010085.
Patient complained of itching on chest. Chest appears slightly red; Benadryl 50 mg po given. 0846 BP 138/80, HR 83, R 14, SpO2 98%.  0900 c/o nausea; Pepcid 20 mg po given. BP 137/82, HR 82, R 14, SpO2 98%.  1000 - Patient states feels better and okay to go home. She is released home with her husband.  She is to call 911 for trouble breathing, itchy throat of fullness in throat.
After the second dose, the chest pain has been more persistent.; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGE for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took received her first dose of BNT162B2 on an unspecified date for COVID-19 immunization. After the second dose, the patient experienced the chest pain has been more persistent. After getting the first dose of the vaccine, she had some chest pains that would come and go. After the second dose, the chest pain has been more persistent. Also, with her COPD, in the mornings, she would cough up phlegm. But since getting both doses of the vaccine, she did not cough up anything. She was wondering if there is phlegm there and it was just not coming up. The seriousness of the event was reported as non-serious. The clinical outcome of the event was unknown.  Follow up needed, Information on the lot/batch number has been requested.
Fever, chills, muscle aches (full body), very sore arm, headache.  Starting 11 hrs. after receiving vaccine.  Lasted about 12 hours.
A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a registered nurse/health professional concerning a 34-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose (0.1ml) of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
patient received a dose of pfizer that had expired on 8/18.  he had a sore arm from administration.  repeated dose with non-expired vaccine on 10/3
This spontaneous report as received from a physician, as part of a marketing research program conducted by agency, refers to a patient of unknown age (reported as "65? (unsure)") and gender (reported as "male?"). The physician did not remember the patient's race. "4 or so years ago", in approximately 2011, the patient got shingles 7-10 days after receiving a single dose of ZOSTAVAX (lot#, dose and route were not provided). The outcome of the event was not provided. The reporter considered the event to be a co-incidence and he did not believe the shot caused the shingles because "with one million cases of shingles a year someone is bound to get them right after being vaccinated". Additional information has been requested.
Swollen lymph nodes in left side of neck and left arm; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Other medical history was not reported. Concomitant medications taken within two weeks of vaccination included loratadine, pseudoephedrine sulfate (CLARITIN-D), liothyronine sodium (CYTOMEL), levothyroxine sodium (SYNTHROID) and amlodipine besilate (AMLODIPINE BESYLATE) all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Mar2021 at 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced swollen lymph nodes in left side of neck and left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event swollen lymph nodes in left side of neck and left arm was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Did not feel well on Saturday, 10/3/2020,low grade fever (99.5)and muscle aches on Sunday 10/4/2020 and Monday 10/5/2020. I had a Covid-19 test on Monday, 10/6/2020; result NEGATIVE on Tuesday, 10/7/2010. Hands and ankles were swollen and rash on forearms developed on Wednesday, 10/7/2020. Saw new doctor, Dr. (previous internist just retired) on Friday, 10/9/2020.. She ordered Nuclear Antibody ANA blood test; result NEGATIVE on Monday, 10/12/2020. Dr. prescribed Prednisone which relieved all symptoms by 5 days later.