chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's husband reported that patient was experiencing severe side effects such as chill, and nauseas and hard to get out of bed the night after she got her Pfizer booster.
pt recvd DTP/HIB/OPV & w/in 24 hrs p/vax exp urticaria; tx included DPH; rash was not seen by MD; recovered;
I was admitted to the hospital with pain in shoulder and nausea. Did cardiac catheterization and I was diagnosed with myocarditis.  Was sent home the next day and was prescribed Toprorol 12.5 mg daily.  Seeing cardiologist and just wore a heart monitor for 24 hours because of irregular heart beats and shortness of breath. Continues to follow up with cardiologist
headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication and treatment information was provided.
This spontaneous report as received from other health professional refers to a patient of unknown age and gender. Medical history was not reported. On 23-APR-2014 the patient was vaccinated with PROQUAD (subcutaneous, dose number, frequency, anatomical locations, lot number was not reported). Concomitant medications were not reported. The reporter stated that the patient was administered PROQUAD which was out of range for 108 hours reaching -14 degree Celsius. The vaccines were supported. No adverse effects reported. This report is linked with another MARRS # 1405USA011991 (same reporter link). Additional information has been requested.
Fever 2 days,  body aches,  headache,  swollen lymph node.   This happened with both doses.
I HAD THE 1ST DOSE OF SHINGRIX AT PHARMACY. I AM HAVING A STRANGE SIDE EFFECT. ASIDE FROM THE REDNESS AND SWELLING, THERE IS A DARK LINE MEASURING APPROXIMATELY 1 1/2 INCHES RUNNING DIAGONALLY ACROSS MY LEFT BICEP WHERE THE INJECTION SITE WAS. THE NEEDLE WAS VERY PAINFUL GOING IN. AFTER THE PHARMACIST INJECTED ME, THERE WAS AN UNUSUAL AMOUNT OF BLEEDING DOWN MY ARM. MY BICEP IS EXTREMELY SORE--MUCH MORE THAN I EXPECTED. WHAT IS THIS DARK LINE ON MY BICEP? DID THE PHARMACIST INJECT ME CORRECTLY? PLEASE CONTACT ME. THANK YOU FOR YOUR ASSISTANCE. I AM VERY CONCERNED.
Patient received  the 2nd booster pfizer vaccine on 05/20/2022 at  the pharmacy  3 month and 12 days after the 1st booster shot.She had the 1st pfizer booster on 02/08/2022 . She received the 2nd booster vaccine  18 days early.
Fever 103.5, chills, joint and muscle aches, vomiting. No treatment except fluids
Mom noticed 3 week ago that patient had new bruises everyday and they were taking a long time to heal. Diagnosed with: Thrombocytopenia.
Patient was given Pfizer vaccine that was out of the freezer for more than 5 days.  Patient was informed of this and offered new vaccine.  At this time, patient showed no adverse reactions.
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 14-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007011:
Had facial swelling/warmth/redness within 15 months of getting the vaccine. Then had hives on and off over the next 4-5 days.
This spontaneous report as received from a Licensed Vocational Nurse refers to unspecified number of patients of unknown age and gender. It was reported that unspecified number of doses of PEDVAXHIB were exposed to a total of 72 hours with a highest temperature of 57F. These doses were adminstered to an unspecified number of patients on unspecified dates (doses, routes and lot # not reported). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Child woke up at 5:00 AM and was crying and had a fever. Child threw up then was staring and had jerky movements and difficulty breathing. Ambulance called and was taken to medical center.
Pt. received flu shot Sanofi UI 173AB on 10/9/14 and on 10/11/14 woke with swelling, redness and bruising in (L) deltoid area. Rx'd w/Prednisone 10mg x1, BENADRYL 50 mg, TYLENOL 750 mg
Pt reported to pharmacy today. Said starting the next day, redness, swelling, itching around injection site, (about 5 inches square around arm). Said she is taking ibuprofen, I recommended topical Benadryl, or can also use oral, but cautioned drowsiness. Told her she should see improvement within 2-3 days. Also told her if it continues to worsen or swelling goes to head or neck to go to clinic right away.
Information regarding Flumist nasal solution was received from a consumer regarding a 5 year old male patient who experienced high fever of 105 degrees F, throwing up, stomach hurting, stuffiness and cough. At 5 years of age, the patient received a dose on 12/15/03. The patient's concurrent illness includes cough. The patient had respiratory symptoms with cough prior to Flumist administration; however, the mother thought the acute phase had passed. The patient had two days of oral steroid therapy four days prior to Flumist administration. Indication for Flumist was immunization. Product was administered on 12/15/03. Dose regimen was 1 (IN). Patient was not taking concomitant therapy. The patient experienced high fever of 105 degrees F, throwing up, stomach hurting, stuffiness, and cough on 12/15/03. The patient was treated with Tylenol every four hours. As of 12/16/03, the fever of 105 degrees F persisted. No additional information was available at the date of this report.
Onset of rash and fever 9-10 days after MMR vaccine was given. Rash is blanching flat erythematous maculopapular in nature. No pruritus. Rash located on face/chest/neck/ears/trunk. Child nontoxic, all these findings from 2/7/05 exam. Patient's mother is 1 month pregnant but is Rubella immune.
Diarrhea; Severe Headache; Dizziness; Some Blood In Urine; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201), via an unspecified route of administration in the right arm on Mar2021 at 23:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19.Since the vaccination, patient had not been tested for COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any allergies to medications, food, or other products. On 06Mar2021, the patient experienced diarrhea, severe headache, dizziness, and some blood in the urine. The patient did not receive any treatment for the events. The clinical outcomes of the evente diarrhea, severe headache, dizziness, and some blood in urine were recovered.   No follow-up attempts are needed. No further information is expected
Pt rec'd vax in the AM @ 5PM mom stated pt started screaming & 6PM took to ER seen by MD pt had fever, lt leg very swollen;
Dizziness, Headache & NauseaVomiting Narrative: VACCINE ADMINISTERED AT APPROX 0900, PT REPORTED PREVIOUS REEACTION TO RN & WAS INFORMED TO EXTEND OBSERVATION PERIOD TO 30 MIN REPORTED HEADACHE/NAUSEA AT APPROX 0920 BP 139/50, HR 80s, SP02 100%, ORAL TEMP 98.4 PT TRANSFERRED TO ED VIA W/C ACCOMPANIED BY RN.
6FEB97 7PM rash on neck inc to hives;tx w/DPH;7FEB97 welts size of quarters on neck;inc over body cont DPH;8FEB97 seen by MD dec itching;10FEB97 hives cont;21FEB97 cont to break out in raised welts when touched or if hot & sweaty;
This non-serious spontaneous case, initially received on 01-Oct-2018, reported by a pharmacist, concerning a 1-year-old, female infant patient. On 01-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch number: 252381, expiry date: 31-May-2019 and anatomical location: not reported).
Nausea started around 4 PM on April 3 approximately 5 hours after the shot. Lasted for a few hours. Felt better after I fell asleep around 7 PM and woke up about 9 PM.   Diarrhea started about 10 AM April 4 and has continued for close to 24 hours. Feeling exhausted as of now (9:30 AM) but diarrhea has slowed.
The patient experienced redness, swelling, warmth and muscle tremors at the site of the injection. The patient also had a fever and chills.
Booster shot given on 11/17/21 from a multidose vial that expired on 9/21/21.
Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and NAUSEA (Nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, FENOFIBRATE, LOSARTAN and Allergy pill for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Tylenol (both occasions)
Patchy hair loss. It began with a patch in the beard and has spread over the majority of the beard and part of the scalp over the last 8 months.
After the first shot I called the doctor because I felt like I had a major flu. He did not prescribe anything, he just told me to take Tylenol. The second one messed up my cycle, it came later and heavier, I also had a headache and migraines. I called the doctor, and they just upped my blood pressure medication. I got anemia after the second dose.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 041L50A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Pain in hip, Vertigo, Schwannoma (Right facial nerve/mastoid 2 3 5 mm), Fasciitis plantar, Thrombocytopenia, Carotid artery disease, Edema, GERD, Cataracts, Congenital spine malformation NOS (Anomalies of spine ,S1 cleft posterior lamina with dysraphism), Radiculopathy (Left lumbar), Leukopenia, Coronary artery disease, Rotator cuff syndrome, Sensorineural hearing loss, BPH, Familial hypercholesterolaemia (Bleeding disorder), Prostate cancer, Hematuria, Lumbar disc disease, Ingrown toe nail (without infection) and Leg edema (Bilateral). Previously administered products included for Product used for unknown indication: influenza (series 1) on 11-Aug-2018. Past adverse reactions to the above products included No adverse event with influenza. Concurrent medical conditions included Fatigue, Dyspnea, Hypertension, Hyperlipidemia, Lung cancer and Colon cancer. Concomitant products included FINASTERIDE (PROSCAR), VITAMIN C [ASCORBIC ACID], FOLIC ACID, VITAMIN D3, UBIDECARENONE (COQ10 [UBIDECARENONE]), VITAMIN B12 [VITAMIN B12 NOS], ASPIRIN [ACETYLSALICYLIC ACID], FISH OIL, BIMATOPROST (LUMIGAN), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA), GLUCOSAMINE & CHONDORITIN, TIMOLOL MALEATE (ISTALOL) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood iron: elevated (High) increased. On an unknown date, Blood testosterone: elevated (High) Increased. On an unknown date, Red blood cell count: abnormal (Inconclusive) Abnormal. On an unknown date, Spirometry: abnormal (abnormal) Restrictive lung findings on spirometry was mild.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medication was provided   Patient had pre-operative examination, NON OBSTRUCTIVE CALCIUM HEART SCORE OF 767, used antihyperlipidemic for long term, screening of skin, had physical examination, RSR in V1 and v2 non-significant and had screening for skin conditions  Patient concomitant medication included cranberry capsule500 mg oral ,once daily   Patient had services due od  Hemoccult or sigmoid ,Flu  vax,pneumovax,TD Booster.
This is a spontaneous report from a contactable consumer, the patient. A 79-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 01Apr2021 (at the age of 79-years-old), as a single dose for COVID-19 immunisation. Medical history included arthritis and thyroid. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included unspecified medications for thyroid and arthritis; unspecified vitamins for unspecified indication; all from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in 2021, after shot, the patient experienced discomfort on left shoulder and up neck, little later pain continued up left side of head causing bad pain, which patient had at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events discomfort on left shoulder, up neck and little later pain continued up left side of head causing bad pain was not resolved at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.
Large hard, red, hot, swollen lump with bruising.  The red spot is bigger on the third day.  About the size of an egg. Headache lasting 2 days so far.
This spontaneous report as received from a certified medical assistant refers to a 63 year old female patient with hypertension and blood cholesterol increased. The patient's medical history included colon cancer and herpes zoster. The patient had no known drug reactions or allergies. On 14-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX, lot # J007210, expiration date 20-SEP-2014, 0.65 ml, subcutaneous. Concomitant therapies included SYNTHROID, lisinopril (manufacturer unknown) and simvastatin (manufacturer unknown). On 25-FEB-2015, the patient experienced herpes zoster as since this date, the patient developed pain under the left axilla and over the left breast and his left nipple became tender. Then on 28-FEB-2015, the patient developed rash in 3 different areas on his left side. On 05-MAR-2015, the patient was seen by the physician in regards to the symptoms. The physician diagnosed the patient with herpes zoster and prescribed acyclovir and tramadol hydrochloride for treatment. There were no laboratory diagnostics studies performed. Regarding the patient present status it was reported that the patient was not as bad as it was, the herpes zoster was still there but the rash was starting to crust over, so the patient was recovering. Additional information has been requested.
Red around inj site - ("dime size"). Anterior armpit sore with 2-3 areas of redness ("about size of 50 cent piece").
7 days after first injection - left arm felt heavy and sore. Hot to the touch. Painful. Next day, iced it continuously. Red Swelling visible and spreading around and down upper half of left arm. Tight. Itchy.
On November 10, 2009, the date the vaccine was administered, I was 6 weeks 3 days pregnant. Five days later, on November 15 I learned the fetus may have stopped growing. A sonogram conducted November 18 showed a gestational sac aged 6 weeks 6 days. The pregnancy was determined to be no longer viable, and a D&C was performed on November 24th.  1/6/2010 ED records received. Service date 11/15/09. Assessment: Hyperemesis gravidarum. Pregnant (7 Weeks) patient presents with nausea and vomiting, sweats, weakness. Morning sickness. Subchorionic hemorrhage. Intramural (uterine) fibroids.  1/7/2010 OB/GYN records received. Service dates 11/18/09 to 11/20/09.  Assessment: "Still not a viable pregnancy."
1/8 vaccination 1/9 I woke up and my throat was thick. Happens a lot with allergies. I ate breakfast, but felt like something stuck in my throat. White spots in back of throat.  Drank a lot of water, monitored.  1/10 Walk-in Medical Center.  I used mouthwash and hydrogren peroxide; gargled. By Monday the spots were gone.  Strep; negative COVID ; Negative  *no medicine prescribed **nurse so I felt I needed to follow up with Doctors office
Information has been received from a healthcare worker (also a medical assistant) referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot # K012457 with expired date 04-JUN-2017, lot# L018499 with expired date 25-FEB-2017, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received Janssen and passed out for roughly 15 seconds.  Blood pressure 112/58 , pulse was 58, pulse ox was 96%
Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE. The patient may have received 0.5mL per dose instead of 0.25mL per dose. The manufacture provided 0.5mL per single dose vial.
On 1/3/2020 patient reported to pharmacy for second dose of Shingrix.  During consultation prior to administration when asked on reaction to first vaccine, he reported no issue except an ongoing reduced range of motion in the left arm.  He reported no pain but an inability to extend arm past 90 degrees when moving above head.  Comparison to other arm was roughly  30-45 degrees less in upwards range of motion.   He reports this has been ongoing since administration of first vaccine.  No complaint at this time however, patient stated he has an appointment with physician 1/6/2020 and will ask physician to evaluate range of motion and for injury prior to second dose administration.
Per DH: Regarding The VSIR for clinic on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing a VAERS Reports on the all clients you have identified.
This spontaneous report was received from a licensed practical nurse and refers to a 15 year old patient (gender was not reported). The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient inadvertently received an unspecified dose of PROQUAD injection (lot # N022972 with expiration date on 19-FEB-2019; dose and route of administration were not reported), instead of M-M-R II and VARIVAX. No adverse effect was reported.
After the fifteen minute observation time. My left hand where my arm was injected became tingling and numb.   Ever since then my arm has been a numb feeling. After the second vaccine both sides of my cheeks get this numb tingling feeling. Like muscle weakness. Both arms now feel week and a numbing twisting feeling. I?ve never had this feeling before and feeling like I can?t grip. The feeling is like the arm was slept on. Or fingers being pulled backwards. The facial problem is quite concerning and happens anytime during the day.
Patient presented with arm redness and itchiness. There is no sign of cellulitis currently.
My face itches, Everything under myeyes to my chin. Nose, cheeks, chin; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6207) via an unspecified route administration in the left arm on 26Mar2021 at 01:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. There were no known allergies reported. The patient was not on any concomitant medications. The patient had not received any other vaccines within 4 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 10:00, the patient experienced face itches, everything under eyes to chin, it was nose, cheeks and chin, had started the next morning which had lasted all day. The events had not resulted in the visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measure was taken as a result of the adverse events. The clinical outcome of the event itchy was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
After 1 week. Having a rash and itchy at injection site. Also there feels like a knot at the injection site.