chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported premature labor with an onset of 11/06/09. The patient sought care at a hospital, which resulted in hospitalization for an unknown length of time. The patient reported the adverse event lasted two days. The agency has not been able to contact this patient.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 14-NOV-2017, the patient was vaccinated with improperly stored dose of M-M-R II (dose, frequency and route of administration were not reported) lot # M036544 and expiration date: 15-AUG-2018. The vaccine was reconstituted with an improperly stored sterile diluent (manufacturer unknown) (lot # M023895 and expiration date: 18-JAN-2019). No adverse effects were reported. On 08-NOV-2017, the M-M-R II and sterile diluent (manufacturer unknown) were stored in between 47 Fahrenheit degrees to 77 Fahrenheit degrees for 45 minutes and on 14-NOV-2017, between the same temperatures for 15 minutes. There was no previous temperature excursions. The digital data logger was involved in recording the temperature excursion. This is one of five reports received from the same reporter. Sender's Comments: US-009507513-1711USA006683: US-009507513-1711USA006684: US-009507513-1711USA006685: US-009507513-1711USA006084.
This  59 year old female received the Pfizer Covid shot on  1/26/21    and went to the ED on 2/4/21     and was admitted  on 2/4/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) I63.9 - Cerebral infarction, unspecified R29.810 - Facial weakness
This initial report was received from a pharmacist via company representative, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, dose 1 (dose, strength, route of administration, anatomical location and lot number were not reported). At the time of administration, the PNEUMOVAX 23 had expired. At the time of reporting, the patients outcome was unknown. Additional information is not expected since the reporter did not give consent to be contact.
pt recvd vax; mom states pt was unresponsive, sl fever & restless on 9jan96; to md;pt responsive & active again on 10jan96;
nauseous; discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and DISCOMFORT (discomfort) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nauseous) and DISCOMFORT (discomfort). The patient was treated with FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, NAUSEA (nauseous) and DISCOMFORT (discomfort) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator
pt recv vax @ clinic @ 530PM;got home about 820PM mom noticed redness of lt upper arm size of fifty cent piece;took temp 99.2;mom gave APAP in evening & following day;11APR97 redness & induration lt deltoid 3"x3";
Second Shot is scheduled for 06APR2021; Head Cold; Congested; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Shot is scheduled for 06APR2021), NASOPHARYNGITIS (Head Cold) and NASAL CONGESTION (Congested) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced NASOPHARYNGITIS (Head Cold) and NASAL CONGESTION (Congested). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Shot is scheduled for 06APR2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Shot is scheduled for 06APR2021), NASOPHARYNGITIS (Head Cold) and NASAL CONGESTION (Congested) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Patient was not vaccinated at our site however was admitted approximately 7-10 days post vaccination and expired.
Started with red raised hives on chest area at 2 am. Were itching and woke her up. Patient came to work and then complained of an itchy throat, denied shortness of breath. Was advised to go to urgent care, which she did. Instructed to get BENADRYL and go home and rest.
I received my second shot on April 17th, 2021.  I injured my foot on April 21, 2021.  I went to my General Physician the following day and received a tetanus shot.  Up until that time, my side effects were very light; slight headache, arm muscle pain.  Two days after receiving my tetanus shot I could barely get out of bed.  I woke up feeling as if someone had drugged me; my mind was very fuzzy and it was hard to focus.  Every muscle in my body was in extreme pain and it hurt to breathe.  I had bouts of terrible stomach cramps.  I felt nauseous to the point that I was unable to eat solid food other than chicken soup and crackers for three days.  I do fully believe my side effects happened because of the tetanus shot as I had very little side effects before the shot.  I felt like I was dying.  Luckily I had some medicine at home that helped with the symptoms; gabapentin for my shoulder injury, zofran from a past hospital visit, and I took tylenol.  I am a Medical Assistant and didn't feel the hospital or the Dr. office could have offered me any relief from my symptoms.
8/16 Temp 102, rapid pulse, fussy - examined by doctor no dx. 8/18 - 8/19 Bloody nose, irritated eyes, red scratchy. 8/20 Rash appeared. 8/21 visit to Doctor office dx reaction to MMR.
Fever of 101.4. Body Aches. Shivering. Headache.  Pain at injection site.
sore eye balls; chills so bad "she couldn't walk"; Sore Arm at the injection site; Chills; Headache; shakiness; Sore Throat; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), GAIT DISTURBANCE (chills so bad "she couldn't walk"), HEADACHE (Headache), EYE PAIN (sore eye balls) and TREMOR (shakiness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE, LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), TREMOR (shakiness), OROPHARYNGEAL PAIN (Sore Throat) and DIZZINESS (Dizziness). On an unknown date, the patient experienced GAIT DISTURBANCE (chills so bad "she couldn't walk"), EYE PAIN (sore eye balls) and VACCINATION SITE PAIN (Sore Arm at the injection site). At the time of the report, CHILLS (Chills), GAIT DISTURBANCE (chills so bad "she couldn't walk"), HEADACHE (Headache), EYE PAIN (sore eye balls), TREMOR (shakiness), OROPHARYNGEAL PAIN (Sore Throat), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Sore Arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-065430 (Patient Link).
lowcount of Lymphocytes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOPENIA (lowcount of Lymphocytes) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 0AJ20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Hypertension.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced LYMPHOPENIA (lowcount of Lymphocytes). At the time of the report, LYMPHOPENIA (lowcount of Lymphocytes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Aspartate aminotransferase decreased: low Low. On 06-Feb-2021, Blood chloride: high High. On 06-Feb-2021, Lymphocyte count: low Low.         No relevant concomitant medications were reported. No treatment information was provided.
Extremely high fever , temp max of 105.4 at approximately the 24 hour mark . Hive rash , facial and orbital swelling . I started taking Tylenol 650 q 4 , Benadryl 50mg  q 6 hrs , and started on steroids .  The fevers and facial swelling lasting  approx 1 week . The symptoms were most severe at my 24 hour mark .  I was recommended to go to the hospital , however I refused to decided to treat at home.
Trouble breathing; Chest pain; Felt terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 09Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset Jun2021, outcome "unknown", described as "Trouble breathing"; CHEST PAIN (non-serious) with onset Jun2021, outcome "unknown", described as "Chest pain"; ANXIETY (non-serious) with onset Jun2021, outcome "unknown", described as "Felt terrible".  Additional information: Patient had the second dose of the covid vaccine on 9Jun2021. He had some adverse events, had heart issues like trouble breathing, chest pain and felt terrible when he was in a cold place. If in a hot room, his temperature would rise. He experienced a different perception when it comes to temperature. He is worried that the same thing might happen with the booster. He is just trying to figure out if should take the booster shot tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shingles Rash, started on Valacyclovir 1 gram, PO, TID
Missed second dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (Missed second dose of Moderna vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL, AMLODIPIN [AMLODIPINE] and METOPROLOL for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRODUCT DOSE OMISSION IN ERROR (Missed second dose of Moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (Missed second dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
no adverse event; vaccine was administered following multiple temperature excursions; This spontaneous report has been received from an office manager referring a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and previous drug allergies or reactions were not provided. Concomitant medication included sterile diluent (MERCK STERILE DILUENT).   On 08-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 ml once, lot number W006583, expiration date: 23-AUG-2023 (strength, route of administration, and anatomical location were not reported) as prophylaxis following a temperature excursion (product storage error). Excursions occurred before patient's administration included: on 11-MAY-2022 a temperature of 5.7 Fahrenheit degrees (F) for 7 minutes; on 27-MAY-2022 a temperature of 5.7 F for 5 minutes; on 06-JUN-2022 a temperature of 5.9 F for 6 minutes. There was no temperature excursions prior to 11-MAY-2022. The patient had no adverse effect or other symptoms as a result of the vaccine administration (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2207USA007928:
Fever of 102 deg. F. on the evening of shots. Thursday and Friday fever down to 100.1 deg. F, irritability, not eating. Saturday no fever but has had crying episodes off and on for 30 mins or longer.
Information has been received from a pharmacist concerning a patient who was vaccinated with PNEUMOVAX 23 (lot # 662664/0981X). Subsequently the patient experienced cellulitis. It's unknown if the patient had sought any medical attention. Follow up information has been received from the pharmacist reported that the 77 years old patient (date of birth unknown to the reporter) who was vaccinated with PNEUMOVAX 23 on 09-JUL-2009. The pharmacist did not know if the patient received concomitant vaccines when the vaccine was administered. The patient had pain at the injection site after the vaccination (not cellulitis as previously reported). The patient was not hospitalized. It was unknown if the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Received vaccine IM in (L) deltoid at 230pm. Itching of (L) arm started at 4pm and spread to both arms, head, chest and legs. BENADRYL po taken at onset of itching and repeated 4 hours later.
Patient noted very low blood pressure that evening after having the vaccination. Felt very dizzy. Took blood pressure and it was 54/45. No recent changes in medication dosing.
Breakthrough case after two vaccines Moderna 11/12/21 Lot# 034F21A;  Moderna 12/3/21 Lot# 034F21A
230 pm  vaccine given ..Allergic reaction.  I immediately had burning, then I got dizzy, my teeth started hurting, nausea, I took a Benadryl within 5 minutes, then I felt like my throat was swelling, I took a second dose of Benadryl.  My lips started swelling.  Benadryl started easing things down about 30 minutes later.  My mouth is still burning.
Dizziness occurring 3 hours post injection including loss of balance.; Dizziness occurring 3 hours post injection including loss of balance.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included adult stills disease (AOSD). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included anakinra (KINERET), methotrexate (MANUFACTURER UNKNOWN), duloxetine hydrochloride (CYMBALTA) and bupropion (MANUFACTURER UNKNOWN); all from unknown date for unknown indications and an unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Mar2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient previously took moxifloxacin hydrochloride (AVELOX) and codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 20Apr2021 at 04:30, the patient experienced dizziness occurring 3 hours post injection including loss of balance. Since the vaccination, the patient had not been tested for COVID-19. 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 reported events. The clinical outcome of events dizziness occurring 3 hours post injection including loss of balance was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Presents on account of increasing shortness of breath, cough and fever despite a course of prednisone at home. COVID test came back positive,not hypoxic received IV steriods and antibiotics,monoclonal antibodies  to arrange as outpatient as it has not available in the hospital. When she was stable arrangements were made for discharge. Completed COVID Vaccine 2/26/2021
After donation and Tetanus immunization, donor felt dizzy/faint feeling. Donor was pale. Donor lowered to bed. Water given. Donor recovered within ten minutes.
During the 2nd Engerix-B inject many employees complained about soreness of the inject site & painful inject; no pain was reported during the 1st inject of Engerix-B;
pain in her shoulders and legs/the pain in her shoulders is bilateral; pain in her shoulders and legs; difficult for her to sleep at night; anytime she has to engage her muscles to move it hurts; her blood pressure was elevated but not at an alarming level; her inflammatory markers were elevated; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number and expiry date not reported) via an unspecified route of administration as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing The patient's concomitant medications were not reported. On an unspecified date, patient started experiencing pain in her shoulders and legs that was making it difficult for her to sleep at night. She states that anytime she has to engage her muscles to move it hurts. She notices it mostly when she has been lying or sitting still for long periods of time and then tries to move. She also states that once she is moving around it doesn't bother her as much. She has a history of arthritic problems in the past but she has never experienced pain in her legs before now. She reports that she did not have any arm pain at the injection site and the pain in her shoulders is bilateral. Her husband stated that she did call and report these symptoms to Pfizer already but they would like to know if these symptoms could be related to the vaccine or if they could potentially be related to something else. The patient did see her PCP on Tuesday of this week for these symptoms and she noted that her blood pressure was elevated but not at an alarming level. On 26JAN2021, the patient underwent lab tests and procedures which included blood pressure measurement: elevated, blood test: inflammatory markers were elevated. Her blood pressure elevated but not at alarming level. The patient wanted to know if she should receive the second dose of the Pfizer COVID-19 vaccine since she has experienced these side effects. The outcome of events was unknown.   No follow up attempts possible. No further information is expected.
Ringing in ears started approximately 48 hours after second dose. Happens a couple times a day and lasts 10 seconds. Not always the same ear.
PATIENT REPORTED EXTREME HEADACHE, MUSCLE STIFFNESS, AND NAUSEA. PT WENT TO THE EMERGENCY ROOM FOR TREATMENT.
his heart is inflamed; heart has been acting up; he is tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunization.The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "his heart is inflamed"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "heart has been acting up"; FATIGUE (non-serious), outcome "unknown", described as "he is tired". it was explained that the patient got his 2nd dose like might be a couple of months ago and his heart has been acting up and he was tired. He works in close contact because he was in the hospital obviously. He was completely healthy person and now 3 different doctors have said that his heart was inflamed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning an approximately 18 year old female who on approximately 02-Nov-2006 was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On week after vaccination, on approximately 09-Nov-2006, the patient experienced pain at the injection site, and had redness, soreness and swelling. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Pfizer-BioNTechCovid-19 vaccine EUA. Headache and migraine lasting approximately 36 hours.
Patient reports she received Tdap vaccine 0.5ml on 8/23/17, on 8/24/17 patient noted left deltoid redness, swelling and pain. Patient started taking ibu, ALEVE, and TYLENOL. Patient presented today with left arm pain, and was diagnosed by Dr. with left subdeltoid bursitis. Patient discharged with a prescription of prednisone.
administered an expired dose of ActHib vaccine to a 4 month old, no AE; Initial information received on 11-Mar-2020 regarding an unsolicited valid non-serious case received from consumer or non-healthcare professional.  This case involves a four month old patient who was administered an expired HIB (PRP/T) VACCINE [ACT-HIB] (lot number not reported, Exp. Date 29-Nov-2019) via an unknown route in an unknown administration site on an unknown date, for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.