chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The Pfizer Covid injection was mixed incorrectly. Instead of 1.8 ml of 0.9% sodium chloride is was diluted with 0.9 ml.  Pharmacy was called and spoke to pharmacist was directed to call Pfizer. Pfizer was called option three. Pfizer's recommendation was to follow CDC recommendation which indicates no harm to patient. Also reported Journal states no adverse reaction has been reported. Only report was very sore arm for three to four days at site of injection.
Pt recv vax on 11/6/98; on 11/9/98 pt exp fever (100.8F), diarrhea x 5 day; on 11/12/98 pt exp bloody stool
No problems with first dose just sore arm. Second dose 14 hours after dose lost vision and experienced 2 syncope episodes. On the second syncope episode I also urinated on myself.
Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.
Immediately following the injection, my right shoulder, elbow, forearm and wrist started to get sore. Each day thereafter my shoulder was really  sore, I am having these burning sensations in my right forearm and my wrist is in pain. It has been 5 days since my second vaccine and each day has been very rough to get through. I have 2 jobs and the pain is interfering with my job duties. And when I'm trying to sleep, it's very uncomfortable and I haven't been able to get a full night's rest. I haven't seen any doctors or taken any medication because I thought that the symptoms would go away but they haven't. I don't know what to do
Mom reports on day of vaccines around 6 pm cheeks and chin was red and injection site (lt arm) red and warm to touch. Pt c/o it burning Has not felt good  and has not wanted to eat since then. On left upper arm at injection site is red (8 cm x 9 cm). Seen by provider today and was place on Amoxicillin.
Evening after receiving shot arm began burning and itching. Fever of 101.7, chills, extremely stiff muscles, could not stand without assistance, very sore throat worse than strept, sweat through sheets and saturated mattress, full body pain, severe headache, loud ringing ears, teeth chatters with severe jaw pain, nausea and diarrhea, shallow breathing that burned cold in lungs and cough. Fever continued for 2 days as symptoms gradually lessened. Lungs have remained sensitive to deep breathing or cough. Stayed home from work and in bed until the next week.
Chills; fever at 38.4 C; joint and muscular pain; joint and muscular pain; first dose on 27Dec2020 and second dose on 13Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the right arm on 13Jan2021 at 11:00 at a single dose for COVID-19 immunization. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number and expiration date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 at 10:00. Both doses were administered at the workplace clinic. The patient had no medical history; she had no known allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient received the first dose on 27Dec2020 and second dose on 13Jan2021. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She was not tested for COVID post vaccination. On 13Jan2021 at 21:00, the patient experienced chills, fever at 38.4 Centigrade (C), and joint and muscular pain. Therapeutic measures were taken as a result of chills, fever at 38.4 C, and joint and muscular pain, which included acetaminophen and ibuprofen. The patient recovered from the events on an unspecified date.  Information on the lot/batch number has been requested.
arm soreness; This is a spontaneous report from a non-contactable other health professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arm soreness on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Case number PHEH2012US018688 is an initial spontaneous report received from a health care professional on 05 Sep 2012 with a follow up information received on 16 Oct 2012: This report refers to a 16-year-old female patient whose medical history included allergy to BACTRIM. Her vaccination history included administration of MENVEO (batch number: not reported) on 14 Aug 2007 which was well tolerated. Her concomitant vaccination included administration of 0.5 ml influenza vaccine (manufacturer unknown, batch number: 44531AA) intramuscularly on 31 Aug 2012. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly on to left arm on 31 Aug 2012. It was reported that the storage refrigerator of the vaccine was affected by a power outage and that the vaccine had reached up to 11 degree Celsius for 30 to 60 minutes. It was also reported that he vaccine was stable and was okay to administer. No adverse event was reported following this administration error. Follow up information received on 16 Oct 2012: Patient demographics (height and weight), medical and vaccination history, concomitant vaccine information route and site of administration of suspect vaccine were updated.
Day after second vaccine blood clots in legs and lungs, mesh inserted, started bleeding vaginally and now in intensive care almost on life support.
Intermittent pain in arm several inches away from injection site which has continued for 10 days.
muscular discomfort; a nodule with multiple nodules appeared in the thyroid isthmus; This is a spontaneous report from a contactable other hcp.    A female patient of an unspecified age received bnt162b2 (BNT162B2 Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose, dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  Medical history included covid-19 from Jul2020 lymphadenopathy, phlebitis. The patient's concomitant medications were not reported.  The patient experienced muscular discomfort, a nodule with multiple nodules appeared in the thyroid isthmus on an unspecified date with outcome of unknown.    Follow-up (19Apr2021): This follow-up report is for reporter mother. No new safety information is provided in the F/U source document.  During conversation for INT00208789 she reported that her mother had the same AE after her second dose of Pfizer-BioNTech COVID-19 Vaccine. Thyroid nodules. Her mother is 72 and had lung cancer. No more information was provided.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Proposed response:  In clinical studies, adverse reactions in participants 16 years of age and older included lymphadenopathy (0.3%). Dose 1 through 30 days after Dose 2, reports of lymphadenopathy were imbalanced with notably more cases in the Pfizer-BioNTech COVID-19 Vaccine group (64) vs. the placebo group (6), which is plausibly related to vaccination. Published safety and final efficacy results from the Phase 2/3 part of the ongoing, placebo-controlled, pivotal study reported a total of 64 vaccine recipients (0.3%) and 6 placebo recipients (<0.1%) reported an event of lymphadenopathy. This included 26 male participants (0.3%) and 38 female participants (0.4%). In cases where location was specified, AEs of lymphadenopathy occurred in the arm and neck region (in axillary, left axillary, left para clavicular, left supra clavicular, bilateral cervical, or unspecified lymph nodes). Most lymphadenopathy events were reported within 2 to 4 days after vaccination (15 events were reported =8 days after vaccination, including 1 event reported 98 days after). The average duration of these events was approximately 10 days, with 11 events ongoing at the time of the data cutoff.
The expiration date for the vaccine was 3MAY2022, Patient received expired vaccine on 4MAY2022; Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (The expiration date for the vaccine was 3MAY2022, Patient received expired vaccine on 4MAY2022) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 034F21A, 024M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The expiration date for the vaccine was 3MAY2022, Patient received expired vaccine on 4MAY2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and PRODUCT STORAGE ERROR (The expiration date for the vaccine was 3MAY2022, Patient received expired vaccine on 4MAY2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. On 21APR2022 at 6AM 6 vials were removed rom the Freezer of the nurse's Facilities Pharmacy and sent to the Nurses Office. The 6 vials were placed in the offices refrigerator on 21APR2022. The bag that the Nurses Pharmacy sent the vials in was marked as expires in twelve days.
Patient reports swelling, redness, and bumps at the reaction site occurring within 24 hours of the vaccine.
6/3/21 PMHx of HTN, CAD, OSA, ESRD on CAPD, T1DM, GERD, admitted for AMS secondary to DKA
COVID-19; chills; headache; Nasal Congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION, COVID-19 (COVID-19), CHILLS, and HEADACHE in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN BASAGLAR, LEXAPRO, and ACYCLOVIR for an unknown indication.   On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced NASAL CONGESTION. On 19-Apr-2021, the patient experienced CHILLS and HEADACHE. On 20-Apr-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with TYLENOL at an unspecified dose and frequency and DAYQUIL at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION, COVID-19 (COVID-19), CHILLS, and HEADACHE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, SARS-CoV-2 test: Positive COVID.         Concomitant included Novolog and Birth Control Pill were noted.
a 13 years-old was administered a dose of FLUBLOK QUADRIVALENT/ No AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2028, expiry date: 30-Jun-2021) via intramuscular route on left arm on an unknown date (also reported as 24-Sep-2020 or 26-Sep-2020) for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No concomitant vaccines received by the patient.  It was an actual medication error due to inappropriate age at vaccine administration.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
This spontaneous report as received from a nursing student refers to a female patient of unknown age. The patient's medical history included allergy to latex. On 25-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (Lot # and exp. date not reported) (0.65 ml, subcutaneous). Concomitant therapies were not reported. In approximately 2014 ("reported as now the patient had shingles") the patient experienced shingles. The patient sought unspecified medical attention and received Acyclovir and an unspecified pain medication for the treatment of shingles. The outcome of shingles was reported as not recovered. Additional information is not expected, since the nursing student does not want to be contacted, and she needed to get permission from her supervisor to give additional information.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 15-MAY-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot # R013573, expiration date: 22-MAR-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
Fever to 101.6F, chills, headache, body aches, tachycardia to 140
Patient did not receive 2nd dose on her HCP's medical advice/recommendation; Fever that was 102; Severe vertigo with spinning right to left and up and down; Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers; Red streaks down her arm; Red streaks are hot; could not move her elbow; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Patient did not receive 2nd dose on her HCP's medical advice/recommendation), PERIPHERAL SWELLING (Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers), ERYTHEMA (Red streaks down her arm), SKIN BURNING SENSATION (Red streaks are hot) and VERTIGO (Severe vertigo with spinning right to left and up and down) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.    On 02-Mar-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ERYTHEMA (Red streaks down her arm), SKIN BURNING SENSATION (Red streaks are hot), HYPOKINESIA (could not move her elbow) and VOMITING (Throwing up). On 02-Mar-2021 at 10:00 PM, the patient experienced PERIPHERAL SWELLING (Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers). On 03-Mar-2021, the patient experienced VERTIGO (Severe vertigo with spinning right to left and up and down). On an unknown date, the patient experienced OFF LABEL USE (Patient did not receive 2nd dose on her HCP's medical advice/recommendation) and PYREXIA (Fever that was 102). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (Patient did not receive 2nd dose on her HCP's medical advice/recommendation), ERYTHEMA (Red streaks down her arm), SKIN BURNING SENSATION (Red streaks are hot), VERTIGO (Severe vertigo with spinning right to left and up and down), PYREXIA (Fever that was 102) and VOMITING (Throwing up) outcome was unknown and PERIPHERAL SWELLING (Severe reaction in that her arm started swelling to the point she could not move her elbow and went down to her fingers) and HYPOKINESIA (could not move her elbow) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's Health care provider gave her letter stating she could skip 2nd dose as she had severe reaction for the first dose.  No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow-up appended
Patient was to receive MMR and Varicella. She was inadvertently given MMRV and Varicella. Per doctor patient should not have any ill effects from receiving the double dose of Varicella. Mom was notified and at the time of call patient was sleeping and was not showing any signs or symptoms.  As of this time patient has not had any ill effects reported by mom.
This spontaneous case reported by a consumer, describes the occurrence of fatigue (tired) and pain in extremity (sore arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history provided. On Jan 21, 2021,  patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 21, 2021, patient experienced fatigue (tired) and pain in extremity (sore arm). At the time of the report, fatigue (tired) and pain in extremity (sore arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Patient received a Pfizer vaccine for 5-11 year olds and was only 4 years old at the time.  Did not report any symptoms, was unaware of the error until they returned for the 2nd dose.
Body pain all over; Dizzy; Fatigue; Slept for 27 hours straight; I thought I was dying; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 10Oct2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 10Sep2021 at 17:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 11Oct2021 at 01:45, the patient experienced the most extreme body pain all over that lasted for 24 hours after it began also dizzy and fatigue. The patient slept for 27 hours straight and thought she was dying. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event most extreme body pain all over was resolved on 12Oct2021; while that of event dizzy, fatigue, slept for 27 hours straight and thought was dying was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
begun w/nausea, vomiting, diarrhea, severe dehydration;In ER for 1 day on IV fluid;