chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The second dose was dive on day 5, instead of Day 3 due to the office being closed on the weekend; Case reference number US-BN-2021-000003 is a spontaneous case report initially received from nurse on 11-JAN-2021, and concerns a 19-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 09-Dec-2020, the patient started therapy with RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose for a dog bite.   On 14-Dec-2020 (day 5), the patient received the second dose of RabaVert  (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at an unknown dose for a dog bite (Inappropriate schedule of vaccine administered). It was reported that the second dose was given on day 5 instead of day 3 due to "the office being closed on the weekend".  On 16-Dec-2020, the patient received the third dose of RabaVert  (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose for dog bite.  On 23-Dec-2020, the patient received the last dose of RabaVert  (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dose for dog bite.  At the time of this report ,it was not known whether the patient developed any adverse event and It was known nurse stated that patient still need last dose.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed by convention. Reportedly, the patient received the second dose of RabaVert on day 5, instead of day 3, due to human action which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of product (vaccine) administration is not related to the RabaVert, but to human action.; Sender's Comments: Inappropriate schedule of product administration is listed by convention. Reportedly, the patient received the second dose of RabaVert on day 5, instead of day 3, due to human action which is considered to be inappropriate schedule of vaccine administered. No adverse events were reported. Inappropriate schedule of product (vaccine) administration is not related to the RabaVert, but to human action.
Swelling, hard nodule size of a quarter immediately following injection. Gave Benadryl.
Information has been received from a physician concerning a female (age unknown) with no pertinent medical history, who was vaccinated (route unknown) with a first and second dose of GARDASIL (Lot #'s unknown).  The physician indicated that the patient reported after the first dose it was painful.  When the patient received the second dose, "just last week", she reported no pain; however, she fainted.  The patient's outcome is reported as recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  No additional information is expected.
Pt states she received tetanus shot at OV 2/22/20 and since early Sunday, 2/23, she has had pain at the site in left shoulder, into left neck and jaw, headache, fever of 100, 100.5 Sun, Mon, even with Tylenol and Advil. States temp 99.5-100 Tuesday. States she still has mild chills at times and malaise. States left jaw pain has decreased, and overall she feels better, feels like she has "turned the corner."
First difficulty breathing, shortness of breath; then tiredness, stiffness, entire body and muscle aches, and an outbreak of acne. Feeling unwell in general.
Headache, Myalgia, Diarrhea, NauseaVomiting, SORE AT INJECTION SITE/CHILLS/FATIGUE Narrative:
heat/hot; redness; swelling; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat/hot), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (itchiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LR0A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE WARMTH (heat/hot), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (itchiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (heat/hot), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications include allergy shots on every Friday. Treatment details also include, ice packs.
Nausea; Muscle pain; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea and muscle pain after meningococcal group b rlp2086 was administered. The physician prescribed ondansetron hydrochloride (ZOFRAN) after meningococcal group b rlp2086 was administered to prevent adverse events. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
gave TDAP designed for a 4 to 6 week old to a 25 year old accidentally with no reported adverse event.; Initial information received on 01-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 25 years old and unknown gender patient who was given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] designed for a 4 to 6 week old with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Sep-2022, the patient received a 0.5 ml total dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5828AA, 30-Mar-2023) via intramuscular route in the left deltoid as Immunization   .  On 01-Sep-2022 (latency: same day), the patient developed a non-serious "gave tdap designed for a 4 to 6 week old to a 25 year old accidentally with no reported adverse event" (product administered to patient of inappropriate age) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event   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 the 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.
Within 10 minutes after 1st vaccine I developed a head rash where my shoulder is where needle was injected. The rash was gone within a day.
On 2/12/2023, patient presented to the emergency department for evaluation of cough and progressively worsening shortness of breath. He was given a COVID-19 NAA test which resulted positive; His chest x-ray showed opacities and small bilateral pleural effusions. Patient had tachycardia and was found to be hypoxic at 88% on room air; He was treated with oxygen supplementation and Decadron. Patient was diagnosed with Covid-19 pneumonitis, hypoxia, and acute on chronic heart failure. He was admitted to the hospital for further evaluation and treatment.   Submitter does not have access to further medical information on this case including discharge date. If more information is needed, please contact the admitting hospital
Below patients left arm where shot was given, the day after immunization was given the area became very red and sore. The patient followed up with her PCP and Dr. determined that the patient had cellulitis from the vaccine. The patient had no previous reaction with the first dose of the vaccine.
3 cm diameter erythema, induration, warmth, pain, tender, left deltoid area.
Hives/broke out in hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 28Dec2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Jul2022 (unspecified if ongoing). Concomitant medication(s) included: YELLOW FEVER VACCINE. The following information was reported: URTICARIA (non-serious), outcome "not recovered", described as "Hives/broke out in hives". Therapeutic measures were taken as a result of urticaria.  Additional information: Patient asked if the Pfizer COVID -19 Vaccine has affected 1% of the population with hives. Patient has been under her doctor's care for this and was given prednisone, antihistamine and creams. Patient stated that the antihistamines have not been working for her. Patient took Benadryl which dried off her mouth. Patient also took Zyrtec. Patient took Allegra for hives which she plans to stop. Patient also takes prescription cream which she has been using all over her body. Patient only took the Pfizer COVID Vaccine for her supposed travel for a wedding in Feb. Patient had her first dose on 28Dec2022 and 2nd dose at the end of Jan2023. Caller also took yellow fever shots. Last visit, doctor told her it may take 8 weeks to get over the hives. Patient described the hives as debilitating to her sleep pattern. Patient mentioned that Pfizer should make an antidote. Patient mentioned about her friend who works in the medical community and had a COVID shot when it first came out. Patient's friend has been itching for 2 years and had gone to different allergists. Patient was not sure if her friend has hives. Patient blames Pfizer on it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300135898 Same patient/vaccine, different dose, similar event;
Felt a slight numbness is throat, possible slight swelling in throat- felt this 20 minutes after shot and it lasted about 30 minutes.... 30 minutes after the shot my face turned red and my ears were very red, almost purple , and hot. This lasted for several hours after... At 11:30pm, almost 7 hours after the shot, I started to feel lousy. I started to get body aches and chills. Within 30 minutes they were fairly intense body aches and chills, shaking. At 1:00am I started to feel nauseas . At 1:30 am I started dry heaving. At approximately 2:30 I threw up twice, and the dry heaving and nausea lasting until 4am , when I took an anti nausea pill. I finally fell asleep at 430am. I woke up at 8am and felt tired, and no longer nauseated.
Headache, Myalgia, fatigue; redness/itching at injection site Narrative:  Other Relevant History:
JUN11, 2021 was having heart pain on right lower side of the belly. Left bottom side of the heart, no resting in between the heartbeats. 1st dose on Jun 14  - body aches. Tested positive for COVID on 16 Jun 2021. - July 3nd, negative. 12 Jul 2021 was for 2nd dose. High blood, fast heartbeats, sweating and no temperature. Back side of the head feeling tired and hard to breathe and sweat. Doctors on 7Oct2021 - Told doctor about breathing and got chest x-ray. 2 Nov2021 - have an appt to do a stress test.
Purple bruises lasting weeks and then itching and turning into a rash that hurts doesn?t go away with cortisone cream and last for weeks
This spontaneous report as received from a registered nurse refers to a female patient of unknown age with psoriasis flare ups. On 19-SEP-2012, the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) and on 07-MAR-2013, the patient received the second dose of GARDASIL (Lot # not reported). The nurse reported that the patient received the second dose of GARDASIL until 07-MAR-2013 because her psoriasis flare-up occurred several months after receiving the first dose of GARDASIL. The outcome of psoriasis flare-up was unknown. The nurse did not think that psoriasis flare-up to were related to GARDASIL. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of currently 1 year old and unknown gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of both PROQUAD with lot number M033210 and expiration date of 09-JAN-2018, subcutaneously (strength, dose and anatomical location were unknown) and a dose of VARIVAX with lot number M024683 and expiration date of 18-MAY-2018, subcutaneously (strength, dose and anatomical location were unknown) at the same office visit for prophylaxis. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
This spontaneous report has been received from a pharmacist via company representative concerning to a male patient of unknown age. Current conditions, medical history and drug reactions/allergies unspecified by reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, lot# and route not provided). Concomitant medication was not reported. On an unknown date, the patient experienced a vaso-vagal reaction and "passed out". None laboratory diagnostics studies performed. The patient did not require any treatment for the adverse events. The patient recovered fully while in the pharmacy. Additional information has been requested.
runny nose; nausea; feeling unwell; vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 10:00 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, administration date 16Oct2021; VITAMIN D [VITAMIN D NOS]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PROBIOTIC [BIFIDOBACTERIUM LACTIS].  The following information was reported: RHINORRHOEA (non-serious) with onset 14Nov2021 06:00, outcome "recovering", described as "runny nose"; NAUSEA (non-serious) with onset 14Nov2021 06:00, outcome "recovering", described as "nausea"; MALAISE (non-serious) with onset 14Nov2021 06:00, outcome "recovering", described as "feeling unwell"; VOMITING (non-serious) with onset 14Nov2021 06:00, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of rhinorrhoea, nausea, malaise, vomiting.  Additional information: The patient had no Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient received other vaccine in four weeks included Flu vaccine. The patient received within 2 weeks of vaccination included vitamin D, Zyrtec, multi, probiot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient contracted COVID-19 twice after having been vaccinated.; The patient contracted COVID-19 twice after having been vaccinated.; The patient contracted COVID-19 twice after having been vaccinated.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "The patient contracted COVID-19 twice after having been vaccinated.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain since 24 hours after injection, generalized aches, now recovered from this. Currently has localized pain in rt. deltoid; arm is painful at night.
Uncontrollable cough, some minor headaches, fatigue, itchy throat, some nausea symptom, and some difficulties taken deep breaths.
Difficulty breathing, chest tightness, wheezing, cough. Patient tried her inhaler and a nebulizer treatment and checked her peak flow.
full body rash, worse on hands. itching, feeling of tingling and numbness. fluttering feeling in chest.
3:12 PM. C/O stomach hurting and aching. Provided with rest. V.S.S. Left to go home with mother, 3:50 PM.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 29-AUG-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. Other suspect therapies included ROTATEQ, PEDVAXHIB and M-M-R II (rHA). Concomitant therapies included sterile diluent. On 29-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to M-M-R II, ROTATEQ, PEDVAXHIB and VAQTA. The reporter considered no adverse event to be not related to ROTATEQ, M-M-R II, PEDVAXHIB and VAQTA. Sender's Comments: US-009507513-1708USA012838: US-009507513-1708USA013542: US-009507513-1708USA013545: US-009507513-1708USA013546: US-009507513-1708USA013548: US-009507513-1708USA013549: US-009507513-1708USA013550: US-009507513-1708USA013551: US-009507513-1708USA013552: US-009507513-1708USA013538: US-009507513-1708USA013537: US-009507513-1708USA013539: US-009507513-1708USA013540: US-009507513-1708USA013541: US-009507513-1708USA013543: US-009507513-1708USA013544.
The next day I noticed swollen lymph nodes that turned into a blood clot in my neck and shoulder. Went to ER couple of days followed up with my doctor. After three weeks swelling was gone.
Pt administered 3rd dose of ped Hep A. MOP stated there were no ill side effects.
MD noticed an inc incidence of hematomas @ the inject site following immun w/vax; 1 of 5 pts (out of 10 pts immunized) who exp hematomas, approx 1 inch in diameter;
Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA  Pfizer Bivalent was inadvertently administered to the patient as a primary dose. The Pfizer bivalent vaccine packaging is identical to that of the Pfizer monovalent vaccine packaging, making it difficult to distinguish except for the word "bivalent" printed in small script  on the box and vial.  Our clinic was awaiting shipment of the monovalent Pfizer vaccines  to our other clinic site the day prior to this administration. The shipment instead arrived on 09/20/2022 at our clinic and needed to be transported to the clinic, at which the vaccine administration error occurred.
Vial was at room temperature for 25 hours; No Adverse event; Bivalent vaccine given to patient from a vial punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine given to patient from a vial punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Vial was at room temperature for 25 hours) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine given to patient from a vial punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was at room temperature for 25 hours) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine given to patient from a vial punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Vial was at room temperature for 25 hours) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine given to patient from a vial punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Vial was at room temperature for 25 hours).    Patient was over the age of 65. No concomitant information was reported. The size of the vial was 5.5ml. The vial was initially stored in the refrigerator on 12-Oct-2022. The date and time vial was first punctured on 19-Oct-2022 at 10:00am. The vial was administered to 3 different patients on 20-Oct-2022 at 10:13,10:15 and 11:00 respectively.  The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range was just over 25 hours. This case was for 3rd patient out of 3 patient which reported by reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-661792, US-MODERNATX, INC.-MOD-2022-661788  Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661792:patient 2 US-MODERNATX, INC.-MOD-2022-661788:Patient 1