chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 10 months 28 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
19 month old child had received 1ST Moderna Monovalent dose 7/6/2022 and 2nd dose 8/3/2022. On 8/2/2023, child presented for a well care visit at which time parents requested 3rd dose of Covid Vaccine. Child was administered Pfizer Bivalent 3mcg/0.2 ml dose at time of visit. Unauthorized mix and match for his age group.
Started with a red area the size of a quarter with a knot in it.  The redness and knot has gotten about the size of a half a dollar.  The redness and knot is at the injection site.  Only part of arm that is painful is the injection site.
As of 9/5/12-arm is red and warm. It hurts all the way down arm. Pinky finger has some numbness and tingling. On 9/29/12-patient reported that she was fine.
injection site reaction; she can feel her skin tingling on both arms; she can feel her skin burning on both arms; skin peel off her face/skin peel off her neck; skin on her face itches; The rectangle traveled over to a scar on her left arm from when she had skin melanoma removed in 2020/skin is red on her face and neck.; moderate fever; sore left arm; chills; The site reaction stayed and turned into a red rectangle.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (injection site reaction), PARAESTHESIA (she can feel her skin tingling on both arms), SKIN BURNING SENSATION (she can feel her skin burning on both arms), SKIN EXFOLIATION (skin peel off her face/skin peel off her neck) and PRURITUS (skin on her face itches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin melanoma (skin melanoma removed in 2020) in 2020 and Laser therapy (laser peel done at a skin care clinic).    On 09-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced INJECTION SITE REACTION (injection site reaction), PARAESTHESIA (she can feel her skin tingling on both arms), SKIN BURNING SENSATION (she can feel her skin burning on both arms), SKIN EXFOLIATION (skin peel off her face/skin peel off her neck), PRURITUS (skin on her face itches), ERYTHEMA (The rectangle traveled over to a scar on her left arm from when she had skin melanoma removed in 2020/skin is red on her face and neck.), PYREXIA (moderate fever), VACCINATION SITE PAIN (sore left arm), CHILLS (chills) and VACCINATION SITE ERYTHEMA (The site reaction stayed and turned into a red rectangle.). At the time of the report, INJECTION SITE REACTION (injection site reaction), PARAESTHESIA (she can feel her skin tingling on both arms), SKIN BURNING SENSATION (she can feel her skin burning on both arms), SKIN EXFOLIATION (skin peel off her face/skin peel off her neck), PRURITUS (skin on her face itches), ERYTHEMA (The rectangle traveled over to a scar on her left arm from when she had skin melanoma removed in 2020/skin is red on her face and neck.), PYREXIA (moderate fever), VACCINATION SITE PAIN (sore left arm), CHILLS (chills) and VACCINATION SITE ERYTHEMA (The site reaction stayed and turned into a red rectangle.) outcome was unknown.            No concomitant products was provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2021-294376 (Patient Link).
Fainted after 10 minutes of the vaccine. Patient laid down until she felt better. The doctor took her blood pressure and it was WNL.
Red papules on right thigh noted 8 days after immunization.  Then developed fever 101.3, large, red, tender lump.  Treated with oral Keflex.  Patient was instructed to call or return if not improving in 1-2 days.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions) in a 41-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. The  concomitant medications on use were not provided. The vial was exposed at minimum temperature of 199.9 degree Celsius for 30 minutes. Storage condition at the time of the excursion was refrigerated storage. No treatment information was provided.
Patients vaccinated using old vial from 03/10/21; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-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 EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drugs were reported. No concomitant drugs were reported.   This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-207548, MOD-2021-258660 (Patient Link).; Reporter's Comments: This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-207548 (Patient Link).
Discharge Provider:  Primary Care Provider:  Admission Date: 7/5/2022 Discharge Date: Jul 12, 2022  PRESENTING PROBLEM: Weakness [R53.1] COVID-19 [U07.1] Acute encephalopathy [G93.40]   HOSPITAL COURSE: 94 y.o. male with known BPH, symptomatic bradycardia s/p pacemaker, CKD, HTN who presented on 07/05/2022 with acute encephalopathy from Assisted Living Facility.  At baseline patient is oriented to 4, still his own decision maker, hard of hearing.  COVID infection going around his facility, developed worsening weakness that started last week June 28. Patient tested positive at facility the day that patient was sent to emergency department.  There was a plan hospice meeting by family on 07/06 but facility unable to take care of patient hence sent here to Hospital. In ED, pt VSS. CXR showing atypical pneumonia. CBC showing mild leukocytosis. CMP showing stable renal dysfunction. Pt had right femur and pelvic x-ray unremarkable. CT head w/o contrast showing no acute process, old ischemic changes and possible NPH.    Patient was given a course of Remdesivir with liver and renal function monitored.  Patient had shown improvement of his metabolic encephalopathy after the 1st 48 hours of stay.  Was then was able to evaluate and patient started on soft diet.  Hospice meeting with health hospice and 2nd hospice occurred.  Patient met hospice criteria.  Planned to sign up for hospice with Hospice.  He was made comfort measures inpatient. Placement was arranged on 7/12/22.
The patient had blisters on her right arm, pain, stiffness, unable to move for 5 days without pain in the chest, shoulder and right arm. The patient was off work from 11/7 to 11/16 after seeing his reqular doctor.
Swollen lymph node Right axilla for 3 days to where I could not comfortably place my arm to side. Weeks after still have slight discomfort with same motion. Node is not as swollen as before.
Parent reported facial itching and swelling, unilateral eye swelling, and facial hives approx. 5 hours after vaccination. Parent gave benadryl, symptoms continued to worsen so parent took patient to urgent care. Urgent care gave prednisone in office and rx for 15 day prednisone taper and Epi-Pen. Facial swelling resolved in about 24 hours, hives resolved in about 5 days. Patient has made full recovery and no lasting effects have been observed or reported.
Arthralgia, UrticariaPruritus, fatigue, arm pain Narrative:  Other Relevant History:
My arm where I got the shot, I can barely lift it. I can't even hold a cup.; My body aches seems to be progressing. I've been in bed all day; I don't think I have a fever but it feels like mini chills.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (My arm where I got the shot, I can barely lift it. I can't even hold a cup.), MYALGIA (My body aches seems to be progressing. I've been in bed all day) and CHILLS (I don't think I have a fever but it feels like mini chills.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced HYPOKINESIA (My arm where I got the shot, I can barely lift it. I can't even hold a cup.), MYALGIA (My body aches seems to be progressing. I've been in bed all day) and CHILLS (I don't think I have a fever but it feels like mini chills.). At the time of the report, HYPOKINESIA (My arm where I got the shot, I can barely lift it. I can't even hold a cup.), MYALGIA (My body aches seems to be progressing. I've been in bed all day) and CHILLS (I don't think I have a fever but it feels like mini chills.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided
Patient given pneumovax vaccine on 10/20/2003.  (Merck Lot # 0287N).  The next day patient experienced pain, swelling, fever to 101.4.  Came to office today and has 8-10 cm area erythema, induration below injection site.
12 y/o male patient came to clinic to get his booster (Pfizer) . Pfizer 1st dose was administered on 8/18/2021, 2nd dose was administered on 9/8/2021 and pt. was scheduled to receive his booster Pfizer instead pt. received a Moderna vaccine (0.25ml)
8-year-old patient received ADACEL with no reported adverse event; Initial information was received on 15-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA251941(CLUSTER).  This case involves a 8 years old and unknown gender patient who  received diphtheria-2/tetanus/5 AC pertussis vaccine [ADACEL] with no reported adverse event.  The patient's past vaccination(s) included PENTACEL in 2015 with 3 doses, PENTACEL in 2017 with 1 dose (Dose 4) and ADACEL in 2017 with 1 dose. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot number, expiry date, strength: unknown) via intramuscular route in unknown administration site for Immunization. The information on the batch number will not be available.  On an unknown date, 8-year-old patient received adacel with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  Reportedly, She reports the patient has had 4 doses of PENTACEL, 3 doses in 2015 and a fourth dose in 2017, reports she has only had 4 doses of IPOL in the PENTACEL, and one dose of ADACEL in 2017 at 2 years old. Caller reports they have QUADRACEL and ADACEL in stock asking which would be appropriate to catch child up with diphtheria, tetanus, pertussis and polio.   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.
HIGH BLOOD SUGAR READING -- WENT UP OVER 300 POINTS FROM MORNING READING. HEART RATE WENT UP DRAMATICALLY (UP TO 110, NORMALLY RUNS AROUNG 70-75 AT THAT TIME OF DAY.)
The pt complained of a swollen arm, painful with chills the night of the vax. The chills went away when covered up. Put ice on arm. No meds.
Started off with a hive at injection site.  The next day pt. went to school.  I got a call from school saying he was itchy. When the nurse looked over him he had hives on different parts f his body.  He was in gym and we were thinking a surplus of histamines  during exercise made it flare from gym.   Pt was given Benadryl by the nurse. After he came home that night he was fine. The nurse thought I should call a HCF and report it to his doctor.  The person I spoke to at the HCF thought I should tell the health department. After talking to them they told me to report it online.
Patient had orange sized red area develop around injection site in left deltoid region.  Area was warm to the touch.  It began the day after she received the flu immunization (11/6/2019).  No fevers, or excess pain.  Area was warm to the touch.
Pretty bad arm pain immediately after shot.  Still continuing today 48 hours later.  Yesterday (24 hours after) felt generally bad, sore muscles.
Pain at injection site for 2 days; vivid dreams for 2 nights, fatigue and headache for 1 day
Will it hurt like when she gets the senior flu shot; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves elderly female patient who reported that it hurt when she gets the senior flu shot  influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation; strength; expiry date; lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date the patient was hurt like when she got the senior influenza vaccine shot  (vaccination site pain) (unknown latency).  It was reported, "Product safety warm transferred caller who was ordered DUPIXENT for Chronic Obstructive Pulmonary Disease and will take her loading dose today or tomorrow. She wants to know how long she needs to wait between the first and second injection of the loading dose? Consumer had questions about how to perform the injection and has watched the video. Wants to know if she can attempt it herself or should she go to the doctor's office? Will it hurt like when she gets the senior flu shot but doesn't know a name of the flu shot? Agency reviewed injection technique and informed her everyone is different about whether the injection hurts and she should contact her provider if she wants to go to the office for her first injection."   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.
A tinnitus started in my ears - a hissing or sound of static - constant and loud. Never experienced this before.
ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005236: US-009507513-2103USA005237: US-009507513-2103USA005238: US-009507513-2103USA005239: US-009507513-2103USA005240: US-009507513-2103USA005234: US-009507513-2103USA005233: US-009507513-2103USA005235:
hair breakage; excessive hair loss; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is a 1st of 3 reports. This female consumer (patient) reported that: A 71-year-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced hair breakage and excessive hair loss. It was reported that the patient states that a friend of hers also had the Pfizer Covid 19 vaccine and her friend, who is female, experienced the same issue with excessive hair loss and hair breakage. The clinical outcome of the events was unknown  The lot number for [BNT162B2], was not provided and will be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101599235 same reporter/drug/event, different pt;US-PFIZER INC-202101599236 same reporter/drug/event, different pt
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-APR-2016 the patient was vaccinated with an improperly stored dose of VAQTA 10PK 50U/1ml (lot # L017757, expiration date 08-APR-2018, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 368 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Feeling sick; Heavy chest; Fever; Feeling bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53-year-old female patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: ER8730) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary fibrosis", start date: 2019 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: chemo; "Lupus", start date: 2016 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: Medication; "chronic migraines", start date: 2010 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: Medication; "Fibromyalgia", start date: 2016 (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: Medication; "Chemo" (unspecified if ongoing), notes: Pertinent Details Include surgical procedures and dates: chemo. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "unknown", described as "Feeling bad"; MALAISE (non-serious) with onset 15Apr2021, outcome "unknown", described as "Feeling sick"; PYREXIA (non-serious) with onset Apr2021, outcome "unknown", described as "Fever"; CHEST DISCOMFORT (non-serious) with onset Apr2021, outcome "unknown", described as "Heavy chest". The events "feeling sick", "heavy chest", "fever" and "feeling bad" required physician office visit and emergency room visit.  Additional information: Started feeling bad over the next few days went to doctor after about 10 days not feeling good. Had COVID. Mid Jul till 09Sep2021 died 03:00 PM. No vaccinations were taken within four weeks prior to the first administration date of the suspect vaccine. Was a culture performed? Yes, COVID.
Severe redness around injection site, fever to 103 with myalgias.  Redness ended up involving the entire left upper arm.