chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath; Nausea; Fever; Headache; Swollen at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE SWELLING (Swollen at the site of injection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE SWELLING (Swollen at the site of injection). At the time of the report, DYSPNOEA (Shortness of breath), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE SWELLING (Swollen at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the event included Tylenol. No relevant Concomitant medications were reported.
they had a patient who was accidentally administered with ACTHIB and VAXELIS at the same with no reported adverse event; Initial information was received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 6 months old male patient who was accidentally administered with hib (prp/t) vaccine [ACT-HIB] and vaxelis at the same with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (Rotateq) for Prophylactic vaccination.  On 31-Jul-2023, the patient received a dose 1 of 0.5 ml of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (lot U7374BA, strength and expiry date unknown) via intramuscular route in right vastus lateralis for Immunization and they had a patient who was accidentally administered with acthib and vaxelis at the same with no reported adverse event (contraindicated product administered) (latency : same day).   It is unknown if there were lab data/results available.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event they had a patient who was accidentally administered with acthib and vaxelis at the same with no reported adverse 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.
Patient received vaccination during the day on 8/15/17 and reported that night a rash and swelling began. Patient presented with approximately 4 inch in diameter rash that was red, raised and she reported to be warm, and hard.  Patient reported the rash had been spreading over the previous 24 hours.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. Information on their concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with improperly stored dose of VARIVAX lot # K003409, expiry date 13-MAY-2017 (dose number, dose units, route and anatomical location were not reported). Concomitant medications were not reported. There was no Product Quality Complaint (PQC) involved. This case is linked to MARRS# 1607USA001599 (same reporter link). Additional information has been requested.
First Moderna vaccine dose was in Rigth Deltoid from lot # 047A21A
NUMBING SENSATION; WHOLE ARM FEELS WEIRD; TOP OF THE HAND HURTS; SORE ARM; INJECTION SITE PAIN; FEVER; CHILLS; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced sore arm. On 15-APR-2021, the subject experienced injection site pain. On 23-APR-2021, the subject experienced numbing sensation. On 23-APR-2021, the subject experienced whole arm feels weird. On 23-APR-2021, the subject experienced top of the hand hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 04-APR-2021, and had not recovered from sore arm, injection site pain, top of the hand hurts, numbing sensation, and whole arm feels weird. This report was non-serious.
Catheter placement; Gout; Lymphedema; Pain in arm; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4189167-00.  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single and intramuscular, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1141056) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CATHETER PLACEMENT (medically significant), outcome "recovering", described as "Catheter placement"; GOUT (non-serious), outcome "unknown", described as "Gout"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain in arm"; LYMPHOEDEMA (non-serious), outcome "unknown", described as "Lymphedema". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) high. The action taken for upadacitinib was unknown. It was reported that, solicited report by a consumer of a 73-year-old female with events of catheter placement and non-serious gout, pain in arm, lymphedema with RINVOQ (UPADACITINIB). There was no reported medical history. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. Stated that, the patient was going to a follow up heart physician for her catheter. The physician found that, the swelling in her leg and feet were due to the Gout and or Lymphedema. Stated that, she would know for sure until she went back to the physician for the follow up next. Stated that, she only had pain in arm with all Covid-19 vaccines. It was unknown whether the patient was enrolled in a COVID-19 Vaccine trial.  Causality for RINVOQ (UPADACITINIB) The reporter's causality for the event(s) of catheter placement was not reported. The reporter's causality for the event(s) of gout, pain in arm and lymphedema with RINVOQ (UPADACITINIB) was no reasonable possibility. Authority's opinion was that there was no reasonable possibility that, the events of catheter placement, gout, pain in arm are related to RINVOQ (UPADACITINIB). Authority's opinion was that the event of lymphedema was not assessable.   Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) The reporter's causality as per reporter for the events catheter placement, gout, lymphedema was not related and for the event pain in arm was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The event of pain in arm is related to the suspect product BNT162B2 based on plausible temporal relationship. The events of catheter placement, gout and lymphoedema are unrelated to the suspect product BNT162B2 since these events are associated with chronic medical conditions with long latency period.
Information has been received from a registered nurse concerning a 10 year old male who on 15-JUL-2008 was inadvertently vaccinated with a dose of ZOSTAVAX (Oka/Merck) (LOT# 657675/0618U) instead of VARIVAX (Oka/Merck). No adverse effects were reported. This was a human error. The responsible vaccination nurse was new. Both ZOSTAVAX (Oka/Merck) and VARIVAX (Oka/Merck) were stored in the same freezer next to each other and the nurse picked the wrong vial. The registered nurse did not have any suggestions. The patient's outcome was unknown. The patient did not seek medical attention. The registered nurse also reported the same events for patient's sibling (refer to WAE# 0807USA05679). Additional information is not expected.
Breaks out in "pox" after 2 months on trunk, neck and hips, since Varicella vaccine. Hurt to touch. No fever or itching. But it seems to return.
Patient with history of CKD stage 3 and diabetes. He was seen in the ED on 12/10/22, and reported symptom onset on 12/1/22 with muscle aches, fatigue, cough, and nausea. He took a home COVID-19 test the day prior (12/9) which was positive. A COVID PCR test was also done in the ED which resulted positive. Ultimately he was admitted to the hospital 12/10/22 - 12/11/22 for generalized malaise secondary to COVID. Patient has received the primary COVID vaccine series and one booster.
fever 104.2, sz x3 >1st 24hr;body rash >4 days;
Approximately 2PM my voice became hoarse and my lips started tingling and swelling. (I was driving home from the city to hospital at the time) Upon arriving home I phoned my doctor's office and talked to her nurse who advised me to go to Hospital. There I was given Benedryl and Prednosone (sp?) and waited for my symptoms pass. When they did, I was free to go home. The next day I felt icky and spent the day eating dry crackers and drinking 7-up. Three days later, I noticed that the site of the shot had become hard, red, hot and itchy. For the next five days I put some Triamcinolone Acetonide on the area which is only a pale pink as of this date.
pt recvd vax approx 8PM APAP given 830PM; 11PM irritable, crying, fever 100.0; irritable & fussy w/any movement during the noc; unable to walk next AM; rt leg very sore; refused to walk all day; t102 w/APAP given q 4 hrs;
We gave 1 shot of Moderna 3rd dose to a 16 year old. Moderna is only approved for 18 and above.
Patient's face is red and warm, actually looks like Shingles. She said is a little painful and itchy too.
Patient received an expired dose / Child received expired Menveo; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date 31st March 2022) for prophylaxis.   On 6th June 2022, the patient received Menveo. On 6th June 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-Jun-2022 Reporter's Comments: The reporter stated that the patient received Menveo that was expired. The reporter had nothing else to report. The reporter consented to follow up.  Additional Supportive Information: The patient received Menveo that was expired, which led to Expired vaccine administered.
About 10 hours after her immunizations, patient experienced cold sweats, vomiting, felt like an "elephant was sitting on her chest" so went to the hospital because she thought she was having a heart attack.  Hospital could not find any proof of a heart attack.  The next day the patient noticed warmth, redness, and inflammation at the injection sites which seemed to spread, mostly horizontally.  Patient went to urgent care and was given steroids for the reaction.
improperly stored PEDVAX HIB, GARDASIL, GARDASIL 9 and MMR II; No additional AE/PQCS reported.; This spontaneous non-valid report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of: - haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T000883, expiration date 28-MAY-2022 (dose and route of administration were not reported), administered doses of vaccines experienced the temperature excursion of below 36 (35.2) degrees Fahrenheit for 14 minutes; - quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (lot number, expiration date, dose and route of administration were not reported), administered doses of vaccines experienced the temperature excursion of below 36 (35.2) degrees Fahrenheit for 14 minutes; - hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # 1637648, expiration date 19-JUN-2022 (dose and route of administration were not reported), administered doses of vaccines experienced the temperature excursion of below 36 (35.2) degrees Fahrenheit for 14 minutes; - measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # S015428, expiration date 20-MAY-2021, albumin status recombinant Human albumin (rHA) (dose and route of administration were not reported), administered doses of vaccines experienced the temperature excursion of minus 58 and plus 46 (35.2) degrees Fahrenheit for 14 minutes. There was no adverse effect reported. Data logger was involved. There were no previous excursions reported. This case is non-valid due to non of patients' identifier provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637648; expirationdate: 19-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Diffuse redness covering entire upper arm with warmth, axillary gland swelling, localized pain. With fever upon medical examination on 5/22/17 - antibiotics administereed.
After I came home from my appointment at the clinic, my left arm started to hurt a little. Then got progressively worst so around 4:00 PM I laid down on my bed in pain. I couldn't lift my arm it hurt so bad, the pain was going across my chest. So around 7:00 PM my husband took me to the emergency room.
She throw up. It triggered another period. She bled so much she ended up in the hospital and needed two blood transfusion.
Went to bed at approximately 12:00 am, extremely cold.  Work up every 2 hours with dry mouth (needing to drink 60 oz of water, and sore muscles throughout my entire body.  At 7 am work with a severe headache and felt is I was running a fever, which I was not.  At 11 am all was fine.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 31-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R002051, expiration date: 22-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with sterile diluent (MERK STERILE DILUENT) (lot# and expiration date not reported) properly stored. The administered dose of the VARIVAX experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA002034: US-009507513-1809USA002035: US-009507513-1809USA002033: US-009507513-1809USA002037: US-009507513-1809USA001866: US-009507513-1809USA002032: US-009507513-1809USA002031:
Lump/swelling in back of the throat; muscle pain/discomfort; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included (IBS) irritable bowel syndrome, sleep apnea, fatty liver and known allergy to melons. Concomitant medications included fluticasone propionate (FLONASE) for an unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH6207), via an unspecified route of administration in the left arm on an unknown date of Mar2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 10:15, the patient experienced lump/swelling in the back of the throat, muscle pain/discomfort, and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events lump/swelling in the back of the throat, muscle pain/discomfort, and tiredness were recovered on 07Apr2021.  No follow-up attempts are needed. No further information is expected.
Initial report was received on 08 February 2012 from an electronic lay press article. It represents a cluster of two confirmed cases of pertussis following vaccination with a pertussis vaccine (manufacturer not reported). The second patient is captured in case number 2012-01547. A child in elementary school (age and gender not reported) received an injection of pertussis vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, developed pertussis. The patient was reported as being immunized. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Significant injury to the deltoid muscle and nerves.; still in pain; Significant injury to the deltoid muscle and nerves.; Initial information received on 27-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp found on a public social media platform.  This case involves an unknown age and unknown gender patient who experienced significant injury to the deltoid muscle and nerves and was still in pain while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer (lot number, frequency and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious "significant injury to the deltoid muscle and nerves" (muscle injury) (Nerve injury) (unknown latency) following the administration of INFLUENZA VACCINE (QUADRIVALENT).  On an unknown date the patient developed a non-serious "still in pain" (pain) (unknown latency) following the administration of INFLUENZA VACCINE (QUADRIVALENT).  It was reported " It can cause significant injury to the deltoid muscle and nerves. I know. 7 weeks later and still in pain!"  Action taken with QUADRIVALENT INFLUENZA VACCINE (INFLUENZA VACCINE (QUADRIVALENT)) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Significant injury to the deltoid muscle and nerves., still in pain).  At time of reporting, the outcome was Unknown for the event significant injury to the deltoid muscle and nerves and was Unknown for the event still in pain.
throat closing up; chest tightness; Her voice was very hoarse, almost a whisper; difficulty breathing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of THROAT TIGHTNESS (throat closing up), CHEST DISCOMFORT (chest tightness), DYSPHONIA (Her voice was very hoarse, almost a whisper) and DYSPNOEA (difficulty breathing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT TIGHTNESS (throat closing up), CHEST DISCOMFORT (chest tightness), DYSPHONIA (Her voice was very hoarse, almost a whisper) and DYSPNOEA (difficulty breathing). The patient was treated with EPINEPHRINE (EPIPEN) (intramuscular) at a dose of 0.3 UNK. At the time of the report, THROAT TIGHTNESS (throat closing up), CHEST DISCOMFORT (chest tightness), DYSPHONIA (Her voice was very hoarse, almost a whisper) and DYSPNOEA (difficulty breathing) 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 concomitant medications reported by investigator   Patient also reported history of allergic reactions and use of epinephrine pen of 0.3mg IM administered at approximately 1:20pm in right anterior within 1 min of Epinephrine administration. Visibly calmer. Respirations less labored and rate appeared within normal limits.   This case was linked to MOD-2021-073487 (Patient Link).
11AM-O2 sats @74%, HR 204, temp 97.7, moaning, upper extremities cold. Tylenol given for pain. 1:10PM-nasal flaring, O2 sats @ 74%, HR 82, temp 99.9, RR 42. EMS called and subsequent code blue. Chest compressions and ambu-bagged, epinephrine given. Transferred to hospital. Pronounced dead at hospital.