chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient has not had any symptoms/ No additional AE/no PQC; a patient received an expired dose of RECOMBIVAX HB; This spontaneous report was received from a medical assistant referring to a 42 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml for prophylaxis (strength, route of administration, lot number and expiration date were not reported).   On 01-AUG-2023, the patient was vaccinated with the second dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (lot# U019139, expiration date reported as 30-JUN-2023, but upon internal validation established as 11-JUN-2023; strength, dose and route of administration were not reported) in left deltoid (LD) at private doctor's office/hospital (expired product administered). The patient had no side effects at the reporting time, and she was feeling okay.
Redness and pain at injection site X 7 days and also crying for extended periods of time X 7 days.
Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
injection site pain, headache, daytime sleepiness, sleep excessive, sore throat, swallowing difficult (because of throat pain), difficulty talking because of pain, lethargy, nasal stuffiness, nasal drip, swollen cervical glands, cough lasted 5 days, left cheek swelling
24 hrs post vaccination, pt noted redness, swelling 300 mm x 300 mm. Area hot to touch. Itching. Continued to be present w/o change for 24 hrs, then gradually subsided over 3 days. Took Benadryl & symptoms completely resolved by day 5.
Severe, debilitating muscle pain over whole body beginning AM 2/11/21-AM 2/12/21. Moderate-severe muscle pain of back continued through 2/12 and became mild 2/13 AM until resolution felt 2/14.  Fever ~101 F Afternoon 2/11-Early morning 2/12. Extreme thirst for only cold fluids afternoon 2/11-mid-morning 2/12. Severe fatigue 2/11 AM to 2/13 AM with dreams unable to awake from.
Cousin died from cancer today. Diagnosed with cancer. 6th person I know who has died from cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEOPLASM MALIGNANT (Cousin died from cancer today. Diagnosed with cancer. 6th person I know who has died from cancer) in an adult 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. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cousin died from cancer today. Diagnosed with cancer. 6th person I know who has died from cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication was not reported.  The treatment medication was not reported.  Company Comment  This fatal spontaneous case concerns an adult patient with no medical history  reported who experienced the unexpected seriousness criteria death and medically significant event of neoplasm malignant unknown days after a dose of mRNA-1273 bivalent vaccine. Concomitant medication nor treatment medication were reported Death occurred on unknown day. The cause of death was not reported.  It is unknown if an autopsy was performed  The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2023-715634 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715634:Other Patient Case; Reported Cause(s) of Death: Cancer
Hospitalization for COVID19, AFIB, hypoxia. Treated with dexamethasone 6 mg IV daily and Remdesivir.
Child was given the bivalent COVID-19 booster for 12 and older, should have received the 5-11 dose.
a potential false blood pressure readings/The readings were over 200/140/took it on his wrist and measured at 215/147; the pain at the location of the lower arm got near tremble; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included blood pressure abnormal, blood cholesterol abnormal, deafness. The patient's concomitant medications included unspecified products received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 06Apr2021 01:15 PM at arm left for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, he has not been tested for COVID-19. The patient reported a potential false blood pressure readings on 29Apr2021, a day after administered 2nd dose. The readings were over 200/140 and he took it at home using a blood pressure reading device. He took it on his wrist and measured at 215/147. In his recent doctors visit prior to administer the 2nd dose, the accurate readings was 183/136 (estimated). With the false blood pressure readings, the pain at the location of the lower arm got near tremble due to the fact of the false readings has been taken. The events outcome was unknown.  Information on the Lot/Batch number has been requested.
Crying, pain to right arm and headache on 9/1/16, couldn't get out of bed throughout the night, wet the bed, felt pressure in head and eyes; had dizziness, and blurry vision was taken to school but couldn't get out of the car because of pain and weakness. Patient was taken to hospital ER, had lab work done and labs came back within normal limits (CBC, UA, CMP) Grandmother was told by ER physician that patient could be having possible reaction to HPV vaccine.
Localized rash along forearm within 30 mins of given vaccine. Told to monitor.
No adverse reaction; Improperly stored Proquad; This spontaneous report was received from a registered nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent (DILUENT MRK INJ).  On 11-APR-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, 0.5 ml (lot # R015739, expiry date: 02-DEC-2019) subcutaneously for prophylaxis. It was not known how the sterile diluent (DILUENT MRK INJ) (lot # and expiry date were not reported) used to reconstitute the administered vaccines was stored. The vaccine was stored in maximum temperature of -10.3 degree Celsius (C) for 16 hours 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001299: US-009507513-1905USA001301: US-009507513-1905USA001304: US-009507513-1905USA001305: US-009507513-1905USA001306:
Increased resting heart rate.  He wears a fitness tracker and resting heart rate increased to 104-105 BPM.  When he went on a walk increased to 160-170 bpm.  Lasted 2 days from onset (approx 24 hours after injection)
9 hours after receiving Hep.B vaccine developed severe hives on her extremities. Feet, Face Hands and neck became severly swollen. Fever 101.9. Diff. breathing.  Lasted 3 days. ER visit x2. Information received from medical records states difficulty breathing, dizzy, headache, neck pain and fatigue. msv Medical record states facial edema. msv
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. Nurse reports that patient received first dose of GARDASIL (strength, lot#, dose/frequency, route and duration were unspecified) on 30-JUN-2012 and would received 2nd dose (strength, lot#, dose/frequency, route and duration were unspecified) today (02-MAY-2013). No adverse effect reported. At time of reporting, action taken, outcome and causality were not provided. Additional information has been requested.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 29-JAN-2018, 02-APR-2018 and 04-JUN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively (Incorrect product storage). The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
swollen occipital lymph node on left side; swollen, painful, occipital lymph node on left side; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL-9269 and expiration date: not available), via an unspecified route of administration in the left arm on 08Feb2021 at 11:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included Diabetes Type II and chronic Depression. The patient had no known allergies. The patient had no other vaccine in four weeks. It was reported that patient took concomitant medications in two weeks. On 09Feb2021 at 02:00 the patient experienced swollen, painful, occipital lymph node on left side. The patient not had covid prior vaccination; not tested covid post vaccination. The patient did not receive any treatment for the events. The outcome of the events was unknown.
Left arm next to where vaccine was given, red rash about the size of your palm. Feels warm to touch and slightly swollen. Rash is not on surface of skin, but skin looks red and swollen. I called my primary care and was told to put hydrocortisone cream and cold compress. I am due to get the second dose on 2/22/21 and am a little concerned.
patient came in for moderna bivalent but was given moderna pediatric monovalent. no adverse reaction
Information has been received from a physician concerning a 74 year old female  with asthma who on 17-NOV-2007 received a subcutaneous dose in her arm of ZOSTAVAX. Concomitant therapy included ADVAIR and montelukast sodium (MSD), the patient developed an injection reaction reported as swelling and an erythema at the injection site with a fever in the evening of 17-NOV-2007. The swelling was described as around four inches in diameter with the erythema around two inches in diameter both at the injection site. It was reported that she had a fever of 100.2 degrees Fahrenheit through 18-NOV-2007. As of 19-NOV-2007. As of 19-NOV-2007, it was reported that the swelling and erythema was unchanged. Further information was not available. Additional information has been requested.
Patient had Shingrix in left deltoid and TDap in right deltoid on 7/26/20. Patient started to experience that day headache, fever above 100 degrees, chills, body aches, cough. These symptoms remained for 24 hours. Then symptoms became less severe. On 7/28/20, patient had nausea, body aches, and upset stomach. On 7/29/20, hives, body aches, cough, and itching all over became sypmtoms. Patient is seeing PCP today.
In June of 2021 pain, stiffness, and muscle wasting on my left upper body resulted in a doctor visit. I underwent MRI and was diagnosed with mild to severe spinal stenosis and disc degeneration in my cervical spine.  The following year I was diagnosed  with hypothyroidism and Hashimoto?s.  Please note that I do not suspect that the vaccine caused these conditions. When I reported these conditions on the VSafe survey, I was encouraged to report this information on VAERS.
Patient describes patchy rash on legs, back, and trunk.  She applied hydrocortisone and took Benadryl orally.  She also received a Medrol dosepak from physician. Patient picked up Medrol dosepak today 5-28-20.
No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter. .  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-622823 (Patient Link).
Low grade fever, general body pain, chills.  Began overnight, went away by 3pm on the 9th
COVID-19 symptoms started on 05/15/22; tested positive on 05/16/22. Symptoms were body aches, headache, flu-like symptoms, runny nose, and congestion. I took vitamin c, d, zinc, and Paxlovid. Symptoms lasted for 2 weeks.
Fever; aches; severe arm pain; skipped menstrual cycle completely; chills; This is a spontaneous report from a contactable consumer (Patient). A 30-years-old not pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, in arm right, on 15Feb2021 at 11:30 AM (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Patient past medical history included Asthma, depression, anxiety. Patient concomitant medications were not reported. The patient had experienced fever, chills, aches, severe arm pain, skipped menstrual cycle completely on 16Feb2021, 03:00 AM. Outcome of the events were recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Rash over body from groin all the way up including arms, itching; started 48 hours post shot; also for 30 min. has chest burning and heart palpitation. Second tome this happened, first was w/steroid injection of knee. Also occurred after 48 hours; pt took ZYRTEC (pt allergic to BENADRYL).
Case number PHEH2014US004885, is a combined initial and follow up spontaneous report from a physician received on 07 Mar 2014 and 10 Mar 2014 respectively. This report refers to a 57-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1310201) intramuscularly on 18 Nov 2013. On 19 Nov 2013, she woke up in the morning with pain in joints, body aches, stiffness, light-headed and unable to walk up and down the stairs. However she had no fever. The symptoms continued for six weeks. Approximately six weeks after vaccination with FLUVIRIN, she developed sciatica, night-time urgency with a frequency of up to seven times per night and urinary incontinence. She consulted a physician three weeks ago. The final outcome of the event sciatica was condition unchanged; urinary incontinence was condition improving and urination was occurring only during the night; pain in joint was complete recovery and outcome of the rest of the events was unknown. The seriousness and causality of the events were not reported.
Patient called on 6/6/05 to report symptoms which started 6/3/05. States she had achiness, fatigue, and labored breathing which have resolved. Had fever which peaked at 100.9 and is now afebrile. Reports bumpy rash on back, face, scalp, and ears which is fading and a swollen pre-auricular node on left. No swelling, erythema, heat or pain at injection site.
Chills and hot flashes; extreme achiness. Enflamed lymph node above left collar bone, noticed day after vaccine. Continued to grow in size for a week, still present after 5 weeks, but does seem to be decreasing in size.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. The patient had no known allergy. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM). No concomitant product reported by reporter. It was unknown if patient had the ever been diagnosed with Covid-19. It was unknown if patient had acute illness at the time of vaccination as well as unknown for chronic health conditions. It was unknown if patient experienced similar adverse event in the past. Vaccine did not undergone any temperature excursion issue. Vaccine was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM. Dose administered after 30 day Use By Date or after manufacturer date of expiry. No treatment medication reported by reporter.
The pt experienced a chicken pox like rash at the site of the varicella vaccination. Reassurance given at the office visit.
pain & numbness shooting pain down arm & elbow joint;swelling & tenderness under lt arm (axilla) & upper arm;As of 22NOV all resolved;
Patient had a vasovagal response, low BP, Pulse, diaphoretic. 911 called by monitoring nurse but patient refused transport, all vitals were fine and symptoms resolved within 30mins of onset of symptoms.
A spontaneous report has been received from a physician via Pfizer concerning a female patient. Physician reported that the patient experienced anaphylaxis after injections of varicella vaccine and nasal FLUMIST (intranasal) and had to be put in an ambulance. The patient later went to an allergist and was determined to be allergic to gelatin. The physician stated on of the vaccines, patient could not remember if it was varicella or FLUMIST, contained gelatin. The patient recovered from anaphylaxis on an unspecified date and the outcome of allergic to gelatin was unknown. The company physician considered anaphylaxis to be serious due to important medical event and allergic to gelatin was identified and captured by company physician as non-serious.
A nurse reported the occurrence of shingles in a 28 y.o. male who was vaccinated with Hep B vaccine recombinant (Engerix-B). Medical history, concurrent medical conditions, and concomitant medications were not specified. On 8/19/02, the subject received the first injection of Hep B vaccine recombinant in the left arm. One day later, on 8/20/02, the subject developed shingles. The subject was seen by a physician and treated with famciclovir (Famvir) for two weeks at his doctor's office. The subject is reportedly feeling much better after treatment. As of 9/19/02, the shingles reportedly persisted, however have improved. Follow up on 01/16/02: "The pt received the second and third injections of Engerix-B on an unspecified date and on 06/26/03, respectively, without adverse event."
The pt was given immunizations at approximately 10am. She was seen in the ED at approximately 8pm with a febrile seizure. Blood and urine cultures were obtained. She was given IM Rocephin and followed up in the office on 3/26/03.