chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a health professional concerning a 5 months old, female patient. The patient's concomitant medications, medical history and concurrent diseases were not reported. Patient had been receiving FLUMIST QUADRIVALENT (intranasal) started on 15-Sep-2014. On 15-Sep-2014, patient experienced administered FLUMIST QUADRIVALENT to a nursing mother. Action taken with FLUMIST QUADRIVALENT was unknown. The outcome of the event of administered FLUMIST QUADRIVALENT to a nursing mother was unknown. The reporter considered the event of administered FLUMIST QUADRIVALENT to a nursing mother to be non serious.
Experienced flushing and lightheadedness, required extended monitoring. Returned to work after 35 minutes of monitoring.
Approximately 5 hrs after receiving FLUVIRIN and PNEUMOVAX the patient had vomiting for 8 hours, fever for 24 hours, red blotchy rash on arm from injection site to elbow.
HEADACHE PERSISTING AND UNABLE  TO CONTINUE WITH REGULAR DAILY TASKS; TIREDNESS; This spontaneous report received from a consumer concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seizures, high blood pressure, and bad stomach. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 07-AUG-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-JUN-2021, the subject experienced headache persisting and unable to continue with regular daily tasks. On 14-JUN-2021, the subject experienced tiredness.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache persisting and unable to continue with regular daily tasks, and the outcome of tiredness was not reported. This report was non-serious.
w/in 24 hrs of receiving the flu vax pt exp sl swelling of the lt side of face & sensitivity on inside of mouth; also exp swelling of the gland in jaw & difficulty swallowing; sore throat & similar sx w/flu;
Patient was very high risk for anaphylaxis with history of medically-refractory idiopathic anaphylaxis (carcinoid syndrome not yet excluded) and history of frequent spontaneous or medication triggered  anaphylaxis to low risk drugs (local anesthetics, dupilumab) and higher risk drugs (omalizumab).  In observed setting, patient received full dose of Pfizer COVID19 vaccine, and developed facial/shawl distribution macular erythematous pruritic eruption wihtin 10 min, followed later with coughing without wheeze/hypoxia suspicious for bronchospasm. Epinephrine was provided IM, followed by albuterol nebs x 2 and cetirizine 10mg x 1. Vomiting started ~1.5hrs post ingestion, prompting another EPI and RRT transport to emergency room. Pt stabilized with no second phase reaction after second epinephrine.
2 to 3 minutes after vaccination patient had chills, sweaty feeling, and nausea. the symptoms resolved completely after 10 minutes per patient. She states she has had this feeling after other procedures so it may be nerves.
pt recv vax 3AUG96 & devel 8-9 lesions on stomach;8-9 lesions on back;scattered on extremities & face;afeb;
Tested positive for Covid 7 days after the 1st dose of the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid 7 days after the 1st dose of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid 7 days after the 1st dose of the Moderna vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid 7 days after the 1st dose of the Moderna vaccine) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
No adverse event. Vaccine given after beyond use date. Dad informed today 1-3-23.
This spontaneous report as received from a 78 year old female patient regarding herself. The patient had a history of shingles. The patient's pertinent medical history included type 2 diabetes mellitus. The patient had drug reaction or allergies to Penicillin (manufacturer unknown) and Mycins (manufacturer unknown). On an unknown date at an unspecified time in 2008 the patient was vaccinated with ZOSTAVAX refrigerated vial 19400 PFU (lot number and expiry date unknown) (dosing regimen and frequency unknown) injection subcutaneously. The concomitant medications included three unspecified medications for diabetes. On an unknown date approximately in 2008 (also reported as since the injection) the patient has had recurring outbreak of shingles. On an unknown date approximately in March 2016 (also reported as a month ago) the patient experienced her most recent shingles. There were no lab diagnostics studies performed. The patient was treated with an unspecified dose of lidocaine (manufacturer unknown). It was also reported that the therapy with ZOSTAVAX was continued. The outcome of herpes zoster was unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality complaint involved. Additional information has been requested.
I started to break out in little red bumps. One bump started to blister and it started to spread out on the right side of the body.
Itchy and warm painful reddened raised area developed slightly less than 48 hours after receiving  the dose of vaccine. Upper arm slightly swollen and warm reddened area was below injection sight.
Pt had anthrax #6 in left arm on 8/20/07. on 8/21 had pain in left arm and left axilla. Also c/o of headache and fatigue. States she had a similiar reaction with AVA 1-5. All sx resolved on 8/28/07
Information has been received from a pharmacist that heard about a child who on an unspecified date was vaccinated with a dose of MMR II. The pharmacist did not know who the patient was or what the reaction was but he thought the child might had had a hypersensitivity reaction. The reporter stated. "It was not a reaction such as autism. I believed the child had an immune response to the vaccine which showed he was allergic to it." It was unknown if the patient sought medical attention. The pharmacist had no other details because the parent who told him about it did not want to provide anymore information to him. At the time of this report, the patient's outcome was unknown. No further information is available.
Normal swelling, warm arm after the vaccines, a lot of itching in both arms; I still have the itching now on the area where I had the injection. I had issues with my gallbladder. Pain on and off for a few months, I had ultrasound, in January 31stthe gallbladder was removed.
pt recv vax 9OCT98 around noon & w/in 8hr flu sx developed;w/in 24hr devel full flu sx & has been ill for 9 days;
Severe Arm and rib pain. I still do not have full mobility in my arm over a month later. I also broke out in an underarm rash.
I stoped ovulating. I have been doing ovulation predictor kits for 5 years and actively participating in fertility treatments. In January I took a break from fertility treatment but continued to monitor my cycles.  I ovulated 4/19/21, received my vaccine 4/24/21 and that was the last time I ovulated.  I naturally produce 3-5 follicles each month.  I am not the only one with these results from the vaccine.  Please take this seriously.
Patient developed COVID 1 month after being fully vaccinated and admitted to hospital with COVID pneumonia symptoms.  Patient with multiple other co-morbidities cancer.
Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C\possible administration of invalid dose to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C\possible administration of invalid dose to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C\possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C\possible administration of invalid dose to patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data(between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided(057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  Treatment information was not reported.
no additional adverse effect reported; temperature excursion for GARDASIL 9; This spontaneous report as received from a Medical assistant refers to a 15 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.    On 28-JUL-2021, the patient was vaccinated with an incorrectly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1687291 expiration date 11-SEP-2022 , 0.5 milliliter (route unknown) for prophylaxis, which was stored at a temperature of 80.6 °F for 14 hours and 51 minutes. Previous temperature excursion was reported as 73.2°F for 9 hours and 25 minutes and 73.4°F for 8 hours and 48 minutes. No additional adverse effect reported. The call was registered due to a data logger.    This is one of several reports received from the same reporter. 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: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA008709: US-009507513-2107USA008566: US-009507513-2107USA008701:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.A 64-year-old male patient received bnt162b2 (COMIRNATY), administration date 23Mar2021 (Lot number: ER8727) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EN6202), administration date: 04Mar2021, when the patient was 63 years old, for Covid-19 immunization, reaction(s): "No side effects".The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious) with onset 2021, outcome "unknown", described as "I got the 3rd vaccine because of the COPD". Additional information: The patient reported that he had no problem with it, he was still great, he felt great with no side effects at all. The patient took both shots and the booster. The patient got the third vaccine because of the COPD. And it was like disease. Date of administration of third dose: 20Oct2021 (lot EW0185). NDC number, UPC number and expiry date were reported as unknown. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 27-JUN-2016, the patient was vaccinated with an expired dose of M-M-R II lot # K002527, expiry date: 18-FEB-2016. No adverse events were reported. No information was provided. There was no product quality complaint (PQC) involved. Additional information is not expected as the reporter did not want to be contacted.
No adverse event occurred- full dose given of Moderna vaccine instead of the 1/2 dose recommended. Pt received one prior dose of Janssen vaccine on 8/26/21. No symptoms/signs or treatment indicated.
11/18 threw up 1 time 11/18-11/30 off and on tummy ache and headaches  11/30 threw up 1 time, headache, tummy ache, low grade fever 99.7
This report was received from a health care professional on 16 April 2009, and refers to a serious adverse event experienced by a subject participating in a study. A previously healthy 18-year-old male subject received study product FLUZONE SV 2008-2009 (lot not reported) on 03 November 2008. On 01 December 2008, 28 days post-vaccination, he presented to the emergency room with right lower quadrant pain and nausea. A CT of the abdomen revealed a normal proximal appendix; the distal portion of the appendix could not be visualized. A focal region of the peritoneal fat stranding and free fluid, noted to be secondary signs of appendicitis, were observed. The subject underwent an appendectomy, and histopathology diagnosis was follicular lymphoid hyperplasia of the appendix and omental infarct with fat necrosis. He was discharged from the hospital on 02 December 2008, and prescribed VICODIN as needed for pain. Outcome was not reported. According to study investigator, the event was unrelated to FLUZONE.
No adverse event; 15 months old patient received a 0.2ml dose from a vial with a Dark Pink Cap and a Label with a Yellow Box as a second dose -instead of 0.25ml dose of the correct vial; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (15 months old patient received a 0.2ml dose from a vial with a Dark Pink Cap and a Label with a Yellow Box as a second dose -instead of 0.25ml dose of the correct vial) and NO ADVERSE EVENT (No adverse event) in a 15-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214k22a) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID19 vaccine (AS1417B First dose) on 04-Apr-2023. Past adverse reactions to the above products included No adverse event with Moderna COVID19 vaccine.    On 08-Aug-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 08-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (15 months old patient received a 0.2ml dose from a vial with a Dark Pink Cap and a Label with a Yellow Box as a second dose -instead of 0.25ml dose of the correct vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (15 months old patient received a 0.2ml dose from a vial with a Dark Pink Cap and a Label with a Yellow Box as a second dose -instead of 0.25ml dose of the correct vial) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (15 months old patient received a 0.2ml dose from a vial with a Dark Pink Cap and a Label with a Yellow Box as a second dose -instead of 0.25ml dose of the correct vial).    No concomitant medication was reported.  No PQC was reported. No treatment information was reported.
First reaction swollen nodes right after 1 shot in 1998. After 2nd shot, same reaction. Same after 3rd shot-pt still having some symptoms. Pt saw doctor 2/25/2002
Hard, swollen (about 5" diameter-slightly raised and firm) spot at injection site of PREVNAR-13 inj.-area red and warm started 3 days after inj. began to resolve 4-5 days later also large bruising area about 4" x 5" and below by 4" of FLUVIRIN injection on opposite arm-may or may not be from flu shot.
Information has been received from a licensed practical nurse (L.P.N.), for the pregnancy registry for GARDASIL concerning a 21 year old female with a history of anemia, Crohn's disease and abnormal Papanicolaou smears who on 28-JUN-2007 was vaccinated intramuscularly with her first dose of GARDASIL. Concomitant therapy included ORTHO-NOVUM. On 22-AUG-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL. On 12-DEC-2007 the patient was vaccinated intramuscularly with her third dose of GARDASIL. On 17-DEC-2007 the patient found out she was pregnant with a positive home pregnancy test the patient's LMP was 10-NOV-2007 (also reported as 06-NOV-2007) (due date = 13-AUG-2007). The patient was seen on 03-JAN-2008 for her first prenatal visit and an ultrasound was preformed; results showed a viable pregnancy. The patient was placed on daily prenatal vitamins. The patient has not experienced any difficulties with the pregnancy at this time. Follow-up information was received on 02-SEP-2008 from a L.P.N. indicating that on 01-JUL-2008 the patient delivered a normal female baby weighing 5 pounds, 1.1 ounces. There was no congenital abnormalities. There was no infections or illness during pregnancy. There was no complication during delivery. Other medications used during pregnancy included Celestone and Procardia. Additional information is not expected.
This was the Moderna booster shot. The next morning I experienced severe fatigue, muscle ache, headache and my teeth hurt. Over the next few days , most symptoms abated, but I continued to have teeth and face pain. I practice good dental hygiene and despite pain, I became extra careful. On 12/10, I decided I needed to see a dentist and made an appointment for 12/14, the first one available. At that point I was diagnosed with infection and in need of a root canal. After a course of antibiotics, that was done on 12/18.
Stinging on his left arm; Itching; Redness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JUN-2023, the patient received the 1st dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Stinging on his left arm), pruritus (Verbatim: Itching) and erythema (Verbatim: Redness). The outcome of the pain in arm, pruritus and erythema were not resolved.   It was unknown if the reporter considered the pain in arm, pruritus and erythema to be related to Shingrix.     It was unknown if the company considered the pain in arm, pruritus and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter was the patient's wife.  She stated that the patient received a dose of Shingrix on Saturday. The patient experienced redness, itching, and stinging on his left arm, which had not resolved. This case has been linked to the case US2023079166 reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023079166:
no additional information; VAQTA was administered 4 days after its expiration date; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 08-JUN-2021, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (expiration date 04-JUN-2021; strength, dose, route of administration, anatomical location and lot# were not reported) for prophylaxis, which was administered 4 days after its expiration date (expired product administered). No product quality complaint (PQC) was involved. No additional information (no adverse event).
Site was red, swollen, warm, started day of vaccine, still there but now going away. Just let us know.
p/receiving vax pt became pale, weak, fell to floor, no twitching or loss of body functions; grandma reported that pt had a sz;nurse states pt never loss consciousness and did not have any twitching or tremors.
feeling ill; high blood pressure; high temperature; chills; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling ill), HYPERTENSION (high blood pressure), PYREXIA (high temperature), CHILLS (chills) and MYALGIA (body aches) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included COLECALCIFEROL (VITAMIN D 3) and POTASSIUM for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced MALAISE (feeling ill), HYPERTENSION (high blood pressure), PYREXIA (high temperature), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea). At the time of the report, MALAISE (feeling ill), HYPERTENSION (high blood pressure), PYREXIA (high temperature), CHILLS (chills), MYALGIA (body aches) and NAUSEA (nausea) outcome was unknown. Not Provided          Concomitant medications included Blood pressure medications and Cholesterol medications(names were not specified). Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   This case was linked to MOD-2021-020516 (Patient Link).
Resident was being monitored and when asked if needed to go after 15 minutes she complained  that she felt funny and chest and throat . BP 199/97  P 81 , sat 97% 245pm  case stated she was having some difficulty swallowing. Benadryl 25mg, per RN  B/P 180/100, P72, STAT 97% . AAA called per agreement per case, RN  BP194/100 , P 77 sat97% 255pm recheck b/p175/83, p 77, sats 97 R 20. case stated " at this time swallowing was a bit better."