chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient approached flu shot table event and asked for flu vaccine for over 65yo, patient said she had not received the flu vaccine yet this season.  The tabling event ran from 10 am to 130pm and forms were processed after that.  Upon checking Shots, patient received the HD flu vaccine at pharmacy on Aug 2023.  Patient was contacted and has no adverse events
I had the many of the symptoms I experienced when sick with COVID. I was nauseous and had extreme fatigue but did not develop a cough.
Chills, joint pain, chest pain, shortness of breath, low grade fever, nausea, vomiting, headache. Recovered from COVID in 8/2020.
Muscle aches , joint inflammation, sporadic intestinal tightness, and finally and flu blown case of the flu - this happened up and including the date of report 11/19/2016.
Headache, Myalgia, Fatigue, Injection site soreness, Neck pain, Mass at injection site
One week following the vaccine: muscle aches and chills, fever to 101.3. The following morning no symptoms and no fever
Hives; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives) in a 30-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) (unknown route) 1 dosage form. On 29-Jun-2023, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) was resolving.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  It was unknown if the patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient was administered vaccination and receive side effect of hives after taking the Menactra Vaccination. Only reported allergy was the side affect after vaccination administer.    Treatment Medication use information was not provided by reporter.
Developed large swelling around injection site right after vaccination, but this went away 3-4 days post injection.  On 01/23/2021 in the later afternoon (12 days after the vaccination), noticed small reddened area around the injection site. This spread throughout the evening and became raised and warm to touch.  By morning of 01/23/2021 the reddened area was approximately 3 X 4 inches. Went to Urgent Care and was diagnosed with cellulitis starting at injection site.  Was started on cephalexin 500 mg four times a day for 5 days.
Just below site of injection arm was red, swollen, firm, warm to touch, painful. low grade fever. But 48 hours arm was still spreading redness at fast rate.  4 inches in diameter. Dx with Celulitis and told given antibiotics.Told to follow up in 2 days.Pictures taken by reporter.
Hospice patient, started with dysphagia. POC of the home refers death by asphyxiation
pt recv vax 2JUN95 & 22MAY96 pt devel chicken pox w/141 pox;tx w/med;pt recovered;MD felt this was a vaccine failure;
rash (all over the body); This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash (all over the body)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history was provided by the Reporter.     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 RASH (rash (all over the body)). At the time of the report, RASH (rash (all over the body)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant  information was provided by the reporter. No Treatment information was provided by the reporter.
Large local reaction - edema, erythema and pain 7cm x 6cm around injection sites start 24 hours after injection.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product Storage Error) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product Storage Error). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product Storage Error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment was provided by the reporter.
I had symptoms of a head cold. I had a horrendous post-nasal drip, coughing, and sore throat. I tested for COVID-19 multiple times, but the outcome was negative for each one. The head cold symptoms continued. It turned into a sinus infection, which is why I went to the doctor on March 7, 2023. The doctor gave me an antibiotic. I am still dealing with post-nasal drip issues.
Red patch on my arm. Arm pain for a few days but now it is just red and feels hard
lethargy; ran a slight fever, 101F; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargy) and PYREXIA (ran a slight fever, 101F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and PALBOCICLIB (IBRANCE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LETHARGY (lethargy) and PYREXIA (ran a slight fever, 101F). At the time of the report, LETHARGY (lethargy) and PYREXIA (ran a slight fever, 101F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 101 F.         No concomitant medications were reported.   It was reported that, after receiving the 1st booster dose of the Moderna COVID-19 vaccine, the patient experienced a little reaction: lethargy and ran a slight fever. The patient referred to healthcare professional for treatment recommendations.  No treatment details were reported.
30 mins after vaccine was shopping at the store that administered the vaccine and had a severe dizzy/vertigo episode. Had to hold shopping cart and sit down. 3 mins into dizziness I became nauseated and had to find a garbage can to vomit into. I had 4 episodes of dry heaving and was diaphoretic and sat for 15 mins and slowly the dizziness subsided. Pharmacist asked me to return to pharmacy the gave me water and took my BP. 136/86 HR68. It is now 3 hours later and I feel much better. I just ate lunch. I'm very healthy with no issues and this literally floored me.
19 year old female reaction to Covid 19 vac; she is alert and orientated; complaining of rash, difficulty breathing, dizzy, lump in throat, headache, nausea, cough.  1 dose of Benadryl 25 mg  given at 1430.  Patient states she is medical fragile and has a HX of epilepsy. EMS called at 1500 evaluation mild allergic rxn will transport to hospital for further evaluation.
Pt woke up at 4:00 am the morning after getting her flu shot and was itching very badly.  She noticed she had hives on her lower trunk and legs.  She called her physician and they told her to take Benadryl and use hydrocortisone cream.
Rashy & itchy at site of administration. Under both arms rash. Pt used NEOSPORIN under arm and BENADRYL spray at site of injection. I told pt to take BENADRYL by mouth. Pt not sure if it could be heat rash, I suggested to take BENADRYL by mouth and to see her Dr. on Monday and I will follow up Monday afternoon.
flu shot at a different facility and presented to our office (his PCP) with redness and swelling of arm , starting in shoulder and down to forearm and hand when seen at our office 3 days later  No information in system about the vaccine
Local swelling, erythema, induration and warmth of (L) leg about 3 x 3" diameter.
On the 9th day post vaccine the pt developed fever 101F, petechia rash L arm. No fever on 10th day. No progression of petechia.
Information has been received from a registered nurse concerning a 73 year old female patient who on 05-JUL-2007, was vaccinated IM into the left deltoid with a 0.5ml dose of PNEUMOVAX 23 (Lot# 654977/0888F). Subsequently, the patient described a severe local injection site reaction described as redness through the shoulder into the arm, pain and induration. Unspecified medical attention was sought. It was reported that the reactions subsided in several days. TYLENOL was ordered for pain. On an unspecified date, the patient fully recovered. No product quality complaint was involved. A standard lot check investigation was performed. All in-process quality check for the lot number in question were satisfactory. The lot met the requirements of the government and was released. This is one of three reports from the same source. Additional information has been requested.
received a box of expired Fluzone High Dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA400131(CLUSTER), 2022SA400367(CLUSTER), 2022SA400987(CLUSTER), 2022SA400369(CLUSTER), 2022SA400371(CLUSTER), 2022SA400976(CLUSTER), 2022SA401056(CLUSTER), 2022SA400981(CLUSTER) and 2022SA401104(CLUSTER).  This case involves unknown gender elderly patient who was given expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] for with no reported adverse event.  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 QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA, exp date: 30-Jun-2022) via unknown route in unknown administration site for Immunization.  On an unknown date the patients developed a non-serious "received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses. with no reported adverse event" (expired product administered) (latency: same day).  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.
Administered Heplisav-B to a 5 Week-Old; Injection Location was Upper Right Thigh; Initial Report Received on 30-Jul-2021  A clinical administrator reported that a 5 week-old female (race and ethnicity not provided) was administered a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported. There were no known drug allergies.  No relevant concomitant medications were reported.  On 30-Jul-2021, the 5 week-old female patient received a dose of HEPLISAV-B (Lot # 934600, Expiration 28-Feb-2022; NDC # 4342-8-003-01) in the upper right thigh from a licensed practical nurse. No adverse reactions were reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
woozy", lightheaded, and felt fatigue; "as if when you feel drunk."; just wanted to put her head down.; woozy", lightheaded, and felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (woozy", lightheaded, and felt fatigue), FATIGUE (woozy", lightheaded, and felt fatigue), FEELING DRUNK ("as if when you feel drunk.") and ASTHENIA (just wanted to put her head down.) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FATIGUE (woozy", lightheaded, and felt fatigue). On 24-Mar-2021, the patient experienced DIZZINESS (woozy", lightheaded, and felt fatigue), FEELING DRUNK ("as if when you feel drunk.") and ASTHENIA (just wanted to put her head down.). At the time of the report, DIZZINESS (woozy", lightheaded, and felt fatigue), FATIGUE (woozy", lightheaded, and felt fatigue), FEELING DRUNK ("as if when you feel drunk.") and ASTHENIA (just wanted to put her head down.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information were not provided. No treatment medication information were not provided.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (one drink per day) on 12-Jun-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 12-Jun-2021 to an unknown date for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 07-Nov-2020 and the estimated date of delivery was 14-Aug-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2020, Pregnancy test: positive (Positive) positive. On 26-May-2021, Glucose tolerance test: normal (normal) normal.         Patient's estimated date of conception was reported as 19-NOV-2020. Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added patient demographics, LMP date, Due date, Medical history, Lab data, Dose1 and 2 details, concomitant medication. This case was received for pregnancy data clean up, but at level it was observed that FU 1 was not processed . hence FU 1 information is added now into this case as well as changes were made in pregnancy data field.
LEFT DELTOID: 7CM X 12 CM OF REDNESS AND INDURATION WITH ITCHING. NO PAIN REPORTED. ONSET:8/16/2020
irritable, screaming on day of vax-10 days later broke out in a rash;
Shingles; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-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 ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) was resolving and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medicine were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, the reporter causality for the event of Shingles and Flu like symptoms was no reasonable possibility.  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. No treatment medicine were provided.   Reporter did not allow further contact
face swelled; Rash; This is a spontaneous report received from contactable consumer (the patient). A patient of unspecified age and gender received the received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date, patient experienced face swelled and rash. Patient stated that, i was calling to reaction because I had been having reaction to Pfizer and I just want to know how proceed with my second shot, my second shot is 19 of this month 19Jul2021 (Further clarification unknown) and doctor had helped me with that so much so my face swelled and had a bad rash, my doctor put in for it. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Woke up to child in tonic-clonic (febrile) seizure.  Unsure how long he was seizing; although it was at least three minutes once we became aware of seizures occuring.  Had a fever of 103 degrees at the time.  After cooling measures (stripping clothing, cool rags, and bath) and Motrin were given temperature decreased and he became stable.  We contacted his doctor who saw him the following morning.  No additional events beyond that one seizure.  Dr. did not feel there was a connection between seizure and flu shot at the time.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 08-DEC-2016 the patient received an expired dose of GARDASIL (dosing details were not reported) (lot # L001442; expiration: 04-NOV-2016) intramuscularly for prophylaxis (expired product administered). No known adverse effects. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Patient was given dose on 5/13/23 but BUD for this product was 5/11/23. Moderna was contacted and we will receive report on lot stability in 3 to 5 days. I called patient to discuss error and she says she experienced arm pain at the injection site, joint aches, a fever, and slight nausea for about 24 hours after the dose. This reaction was similar to her reactions with previous doses of Moderna. The day of report patient reports all side effects are resolved except for injection site pain.
Pt recvd vax 25OCT89 & following vax pt devel unspecified serious & substantial injuries; No further details were provided;
HCP told him not to take the second dose; started getting weak; Chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (HCP told him not to take the second dose), PAIN IN EXTREMITY (sore arm), ASTHENIA (started getting weak) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (HCP told him not to take the second dose), PAIN IN EXTREMITY (sore arm), ASTHENIA (started getting weak) and CHILLS (Chills). At the time of the report, PRODUCT DOSE OMISSION ISSUE (HCP told him not to take the second dose) had resolved and PAIN IN EXTREMITY (sore arm), ASTHENIA (started getting weak) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
per Tmax 102 w/hives (urticaria) on the day of vaccination. Seen at the emergency room hospital. tx with BENADRYL 81 mg
Hot flash. Feet felt like on fire for 6 hours.; Hot flash felt like on fire for 6 hours.;This is a spontaneous report from a non-contactable consumer, the patient. A 35-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via unspecified route of administration and anatomical site on 16Mar2021 at the age of 35-years-old as a single dose for COVID-19 Immunisation. The patient was allergic to dairy, bactrin and iodine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient concomitant medication includes thyroid, anti-anxiety and allergy medications (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination the patient was not been tested for COVID-19. On an unknown date, the patient experienced hot flash, feet felt like on fire for 6 hours. No therapeutic measure was taken for the adverse event. The clinical outcome of the event hot flash was unknown.   Information about lot/ batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's First Name added, patient's Age/Units captured as 35 years per administration date 16Mar2021 conservatively, since event onset date not provided. For suspect vaccine: Indication "COVID-19 Immunisation" captured twice, removed one. Unknown removed from Lot# field, known_allergies, bactrin, iodine captured as past drug event, known_allergies Dairy was already captured as relevant history. Notes updated  Pending PSSR review. For event: Treatment Received NO was selected due to provided if_treatment_ae No. Event " Hot flash Feet felt like on fire for 6 hours."Also coded as Feeling hot. Final sentence "Information about lot/batch number cannot be obtained. No further information is expected." updated as "No follow-up attempts are needed; information about lot/batch number cannot be obtained." Per SER055
Chills first night Tiredness for a couple weeks Rash 2  1/2 weeks after injection -  large area around rectum  inflamed and spots extremly painful Treated with gentle wipes, A&D ointment   Healing began Oct 4    after 9 days
Client felt nausea and dizziness within minutes of receiving vaccine. client was on his way to observation unit, client sat down at an empty station and proceeded to vomit. Evaluated by MD and EMt. Vitals obtained BP 133/87, HR 85 and oxygenation 100% . Client reported feeling better after a few minutes and was then walked over to observation area.  Report given to nurse to monitor client. Clients mother at his side.