chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction Menactra vaccine; Initial information regarding an unsolicited valid non serious case was received from Pfizer (non-licensed partner) (MFR Control No: 2020290909) in the form of courtesy via a consumer or other non- healthcare professional and transmitted to Sanofi on 01-Aug-2020.  This case involves female patient (age not reported) who experienced allergic reaction to Menactra vaccine (drug hypersensitivity), while she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history included adverse food reaction and adverse drug reaction.  At the time of the event, the patient had ongoing milk allergy and food allergy.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic reaction to Menactra vaccine (drug hypersensitivity), unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Laboratory details were not reported.  Final diagnosis was drug hypersensitivity.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for drug hypersensitivity.   There will be no information available on the batch number for this case.
left eye swelling aches; left eye swelling aches; This is a spontaneous report from a contactable (Nurse) other-health care professional (Patient). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL0140 and expiration date was not reported), first dose via intramuscular route of administration, administered in arm left on 21Dec2020 18:00 (at the age of 24 years) as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22Dec2020 18:00 the patient experienced left eye swelling aches. Adverse events did not require a visit to Emergency Room or Physician Office. The outcome of the events was recovered on 23Dec2020.    No follow-up attempts are needed. No further information is expected.
pt recvd vax & 3 hrs later devel h/a, malaise & fatigue which lasted for 24 hrs; No further details were provided;
fever, crying spells, twitching (sz), nervousness, rash, diarrhea;pt exp rash & takes med;pt also takes med for sz & pt diet is regulated to control sz;
An MA staff mixed the pfizer with .18 diluent instead of 1.8. The pt was given the full dose. I have not been able to contact the pt to see if she is having adverse symptoms.
This spontaneous report as received from a female consumer of unknown age reporting on herself. On 04-AUG-2013, "4 days ago", the consumer was vaccinated with the first dose of GARDASIL (route and lot # not reported). The consumer reported that in August 2013, she experienced memory loss and vomiting. The consumer stated that she went to the ER but did not state if she was admitted to the hospital. The patient did not receive treatment for the adverse events. The outcome of memory loss and vomiting was reported as not recovered/not resolved. Additional information is not expected.
Narrative:  76yo male patient died on 11/10/2021. Pt was found in his car at his dialysis clinic deceased. Pt with the followingCURRENT PROBLEM LIST: ESRD - End stage renal disease (SCT 4617DM - Diabetes mellitus (SCT 73211009) Benign essential hypertension (SCT 12010HLD - Hyperlipidemia (SCT 55822004) Coronary artery disease (SCT 53741008) End stage renal disease (ICD-9-CM 586.) Arteriovenous Fistula (ICD-9-CM 477.0) Chronic Kidney Disease, Stage IV (Severe) (ICD-9-CM 585.4) Family History of Malignant Neoplasm of Chronic Kidney Disease, Stage III (Moderate) (ICD-9-CM 585.3) Diabetic Nephropathies (ICD-9-CM 250.40)Anemia in end stage renal disease (SCT 707324008) Renal Insufficiency with Hypertension (CImpotence of organic origin (ICD-9-CM 607.84) Chest Pain (ICD-9-CM 786.50) Neck Pain (ICD-9-CM 723.1) PERIODONTAL DISEASE NEC (ICD-9-CM 523.8)Hyperlipidemia (ICD-9-CM 272.4) Benign hypertension (ICD-9-CM 401.9) DIABETES MELLI W/O COMP TYP II (ICD-9-CM 250.00) DIABETES MELLITUS, TYPE I (ICD-9-CM 250. Pt had received covid vaccines on 1/7/21 & 2/4/21. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration
Woke up during the night and experienced vomiting and diarrhea followed by syncope
01/30/04: Received DTAP, IPV in right arm.  Grandparents noted redness and swelling to right arm that evening.  Grandparents called ask a nurse and was told to give Tylenol. Grandparents reported no fever.  Contacted CDC with no success.  GM states no one answered.
pain away from injection site; tiny bump that raised at injection site; arm was a little swollen; arm was red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain away from injection site), VACCINATION SITE URTICARIA (tiny bump that raised at injection site), VACCINATION SITE SWELLING (arm was a little swollen) and VACCINATION SITE ERYTHEMA (arm was red) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event reported).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (pain away from injection site), VACCINATION SITE URTICARIA (tiny bump that raised at injection site), VACCINATION SITE SWELLING (arm was a little swollen) and VACCINATION SITE ERYTHEMA (arm was red). At the time of the report, PAIN (pain away from injection site), VACCINATION SITE URTICARIA (tiny bump that raised at injection site), VACCINATION SITE SWELLING (arm was a little swollen) and VACCINATION SITE ERYTHEMA (arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        No treatment information was provided.   No relevant concomitant medications were reported.
Patient shook 3-5 minutes after shot then slumped over. Gave patient water and within 5-10 minutes, patient shook and passed out again. Patient has history of fainting when given shots or blood work. 20 mintues after given candy, patient's blood sugar was 161.
CHILLS, SEVERE FATIGUE, NAUSEA, SWOLLEN ARIAL LYMPH NODE LEFT SIDE (INJECTION SITE), AND HEADACHE. TOOK TYLENOL AND MOTRIN. REST. SYMPTONS LASTED 24-48 HRS
strong heart palpitations beginning the evening of the 2nd day after vaccination, weakness, some dizziness, sore arm at injection sight, lots of tightness in chest lots of , heaviness in chest, tenderness at injection sight.. pain across shoulders from left arm across shoulders to right arm and shoulder happened on the 8th day after. The sixth day left arm became stiff in the morning.  My current prescriptions have helped me get thru the day with little palpitations, but they come back in early evening and some during the night.
This is a spontaneous report from a contactable Medical assistant on behalf of a Physician. An 11-year-old male patient of an unspecified ethnicity received TRUMENBA, intramuscular at 1 0.5 ml single on 30MAR2016. The patient medical history was not reported. There were no concomitant medications. The following day, on 31MAR2016, the patient experienced fever, swelling on the injection site, vomiting and outcome of unknown. The reporter assessed the events as related to TRUMENBA. Follow-up (11-MAY-2016): Follow-up attempts are completed. No further information is expected.
patient got shingles one week after getting shin grid first dose; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age grp was selected as an adult as per vaccine indication. The reporter wanted to know if a patient got shingles one week after getting shingles dose would GlaxoSmithKline recommend not getting the second dose. The reporter disconnected the chat before providing credentials or any additional details as to whether there was an incident or general inquiry. The reporter did not consent to follow up.
A legal complaint was received from an attorney concerning the father of an infant female. In May 1979, the infant received a dose of Orimune. The legal complaint states that within 3 weeks post-immunization, the father contracted paralytic poliomyelitis as a result of having contact with live polio virus which had been excreted by his infant daughter. The legal complaint states that the father was and is still rendered sick, sore, lame and disabled. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by FDA.
70 year old patient felt funny after shot. EMS was called vitals were taken BP 174/80  99% O2 room air HR 78. Chest Pain, Non-Cardiac but patient refused additional evaluation and care.  Released against medical advice.
Losing their hearing after getting the vaccine; 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 DEAFNESS (Losing their hearing after getting the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 DEAFNESS (Losing their hearing after getting the vaccine) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Losing their hearing after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.   This case was linked to MOD21-065420, US-MODERNATX, INC.-MOD-2021-062192 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. MOD21-065420: US-MODERNATX, INC.-MOD-2021-062192:
Tired; High Fever; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of CHILLS (chills), FATIGUE (Tired) and PYREXIA (High Fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]) and LISINOPRIL for Hypertension, VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and CLONIDINE for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 30-Jun-2021, the patient experienced FATIGUE (Tired) and PYREXIA (High Fever). The patient was treated with NAPROXEN for Fever, at a dose of 500 mg. On 26-Apr-2021, CHILLS (chills) had resolved. At the time of the report, FATIGUE (Tired) and PYREXIA (High Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jun-2021, Body temperature: 102 to 103 degree Celsius (High) High. On 30-Jun-2021, Body temperature: 101.4 degree Celsius (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Pt states that her right arm where she received her PNEUMOVAX vaccine was sore 10/9/12. On 12/16/12 she reports that it is still sore and numb, and worried that it is her heart. Pt has Dr. appt.
Redness at the injection site presented at the injection site /redness is a 4cm circle around the injection site; swelling at the injection site presented at the injection site / swelling is a 4cm circle around the injection site; area started to itch 2-3 days following the administration; shingles like rash presented down the left arm; This case was reported by a consumer and described the occurrence of injection site erythema in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site itching and vesicular rash. The patient was treated with triamcinolone. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site itching and vesicular rash were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm and experienced redness and swelling. The redness and swelling was 4cm circle around the injection site. The reporter described it as looking like big, bad spider bite around the area. The area started to itch 2 to 3 days following the administration. The patient also experienced shingles rash a week following the vaccination. The patient was treated with triamicilone and the events resolved. The patient has not yet received the 2nd dose. The reporter consented to follow up.
Patient received a Pfizer vaccine after receiving two moderna vaccines. No issues were observed during the observation period.
Pt noted small bump to area of vaccines, itching and small bumps to arms and chest with increasing redness to left deltoid next day. Benadryl po given.
Patient reported twitching to right eye and a warm sensation 5 mins after injection. Resolved by 10:41am.
This spontaneous report was received from a medical assistant and refers to a female patient unknown age. No pertinent medical history, drug reactions or allergies or concurrent conditions were reported.    On unspecified date, an unspecified nurse cut her hand on a broken GARDASIL 9 pre-filled syringe (lot number: 1581027 with expiration date on: 03-JUN-2021) and experienced occupational exposure to product, accidental exposure to product and wound. The patient recovered from the events, and no medical intervention was provided. It was confirmed by the reporter that patient did not missed a dose. The causality assessment between GARDASIL 9 and the adverse event wound was unknown at the moment of the report.
smells like a "putrid odor" because he has been vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of SKIN ODOUR ABNORMAL (smells like a "putrid odor" because he has been vaccinated) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN ODOUR ABNORMAL (smells like a "putrid odor" because he has been vaccinated). At the time of the report, SKIN ODOUR ABNORMAL (smells like a "putrid odor" because he has been vaccinated) outcome was unknown.            Concomitant medications was not reported.  Treatment medications was not reported.   Reporter did not allow further contact
6/19/06 Client took oral typhoid; started 6/15/06 1st dose and 6/17/06 dose 2. Broke out in rash - bilateral arms and right leg - warm to touch and slightly swollen. Rash increased by Saturday 6/17/06. Doctor notified. Client advised to hold-stop the last 2 doses. 6/21/06 Called clients mother - client doing better - rash is still present but decreasing.
Immunized pt. w/ PNEUMOVAX at approximately 11:50AM. Pt. returned at approximately 12pm complaining of sharp pain in lower back radiating down both legs. Pt. also c/o loss of balance (difficulty walking) & blurry vision. Told patient to have a seat to be observed. Pt. refused to sit & continued to walk around in the waiting area of pharmacy. Dr. (patient's primary care physician) was called at about 12:06pm on 10/11/11. Doctor stated that the patient's records indicated that patient received PNEUMOVAX in 2010, but not at his office. This was information that was told to his office by the patient. I asked the patient before getting the vaccine of the date of last PNEUMOVAX. The patient stated she "thinks she received the PNEUMOVAX at a pharmacy". I viewed the patient's profile and did not see a PNEUMOVAX vaccine on her profile (only 2 flu shots - 1 in 2008 and 1 in 2010). The patient stated that she could not remember and wanted to be vaccinated. I explained this to Dr. and the complaints of the patient. Dr. stated to have patient call his office. Dr. also stated that it is ok if the patient received more than 1 dose of PNEUMOVAX in less than a 5 year period. Relayed information given by Dr. to the patient. Patient remained in the store until about 12:10pm. Patient stated that she no longer had any pain, blurry vision, nor difficulty walking. Patient was told to call the pharmacy or go to E.R. if any more problems. Patient stated she was OK and asked for a copy of the VARS form. Patient was given a copy. Also on file is signed documentation that the patient was ok before leaving the pharmacy. The document is signed by immunizing RPh, witness (store manager), and the patient.
Around 2 pm of injection day I have severe chills with no fever. Lasted a good 12 hours The next day developed bad rashes around neck and lower right stomach.
The patient had a raised red rash at the site of injection that got better, then larger again.  after triple abx treatment patient did say it got better.  This am she said it became round  with red ring and a white center (like ring worm) and itchy.
Both arms radiating pain and tingling, flu-like symptoms, redness and warm to touch.
injection site tenderness; fatigue; moderate headache for around 24 hours; Slight chills for a few hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Apr2021 10:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sulfa drugs" (unspecified if ongoing), notes: Known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Apr2021 20:00, outcome "recovered" (04Apr2021), described as "injection site tenderness"; FATIGUE (non-serious) with onset 03Apr2021 20:00, outcome "recovered" (04Apr2021), described as "fatigue"; HEADACHE (non-serious) with onset 03Apr2021 20:00, outcome "recovered" (04Apr2021), described as "moderate headache for around 24 hours"; CHILLS (non-serious) with onset 03Apr2021 20:00, outcome "recovered" (03Apr2021), described as "Slight chills for a few hours". Therapeutic measures were taken as a result of vaccination site pain, headache. Therapeutic measures were not taken as a result of fatigue, chills.  Additional information: Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Other medications the patient received within 2 weeks of vaccination: Unknown. Prior to vaccination, the patient diagnosed with COVID-19: No. Since the vaccination, the patient been tested for COVID-19: No. Took 400mg ibuprofen for the events Injection site tenderness and moderate headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm, near injection site started to itch. About eight days after vaccination. The area got very red and swollen.  The area was approximately 3 inches by 5 inches.  It was not specifically painful, more uncomfortable and annoying it continued to be very itchy!  The redness,swelling and itchin began to subside after about 4 days and basically completely gone after a week from its first inception.
cold sore; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sore), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 05-Mar-2021, the patient experienced ORAL HERPES (cold sore), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). At the time of the report, ORAL HERPES (cold sore) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
SEVER HEADACHE SEVERE BODY ACHES SEVERE BONE ACHES FEVER FATIGUE - STAYED IN BED 1 WEEK STILL HAVE ISSUES
induration, swelling, erythema & callos over lt deltoid extending distally to lt elbow/anterior region;
Employee developed a 6 x 3 1/2 cm area of redness 4" below the site of her influenza vaccination 1 day after receiving the flu vaccination.
Palpitations, high blood pressure requiring  higher doses of meds.  Still the BP is staying up.
Pt received imms and was going to wait 30 minutes observation for JE but after 15 minutes he had trouble breathing, said it was hard to swallow and his throat was closing up, given BENADRYL and EPI IM, observed for awhile by Dr, released on prednisone pills, not to have 2nd JE.
12/23/20 1ST DOSE (AFTERNOON/EVENING): CHILLS, BODY ACHES, TEARING/CRYING. BACK PAIN 1/12/21 2ND DOSE (AFTERNOON/EVENING): WORDS/CHALLENGES COMMUNICATING FOR 24 HRS
Nauseous; 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 NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown.            The action taken with mRNA-1273 in response to the events were not applicable.  No concomitant product use was provided by the reporter.  No treatment medication was provided.   This case was linked to MOD-2021-254070 (Patient Link).