chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "recovering", described as "Tested negative/A few days later, tested positive again"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive any other medications in 2 weeks. Reason for lot number unknown reported as not available at the time of report completion. It was reported that anti viral details of Paxlovid treatment started on 24Aug2022 and stopped at 28Aug2022. Patient also reported that continued to have fever during treatment, tested negative and a few days later again tested positive, still have a fever. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5 minutes post administration of VARIVAX one hive noted to right thigh laterally to injection site. MD made aware and examined site, BENADRYL 5 mg was given P.O. 27 minutes post administration. Site reassessed. Redness and swelling persisted but no increase in size or redness noted. No SOB or difficulty breathing noted. E.R. precautions given. Pt. discharged.
After both sets of shots, 2 and 4 month set, he had a fever 102, excessive diarrhoea, extreme fussiness.  Lasted 3-4 days and resolved.
Refridgeration excursions identified; No adverse event; Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022 at 5:51 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Sep-2022 at 5:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Vials were moved from freezer to refrigerator on 7-Sep-2022 and vaccines were housed in the units).    No concomitant products were reported.  Anatomical location for vaccine administration was reported as deltoid.  It was reported that refrigeration excursions identified, vaccine was housed in these units. There were excursions noted. Manufactures were notified and the department and made aware of the situation.The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. No adverse reactions reported for the patient.  No treatment products were reported.
Reported to MD  via portal message that she doesn't think she should have any more COVID vaccines. She reports had 2nd injection on Wednesday afternoon and later that evening she started having hives and wheezing with chest pain and feeling like she couldn't breathe. She also reported having terrible nausea and this was followed by a fever and horrible body aches. Still having headache this morning.
Severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headaches) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headaches). At the time of the report, HEADACHE (Severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
I was diagnosed on 3/17/22 that I had Guillain-Barré syndrome and all my extremities were hardly usable. I'm 20% better now 9 months later.
Patient reported experiencing flu like symptoms - fever, body aches, nausea, vomiting - for 3-4 days following Men B vaccination.
Initially malaise & general aches, subsequently fever >101F, greater pain, felt like I would pass out during evening even with head between knees, soreness at injection location. Still weak next morning, mostly recovered in 24 hrs except slight weakness and site of injection.
Horrible bad headache; Body aches; Fever; Chills; Nausea; Feeling just awful; Tired; Arm pain & swelling; Arm pain & swelling; Bruised arm; Muscle pain; Slight body rash; Booster; This is a spontaneous report from a non-contactable consumer, the patient. A 66-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWD164) via an unspecified route of administration in the left arm on 27Sep2021 at 11:00 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to lactose, ragweed and molds. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and unspecified vitamins; both for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 13Feb2021 (at the age of 65-year-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 65-year-old); both as a single dose for COVID-19 immunisation. On 28Sep2021 at 09:00, the patient experienced horrible bad headache, body aches, fever, chills, nausea, feeling just awful, tired, arm pain & swelling, bruised arm, muscle pain, and slight body rash. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included contacting pharmacy to enquire what should be done. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events horrible bad headache, body aches, fever, chills, nausea, feeling just awful, tired, arm pain & swelling, bruised arm, muscle pain, and slight body rash were resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
First Shot - April 12 - Second Shot May 3. After second shot on May 3rd, Very large red, itchy, burning hives and rash on top back of both thighs which covered a lot of area- (7 days- have photos); Fever (4 days); Aches and Pains (4 days); Headache  (4 days); Fatigue (5 days); Sore arm (4 days).  THEN - on May 13 pains in all around abdomen -- May 17 Acute Perforated Appendicitis!!  ER and hospital admittance. Hospital Stay 4 days; 3 nights.  Very stressful right after being sick post vaccine shot -- and expensive.
Pt states devel sl swelling @ site of inject which lasted approx 15 mins; denies pain or redness; completely recovered;
Major cramp diarrhea that night following by extreme bloating and abdominal/gastrointestinal pain.
Super heavy period; Soreness; Swollen lymph node; This spontaneous case was reported by a  and describes the occurrence of PAIN (Soreness), HEAVY MENSTRUAL BLEEDING (Super heavy period) and LYMPHADENOPATHY (Swollen lymph node) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2020, the patient experienced LYMPHADENOPATHY (Swollen lymph node). On 22-Jan-2021, the patient experienced PAIN (Soreness). On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Super heavy period). On 25-Jan-2021, LYMPHADENOPATHY (Swollen lymph node) was resolving. At the time of the report, PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: No specific follow-up information recorded.
WOKE UP WITH PAIN AND BODY ACHES IN BACK AND LEFT SIDE AND FEELS LIKE THE PAIN IS ENLARGING; FEELING BAD; FELT FEVERISH; DIZZINESS; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart valve replacement, and concurrent conditions included abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient has history of no drug drug abuse or illicit drug usage. the patient was taking blood thinning medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the subject experienced dizziness. On 04-JUN-2021, the subject experienced feeling bad. On 04-JUN-2021, the subject experienced felt feverish. On 05-JUN-2021, the subject experienced woke up with pain and body aches in back and left side and feels like the pain is enlarging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt feverish, dizziness, and woke up with pain and body aches in back and left side and feels like the pain is enlarging, and the outcome of feeling bad was not reported. This report was non-serious.
?Pfizer-BioNTech COVID-19 Vaccine EUA?  fatigue, chills, fever (101 degrees), joint pain (all joints including fingers, headache, 2 inch bruise at injection site, lymph node/underarm swelling, insomnia
Confirmed with the customer that no other AE occurred.; a dose of PROQU AD that was administered after experiencing a temperature excursion.; This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-APR-2021,the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 1 dose, lot # t028139, expiration date 15-FEB-2022 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. Albumin status for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) has been verified as recombinant human albumin (rHA). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of (-10.7) Celsius for 1 hour and 6 minutes. Data logger was involved. There were no previous excursions reported.
never got second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never got second shot) 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 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never got second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never got second shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitants were reported. No treatment was reported.
Cellulitis LFA with 6mmx5mm induration. (there were 3 other similar cases)
Breathing issues, rapid heartbeat, swollen arm  area, extreme tiredness, weakness, light headedness  EKG, CHEST X-RAY and blood tests
About 2.5 weeks after the first dose, I began having pain and a rash developed near my temple/beneath my hairline. I initially thought it was an acne breakout. After I received the second dose I developed several symptoms including fever/chills, pain, and swollen lymph nodes in my neck and by my ear. These side effects were all expected however around the same time the rash from my temple area spread and worsened, and there was a large, half golf ball sized knot at my temple. I had also been informed of a possible COVID exposure that day, which would have been 1-3 days prior to the second vaccine dose. Upon discovering this knot and realizing the rash was painful and worsening I went to the ER on 4/13.  I was diagnosed with shingles.
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     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. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a stroke following immunization.  Company Comment : Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Fever, chills, headache/ pain behind my eyes, fatigue. 8/22/12 erythema nodosum on both legs-redness, tenderness and swelling.  Saw employee health md 8/23 and he diagnosed erythema nodosum, temp at that time was 102.4-advised to see my family md. Saw family md at 3pm that day-said I had a reaction to chickenpox vaccine. Fever continued over 101 degrees for 3 more days plus extreme fatigue. Noticed change-darkening of urine and had labs drawn on 8/25-routine employee health orders. Elevated liver enzymes. Went to minor care on 8/26 and sent to ER. Fatigue, SOB. O2 Sat 95, and 92. Elevated d-dimer, liver enzymes, sl elevated wbc. urine normal. Blood cultures drawn-negative. Temp sl elevated. Had discontinued Lamisil on 8/24.  Had taken this medication several years ago with no problem. Fatigue continued for 3 more days. Follow-up visit with md. Had labs repeated-told all was back to normal. Supposed to have second shot, but I will not.
Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Rapid heart beat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PALPITATIONS (Rapid heart beat). At the time of the report, PALPITATIONS (Rapid heart beat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
The patient received an expired vaccine (12/31/2021). No adverse events reported at this time.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced URTICARIA (Hives). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) (topical) ongoing since an unknown date at a dose of 1 dosage form. On 12-Feb-2021, URTICARIA (Hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported her hand, forearm, left shoulder, and outer thigh were red and itchy.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received on 14-JUL-2021 and included event outcome.
Patient had no reactions to the vaccine.  Patient received 3rd dose.  MD made aware.
I felt extreme stomach burning and pain on the evening of Saturday, August 14, 2021 and it lasted the duration of the whole night. It stopped the next morning.   By around 7PM of Sunday, August 15, 2021 I blacked out and then the left side of my face and head felt a tingling sensation which lasted a few hours.   The next day, Monday, August 16, 2021, I began feeling the tingling sensation around my mouth and lip area.   On Tuesday, August 17, 2021 I lost my balance and felt extreme dizziness.   On Wednesday, August 18, 2021 I blacked out again.   On Thursday, August 19, 2021 I began worrying because my symptoms did not go away. I initially assumed they were normal and would go away but since they didn?t I went to urgent care and they sent me to the ER. All my tests (chest xray, CT of head, ecg and lab blood work was performed) and the ER physician noted my elevated lipase levels. My lipase at the time of my ER visit was 628 and the physician concluded adverse reaction to the COVID-19 vaccine. He instructed me to get on a liquids only fast, avoiding fats and sugar. I had been doing that and experienced more pain on Friday (8/20), Saturday (8/21) and Sunday (8/22).  The doctor instructed to come back on Monday, August 23, 2021 for another round of lipase labs and to schedule an appointment with a GI specialist after 1 week.
This spontaneous report was received from a Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies was not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot number, expiration date, concentration, dose, route of administration and frequency were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax in 19920 or 1993;in 1995 lab eval revealed elevated SGOT & SGPT in the mid 100s;
Information has been received from a physician concerning a 14 month old patient who on 5/24/2005 was vaccianted with a dose of varicella virus vaccine live. On 6/3/2005 the patient developed breakthrough varicella with a fever. It was reported that the fever lasted 1 day and that the patient had less than 50 lesions. The patient had no prior history of chickenpox. There were no complications. The patients chickenpox was not confirmed by the laboratory. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Burning during urination and cloudy urine. Diagnosed with UTI (Urinary Tract Infection)
Swollen Lips - 9:45 am injection. Noted 1:30 pm swelling. DEPO MEDROL dose shot 80mg IM at 4:30 pm. Over next 3days Prednisone 10mg 3/day to 2 per day to 1 per day. ATAVAN 10mg 1 tid x 3 days.
Immediately after vaccination patient had swelling at the injection site.  Oral benadryl was administered.  Patient never developed any respiratory symptoms (cough, SOB, wheezing, etc).
Approximately one week after vaccine symptoms began; Severe Abdominal Pain & Shortness of Breath
Develop allergies to grass. Went into anaphylaxis for the first time, twice in less than 24hours in march 2022.
12/26/2020 AT 3:00 AFTER VACCINATION, EXPERIENCED HEADACE, LEFT ARM PAIN, FATIGUE. MILD AT FIRST. INCREASED IN SEVERITY FOR THE NEXT 24 HOURS. SUBSIDED. INSOMNIA (NO HISTORY) 12/27/2020 SYMPTOM FREE UNTIL 11AM. HA INCREASED IN SEVERITY. WAS NOT RESPONSIVE TO TYLENOL. MORE SEVERE HA. SENT HOME FROM WORK DUE TO HA AND SEVERITY; MISSED 12/27/2020-12/28/2020; COVID TEST ON TUES; NEGATIVE. FATIGUE HAS RECOVERED.  12/30/2020 - MILD HA CONTINUING, BP IS GOOD 2ND PREGNANCY; DOB 06/2121  ONGOING HA