chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme fatigue; heavy and constant menstrual bleeding; This is a spontaneous report from a contactable consumer or other non health care professional. A 17-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on Apr2021 (at the age of 17-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on an unspecified date of may2021 at 12:00pm the patient experienced extreme fatigue, heavy and constant menstrual bleeding. The adverse event resulted in doctor or other healthcare professional office/clinic visit. 10 days estrogen pills were received as treatment for the adverse event. Therapeutic measures were taken as a result of extreme fatigue, heavy and constant menstrual bleeding. The reporter assessed the seriousness as non-serious. The outcome of the events was not recovered.  Information about lot/batch no has been requested.
Slight soreness at injection site, but not as bad as 1st dose; some fatigue on day 2, breakout in hives on evening of day 2 on back, neck arms and scalp that went away a couple hours after taking one benadryl pill.
At 5:30 pm, patient came in with a red raised patchy and papular rash of axilla bilat. and wrists bilat. Very itchy. Also throat felt swollen and hoarse, lips felt swollen and tingly. VS 98.5, 126/81, 99, 20. LS clear ENT WNL. Face flushed. No HX of any kind of allergies. Had taken 50mg of liq. Benadryl just prior to visit at clinic. Itching and facial flush resolved while here. Advised to continue the Benadryl and return to clinic if worse not better.
about 5 minutes after receiving her covid Pfizer vaccine pt fainted. her blood pressure was 90/50, blood sugar 74, pulse 82. she was taken to the hospital and discharged without issues.
pt recvd vax & c/o lethargy; ? resp distress; ambulance called, O2 administered;
I got my vaccine at 4:00 p.m. About 10 hours (2:00 a.m.) after the vaccine I started getting aching back pain and bilateral shoulder pain.  About 12 hours after the vaccine I spiked a fever and felt like I was hallucinating.  I was unable to check my temperature until 10:30 a.m. the next morning and it was 102.4.  I had a fever, body aches, and headache the entire following day. My fever broke to 99.0 around 6:00 p.m.  I also had severe pain at the injection site that started several hours after my injection and continued to get worse.  The pain was so bad it was too painful to move my arm.  Today is day two post-vaccine, I have no fever but feel very weak and lethargic.
Vomiting / Nausea 101*F Fever / Dizziness Chills Headache Body Aches
this pt began w/screaming uncontrollably on 25SEP92; pt lies listless since, refuses to smile, acts sore; exam: shows listless w/devel delay & LOM;
Extreme joint pain all over body and swelling; Extreme joint pain all over body and swelling; Severe hair loss-comes out in bunches; numbness in neck radiating down arms into hands, right arm and hand are still tingling and numb; right arm and hand are still tingling and numb; This is a spontaneous report from a contactable consumer, the patient. This 65-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0196) via unspecified route in the left arm on 20Jul2021 at 15:00 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, diabetes, COVID, and allergies to sulfa and penicillin. There were no other vaccines received within four weeks of the COVID vaccine. Concomitant medications received within two weeks of the vaccine included metformin, sitagliptin phosphate (JANUVIA), metoprolol, valsartan. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0181) via unspecified route in the left arm on 29Jun2021 at 15:00 (at the age of 65-years-old) as a single dose for COVID-19 immunization. On 21Jul2021 at 02:00, patient experienced extreme joint pain all over body and swelling, numbness in neck radiating down arms into hands, right arm and hand are still tingling and numb, severe hair loss-comes out in bunches. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment included unspecified medication to reduce pain. The outcome of the events was not recovered. The patient was not tested for COVID post vaccination.
fever of 101; headache; muscle soreness and stiffness; muscle soreness and stiffness; extreme fatigue; Cannot hear out of it at all; have tinnitus in my left ear; This is a spontaneous report from a contactable consumer (who is also the patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729), via an unspecified route of administration in the left arm, on 06Apr2021 15:00, as single dose, for COVID-19 immunisation. Medical history included blood clot. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included apixaban (ELIQUIS) taken for an unspecified indication, therapy dates not reported. The patient did not have COVID-19 prior to vaccination and had not tested for COVID-19 post vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) received at age 42 years, via an unspecified route of administration in the left arm, on 12Mar2021 16:45, for COVID-19 immunization, and  within 24 hours, the patient experienced tinnitus in left ear and cannot hear out of it at all which took two weeks to return after the first dose. The patient did not receive other vaccines in for weeks. On 06Apr2021, the patient received the second dose. On 07Apr2021 at 02:30, the patient had tinnitus in his left ear and could not hear out of it at all. On 07Apr2021 at 03:00, 12 hours after the injection, the patient had a fever of 101 along with headache, muscle soreness and stiffness, and extreme fatigue. No treatment was given for the events. The outcome of the events was not recovered.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 11:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had a ethnicity. The patient had received the vaccine dose number as booster. No concomitant medications were reported. It was reported that a series of an approximately 540 patients had received lot number of 066H21A in past and had an its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed. No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Information has been received from a physician concerning a 6 month old female with no medical history or drug allergies, who "45-46 days ago" on approximately 07-JUL-2007 was vaccinated with her second oral dose of Rotateq. There was no concomitant medications. On approximately 07-JUL-2007 the patient developed blood in her stool and watery diarrhea. Medical attention was sought through via gastroenterology visit. Lab diagnostic studies confirmed that the patient was negative for rotavirus antigen. As of 22-AUG-2007, the diarrhea decreased but the blood continued to be in the patient's stool. Subsequently the patient was noted to be resolving. It was also noted by the physician that there was a longer than recommended interval between first and second dose. There was no product quality complaint. Upon internal review, blood in stool was considered to be an other important medical event. Additional information has been requested.
Slight fever to 100.2 on 5/10/05. Morning 5/11/05 1 1/2 inch oval red patch just below site of injection, warm to touch. Area sensitive to touch.
Measles (Rubella), rash, fever. Coryza/Conjunctivitis 10-12 days after vaccine.
HIVES ON CHEST, UPPER BACK, L ARM  SELF-RESOLVED IN 15 MIN  2ND DOSE IN SERIES  BAND-AID REMOVED FROM L ARM
4 days following all over body itching, 12 days later injection site was red, warm, painful and swollen, itching as well.  Random itching all over body. Benadryl relieved the first body itching.  Taken for site spot, Benadryl did not help.  Haven't started Benadryl for the remaining itching.
Developed 2 pink maculopapular nonpruritic rashes on right breast and right buttock.  She still has them today and they appear to be pityriasis rosea.  This initial rash appeared 2 days after her second vaccine. 2 weeks after, she developed what she describes as hives that were not pruritic and were not visible to the eye but can be felt on her skin.  They resolved on their own and are not present today. She occasionally will get the pink maculopapular rashes appearing on her trunk still.  No treatment.
Initially, flank pain R radiating to front. On 10/04/2014 rash of Herpes Zoster appeared.
Pt. returned for booster 11-30-11 & reported localized swelling "golf ball size" with redness, firmness, & tenderness at injection site. Swelling persisted x 1 week - tenderness x 2 weeks.
Whole face was numb; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Mar2021 at 08:30(at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included fluoxetine hydrochloride (PROZAC), multi-vitamin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 08:45, the patient's whole face was numb. Therapeutic measures were taken as a result of events and included treatment with BENADRYL & two days in bed. The clinical outcome of the event whole face was numb was recovered on an unknown date in April2021 at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
My arm swelled like a big knot, bruised and hardened. I felt woozy and out of it like not alert for 3 days already i would also sweat and feel weak like passing out, i had fever spikes of 100 degrees for 3 days and had to take tylenol plus had headpain, confusion. I felt nsuseated. I had flu chills in the first 24 hours and aches for 3 days the wooziness and disoriented effects lasted 5 days and came in waves. I took tylenol and stayed home from work
dizziness; feels really warm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and FEELING HOT (feels really warm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced DIZZINESS (dizziness) and FEELING HOT (feels really warm). At the time of the report, DIZZINESS (dizziness) and FEELING HOT (feels really warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: 110 (High) fast heartbeat, which is normally in the 50s but was at 110.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
onset of rash 10 days post vax;morbilliform rash started in face & extended to extremities;now clearing on face
ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005236: US-009507513-2103USA005237: US-009507513-2103USA005238: US-009507513-2103USA005239: US-009507513-2103USA005241: US-009507513-2103USA005234: US-009507513-2103USA005233: US-009507513-2103USA005235:
Moderna COVID-19 Vaccine EUA Had a small hardness and tenderness at injection site on the first day.  8 days later, noticed an  slightly itchy red rash at injection site and down the arm. Approx 2 inches long and 1 inch wide.  No other symptoms. Still planning to get 2nd dose scheduled for May 3
Narrative:  65 yo patient with PMH: CAD, COPD, low back pain, OA, squamous cell carcinoma of lung, HLD, Schatzki's ring, SCC of tongue who was admitted on 8/31/2021 or acute hypoxic respiratory failure secondary to covid19 pneumonia, severe sepsis, AKI and malnutrition. Patient has full vaccination status (PFizer, 2/4/2021, 2/25/2021) Pt's prognosis was guarded (per note) due to poor pulmonary reserve and chemo-induced immunosuppression. Patient had worsening clinical status after a couple of days. Family opted for comfort measure on 9/3/2021 and patient passed away on 9/4/2021.
mom reports pt rt arm was red about 1 hrs p/inj; approx 1 1/2wks later there was a pimple like area which drained a clear liquid w/in the red area;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe
21 year old female with ACUT appt with reaction to Anthrax, left arm, states swollen on 3/13/03 with itching and redness. Significant erythema/pain in upper arm mostly down to lower arm. Also marked swelling. Seen in ER and given IM Benadryl; PO Motrin 800 to go and PO Keflex 250mg BID. Return for recheck tomorrow. Sick at quarters X 24 hours. Keep arm above level of heart and "continue" Keflex, just in case. Left arm 30.5cm X 27cm.
Breakthrough case: My symptoms included congestion, fatigue, headache, loss of taste & smell, and loss of appetite. I received monoclonal antibodies on 09/07/2021. I am still dealing with the fatigue and headache.
Patient is fully vaccinated and boosted 10/24/2021. COVID positive. 64 y/o female with CAD, COPD, Hx of 7 reported cardiac stents with multiple cardiac catheretization, most recently in '21 who presents to the ED today with the concern of heart palpations. Positive for neck pain. She denies any chest pain or diaphoresis at this time. She reports numbness and tingling in her right hand. Positive for congestion.CXR: no acute pulmonary process.  BP (!) 200/85  | Pulse 100  | Temp 98.2 °F (36.8 °C) (Oral)  | Resp 18  | Ht 157.5 cm (5' 2")  | Wt 64 kg (141 lb)  | SpO2 98%  | BMI 25.79 kg/m² She was given Toradol and IVF. Cardiac work up was unremarkable. She completed cervical spine and head CT that was negative for any acute process.She was given a prescription for Motrin 800 mg for pain control.Pt discharged from ED.
Arm soreness at injection site; Fatigue; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 8 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 Immunization. The following information was reported: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Arm soreness at injection site"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Weakness and dizziness. Not fully coherent to take evening blood pressure pill at 7:30 pm. Right hand motor skills not good. Could not hold water bottle to take pill.
So much pain that you can hardly lift your arm and this never happens with flu shots; So much pain that you can hardly lift your arm and this never happens with flu shots; She did report that she had injection site pain that was worse than any other vaccine she has received; She did report that she had injection site pain that was worse than any other vaccine she has received; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shots (So much pain that you can hardly lift your arm and this never happens with flu shots), for immunization. The following information was reported: LIMB DISCOMFORT (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "So much pain that you can hardly lift your arm and this never happens with flu shots"; VACCINATION SITE PAIN (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "She did report that she had injection site pain that was worse than any other vaccine she has received".  Additional information: The patient stated that she received her first dose of the Pfizer Covid 19 vaccine two days ago. She did report that she had injection site pain that was worse than any other vaccine she has received. So much pain that you can hardly lift your arm and this never happens with flu shots. It did not hurt going in and it just hurt after. She confirmed that this has resolved. She reports everyone that she has talked to has experienced this and references hundreds of people. The patient asked the efficacy of the first shot percentage and how many days. The patient asked how long after second dose for maximum efficiency. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101076590 same reporter/product/event, different patient
I tested positive on 01May2023 with a home test.; I tested positive on 01May2023 with a home test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 5 (booster), single (Lot number: gj6742) at the age of 59 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: el3247), on 25Mar2021 as dose 2, single (Lot number: ep6955), in right arm, on 29Oct2021 as dose 3 (booster), single (Lot number: fe3509), in right arm and on 07Apr2022 as dose 4 (booster), single (Lot number: fl3197), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMBIEN. The following information was reported: VACCINATION FAILURE (medically significant) with onset 01May2023, outcome "not recovered", COVID-19 (medically significant) with onset 01May2023, outcome "not recovered" and all described as "I tested positive on 1May2023 with a home test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2023) Positive, notes: I tested positive on 01May2023 with a home test. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Information: Facility type vaccine was  clinic. No other other vaccine in four weeks. Other medications in two weeks: ambien. Patient tested positive on 1May2023 with a home test. No covid prior vaccination. If covid tested post vaccination was Unknown