chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female who on 30-JUN-2008 was vaccinated with the first dose of GARDASIL 0.5 ml IM.  On 30-JUN-2008 the patient experienced faint and tonic clonic for 10 seconds.  The patient regained consciousness and was observed in the office for 30 minutes.  The patient was given juice and her blood pressure and pulse were monitored.  The patient was discharged home.  The patient recovered from faint and tonic clonic on that same day.  The patient sought medical attention in office.  Upon internal review, tonic clonic was determined to be an other important medical event.  Additional information has been requested.
pt recvd vax; lt arm is swollen & blistered; given dph; itch per MD on 4oct95;
This case was reported by a nurse and described a 75-year-old female subject who was vaccinated with Engerix-B and subsequently tested positive for hepatitis B surface antigen. Medical history included renal failure (cause not specified) requiring hemodialysis. Concurrent medications included Enalapril, Nephro caps (Nephro cap), Biotin, Tramadol hydrochloride (Ultram), Amitriptyline hydrochloride (Elavil), Lansoprazole (Prevacid),  Diltiazem hydrochloride (Elavil), Lansoprazole (Prevacid), Diltiazem hydrochloride (Cardizem), Amiodarone hydrochloride (Cordarone), Aspirin (ASA), Thyroxine sodium (Synthyroid) and Psyllium husk (Regulan). On 04 February 2006 the subject received 1st dose of Engerix-B (lot AHBVB194AA). On 09 February 2006, 25 days after vaccination with Engerix-B, the subject "had lab work done" that was positive for hepatitis B surface antigen. The event resolved on an unspecified date on or before 22 February 20006. The nurse considered the event to probably be related to vaccination with Engerix-B.
16JUN96 seen by MD swollen lymph nodes, inc temp (placed on ceclor);19JUN96 screams when eats, awake @ noc, not eating, spots,-flat, reddened on torso, neck
Saturday midnight stared with a headache, Sunday morning woke up around 9:30 to get milk for my 2 year old boy, wanted to take a Tylenol for the headache when I stared to feel really nauseous and fainted. I remember waking up laying down on the floor, I screamed at my husband I couldn?t get up. And my husband got me up from the floor  when I fainted again in his Arms. He states I was unconscious for 10-15 seconds. After I wake up my headache and nauseous went always. I was fine the whole day.
Patient reports pain and loss of use of arm after receiving Prevnar13.; Patient reports pain and loss of use of arm after receiving Prevnar13; This is a spontaneous report from a contactable consumer (patient) communicated to Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history was not reported and concomitant medications were not reported. The patient reported pain and loss of use of arm after receiving Prevnar13. She explains it was two to three years ago and she still does not have full range of motion in the arm and still has pain. Event took place after use of product. The event outcome was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
I was positive for COVID-19 on 12FEB2023, I had fever and very nauseous, diarrhea and very fatigued. I was given PAXLOVID from the urgent care because I was so sick. I started feeling better about day 3.
pt recv vax 14JUL97 & the next day pt exp a large local rxn described as red, swollen, warm, raised & the size of 3 silver dollars;
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided
Arm pain with redness, warmth, induration at injection site.  Decreased limb mobility secondary to pain.
89yo admitted to HCF from another facility following an admission for heart failure and pneumonia.  Developed dyspnea and fever, diagnosed with influenza.  Elevated troponin levels prompted a cardiology evaluation and diagnosis of NSTEMI.  Worsening of his CHF necessitated use of milrinone and increased diuresis.  Was needed to be in the ICU due to hypoxia.  Treated for MSSA pneumonia and MSSA bacteremia. TEE negative for bacteremia.   Discharged on high flow O2 and bipap to SSH. NP discussed his goals of care. Patient told NP he was ready to be comfortable and does not want HD or a feeding tube.  NP explained that the cessation of treatment would lead to death. Patient request for Hospice and change in code status to DNR/DNI with an emphasis on comfort is appropriate with his current medical condition, new HD requirement, and comorbidities.   He voiced clear wishes to go home to die. Transitioned to focus on comfort. Patient was pronounced at 0548.
Approximately 10 days post vax pt developed a rash that consisted of approximately 20 lesions. The pts siblings had a similar experience following exposure to varicella virus vaccine live. Pt experienced a second rash that was most likely a breakthrough infection after being exposed to her unvaccinated sibling who had a rash approximately 3 weeks prior.
Face, arm and neck rash; Red around nail beds of fingers; This is a spontaneous report from a non-contactable consumer or other non HCP (patient). A 62-year-old female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 19:45 (Batch/Lot Number: En6201) as DOSE 1, SINGLE (at the age of 62-year-old) for covid-19 immunisation. Medical history included Et (platelets disorder) and Known allergies to Mangos, walnuts, red peppers and Latex from an unknown date and unknown if ongoing. Concomitant medications included interferon alfa-2b and acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had face, arm and neck rash and red around nail beds of fingers on 10Feb2021 at 20:45. It was reported that this event lasted about an hour then went away. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events reported as recovered on 10Feb2021.  No follow-up attempts are possible. No further information is expected.
Developed redness, warmth, swelling right anterior thigh less than 24 hours after immunization.
headache/headache that turned into a migraine; migraine/headache that turned into a migraine; vomiting/she is throwing up; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (reporter's mother) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller spoken to safety before being transferred. Caller called on behalf of his mother. Caller stated my mom's got the second dose of the Pfizer Covid-19 vaccine. She developed a headache, migraine and vomiting post vaccination on 10Feb2021. Caller wants to know if it was safe to use excedrin an over the counter medication. Caller stated I was transferred several times. I had to give my information each time. His mom received the second shot of the covid vaccine. She woke up today with a headache which turned into a migraine. Now she was throwing up. Asking if it is safe to take generic Excedrin. He was on hold for a long time and was told we would be able to answer his question. He declined to complete a report and requested to be transferred to address question. The clinical outcome of events was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a patient's husband via Bayer HealthCare Pharmaceuticals (BUS-2016-US-008010) and refers to a 60 year old female patient who was not pregnant. The patient's medical history and current conditions were not provided. On 11-JAN-2016, the patient was vaccinated with a dose of ZOSTAVAX (manufacturer unknown) (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported, On an unknown date approximately in 2016, the patient's arm became swollen and red. After going to the urgent care, she was prescribed unspecified antibiotics but the redness continued all the way to her elbow. She went back to urgent care and was prescribed LEVAQUIN. The outcome of adverse events was reported as recovered on an unknown date approximately in 2016 (reported as "subsided"). The relatedness between adverse events and ZOSTAVAX (manufacturer unknown) was not reported. Additional information has been requested.
Severe shaking, chills, crying, 102 fever, nauseous, anxiety attack that lasted 4 hours, fatigue, dizziness, and weakness
He received the vaccine in the afternoon and a few hours later started experiencing pain on his left ankle and lower leg. He described this as muscle pain around his ankle and shin, including his Achilles tendon.
Chest tightness; Numbness of the toes 3 plus days after taking the booster shot; Dose received 3; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 06Dec2021 at 10:30 (Lot number: 33130BA) at the age of 27 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN6206; Anatomical site: Left arm; Administration time: 12:00), administration date: 15Mar2021, when the patient was 26 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0150; Anatomical site: Left arm; Administration time: 12:00), administration date: 11Apr2021, when the patient was 26 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 at 10:30, outcome "unknown", described as "Dose received 3"; CHEST DISCOMFORT (non-serious) with onset 07Dec2021 at 12:00, outcome "not recovered", described as "Chest tightness"; HYPOAESTHESIA (non-serious) with onset 07Dec2021 at 12:00, outcome "not recovered", described as "Numbness of the toes 3 plus days after taking the booster shot". Therapeutic measures were not taken as a result of chest discomfort and hypoaesthesia.  Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted immediately after dose, fell and hit his head, a scrape on his forehead was cleaned up with hydrogen peroxide, applied antibiotic ointment, and covered up. Patient was given water and orange juice, his BP and pulse were within normal limits. Advised him not to drive home and to make appointment with doctor to rule out concussion. A relative is picking him up.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site erythema (red circle at the injection site) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026L20A) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. On an unknown date, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced  vaccination site erythema (red circle at the injection site). At the time of the report, vaccination site erythema (red circle at the injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications and treatment information provided.
puffiness; raised areas; rash; Very tired; Pink blotch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (puffiness), RASH PAPULAR (raised areas), RASH (rash), FATIGUE (Very tired) and VACCINATION SITE ERYTHEMA (Pink blotch) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Pink blotch). On 25-Mar-2021, the patient experienced VACCINATION SITE SWELLING (puffiness), RASH PAPULAR (raised areas), RASH (rash) and FATIGUE (Very tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 26-Mar-2021, FATIGUE (Very tired) had resolved. At the time of the report, VACCINATION SITE SWELLING (puffiness), RASH PAPULAR (raised areas), RASH (rash) and VACCINATION SITE ERYTHEMA (Pink blotch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-060118 (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site pain , vaccination site swelling, vaccination site erythema, fatigue and rash are consistent with the known safety profile of the vaccine. US-MODERNATX, INC.-MOD-2021-060118:Case for first dose
I have had a headache not resolved by medication since this date. It is nearly unbearable at times. I have just recently contacted my employee health department. Another employee who received her shot the same day is also complaining of a headache.
Patient received SARS-CoV-2 (COVID-19) mRNA BNT-162b2 vaccine (COVID Vaccine ? Pfizer 30 mcg/0.3 mL).  They should have received their bivalent Pfizer COVID booster.
Approximately 5-6 days after receiving the first vaccine shot, I experienced severe ringing in my left ear and reduced hearing.    I've seen an ENT. I was initially prescribed an oral steroid for 2 weeks.   Symptoms didn't improve after 2 weeks on the oral steroid.  I'm now receiving steroid injections direction into my ear drum.     The symptoms have not yet improved.   The ringing in my left ear is fairly severe and I've experienced significant reduction in higher tone hearing in my left ear (based on hearing tests at the ENT).
Information was received regarding a case in litigation concerning a 26 year old female who suffered from Type 1, Juvenile Diabetes for the majority of her lifetime. On or about 13-DEC-2011, the patient was admitted to the hospital with a diagnosis of uncontrolled diabetes mellitus with ketoacidosis (DKA). The patient was treated with an insulin drip and met with a dietician while in the hospital. On 14-DEC-2011, while preparing for discharge, the patient was administered PNEUMOVAX23 and FLUZONE. The patient began experiencing shortness of breath on 18-DEC-2011 and was taken to hospital via ambulance. At the hospital the patient was diagnosed with pneumonia, acute respiratory failure and diabetic ketoacidosis (DKA). The patient was orally intubated and mechanically ventilated. Shortly after admission, the patient went into acute respiratory distress and became septic. The patient fell into a coma for approximately one month. The patient was hospitalized for a total of two months and was discharged on or about 09-FEB-2012. The patient never fully recovered from this hospitalization and spent the remainder of her life in and out of hospitals. The patient passed away on 02-NOV-2013 as a result of pneumonia. The patient suffered pneumonia, sepsis, respiratory distress/failure, coma and death which were a direct and proximate result of PNEUMOVAX23 and FLUZONE vaccinations. Upon internal review, coma, sepsis, and diabetic ketoacidosis were determined to be medically significant events. Additional information has been requested.
throat tightening up; trouble breathing; I had scratches all over my body; tounge and mouth were swollen; tounge and mouth were swollen; hives; This spontaneous report was received from a 67-year-old female consumer reporting on herself. The patient's concurrent conditions included diabetes. The patient's concomitant therapies included losartan, ezetimibe(ZETIA), levothyroxine sodium(SYNTHROID), duloxetine hydrochloride(CYMBALTA), gabapentin, insulin aspart(NOVOLOG), insulin detemir(LEVEMIR), dulaglutide(TRULICITY), omega 3 and metformin. The patient's historical medications included a pneumococcal vaccination in 2020. The patient's historical conditions were not reported.      On 22-FEB-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the left upper arm for prophylaxis (dose, route of administration, lot number and expiration date not reported).      In February 2022, the patient experienced hives (urticaria), swollen tongue, mouth swelling and scratches all over her body.  On 24-FEB-2022, the patient experienced throat tightness and dyspnoea. the patient went to the emergency department where Benadryl, prednisone and pepcid were administered intravenously, and was prescribed famotidine, banophen and prednisone tablets 50 milligrams all for 7 days to be taken at home,     The outcome of urticaria, swollen tongue, mouth swelling, scratch, dyspnoea and throat tightness was reported as resolved on 28-FEB-2022. The reporter considered the events related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).     Upon internal review, all the events were considered medically significant.
I received my Bivalent booster on 09/28/2022. My COVID-19 symptoms started on 12/05/2022 in the afternoon around 03:00PM. I had a runny nose and sneezing. The following day 12/06/2022 I had runny nose, sneezing and cough. Since, I wasn't feeling well and I had an appointment with my doctor on 12/08/2022. I took a home COVID-19 test on the 12/07/2022 which was positive. I did another home COVID-19 test just to make sure and it was positive again. I called my doctor to tell him that I was positive. He prescribed me with PAXLOVID for 5 days. I had very mild symptoms.
A report was received from a health care professional on 11/20/03 concerning a male vaccinee in his 20's who experienced a red, swollen and warm to touch injection site immediately after inadvertently receiving Fluvirin via a needleless injector on 11/13/03. On 11/13/03 the vaccinee experienced a red, swollen and warm to touch injection site after inadvertently receiving Fluvirin via a needleless injector. The outcome of the events was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
2/27/04 Phone call. Mom noticed large lump in left thigh, swelling around thigh reddened and warm to touch. No fever went to doctor. Diagnosed as infection at the site. Prescribed Z-Pac. Follow-up report: 2/27/04 Initial report of localized swelling at injection site treatment with Zithromax. 2/28/04 continued swelling, redness, heat to left thigh. Taken to ER. Site measured at 10 cm x 11 cm. Admitted for IV antibiotics. Child doing well active, continue with small lump at injection site. Discoloration to affected site. No other complaints.  Follow up 05/10/2004 Telephone call from pt mother. Family has been on holiday for the past 2 1/2 weeks. Follow up call on child: pt is doing great. She continues with discoloration at indentation surrounding the site, and a lump at the injection site. No other c/o. No difficulties with activities. Information from Annual Follow-up report states , Mother states, "Completely recovered," 4/19/05.
He got his vaccine, felt punky, just didn't feel normal.  He got up that morning and sat around, he talked with his wife, and he went into the bathroom and took a shower, standing at the sink shaving and got half done and felt light headed and he stopped shaving, laid everything down and the next thing he was on the floor.  He does not think that he was out that long, while he was falling he hit the wall, probably slid down the wall and his wife heard him and found him.  His wife called the clinic, which is part of hospital system, and talked to a nurse who told them if it happened again to come in.  His BP was just very slightly elevated, and pulse and everything else was good.  He did not have any more episodes.  When he finally got on his feet, slept for a while and when he got up he felt great.
Information has been received from a RN concerning a 6 y/o male pt with no allergies and no past medical history who on 13Jul98 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. Illness at the time of vaccination included pharyngitis. There was no concomitant medication. On 01Sep2003 the pt developed a rash that included approx. 500 to 700 maculopapular lesions described as "insect bite like lesions" on his face, chest, back, arms and legs. Laboratory tests were no performed and treatment was not required. Subsequently, the patient recovered. The reporter noted that therapy with varicella virus vaccine live was discontinued on 13Jul1998. A product quality complaint was not involved.  Additional information is not expected.