chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 14 year old female with no medical history and no allergies who on 02-FEB-2007 was vaccinated with a second dose of HPV (lot # 655503/00120), intramuscularly. The first dose of GARDASIL was given on 27-Oct-2006. There was no concomitant medication. On 02-FEB-2007 the patient experienced intermittent headache and soreness at the injection site of the left arm. The patient was examined by the physician on 20-FEB-2007 and was recommended Tylenol. The patient's symptoms lasted for three weeks after which she recovered. No product quality complaint was involved. It was noted that the first dose of HPV was received on 27-OCT-2006. At the time of the report, the patient was considered to be not recovered. Additional information has been requested.
temp 101, fever, rash, cough, vomiting, malaise; has an appt 28MAY93; seen on 26MAY93 w/sore throat & sleepy;
Headache, Fever, Diarrhea & NauseaVomiting Narrative
Have noted approx. 5 separate local injection site redness, inflammation, swelling of suspected DTH reaction at injection site with pneumococcal vaccine. All spontaneously resolved.
During post shot observation time of 30 minutes, patient developed globulus sensation at the 20 minute mark. Water was provided to see if it alleviated symptoms. At 30 minute mark, patient reported no change in condition and stated "it feels similar to when you are punched in the throat". Patient taken to medic area for vital signs and further assessment and evaluation. Recommendation made to patient by NP and Paramedic to transport to ER, patient refused transport. Risks explained to patient and patient verbalized understanding and refusal for medical transport to ER. Patient remained in observation for 15 more minutes  with no change in condition. Patient discharged home with companion and educated on seeking medical treatment if condition worsened. Patient and companion verbalized understanding and understanding of risks.
positive for covid-19.  EE stated coughing, running nose on 8/24/21 and lost of smell 8/25/21
Patient stated her blood pressure increased from SBP~140 to SBP ~170.  She stated blood pressure remained elevated for about a week, then returned to normal levels.
Moderna vaccine was administered outside of our facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED ---------------------------------------------------------------------------------------------------------------------- I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 6/9/2021 LEFT LEG CELLULITIS I95.9 HYPOTENSION 6/22/2021 LEFT LEG CELLULITIS
no adverse event; Patient was administered improperly stored Vaqta; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  On 05-FEB-2022, the hepatitis a vaccine, inactivated (VAQTA) (lot # U024504, expiration date 15-OCT-2022) was exposed to a temperature excursion of 0.8 degrees C for 35 minutes, and on 10-FEB-2022, the patient was vaccinated with it as prophylaxis (dose, route and anatomical location were not reported) (product storage error).  There was not previous temperature excursion.   This is one of multiple cases received from the same reporter.
11/3/2022: Pt admitted to hospital primarily for GI bleed, diarrhea, N&V, hypotension, dizziness, SOB.  Patient does have T-cell leukemia with chronic anemia and thrombocytopenia. He presents to clinic frequently for transfusions and IV fluids. He was there yesterday for the same.  Acute hypoxia - no respiratory symptoms, comfortable on 4 L - suspecting volume overload from IV fluids and transfusion - crackles on auscultation - check chest x-ray . 11/4/2022: Hospital course continues to be more complicated now noted to be in A. fib with RVR  Assessment and plan A. fib with RVR - likely due to hypoxia and respiratory insult Submitter does not have access to full hospital medical record. If further information is needed, please contact the local Hospital
Developed high blood pressure 168/100 (MAP 101)around 40 mins after vaccination which lasted more than an hour. I had pain from my left shoulder , left neck up to the base of my left head like throbbing pain. My left ear felt numb and warm since i was slightly reddish up to my arms. I didn't have to take any antihistamine since it subsided after half an hour.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 08-SEP-2022) dose was not reported, administered on 12-SEP-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 12-SEP-2022, 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. This report was associated with product quality complaint: 90000251570, 90000251571.
Anaphylaxis; Lightheaded/Dizziness; Throat Swelling; Scratchy Throat; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955), via an unspecified route of administration, administered in left arm on 12Apr2021 at 09:30 (at 24-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included known allergies: tree nuts. The patient had Covid-19 prior vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. No other medications were received in two weeks. On 12Apr2021 at 10:00 AM, the patient experienced anaphylaxis; lightheaded/dizziness; scratchy throat; throat swelling. The events resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events included epinephrine and steroids to prevent swelling. The outcome of the events was recovered on an unspecified date in Apr2021. The patient did not have covid test post vaccination.
Patient has developed localized redness, swelling & tenderness in right upper arm & Rt shoulder area, redness extending into the upper chest clavicular area. Pt was put on prednisone 20mg q daily & cetirizine 10mg daily.
scraped her left knee; scraped her third finger from her pinky; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (scraped her left knee) and LIMB INJURY (scraped her third finger from her pinky) 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 SCRATCH (scraped her left knee) and LIMB INJURY (scraped her third finger from her pinky). The patient was treated with ISOPROPYL ALCOHOL for Adverse event, at an unspecified dose and frequency. At the time of the report, SCRATCH (scraped her left knee) and LIMB INJURY (scraped her third finger from her pinky) outcome was unknown.            No relevant Concomitant medications were reported.   Reported treatment was OTC cut and burn antibiotic.    This case was linked to MOD-2021-077009 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (scraped her left knee) and LIMB INJURY (scraped her third finger from her pinky) 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 SCRATCH (scraped her left knee) and LIMB INJURY (scraped her third finger from her pinky). The patient was treated with ISOPROPYL ALCOHOL for Adverse event, at an unspecified dose and frequency. At the time of the report, SCRATCH (scraped her left knee) and LIMB INJURY (scraped her third finger from her pinky) outcome was unknown.            No relevant Concomitant medications were reported.   Reported treatment was OTC cut and burn antibiotic.    This case was linked to MOD-2021-077009 (E2B Linked Report).; Sender's Comments:  MOD-2021-077009:First dose of vaccine case.
Multiple shingles reactions (2 times, 2 different dermatomal locations) Patient had up to date shingles vaccine in the past
Lateral lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 07Mar2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, diabetes and allergy to iodine in vein (Iodine allergy). Prior to vaccination it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 09Mar2021 at 09:00, the patient experienced lateral lower back pain. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of lateral lower back pain and included treatment with Hydrocodone-Acetaminophen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lateral lower back pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Localized infection at site of Comvax. Omnicef 200 twice a day for 7 days.
upper respiratory infection; sinus infection; bronchitis; Flu; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a patient via Digital Media.  This case involves an unknown age and unknown gender patient who experienced upper respiratory infection, sinus infection, bronchitis and flu while receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious "upper respiratory infection" (upper respiratory tract infection) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious "sinus infection" (sinusitis) (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious "bronchitis" (unknown latency) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported " Author/Reporter Comment: Not getting this jab either. The only times I've had the flu was when I got the shot. Last time I had the flu, then upper respiratory infection then sinus infection then bronchitis. I'll take my chances without the flu jab. It is unknown if the patient experienced any additional symptoms/events. There were no lab data/results available."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (upper respiratory infection, sinus infection, bronchitis, Flu).  At time of reporting, the outcome was Unknown for the event upper respiratory infection, was Unknown for the event sinus infection, was Unknown for the event bronchitis and was Unknown for the event flu.
Patient seems confused post immunization. While being interrogated about his symptoms by pharmacist, wife stated his symptoms might be due to not having eaten after his insulin. Upon checking glucose level was 39 mg/dl. Patient has been given glucose tablet and soda which did not seem to normalize levels. EMS was called and administered D50 IV. Patient felt better within a few minutes of starting D50.
8/13/2012 Patient assessed by RN: 2 cm (width) x 1 cm (length) x 0.2 cm pink/red raised area from dermus. Warm to the touch.  Patient reports itching at site. Dr. assesed patient.  Cool compresses ordered.
chills, fever, shaking, sensitive skin, fatigue, itchy/painful rash, sore throat
Diaphoresis, itchy throat.  Patient has history of anaphylaxis.  Received 0.3 mg epinephrine, no change in symptoms.  Placed on 15L O2 via face mask.  Received second dose of 0.3 mg epinephrine and 50 mg diphenhydramine.  Transferred to Urgent Care, improved after transfer and was discharged to home.
On 05/01 pt developed redeness, soreness at inj. site. Used cold compress 5/1 and 5/2, at present pt arm is red, swollen approximately 1/3 of outter arm. Hot to touch. No lymphadenopathy on exam, no fever, full ROM.
Information has been received from a pharmacist referring to a 53 years old female patient with anemia, low iron level and unspecified thyroid issue. The patient was in an unspecified hospital two weeks ago (on approximately 05-SEP-2016) for low iron level and she received an iron infusion. Concomitant therapies included unspecified thyroid medication, hydrochlorothiazide (manufacturer unknown), PLAVIX, and NORVASC. The patient had no drug reaction or allergies. On 16-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, lot # L038926, expiration date: 06-JAN-2017) subcutaneously. On an unspecified date in September 2016, after receiving the vaccine, the patient noted redness and itching at the injection site where she received the ZOSTAVAX. The patient called the reporter's pharmacy and reported the events. She came into the pharmacy to seek medical attention on 18-SEP-2016, and the pharmacist noted redness and swelling at the injection site as well as "the area surrounding the ZOSTAVAX injection site was warm to the touch". Unspecified treatment had been given for the events. No lab test was performed. The patient did not recover from the events. The causal relationship between the events and ZOSTAVAX was unknown. Additional information has been requested.
It was reported, that a female pt received vaccines on 8/4/99. Reportedly, 4 hours, post vax, the pt experienced swelling of her left thigh from knee to thigh, redness and tenderness to touch. From additional information received on 8/19/99, additional pt and doctor information was provided.
The patient received their vaccination and before my immunizing technician could apply his bandaid he fell straight back while seated in his chair.  She was able to catch his fall and lie him on the ground.  I went into the immunization room to assist immediately and he was apologizing for scaring.  I asked him to lie there for a few minutes and take some deep breaths.  He was talking and aware of his surroundings.  I asked him about his medication history which was null.  I asked him if he had been nervous and he said he didn't think so. She said that he did mention he did not like needles.  He had not eaten since the morning (a bagel) and it was late in the afternoon.  After a few minutes I asked him if he would like to sit up so I could see how he was doing.  Management arrived and observed while I went to get a cold cloth for his neck/face.  Management asked him if he would like to sit in a chair.  He sat in a chair and before I came back after just a few minutes, he had slumped over to the side with his eyes rolling back.  Management  was concerned so they immediately called 911.  fire department and EMS arrived.  They tested his blood pressure, etc and said they believed he had just passed out.  They asked him if he wanted to go to the hospital.  He declined.  He called a family member to pick him up who arrived about 45 minutes after his vaccination.  He was walking around and coherent when he left.
Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA077678 (same reporter). This case involves a 6 months old female patient who received an expired dose of vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; ROTATEQ for Immunisation; HIB VACCINE for Immunisation; and POLIO VACCINE for Immunisation. On 18-Mar-2019, the patient received a dose dose of suspect DAPTACEL lot C5157AA via unknown route in the right leg. It was a case of actual medication error due to expired vaccine used. It was unknown whether adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Moderna COVID 19 Vaccine EUA facial numbness, quick onset, 20 minutes post injection. began at nose, and spread quickly across cheeks, to chin. very slight tingling at tip of tongue. No swelling, No difficulty swallowing or breathing. Resolved without intervention beginning after about 1 hour and totally resolved 1 1/2 hours after onset.  Over next 4 days periodic recurrence of facial numbness less pronounced, with rapid resolution within minutes  (total 3-4 episodes). Always beginning at nose and spreading across cheeks and chin.
My arm began itching shortly after the vaccine at the site administered and continued the next few days. On day 4 I woke with hives beginning on my chest which spread throughout the day to my scalp, hairline, sides of face and neck accompanied by INTENSE continual itching that didn't allow me to sleep. Hyrdrocortisone cream did not alleviate itching at all. My entire scalp itched insanely. Symptoms and hives continued for 2-3 days before subsiding.  Symptoms began Saturday and my dr. office was closed, I contacted nurse Monday Oct. 17 and was advised to take Benadryl for itching. Took Benadryl Tuesday but symptoms already subsiding considerably upon waking that morning. Hives and itching gradually diminished.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 30-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot#  N013863 and expiration date 31-OCT-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
IMMEDIATE ITCHING, SORE THROAT, SWELLING - APPROXIMATELY 3"X3" - RED, HOT--- ONGOING, CURRENT SYMPTOMS.
Client suddenly began to feel "woozy" during her post-vaccination monitoring period. She put her head down and said "I'm seeing colors". Client's responses were appropriate. Onsite EMS was called, client "perked up" and said, "I feel better". Client was evaluated by the medics, they cleared her to discharge home. Patient left facility of own volition.
Patient Requested to receive Janssen Vaccine, but Pfizer vaccine was administered instead. Patient is aware that she will need to return for a second dose to complete series on September 23 at Clinic. No harm was caused to patient.  Root Cause Analysis performed by Leadership team to avoid future events.
Swelling of axillary area, very pain darking tissue in the rt arm where the infection was given in my rt deltoid.
8/7/03 Rash on buttocks (diaper area). Diagnosed Candidae. Treatment: Nystatin cream QID. 8/13/03 Rash spread; papulovesicular lesions (about 8.9 lesions). Prescribed Isolate susceptible household contacts. Tylenol (infant) syrup 3/4 teaspoon every 4-6 hours and Calamine lotion PRN. 8/14/03 Follow up rash - all lesions over lower to mid abdomen are in different stages, papules, vesicles and scabbed. 8/23/03 Seen by unknown provider for weight check.
This spontaneous report was received from a medical assistant who reported that a 19 year old patient (gender not provided) was administered a pediatric dose of VAQTA, 0.5 ml, intramuscular (lot # not reported) on 03-JUN-2013. No adverse effect reported. Additional information is not expected.
Nausea onset the evening vaccine was received - 03/08/2021.   Severe headache the following day 03/09/2021.   Symptoms persisted and continued to progress/worsen.   Patient presented with neck stiffness, chest tightness, difficulty breathing, severe migraine.   Admitted to hospital where she was tested for viral meningitis and had lumbar puncture and CT Scan.   Treated with steroids.
Headache; Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIZZINESS (Dizziness) and NAUSEA (Nausea) in a 31-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache), DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Hives covering body.  Gave Benadryl.  She still has hives at this time.  It has been a month.  We have been to three doctors.  Taking 20mL of Zyrtec to help with hives.