chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A pharmacist reported that an 11 year old female pt inadvertently received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 Formula) nasal solution (frozen)) into a single nostril on 12/12/2003.  The reporter indicated that the pt does not have any relevant medical history.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/12/03.  Concomitant medications were not reported.  Concomitant vaccines were not administered.  On 12/12/03, a female pt inadvertently received a dose of Flumist into a single nostril.  The reporter indicated that the pt stated the Flumist "tasted sweet" right after administration.  No additional information was available at the time of this report.
Information has been received from a 59 year old female physician with multiple sclerosis and no known allergies who in 1992 received her first series of Recombivax HB and a second series in 1999 for a total of 6 doses.  There was no concomitant medication.  On 05-NOV-2007, laboratory studies revealed a negative titer.  It was reported that the patient was seen by a physician for unspecified treatment.  At the time of this report, the patient had not recovered.  A product quality complaint was not reported.  Additional information has been requested.
DTP administered 14OCT93 fever to 103: excessive crying inconsolable for 3 hrs;
I started feeling little sniffly on 09/30/22. I tested on Friday 10/01/22 using a home COVID-19 test but it came back negative. I tested again on Monday 10/3/22 using a home COVID-19 test that came back positive. Once I got the positive my Midwife who advised me to receive the monoclonal antibodies, I was also advised to drink plenty of water monitor for fever standard protocol for sickness. I am feeling better just fatigued. I have had a normal pregnancy, estimated delivery date 01/31/23.
This is a spontaneous report from a contactable nurse. A 61 years old female patient received on 17DEC2014, the first dose of PREVNAR13 at 0.5 ml single, intramuscular, in the arm. No other vaccines were given on the same date along with suspect vaccine. Medical history was not provided. The nurse stated the patient was on so many medications and was in a hurry, so the medications were not provided to the caller. Within an hour after receiving the product, on 17DEC2014, there was a golf ball sized injection site reaction. The patient returned to the doctor on 19DEC2014 after the reaction worsened and got bigger extending from her shoulder to her elbow. At the time of the report the event was not resolved.
pain; swelling; headache; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced pain, swelling and headache. On an unknown date, the outcome of the pain, swelling and headache were unknown.   It was unknown if the reporter considered the pain, swelling and headache to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient wanted to know how long would patient expect to suffer from pain, swelling and headache. No additonal information could be obtained.
swollen lymph nodes around my neck; diarrhea; severe headache; chills; fever near 102; muscle aches; profuse sweating; felt freezing cold; inability to sleep; This is a spontaneous report from a contactable other hcp, the patient.   A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, administered in the left arm on 25Feb2021 at 10:00 (at the age of 22-years-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received the first dose of BNT162b2 on 04Feb2021 at 10:00 (Lot Number: UNKNOWN; at age of 22-years-old) via an unspecified route of administration in the left arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Feb2021 at 16:30, the patient experienced in order, diarrhea, severe headache, chills, fever near 102, muscle aches, profuse sweating although felt freezing cold, inability to sleep. The headache has lasted 3 days now as well as swollen lymph nodes around his neck. The patient did not receive any treatment for the events. The patient was recovering from the events, swollen lymph nodes around his neck, diarrhea, severe headache, chills, fever near 102, muscle aches, profuse sweating, felt freezing cold, and inability to sleep.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
I woke up the next day with my entire body sore.  I felt like I had been in a car accident.  My left quad muscle hurt the most.  I was actually limping around.  I was exhausted and slept for most of the day.  That lasted about 24 hours.  Two days after the vaccine, I had a rash on my chest, stomach, back and neck.  It was red and bumpy, but did not itch. I did not take anything for it and it lasted 2 days. I tested positive for covid 6 weeks before receiving the vaccine.
Pt received Menveo, influenza and Gardasil vaccinations.  Immediately after administration of last vaccine, Gardasil, pt began experiencing syncope, stiffening, arching back and demonstrated seizure-like movements.  Episode lasted about 10-15 seconds.  Pt. was seated during immunizations.  Restrained pt in chair until alert.  Pt stayed in chair, periodically putting head between knees, and observed for 30 min.  Pt was alert upon leaving clinic.
Pt recvd 1st & 2nd dose of Hep B vax & following 2nd dose pt donated blood & tested pos for Hep B;
Patient is a 43 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER8732 on 3/25/2021. The patient experienced the following reaction(s) during the immediate  of observation: 11:58am Patient vaccinated. 12:14pm Patient c/o difficulty breathing and shortness of breath at rest during observation period. Patient was treated/managed as follows:  12:15pm VS BP 142/72, HR 94, RR 20, O2 sat 96% on room air. Patient educated on breathing techniques. No swelling noted to mouth, tongue or throat. Patient reports symptoms slightly improving. 12:25pm VS BP 138/78, HR 85, RR 20, O2 sat 98% on room air. Patient reports feeling better and symptoms subsiding. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 12:33pm Patient escorted to car by site lead Parnesh and patients daughter.
administered ACTHIB to a patient but the diluent had expired 4 days prior/ no AE; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case received from the other health care professional (Medical assistant) via Medical Information (Reference number- 00378491).  This case involves a 17 months old male patient who received a 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] single-dose vial (lot: UJ175AAA, diluent expiry date: 26-Nov-2020, vaccine expiry date: 02-May-2021) via intramuscular route in the right outer thigh, on 30-Nov-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) and INFLUENZA VACCINE (FLU) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).   Medical Assistant (MA) reports that they administered ACT-HIB on Monday to a patient but the diluent had expired 4 days prior. MA requests to know if there no contraindication or side effects. They discarded the expired diluent. Patient received a dose of ACT-HIB on 30 Nov 2020 for which the diluent had expired on 26-Nov-2020, although the ACT-HIB vial itself did not expire until 05 Feb 2021. MD name and dose number in series not available. Medical assistant did not have the lot number for the diluent vial. Product used: Used.  At the time of report no adverse event was reported.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Unwitnessed fall to the floor.  Pt was standing when mom turned to get belongings.  Mom heard a "thump" and turned to see pt laying face down on floor motionless.  She picked pt up who was awake and immediately began crying.  This all happened in one minute or less, and occurred several minutes after child received vaccinations because mom put pants, socks, shoes, and coat on child before putting her on the floor.  Child was examined after the fall and was found to be appropriate, neurologically intact and with no injury that needed further treatment.  She was allowed to go home with mom.
Felt dizzy - BP 126/71 (supine), 110/70 (sitting), HR 90, O2 sat 98%. Patient rested then felt better.
Patient had a several vagal down response almost right at the 15 minute wait time mark. She started sweating, going cold, light headed, and nearly passed out. She was assisted in lying down and was given cold water. She recovered from the reaction shortly after and was able to go home on her own with no continued issues.
FLU-LIKE SYMPTOMS; This spontaneous case report (PVX2019-2659) was received from a consumer on 24-Oct-2019. Additional information was received on 28-Oct-2019. It described a 71-year-old elderly female consumer who experienced flu-like symptoms (PT: Influenza like illness), while being on Vivotif (lot number: 3003277) for traveling.   Case report: The consumer took her first dose of Vivotif on 18-Oct-2019. On 23-Oct-2019, she started experiencing flu-like symptoms included feeling sick and coming down with the cold or flu. She was coughing all day and she had a runny nose. She took her last dose of Vivotif on 24-Oct-2019. The consumer stated that the symptoms were not getting better or worse. She started gargling with warm salt water as a treatment which was not helping a lot and was planning to take Sudafed.  The consumer's past medication included flu shot on 17-Sep-2019.  Action taken with Vivotif with respect to reported event was dosage maintained.  The consumer had not recovered from the reported event.  Company's Comment: In this case, it was reported that the consumer had flu-like symptoms following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, flu-like symptoms are labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had flu-like symptoms following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, flu-like symptoms is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Dizziness, Diarrhea, NauseaVomiting, fatigue and stomach upset a few hours later; the dizziness and chills; resolving
Heart palpitations; Dizzy/Light headed; Blood pressure dropped; Tachycardia; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 09Aug2021, this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: ER8727; expiration date: 30Jun2021), intramuscularly administered in the left arm on 28Mar2021 15:15 (at the age of 65-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included hypothyroidism, sensitivity to cold medicines, and atrioventricular nodal reentrant tachycardia (AVRNT) from 2015 to 20Apr2021 (ablation done on 20Apr2021). Concomitant medications included thyroid (ARMOUR THYROID) and levothyroxine sodium (SYNTHROID). The patient previously took guaifenesin/phenylephrine hydrochloride (ENTEX) and sulindac (CLINORIL) and experienced drug allergy with both drugs. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205; expiration date: 30Jun2021) intramuscularly administered in the upper arm (unspecified which side) on 07Mar2021 15:00 (at the age of 65-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccinations within 4 weeks of the COVID vaccine. On 28Mar2021, the patient experienced heart palpitations, tachycardia, dizzy/light headed, and blood pressure dropped approximately 1 and a half to 2 hours after the vaccination. The heart palpitations and tachycardia lasted for 15 minutes. Therapeutic measures were not taken as result of the events. The outcome of events palpitations and tachycardia was recovered on 28Mar2021. The outcome of event dizziness was recovered on an unspecified date while the outcome of event blood pressure dropped was unknown. The event palpitations was reported as serious (important medical event).  Follow-up attempts are completed. No further information is expected.
WITH IN THE FIRST 15 MINUTES I EXPERIENCED DIZZINESS. WITHIN THE FIRST HOUR MY EYE BROWS SWELLED AND I HAD A RIGHT SIDED FRONTAL HEADACHE. I TREATED WITH ICE PACK, TYLENOL, AND CLAIRITIN. 2 HOURS LATER I FELT LIKE I WAS AT HIGH ALTITUDE WHICH LASTED FOR 36-48 HOURS. tHE SWELLING BROKE DURING THE NIGHT WITH MASSIVE EYE TEARING AND POST NASAL DRIP. I CRAVED BLACK LIC0RICE LIKE MAD.
Rectangular rash 6 x 14 cm at injection site 2 days after administration oval central raised granular texture/early flat coalesced vesicles. Pruritic.
This spontaneous report as received from a registered nurse, via company representative, refers to a 21 year old non pregnant female patient of unknown age. The patient did not have any pertinent medical history or concomitant medications. The patient's concurrent conditions included shellfish allergy. On 06-DEC-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # N021571, expiration date 29-APR-2020 (dose number and route of administration were not provided) for prophylaxis (reported as "routine vaccination"). In December 2017, after receiving GARDASIL 9, the patient experienced pain in her ribs (musculoskeletal chest pain), joint pain, fatigue and bloating. The patient sought medical attention by calling her physician on 14-DEC-2017. Moreover,  blood work, chest X-rays were performed, she also went to the cardiologist.  Additionally, the patient's mother called the reporting nurse to state that the patient was having insomnia, her feet and hands were numb (Hypoesthesia) and constantly sweating (Hyperhidrosis) and she was "easily winded" (Dyspnoea). The reporter considered that there was significant disability or incapacity as the patient was not able to go to school and leaving the house. The outcome of patient's pain in ribs, joint pain, fatigue and bloating was not reported. While the outcome of the patient's insomnia, feet and hands numbness, constantly sweating and dyspnoea was not recovered at the time of reporting. The reporting nurse did not relate the patient's adverse events to GARDASIL 9. The reporting nurse did not assess the causal relationship between the patient's adverse events to GARDASIL 9.
Approximately  30 minutes after vaccine, she experienced an itchy red rash on neck, and "minor throat thickening".  Had gone to lunch following  the vaccine, and didn't know if it was related to something she ate, or the vaccine. She returned to the clinic to be checked by the nurse there. Was given 25 mg of Benadryl.  Felt better and sent home.
administered the Moderna vaccine after the manufacturer date of expiry, to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna vaccine after the manufacturer date of expiry, to a patient) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084j21a, 026d21a and 054c21a) for COVID-19 vaccination.     Patient had no allergies to medicines, food and other products. It was unknown that patient ever had COVID test or diagnosis. Patient had no history related to AE both acute or chronic illnesses at the time of vaccination.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna vaccine after the manufacturer date of expiry, to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the Moderna vaccine after the manufacturer date of expiry, to a patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications  were reported. The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized) The patient had not experienced a similar event in the past. Patient had no symptoms after receiving the vaccine. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The date vial was initially stored in the refrigerator 11-Apr-2022.The vial did not undergo any temperature excursions. No treatment details  was reported.
Sharp pain in the ears as if in an ear infection before the drums burst. Tingling and burning in the face. Dizziness and vertigo. Had to hold onto things while going to bathroom as of not to fall. Also the more usual side effects (same as with 2nd dose) of fever, severe chills, fatigue, pain in muscles and spine (mostly back and neck). Half a tennis ball size hard red swelling that burns and is painful to touch.
blood sugars have been out of control in the range of 400-500's; This is a spontaneous report from a contactable nurse reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EH9899/expiration date: not provided), via an unspecified route of administration, on 31Dec2020 at 04:15 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included insulin-dependent diabetes mellitus (IDDM) ongoing since an unknown date and thyroid cancer excised on an unknown date. The patient had a penicillin allergy and Nubain allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included insulin lispro (HUMALOG), insulin glargine (LANTUS) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jan2021, the patient experienced blood sugars have been out of control in the range of 400-500's. The event blood sugars have been out of control in the range of 400-500's did not result in hospitalization. The patient received treatment for the event blood sugars have been out of control in the range of 400-500's included increasing the amount of insulin. The patient reported that after receiving the vaccination, her blood sugars have been out of control in the range of 400-500's. She was doubling the amount of insulin with little ability to get her sugars within normal range. It took a week to 10 days for her insulin requirement to come close to baseline after the first vaccine dose. The outcome of the event blood sugars have been out of control in the range of 400-500's was unknown. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on a compatible temporal association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to event "blood sugars have been out of control in the range of 400-500's" in this insulin-dependent diabetes mellitus patient cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt reports generalized body aches, fatigue, fever 3/26, one day after receiving vaccine. Evaluated at ED 3/28, received Ketorolac and was discharged. While in parking lot, patient experienced blurring of vision, lightheadedness, nausea, SOB, and left-sided chest pain with return for re-evaluation. Pt treated for possible allergic reaction and concurrent EKG and blood work showed elevated troponin and transient ST elevation. Cardiology consulted and evaluated patient to have severe acute onset systolic heart failure, cardiogenic shock with pulmonary edema, Idiopathic fulminant myocarditis with myonecrosis, and hypoxic respiratory failure. Placed on furosemide, supplemental oxygen, and pending MRI.
When I got home, I had a headache. I felt tired. I took a nap. When I woke up, I was sick. I was nauseated, my stomach and body hurt all over. The headache was three days long. I felt achy and sore the next day as well. I felt like I had a flu. There were huge blood clot looking blisters, and red dots on both my arms. My left arm was worse than my right arm. I called the doctor and she asked me to come in, but I had to take pictures first of my arms before coming in. Then when I was able to go to the office, I took blood tests and the MRI. Everything came back okay.
Right arm redness, swelling, hardness occurred after patient left clinic, went to ED that night. Was prescribed cephalexin and didn't take it. Used cold compresses without relief.
Severe headaches, sweating, fevers, back/body aches, muscle cramps in thighs, small rash on left arm.
Fever 101.6, body aches, chills lasting a little over 2 days