chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning a her 12 month old son with no pertinent medical history and known drug reactions or allergies who on 11-SEP-2007 was vaccinated with VARIVAX (Oka/Merck) (658021/0827U). Concomitant vaccinations on 11-SEP-2007 include MMR II (lot # 654822/0806F), and HAVRIX on in each thigh. On 15-SEP-2007, 4 days after vaccination (also reported as 01-OCT-2007), the patient developed fever. The fever resolved and he was "fine" for 3 days but then on 08-OCT-2007 he developed a fever of 99F-101F for 3 to 4 days. His fever rose to 104F-105F until 18-OCT-2007. While her son was experiencing fever he was treated with MOTRIN and TYLENOL around the clock. He experienced shaking while he had a fever. Around 19-OCT-2007 he was referred for further investigation. He was examined by Infectious disease, Rheumatology and Hematology Department. Laboratory test revealed: White Blood Cell count was low, bone marrow biopsy was normal, sedimentation rate was high, neutrophil count was very low, Anti-neutrophil antibody (results not reported) and absolute neutrophil count was 78. At the time of the report on 19-JAN-2009 the patient was recovering. Patient sought medical attention at the office visit. No further information is available.
Patient received J & J vaccine in the morning.  By 4 pm, patient presented to ER with complaints of chills, lightheadedness, shortness of breath, chest tightness radiating to upper back.  Patient is tachycardic (heart rate = 107).  Patient has temp of 100.4 F.   Patient is treated with IV acetaminophen, ketorolac, and IV fluids. Vital signs normalized and patient is discharged home.
11/10/09 weakness in both legs & arms increased in left arm, tingling & numbness in hand & feet. 1st 2 weeks shooting pain down legs - now gone. Some memory loss - shaky & SOB continues. Has not been seen by MD headache x 3 wks.
Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse manager. This case involves a 4 months old male patient who received expired vaccine PENTACEL. The patients past medical history, concomitant medication and family history were not provided. On 02-Jan-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5449AA, expiry date 07-Dec-2018 via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used, as patient received expired PENTACEL. PENTAVEL box and the lyophilized powder were mixed from components from same box and 0.5 mL dose given. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
About 40 minutes after I received the injection in my right arm,  my right arm began to tingle all the way to my fingertips.   The sensation lasted for approximately 30-40 minutes,  then subsided.   No other reactions so far after that.   No loss of mobility in my arm or hand.
I was taking antibiotics (Levaquin) for Diverticulitis and had both The flu and Pneumonia vaccines. The right arm which had the Pneumovax was swollen with a rash The next day. (Fri). By Sat. I could barely move it. It stayed swollen and painful for 2 weeks in spite of ice, heat, & Aleve. It is still sore with movement. My doctor said it was probably a reaction with the Levaquin I was taking for the diverticulitis. Apparently one of the side effects of Levaquin is tendinitis and tendon rupture. I did have popping in my upper arm when the pain was at it's worst. I am worried because it is still sore  and online it says sometimes damage is permanent.
Not feeling well; Feels hot; Achiness all over; Chills; inadvertently given the Moderna vaccine  (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling well), FEELING HOT (Feels hot), MYALGIA (Achiness all over) and CHILLS (Chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (inadvertently given the Moderna vaccine  (2nd dose)). On 11-May-2021, the patient experienced VACCINATION COMPLICATION (Not feeling well) (seriousness criterion medically significant), FEELING HOT (Feels hot) (seriousness criterion medically significant), MYALGIA (Achiness all over) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 10-May-2021, WRONG PRODUCT ADMINISTERED (inadvertently given the Moderna vaccine  (2nd dose)) had resolved. At the time of the report, VACCINATION COMPLICATION (Not feeling well), FEELING HOT (Feels hot), MYALGIA (Achiness all over) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and lab values were reported. No treatment related information has been reported. This report refers to a case of wrong product administered for mRNA -1273, lot # 044B21A with AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of wrong product administered for mRNA -1273, lot # 044B21A with AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fatigued and tired, heart palpitations, shortness of breath at times, lightheaded ( felt like passing out 3 days after vaccine) Overall did not feel well. On the third day after the vaccine, i developed a rash type redness around my left eye, the rash went away by evening.
Started having dizziness, blurred vision and headaches when changing positions, going from laying to sitting to standing . When her heart rate was monitored it would increase from 65 to 110 -120 upon sitting and 140 -160 when standing. Symptoms started  August 30th and then proceeded to get worse. We saw primary doctor on 9/13/21 and was referred to cardiologist on 9/16/21. Dr. prescribed fludrocortisone to assist with stabilizing heart rate and blood pressure.
Hypoxia; cardiac arrest; This is a spontaneous report from a contactable physician. A 67-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via intramuscular route of administration on 03Apr2021 at 15:15 (at the age of 67 years) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Mar2021 (at the age of 67 years) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 05Apr2021, the patient experienced hypoxia and subsequent cardiac arrest. The events resulted in Emergency room/department or urgent care and hospitalization. The events were considered life threatening. Therapeutic measures were taken as a result of the events which included CPR and intubation.  It was unknown if patient has been tested for COVID-19. The outcome of the events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events hypoxia and cardiac arrest cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
I developed a rash on first my chest, then both arms,under both breasts, both underarms, backs of both hands, then my neck.
I don?t know if it is related. My Sarcoidosis had shown only a small change during the 3.5 years it had been monitored before being confirmed in January of 2020. The CT scan done in July of 2020 showed no change. In October 2021, I was late getting the scan by 3 months, it showed an increase in size from under 1cm to over 3cm in the left lung and a new nodule under 1cm in the right lung. The doctor then started a regimen of Prednisone to suppress my immune system and stop the nodule/granulomas growth.
redness, itching on day of inj area is red, raised, & warm to touch;
Started with left arm swelling and pain, T=102 and "all over body itching with a rash/hives" and very nauseated. Had someone else drive her that day=unable to drive her own motorcycle.
Woke up with entire left thigh (where vaccine was injected) completely swollen, red, and hot to the touch. Patient was limping when walking. He was very lethargic all day as well as overly fussy. Two days later, he is still having the same symptoms.
I missed my 2nd dose because I had pneumonia and was in the hospital; I am overdue for my 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (I missed my 2nd dose because I had pneumonia and was in the hospital) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included TRAZODONE and VITAMINS NOS for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PNEUMONIA (I missed my 2nd dose because I had pneumonia and was in the hospital) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (I am overdue for my 2nd dose). The patient was hospitalized from 30-Mar-2021 to 05-Apr-2021 due to PNEUMONIA. At the time of the report, PNEUMONIA (I missed my 2nd dose because I had pneumonia and was in the hospital) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (I am overdue for my 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment mediaction provided included Cefuroxime for Pneumonia.  Very limited information regarding these events have been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time.  Further information has been requested.
extreme swelling in both hands, swelling is extremely bad; extreme pain in both hands; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (extreme swelling in both hands, swelling is extremely bad) and PAIN IN EXTREMITY (extreme pain in both hands) in a 73-year-old male patient 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, the patient experienced PERIPHERAL SWELLING (extreme swelling in both hands, swelling is extremely bad) and PAIN IN EXTREMITY (extreme pain in both hands). At the time of the report, PERIPHERAL SWELLING (extreme swelling in both hands, swelling is extremely bad) and PAIN IN EXTREMITY (extreme pain in both hands) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.  A patient called in to report that after receiving the 2nd dose of the Moderna COVID 19 Vaccine he experienced severe swelling and pain in both of his hands. The swelling is extremely bad to the point where he is not able to use his arms. Patient received the 2nd dose the end of February. Additionally, after receiving the 1st dose he completely lost control of his bladder and urinated on himself daily for about 2 1/2 days.   This case was linked to MOD-2021-181925 (Patient Link).
Believed to be pericarditis; Believed to be inflammation of/around the heart, as evidenced with pain in chest similar to when I was sick with Covid-19 in 2020.; Believed to be inflammation of/around the heart, as evidenced with pain in chest similar to when I was sick with Covid-19 in 2020.; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 35-year-old male patient received first dose of BNT162B2 (PFIZER/BIONTECH Covid-19 Vaccine, Solution for Injection, Batch/Lot number: Ew0178), via an unspecified route in the left arm on 09Jun2021 at 16:30 (age at vaccination: 35-year-old), as a dose 1, single for covid-19 immunization. Patient medical history included covid-19 in 2020. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 15Jun2021, patient experienced inflammation of/around the heart, as evidenced with pain in chest similar to when he was sick with Covid-19 in 2020. Believed to be pericarditis, as diagnosed before. Patient did not receive any treatment for the events. The patient underwent lab test and procedure which included SARS-CoV-2 test positive in 2020. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Moderate difficulty breathing for about 36 hours, relieved somewhat by Albuterol Inhaler.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected immunological vaccine failure and reported no antibodies in recent COVID-19 antibody test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was associated with product complaint number: 90000182923. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210632871- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected Immunological Vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Patient was to receive the Bivalent COVID 12 years and up instead received Monovalent COVID 12 years and up in error.
After receiving shot in AM of 4-7-09 pt c/o shortness of breath in the afternoon at home with mother - *Nurse informed mom to watch patient closely for x24 hrs. ER in rescue if needed. Our f/u call next AM 4-8-09 pt fine now.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 15-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 360 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Pt experienced no Adverse reactions. Only concern was that pt had been given the Covid-19 Moderna Vaccine 8 days after pts Tdap.
Pt felt light headed and warm several minutes after the vaccine. She has passed out with blood draws in the past and says her symptoms now are similar to previous episodes. Transported to med obs at 1500.  Pt given water and crackers and almost immediately feels better. Pt released to home by self via public transportation at 1522. Vitals as follows: 1500 BP 135/91 HR 85 SPO2 98 1505 BP 125/80 HR 91 SPO2 98 1510 BP 125/80 HR 82 SPO2 99 1515 SITTING BP 125/84 HR 85 SPO2 100 1520 STANDING BP 150/88, 124/79 HR 93 SPO2 100
pt states that she wasnt feeling like herself and having heart palpitations.  The next day she felt fine.   4/2/2021 she was very tired and slept 10 hours and 56 minutes which is very unusual for her.   4/5/2021 she was having trouble swallowing and is still feeling tired so slept 14 hours and 55 minutes.   Every day she is sleeping more than usual and is very fatigued.  Pt is waiting on a CB from her Psychiatrist and PCP and or go to UC .
Red, swollen area around site of injection. About 1 and 1/2 inches diameter. Patient did not notice until 8 days after the vaccination date. Patient did not report pain or raised skin.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 08-JUN-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
general ache in body particularly in knees and feet, tired, felt like I was getting the flu
Severe headache; This is a spontaneous report from a contactable other hcp. A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6203) intramuscular, administered in Arm Left on 05Mar2021 15:15 as DOSE 1, SINGLE (at the age of 31-year-old) for covid-19 immunisation. Patient received bnt162b2, Batch/Lot number: ER8734, intramuscularly on 19Apr2021 06:30 PM as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism, PCOS, polycystic ovaries, drug hypersensitivity (known allergies: Sulfa antibiotics). Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); metformin (METFORMIN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, on 05Mar2021 at 15:45 30 minutes after initial injection patient experienced severe headache that lasted about 12 hours. Therapeutic measures were taken as a result of severe headache. AE resulted in doctor or other healthcare professional office/clinic visit. AE treatment informed to take NSAIDs to help with total body discomfort. The outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
18yo M pt was nervous for vaccine, got vaccine, walked over to waiting area, sat for 5 minutes before passing out and falling out of chair onto floor, dad yelled for help by the time I got over there he was coming to, sat on the floor was slightly hyperventilating, gave him water, complained about not being able to feel his hands, was white as a ghost, paramedics were already at store for a separate incident, came over, took his vitals, offered him a ride to hospital but didnt think it was needed, pt left with his father