chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It's like my heart was going to rip of my chest, so I get closed off down, it said my heart rate was 125/Whenever I move around, walk in around my heart rate jumps up, it were 130,125,113; I get shortness of breath and get out breath, when I start walk; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 (Lot number: EW0176) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bulging Disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEART RATE INCREASED (non-serious) with onset 31Jul2021, outcome "unknown", described as "It's like my heart was going to rip of my chest, so I get closed off down, it said my heart rate was 125/Whenever I move around, walk in around my heart rate jumps up, it were 130,125,113"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "I get shortness of breath and get out breath, when I start walk"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache". The events "it's like my heart was going to rip of my chest, so i get closed off down, it said my heart rate was 125/whenever i move around, walk in around my heart rate jumps up, it were 130,125,113", "i get shortness of breath and get out breath, when i start walk" and "headache" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased.  Additional Information: Prior vaccination within 4 weeks was reported as none and they give D10 or something to make sure the patient didn't have any clot.  No follow-up attempts are possible. No further information is expected.
Mild pain at site following injection. On 9/14/08 noticed rash on left arm deltoid area. No pain or itching. Appears today as small red raised bumps in 2inch circular pattern on left deltoid area.
Information has been received from a physician concerning a 4 month old male patient who in approximately 06-DEC-2008, was vaccinated with second dose of ROTATEQ (Lot # not reported) 2ml, orally.  After he received the second dose of vaccine, he experienced a fever 103 degrees.  The patient recovered within 24 hours.  Patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/13/2009.  Information has been received from a physician concerning a 4 month old male patient who in approximately 06-DEC-2008, was vaccinated with second dose of ROTATEQ (Lot # not reported) 2ml, orally.  After he received the second dose of vaccine, he experienced a fever 103 degrees.  The patient recovered within 24 hours.  Patient sought unspecified medical attention.  Follow up information has been received from medical assistant who reported that on 07-NOV-2008 the patient was vaccinated with a first dose of ROTATEQ (Lot # 661427/0897X) orally at 11:00 AM.  On 16-JAN-2009 he received second dose of ROTATEQ (Lot # 663260/1794X) orally at 11:00 AM.  On 08-NOV-2008 next day post vaccination the patient experienced fever to 103 degrees during 24 hours and multiple lost stools and vomiting fourth times during 24 to 48 hours.  No other family members were diagnosed and child wasn't in day care setting or exposed to any their people.  No further information is expected.
The diluent used to mix the pediatric covid-19 bivalent vaccine was sterile water (Lot# W009643 Exp 11/14/24) rather than sodium chloride 0.9%. Mom was called after discovery, however it went to voicemail, left message for her to call us back. Spoke with a pharmacist at pfizer on how to provide. Per pharmacist, pfizer has no recommendations as to count that dose as valid or invalid. However, per Organization it is recommended either to repeat dose immediately or wait another 8 weeks prior to redoing the dose due to myocarditis. We are still waiting on mom to call back in terms of how she would like to proceed.
06/05/02, pt was taken to Urgent care, right leg was swollen was given Benadryl and placed ice on area. On 06/06/02, pt in office with moter and sibling had 9 x 10 1/2cm reddened area surrounding a 9x5cm pink/white area c/o itching and tender to touch no fever. 06/10/02 mother states daughter OK.
temperature excursion for 1.7C for 30 minutes of Ipol and administered to 3 patients after the excursion; Initial information received on 23-May-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center  This case is linked to case 2022SA192719 and 2022SA192724.   This case involves a 7 years old female patient who experienced temperature excursion for 1.7c for 30 minutes of ipol and administered to 3 patients after the excursion while receiving vaccine IPV (VERO) [IPOL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis a vaccine (HEPATITIS A), hepatitis b vaccine (HEPATITIS B [HEPATITIS B VACCINE]) and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) for Immunisation.  On 09-May-2022, the patient received 0.5 ml of suspect ipv (vero) lot T1E871M via intramuscular route in the left deltoid (formulation unknown, strength: standard and expiry date: 10-Oct-2022) for immunization.  On 09-May-2022 the patient experienced non-serious event temperature excursion for 1.7c for 30 minutes of ipol and administered to 3 patients after the excursion (poor quality product administered) (latency same day) following the administration of ipv (vero).  Action taken:was not applicable.  At time of reporting, the outcome was Unknown for the event temperature excursion for 1.7c for 30 minutes of ipol and administered to 3 patients after the excursion.  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 the guidelines. 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.
Patient received MENACTRA and TDaP vaccines. Within 20 minutes developed symptoms of anaphylaxis i.e. throat closing, tongue swollen, difficulty swallowing, breathing and received Epinephrine 0-3 mg IM.
Information has been received from a nurse referring to unspecified patients of unknown gender and age. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On 14-AUG-2017, 1 unspecified patient was vaccinated with improperly stored PROQUAD (Lot# N004631, expiration date 07-AUG-2018, strength, dose, and route unknown) for prophylaxis, the diluent (manufacturer unknown) used to reconstitute the vaccine above was properly stored. The vaccine was stored at 6 to 14 degrees Fahrenheit for 15 hours and 45 minutes. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-708USA007019: US-009507513-1709USA009152: US-009507513-1709USA009150: US-009507513-1709USA009151: US-009507513-1708USA008578: US-009507513-1709USA007605: US-009507513-1709USA007604: US-009507513-1709USA007603: US-009507513-1709USA007602: US-009507513-1709USA007601.
on 3/24 I had a TIA with an intense heat pressure behind the right temple which resulted in complete numbness, heaviness, and tingling on my entire right side of the my body.  I was transported by ambulance to the hospital. A CT and MRI was done, no signs of blood clots or stroke.  I am still experiencing numbness and tingling in the right arm. Follow up appointments with the eye doctor indicate additional vision loss in the right eye with pressure behind the eye. I have a follow up appointment today with the neurologist for a brain scan and tomorrow for an eeg. My PCP, eye doctor, and neurologist believe it may be a blood flow issue. I have not had this type of event before.
Patient c/o throat constriction w/ soreness, increased anxiety. Oxygen and oral hydration were admin w/o c/o. Patient tolerated well.
Not sure if it's attributed to the vaccine but I want to report it. 7 months after vaccine, I developed a pink eye. It was so severe and painful I went to my PCP and was then referred to an Ophthalmologist. He had given me eye drops. It seemed to help briefly, but then it came back even stronger and this time it was on my face and hands as well. I was sent to a Dermatologist and was told that it seemed like a strong Allergic Reaction possibly stemming from the vaccine. The doctor said a lot of people have experienced this. He gave me a topical ointment and Prednisone. It seemed to keep it at bay for a while, then it returned about a month later and I was given Ketoconazole. It seemed to help but reactions still came back a couple of months later. It's still affecting the top of my hands and left eye.
About 24 hours after I started to get lightheaded and dizzy. This continued for 3 weeks. I saw my primary care and talked to my neurologist. I am still getting lightheaded and dizzy for bouts daily. I have have never had this before
not felt good; This case was reported by a consumer via other manufacturer and described the occurrence of malaise in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On 16th September 2020, the patient received Influenza vaccine Quadrivalent unspecified season. On 17th September 2020, 1 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient received Flu vaccine and had malaise. The reporter mentioned that it might related to flu shot.
Has slightly raised, pink itchy area about 4 cm x 6 cm since given vax 12/12/2016. No improvement over last 5 weeks. (L) deltoid.
On about 4/14/2021 I noticed what initially looked like a bug bite on my left hip. I came to the conclusion it is a case of Shingles. I additionally broke out with a Herpes 2 outbreak on 4/19/2020. I have had Herpes Simplex Virus 2 since November 2017. However, this is the first case of Shingles I have ever had.
No adverse side effects reported by Mother. Was given Tdap vaccine instead of DTaP vaccine by mistake.
The evening after the shot patient's right arm became swollen and red. Patient applied ice and it got bigger in size. The next day it was hard, warm to the touch and the size of a fist in surface area. Nurse at clinic recommended Ibuprofen and BENADRYL and swelling has gone down.
feeling severe arm soreness; headache; very fatigued; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (feeling severe arm soreness), HEADACHE (headache) and FATIGUE (very fatigued) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced VACCINATION SITE PAIN (feeling severe arm soreness), HEADACHE (headache) and FATIGUE (very fatigued). At the time of the report, VACCINATION SITE PAIN (feeling severe arm soreness), HEADACHE (headache) and FATIGUE (very fatigued) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINATION SITE PAIN (feeling severe arm soreness), HEADACHE (headache) and FATIGUE (very fatigued) to be possibly related.    No concomitant medication details was reported. No treatment medication details was reported.  This spontaneous case concerns a patient, of unknown age and unknown gender, with no relevant medical history, who experienced the unexpected, non-serious event of pain in extremity with other associated expected, non-serious events. The events occurred 1 day after administration of the third dose of the Moderna mRNA-1273. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a patient, of unknown age and unknown gender, with no relevant medical history, who experienced the unexpected, non-serious event of pain in extremity with other associated expected, non-serious events. The events occurred 1 day after administration of the third dose of the Moderna mRNA-1273. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.
Rt thigh area red and indurated with 3-4cm area affected, within 24 hour, post vax.
A report has been received from a Pharmacist concerning a 53 year old, Female subject, who had been receiving FLUMIST. FLUMIST started on 10-Sep-2013. It was reported they inadvertently administered FLUMIST to a patient over 49 on 10-Sep-2013. The outcome of the event of inadvertently administered FLUMIST to a patient over 49 is unknown. The report was considered to be non-serious.
Patient received FLUVIRIN and ZOSTAVAX on 8-29-13. The following few days she felt under the weather with worsening symptoms on Sunday 9-1-13. She suffered a seizure and was treated at medical center by Dr. She was sent home on KEPPRA with orders to follow up later this week.
mild case of shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated that he/she just got over a mild case of shingles and it was painful too. The patient would get another dose in 3 months. The follow-up would not possible as no contact details were available.
This spontaneous report was received from a physician refers to a patient of unknown age (gender unspecified). On 14-SEP-2012, the patient was vaccinated with dose 1 ROTATEQ (Lot# and route not reported). No concomitant medications were reported. On 28-SEP-2012, the patient was vaccinated with second dose of ROTATEQ (Lot# and route not reported). No adverse symptoms were reported. Additional information has been requested.
pt c/o severe h/a about 30 min p/vax administered; advised to see MD concerning sx; t106 as stated by mom; took APAP & Ibuporfen; pt was listless 2nd day but recovered 3rd day;
Headache, Myalgia, Fever, HYPERtension & Tachycardia Narrative:
post inj & laying on it that noc for past 3-4 days has really hurt-can't lift arm-hurts to drive-went to MD;fluid built up muscle or it looks like it;
rash on left arm which was itchy, red and warm; troubles with memory; This is a spontaneous report was received from a contactable consumer or other non hcp. Follow up (24Feb2021) received from a contactable consumer was processed together with initial information.   An 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in right arm on 22Feb2021 as 2nd dose, single for covid-19 immunisation. The patient's medical history included high blood pressure. Concomitant medications included metoprolol, amiodon and hydralazine all used for high blood pressure and dates were unspecified. On 27Jan2021, the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number- EL9262) first dose, single for covid-19 immunisation. On 23Feb2021, next day of vaccination the patient developed rash on left arm (the opposite arm from where she got the vaccine) states it itches, and it was red and a little warm. It was reported that the patient applied some hydrocortisone. She also had troubles with her memory. The patient had not recovered from the rash on left arm and the outcome of the event troubles with memory was unknown.   No follow-up attempts are possible. No further information is expected.
Patient had pain after vaccination. Pain spread to elbow and hand. Patient went to Dr office and receive a steroid shot.
ringing in ears approx 2hrs p/vax;subsequently had episode inc x 1 w/t103, chills-progressive swelling beginning distal to inj site;tx Topicort, Atarax, & Duricef
hospitalized with extensive bilateral pulmonary emboli and right leg deep vein thrombosis after 1st vaccine dose.  Required high-flow nasal canula for oxygen support.  ultimately discharged on hospice
Upraised lesions/chickenpox lesions/blisters in a cluster at the vaccination site (approx 4 cm in diameter) with surrounding cellulitis which extends from upper deltoid to above the elbow - warm, tender, painful with localized induration.
I had a sore arm, fatigue and achy for four days after the vaccine. I tested positive for COVID-19 on 09/11/2022 with a home test. I contacted my doctor via the patient portal and was prescribed PAXLOVID and prednisone. I had fever, chills, fatigue and body aches. I tested positive for 15 days.
Patient received 2 Pfizer vaccines previously but did not disclose that to pharmacy staff and was given one dose of Moderna COVID vaccine
Swelling that night and now its down past the crease of my elbow and spread down under the inside of my arm / It is still spreading; Getting red that night and now its down past the crease of my elbow and spread down under the inside of my arm/ It is still spreading; It is still hot; Didn't feel good; Headache; Diarrhea; Fatigue; Felt like throwing up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling that night and now its down past the crease of my elbow and spread down under the inside of my arm / It is still spreading), ERYTHEMA (Getting red that night and now its down past the crease of my elbow and spread down under the inside of my arm/ It is still spreading), FEELING HOT (It is still hot), FEELING ABNORMAL (Didn't feel good) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling that night and now its down past the crease of my elbow and spread down under the inside of my arm / It is still spreading), ERYTHEMA (Getting red that night and now its down past the crease of my elbow and spread down under the inside of my arm/ It is still spreading), FEELING HOT (It is still hot), FEELING ABNORMAL (Didn't feel good), HEADACHE (Headache), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and NAUSEA (Felt like throwing up). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING (Swelling that night and now its down past the crease of my elbow and spread down under the inside of my arm / It is still spreading), ERYTHEMA (Getting red that night and now its down past the crease of my elbow and spread down under the inside of my arm/ It is still spreading) and FEELING HOT (It is still hot) had not resolved and FEELING ABNORMAL (Didn't feel good), HEADACHE (Headache), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and NAUSEA (Felt like throwing up) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information included Allergy pill and ice.
Information has been received from a nurse practitioner referring to a 24 year old female patient. The patient had no pertinent medical history and no drug allergies. On 28-JAN-2015 the patient was vaccinated with a dose of VARIVAX (Merck) injection (dose, route and lot number were not reported). Other suspect therapies included a dose of M-M-R II (dose, route and lot number were not reported) on the same date. There was no concomitant therapy. Subsequently the patient was determined to be pregnant with last menstrual period (LMP) of 29-JAN-2015 and estimated date of delivery (EDD) of 05-NOV-2015. A home pregnancy test performed on an unknown date in 2015 was positive and then a prenatal ultrasound in the office confirmed the pregnancy. No problems reported. It was reported that no treatment was given to the patient. At the time of this report, the patient had a gestation of 4 weeks. The pregnancy outcome was unknown. Additional information is not expected since the reporter is not allowed to be contacted.
pt recv vax 1OCT97 & 15OCT97 pt devel no more than 10 spots all around trunk;two are pustules, two on face, 5-6 on trunk;
21OCT92 arches are sore on both feet, rt hip is painful; no elevated temp didn't see MD;
Patient presented to the primary care office on April 16, 2021 with veslcular rash and low grade fever for 3 days prior to office visit.  Patient was also seen at the walk-in on the 4-15-2021 and was advised to follow with primary care provider  Discussion with regulatory authority- viral culture sent Patient's mom to notify her OB as she is currently pregnant Mupiricin ointment prescribed
shivering; having a low grade fever; a bit tired; stiffness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (shivering), PYREXIA (having a low grade fever), FATIGUE (a bit tired) and INJECTION SITE MOVEMENT IMPAIRMENT (stiffness at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 14-Jan-2021, the patient experienced INJECTION SITE MOVEMENT IMPAIRMENT (stiffness at the injection site). On 19-Jan-2021, the patient experienced CHILLS (shivering), PYREXIA (having a low grade fever) and FATIGUE (a bit tired). At the time of the report, CHILLS (shivering), PYREXIA (having a low grade fever), FATIGUE (a bit tired) and INJECTION SITE MOVEMENT IMPAIRMENT (stiffness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: 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.